Trial Outcomes & Findings for Dose Escalation Study of GSK2820151 in Subjects With Advanced or Recurrent Solid Tumors (NCT NCT02630251)

NCT ID: NCT02630251

Last Updated: 2020-02-12

Results Overview

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 5 participants
• Primary outcome timeframe: 2 years 8 months
• Results posted on: 2020-02-12

Participant Flow

This was a single-agent open-label dose escalation study to determine the Maximum tolerated dose (MTD)

The study was terminated due to development of another bromodomain and extra-terminal(BET) Inhibitor with a better understanding of the risk benefit profile.

Participant milestones

Measure	GSK2820151 3 mg Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Overall Study STARTED	2	1	1	1
Overall Study COMPLETED	2	1	0	1
Overall Study NOT COMPLETED	0	0	1	0

Reasons for withdrawal

Measure	GSK2820151 3 mg Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Overall Study Physician Decision	0	0	1	0

Baseline Characteristics

Dose Escalation Study of GSK2820151 in Subjects With Advanced or Recurrent Solid Tumors

Baseline characteristics by cohort

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized White/Caucasian/European Heritage	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants

PRIMARY outcome

Timeframe: 2 years 8 months

Population: All Treated Population included all participants who received at least one dose of GSK2820151.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	2 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	2 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 2 years 8 months

Population: All Treated Population

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Number of Participants With Dose Delays and Reduction	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 2 years 8 months

Population: All Treated Population

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Withdrawals due to toxicities were evaluated.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Number of Participants Withdrawn Due to Toxicities	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 2 years 8 months

Population: All Treated Population

Blood samples were collected at indicated time-points for the analysis of clinical chemistry parameters like total and direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total protein, albumin, sodium, potassium, calcium, blood urea nitrogen (BUN), creatinine, chloride, fasting glucose, ionized calcium, gamma-glutamyltransferase, total carbon dioxide , uric acid, and magnesium.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Number of Participants With Clinically Significant Abnormalities for Clinical Chemistry Parameters	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 2 years 8 months

Population: All Treated Population

Blood samples were collected at indicated time-points for the analysis of hematology parameters like hemoglobin (HGB), platelet count, red blood cell (RBC) count, white blood cell (WBC) count, neutrophils, lymphocytes, monocytes, eosinophils, and basophils.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Number of Participants With Clinically Significant Abnormalities for Hematology Parameters	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 2 years 8 months

Population: All Treated Population

Urine samples were collected at indicated time-points for the analysis of urinalysis parameters like potential of hydrogen (pH), microscopic examination, specific gravity, ketones, protein, glucose, and blood.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Number of Participants With Clinically Significant Abnormalities for Urinalysis Parameters	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 2 years 8 months

Population: All Treated Population

Blood samples were collected at indicated time-points for the analysis of gastrointestinal parameters like cytokines and C-peptide.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Number of Participants With Clinically Significant Abnormalities for Gastrointestinal Parameters	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 2 years 8 months

Population: All Treated Population

Vital signs included systolic blood pressure and diastolic blood pressure, heart rate, and temperature.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Number of Participants With Clinically Significant Abnormalities for Vital Signs Parameters	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 2 years 8 months

Population: All Treated Population

Triple 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT and corrected QT using Fridericia's formula (QTcF) intervals.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Number of Participants With Clinically Significant Abnormalities for Electrocardiogram (ECG)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 4 weeks

Population: All Treated Population

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. DLTs included Grade 4 neutropenia, Febrile neutropenia, Grade 4 anemia, Grade 3 thrombocytopenia, Alanine aminotransferase (ALT) >3 times upper limit of normal (ULN) plus bilirubin >=2 times ULN (>35 percent direct) or ALT between 3-5 times ULN with bilirubin < 2 times ULN but with hepatitis symptoms or rash, Grade 3 nausea, vomiting or diarrhea, Grade 3 hypertension, Grade 4 hypertension, Grade 3 or greater clinically significant non-hematologic toxicity, Grade 2 troponin B elevation were considered as DLT.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Number of Participants With Dose-limiting Toxicities (DLT)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and up to 2 years 8 months

Population: All Treated Population

Changes in cardiac parameters like QTc, PR Interval, QRS duration, and QT interval were assessed. Baseline is defined as the most recent, non-missing value prior to or on the first study treatment dose date for GSK2820151. Change from baseline was calculated as visit value minus Baseline value.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Changes in Cardiac Safety Including Corrected QT Interval (QTc)	-5.33 Milliseconds Standard Deviation 17.272	-9.25 Milliseconds Standard Deviation 13.849	4.91 Milliseconds Standard Deviation 11.274	-24.95 Milliseconds Standard Deviation 10.400

