Trial Outcomes & Findings for Open-label Study to Evaluate the Safety, PK, and PD of MEK Inhibitor GSK1120212 in Subjects With Relapsed or Refractory Leukemias (NCT NCT00920140)

NCT ID: NCT00920140

Last Updated: 2014-04-02

Results Overview

An AE is any untoward medical occurrence in a participant (par.) or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 97 participants
• Primary outcome timeframe: From the start of the study drug until the final study visit (up to approximately 407 days)
• Results posted on: 2014-04-02

Participant Flow

This is a Phase I/II study. Phase I is a dose escalation phase in participants with relapsed or refractory leukaemias to identify the recommended dose of GSK1120212 for Phase II. Phase II further evaluates the safety and efficacy of the recommended dose.

Participant milestones

Measure	GSK1120212 < 2 mg OD Participants with relapsed or refractory leukemias received either GSK1120212 3 milligrams (mg) loading dose (LD) followed by 1 mg once daily (OD) (3/1 mg LD/OD), or 1 mg OD as a continuous dose.	GSK1120212 2 mg OD Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.	Cohort 1: AML/MDS With RAS Mutation Participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplasia (MDS) with rat sarcoma (RAS) mutation received GSK1120212 2 mg OD as a continuous dose.	Cohort 2: AML/MDS/CMML With RAS wt/Unknown Participants with relapsed or refractory AML or MDS or chronic myelomonocytic leukemia (CMML) with RAS wild type (wt) or unknown mutation received GSK1120212 2 mg OD as a continuous dose.	Cohort 3: CMML With RAS Mutation Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
Phase 1 (Dose Escalation) STARTED	5	9	0	0	0
Phase 1 (Dose Escalation) COMPLETED	0	0	0	0	0
Phase 1 (Dose Escalation) NOT COMPLETED	5	9	0	0	0
Phase 2 STARTED	0	0	50	22	11
Phase 2 COMPLETED	0	0	0	0	0
Phase 2 NOT COMPLETED	0	0	50	22	11

Reasons for withdrawal

Measure	GSK1120212 < 2 mg OD Participants with relapsed or refractory leukemias received either GSK1120212 3 milligrams (mg) loading dose (LD) followed by 1 mg once daily (OD) (3/1 mg LD/OD), or 1 mg OD as a continuous dose.	GSK1120212 2 mg OD Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.	Cohort 1: AML/MDS With RAS Mutation Participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplasia (MDS) with rat sarcoma (RAS) mutation received GSK1120212 2 mg OD as a continuous dose.	Cohort 2: AML/MDS/CMML With RAS wt/Unknown Participants with relapsed or refractory AML or MDS or chronic myelomonocytic leukemia (CMML) with RAS wild type (wt) or unknown mutation received GSK1120212 2 mg OD as a continuous dose.	Cohort 3: CMML With RAS Mutation Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
Phase 1 (Dose Escalation) Adverse Event	3	3	0	0	0
Phase 1 (Dose Escalation) Lack of Efficacy	2	4	0	0	0
Phase 1 (Dose Escalation) Withdrawal by Subject	0	2	0	0	0
Phase 2 Adverse Event	0	0	14	2	3
Phase 2 Lack of Efficacy	0	0	29	14	5
Phase 2 Lost to Follow-up	0	0	0	1	0
Phase 2 Physician Decision	0	0	3	3	2
Phase 2 Withdrawal by Subject	0	0	4	2	1

Baseline Characteristics

Open-label Study to Evaluate the Safety, PK, and PD of MEK Inhibitor GSK1120212 in Subjects With Relapsed or Refractory Leukemias

Baseline characteristics by cohort

Measure	GSK1120212 <2 mg OD n=5 Participants Participants with relapsed or refractory leukemias received either GSK1120212 3 milligrams (mg) loading dose (LD) followed by 1 mg once daily (OD) (3/1 mg LD/OD), or 1 mg OD as a continuous dose.	GSK1120212 2 mg OD n=9 Participants Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.	Cohort 1: AML/MDS With RAS Mutation n=50 Participants Participants with relapsed or refractory AML or MDS with RAS mutation received GSK1120212 2 mg OD as a continuous dose.	Cohort 2: AML/MDS/CMML With RAS wt/Unknown n=22 Participants Participants with relapsed or refractory AML or MDS or CMML with RAS wt or unknown mutation received GSK1120212 2 mg OD as a continuous dose.	Cohort 3: CMML With RAS Mutation n=11 Participants Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.	Total n=97 Participants Total of all reporting groups
Age, Continuous	70.4 Years STANDARD_DEVIATION 15.71 • n=5 Participants	60.2 Years STANDARD_DEVIATION 15.86 • n=7 Participants	65.6 Years STANDARD_DEVIATION 10.71 • n=5 Participants	59.6 Years STANDARD_DEVIATION 18.89 • n=4 Participants	67.7 Years STANDARD_DEVIATION 6.87 • n=21 Participants	64.2 Years STANDARD_DEVIATION 13.69 • n=10 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	22 Participants n=5 Participants	7 Participants n=4 Participants	6 Participants n=21 Participants	41 Participants n=10 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	7 Participants n=7 Participants	28 Participants n=5 Participants	15 Participants n=4 Participants	5 Participants n=21 Participants	56 Participants n=10 Participants
Race/Ethnicity, Customized African American/African Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	8 Participants n=10 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	4 Participants n=5 Participants	9 Participants n=7 Participants	40 Participants n=5 Participants	18 Participants n=4 Participants	9 Participants n=21 Participants	80 Participants n=10 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=10 Participants

PRIMARY outcome

Timeframe: From the start of the study drug until the final study visit (up to approximately 407 days)

Population: All Treated Population: all participants who received at least one dose of study medication. Safety data was evaluated based on this population. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed.

An AE is any untoward medical occurrence in a participant (par.) or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.

Outcome measures

Measure	GSK1120212 <2 mg OD n=6 Participants Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.	GSK1120212 2 mg OD n=91 Participants Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.	Cohort 3: CMML With RAS Mutation Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) by Dose Any AE	6 Participants	91 Participants	—
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) by Dose Any SAE	2 Participants	64 Participants	—

PRIMARY outcome

Timeframe: From the start of the study drug until the final study visit (up to approximately 407 days)

Population: All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed.

Hematology and clinical chemistry data were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 3.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Hematology tests where the toxicity grade is defined by NCI-CTCAE includes hemoglobin, international normalized ratio (INR), lymphocytes, total neutrophils, platelet count, and partial thromboplastin time (PTT). Participants with missing baseline grades were assumed to have a baseline grade of 0. Only those participants (par.) with laboratory values for worst-case on-therapy (defined as the worst shift that occurred at any time during the treatment period) are presented.

Outcome measures

Measure	GSK1120212 <2 mg OD n=6 Participants Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.	GSK1120212 2 mg OD n=91 Participants Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.	Cohort 3: CMML With RAS Mutation Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose Hemoglobin (Low), Grade 3, n=6, 91	3 Participants	28 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose Hemoglobin (Low), Grade 4, n=6, 91	0 Participants	7 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose INR (High), Grade 3, n=6, 75	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose INR (High), Grade 4, n=6, 75	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose Lymphocytes (Low), Grade 3, n=6, 90	0 Participants	12 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose Lymphocytes (Low), Grade 4, n=6, 90	0 Participants	7 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose Total Neutrophils (Low), Grade 3, n=6, 89	1 Participants	4 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose Total Neutrophils (Low), Grade 4, n=6, 89	1 Participants	21 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose Platelet count (Low), Grade 3, n=6, 91	0 Participants	5 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose Platelet count (Low), Grade 4, n=6, 91	1 Participants	28 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose PTT (High), Grade 3, n=5, 75	0 Participants	1 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose PTT (High), Grade 4, n=5, 75	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose White Blood Cell count (Low), Grade 3, n=6, 91	1 Participants	13 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose White Blood Cell count (Low), Grade 4, n=6, 91	0 Participants	15 Participants	—

PRIMARY outcome

Timeframe: From the start of the study drug until the final study visit (up to approximately 407 days)

Population: All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed.

Hematology and clinical chemistry data were summarized according to NCI-CTCAE grade, version 3.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Clinical chemistry tests where the toxicity grade is defined by NCI-CTCAE includes albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase (AST), total bilirubin, calcium, creatinine, glucose, bicarbonate, potassium, magnesium, sodium, and phosphorus. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. Only those participants (par.) with laboratory values for worst-case on-therapy are presented.