SECONDARY outcome

Timeframe: Baseline and up to 2 years 8 months

Population: All Treated Population

Change in heart rate was assessed. Baseline is defined as the most recent, non-missing value prior to or on the first study treatment dose date for GSK2820151. Change from baseline was calculated as visit value minus Baseline value.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Changes in Cardiac Safety Including Heart Rate	-0.44 Beats per minute Standard Deviation 7.719	11.51 Beats per minute Standard Deviation 8.072	3.41 Beats per minute Standard Deviation 5.929	2.03 Beats per minute Standard Deviation 4.609

SECONDARY outcome

Timeframe: 2 years 8 months

Population: All Treated Population

The ORR is defined as the percentage of participants with a confirmed complete response (CR) or a partial response (PR) at any time as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Overall Response Rate (ORR)	0 Percentage of participants	0 Percentage of participants	100 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: 2 years 8 months

Population: All Treated Population

PFS is defined as the interval of time (in weeks) between the start date of treatment and the earlier of the date of disease progression and the date of death due to any cause. PFS was censored at the last adequate assessment where visit level response is CR, PR, or stable disease.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Progression Free Survival (PFS) Participant 1	5.3 Weeks	0 Weeks	0 Weeks	0 Weeks
Progression Free Survival (PFS) Participant 2	9.9 Weeks	0 Weeks	0 Weeks	0 Weeks
Progression Free Survival (PFS) Participant 3	0 Weeks	8.4 Weeks	0 Weeks	0 Weeks
Progression Free Survival (PFS) Participant 4	0 Weeks	0 Weeks	72.1 Weeks	0 Weeks
Progression Free Survival (PFS) Participant 5	0 Weeks	0 Weeks	0 Weeks	8.1 Weeks

SECONDARY outcome

Timeframe: 2 years 8 months

Population: PK Population. Data was not collected for this endpoint as the study was terminated.

Blood samples were planned to be collected for analysis of protein PD biomarkers like cytokines and acute phase proteins.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years 8 months

Population: PK Population. Data was not collected for this endpoint as the study was terminated.

Blood samples were planned to be collected for analysis of mRNA.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)

Population: PK Population

Blood samples were collected at indicated timepoints for analysis of Cmax. The average Standard Deviation (SD) for each participant was calculated over indicated time points Week 1, Day 1and Week 3, Day 4. Pharmacokinetic (PK) parameters were conducted by non-compartmental methods using Phoenix WinNonlin. PK Population consisted of all subjects from the All Treated Population for whom a PK sample is obtained and analyzed

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Maximum Observed Concentration (Cmax) of GSK2820151	31.78 Nanograms per milliliter Standard Deviation 9.599	35.08 Nanograms per milliliter Standard Deviation 1.061	36.17 Nanograms per milliliter Standard Deviation 8.237	148.11 Nanograms per milliliter Standard Deviation 14.595

SECONDARY outcome

Timeframe: Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)

Population: PK Population

Blood samples were collected at indicated timepoints for analysis of Tmax. PK parameters were conducted by non-compartmental methods using Phoenix WinNonlin.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Time to Cmax (Tmax) of GSK2820151	1.50 Hours Interval 1.0 to 2.0	2.50 Hours Interval 1.0 to 4.0	1.00 Hours Interval 1.0 to 2.0	0.75 Hours Interval 0.5 to 1.0

SECONDARY outcome

Timeframe: Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)

Population: PK Population

Blood samples were collected at indicated time-points for analysis of AUC(0-t). The average SD for each participant was calculated over indicated time points Week 1, Day 1and Week 3, Day 4. PK parameters were conducted by non-compartmental methods using Phoenix WinNonlin

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Area Under the Plasma Concentration-time Curve From Zero to Time (AUC[0-t]) of GSK2820151	356.10 Hours* nanogram per milliliter Standard Deviation 237.739	392.17 Hours* nanogram per milliliter Standard Deviation 54.801	211.84 Hours* nanogram per milliliter Standard Deviation 16.349	958.35 Hours* nanogram per milliliter Standard Deviation 92.900

SECONDARY outcome

Timeframe: Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)