Outcome measures

Measure	GSK1120212 <2 mg OD n=6 Participants Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.	GSK1120212 2 mg OD n=91 Participants Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.	Cohort 3: CMML With RAS Mutation Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Albumin (Low), Grade 3, n=6, 90	0 Participants	9 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Albumin (Low), Grade 4, n=6, 90	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Alkaline Phosphatase (High), Grade 3, n=6, 89	0 Participants	2 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Alkaline Phosphatase (High), Grade 4, n=6, 89	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Alanine Amino Transferase (High), Grade 3, n=6, 89	0 Participants	6 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Alanine Amino Transferase (High), Grade 4, n=6, 89	0 Participants	1 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose AST (High), Grade 3, n=6, 86	0 Participants	5 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose AST (High), Grade 4, n=6, 86	0 Participants	2 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Total Bilirubin (High), Grade 3, n=6, 89	0 Participants	3 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Total Bilirubin (High), Grade 4, n=6, 89	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Calcium (hypercalcemia), Grade 3, n=6, 91	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Calcium (hypercalcemia), Grade 4, n=6, 91	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Calcium (hypocalcemia), Grade 3, n=6, 91	0 Participants	8 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Calcium (hypocalcemia), Grade 4, n=6, 91	0 Participants	2 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Creatinine (High), Grade 3, n=6, 91	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Creatinine (High), Grade 4, n=6, 91	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Glucose (hyperglycemia), Grade 3, n=6, 91	0 Participants	7 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Glucose (hyperglycemia), Grade 4, n=6, 91	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Glucose (hypoglycemia), Grade 3, n=6, 91	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Glucose (hypoglycemia), Grade 4, n=6, 91	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Bicarbonate (Low), Grade 3, n=5, 82	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Bicarbonate (Low), Grade 4, n=5, 82	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Potassium (hyperkalemia), Grade 3, n=6, 91	0 Participants	1 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Potassium (hyperkalemia), Grade 4, n=6, 91	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Potassium (hypokalemia), Grade 3, n=6, 91	0 Participants	7 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Potassium (hypokalemia), Grade 4, n=6, 91	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Magnesium (hypermagnesemia), Grade 3, n=6, 88	0 Participants	3 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Magnesium (hypermagnesemia), Grade 4, n=6, 88	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Magnesium (hypomagnesemia), Grade 3, n=6, 88	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Magnesium (hypomagnesemia), Grade 4, n=6, 88	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Sodium (hypernatremia), Grade 3, n=6, 91	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Sodium (hypernatremia), Grade 4, n=6, 91	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Sodium (hyponatremia), Grade 3, n=6, 91	2 Participants	9 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Sodium (hyponatremia), Grade 4, n=6, 91	0 Participants	0 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Phosphorus, Grade 3, n=6, 88	0 Participants	5 Participants	—
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose Phosphorus, Grade 4, n=6, 88	0 Participants	1 Participants	—

PRIMARY outcome

Timeframe: From the start of the study drug until the final study visit (up to approximately 407 days)

Population: All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed.

Change from Baseline in heart rate is categorized as decrease to <60 beats per minute (bpm), change to normal or no change, and increase to >100 bpm. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants are counted twice if the participant heart rate value decreased to <60 bpm and increased to >100 bpm post-baseline. Only those participants (par.) with heart rate values for worst-case on-therapy are presented.

Outcome measures

Measure	GSK1120212 <2 mg OD n=6 Participants Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.	GSK1120212 2 mg OD n=91 Participants Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.	Cohort 3: CMML With RAS Mutation Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
Number of Participants With a Change From Baseline in Heart Rate by Dose Decrease to <60, n=6, 90	0 Participants	10 Participants	—
Number of Participants With a Change From Baseline in Heart Rate by Dose No Change, n=6, 90	4 Participants	67 Participants	—
Number of Participants With a Change From Baseline in Heart Rate by Dose Increase to >100, n=6, 90	2 Participants	19 Participants	—

PRIMARY outcome

Timeframe: From the start of the study drug until the final study visit (up to approximately 407 days)

Population: All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed.

Change from Baseline in systolic blood pressure (SBP) is categorized as: Grade 0 (<120 millimeters of mercury [mmHg]), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), and Grade 3/4 (>=160 mmHg). Change from Baseline in diastolic blood pressure (DBP) is categorized as: Grade 0 (<80 mmHg), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), and Grade 3/4 (>=100 mmHg). An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values are assumed to have a Baseline value of grade 0. Only those participants (par.) with blood pressure values for worst-case on-therapy are presented.

Outcome measures

Measure	GSK1120212 <2 mg OD n=6 Participants Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.	GSK1120212 2 mg OD n=91 Participants Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.	Cohort 3: CMML With RAS Mutation Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
Number of Participants With a Change From Baseline in Systolic and Diastolic Blood Pressure by Dose DBP, Increase to Grade 1, n=6, 90	1 Participants	23 Participants	—
Number of Participants With a Change From Baseline in Systolic and Diastolic Blood Pressure by Dose DBP, Increase to Grade 2, n=6, 90	1 Participants	13 Participants	—
Number of Participants With a Change From Baseline in Systolic and Diastolic Blood Pressure by Dose DBP, Increase to Grade 3/4, n=6, 90	0 Participants	4 Participants	—
Number of Participants With a Change From Baseline in Systolic and Diastolic Blood Pressure by Dose SBP, Increase to Grade 1, n=6, 90	0 Participants	16 Participants	—
Number of Participants With a Change From Baseline in Systolic and Diastolic Blood Pressure by Dose SBP, Increase to Grade 2, n=6, 90	2 Participants	19 Participants	—
Number of Participants With a Change From Baseline in Systolic and Diastolic Blood Pressure by Dose SBP, Increase to Grade 3/4, n=6, 90	1 Participants	13 Participants	—

PRIMARY outcome

Timeframe: From the start of the study drug until the final study visit (up to approximately 407 days)

Population: All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed.

Change from Baseline in temperature is categorized as a decrease to <=35 degrees celsius (C), change to normal or no change, and increase to >=38 degrees C. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants (par.) are counted twice if the participant temperature value decreased to <=35 degrees C and increased to >=38 degrees C post-Baseline. Only those participants with temperature values for worst-case on-therapy are presented.

Outcome measures

Measure	GSK1120212 <2 mg OD n=6 Participants Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.	GSK1120212 2 mg OD n=91 Participants Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.	Cohort 3: CMML With RAS Mutation Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
Number of Participants With a Change From Baseline in Temperature by Dose Decrease to <=35, n=6, 90	0 Participants	4 Participants	—
Number of Participants With a Change From Baseline in Temperature by Dose No Change, n=6, 90	4 Participants	76 Participants	—
Number of Participants With a Change From Baseline in Temperature by Dose Increase to >=38, n=6, 90	2 Participants	12 Participants	—

PRIMARY outcome

Timeframe: From the start of the study drug until the final study visit (up to approximately 407 days)

Population: Efficacy Population: all participants included in the All Treated Population who had received at least one dose of 2 mg of study drug in Phase 2. The number of participants for the Cohort 2: AML/MDS/CMML with RAS wt/Unknown treatment group is equal to the 8 participants from Phase 1 plus the 22 participants from Phase 2 (total of 30).

Overall response rate (ORR=CR+CRp+Marrow CR+MLFS+PR) was calculated from the investigator's assessment of response recorded within the first eight weeks of treatment. CR includes complete remission. Complete remission is a state in which the participant must be free of all symptoms related to leukemia and have an absolute neutrophil count >=1 x 10^9/L, platelet count >=100 x 10^9/L, and normal marrow differential (<=5% blasts). PR includes partial remission. Partial remission is a state in which the participant has a CR with 6 to 25% abnormal cells in the marrow or 50% decrease in bone marrow blasts. CRp is as per CR but platelet count <100 x 10^9/L. MLFS is a state in which the participant has a normal marrow differential (<5% blasts), neutrophil, and platelet counts are not considered.

Outcome measures

Measure	GSK1120212 <2 mg OD n=50 Participants Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.	GSK1120212 2 mg OD n=30 Participants Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.	Cohort 3: CMML With RAS Mutation n=11 Participants Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
Number of Participants With an Investigator-assessed Best Response (Achieving Complete Response [CR], Marrow CR, Partial Response [PR], Complete Response Without Platelet Recovery [CRp] or Morphologic Leukaemia-free State[MLFS]) by Cohort CR	4 Participants	0 Participants	1 Participants
Number of Participants With an Investigator-assessed Best Response (Achieving Complete Response [CR], Marrow CR, Partial Response [PR], Complete Response Without Platelet Recovery [CRp] or Morphologic Leukaemia-free State[MLFS]) by Cohort CRp	1 Participants	0 Participants	1 Participants
Number of Participants With an Investigator-assessed Best Response (Achieving Complete Response [CR], Marrow CR, Partial Response [PR], Complete Response Without Platelet Recovery [CRp] or Morphologic Leukaemia-free State[MLFS]) by Cohort Marrow CR	1 Participants	0 Participants	1 Participants
Number of Participants With an Investigator-assessed Best Response (Achieving Complete Response [CR], Marrow CR, Partial Response [PR], Complete Response Without Platelet Recovery [CRp] or Morphologic Leukaemia-free State[MLFS]) by Cohort MLFS	3 Participants	0 Participants	0 Participants
Number of Participants With an Investigator-assessed Best Response (Achieving Complete Response [CR], Marrow CR, Partial Response [PR], Complete Response Without Platelet Recovery [CRp] or Morphologic Leukaemia-free State[MLFS]) by Cohort PR	1 Participants	1 Participants	0 Participants
Number of Participants With an Investigator-assessed Best Response (Achieving Complete Response [CR], Marrow CR, Partial Response [PR], Complete Response Without Platelet Recovery [CRp] or Morphologic Leukaemia-free State[MLFS]) by Cohort ORR	10 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 1 Day 15

Population: Pharmacokinetic Population: all participants included in the All Treated Population for whom a PK sample was obtained and analyzed. Only participants with data available at the indicated time points were analyzed.