Population: PK Population

Blood samples were collected at indicated timepoints for analysis of AUC(0-inf). The average SD for each participant was calculated over indicated time points Week 1, Day 1and Week 3, Day 4. PK parameters was conducted by non-compartmental methods using Phoenix WinNonlin.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC[0-inf])	488.40 Hours* nanogram per milliliter Standard Deviation 381.276	479.12 Hours* nanogram per milliliter Standard Deviation 127.755	216.65 Hours* nanogram per milliliter Standard Deviation 18.215	1107.74 Hours* nanogram per milliliter Standard Deviation 147.297

SECONDARY outcome

Timeframe: Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)

Population: PK Population

Blood samples were collected at indicated time-points for analysis of AUC(0-tau). The average SD for each participant was calculated over indicated time points Week 1, Day 1and Week 3, Day 4. PK parameters were conducted by non-compartmental methods using Phoenix WinNonlin.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Area Under the Plasma Concentration-time Curve From Zero to Tau (AUC[0-tau]) of GSK2820151	328.55 Hours* nanogram per milliliter Standard Deviation 209.993	377.60 Hours* nanogram per milliliter Standard Deviation 75.413	210.32 Hours* nanogram per milliliter Standard Deviation 16.761	918.11 Hours* nanogram per milliliter Standard Deviation 149.815

SECONDARY outcome

Timeframe: Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)

Population: PK Population

Blood samples were collected at indicated time-points for analysis of t1/2. The average SD for each participant was calculated over indicated time points Week 1, Day 1and Week 3, Day 4. PK parameters were conducted by non-compartmental methods using Phoenix WinNonlin.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Apparent Terminal Phase Half-life (t1/2) of GSK2820151	11.66 Hours Standard Deviation 6.300	10.91 Hours Standard Deviation 1.153	4.77 Hours Standard Deviation 0.336	10.14 Hours Standard Deviation 1.379

SECONDARY outcome

Timeframe: Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)

Population: PK Population

Blood samples were collected at indicated timepoints for analysis of Ctau. The average SD for each participant was calculated over indicated time points Week 1, Day 1and Week 3, Day 4. PK parameters were conducted by non-compartmental methods using Phoenix WinNonlin.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Trough Concentration (Ctau) of GSK2820151	7.02 Nanograms per milliliter Standard Deviation 6.674	6.04 Nanograms per milliliter Standard Deviation 2.871	0.91 Nanograms per milliliter Standard Deviation 0.276	12.77 Nanograms per milliliter Standard Deviation 2.036

SECONDARY outcome

Timeframe: Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)

Population: PK Population

Blood samples were collected at indicated timepoints for analysis of Ro. Ro was calculated as the ratio of AUC(0-tau) on Week 3 Day 4 divided by AUC(0-tau) on Week 1 Day 1. The ratio was calculated from AUC(0-tau) on Week 3 Day 4 and AUC(0-tau) on Week 1 Day 1 parameters for each participant.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Accumulation Ratio (Ro) of GSK2820151	1.17 Ratio Standard Deviation 0.999	1.33 Ratio Standard Deviation NA Standard deviation could not be derived as a single participant was analyzed	0.95 Ratio Standard Deviation NA Standard deviation could not be derived as a single participant was analyzed	1.26 Ratio Standard Deviation NA Standard deviation could not be derived as a single participant was analyzed

SECONDARY outcome

Timeframe: Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)

Population: PK Population.

Blood samples were collected at indicated timepoints for analysis of time invariance. Time invariance was calculated as the ratio of AUC(0-tau) on Week 3 Day 4 divided by AUC(0-inf) on Week 1 Day 1. The ratio for SD was calculated from AUC(0-tau) on Week 3 Day 4 and AUC(0-inf) on Week 1 Day 1 parameters for each participant.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Time Invariance of GSK2820151	0.87 Ratio Standard Deviation 0.366	1.10 Ratio Standard Deviation NA Standard deviation could not be derived as a single participant was analyzed	0.92 Ratio Standard Deviation NA Standard deviation could not be derived as a single participant was analyzed	1.02 Ratio Standard Deviation NA Standard deviation could not be derived as a single participant was analyzed

SECONDARY outcome

Timeframe: Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)

Population: PK Population

Blood samples were collected at indicated timepoints for analysis of CL/F. The average SD for each participant was calculated over indicated time points Week 1, Day 1and Week 3, Day 4. PK parameters were conducted by non-compartmental methods using Phoenix WinNonlin.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Clearance (CL/F) of GSK2820151	11.29 Liters per hour Standard Deviation 8.910	12.96 Liters per hour Standard Deviation 3.373	66.92 Liters per hour Standard Deviation 15.339	18.21 Liters per hour Standard Deviation 2.425

SECONDARY outcome

Timeframe: Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)

Population: PK Population

Blood samples were collected at indicated timepoints for analysis of Vz/F. The average SD for each participant was calculated over indicated time points Week 1, Day 1and Week 3, Day 4. PK parameters were conducted by non-compartmental methods using Phoenix WinNonlin.