Area under the concentration-time (AUC) curve from time zero (pre-dose) to 24 hours (AUC[0-24]) for Cycle 1 Day 1 (C1D1), from time zero to the last time of a quantifiable concentration (AUC[0-t]) for C1D1 and Cylce 1 Day 15 (C1D15) and AUC curve over the dosing interval AUC[0-tau] for C1D15 were measured. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 minutes [min] before study drug administration) and at 0.5 hour (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).

Outcome measures

Measure	GSK1120212 <2 mg OD n=3 Participants Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.	GSK1120212 2 mg OD n=2 Participants Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.	Cohort 3: CMML With RAS Mutation n=9 Participants Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
AUC(0-24), AUC(0-t), and AUC(0-tau) of GSK1120212 in Part 1 C1D1, AUC(0-24), n=3, 2, 9	77.6 nanograms*hour/milliliter Geometric Coefficient of Variation 25.1	29.4 nanograms*hour/milliliter Geometric Coefficient of Variation 5.2	28.0 nanograms*hour/milliliter Geometric Coefficient of Variation 51.0
AUC(0-24), AUC(0-t), and AUC(0-tau) of GSK1120212 in Part 1 C1D1, AUC(0-t), n=3, 2, 9	77.6 nanograms*hour/milliliter Geometric Coefficient of Variation 25.1	29.4 nanograms*hour/milliliter Geometric Coefficient of Variation 5.2	28.0 nanograms*hour/milliliter Geometric Coefficient of Variation 51.0
AUC(0-24), AUC(0-t), and AUC(0-tau) of GSK1120212 in Part 1 C1D15, AUC(0-t), n=2, 2, 8	172 nanograms*hour/milliliter Geometric Coefficient of Variation 18.4	155 nanograms*hour/milliliter Geometric Coefficient of Variation 61.9	298 nanograms*hour/milliliter Geometric Coefficient of Variation 58.8
AUC(0-24), AUC(0-t), and AUC(0-tau) of GSK1120212 in Part 1 C1D15, AUC(0-tau), n=2, 2, 8	170 nanograms*hour/milliliter Geometric Coefficient of Variation 17.2	241 nanograms*hour/milliliter Geometric Coefficient of Variation 5.6	330 nanograms*hour/milliliter Geometric Coefficient of Variation 34.6

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 1 Day 15

Population: Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.

Cmax is defined as the maximum observed concentration of GSK1120212 and was measured for C1D1 and C1D15. Cmin is defined as the minimal observed concentration of GSK1120212 and was measured for C1D15. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).

Outcome measures

Measure	GSK1120212 <2 mg OD n=3 Participants Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.	GSK1120212 2 mg OD n=2 Participants Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.	Cohort 3: CMML With RAS Mutation n=9 Participants Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
Cmin and Cmax of GSK1120212 in Part 1 C1D1, Cmax, n=3, 2, 9	7.67 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 27.6	3.69 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 35.5	3.27 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 93.2
Cmin and Cmax of GSK1120212 in Part 1 C1D15, Cmax , n=2, 2, 8	12.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 19.4	15.1 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 15.6	18.7 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 36.1
Cmin and Cmax of GSK1120212 in Part 1 C1D15, Cmin, n=2, 2, 8	4.79 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 6.6	8.50 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 19.4	10.8 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 36.8

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (t1/2) and Cycle 1 Day 15 (t1/2eff)

Population: Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.

t1/2 is defined as terminal phase half-life, which is the time required for the amount of the drug in the body to decrease by half and was measured for C1D1. t1/2eff. is defined as the effective half-life and was measured for C1D15. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).

Outcome measures

Measure	GSK1120212 <2 mg OD n=3 Participants Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.	GSK1120212 2 mg OD n=2 Participants Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.	Cohort 3: CMML With RAS Mutation n=9 Participants Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
t1/2 at C1D1 and t1/2 Effective (Eff.) at C1D15 of GSK1120212 in Part 1 C1D1, t1/2, n=3, 1, 8	33.5 Hours Geometric Coefficient of Variation 43.7	25.0 Hours Geometric Coefficient of Variation NA There is only one participant in this cohort so dispersion can not be calculated.	37.0 Hours Geometric Coefficient of Variation 76.2
t1/2 at C1D1 and t1/2 Effective (Eff.) at C1D15 of GSK1120212 in Part 1 C1D15, t1/2 eff., n=2, 2, 8	96.41 Hours Geometric Coefficient of Variation 18.1	128 Hours Geometric Coefficient of Variation 11.6	174 Hours Geometric Coefficient of Variation 80.3

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 1 Day 15

Population: Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.

Tmax is defined as the time to reach the observed maximum concentration and was measured for C1D1 and C1D15. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).

Outcome measures

Measure	GSK1120212 <2 mg OD n=3 Participants Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.	GSK1120212 2 mg OD n=2 Participants Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.	Cohort 3: CMML With RAS Mutation n=9 Participants Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
Tmax of GSK1120212 in Part 1 C1D1, tmax, n=3, 2, 9	2.0 Hours Interval 1.0 to 3.0	1.25 Hours Interval 1.0 to 1.5	3.0 Hours Interval 0.5 to 5.0
Tmax of GSK1120212 in Part 1 C1D15, tmax, n=2, 2, 8	1.75 Hours Interval 1.5 to 2.0	2.25 Hours Interval 1.0 to 3.5	3.0 Hours Interval 1.0 to 24.0

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 1 Day 15

Population: Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.

AR is the ratio of the Day 15 AUC0-tau (0 hour to last dose interval) and Day 1 AUC0-tau (AUCtau C1D15/AUCtau C1D1). Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).

Outcome measures

Measure	GSK1120212 <2 mg OD n=2 Participants Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.	GSK1120212 2 mg OD n=2 Participants Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.	Cohort 3: CMML With RAS Mutation n=8 Participants Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
Accumulation Ratio (AR) of GSK1120212 in Part 1	6.32 Ratio Geometric Coefficient of Variation 16.5	8.19 Ratio Geometric Coefficient of Variation 10.8	11.1 Ratio Geometric Coefficient of Variation 76.5

SECONDARY outcome

Timeframe: C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1 and C12D1

Population: Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.

Ctau is the pre-dose (trough) concentration at the end of the dosing interval and was measured for Cycle 1 Day 15 (C1D15), Cycle 2 Day 1(C2D1), Cylce 3 Day 1 (C3D1), Cycle 4 Day 1 (C4D1), Cycle 5 Day 1 (C5D1), Cycle 6 Day 1 (C6D1), Cycle 7 Day 1 (C7D1), Cycle 8 Day 1 (C8D1), Cycle 9 Day 1 (C9D1), Cycle 10 Day 1 (C10D1), Cycle 11 Day 1 (C11D1) and Cycle 12 Day 1 (C12D1). Blood samples for PK analysis were collected pre-dose (i.e., no later than 15 min prior to dosing).

Outcome measures

Measure	GSK1120212 <2 mg OD n=75 Participants Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.	GSK1120212 2 mg OD Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.	Cohort 3: CMML With RAS Mutation Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
Ctau of GSK1120212 in Part 2 C1D15, n=72	10.8 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 63.8	—	—
Ctau of GSK1120212 in Part 2 C2D1, n=57	9.34 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 78.9	—	—
Ctau of GSK1120212 in Part 2 C3D1, n=38	10.0 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 64.9	—	—
Ctau of GSK1120212 in Part 2 C4D1, n=21	9.17 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 99.9	—	—
Ctau of GSK1120212 in Part 2 C5D1, n=10	12.05 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 37.4	—	—
Ctau of GSK1120212 in Part 2 C6D1, n=6	9.73 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 44.8	—	—
Ctau of GSK1120212 in Part 2 C7D1, n=6	8.94 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 55.0	—	—
Ctau of GSK1120212 in Part 2 C8D1, n=5	6.01 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 222.3	—	—
Ctau of GSK1120212 in Part 2 C9D1, n=3	11.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 30.7	—	—
Ctau of GSK1120212 in Part 2 C10D1, n=2	5.01 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 73.9	—	—
Ctau of GSK1120212 in Part 2 C11D1, n=1	2.01 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA There is only one participant in this cohort so dispersion can not be calculated.	—	—
Ctau of GSK1120212 in Part 2 C12D1, n=1	0.644 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA There is only one participant in this cohort so dispersion can not be calculated.	—	—

SECONDARY outcome

Timeframe: From the start of the study drug until the final study visit (up to approximately 407 days )

Population: Efficacy Population. The number of participants for the Cohort 2: AML/MDS/CMML with RAS wt/Unknown treatment group is equal to the 8 participants from Phase 1 plus the 22 participants from Phase 2 (total of 30).

Overall survival is defined as the time from the start of study treatment (GSK1120212) until death due to any cause. For the analysis of overall survival, the last date of known contact was used for those participants who had not died at the time of analysis; such participants were considered censored.

Outcome measures

Measure	GSK1120212 <2 mg OD n=50 Participants Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.	GSK1120212 2 mg OD n=30 Participants Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.	Cohort 3: CMML With RAS Mutation n=11 Participants Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
Overall Survival by Cohort	4.9 Months Interval 4.0 to 5.7	3.0 Months Interval 1.8 to 7.4	14.5 Months Interval 8.6 to Due to the high censoring rate, the upper bound of the 95% CI cannot be calculated.