Outcome measures

Measure	GSK2820151 3 mg n=2 Participants Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 Participants Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Volume of Distribution (Vz/F) of GSK2820151	136.07 Liters Standard Deviation 63.572	201.07 Liters Standard Deviation 31.480	455.65 Liters Standard Deviation 72.602	268.91 Liters Standard Deviation 71.679

Adverse Events

GSK2820151 3 mg

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

GSK2820151 6 mg

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

GSK2820151 12 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

GSK2820151 20 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Measure	GSK2820151 3 mg n=2 participants at risk Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 participants at risk Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 participants at risk Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 participants at risk Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Gastrointestinal disorders Nausea	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Gastrointestinal disorders Vomiting	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Infections and infestations Urinary tract infection	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.

Other adverse events

Measure	GSK2820151 3 mg n=2 participants at risk Participants received GSK2820151 capsules at a dose of 3 milligram (mg) once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 3 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 6 mg n=1 participants at risk Participants received GSK2820151 capsules at a dose of 6 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 6 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 12 mg n=1 participants at risk Participants received GSK2820151 capsules at a dose of 12 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 12 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.	GSK2820151 20 mg n=1 participants at risk Participants received GSK2820151 capsules at a dose of 20 mg once daily on days 1, 3, 4 and 5 on Week 1, during Week 2 once daily on days 1, 2, 3, 4, and 5. Participants received GSK2820151 20 mg once daily from Week 3 onwards every 4 weeks, until the end of the treatment.
Gastrointestinal disorders Constipation	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Investigations Electrocardiogram QT prolonged	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Blood and lymphatic system disorders Lymphoedema	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Gastrointestinal disorders Abdominal pain	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Blood and lymphatic system disorders Anaemia	100.0% 2/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Gastrointestinal disorders Abdominal distension	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Musculoskeletal and connective tissue disorders Back pain	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Gastrointestinal disorders Nausea	0.00% 0/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	100.0% 2/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Gastrointestinal disorders Vomiting	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Gastrointestinal disorders Dehydration	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
General disorders Fatigue	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Blood and lymphatic system disorders Thrombocytopenia	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Metabolism and nutrition disorders Hypercalcaemia	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Vascular disorders Deep vein thrombosis	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Metabolism and nutrition disorders Hypoalbuminaemia	100.0% 2/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Investigations Brain natriuretic peptide increased	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Cardiac disorders Tachycardia	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Infections and infestations Urinary tract infection	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
General disorders Pyrexia	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
General disorders Oedema peripheral	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Respiratory, thoracic and mediastinal disorders Dyspnoea	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Investigations Urine abnormality	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Renal and urinary disorders Dysuria	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Renal and urinary disorders Urine odour abnormal	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Metabolism and nutrition disorders Hypokalaemia	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Investigations Blood creatinine increased	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Respiratory, thoracic and mediastinal disorders Painful respiration	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Gastrointestinal disorders Ascites	50.0% 1/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Blood and lymphatic system disorders Haemoglobin decreased	0.00% 0/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Investigations Lymphocyte count decreased	0.00% 0/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Injury, poisoning and procedural complications Hyperaesthesia	0.00% 0/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Investigations Aspartate aminotransferase increased	0.00% 0/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Renal and urinary disorders Flank pain	0.00% 0/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Investigations Transaminases increased	0.00% 0/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Nervous system disorders Dizziness	0.00% 0/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Cardiac disorders Dyspnoea exertional	0.00% 0/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Blood and lymphatic system disorders Hyperbilirubinaemia	0.00% 0/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Vascular disorders Orthostatic hypotension	0.00% 0/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
General disorders Malaise	0.00% 0/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Nervous system disorders Headache	0.00% 0/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/2 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	100.0% 1/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.	0.00% 0/1 • Non-serious AEs and SAEs were collected from the start of study treatment up to 2 years 8 months. Non-serious AEs and SAEs were reported for the All Treated Population which comprised of all participants who received at least 1 dose of GSK2820151.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

Results disclosure agreements

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

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