Adverse Events

GSK1120212 <2 mg OD

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

GSK1120212 2 mg OD

Serious events: 64 serious events

Other events: 90 other events

Deaths: 0 deaths

Serious adverse events

Measure	GSK1120212 <2 mg OD n=6 participants at risk Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.	GSK1120212 2 mg OD n=91 participants at risk Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
Infections and infestations Pneumonia	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	18.7% 17/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Sepsis	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	7.7% 7/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Urinary tract infection	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	4.4% 4/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Bacteraemia	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	4.4% 4/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Cellulitis	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	4.4% 4/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Staphylococcal infection	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	3.3% 3/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Bacterial sepsis	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	2.2% 2/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Escherichia bacteraemia	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	2.2% 2/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Staphylococcal bacteraemia	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	2.2% 2/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Oral infection	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	2.2% 2/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Clostridium difficile colitis	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Cystitis	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Device related infection	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Enterococcal bacteraemia	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Epiglottitis	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Lobar pneumonia	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Lung infection	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Neutropenic sepsis	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Periorbital cellulitis	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Pharyngitis	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Pneumonia fungal	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Pseudomonas infection	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Pyelonephritis	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Septic shock	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Staphylococcal sepsis	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Streptococcal bacteraemia	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Zygomycosis	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	16.5% 15/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	4.4% 4/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Blood and lymphatic system disorders Leukocytosis	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	2.2% 2/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Blood and lymphatic system disorders Neutropenia	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Blood and lymphatic system disorders Pancytopenia	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Cardiac disorders Atrial fibrillation	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	3.3% 3/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Cardiac disorders Left ventricular dysfunction	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	2.2% 2/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Cardiac disorders Acute myocardial infarction	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Cardiac disorders Atrioventricular block	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Cardiac disorders Cardiac arrest	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Cardiac disorders Cardio-respiratory arrest	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Cardiac disorders Left ventricular failure	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Cardiac disorders Mitral valve incompetence	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Cardiac disorders Myocardial infarction	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	4.4% 4/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	3.3% 3/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Gastrointestinal disorders Vomiting	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	3.3% 3/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Gastrointestinal disorders Ileus paralytic	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Gastrointestinal disorders Nausea	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Gastrointestinal disorders Oesophagitis	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Gastrointestinal disorders Stomatitis	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Nervous system disorders Cerebrovascular accident	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	3.3% 3/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Nervous system disorders Convulsion	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	3.3% 3/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Nervous system disorders Cerebral haemorrhage	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Nervous system disorders Extrapyramidal disorder	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Nervous system disorders Tremor	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
General disorders Pyrexia	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	3.3% 3/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
General disorders Asthenia	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
General disorders Mucosal inflammation	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	2.2% 2/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	2.2% 2/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Skin and subcutaneous tissue disorders Acute febrile neutrophilic dermatosis	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Psychiatric disorders Mental status changes	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	2.2% 2/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Psychiatric disorders Delirium	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Vascular disorders Hypotension	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Vascular disorders Ischaemia	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Immune system disorders Graft versus host disease in intestine	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Investigations Blood culture positive	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Metabolism and nutrition disorders Decreased appetite	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Musculoskeletal and connective tissue disorders Neck mass	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Renal and urinary disorders Renal failure acute	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .

Other adverse events

Measure	GSK1120212 <2 mg OD n=6 participants at risk Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.	GSK1120212 2 mg OD n=91 participants at risk Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
Gastrointestinal disorders Oral pain	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	4.4% 4/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Gastrointestinal disorders Haemorrhoids	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	5.5% 5/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Gastrointestinal disorders Diarrhoea	83.3% 5/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	47.3% 43/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Gastrointestinal disorders Nausea	50.0% 3/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	26.4% 24/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Gastrointestinal disorders Vomiting	33.3% 2/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	19.8% 18/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Gastrointestinal disorders Constipation	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	13.2% 12/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	12.1% 11/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Gastrointestinal disorders Stomatitis	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	7.7% 7/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Gastrointestinal disorders Gingival bleeding	33.3% 2/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	3.3% 3/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Gastrointestinal disorders Gastrointestinal haemorrhage	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	2.2% 2/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Gastrointestinal disorders Abdominal pain upper	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Gastrointestinal disorders Haemorrhoidal haemorrhage	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Gastrointestinal disorders Rectal ulcer	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Gastrointestinal disorders Upper gastrointestinal haemorrhage	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
General disorders Fatigue	33.3% 2/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	24.2% 22/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
General disorders Oedema peripheral	50.0% 3/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	23.1% 21/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
General disorders Pyrexia	50.0% 3/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	23.1% 21/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
General disorders Mucosal inflammation	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	9.9% 9/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
General disorders Asthenia	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	6.6% 6/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
General disorders Chills	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	5.5% 5/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
General disorders Pain	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	2.2% 2/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
General disorders Swelling	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	26.4% 24/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Skin and subcutaneous tissue disorders Dry skin	33.3% 2/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	8.8% 8/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Skin and subcutaneous tissue disorders Pruritus	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	7.7% 7/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	6.6% 6/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Skin and subcutaneous tissue disorders Erythema	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	2.2% 2/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Skin and subcutaneous tissue disorders Alopecia	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Skin and subcutaneous tissue disorders Exfoliative rash	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Metabolism and nutrition disorders Hypokalaemia	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	14.3% 13/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Metabolism and nutrition disorders Decreased appetite	33.3% 2/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	11.0% 10/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Metabolism and nutrition disorders Hypoalbuminaemia	33.3% 2/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	11.0% 10/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Metabolism and nutrition disorders Hypomagnesaemia	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	12.1% 11/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Metabolism and nutrition disorders Hyponatraemia	66.7% 4/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	8.8% 8/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Metabolism and nutrition disorders Hypocalcaemia	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	9.9% 9/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	8.8% 8/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	6.6% 6/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Metabolism and nutrition disorders Hyperglycaemia	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	4.4% 4/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Metabolism and nutrition disorders Hyperkalaemia	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	3.3% 3/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Metabolism and nutrition disorders Hyperphosphataemia	33.3% 2/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Metabolism and nutrition disorders Hypouricaemia	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Pneumonia	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	12.1% 11/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Urinary tract infection	33.3% 2/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	11.0% 10/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Cellulitis	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	8.8% 8/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Staphylococcal infection	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	6.6% 6/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Enterococcal infection	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	2.2% 2/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Gingivitis	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Herpes simplex	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Infections and infestations Vulval cellulitis	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Investigations Alanine aminotransferase increased	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	23.1% 21/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Investigations Aspartate aminotransferase increased	33.3% 2/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	20.9% 19/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Investigations Blood alkaline phosphatase increased	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	4.4% 4/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Investigations Brain natriuretic peptide increased	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Investigations Prothrombin time prolonged	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Investigations Activated partial thromboplastin time prolonged	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Investigations Blood glucose increased	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Investigations Blood potassium increased	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	14.3% 13/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	12.1% 11/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	12.1% 11/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	7.7% 7/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Blood and lymphatic system disorders Anaemia	33.3% 2/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	19.8% 18/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Blood and lymphatic system disorders Thrombocytopenia	50.0% 3/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	15.4% 14/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Blood and lymphatic system disorders Febrile neutropenia	50.0% 3/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	4.4% 4/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Blood and lymphatic system disorders Leukocytosis	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Nervous system disorders Headache	33.3% 2/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	11.0% 10/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Nervous system disorders Dizziness	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	4.4% 4/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Nervous system disorders Syncope	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	5.5% 5/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Nervous system disorders Presyncope	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Eye disorders Vision blurred	33.3% 2/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	14.3% 13/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Eye disorders Glaucoma	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Cardiac disorders Left ventricular dysfunction	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	7.7% 7/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Cardiac disorders Tachycardia	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	7.7% 7/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Cardiac disorders Pericardial effusion	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	2.2% 2/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Cardiac disorders Arrhythmia	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Cardiac disorders Cardiomyopathy	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Renal and urinary disorders Proteinuria	33.3% 2/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	5.5% 5/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Renal and urinary disorders Haematuria	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	5.5% 5/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Renal and urinary disorders Renal failure acute	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	4.4% 4/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Renal and urinary disorders Dysuria	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Vascular disorders Hypotension	50.0% 3/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	7.7% 7/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Vascular disorders Haematoma	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	2.2% 2/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Musculoskeletal and connective tissue disorders Muscle spasms	33.3% 2/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	3.3% 3/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	2.2% 2/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Musculoskeletal and connective tissue disorders Myalgia	33.3% 2/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Musculoskeletal and connective tissue disorders Coccydynia	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Psychiatric disorders Anxiety	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	6.6% 6/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Psychiatric disorders Insomnia	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	1.1% 1/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Injury, poisoning and procedural complications Contusion	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Injury, poisoning and procedural complications Fall	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	0.00% 0/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .	6.6% 6/91 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study drug until the final study visit (up to approximately 407 days). SAEs and non-serious AEs were collected in members of the All treated Population, comprised of all participants (par.) who received at least one dose of study medication. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. .

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER