A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01587703
• Collaborator: (none)
• Enrollment: 196
• Locations: 17
• Arms: 3
• Actual Duration (Months): 88
• Patients Per Site: 11.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study is divided into two parts; Part 1 of the study is a dose escalation phase to select the recommended dose for Part 2 based on the safety, pharmacokinetic, and pharmacodynamic profiles observed after oral administration of GSK525762 in the following subjects: NMC, small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), neuroblastoma (NB), castration resistant prostate cancer (CRPC), triple negative breast cancer (TNBC), estrogen receptor positive (ER positive) breast cancer, and MYCN driven solid tumor subjects. Part 2 of the study will explore the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of the recommended dose from Part 1 in cohorts comprised of NMC, small cell lung cancer (SCLC), castration resistant prostate cancer (CRPC), triple negative breast cancer (TNBC), and estrogen receptor positive (ER positive) breast cancer subjects. Approximately 60 subjects will be enrolled in the Part 1 and approximately 150 subjects will be enrolled in Part 2. A sub-study will be opened in Part 1 to approximately 10-12 subjects in the United States to investigate the relative bioavailability of the besylate tablet compared to the amorphous free-base tablet at the maximum tolerated dose (MTD) or recommended phase 2 dosing (RP2D), the effect of high-fat high-calorie meal on the bioavailability of the besylate tablet at the MTD or RP2D and the dose proportionality of 2 doses of GSK525762 administered as besylate tablet.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Midline	Drug: GSK525762	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 196 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I/II Open-Label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers
• Actual Study Start Date: Mar 28, 2012
• Actual Primary Completion Date: Apr 13, 2018
• Actual Study Completion Date: Jul 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single and Repeat Dose finding cohort All subjects will follow a 3+3 dose escalation design for GSK525762 and the dose will be escalated based on all available data, including PK data and the safety profile of prior cohorts, as well as the recommended dose from the Neuenschwander- Continuous Reassessment Method (N-CRM) design.	Drug: GSK525762; Begin at Dose Level 1 and increase up to 2 fold
Experimental: Expansion Cohort Up to 150 additional subjects with NMC and other solid tumors may be enrolled in expansion cohorts. The recommended Phase 2 (Part 2) dose (RP2D) of GSK525762 will be determined based on the MTD or biologically active dose (example: clinical response), the safety profile and available pharmacodynamic data generated from all subjects in Parts 1	Drug: GSK525762; Begin at Dose Level 1 and increase up to 2 fold
Experimental: Besylate Sub study Tablet and amorphous tablet in one of the two sequences (ABCD or BACD). Where Treatment A: RP2D/MTD as amorphous free-base tablet + low dose stable isotope in solution, fasted Treatment B: RP2D/MTD as besylate tablet + low dose stable isotope in solution, fasted. Treatment C: half to one-third of RP2D/MTD as besylate tablet + low dose stable isotope in solution, fasted. Treatment D: RP2D/MTD as besylate tablet, fed	Drug: GSK525762; Begin at Dose Level 1 and increase up to 2 fold

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QD [Median of 1.38 months of drug exposure]

   An AE is any untoward medical occurrence in a participant 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 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; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment. All Treated Population comprised of all participants who received at least one dose of study treatment.

2. Number of Participants With AEs and SAEs-Part 1 BID [Median of 1.41 months of drug exposure]

   An AE is any untoward medical occurrence in a participant 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 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; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment

3. Number of Participants With AEs and SAEs-Part 2 [Median of 1.41 months of drug exposure]

   An AE is any untoward medical occurrence in a participant 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 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; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment.

4. Number of Participants With Dose Reductions or Delays-Part 1 QD [Median of 1.38 months of drug exposure]

   The number of participants who had any dose reductions or delays is presented.

5. Number of Participants With Dose Reductions or Delays-Part 1 BID [Median of 1.41 months of drug exposure]

   The number of participants who had any dose reductions or delays is presented.

6. Number of Participants With Dose Reductions or Delays-Part 2 [Median of 1.41 months of drug exposure]

   The number of participants who had any dose reductions or delays is presented.

7. Number of Participants With Dose Reductions or Delays-Besylate Sub-study [Median of 1.87 months of drug exposure]

   The number of participants who had any dose reductions or delays is presented.

8. Number of Participants Withdrawn Due to Toxicities-Part 1 QD [Median of 1.38 months of drug exposure]

   Number of participants withdrawn due to toxicities is presented.

9. Number of Participants Withdrawn Due to Toxicities-Part 1 BID [Median of 1.41 months of drug exposure]

   Number of participants withdrawn due to toxicities is presented.

10. Number of Participants Withdrawn Due to Toxicities-Part 2 [Median of 1.41 months of drug exposure]

    Number of participants withdrawn due to toxicities is presented.

11. Number of Participants Withdrawn Due to Toxicities-Besylate Sub-study [Median of 1.87 months of drug exposure]

    Number of participants withdrawn due to toxicities is presented.

12. Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD [Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure]

    Blood samples were collected for the analysis of: glucose, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), amylase, aspartate aminotransferase (AST), direct bilirubin (Dir bil), bilirubin, N-Terminal proB-type natriuretic peptide (NT-BNP), calcium, cholesterol, creatine kinase (CK), chloride, carbon dioxide (CO2), creatinine, gamma glutamyl transferase (GGT), high and low density lipoprotein (HDL and LDL), insulin, potassium, lactate dehydrogenase (LDH), lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Grading was done according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on first study treatment dose date. Data for worst case post-Baseline is presented.

13. Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID [Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure]

    Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post-Baseline is presented.

14. Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2 [Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure]

    Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides (triglyc), troponin I and T, urate and urea. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post-Baseline is presented.

15. Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study [Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure]

    Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.

16. Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD [Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure]

    Blood samples were collected for the analysis of hematology parameters: activated partial thromboplastin time (aPTT), platelet count, red blood cell count (RBC), white blood cell count (WBC), prothrombin international normalized ratio (INR), prothrombin time (PT), fibrinogen (Fib), hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.

17. Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID [Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure]

    Blood samples were collected for the analysis of hematology parameters: aPTT, platelet count, RBC, WBC, INR, PT, Fib, hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.

18. Number of Participants With Grade Change From Baseline in Hematology Data-Part 2 [Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure]

    Blood samples were collected for the analysis of hematology parameters: aPTT, platelet count, RBC, WBC, INR, PT, Fib, hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.

19. Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study [Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure]

    Blood samples were collected for the analysis of hematology parameters: aPTT, platelet count, RBC, WBC, INR, PT, Fib, hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.

20. Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD [Baseline (pre-dose Week1 Day1) and Weeks 5, 9, 17, 25, 33, 41, 49 and discharge/progression (disc/prog)]

    Urine samples were collected for the analysis of following urine parameters: potential of hydrogen (pH), glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented.

21. Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID [Baseline (pre-dose Week1 Day1) and Weeks 5,9,17 and discharge/progression]

    Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented.

22. Number of Participants With Maximum Urinalysis Change From Baseline-Part 2 [Baseline (pre-dose Week1 Day1), Weeks 5,9,13,25,37, 49, 73, 85 and discharge/progression]

    Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented.

23. Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study [Baseline (pre-dose Week1 Day1), Weeks 5,9,17,25 and disc/prog]

    Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented.

24. Number of Participants With Changes in Pulse Rate From Baseline-Part 1 QD [Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure]

    Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for pulse rate is <60 beats per minute and >100 beats per minute. Participants were counted twice if the participant "Decreased to <60" and "Increased to >100" post-baseline. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented

25. Number of Participants With Changes in Pulse Rate From Baseline-Part 1 BID [Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure]

    Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.

26. Number of Participants With Changes in Pulse Rate From Baseline-Part 2 [Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure]

    Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for pulse rate is <60 beats per minute and >100 beats per minute. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented. Participants were counted twice if the participant "Decreased to <60" and "Increased to >100" post-baseline.

27. Number of Participants With Changes in Pulse Rate From Baseline-Besylate Sub-study [Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure]

    Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for pulse rate is <60 beats per minute and >100 beats per minute. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.

28. Number of Participants With Increase in Blood Pressure From Baseline-Part 1 QD [Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure]

    Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (>=160) and DBP: Grade 0 (<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented

29. Number of Participants With Increase in Blood Pressure From Baseline-Part 1 BID [Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure]

    SBP and DBP were measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (>=160) and DBP: Grade 0 (<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented

30. Number of Participants With Changes in Blood Pressure From Baseline-Part 2 [Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure]

    SBP and DBP were measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (>=160) and DBP: Grade 0 (<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.

31. Number of Participants With Increase in Blood Pressure From Baseline-Besylate Sub-study [Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure]

    SBP and DBP were measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (>=160) and DBP: Grade 0 (<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.

32. Number of Participants With Changes in Temperature From Baseline-Part 1 QD [Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure]

    Temperature was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for temperature is <=35 degree Celsius and >=38 degree Celsius. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.

33. Number of Participants With Changes in Temperature From Baseline-Part 1 BID [Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure]

    Temperature was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for temperature is <=35 degree Celsius and >=38 degree Celsius. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.

34. Number of Participants With Changes in Temperature From Baseline-Part 2 [Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure]

    Temperature was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for temperature is <=35 degree Celsius and >=38 degree Celsius. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.

35. Number of Participants With Changes in Temperature From Baseline-Besylate Sub-study [Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure]

    Temperature was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for temperature is <=35 degree Celsius and >=38 degree Celsius. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.

36. Overall Response Rate-Part 1 QD [Median of 1.38 months of drug exposure]

    Overall response rate is defined as the percentage of participants who achieved a confirmed complete response (CR) or partial response (PR) from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST version (v) 1.1). CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeters (mm) in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.

37. Overall Response Rate-Part 1 BID [Median of 1.41 months of drug exposure]

    Overall response rate is defined as the percentage of participants who achieved a confirmed CR or PR from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.

38. Overall Response Rate-Part 2 [Median of 1.41 months of drug exposure]

    Overall response rate is defined as the percentage of participants who achieved a confirmed CR or PR from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.

39. Overall Response Rate-Besylate Sub-study [Median of 1.87 months of drug exposure]

    Overall response rate is defined as the percentage of participants who achieved a confirmed CR or PR from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.

40. Number of Participants With Prostate Specific Antigen (PSA)50 Response-Part 1 QD [Median of 1.38 months of drug exposure]

    PSA 50 response rate is defined as the response rate that a PSA reduction from Baseline >=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA >=50% reduction is presented along with 95% confidence intervals.

41. Number of Participants With PSA50 Response Rate-Part 1 BID [Median of 1.41 months of drug exposure]

    PSA 50 Response rate is defined as the response rate that a PSA reduction from Baseline >=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA >=50% reduction is presented along with 95% confidence intervals.

42. Number of Participants With PSA50 Response-Part 2 [Median of 1.41 months of drug exposure]

    PSA 50 response rate is defined as the response rate that a PSA reduction from Baseline >=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA >=50% reduction is presented along with 95% confidence intervals.

43. Number of Participants With PSA50 Response-Besylate Sub-study [Median of 1.87 months of drug exposure]

    PSA 50 Response rate is defined as the response rate that a PSA reduction from Baseline >=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA >=50% reduction is presented along with 95% confidence intervals.

44. Area Under the Concentration-time Curve (AUC) From Time Zero to 24 Hours(AUC[0 to 24]); AUC From Time 0 to Last Quantifiable Concentration (AUC [0 to t]) and AUC Extrapolated to Infinity (AUC[0 to Inf]) of GSK525762-Besylate Sub-study [Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)]

    Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points. Besylate sub-study pharmacokinetic (PK) Parameter Population consisted of all participants in the PK Parameter Population who participated in the besylate substudy.

45. Maximum Observed Concentration (Cmax) of GSK525762-Besylate Sub-study [Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)]

    Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points.

46. Apparent Terminal Phase Elimination Rate Constant (Lambda z) for GSK525762-Besylate Sub-study [Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)]

    Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points.

47. Time to Reach Cmax (Tmax) for GSK525762-Besylate Sub-study [Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)]

    Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points.

48. Number of Participants With Non-serious AEs and SAEs-Besylate Sub-study [Median of 1.87 months of drug exposure]

    An AE is any untoward medical occurrence in a participant 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 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; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment

Secondary Outcome Measures

1. Number of Participants With Increase in QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)-Part 1 QD [Median of 1.38 months of drug exposure]

   Electrocardiogram (ECG) measurements were done using an automated 12-lead ECG machine. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (<450 milliseconds [msec]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported.

2. Number of Participants With Increase in QTcF-Part 1 BID [Median of 1.41 months of drug exposure]

   ECG measurements were done using an automated 12-lead ECG machine. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (<450 milliseconds [msec]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported.

3. Number of Participants With Increase in QTcF-Part 2 [Median of 1.41 months of drug exposure]

   ECG measurements were done using an automated 12-lead ECG machine. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (<450 milliseconds [msec]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported.

4. Number of Participants With Increase in QTcF-Besylate Sub-study [Median of 1.87 months of drug exposure]

   ECG measurements were done using 12-lead ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and QTcF intervals. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (<450 milliseconds [msec]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported.

5. Progression Free Survival-Part 1 QD [Median of 1.38 months of drug exposure]

   Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method.

6. Progression Free Survival-Part 1 BID [Median of 1.41 months of drug exposure]

   Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method.

7. Progression Free Survival-Part 2 [Median of 1.41 months of drug exposure]

   Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and the date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method.

8. Progression Free Survival-Besylate Sub-study [Median of 1.87 months of drug exposure]

   Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and the date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method.

9. Time to Response-Part 1 QD [Median of 1.38 months of drug exposure]

   Time to response is defined, for participants with a confirmed CR or PR, as the time from first dose to the first documented evidence of CR or PR. Time to response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.

10. Time to Response-Part 1 BID [Median of 1.41 months of drug exposure]

    Time to response is defined, for participants with a confirmed CR or PR, as the time from first dose to the first documented evidence of CR or PR. Time to response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.

11. Time to Response-Part 2 [Median of 1.41 months of drug exposure]

    Time to response is defined, for participants with a confirmed CR or PR, as the time from first dose to the first documented evidence of CR or PR. Time to response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.

12. Time to Response-Besylate Sub-study [Median of 1.87 months of drug exposure]

    Time to response is defined, for participants with a confirmed CR or PR, as the time from first dose to the first documented evidence of CR or PR. Time to response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.

13. Duration of Response-Part 1 QD [Median of 1.38 months of drug exposure]

    Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve a confirmed CR or PR. Duration of response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.

14. Duration of Response-Part 1 BID [Median of 1.41 months of drug exposure]

    Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve a confirmed CR or PR. Duration of response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.

15. Duration of Response-Part 2 [Median of 1.41 months of drug exposure]

    Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve a confirmed CR or PR. Duration of response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.

16. Duration of Response-Besylate Sub-study [Median of 1.87 months of drug exposure]

    Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve a confirmed CR or PR. Duration of response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.

17. Overall Survival-Part 1 QD [Median of 1.38 months of drug exposure]

    Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.

18. Overall Survival-Part 1 BID [Median of 1.41 months of drug exposure]

    Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.

19. Overall Survival-Part 2 [Median of 1.41 months of drug exposure]

    Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.

20. Overall Survival-Besylate Sub-study [Median of 1.87 months of drug exposure]

    Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.

21. AUC (0 to t), AUC (0 to 24) and AUC (0 to Inf) of GSK525762-Part 1 QD [pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4]

    Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762. PK parameter population comprised of all participants in the PK Concentration Population (all participants in the All Treated Population for whom a blood sample for pharmacokinetics is obtained and analyzed) for whom a PK parameter has been obtained.

22. Maximum Observed Concentration for GSK525762-Part 1 QD [pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4]

    Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.

23. Lambda z for GSK525762-Part 1 QD [pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4]

    Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.

24. Tmax for GSK525762-Part 1 QD [pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4]

    Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.

25. Apparent Clearance of GSK525762-Part 1 QD [pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4]

    Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.

26. Volume of Distribution of GSK525762-Part 1 QD [pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4]

    Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.

27. AUC (0 to Inf), AUC (0 to 24) and AUC (0 to t) of GSK525762-Part 1 BID [pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4]

    Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.

28. Maximum Observed Concentration of GSK525762-Part 1 BID [pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4]

    Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.

29. Lambda z for GSK525762-Part 1 BID [pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4]

    Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.

30. Tmax for GSK525762-Part 1 BID [pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4]

    Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.

31. Apparent Clearance of GSK525762-Part 1 BID [pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4]

    Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.

32. Volume of Distribution of GSK525762-Part 1 BID [pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4]

    Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female 16 years or older, at the time of signing the informed consent.

• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. If the subject is less than 18 years old, an Assent form and parental/guardian Consent form (replacing "you will" with "your child will" will be required).

• Diagnosis of one of the following: Part 1 Only: NUT Midline Carcinoma based on ectopic expression of NUT protein as determined by IHC and/or detection of NUT gene translocation as determined by FISH. Subjects may be treatment naïve or have had prior therapy; SCLC, CRC, NB, TNBC, ER positive BC, CRPC, NSCLC and any other solid tumor which has been confirmed by clinical testing to be MYCN amplified (defined as a MYCN gene copy number gain of >=5). Subjects should have tumor progression after receiving at least one prior standard/approved chemotherapy, or where there is no approved therapy, or where standard therapy is refused. Part 2 only: NUT Midline Carcinoma as diagnosed by the Central Laboratory. Subjects may be treatment naïve or have had prior therapy. SCLC, CRPC, TNBC and ER+BC .

• Subjects with solid tumors, with the exception of CRPC, must demonstrate measurable disease, per RECIST v1.1. NOTE: Subjects with NMC that do not meet the RECIST v1.1 criteria for measurable disease, but have evaluable disease may be considered for enrollment after discussion with the GSK medical monitor..

• All prior treatment- related toxicities must be CTCAE (Version 4.0) <=Grade 1 (except alopecia and peripheral neuropathy) at the time of treatment allocation [NCI-CTCAE, 2009].

• ECOG Performance Status score of 0 or 2 for subjects with NMC; 0-1 for subjects with other tumor types.

• Adequate organ function as follows: Hematologic system: Absolute neutrophil count (ANC), Lab values - >=1.5 X 10^{9/L; Hematologic system: Hemoglobin, Lab values - >=9.5 grams/deciliter (g/dL) (subjects that required transfusion or growth factor need to demonstrate stable haemoglobin for 7 days of 9.5 g/ g/dL); Hematologic system: Platelets, Lab values - >=100 X 10}9/Liter [L] ); Hematologic system: Prothrombin time /International normalized ratio and partial thromboplastin time, Lab values - <=1.5 X upper limit of normal (ULN). Renal system: Creatinine, lab values - <=1.5 X ULN; or Renal system: Calculated creatinine clearance [calculated by Cockcroft Gault formula], lab values - >=50 milliliter (mL)/minute (min); or Renal system: 24-hour urine creatinine clearance>=50 mL/min; Hepatic system: total Bilirubin <=1.5 X ULN (isolated bilirubin >1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin <35% or subject has a diagnosis of Gilbert's syndrome), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >=2.5 x ULN. Cardiac system: Ejection fraction, lab values - >=lower limit of normal (LLN) by Echocardiogram (ECHO) (minimum of 50%); Cardiac system: Troponin ( T), lab values - <=ULN; Cardiac system: Potassium, lab values - >=LLN and <=ULN; Cardiac system: Magnesium, lab values - >=LLN. Thyroid system: thyroid stimulating hormone, lab values >=LLN and <=to ULN. Reproductive /endocrine system: testosterone <50 nanogram (ng)/dL (only for subject with CRPC)

• Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.

• A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 milli international unit/mL and estradiol less than 40 pg/mL (less than 140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status prior to study enrollment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method; Child-bearing potential and agrees to use one of the contraception methods (described in the protocol) for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 7 months after the last dose of study medication; Negative serum pregnancy test <=7 days prior to first study drug dose; Female subjects who are lactating must discontinue nursing prior to the first dose of study treatment and must refrain from nursing throughout the treatment period and for 5 half-lives of GSK525762 or at least 28 days (whichever is longer) following the last dose of study treatment.

• Male subjects must agree to use one of the methods of contraception specified. This method must be used from the time of the first dose of study medication until least 16 weeks after the last dose of study medication. In addition, male subjects whose partners are or become pregnant while on study medication must continue to use condoms for 7 days after stopping study medications.

• Specific eligibility criteria for Part 2 CRPC expansion cohort: Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma, surgically castrated or continuously medically castrated (for >=8 weeks prior to pre-screening).

• Specific eligibility criteria for Part 2 CRPC expansion cohort: Persistent disease with evidence of disease progression following standard therapy(ies) including prior treatment with androgen/androgen receptor directed therapy, including enzalutamide and/or abiraterone

• Specific eligibility criteria for Part 2 CRPC expansion cohort: Ongoing androgen deprivation therapy with a serum testosterone level <1.7 nanomoles/L or <50 ng/dL.

• Specific eligibility criteria for Part 2 CRPC expansion cohort: Prostate-Specific Antigen (PSA) levels >=2.0 ng/mL. Note: If PSA level has been obtained within 14 days of Screening, this test does not need to be repeated and the result previously obtained may be used for the Screening value.

Exclusion Criteria:

• Primary malignancy of the central nervous system or malignancies related to human immunodeficiency virus or solid organ transplant. History of known HIV. History of known Hepatitis B surface antigen or positive Hepatitis C antibody (confirmed by RIBA).

• Prior treatments usage as defined: A) Use of an investigational anti-cancer drug within 14 days or 5 half-lives, whichever is longer, prior to the first dose of the investigational products:; B) A minimum of 14 days between termination of the investigational drug and administration of GSK525762; C) Any therapy related toxicities must also have resolved to Grade 1 or less. Note that an investigational drug is defined as a drug without an approved oncologic indication; D) Chemotherapy, radiotherapy, anti-neoplastic antibody or targeted therapy or immunotherapy within 14 days, major surgery within 28 days (or 42 days for prior nitrosoureas or mitomycin C) prior to the first dose of the investigational product. Anti-androgen (e.g., bicalutamide) therapies for prostate cancer must be stopped 4 weeks prior to enrollment. Second line hormone therapies such as enzalutamide, abiraterone, or orteronel should be stopped 2 weeks prior to enrollment. Subjects with prostate cancer should remain on luteinizing hormone releasing hormone (LHRH) agonists or antagonists. Subjects with prostate cancer may also remain on low-dose prednisone or prednisolone (up to 10 mg/day) and still be eligible for this study.

• Current use of anticoagulants (e.g., warfarin, heparin) at therapeutic levels within 7 days prior to the first dose of GSK525762. Low dose (prophylactic) low molecular weight heparin (LMWH) is permitted. In addition, INR must be monitored in accordance with local institutional practices.

• Current use of a prohibited medication or requires any of these medications during treatment with the investigational drugs (details will be available in the protocol). This includes excluding current medications known or suspected to be associated QT prolongation. In addition, any subject who may require a QT prolonging medication while on trial should not be enrolled.

• Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, cardiac disease, or clinically significant bleeding episodes). Any serious and/or unstable pre-existing medical (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.

• Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. NOTE: Subjects previously treated for these conditions that have had stable central nervous system disease (verified with consecutive imaging studies) for

1 month, are asymptomatic and off corticosteroids, or are on stable dose of corticosteroids for at least 1 month prior to study Day 1 are permitted. Stability of brain metastases must be confirmed with imaging. Subject treated with gamma knife the can be enrolled 2 weeks post-procedure as long as there are no post-procedure complications/stable. In addition, subjects treated or currently taking enzyme-inducing anticonvulsant are allowed on study.

• Cardiac abnormalities as evidenced by any of the following: History or current "untreated" clinically significant uncontrolled arrhythmias; Clinically significant conduction abnormalities or arrhythmias, subjects with Bundle Branch Block; Presence of cardiac pacemaker; History or evidence of current >=Class II congestive heart failure as defined by New York Heart Association (NYHA); History of acute coronary syndromes (including unstable angina and myocardial infarction ), coronary angioplasty, or stenting within the past 3 months.

• Any of the following ECG findings: Baseline QTcF interval >=450 millisecond (msec); Any clinically significant ECG assessments should be reviewed by the site cardiologist prior to study entry.

• GSK525762 is a benzodiazepine class molecule. Any serious known immediate or delayed hypersensitivity reaction(s) to GSK525762 or idiosyncrasy to drugs chemically related to the investigational drug.

• Hemoptysis >1 teaspoon in 24 hours within the last 28 days.

• History of major gastrointestinal bleeding within the last 6 months. Any evidence of active gastrointestinal bleeding excludes the subject.

• Besylate Sub-Study only: unable or unwilling to eat the FDA recommended high-fat high-calorie breakfast (two eggs fried in butter, two strips of bacon, 4 ounce [oz]) of hash brown potatoes and 8 oz of whole milk) within the recommended 30 minutes.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Baltimore	Maryland	United States	21231-2410
2	GSK Investigational Site	Boston	Massachusetts	United States	02215
3	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19104
4	GSK Investigational Site	Nashville	Tennessee	United States	37232
5	GSK Investigational Site	Houston	Texas	United States	77030
6	GSK Investigational Site	Clayton	Victoria	Australia	3168
7	GSK Investigational Site	Bordeaux Cedex		France	33076
8	GSK Investigational Site	Lyon Cedex 08		France	69373
9	GSK Investigational Site	Paris Cedex 5		France	75248
10	GSK Investigational Site	Seoul		Korea, Republic of	03080
11	GSK Investigational Site	Seoul		Korea, Republic of	03722
12	GSK Investigational Site	Amsterdam		Netherlands	1066 CX
13	GSK Investigational Site	Barcelona		Spain	08035
14	GSK Investigational Site	Madrid		Spain	28040
15	GSK Investigational Site	Málaga		Spain	29010
16	GSK Investigational Site	Sutton	Surrey	United Kingdom	SM2 5PT
17	GSK Investigational Site	Newcastle upon Tyne		United Kingdom	NE7 7DN

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Study Protocol - Feb 24, 2017
• Statistical Analysis Plan - Sep 20, 2016

More Information

Publications

• Piha-Paul SA, Hann CL, French CA, Cousin S, Braña I, Cassier PA, Moreno V, de Bono JS, Harward SD, Ferron-Brady G, Barbash O, Wyce A, Wu Y, Horner T, Annan M, Parr NJ, Prinjha RK, Carpenter CL, Hilton J, Hong DS, Haas NB, Markowski MC, Dhar A, O'Dwyer PJ, Shapiro GI. Phase 1 Study of Molibresib (GSK525762), a Bromodomain and Extra-Terminal Domain Protein Inhibitor, in NUT Carcinoma and Other Solid Tumors. JNCI Cancer Spectr. 2019 Nov 6;4(2):pkz093. doi: 10.1093/jncics/pkz093. eCollection 2020 Apr.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01587703
• Other Study ID Numbers: 115521; 2014-004982-25
• First Posted: Apr 30, 2012
• Last Update Posted: Mar 16, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by GlaxoSmithKline: BRD3; GSK525762; NUT Midline Carcinoma; MYCN-amplified Solid Tumor; BRD4; BET inhibitor; bromodomains; NMC; Colorectal C ancer; Small Cell Lung Cancer; Multiple Myeloma; Neuroblastoma; Oncology
• Additional relevant MeSH terms: Carcinoma

Study Results

Participant Flow

Recruitment Details	A total 196 participants were enrolled and randomized in the Part 1 QD (65 participants), Part 1 BID (19 participants), Besylate Substudy (10 participants), and Part 2 (102 participants) groups.
Pre-assignment Detail	This was a 2-Part study conducted in 8 countries-Part 1 (dose-escalation) and Part 2 (dose expansion). A besylate sub-study (four period, crossover) was conducted in 10 participants in the United States.

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID	Part 2: Participants With NMC	Part 2: Participants With SCLC	Part 2: Participants With CRPC	Part 2: Participants With TNBC	Part 2: Participants With ER+BC	Part 2: Participants With GIST	80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes	80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes
Arm/Group Description	Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.	Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762.	Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Castrate-Resistant Prostate Cancer (CRPR) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762.	Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762.	Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.	Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
Period Title: Part1 QD(Median Exposure of 1.38months)
STARTED	3	4	1	3	4	9	32	9	0	0	0	0	0	0	0	0	0	0	0
COMPLETED	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
NOT COMPLETED	3	4	1	3	4	8	32	9	0	0	0	0	0	0	0	0	0	0	0
Period Title: Part1 QD(Median Exposure of 1.38months)
STARTED	0	0	0	0	0	0	0	0	4	10	5	0	0	0	0	0	0	0	0
COMPLETED	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
NOT COMPLETED	0	0	0	0	0	0	0	0	3	10	5	0	0	0	0	0	0	0	0
Period Title: Part1 QD(Median Exposure of 1.38months)
STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	5
COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	5
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: Part1 QD(Median Exposure of 1.38months)
STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	5
COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	5
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: Part1 QD(Median Exposure of 1.38months)
STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	5
COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	5
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: Part1 QD(Median Exposure of 1.38months)
STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	5
COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	5
Period Title: Part1 QD(Median Exposure of 1.38months)
STARTED	0	0	0	0	0	0	0	0	0	0	0	12	14	23	19	21	13	0	0
COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	12	14	22	19	21	13	0	0

Baseline Characteristics

Arm/Group Title	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID	All Participants in Besylate Substudy	Part 2: Participants With NMC	Part 2: Participants With SCLC	Part 2: Participants With CRPC	Part 1: GSK525762 2 mg QD	Part 2: Participants With TNBC	Part 2: Participants With ER+BC	Part 2: Participants With GIST	Total
Arm/Group Description	Participants were administered once daily oral dose of 4 mg GSK525762	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.	All participants who entered besylate sub-study and received 80 mg amor free-base tablet along with 6 mg stable iso in solution in fasted state; 80 mg bes tablet along with 6 mg stable iso in solution in fasted state, 30 mg bes tablet along with 6 mg stable iso in solution in fasted state and 80 mg bes tablet with FDA recommended high fat breakfast in one of the treatment periods were included.	Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762.	Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Castrate-Resistant Prostate Cancer (CRPR) were administered continuous once daily oral dose of 75 mg GSK525762	Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.	Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762.	Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762.	Total of all reporting groups
Overall Participants	4	1	3	4	9	32	9	4	10	5	10	12	14	23	3	19	21	13	196
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	47.0 (19.44)	39.0 (NA)	53.7 (4.19)	49.3 (23.27)	46.7 (17.06)	51.5 (16.82)	58.3 (19.92)	66.5 (6.45)	63.5 (8.42)	60.4 (4.83)	55.2 (9.96)	42.9 (18.05)	58.3 (11.04)	63.8 (6.11)	40.0 (15.77)	50.8 (8.66)	59.7 (10.34)	61.0 (13.23)	55.4 (14.37)
Sex: Female, Male (Count of Participants)
Female	3 75%	1 100%	3 100%	1 25%	6 66.7%	14 43.8%	2 22.2%	2 50%	4 40%	1 20%	5 50%	7 58.3%	9 64.3%	0 0%	1 33.3%	19 100%	21 100%	6 46.2%	105 53.6%
Male	1 25%	0 0%	0 0%	3 75%	3 33.3%	18 56.3%	7 77.8%	2 50%	6 60%	4 80%	5 50%	5 41.7%	5 35.7%	23 100%	2 66.7%	0 0%	0 0%	7 53.8%	91 46.4%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	0 0%	1 100%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 0.5%
Central/South Asian Heritage (Her)	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 8.3%	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%	3 1.5%
Japanese Her/East Asian Her/South East Asian Her	1 25%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 25%	0 0%	0 0%	0 0%	2 16.7%	3 21.4%	0 0%	0 0%	1 5.3%	0 0%	1 7.7%	9 4.6%
Black or African American	0 0%	0 0%	1 33.3%	0 0%	1 11.1%	2 6.3%	1 11.1%	0 0%	0 0%	0 0%	1 10%	0 0%	2 14.3%	0 0%	0 0%	2 10.5%	1 4.8%	1 7.7%	12 6.1%
White	3 75%	0 0%	2 66.7%	4 100%	7 77.8%	30 93.8%	8 88.9%	3 75%	10 100%	5 100%	9 90%	6 50%	8 57.1%	23 100%	2 66.7%	15 78.9%	18 85.7%	10 76.9%	163 83.2%
Missing	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	3 25%	1 7.1%	0 0%	0 0%	1 5.3%	2 9.5%	1 7.7%	8 4.1%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QD
Description	An AE is any untoward medical occurrence in a participant 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 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; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment. All Treated Population comprised of all participants who received at least one dose of study treatment.
Time Frame	Median of 1.38 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	3	4	1	3	4	9	32	9
Any AE	3 75%	4 400%	1 33.3%	3 75%	3 33.3%	9 28.1%	31 344.4%	9 225%
Any SAE	0 0%	2 200%	0 0%	0 0%	1 11.1%	2 6.3%	21 233.3%	3 75%

2. Primary Outcome

Title	Number of Participants With AEs and SAEs-Part 1 BID
Description	An AE is any untoward medical occurrence in a participant 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 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; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment
Time Frame	Median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.
Measure Participants	4	10	5
Any AE	4 100%	10 1000%	5 166.7%
Any SAE	0 0%	4 400%	2 66.7%

3. Primary Outcome

Title	Number of Participants With AEs and SAEs-Part 2
Description	An AE is any untoward medical occurrence in a participant 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 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; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment.
Time Frame	Median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Participants With NMC	Participants With SCLC	Participants With CRPC	Participants With TNBC	Participants With ER+BC	Participants With GIST
Arm/Group Description	Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762
Measure Participants	12	14	23	19	21	13
Any AE	11 275%	14 1400%	23 766.7%	19 475%	21 233.3%	13 40.6%
Any SAE	6 150%	9 900%	16 533.3%	11 275%	15 166.7%	8 25%

4. Primary Outcome

Title	Number of Participants With Dose Reductions or Delays-Part 1 QD
Description	The number of participants who had any dose reductions or delays is presented.
Time Frame	Median of 1.38 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762.	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	3	4	1	3	4	9	32	9
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%	2 6.3%	8 88.9%	7 175%

5. Primary Outcome

Title	Number of Participants With Dose Reductions or Delays-Part 1 BID
Description	The number of participants who had any dose reductions or delays is presented.
Time Frame	Median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.
Measure Participants	4	10	5
Count of Participants [Participants]	0 0%	3 300%	1 33.3%

6. Primary Outcome

Title	Number of Participants With Dose Reductions or Delays-Part 2
Description	The number of participants who had any dose reductions or delays is presented.
Time Frame	Median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Participants With NMC	Participants With SCLC	Participants With CRPC	Participants With TNBC	Participants With ER+BC	Participants With GIST
Arm/Group Description	Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762
Measure Participants	12	14	23	19	21	13
Count of Participants [Participants]	7 175%	4 400%	11 366.7%	6 150%	6 66.7%	4 12.5%

7. Primary Outcome

Title	Number of Participants With Dose Reductions or Delays-Besylate Sub-study
Description	The number of participants who had any dose reductions or delays is presented.
Time Frame	Median of 1.87 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes	80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes
Arm/Group Description	Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.	Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
Measure Participants	5	5
Count of Participants [Participants]	3 75%	1 100%

8. Primary Outcome

Title	Number of Participants Withdrawn Due to Toxicities-Part 1 QD
Description	Number of participants withdrawn due to toxicities is presented.
Time Frame	Median of 1.38 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762.	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	3	4	1	3	4	9	32	9
Count of Participants [Participants]	0 0%	1 100%	0 0%	0 0%	0 0%	2 6.3%	7 77.8%	2 50%

9. Primary Outcome

Title	Number of Participants Withdrawn Due to Toxicities-Part 1 BID
Description	Number of participants withdrawn due to toxicities is presented.
Time Frame	Median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.
Measure Participants	4	10	5
Count of Participants [Participants]	0 0%	2 200%	2 66.7%

10. Primary Outcome

Title	Number of Participants Withdrawn Due to Toxicities-Part 2
Description	Number of participants withdrawn due to toxicities is presented.
Time Frame	Median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Participants With NMC	Participants With SCLC	Participants With CRPC	Participants With TNBC	Participants With ER+BC	Participants With GIST
Arm/Group Description	Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762
Measure Participants	12	14	23	19	21	13
Count of Participants [Participants]	1 25%	3 300%	6 200%	4 100%	6 66.7%	2 6.3%

11. Primary Outcome

Title	Number of Participants Withdrawn Due to Toxicities-Besylate Sub-study
Description	Number of participants withdrawn due to toxicities is presented.
Time Frame	Median of 1.87 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes	80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes
Arm/Group Description	Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.	Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
Measure Participants	5	5
Count of Participants [Participants]	0 0%	0 0%

12. Primary Outcome

Title	Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Description	Blood samples were collected for the analysis of: glucose, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), amylase, aspartate aminotransferase (AST), direct bilirubin (Dir bil), bilirubin, N-Terminal proB-type natriuretic peptide (NT-BNP), calcium, cholesterol, creatine kinase (CK), chloride, carbon dioxide (CO2), creatinine, gamma glutamyl transferase (GGT), high and low density lipoprotein (HDL and LDL), insulin, potassium, lactate dehydrogenase (LDH), lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Grading was done according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on first study treatment dose date. Data for worst case post-Baseline is presented.
Time Frame	Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762.	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	3	4	1	3	4	9	32	9
Glucose; Any grade increase; n=2,4,1,3,4,9,32,9	0 0%	2 200%	1 33.3%	3 75%	2 22.2%	7 21.9%	24 266.7%	8 200%
Glucose; Increase to Grade 3; n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 22.2%	3 75%
Glucose; Increase to Grade 4; n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Albumin; Any grade increase; n=2,4,1,3,4,9,32,9	0 0%	2 200%	0 0%	0 0%	1 11.1%	3 9.4%	12 133.3%	1 25%
Albumin; Increase to Grade 3; n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Albumin; Increase to Grade 4; n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
ALP; Any grade increase; n=2,4,1,3,4,9,31,9	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%	7 77.8%	0 0%
ALP; Increase to Grade 3; n=2,4,1,3,4,9,31,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%
ALP; Increase to Grade 4; n=2,4,1,3,4,9,31,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
ALT; Any grade increase; n=2,4,1,3,4,9,32,9	0 0%	0 0%	1 33.3%	0 0%	1 11.1%	1 3.1%	9 100%	2 50%
ALT; Increase to Grade 3; n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
ALT; Increase to Grade 4; n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Amylase; Any grade increase; n=2,4,1,3,4,9,32,9	1 25%	1 100%	0 0%	1 25%	2 22.2%	0 0%	10 111.1%	1 25%
Amylase; Increase to Grade 3; n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 11.1%	1 25%
Amylase; Increase to Grade 4; n=2,4,1,3,4,9,32,9	0 0%	1 100%	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%
AST; Any grade increase; n=2,4,1,3,4,9,32,9	2 50%	1 100%	1 33.3%	0 0%	2 22.2%	1 3.1%	14 155.6%	3 75%
AST; Increase to Grade 3; n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 25%
AST; Increase to Grade 4; n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Dir bil; Any grade increase; n=2,4,1,3,4,9,30,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Dir bil; Increase to Grade 3; n=2,4,1,3,4,9,30,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Dir bil; Increase to Grade 4; n=2,4,1,3,4,9,30,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Bilirubin; Any grade increase; n=2,4,1,3,4,9,32,9	0 0%	0 0%	1 33.3%	0 0%	1 11.1%	1 3.1%	15 166.7%	8 200%
Bilirubin; Increase to Grade 3; n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%	5 55.6%	1 25%
Bilirubin; Increase to Grade 4; n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
NT-BNP; Any grade increase; n=2,4,1,3,4,9,30,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
NT-BNP; Increase to Grade 3; n=2,4,1,3,4,9,30,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
NT-BNP; Increase to Grade 4; n=2,4,1,3,4,9,30,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Calcium; Any grade increase; n=2,4,1,3,4,9,32,9	1 25%	1 100%	0 0%	1 25%	2 22.2%	1 3.1%	17 188.9%	3 75%
Calcium; Increase to Grade 3; n=2,4,1,3,4,9,32,9	1 25%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Calcium; Increase to Grade 4; n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Cholesterol;Any grade increase;n=2,4,1,3,4,7,29,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	11 122.2%	1 25%
Cholesterol;Increase to Grade 3;n=2,4,1,3,4,7,29,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Cholesterol;Increase to Grade 4;n=2,4,1,3,4,7,29,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
CK;Any grade increase;n=3,4,1,3,4,9,31,9	0 0%	1 100%	0 0%	0 0%	1 11.1%	0 0%	11 122.2%	5 125%
CK; Increase to Grade 3; n=3, 4, 1, 3, 4, 9, 31, 9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 22.2%	0 0%
CK; Increase to Grade 4; n=3, 4, 1, 3, 4, 9, 31, 9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Chloride; Any grade increase; n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Chloride; Increase to Grade 3;n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Chloride;Increase to Grade 4;n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
CO2; Any grade increase; n=2, 4, 1, 3, 4, 9, 32, 9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
CO2; Increase to Grade 3; n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
CO2; Increase to Grade 4; n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Creatinine;Any grade increase;n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%	7 77.8%	3 75%
Creatinine;Increase to Grade 3;n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%
Creatinine;Increase to Grade 4;n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
GGT; Any grade increase; n=2, 4, 1, 3, 4, 9, 31, 7	0 0%	1 100%	0 0%	0 0%	1 11.1%	0 0%	11 122.2%	1 25%
GGT;Increase to Grade 3; n=2,4,1,3,4,9,31,7	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 22.2%	0 0%
GGT; Increase to Grade 4; n=2,4,1,3,4,9,31,7	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%
HDL; Any grade increase; n=2, 4, 1, 3, 4, 7, 28, 9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
HDL; Increase to Grade 3; n=2,4,1,3,4,7,28,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
HDL; Increase to Grade 4; n=2,4,1,3,4,7,28,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Insulin; Any grade increase; n=2,4,1,3,4,9,31,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Insulin; Increase to Grade 3; n=2,4,1,3,4,9,31,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Insulin; Increase to Grade 4; n=2,4,1,3,4,9,31,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Potassium;Any grade increase;n=3,4,1,3,4,9,32,9	2 50%	2 200%	0 0%	3 75%	0 0%	2 6.3%	13 144.4%	3 75%
Potassium;Increase to Grade 3;n=3,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 11.1%	1 25%
Potassium;Increase to Grade 4;n=3,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%
LDH; Any grade increase; n=0, 0, 0, 0, 0, 1, 0, 0	0 0%
LDH; Increase to Grade 3; n=0, 0, 0, 0, 0, 1, 0, 0	0 0%
LDH; Increase to Grade 4; n=0, 0, 0, 0, 0, 1, 0, 0	0 0%
LDL; Any grade increase; n=2, 4, 1, 3, 4, 7, 28, 8	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
LDL;Increase to Grade 3; n=2,4,1,3,4,7,28,8	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
LDL;Increase to Grade 4; n=2,4,1,3,4,7,28,8	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lipase;Any grade increase; n=2,4,1,3,4,9,31,9	1 25%	0 0%	0 0%	0 0%	0 0%	0 0%	8 88.9%	2 50%
Lipase;Increase to Grade 3; n=2,4,1,3,4,9,31,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	3 33.3%	0 0%
Lipase;Increase to Grade 4; n=2,4,1,3,4,9,31,9	1 25%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Magnesium;Any grade increase;n=3,4,1,3,4,9,32,9	0 0%	2 200%	1 33.3%	1 25%	1 11.1%	0 0%	9 100%	2 50%
Magnesium;Increase to Grade 3;n=3,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Magnesium;Increase to Grade 4;n=3,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Protein;Any grade increase; n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Protein;Increase to Grade 3; n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Protein;Increase to Grade 4; n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Sodium;Any grade increase; n=3,4,1,3,4,9,32,9	1 25%	3 300%	0 0%	1 25%	2 22.2%	3 9.4%	16 177.8%	4 100%
Sodium;Increase to Grade 3; n=3,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%	4 44.4%	0 0%
Sodium;Increase to Grade 4; n=3,4,1,3,4,9,32,9	0 0%	1 100%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Thyroxine;Any grade increase;n=2,4,1,3,4,7,29,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Thyroxine;Increase to Grade 3; n=2,4,1,3,4,7,29,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Thyroxine;Increase to Grade 4; n=2,4,1,3,4,7,29,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Testosterone;Any grade increase;n=1,0,0,0,3,3,14,7	0 0%	0 0%	0 0%	0 0%	0 0%
Testosterone;Increase to Grade3;n=1,0,0,0,3,3,14,7	0 0%	0 0%	0 0%	0 0%	0 0%
Testosterone;Increase to Grade4;n=1,0,0,0,3,3,14,7	0 0%	0 0%	0 0%	0 0%	0 0%
Triglyc;Any grade increase;n=2,4,1,3,4,7,29,9	0 0%	2 200%	0 0%	0 0%	2 22.2%	2 6.3%	17 188.9%	6 150%
Triglyc;Increase to Grade 3;n=2,4,1,3,4,7,29,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Triglyc;Increase to Grade 4;n=2,4,1,3,4,7,29,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 25%
Troponin I;Any grade increase;n=0,0,0,0, 2,5,24,5	0 0%	0 0%	0 0%	0 0%
Troponin I;Increase to Grade 3;n=0,0,0,0,2,5,24,5	0 0%	0 0%	0 0%	0 0%
Troponin I;Increase to Grade 4; n=0,0,0,0,2,5,24,5	0 0%	0 0%	0 0%	0 0%
Troponin T;Any grade increase;n=3,4,1,3,4,9,31,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Troponin T;Increase to Grade 3; n=3,4,1,3,4,9,31,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Troponin T;Increase to Grade 4; n=3,4,1,3,4,9,31,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Urate;Any grade increase; n=2,4,1,3,4,9,32,9	1 25%	0 0%	0 0%	0 0%	1 11.1%	0 0%	1 11.1%	0 0%
Urate; Increase to Grade 3; n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Urate; Increase to Grade 4; n=2,4,1,3,4,9,32,9	1 25%	0 0%	0 0%	0 0%	1 11.1%	0 0%	1 11.1%	0 0%
Urea; Any grade increase; n=2,4,1,3,4,9,31,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Urea; Increase to Grade 3; n=2,4,1,3,4,9,31,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Urea; Increase to Grade 4; n=2,4,1,3,4,9,31,9	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

13. Primary Outcome

Title	Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID
Description	Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post-Baseline is presented.
Time Frame	Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.
Measure Participants	4	10	5
Glucose; Any grade increase; n=4, 10, 5	1 25%	9 900%	5 166.7%
Glucose; Increase to Grade 3; n=4, 10, 5	1 25%	3 300%	1 33.3%
Glucose; Increase to Grade 4; n=4, 10, 5	0 0%	0 0%	0 0%
Albumin; Any grade increase; n=4, 10, 5	0 0%	4 400%	1 33.3%
Albumin; Increase to Grade 3; n=4, 10, 5	0 0%	0 0%	0 0%
Albumin; Increase to Grade 4; n=4, 10, 5	0 0%	0 0%	0 0%
ALP; Any grade increase; n=4, 10, 5	0 0%	4 400%	2 66.7%
ALP; Increase to Grade 3; n=4, 10, 5	0 0%	2 200%	0 0%
ALP; Increase to Grade 4; n=4, 10, 5	0 0%	0 0%	0 0%
ALT; Any grade increase; n=4, 10, 5	0 0%	5 500%	1 33.3%
ALT; Increase to Grade 3; n=4, 10, 5	0 0%	1 100%	0 0%
ALT; Increase to Grade 4; n=4, 10, 5	0 0%	0 0%	0 0%
Amylase; Any grade increase; n=4, 10, 5	0 0%	2 200%	2 66.7%
Amylase; Increase to Grade 3; n=4, 10, 5	0 0%	0 0%	0 0%
Amylase; Increase to Grade 4; n=4, 10, 5	0 0%	0 0%	0 0%
AST; Any grade increase; n=4, 10, 5	2 50%	6 600%	1 33.3%
AST; Increase to Grade 3; n=4, 10, 5	0 0%	2 200%	0 0%
AST; Increase to Grade 4; n=4, 10, 5	0 0%	0 0%	0 0%
Dir bil; Any grade increase; n=4, 9, 4	0 0%	0 0%	0 0%
Dir bil; Increase to Grade 3; n=4, 9, 4	0 0%	0 0%	0 0%
Dir bil; Increase to Grade 4; n=4, 9, 4	0 0%	0 0%	0 0%
Bilirubin; Any grade increase; n=4, 10, 5	1 25%	7 700%	2 66.7%
Bilirubin; Increase to Grade 3; n=4, 10, 5	1 25%	1 100%	1 33.3%
Bilirubin; Increase to Grade 4; n=4, 10, 5	0 0%	1 100%	0 0%
NT-BNP; Any grade increase; n=4, 10, 5	0 0%	0 0%	0 0%
NT-BNP; Increase to Grade 3; n=4, 10, 5	0 0%	0 0%	0 0%
NT-BNP; Increase to Grade 4; n=4, 10, 5	0 0%	0 0%	0 0%
Calcium; Any grade increase; n=4, 10, 5	1 25%	2 200%	1 33.3%
Calcium; Increase to Grade 3; n=4, 10, 5	0 0%	0 0%	0 0%
Calcium; Increase to Grade 4; n=4, 10, 5	0 0%	0 0%	0 0%
Cholesterol; Any grade increase; n=2, 9, 5	0 0%	2 200%	0 0%
Cholesterol; Increase to Grade 3; n=2, 9, 5	0 0%	0 0%	0 0%
Cholesterol; Increase to Grade 4; n=2, 9, 5	0 0%	0 0%	0 0%
CK; Any grade increase; n=4, 10, 5	0 0%	3 300%	2 66.7%
CK; Increase to Grade 3; n=n=4, 10, 5	0 0%	0 0%	0 0%
CK; Increase to Grade 4; n=n=4, 10, 5	0 0%	0 0%	0 0%
Chloride; Any grade increase; n=4, 10, 5	0 0%	0 0%	0 0%
Chloride; Increase to Grade 3; n=4, 10, 5	0 0%	0 0%	0 0%
Chloride; Increase to Grade 4; n=4, 10, 5	0 0%	0 0%	0 0%
CO2; Any grade increase; n=4, 10, 5	0 0%	0 0%	0 0%
CO2; Increase to Grade 3; n=4, 10, 5	0 0%	0 0%	0 0%
CO2; Increase to Grade 4; n=4, 10, 5	0 0%	0 0%	0 0%
Creatinine; Any grade increase; n=4, 10, 5	0 0%	2 200%	2 66.7%
Creatinine; Increase to Grade 3; n=4, 10, 5	0 0%	0 0%	0 0%
Creatinine; Increase to Grade 4; n=4, 10, 5	0 0%	0 0%	0 0%
GGT; Any grade increase; n=4, 10, 5	0 0%	4 400%	1 33.3%
GGT; Increase to Grade 3; n=4, 10, 5	0 0%	1 100%	0 0%
GGT; Increase to Grade 4; n=4, 10, 5	0 0%	1 100%	0 0%
HDL; Any grade increase; n=2, 9, 5	0 0%	0 0%	0 0%
HDL; Increase to Grade 3; n=2, 9, 5	0 0%	0 0%	0 0%
HDL; Increase to Grade 4; n=2, 9, 5	0 0%	0 0%	0 0%
Insulin; Any grade increase; n=4, 10, 5	0 0%	0 0%	0 0%
Insulin; Increase to Grade 3; n=4, 10, 5	0 0%	0 0%	0 0%
Insulin; Increase to Grade 4; n=4, 10, 5	0 0%	0 0%	0 0%
Potassium; Any grade increase; n=4, 10, 5	1 25%	5 500%	2 66.7%
Potassium; Increase to Grade 3; n=4, 10, 5	0 0%	0 0%	0 0%
Potassium; Increase to Grade 4; n=4, 10, 5	0 0%	0 0%	0 0%
LDL; Any grade increase; n=2, 9, 5	0 0%	0 0%	0 0%
LDL; Increase to Grade 3; n=2, 9, 5	0 0%	0 0%	0 0%
LDL; Increase to Grade 4; n=2, 9, 5	0 0%	0 0%	0 0%
Lipase; Any grade increase; n=4, 10, 5	0 0%	2 200%	3 100%
Lipase; Increase to Grade 3; n=4, 10, 5	0 0%	1 100%	0 0%
Lipase; Increase to Grade 4; n=4, 10, 5	0 0%	0 0%	0 0%
Magnesium; Any grade increase; n=4, 10, 5	0 0%	2 200%	2 66.7%
Magnesium; Increase to Grade 3; n=4, 10, 5	0 0%	0 0%	0 0%
Magnesium; Increase to Grade 4; n=4, 10, 5	0 0%	1 100%	0 0%
Protein; Any grade increase; n=4, 10, 5	0 0%	0 0%	0 0%
Protein; Increase to Grade 3; n=4, 10, 5	0 0%	0 0%	0 0%
Protein; Increase to Grade 4; n=4, 10, 5	0 0%	0 0%	0 0%
Sodium; Any grade increase; n=4, 10, 5	0 0%	7 700%	2 66.7%
Sodium; Increase to Grade 3; n=4, 10, 5	0 0%	2 200%	0 0%
Sodium; Increase to Grade 4; n=4, 10, 5	0 0%	0 0%	0 0%
Thyroxine; Any grade increase; n=3, 9, 5	0 0%	0 0%	0 0%
Thyroxine; Increase to Grade 3; n=3, 9, 5	0 0%	0 0%	0 0%
Thyroxine; Increase to Grade 4; n=3, 9, 5	0 0%	0 0%	0 0%
Testosterone; Any grade increase; n=1, 4, 4	0 0%	0 0%	0 0%
Testosterone; Increase to Grade 3; n=1, 4, 4	0 0%	0 0%	0 0%
Testosterone; Increase to Grade 4; n=1, 4, 4	0 0%	0 0%	0 0%
Triglycerides; Any grade increase; n=2, 9, 5	0 0%	4 400%	4 133.3%
Triglycerides; Increase to Grade 3; n=2, 9, 5	0 0%	0 0%	0 0%
Triglycerides; Increase to Grade 4; n=2, 9, 5	0 0%	0 0%	0 0%
Troponin I; Any grade increase; n=3, 10, 5	0 0%	0 0%	0 0%
Troponin I; Increase to Grade 3; n=3, 10, 5	0 0%	0 0%	0 0%
Troponin I; Increase to Grade 4; n=3, 10, 5	0 0%	0 0%	0 0%
Troponin T; Any grade increase; n=4, 10, 5	0 0%	0 0%	0 0%
Troponin T; Increase to Grade 3; n=4, 10, 5	0 0%	0 0%	0 0%
Troponin T; Increase to Grade 4; n=4, 10, 5	0 0%	0 0%	0 0%
Urate; Any grade increase; n=4, 10, 5	0 0%	0 0%	0 0%
Urate; Increase to Grade 3; n=4, 10, 5	0 0%	0 0%	0 0%
Urate; Increase to Grade 4; n=4, 10, 5	0 0%	0 0%	0 0%
Urea; Any grade increase; n=4, 10, 5	0 0%	0 0%	0 0%
Urea; Increase to Grade 3; n=4, 10, 5	0 0%	0 0%	0 0%
Urea; Increase to Grade 4; n=4, 10, 5	0 0%	0 0%	0 0%

14. Primary Outcome

Title	Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2
Description	Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides (triglyc), troponin I and T, urate and urea. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post-Baseline is presented.
Time Frame	Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title	Part 2: Participants With NMC	Part 2: Participants With SCLC	Part 2: Participants With CRPC	Part 2: Participants With TNBC	Part 2: Participants With ER+BC	Part 2: Participants With GIST
Arm/Group Description	Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762.	Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762.	Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762.	Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762.	Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762.	Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762.
Measure Participants	12	14	23	19	21	13
Glucose; Any grade increase; n=11,13,23,19,21,12	10 250%	10 1000%	20 666.7%	16 400%	18 200%	9 28.1%
Glucose; Increase to Grade 3; n=11,13,23,19,21,12	0 0%	0 0%	0 0%	0 0%	1 11.1%	2 6.3%
Glucose; Increase to Grade 4; n=11,13,23,19,21,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Albumin; Any grade increase; n=11,13,23,19,21,12	5 125%	6 600%	9 300%	8 200%	7 77.8%	5 15.6%
Albumin; Increase to Grade 3; n=11,13,23,19,21,12	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%
Albumin; Increase to Grade 4; n=11,13,23,19,21,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
ALP; Any grade increase; n=11,13,23,19,21,12	3 75%	1 100%	6 200%	3 75%	4 44.4%	4 12.5%
ALP; Increase to Grade 3; n=11,13,23,19,21,12	0 0%	0 0%	2 66.7%	0 0%	0 0%	0 0%
ALP; Increase to Grade 4; n=11,13,23,19,21,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
ALT; Any grade increase; n=11,14,23,19,21,12	3 75%	6 600%	6 200%	5 125%	12 133.3%	3 9.4%
ALT; Increase to Grade 3; n=11,14,23,19,21,12	0 0%	1 100%	0 0%	0 0%	0 0%	0 0%
ALT; Increase to Grade 4; n=11,14,23,19,21,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Amylase; Any grade increase; n=11,12,22,19,20,12	5 125%	5 500%	9 300%	5 125%	6 66.7%	1 3.1%
Amylase; Increase to Grade 3; n=11,12,22,19,20,12	1 25%	2 200%	2 66.7%	2 50%	2 22.2%	0 0%
Amylase; Increase to Grade 4; n=11,12,22,19,20,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
AST; Any grade increase; n=11,13,23,19,21,12	3 75%	5 500%	10 333.3%	8 200%	14 155.6%	6 18.8%
AST; Increase to Grade 3; n=11,13,23,19,21,12	0 0%	0 0%	1 33.3%	1 25%	3 33.3%	0 0%
AST; Increase to Grade 4; n=11,13,23,19,21,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Dir bil; Any grade increase; n=11,13,23,19,20,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Dir bil; Increase to Grade 3; n=11,13,23,19,20,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Dir bil; Increase to Grade 4; n=11,13,23,19,20,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Bilirubin;Any grade increase;n=11,14,23,19,21,12	8 200%	10 1000%	13 433.3%	6 150%	13 144.4%	4 12.5%
Bilirubin;Increase to Grade 3; n=11,14,23,19,21,12	1 25%	1 100%	2 66.7%	0 0%	3 33.3%	0 0%
Bilirubin;Increase to Grade 4; n=11,14,23,19,21,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
NT-BNP; Any grade increase; n=11,12,22,17,15,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
NT-BNP; Increase to Grade 3; n=11,12,22,17,15,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
NT-BNP; Increase to Grade 4; n=11,12,22,17,15,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Calcium; Any grade increase; n=11,13,23,19,21,12	6 150%	3 300%	8 266.7%	4 100%	3 33.3%	3 9.4%
Calcium; Increase to Grade 3; n=11,13,23,19,21,12	1 25%	0 0%	2 66.7%	0 0%	1 11.1%	0 0%
Calcium; Increase to Grade 4; n=11,13,23,19,21,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Cholesterol;Any grade increase;n=10,12,22,19,20,12	5 125%	2 200%	2 66.7%	2 50%	9 100%	5 15.6%
Cholesterol;Increase to Grade3;n=10,12,22,19,20,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Cholesterol;Increase to Grade4;n=10,12,22,19,20,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
CK; Any grade increase; n=9,9,21,17,18,11	3 75%	2 200%	4 133.3%	0 0%	7 77.8%	5 15.6%
CK; Increase to Grade 3; n=9,9,21,17,18,11	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
CK; Increase to Grade 4; n=9,9,21,17,18,11	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Chloride; Any grade increase; n=11,13,23,19,21,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Chloride; Increase to Grade 3; n=11,13,23,19,21,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Chloride; Increase to Grade 4; n=11,13,23,19,21,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
CO2; Any grade increase; n=11,12,23,19,21,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
CO2; Increase to Grade 3; n=11,12,23,19,21,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
CO2; Increase to Grade 4; n=11,12,23,19,21,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Creatinine;Any grade increase;n=11,14,23,19,21,12	3 75%	4 400%	9 300%	2 50%	6 66.7%	3 9.4%
Creatinine;Increase to Grade3;n=11,14,23,19,21,12	0 0%	0 0%	2 66.7%	0 0%	0 0%	0 0%
Creatinine;Increase to Grade4;n=11,14,23,19,21,12	0 0%	0 0%	1 33.3%	0 0%	0 0%	0 0%
GGT; Any grade increase; n=11,13,22,19,20,12	0 0%	3 300%	7 233.3%	5 125%	6 66.7%	1 3.1%
GGT; Increase to Grade 3; n=11,13,22,19,20,12	0 0%	0 0%	2 66.7%	2 50%	3 33.3%	0 0%
GGT; Increase to Grade 4; n=11,13,22,19,20,12	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%
HDL; Any grade increase; n=10,10,22,19,19,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
HDL; Increase to Grade 3; n=10,10,22,19,19,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
HDL; Increase to Grade 4;n=10,10,22,19,19,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Insulin; Any grade increase; n=11,12,22,19,20,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Insulin; Increase to Grade 3; n=11,12,22,19,20,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Insulin; Increase to Grade 4; n=11,12,22,19,20,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Potassium; Any grade increase; n=11,14,23,19,21,12	6 150%	4 400%	10 333.3%	5 125%	7 77.8%	7 21.9%
Potassium;Increase to Grade3;n=11,14,23,19,21,12	0 0%	0 0%	1 33.3%	0 0%	0 0%	1 3.1%
Potassium;Increase to Grade4;n=11,14,23,19,21,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
LDL; Any grade increase; n=10,10,22,19,19,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
LDL; Increase to Grade 3; n=10,10,22,19,19,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
LDL; Increase to Grade 4;n=10,10,22,19,19,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lipase; Any grade increase; n=11,12,22,19,20,12	3 75%	5 500%	7 233.3%	5 125%	4 44.4%	2 6.3%
Lipase; Increase to Grade 3;n=11,12,22,19,20,12	2 50%	3 300%	0 0%	1 25%	0 0%	0 0%
Lipase; Increase to Grade 4;n=11,12,22,19,20,12	0 0%	0 0%	0 0%	1 25%	1 11.1%	0 0%
Magnesium; Any grade increase; n=11,12,22,19,21,12	2 50%	2 200%	5 166.7%	1 25%	4 44.4%	1 3.1%
Magnesium; Increase to Grade 3;n=11,12,22,19,21,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Magnesium; Increase to Grade4;n=11,12,22,19,21,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Protein; Any grade increase; n=11,13,23,19,21,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Protein; Increase to Grade 3;n=11,13,23,19,21,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Protein; Increase to Grade 4;n=11,13,23,19,21,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Sodium; Any grade increase; n=11, 14,23,19,21,12	5 125%	5 500%	8 266.7%	5 125%	4 44.4%	5 15.6%
Sodium; Increase to Grade 3; n=11, 14,23,19,21,12	0 0%	1 100%	1 33.3%	2 50%	0 0%	2 6.3%
Sodium; Increase to Grade 4; n=11, 14,23,19,21,12	1 25%	0 0%	0 0%	0 0%	0 0%	0 0%
Thyroxine; Any grade increase;n=7,7,20,15,18,8	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Thyroxine; Increase to Grade3;n=7,7,20,15,18,8	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Thyroxine; Increase to Grade4;n=7,7,20,15,18,8	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Testosterone; Any grade increase; n=4,3,18,0,1,5	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Testosterone; Increase to Grade3; n=4,3,18,0,1,5	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Testosterone; Increase to Grade4; n=4,3,18,0,1,5	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Triglyc;Any grade increase;n=10,12,22,19,20,12	7 175%	7 700%	15 500%	10 250%	11 122.2%	8 25%
Triglyc;Increase to Grade3;n=10,12,22,19,20,12	1 25%	0 0%	4 133.3%	0 0%	1 11.1%	0 0%
Triglyc;Increase to Grade4;n=10,12,22,19,20,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Troponin I; Any grade increase; n=7,6,15,15,14,7	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Troponin I; Increase to Grade 3; n=7,6,15,15,14,7	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Troponin I; Increase to Grade 4; n=7,6,15,15,14,7	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Troponin T;Any grade increase;n=11,12,22,19,20,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Troponin T;Increase to Grade3;n=11,12,22,19,20,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Troponin T;Increase to Grade4;n=11,12,22,19,20,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Urate; Any grade increase; n=11,12,22,19,20,12	0 0%	0 0%	2 66.7%	0 0%	0 0%	2 6.3%
Urate; Increase to Grade 3; n=11,12,22,19,20,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Urate; Increase to Grade 4; n=11,12,22,19,20,12	0 0%	0 0%	2 66.7%	0 0%	0 0%	2 6.3%
Urea; Any grade increase; n=11,14,23,17,17,11	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Urea; Increase to Grade 3; n=11,14,23,17,17,11	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Urea; Increase to Grade 4;n=11,14,23,17,17,11	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

15. Primary Outcome

Title	Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study
Description	Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Time Frame	Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title	80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes	80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes
Arm/Group Description	Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.	Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
Measure Participants	5	5
Glucose; Any grade increase; n=5,5	4 100%	5 500%
Glucose; Increase to Grade 3; n=5,5	0 0%	0 0%
Glucose; Increase to Grade 4; n=5,5	0 0%	0 0%
Albumin; Any grade increase; n=5,5	3 75%	3 300%
Albumin; Increase to Grade 3; n=5,5	1 25%	0 0%
Albumin; Increase to Grade 4; n=5,5	0 0%	0 0%
ALP; Any grade increase; n=5,5	1 25%	0 0%
ALP; Increase to Grade 3; n=5,5	0 0%	0 0%
ALP; Increase to Grade 4; n=5,5	0 0%	0 0%
ALT; Any grade increase; n=5,5	1 25%	1 100%
ALT; Increase to Grade 3; n=5,5	0 0%	0 0%
ALT; Increase to Grade 4; n=5,5	0 0%	0 0%
Amylase; Any grade increase; n=5,5	0 0%	0 0%
Amylase; Increase to Grade 3; n=5,5	0 0%	0 0%
Amylase; Increase to Grade 4; n=5,5	0 0%	0 0%
AST; Any grade increase; n=5,5	2 50%	1 100%
AST; Increase to Grade 3; n=5,5	0 0%	0 0%
AST; Increase to Grade 4; n=5,5	0 0%	0 0%
Dir bil; Any grade increase; n=5,5	0 0%	0 0%
Dir bil; Increase to Grade 3; n=5,5	0 0%	0 0%
Dir bil; Increase to Grade 4; n=5,5	0 0%	0 0%
Bilirubin; Any grade increase; n=5,5	3 75%	4 400%
Bilirubin; Increase to Grade 3; n=5,5	1 25%	2 200%
Bilirubin; Increase to Grade 4; n=5,5	0 0%	0 0%
NT-BNP; Any grade increase; n=5,5	0 0%	0 0%
NT-BNP; Increase to Grade 3; n=5,5	0 0%	0 0%
NT-BNP; Increase to Grade 4; n=5,5	0 0%	0 0%
Calcium; Any grade increase; n=5,5	1 25%	2 200%
Calcium; Increase to Grade 3; n=5,5	0 0%	0 0%
Calcium; Increase to Grade 4; n=5,5	0 0%	0 0%
Cholesterol; Any grade increase; n=5,3	1 25%	0 0%
Cholesterol; Increase to Grade 3; n=5,3	0 0%	0 0%
Cholesterol; Increase to Grade 4; n=5,3	0 0%	0 0%
CK; Any grade increase; n=5,5	2 50%	0 0%
CK; Increase to Grade 3; n=5,5	0 0%	0 0%
CK; Increase to Grade 4; n=5,5	0 0%	0 0%
Chloride; Any grade increase; n=5,5	0 0%	0 0%
Chloride; Increase to Grade 3; n=5,5	0 0%	0 0%
Chloride; Increase to Grade 4; n=5,5	0 0%	0 0%
CO2; Any grade increase; n=5,5	0 0%	0 0%
CO2; Increase to Grade 3; n=5,5	0 0%	0 0%
CO2; Increase to Grade 4; n=5,5	0 0%	0 0%
Creatinine; Any grade increase; n=5,5	1 25%	1 100%
Creatinine; Increase to Grade 3; n=5,5	0 0%	0 0%
Creatinine; Increase to Grade 4; n=5,5	0 0%	0 0%
GGT; Any grade increase; n=5,5	0 0%	0 0%
GGT; Increase to Grade 3; n=5,5	0 0%	0 0%
GGT; Increase to Grade 4; n=5,5	0 0%	0 0%
HDL; Any grade increase; n=5,3	0 0%	0 0%
HDL; Increase to Grade 3; n=5,3	0 0%	0 0%
HDL; Increase to Grade 4; n=5,3	0 0%	0 0%
Insulin; Any grade increase; n=5,5	0 0%	0 0%
Insulin; Increase to Grade 3; n=5,5	0 0%	0 0%
Insulin; Increase to Grade 4; n=5,5	0 0%	0 0%
Potassium; Any grade increase; n=5,5	3 75%	3 300%
Potassium; Increase to Grade 3; n=5,5	0 0%	0 0%
Potassium; Increase to Grade 4; n=5,5	0 0%	0 0%
LDL; Any grade increase; n=5,3	0 0%	0 0%
LDL; Increase to Grade 3; n=5,3	0 0%	0 0%
LDL; Increase to Grade 4; n=5,3	0 0%	0 0%
Lipase; Any grade increase; n=5,4	0 0%	0 0%
Lipase; Increase to Grade 3; n=5,4	0 0%	0 0%
Lipase; Increase to Grade 4;n=5,4	0 0%	0 0%
Magnesium; Any grade increase; n=5,5	2 50%	1 100%
Magnesium; Increase to Grade 3; n=5,5	0 0%	1 100%
Magnesium; Increase to Grade 4; n=5,5	0 0%	0 0%
Protein; Any grade increase; n=5,5	0 0%	0 0%
Protein; Increase to Grade 3; n=5,5	0 0%	0 0%
Protein; Increase to Grade 4; n=5,5	0 0%	0 0%
Sodium; Any grade increase; n=5,5	2 50%	3 300%
Sodium; Increase to Grade 3; n=5,5	0 0%	1 100%
Sodium; Increase to Grade 4; n=5,5	0 0%	0 0%
Thyroxine; Any grade increase; n=5,3	0 0%	0 0%
Thyroxine; Increase to Grade 3; n=5,3	0 0%	0 0%
Thyroxine; Increase to Grade 4; n=5,3	0 0%	0 0%
Testosterone; Any grade increase; n=2,1	0 0%	0 0%
Testosterone; Increase to Grade 3; n=2,1	0 0%	0 0%
Testosterone; Increase to Grade 4; n=2,1	0 0%	0 0%
Triglycerides; Any grade increase; n=5,3	1 25%	2 200%
Triglycerides; Increase to Grade 3; n=5,3	0 0%	0 0%
Triglycerides; Increase to Grade 4; n=5,3	0 0%	0 0%
Troponin I; Any grade increase; n=1,0	0 0%
Troponin I; Increase to Grade 3; n=1,0	0 0%
Troponin I; Increase to Grade 4; n=1,0	0 0%
Troponin T; Any grade increase; n=5,5	0 0%	0 0%
Troponin T; Increase to Grade 3; n=5,5	0 0%	0 0%
Troponin T; Increase to Grade 4; n=5,5	0 0%	0 0%
Urate; Any grade increase; n=5,5	0 0%	0 0%
Urate; Increase to Grade 3; n=5,5	0 0%	0 0%
Urate; Increase to Grade 4; n=5,5	0 0%	0 0%
Urea; Any grade increase; n=5,5	0 0%	0 0%
Urea; Increase to Grade 3; n=5,5	0 0%	0 0%
Urea; Increase to Grade 4; n=5,5	0 0%	0 0%

16. Primary Outcome

Title	Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD
Description	Blood samples were collected for the analysis of hematology parameters: activated partial thromboplastin time (aPTT), platelet count, red blood cell count (RBC), white blood cell count (WBC), prothrombin international normalized ratio (INR), prothrombin time (PT), fibrinogen (Fib), hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Time Frame	Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762.	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	2	4	1	3	4	9	32	9
Basophils;Any grade increase	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Basophils;Increase to Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Basophils;Increase to Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Eosinophils;Any grade increase	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Eosinophils;Increase to Grade3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Eosinophils;Increase to Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin;Any grade increase	1 25%	1 100%	0 0%	2 50%	2 22.2%	2 6.3%	21 233.3%	7 175%
Hemoglobin;Increase to Grade 3; n=2,4,1,3,4,9,32,9	0 0%	0 0%	0 0%	0 0%	1 11.1%	1 3.1%	9 100%	1 25%
Hemoglobin;Increase to Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
INR; Any grade increase	2 50%	2 200%	1 33.3%	0 0%	0 0%	1 3.1%	21 233.3%	2 50%
INR;Increase to Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
INR; Increase to Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes;Any grade increase	1 25%	2 200%	1 33.3%	0 0%	2 22.2%	5 15.6%	19 211.1%	4 100%
Lymphocytes;Increase to Grade3	0 0%	1 100%	0 0%	0 0%	0 0%	2 6.3%	8 88.9%	1 25%
Lymphocytes;Increase to Grade4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 11.1%	1 25%
Monocytes;Any grade increase	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Monocytes;Increase to Grade3	0 0%	0 0%	0 0%	0 0%	0 0%	00 0%	0 0%	0 0%
Monocytes;Increase to Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils;Any grade increase	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	7 77.8%	3 75%
Neutrophils;Increase to Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 25%
Neutrophils;Increase to Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%
Platelets;Any grade increase	0 0%	1 100%	0 0%	0 0%	2 22.2%	5 15.6%	26 288.9%	8 200%
Platelets;Increase to Grade 3	0 0%	1 100%	0 0%	0 0%	0 0%	0 0%	11 122.2%	5 125%
Platelets;Increase to Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	1 3.1%	5 55.6%	2 50%
PT; Any grade increase	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
PT; Increase to Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
PT; Increase to Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
RBC; Any grade increase	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
RBC;Increase to Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
RBC;Increase to Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
WBC; Any grade increase	0 0%	1 100%	0 0%	0 0%	0 0%	3 9.4%	11 122.2%	5 125%
WBC; Increase to Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 25%
WBC; Increase to Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%
Fib; Any grade increase	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	4 44.4%	0 0%
Fib;Increase to Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Fib;Increase to Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
aPTT; Any grade increase	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	14 155.6%	2 50%
aPTT; Increase to Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%
aPTT; Increase to Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

17. Primary Outcome

Title	Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID
Description	Blood samples were collected for the analysis of hematology parameters: aPTT, platelet count, RBC, WBC, INR, PT, Fib, hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Time Frame	Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 40 mg GSK525762.
Measure Participants	4	10	5
Basophils; Any grade increase; n=4,10,5	0 0%	0 0%	0 0%
Basophils; Increase to Grade 3; n=4,10,5	0 0%	0 0%	0 0%
Basophils; Increase to Grade 4; n=4,10,5	0 0%	0 0%	0 0%
Eosinophils; Any grade increase; n=4,10,5	0 0%	0 0%	0 0%
Eosinophils; Increase to Grade3; n=4,10,5	0 0%	0 0%	0 0%
Eosinophils; Increase to Grade4; n=4,10,5	0 0%	0 0%	0 0%
Hemoglobin; Any grade increase; n=4,10,5	4 100%	8 800%	4 133.3%
Hemoglobin; Increase to Grade 3; n=4,10,5	0 0%	3 300%	2 66.7%
Hemoglobin; Increase to Grade 4; n=4,10,5	0 0%	0 0%	0 0%
INR; Any grade increase; n=4,10,5	0 0%	6 600%	3 100%
INR; Increase to Grade 3; n=4,10,5	0 0%	0 0%	0 0%
INR; Increase to Grade 4; n=4,10,5	0 0%	0 0%	0 0%
Lymphocytes; Any grade increase; n=4,10,5	2 50%	8 800%	2 66.7%
Lymphocytes; Increase to Grade3; n=4,10,5	0 0%	4 400%	0 0%
Lymphocytes; Increase to Grade4; n=4,10,5	0 0%	0 0%	0 0%
Monocytes; Any grade increase; n=4,10,5	0 0%	0 0%	0 0%
Monocytes;Increase to Grade3; n=4,10,5	0 0%	0 0%	0 0%
Monocytes; Increase to Grade 4; n=4,10,5	0 0%	0 0%	0 0%
Neutrophils; Any grade increase; n=4,10,5	0 0%	0 0%	1 33.3%
Neutrophils; Increase to Grade 3; n=4,10,5	0 0%	0 0%	0 0%
Neutrophils; Increase to Grade 4; n=4,10,5	0 0%	0 0%	0 0%
Platelets; Any grade increase; n=4,10,5	1 25%	10 1000%	5 166.7%
Platelets; Increase to Grade 3; n=4,10,5	0 0%	2 200%	2 66.7%
Platelets; Increase to Grade 4; n=4,10,5	0 0%	0 0%	1 33.3%
PT; Any grade increase;n=4,10,5	0 0%	0 0%	0 0%
PT; Increase to Grade 3; n=4,10,5	0 0%	0 0%	0 0%
PT; Increase to Grade 4; n=4,10,5	0 0%	0 0%	0 0%
RBC; Any grade increase; n=4,10,5	0 0%	0 0%	0 0%
RBC; Increase to Grade 3; n=4,10,5	0 0%	0 0%	0 0%
RBC; Increase to Grade 4; n=4,10,5	0 0%	0 0%	0 0%
WBC; Any grade increase; n=4,10,5	1 25%	0 0%	1 33.3%
WBC; Increase to Grade 3; n=4,10,5	0 0%	0 0%	0 0%
WBC; Increase to Grade 4; n=4,10,5	0 0%	0 0%	0 0%
Fib; Any grade increase; n=4,10,5	0 0%	0 0%	0 0%
Fib; Increase to Grade 3; n=4,10,5	0 0%	0 0%	0 0%
Fib; Increase to Grade 4; n=4,10,5	0 0%	0 0%	0 0%
aPTT; Any grade increase; n=4,10,5	0 0%	5 500%	2 66.7%
aPTT; Increase to Grade 3; n=4,10,5	0 0%	0 0%	0 0%
aPTT; Increase to Grade 4; n=4,10,5	0 0%	0 0%	0 0%

18. Primary Outcome

Title	Number of Participants With Grade Change From Baseline in Hematology Data-Part 2
Description	Blood samples were collected for the analysis of hematology parameters: aPTT, platelet count, RBC, WBC, INR, PT, Fib, hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Time Frame	Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title	Participants With NMC	Participants With SCLC	Participants With CRPC	Participants With TNBC	Participants With ER+BC	Participants With GIST
Arm/Group Description	Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762
Measure Participants	12	14	23	19	21	13
Basophils; Any grade increase; n=11,13,23,19,21,13	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Basophils; Increase to Grade3; n=11,13,23,19,21,13	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Basophils; Increase to Grade4; n=11,13,23,19,21,13	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Eosinophils;Any grade increase;n=11,13,23,19,21,13	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Eosinophils;Increase to Grade3;n=11,13,23,19,21,13	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Eosinophils;Increase to Grade4;n=11,13,23,19,21,13	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Hemoglobin;Any grade increase;n=11,14,23,19,21,13	6 150%	10 1000%	18 600%	10 250%	18 200%	6 18.8%
Hemoglobin;Increase to Grade3;n=11,14,23,19,21,13	3 75%	2 200%	9 300%	4 100%	5 55.6%	3 9.4%
Hemoglobin;Increase to Grade4;n=11,14, 23,19,21,13	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
INR; Any grade increase; n=11,12,21,17,18,12	8 200%	6 600%	13 433.3%	8 200%	11 122.2%	7 21.9%
INR; Increase to Grade3; n=11,12,21,17,18,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
INR; Increase to Grade4; n=11,12,21,17,18,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Lymphocytes;Any grade increase;n=11,13,23,19,21,13	8 200%	7 700%	14 466.7%	9 225%	13 144.4%	6 18.8%
Lymphocytes;Increase to Grade3;n=11,13,23,19,21,13	2 50%	2 200%	6 200%	2 50%	1 11.1%	0 0%
Lymphocytes;Increase to Grade4;n=11,13,23,19,21,13	0 0%	1 100%	0 0%	0 0%	0 0%	0 0%
Monocytes; Any grade increase; n=11,13,23,19,21,13	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Monocytes;Increase to Grade3; n=11,13,23,19,21,13	0 0%	0 0%	00 0%	0 0%	0 0%	0 0%
Monocytes; Increase to Grade4; n=11,13,23,19,21,13	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Neutrophils;Any grade increase;n=11,14,23,19,21,13	4 100%	4 400%	8 266.7%	3 75%	6 66.7%	1 3.1%
Neutrophils;Increase to Grade3;n=11,14,23,19,21,13	1 25%	1 100%	0 0%	2 50%	1 11.1%	0 0%
Neutrophils;Increase to Grade4;n=11,14,23,19,21,13	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Platelets; Any grade increase; n=11,14,23,19,21,13	7 175%	12 1200%	20 666.7%	17 425%	18 200%	7 21.9%
Platelets; Increase to Grade3; n=11,14,23,19,21,13	4 100%	4 400%	5 166.7%	6 150%	6 66.7%	0 0%
Platelets; Increase to Grade4; n=11,14,23,19,21,13	2 50%	3 300%	8 266.7%	4 100%	2 22.2%	0 0%
PT; Any grade increase;n=10,10, 18, 17, 18, 12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
PT; Increase to Grade 3; n=10,10, 18, 17, 18, 12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
PT; Increase to Grade 4; n=10,10, 18, 17, 18, 12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
RBC; Any grade increase; n=11, 13, 23, 19, 21, 13	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
RBC; Increase to Grade 3; n=11, 13, 23, 19, 21, 13	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
RBC; Increase to Grade 4; n=11, 13, 23, 19, 21, 13	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
WBC; Any grade increase; n=11, 14, 23, 19, 21, 13	7 175%	5 500%	9 300%	5 125%	6 66.7%	3 9.4%
WBC; Increase to Grade 3; n=11, 14, 23, 19, 21, 13	1 25%	0 0%	1 33.3%	1 25%	0 0%	0 0%
WBC; Increase to Grade 4; n=11, 14, 23, 19, 21, 13	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Fib; Any grade increase; n=11, 11, 21, 17, 18, 12	2 50%	0 0%	1 33.3%	0 0%	0 0%	1 3.1%
Fib; Increase to Grade 3; n=11, 11, 21, 17, 18, 12	1 25%	0 0%	0 0%	0 0%	0 0%	0 0%
Fib; Increase to Grade 4; n=11, 11, 21, 17, 18, 12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
aPTT; Any grade increase; n=11,12,21,17,18,12	4 100%	4 400%	1 33.3%	3 75%	5 55.6%	4 12.5%
aPTT; Increase to Grade3; n=11,12,21, 17, 18, 12	0 0%	0 0%	0 0%	1 25%	0 0%	0 0%
aPTT; Increase to Grade4; n=11,12,21,17,18,12	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

19. Primary Outcome

Title	Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study
Description	Blood samples were collected for the analysis of hematology parameters: aPTT, platelet count, RBC, WBC, INR, PT, Fib, hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Time Frame	Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes	80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes
Arm/Group Description	Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.	Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
Measure Participants	5	5
Basophils; Any grade increase	0 0%	0 0%
Basophils; Increase to Grade 3	0 0%	0 0%
Basophils; Increase to Grade 4	0 0%	0 0%
Eosinophils; Any grade increase	0 0%	0 0%
Eosinophils; Increase to Grade 3	0 0%	0 0%
Eosinophils; Increase to Grade 4	0 0%	0 0%
Hemoglobin; Any grade increase	4 100%	3 300%
Hemoglobin; Increase to Grade 3	2 50%	2 200%
Hemoglobin; Increase to Grade 4	0 0%	0 0%
INR; Any grade increase	1 25%	1 100%
INR; Increase to Grade 3	0 0%	0 0%
INR; Increase to Grade 4	0 0%	0 0%
Lymphocytes; Any grade increase	3 75%	4 400%
Lymphocytes; Increase to Grade 3	1 25%	0 0%
Lymphocytes; Increase to Grade 4	2 50%	0 0%
Monocytes; Any grade increase	0 0%	0 0%
Monocytes; Increase to Grade 3	0 0%	0 0%
Monocytes; Increase to Grade 4	0 0%	0 0%
Neutrophils; Any grade increase	1 25%	1 100%
Neutrophils; Increase to Grade 3	0 0%	0 0%
Neutrophils; Increase to Grade 4	0 0%	0 0%
Platelets; Any grade increase	5 125%	5 500%
Platelets; Increase to Grade 3	0 0%	2 200%
Platelets; Increase to Grade 4	3 75%	1 100%
PT; Any grade increase	0 0%	0 0%
PT; Increase to Grade 3	0 0%	0 0%
PT; Increase to Grade 4	0 0%	0 0%
RBC; Any grade increase	0 0%	0 0%
RBC; Increase to Grade 3	0 0%	0 0%
RBC; Increase to Grade 4	0 0%	0 0%
WBC; Any grade increase	3 75%	1 100%
WBC; Increase to Grade 3	0 0%	0 0%
WBC; Increase to Grade 4	0 0%	0 0%
Fib; Any grade increase	0 0%	0 0%
Fib; Increase to Grade 3	0 0%	0 0%
Fib; Increase to Grade 4	0 0%	0 0%
aPTT; Any grade increase	4 100%	2 200%
aPTT; Increase to Grade 3	0 0%	0 0%
aPTT; Increase to Grade 4	0 0%	0 0%

20. Primary Outcome

Title	Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD
Description	Urine samples were collected for the analysis of following urine parameters: potential of hydrogen (pH), glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented.
Time Frame	Baseline (pre-dose Week1 Day1) and Weeks 5, 9, 17, 25, 33, 41, 49 and discharge/progression (disc/prog)

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762.	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	3	4	1	3	4	9	32	9
Cellular casts; Week 9; n=0,0, 0, 0, 0,1,4,1	0 0%	1 100%	1 33.3%
Cellular casts; Week 17; n=0,0, 0, 0, 0,0,1,0	1 25%
Cellular casts; Disc/Prog; n=0,0,0,0,0,1,5,1	0 0%	1 100%	0 0%
Hyaline casts;Week 5; n=0,1,0,0,1,2,5,3	0 0%	0 0%	0 0%	2 50%	1 11.1%
Hyaline casts;Week 9; n=0,1,0, 0,0,1,5,3	0 0%	0 0%	0 0%	1 25%
Glucose;Week 5; n=1,2,1,3,2,7,20,7	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	4 44.4%	2 50%
Glucose;Week 9; n=1, 1, 0, 1,1,3,12,5	0 0%	0 0%	0 0%	0 0%	0 0%	1 3.1%	1 11.1%
Glucose;Week 25; n=0,1,0,0,0,0,3,1	0 0%	0 0%	1 33.3%
Glucose;Disc/Prog; n=0, 1, 0,1,0,3,17,2	0 0%	0 0%	0 0%	1 25%	0 0%	1 3.1%	0 0%
Ketones;Week 5; n=1,2,1,3,2,7,20,7	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 22.2%	1 25%
Ketones;Week 9; n=1,1,0,1,1,3,12,5	0 0%	0 0%	0 0%	0 0%	0 0%	2 6.3%	0 0%
Occult blood;Week 5; n=1,2,1,3,2,7,17,7	0 0%	0 0%	0 0%	1 25%	2 22.2%	0 0%	2 22.2%	0 0%
Occult blood;Week 9; n=1,1,0,1,1,3,11,5	0 0%	0 0%	0 0%	0 0%	0 0%	3 9.4%	0 0%
Occult blood;Week 17; n=0, 1,0,0,0,0,5,3	0 0%	1 100%	0 0%
Occult blood;Week 25; n=0,1,0,0,0,0,3,1	0 0%	1 100%	0 0%
Occult blood;Week 33; n=0,1,0,0,0,0,2,0	0 0%	1 100%
Occult blood;Disc/Prog; n=0,1,0,1,0,3,17,2	0 0%	0 0%	0 0%	2 50%	0 0%
pH;Week 5; n=1, 2, 1, 3,2,7,20,7	0 0%	0 0%	0 0%	1 25%	0 0%	5 15.6%	6 66.7%	3 75%
pH;Week 9; n=1,1,0,1,1,3,12,5	0 0%	1 100%	0 0%	1 25%	0 0%	2 6.3%	8 88.9%	2 50%
pH;Week 25; n=0,1,0,0,0,0,3,1	0 0%	1 100%	0 0%	0 0%	1 11.1%	1 3.1%
pH;Week 33; n=0,1,0,0,0,0,2,0	1 25%	0 0%
pH;Disc/Prog; n=0,1,0,1,0,3,17,2	1 25%	0 0%	1 33.3%	9 225%	1 11.1%
Protein;Week 5; n=1, 2,1,3,2,7,20,7	0 0%	0 0%	0 0%	0 0%	0 0%	3 9.4%	9 100%	4 100%
Protein;Week 9; n=1,1,0,1,1,3,12,5	0 0%	1 100%	0 0%	0 0%	1 11.1%	7 21.9%	3 33.3%
Protein;Week 17; n=0,1,0,0,0,0,5,3	0 0%	1 100%	0 0%
Protein;Week 25; n=0,1,0,0,0,0,3,1	0 0%	1 100%	0 0%
Protein;Disc/Prog; n=0,1,0,1,0,3,17,2	0 0%	0 0%	0 0%	5 125%	1 11.1%
Specific gravity;Week 5; n=1,2,1,3,2,7,20,7	1 25%	1 100%	0 0%	2 50%	2 22.2%	5 15.6%	7 77.8%	5 125%
Specific gravity;Week 9; n=1,1,0,1,1,3,12,5	1 25%	0 0%	0 0%	0 0%	2 22.2%	6 18.8%	4 44.4%
Specific gravity;Week 17; n=0,1,0,0,0,0,5,3	1 25%	4 400%	2 66.7%
Specific gravity;Week 25; n=0,1,0,0,0,0,3,1	1 25%	1 100%	0 0%
Specific gravity;Week 33; n=0,1,0,0,0,0,2,0	1 25%	1 100%
Specific gravity;Disc/Prog; n=0,1,0,1,0,3,16,2	1 25%	1 100%	1 33.3%	6 150%	1 11.1%
Specific gravity;Week 41; n=0,0,0,0,0,0,1,0	1 25%
Specific gravity;Week 49; n=0,0,0,0,0,0,1,0	1 25%
Leukocytes;Week 5; n=1,2,1,2,2,6,11,6	0 0%	0 0%	0 0%	0 0%	1 11.1%	2 6.3%	4 44.4%	2 50%
Leukocytes;Week 9; n=1,1,0,1,1,1,6,4	0 0%	0 0%	0 0%	1 25%	0 0%	3 9.4%	1 11.1%
Leukocytes;Week 17; n=0,1,0,0,0,0,1,2	0 0%	1 100%	0 0%
Leukocytes;Disc/Prog; n=0,1,0,1,0,2,6,1	0 0%	0 0%	0 0%	4 100%	1 11.1%

21. Primary Outcome

Title	Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID
Description	Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented.
Time Frame	Baseline (pre-dose Week1 Day1) and Weeks 5,9,17 and discharge/progression

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 40 mg GSK525762.
Measure Participants	4	10	5
Glucose; Week 5;n=2,7,3	0 0%	0 0%	1 33.3%
Glucose; Week 9;n=0,4,2	1 25%	0 0%
Glucose; Week 17;n=0,2,0	1 25%
Glucose; disc/prog;n=0,6,1	1 25%	0 0%
Ketones; Week 5;n=2,7,3	0 0%	1 100%	0 0%
Ketones; Week 17;n=0,2,0	1 25%
Occult blood; Week 5;n=2,7,3	0 0%	2 200%	0 0%
Occult blood; Week 9;n=0,4,2	1 25%	0 0%
Occult blood; disc/prog;n=0,6,1	2 50%	0 0%
pH; Week 5;n=2,7,3	2 50%	4 400%	2 66.7%
pH; Week 9;n=0,4,2	4 100%	1 100%
pH; Week 17;n=0,2,0	1 25%
pH; disc/prog;n=0,7,1	4 100%	1 100%
Protein; Week 5;n=2,7,3	0 0%	3 300%	1 33.3%
Protein; Week 9;n=0,4,2	2 50%	0 0%
Protein; Week 17;n=0,2,0	2 50%
Protein; disc/prog;n=0,7,1	1 25%	1 100%
Erythrocytes; Week 5;n=1,5,1	1 25%	4 400%	1 33.3%
Erythrocytes; Week 9;n=0,1,1	0 0%	1 100%
Erythrocytes; Week 17;n=0,1,0	1 25%
Specific gravity; Week 5;n=2,7,3	2 50%	1 100%	2 66.7%
Specific gravity; Week 9;n=0,4,2	1 25%	1 100%
Specific gravity; Week 17;n=0,2,0	1 25%
Specific gravity; disc/prog;n=0,7,1	2 50%	0 0%
Leukocytes; Week 5;n=1,5,1	0 0%	4 400%	1 33.3%
Leukocytes; Week 9;n=0,1,1	0 0%	1 100%
Leukocytes; Week 17;n=0,1,0	1 25%

22. Primary Outcome

Title	Number of Participants With Maximum Urinalysis Change From Baseline-Part 2
Description	Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented.
Time Frame	Baseline (pre-dose Week1 Day1), Weeks 5,9,13,25,37, 49, 73, 85 and discharge/progression

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title	Part 2: Participants With NMC	Part 2: Participants With SCLC	Part 2: Participants With CRPC	Part 2: Participants With TNBC	Part 2: Participants With ER+BC	Part 2: Participants With GIST
Arm/Group Description	Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762.	Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762.	Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762.	Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762.	Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762.	Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762.
Measure Participants	12	14	23	19	21	13
Granular cast;Week5;n=0,2,2,1,3,0	0 0%	0 0%	0 0%	1 25%
Granular cast;disc/prog;n=1,2,6,3,4,0	0 0%	0 0%	2 66.7%	0 0%	0 0%	0 0%
Hyaline cast;Week5;n=1,2,2,2,4,0	1 25%	0 0%	0 0%	1 25%	1 11.1%
Hyaline cast;Week9;n=0,0,1,2,1,1	0 0%	0 0%	0 0%	1 25%
Hyaline cast;Week13;n=1,1,0,0,0,0	0 0%	1 100%
Hyaline cast;disc/prog;n=1,2,6,3,4,0	0 0%	0 0%	2 66.7%	0 0%	0 0%
Glucose;Week 5;n=8,7,18,12,14,8	1 25%	2 200%	2 66.7%	0 0%	0 0%	1 3.1%
Glucose;Week9;n=8,3,12,3,6,5	2 50%	1 100%	0 0%	0 0%	0 0%	0 0%
Glucose;Week13;n=7,2,6,1,2,2	2 50%	1 100%	1 33.3%	0 0%	0 0%	0 0%
Glucose;Week37;n=3,0,1,0,0,0	1 25%	0 0%
Glucose;Week49;n=1,0,1,0,0,0	1 25%	0 0%
Glucose;Week73;n=1,0,0,0,0,0	1 25%
Glucose;Week85;n=1,0,0,0,0,0	1 25%
Glucose;disc/prog;n=3,6,16,12,12,5	0 0%	0 0%	0 0%	0 0%	1 11.1%	0 0%
Ketones;Week5;n=8,7,18,12,14,8	0 0%	1 100%	0 0%	0 0%	1 11.1%	0 0%
Ketones;Week9;n=8,3,12,3,6,5	0 0%	1 100%	0 0%	0 0%	0 0%	0 0%
Ketones;disc/prog;n=3,6,16,12,12,5	0 0%	1 100%	2 66.7%	0 0%	1 11.1%	0 0%
Occult blood;Week5;n=8,7,18,12,14,8	1 25%	0 0%	5 166.7%	0 0%	0 0%	0 0%
Occult blood;Week9;n=8,3,12,3,6,5	0 0%	1 100%	5 166.7%	0 0%	0 0%	0 0%
Occult blood;Week13;n=7,2,6,1,2,2	1 25%	0 0%	0 0%	0 0%	0 0%	0 0%
Occult blood;Week25;n=2,0,3,0,0,0	0 0%	1 100%
Occult blood;Week37;n=3,0,1,0,0,0	1 25%	0 0%
Occult blood;disc/prog;n=3,6,16,12,12,5	0 0%	0 0%	8 266.7%	0 0%	0 0%	0 0%
pH;Week5;n=8,7,18,12,14,8	6 150%	3 300%	8 266.7%	3 75%	6 66.7%	3 9.4%
pH;Week9;n=8,3,12,3,6,5	5 125%	1 100%	7 233.3%	2 50%	4 44.4%	2 6.3%
pH;Week13;n=7,2,6,1,2,2	2 50%	1 100%	3 100%	1 25%	0 0%	1 3.1%
pH;Week25;n=2,0,3,0,0,0	1 25%	1 100%
pH;Week37;n=3,0,1,0,0,0	3 75%	0 0%
pH;Week49;n=1,0,1,0,0,0	1 25%	0 0%
pH;Week73;n=1,0,0,0,0,0	1 25%
pH;Week85;n=1,0,0,0,0,0	1 25%
pH;disc/prog;n=3,6,16,12,12,5	1 25%	2 200%	6 200%	6 150%	5 55.6%	2 6.3%
Protein;Week5;n=8,7,18,12,14,8	1 25%	1 100%	9 300%	3 75%	5 55.6%	6 18.8%
Protein;Week9;n=8,3,12,3,6,5	3 75%	2 200%	4 133.3%	0 0%	0 0%	3 9.4%
Protein;Week13;n=7,2,6,1,2,2	3 75%	1 100%	2 66.7%	0 0%	0 0%	0 0%
Protein;Week37;n=1,0,1,0,0,0	1 25%	0 0%
Protein;disc/prog;n=3,6,16,12,12,5	1 25%	1 100%	6 200%	2 50%	3 33.3%	2 6.3%
Erythrocytes;Week5;n=3,3,8,4,4,4	2 50%	0 0%	5 166.7%	2 50%	3 33.3%	2 6.3%
Erythrocytes;Week9;n=4,0,2,2,1,2	2 50%	1 100%	1 33.3%	1 25%	1 11.1%
Erythrocytes;Week13;n=3,1,0,0,0,1	3 75%	1 100%	0 0%
Erythrocytes;disc/prog;n=1,2,6,3,4,2	0 0%	0 0%	5 166.7%	1 25%	2 22.2%	0 0%
Specific gravity;Week5;n=8,7,18,12,14,8	4 100%	4 400%	2 66.7%	5 125%	7 77.8%	2 6.3%
Specific gravity;Week9;n=8,3,12,3,6,5	2 50%	1 100%	2 66.7%	2 50%	5 55.6%	3 9.4%
Specific gravity;Week13;n=7,2,6,1,2,2	2 50%	1 100%	1 33.3%	0 0%	0 0%	1 3.1%
Specific gravity;disc/prog;n=3,6,16,12,12,5	0 0%	2 200%	3 100%	3 75%	5 55.6%	1 3.1%
Leukocytes;Week5;n=3,3,8,4,4,4	1 25%	1 100%	5 166.7%	3 75%	4 44.4%	4 12.5%
Leukocytes;Week9;n=4,0,2,2,1,3	0 0%	2 200%	1 33.3%	0 0%	3 33.3%
Leukocytes;Week13;n=3,1,0,0,0,1	1 25%	0 0%	0 0%
Leukocytes;Week25;n=2,0,1,0,0,0	0 0%	1 100%
Leukocytes;disc/prog;n=1,2,7,3,4,1	0 0%	1 100%	2 66.7%	3 75%	3 33.3%	1 3.1%

23. Primary Outcome

Title	Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study
Description	Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented.
Time Frame	Baseline (pre-dose Week1 Day1), Weeks 5,9,17,25 and disc/prog

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title	80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes	80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes
Arm/Group Description	Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.	Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
Measure Participants	5	5
Hyaline casts; Week5;n=1,1	1 25%	1 100%
Hyaline casts; Week9;n=2,1	1 25%	0 0%
Hyaline casts; Week17;n=1,0	1 25%
Hyaline casts; Week25;n=1,0	1 25%
Glucose; Week5;n=3,2	1 25%	1 100%
Glucose; Week9;n=4,1	1 25%	0 0%
Glucose; Week17;n=2,0	1 25%
Ketones; Week9;n=4,1	1 25%	0 0%
pH;Week5;n=3,2	3 75%	1 100%
pH;Week9;n=4,1	3 75%	0 0%
pH;Week17;n=2,0	2 50%
pH;Week25;n=1,0	1 25%
pH;disc/prog;n=2,2	2 50%	1 100%
Protein; Week5; n=3,2	3 75%	1 100%
Protein; Week9; n=4,1	3 75%	1 100%
Protein; Week17; n=2,0	2 50%
Protein; Week25; n=1,0	1 25%
Erythrocytes; Week9; n=4,1	2 50%	1 100%
Erythrocytes; Week17; n=2,0	1 25%
Erythrocytes; Week25; n=1,0	1 25%
Erythrocytes; disc/prog; n=1,0	1 25%
Specific gravity; Week5; n=3,2	1 25%	1 100%
Specific gravity; Week9; n=4,1	2 50%	0 0%
Specific gravity; Week17; n=2,0	1 25%
Specific gravity; Week25; n=1,0	1 25%
Specific gravity; disc/prog; n=2,2	0 0%	1 100%
Leukocytes; Week5; n=3,1	3 75%	1 100%
Leukocytes; Week9; n=4,1	4 100%	1 100%
Leukocytes; Week17; n=2,0	1 25%
Leukocytes; Week25; n=1,0	1 25%
Leukocytes; disc/prog; n=1,0	1 25%

24. Primary Outcome

Title	Number of Participants With Changes in Pulse Rate From Baseline-Part 1 QD
Description	Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for pulse rate is <60 beats per minute and >100 beats per minute. Participants were counted twice if the participant "Decreased to <60" and "Increased to >100" post-baseline. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented
Time Frame	Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at Baseline and the specified time point were analyzed.

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily (QD) oral dose of 2 illigrams (mg) GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762.	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	3	4	1	3	4	8	31	9
Pulse rate; decrease to <60	0 0%	1 100%	0 0%	1 25%	0 0%	1 3.1%	1 11.1%	1 25%
Pulse rate; Change to normal/no change	2 50%	1 100%	0 0%	1 25%	1 11.1%	5 15.6%	12 133.3%	4 100%
Pulse rate; increase to >100	1 25%	2 200%	1 33.3%	1 25%	3 33.3%	2 6.3%	18 200%	5 125%

25. Primary Outcome

Title	Number of Participants With Changes in Pulse Rate From Baseline-Part 1 BID
Description	Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Time Frame	Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.
Measure Participants	4	10	5
Pulse rate; decrease to <60	0 0%	0 0%	0 0%
Pulse rate; Change to normal/no change	3 75%	4 400%	2 66.7%
Pulse rate; increase to >100	1 25%	6 600%	3 100%

26. Primary Outcome

Title	Number of Participants With Changes in Pulse Rate From Baseline-Part 2
Description	Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for pulse rate is <60 beats per minute and >100 beats per minute. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented. Participants were counted twice if the participant "Decreased to <60" and "Increased to >100" post-baseline.
Time Frame	Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at Baseline and the specified time points were analyzed.

Arm/Group Title	Participants With NMC	Participants With SCLC	Participants With CRPC	Participants With TNBC	Participants With ER+BC	Participants With GIST
Arm/Group Description	Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762
Measure Participants	11	14	22	19	20	12
Pulse rate; decrease to <60	0 0%	1 100%	0 0%	0 0%	1 11.1%	1 3.1%
Pulse rate; Change to normal/no change	7 175%	10 1000%	13 433.3%	11 275%	9 100%	8 25%
Pulse rate; increase to >100	5 125%	4 400%	9 300%	9 225%	10 111.1%	3 9.4%

27. Primary Outcome

Title	Number of Participants With Changes in Pulse Rate From Baseline-Besylate Sub-study
Description	Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for pulse rate is <60 beats per minute and >100 beats per minute. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Time Frame	Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes	80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes
Arm/Group Description	Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.	Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
Measure Participants	5	5
Pulse rate; decrease to <60	0 0%	0 0%
Pulse rate; Change to normal/no change	3 75%	1 100%
Pulse rate; increase to >100	2 50%	4 400%

28. Primary Outcome

Title	Number of Participants With Increase in Blood Pressure From Baseline-Part 1 QD
Description	Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (>=160) and DBP: Grade 0 (<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented
Time Frame	Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762.	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	3	4	1	3	4	9	32	9
DBP; Increase to Grade 1	2 50%	1 100%	0 0%	0 0%	0 0%	3 9.4%	9 100%	0 0%
DBP; Increase to Grade 2	0 0%	0 0%	1 33.3%	1 25%	1 11.1%	0 0%	10 111.1%	1 25%
DBP; Increase to Grade 3/4	0 0%	0 0%	0 0%	0 0%	0 0%	1 3.1%	2 22.2%	2 50%
SBP; Increase to Grade 1	1 25%	1 100%	1 33.3%	1 25%	1 11.1%	2 6.3%	11 122.2%	1 25%
SBP; Increase to Grade 2	1 25%	0 0%	0 0%	1 25%	3 33.3%	1 3.1%	9 100%	3 75%
SBP; Increase to Grade 3/4	0 0%	1 100%	0 0%	0 0%	0 0%	2 6.3%	5 55.6%	2 50%

29. Primary Outcome

Title	Number of Participants With Increase in Blood Pressure From Baseline-Part 1 BID
Description	SBP and DBP were measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (>=160) and DBP: Grade 0 (<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented
Time Frame	Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at Baseline and the specified time point were analyzed (indicated by n=X in category titles).

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.
Measure Participants	4	10	5
DBP; Increase to Grade 1;n=4,10,4	2 50%	4 400%	1 33.3%
DBP; Increase to Grade 2;n=4,10,4	0 0%	4 400%	1 33.3%
DBP; Increase to Grade 3/4;n=4,10,4	0 0%	0 0%	1 33.3%
SBP; Increase to Grade 1;n=4,9,5	1 25%	2 200%	2 66.7%
SBP; Increase to Grade 2;n=4,9,5	1 25%	6 600%	1 33.3%
SBP; Increase to Grade 3/4;n=4,9,5	0 0%	0 0%	1 33.3%

30. Primary Outcome

Title	Number of Participants With Changes in Blood Pressure From Baseline-Part 2
Description	SBP and DBP were measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (>=160) and DBP: Grade 0 (<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Time Frame	Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at Baseline and the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title	Participants With NMC	Participants With SCLC	Participants With CRPC	Participants With TNBC	Participants With ER+BC	Participants With GIST
Arm/Group Description	Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762
Measure Participants	11	14	22	19	19	12
DBP; Increase to Grade 1;n=11,14,22,19,19,12	2 50%	3 300%	8 266.7%	5 125%	4 44.4%	3 9.4%
DBP; Increase to Grade 2;n=11,14,22,19,19,12	4 100%	1 100%	4 133.3%	3 75%	6 66.7%	1 3.1%
DBP; Increase to Grade 3/4;n=11,14,22,19,19,12	0 0%	0 0%	1 33.3%	2 50%	1 11.1%	2 6.3%
SBP; Increase to Grade 1;n=11,14,21,19,19,12	4 100%	4 400%	2 66.7%	9 225%	7 77.8%	1 3.1%
SBP; Increase to Grade 2;n=11,14,21,19,19,12	2 50%	4 400%	11 366.7%	3 75%	4 44.4%	7 21.9%
SBP; Increase to Grade 3/4;n=11,14,21,19,19,12	0 0%	1 100%	3 100%	1 25%	1 11.1%	0 0%

31. Primary Outcome

Title	Number of Participants With Increase in Blood Pressure From Baseline-Besylate Sub-study
Description	SBP and DBP were measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (>=160) and DBP: Grade 0 (<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Time Frame	Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes	80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes
Arm/Group Description	Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.	Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
Measure Participants	5	5
DBP; Increase to Grade 1	1 25%	1 100%
DBP; Increase to Grade 2	2 50%	1 100%
DBP; Increase to Grade 3/4	0 0%	0 0%
SBP; Increase to Grade 1	1 25%	1 100%
SBP; Increase to Grade 2	0 0%	1 100%
SBP; Increase to Grade 3/4	0 0%	0 0%

32. Primary Outcome

Title	Number of Participants With Changes in Temperature From Baseline-Part 1 QD
Description	Temperature was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for temperature is <=35 degree Celsius and >=38 degree Celsius. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Time Frame	Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762.	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	3	4	1	3	4	9	32	9
Decrease to <=35	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 22.2%	1 25%
Change to normal/No change	3 75%	3 300%	1 33.3%	3 75%	3 33.3%	9 28.1%	27 300%	8 200%
Increase to >=38	0 0%	1 100%	0 0%	0 0%	1 11.1%	0 0%	3 33.3%	0 0%

33. Primary Outcome

Title	Number of Participants With Changes in Temperature From Baseline-Part 1 BID
Description	Temperature was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for temperature is <=35 degree Celsius and >=38 degree Celsius. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Time Frame	Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.
Measure Participants	4	10	5
Decrease to <=35	0 0%	0 0%	0 0%
Change to normal/No change	4 100%	9 900%	5 166.7%
Increase to >=38	0 0%	1 100%	0 0%

34. Primary Outcome

Title	Number of Participants With Changes in Temperature From Baseline-Part 2
Description	Temperature was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for temperature is <=35 degree Celsius and >=38 degree Celsius. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Time Frame	Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at Baseline and the specified time points were analyzed.

Arm/Group Title	Participants With NMC	Participants With SCLC	Participants With CRPC	Participants With TNBC	Participants With ER+BC	Participants With GIST
Arm/Group Description	Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762
Measure Participants	11	14	22	19	20	12
Decrease to <=35	1 25%	0 0%	0 0%	0 0%	1 11.1%	0 0%
Change to normal/No change	10 250%	11 1100%	20 666.7%	18 450%	18 200%	12 37.5%
Increase to >=38	0 0%	3 300%	2 66.7%	1 25%	1 11.1%	0 0%

35. Primary Outcome

Title	Number of Participants With Changes in Temperature From Baseline-Besylate Sub-study
Description	Temperature was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for temperature is <=35 degree Celsius and >=38 degree Celsius. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.
Time Frame	Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes	80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes
Arm/Group Description	Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.	Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
Measure Participants	5	5
Decrease to <=35	0 0%	0 0%
Change to normal/No change	4 100%	5 500%
Increase to >=38	1 25%	0 0%

36. Primary Outcome

Title	Overall Response Rate-Part 1 QD
Description	Overall response rate is defined as the percentage of participants who achieved a confirmed complete response (CR) or partial response (PR) from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST version (v) 1.1). CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeters (mm) in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Time Frame	Median of 1.38 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762.	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	3	4	1	3	4	9	32	9
Number (95% Confidence Interval) [Percentage of participants]	0 0%	25 2500%	0 0%	0 0%	0 0%	0 0%	3 33.3%	11 275%

37. Primary Outcome

Title	Overall Response Rate-Part 1 BID
Description	Overall response rate is defined as the percentage of participants who achieved a confirmed CR or PR from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Time Frame	Median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.
Measure Participants	4	10	5
Number (95% Confidence Interval) [Percentage of participants]	0 0%	0 0%	0 0%

38. Primary Outcome

Title	Overall Response Rate-Part 2
Description	Overall response rate is defined as the percentage of participants who achieved a confirmed CR or PR from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Time Frame	Median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Participants With NMC	Participants With SCLC	Participants With CRPC	Participants With TNBC	Participants With ER+BC	Participants With GIST
Arm/Group Description	Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762
Measure Participants	12	14	23	19	21	13
Number (95% Confidence Interval) [Percentage of participants]	8 200%	0 0%	4 133.3%	0 0%	0 0%	0 0%

39. Primary Outcome

Title	Overall Response Rate-Besylate Sub-study
Description	Overall response rate is defined as the percentage of participants who achieved a confirmed CR or PR from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Time Frame	Median of 1.87 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Data for Besylate sub-study participants were combined for analysis to provide useful interpretation of study data as pre-specified in RAP.

Arm/Group Title	All Participants in Besylate Substudy
Arm/Group Description	All participants who entered besylate sub-study and received 80 mg amor free-base tablet along with 6 mg stable iso in solution in fasted state; 80 mg bes tablet along with 6 mg stable iso in solution in fasted state, 30 mg bes tablet along with 6 mg stable iso in solution in fasted state and 80 mg bes tablet with FDA recommended high fat breakfast in one of the treatment periods were included.
Measure Participants	10
Number (95% Confidence Interval) [Percentage of participants]	0 0%

40. Primary Outcome

Title	Number of Participants With Prostate Specific Antigen (PSA)50 Response-Part 1 QD
Description	PSA 50 response rate is defined as the response rate that a PSA reduction from Baseline >=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA >=50% reduction is presented along with 95% confidence intervals.
Time Frame	Median of 1.38 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762.	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	3	4	1	3	4	9	32	9
Number (95% Confidence Interval) [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 22.2%	1 25%

41. Primary Outcome

Title	Number of Participants With PSA50 Response Rate-Part 1 BID
Description	PSA 50 Response rate is defined as the response rate that a PSA reduction from Baseline >=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA >=50% reduction is presented along with 95% confidence intervals.
Time Frame	Median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.
Measure Participants	4	10	5
Number (95% Confidence Interval) [Participants]	0 0%	0 0%	0 0%

42. Primary Outcome

Title	Number of Participants With PSA50 Response-Part 2
Description	PSA 50 response rate is defined as the response rate that a PSA reduction from Baseline >=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA >=50% reduction is presented along with 95% confidence intervals.
Time Frame	Median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Participants With NMC	Participants With SCLC	Participants With CRPC	Participants With TNBC	Participants With ER+BC	Participants With GIST
Arm/Group Description	Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762
Measure Participants	12	14	23	19	21	13
Number (95% Confidence Interval) [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

43. Primary Outcome

Title	Number of Participants With PSA50 Response-Besylate Sub-study
Description	PSA 50 Response rate is defined as the response rate that a PSA reduction from Baseline >=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA >=50% reduction is presented along with 95% confidence intervals.
Time Frame	Median of 1.87 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes	80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes
Arm/Group Description	Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.	Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
Measure Participants	5	5
Number (95% Confidence Interval) [Participants]	0 0%	0 0%

44. Primary Outcome

Title	Area Under the Concentration-time Curve (AUC) From Time Zero to 24 Hours(AUC[0 to 24]); AUC From Time 0 to Last Quantifiable Concentration (AUC [0 to t]) and AUC Extrapolated to Infinity (AUC[0 to Inf]) of GSK525762-Besylate Sub-study
Description	Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points. Besylate sub-study pharmacokinetic (PK) Parameter Population consisted of all participants in the PK Parameter Population who participated in the besylate substudy.
Time Frame	Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)

Outcome Measure Data

Analysis Population Description

Besylate Sub-Study PK Parameter Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	GSK525762 80 mg Amorphous+6 mg Stable Isotope	GSK525762 80 mg Besylate+6 mg Stable Isotope	GSK525762 30 mg Besylate+6 mg Stable Isotope	GSK525762 80 mg Besylate Fed
Arm/Group Description	Participants were administered GSK525762 80 mg amorphous free-base tablet along with 6 mg stable isotope in the fasted state.	Participants were administered GSK525762 80 mg besylate tablet along with 6 mg stable isotope in solution in fasted state.	Participants were administered GSK525762 30 mg besylate tablet along with 6 mg stable isotope in solution in fasted state.	Participants were administered GSK525762 80 mg besylate tablet along with Food and Drug Administration (FDA) recommended high fat breakfast.
Measure Participants	9	10	10	8
AUC(0 to 24)	6954.3 (59.1)	7377.9 (44.7)	2977.3 (42.8)	9123.8 (45.2)
AUC(0 to inf)	7292.0 (62.1)	7703.4 (49.9)	3096.9 (45.0)	9727.7 (48.5)
AUC(0 to t)	7227.1 (61.6)	7657.6 (49.9)	3053.9 (44.4)	9597.1 (48.9)

45. Primary Outcome

Title	Maximum Observed Concentration (Cmax) of GSK525762-Besylate Sub-study
Description	Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points.
Time Frame	Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)

Outcome Measure Data

Analysis Population Description

Besylate Sub-Study PK Parameter Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	GSK525762 80 mg Amorphous+6 mg Stable Isotope	GSK525762 80 mg Besylate+6 mg Stable Isotope	GSK525762 30 mg Besylate+6 mg Stable Isotope	GSK525762 80 mg Besylate Fed
Arm/Group Description	Participants were administered GSK525762 80 mg amorphous free-base tablet along with 6 mg stable isotope in the fasted state.	Participants were administered GSK525762 80 mg besylate tablet along with 6 mg stable isotope in solution in fasted state.	Participants were administered GSK525762 30 mg besylate tablet along with 6 mg stable isotope in solution in fasted state.	Participants were administered GSK525762 80 mg besylate tablet along with Food and Drug Administration (FDA) recommended high fat breakfast.
Measure Participants	9	10	10	8
Geometric Mean (Geometric Coefficient of Variation) [Nanograms per milliliter]	1431.41 (51.3)	1483.21 (49.8)	655.33 (21.1)	1305.59 (46.6)

46. Primary Outcome

Title	Apparent Terminal Phase Elimination Rate Constant (Lambda z) for GSK525762-Besylate Sub-study
Description	Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points.
Time Frame	Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)

Outcome Measure Data

Analysis Population Description

Besylate Sub-Study PK Parameter Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	GSK525762 80 mg Amorphous+6 mg Stable Isotope	GSK525762 80 mg Besylate+6 mg Stable Isotope	GSK525762 30 mg Besylate+6 mg Stable Isotope	GSK525762 80 mg Besylate Fed
Arm/Group Description	Participants were administered GSK525762 80 mg amorphous free-base tablet along with 6 mg stable isotope in the fasted state.	Participants were administered GSK525762 80 mg besylate tablet along with 6 mg stable isotope in solution in fasted state.	Participants were administered GSK525762 30 mg besylate tablet along with 6 mg stable isotope in solution in fasted state.	Participants were administered GSK525762 80 mg besylate tablet along with Food and Drug Administration (FDA) recommended high fat breakfast.
Measure Participants	9	10	10	8
Geometric Mean (Geometric Coefficient of Variation) [Per hour]	5.628 (25.9)	5.176 (20.6)	5.088 (23.8)	5.954 (20.2)

47. Primary Outcome

Title	Time to Reach Cmax (Tmax) for GSK525762-Besylate Sub-study
Description	Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points.
Time Frame	Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)

Outcome Measure Data

Analysis Population Description

Besylate Sub-Study PK Parameter Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	GSK525762 80 mg Amorphous+6 mg Stable Isotope	GSK525762 80 mg Besylate+6 mg Stable Isotope	GSK525762 30 mg Besylate+6 mg Stable Isotope	GSK525762 80 mg Besylate Fed
Arm/Group Description	Participants were administered GSK525762 80 mg amorphous free-base tablet along with 6 mg stable isotope in the fasted state.	Participants were administered GSK525762 80 mg besylate tablet along with 6 mg stable isotope in solution in fasted state.	Participants were administered GSK525762 30 mg besylate tablet along with 6 mg stable isotope in solution in fasted state.	Participants were administered GSK525762 80 mg besylate tablet along with Food and Drug Administration (FDA) recommended high fat breakfast.
Measure Participants	9	10	10	8
Median (Full Range) [Hours]	0.5833	0.8083	0.8333	2.0000

48. Secondary Outcome

Title	Number of Participants With Increase in QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)-Part 1 QD
Description	Electrocardiogram (ECG) measurements were done using an automated 12-lead ECG machine. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (<450 milliseconds [msec]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported.
Time Frame	Median of 1.38 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762.	Participants were administered once daily oral dose of 8 mg GSK525762	Participants were administered once daily oral dose of 16 mg GSK525762	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	3	4	1	3	4	9	32	9
Any Grade increase	1 25%	0 0%	0 0%	1 25%	4 44.4%	4 12.5%	13 144.4%	4 100%
Increase to Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	1 3.1%	0 0%	1 25%
Increase to Grade 3	1 25%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

49. Secondary Outcome

Title	Number of Participants With Increase in QTcF-Part 1 BID
Description	ECG measurements were done using an automated 12-lead ECG machine. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (<450 milliseconds [msec]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported.
Time Frame	Median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.
Measure Participants	4	10	5
Any Grade increase	3 75%	4 400%	2 66.7%
Increase to Grade 2	3 75%	0 0%	0 0%
Increase to Grade 3	0 0%	0 0%	0 0%

50. Secondary Outcome

Title	Number of Participants With Increase in QTcF-Part 2
Description	ECG measurements were done using an automated 12-lead ECG machine. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (<450 milliseconds [msec]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported.
Time Frame	Median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Only those participants with data available at the specified time point were analyzed.

Arm/Group Title	Participants With NMC	Participants With SCLC	Participants With CRPC	Participants With TNBC	Participants With ER+BC	Participants With GIST
Arm/Group Description	Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762
Measure Participants	11	14	22	19	20	12
Any Grade increase	1 25%	2 200%	6 200%	1 25%	2 22.2%	0 0%
Increase to Grade 2	0 0%	0 0%	0 0%	0 0%	2 22.2%	0 0%
Increase to Grade 3	1 25%	0 0%	0 0%	0 0%	0 0%	0 0%

51. Secondary Outcome

Title	Number of Participants With Increase in QTcF-Besylate Sub-study
Description	ECG measurements were done using 12-lead ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and QTcF intervals. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (<450 milliseconds [msec]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported.
Time Frame	Median of 1.87 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes	80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes
Arm/Group Description	Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.	Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
Measure Participants	5	5
Any Grade increase	2 50%	0 0%
Increase to Grade 2	0 0%	0 0%
Increase to Grade 3	0 0%	0 0%

52. Secondary Outcome

Title	Progression Free Survival-Part 1 QD
Description	Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method.
Time Frame	Median of 1.38 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	3	4	1	3	4	9	32	9
Median (95% Confidence Interval) [Months]	0.3	4.1	2.2	9.1	3.8	3.6	6.5	7.5

53. Secondary Outcome

Title	Progression Free Survival-Part 1 BID
Description	Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method.
Time Frame	Median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.
Measure Participants	4	10	5
Median (95% Confidence Interval) [Months]	7.7	5.6	8.0

54. Secondary Outcome

Title	Progression Free Survival-Part 2
Description	Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and the date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method.
Time Frame	Median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Participants With NMC	Participants With SCLC	Participants With CRPC	Participants With TNBC	Participants With ER+BC	Participants With GIST
Arm/Group Description	Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762
Measure Participants	12	14	23	19	21	13
Median (95% Confidence Interval) [Months]	4.8	2.2	8.0	2.4	4.7	3.4

55. Secondary Outcome

Title	Progression Free Survival-Besylate Sub-study
Description	Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and the date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method.
Time Frame	Median of 1.87 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Data for Besylate sub-study participants were combined for analysis to provide useful interpretation of study data as pre-specified in RAP.

Arm/Group Title	All Participants in Besylate Substudy
Arm/Group Description	All participants who entered besylate sub-study and received 80 mg amor free-base tablet along with 6 mg stable iso in solution in fasted state; 80 mg bes tablet along with 6 mg stable iso in solution in fasted state, 30 mg bes tablet along with 6 mg stable iso in solution in fasted state and 80 mg bes tablet with FDA recommended high fat breakfast in one of the treatment periods were included.
Measure Participants	10
Median (95% Confidence Interval) [Months]	3.5

56. Secondary Outcome

Title	Time to Response-Part 1 QD
Description	Time to response is defined, for participants with a confirmed CR or PR, as the time from first dose to the first documented evidence of CR or PR. Time to response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.
Time Frame	Median of 1.38 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Participants with incomplete response dates were excluded from the analysis.

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily (QD) oral dose of 2 milligrams(mg) GSK525762	Participants were administered once daily oral dose of 4 mg GSK525762.	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	0	0	0	0	0	0	0	0

57. Secondary Outcome

Title	Time to Response-Part 1 BID
Description	Time to response is defined, for participants with a confirmed CR or PR, as the time from first dose to the first documented evidence of CR or PR. Time to response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.
Time Frame	Median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Participants with incomplete response dates were excluded from the analysis.

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.
Measure Participants	0	0	0

58. Secondary Outcome

Title	Time to Response-Part 2
Description	Time to response is defined, for participants with a confirmed CR or PR, as the time from first dose to the first documented evidence of CR or PR. Time to response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.
Time Frame	Median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Participants with incomplete response dates were excluded from the analysis.

Arm/Group Title	Participants With NMC	Participants With SCLC	Participants With CRPC	Participants With TNBC	Participants With ER+BC	Participants With GIST
Arm/Group Description	Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762
Measure Participants	0	0	0	0	0	0

59. Secondary Outcome

Title	Time to Response-Besylate Sub-study
Description	Time to response is defined, for participants with a confirmed CR or PR, as the time from first dose to the first documented evidence of CR or PR. Time to response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.
Time Frame	Median of 1.87 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Participants with incomplete response dates were excluded from the analysis.

Arm/Group Title	80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes	80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes
Arm/Group Description	Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.	Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
Measure Participants	0	0

60. Secondary Outcome

Title	Duration of Response-Part 1 QD
Description	Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve a confirmed CR or PR. Duration of response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.
Time Frame	Median of 1.38 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Participants with incomplete response dates were excluded from the analysis.

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762.	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	0	0	0	0	0	0	0	0

61. Secondary Outcome

Title	Duration of Response-Part 1 BID
Description	Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve a confirmed CR or PR. Duration of response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.
Time Frame	Median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Participants with incomplete response dates were excluded from the analysis.

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.
Measure Participants	0	0	0

62. Secondary Outcome

Title	Duration of Response-Part 2
Description	Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve a confirmed CR or PR. Duration of response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.
Time Frame	Median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Participants with incomplete response dates were excluded from the analysis.

Arm/Group Title	Participants With NMC	Participants With SCLC	Participants With CRPC	Participants With TNBC	Participants With ER+BC	Participants With GIST
Arm/Group Description	Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762
Measure Participants	0	0	0	0	0	0

63. Secondary Outcome

Title	Duration of Response-Besylate Sub-study
Description	Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve a confirmed CR or PR. Duration of response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.
Time Frame	Median of 1.87 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Participants with incomplete response dates were excluded from the analysis.

Arm/Group Title	80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes	80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes
Arm/Group Description	Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.	Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
Measure Participants	0	0

64. Secondary Outcome

Title	Overall Survival-Part 1 QD
Description	Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.
Time Frame	Median of 1.38 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762.	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	3	4	1	3	4	9	32	9
Median (95% Confidence Interval) [Months]	0.6	4.1	2.2	9.1	3.8	8.9	7.1	9.8

65. Secondary Outcome

Title	Overall Survival-Part 1 BID
Description	Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.
Time Frame	Median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.
Measure Participants	4	10	5
Median (95% Confidence Interval) [Months]	NA	6.0	13.3

66. Secondary Outcome

Title	Overall Survival-Part 2
Description	Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.
Time Frame	Median of 1.41 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	Participants With NMC	Participants With SCLC	Participants With CRPC	Participants With TNBC	Participants With ER+BC	Participants With GIST
Arm/Group Description	Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762	Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762
Measure Participants	12	14	23	19	21	13
Median (95% Confidence Interval) [Months]	5.0	2.6	9.1	5.0	8.8	7.3

67. Secondary Outcome

Title	Overall Survival-Besylate Sub-study
Description	Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.
Time Frame	Median of 1.87 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population. Data for Besylate sub-study participants were combined for analysis to provide useful interpretation of study data as pre-specified in RAP.

Arm/Group Title	All Participants in Besylate Substudy
Arm/Group Description	All participants who entered besylate sub-study and received 80 mg amor free-base tablet along with 6 mg stable iso in solution in fasted state; 80 mg bes tablet along with 6 mg stable iso in solution in fasted state, 30 mg bes tablet along with 6 mg stable iso in solution in fasted state and 80 mg bes tablet with FDA recommended high fat breakfast in one of the treatment periods were included.
Measure Participants	10
Median (95% Confidence Interval) [Months]	6.3

68. Secondary Outcome

Title	AUC (0 to t), AUC (0 to 24) and AUC (0 to Inf) of GSK525762-Part 1 QD
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762. PK parameter population comprised of all participants in the PK Concentration Population (all participants in the All Treated Population for whom a blood sample for pharmacokinetics is obtained and analyzed) for whom a PK parameter has been obtained.
Time Frame	pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the specified time points were available (indicated by n=X in category titles)

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily oral dose of 2 mg GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762.	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	3	4	1	3	4	9	32	9
AUC (0 to 24); Week1;n=3,4,1,3,4,9,32,9	169.2 (39.4)	354.3 (33.8)	431.5 (NA)	867.9 (39.5)	3943.2 (49.5)	4225.0 (39.2)	5692.4 (61.4)	6958.3 (43.5)
AUC (0 to 24); Week3;n=1,2,1,3,4,6,16,6	152.9 (NA)	334.6 (60.5)	329.5 (NA)	671.6 (21.4)	3146.2 (54.5)	2575.6 (47.3)	2959.8 (48.4)	3818.5 (35.8)
AUC (0 to inf); Week1;n=3,4,1,3,4,9,32,9	174.4 (44.3)	360.8 (35.1)	433.1 (NA)	887.1 (39.1)	4464.5 (62.9)	4357.5 (42.1)	5887.2 (62.8)	7295.6 (45.2)
AUC (0 to t); Week1;n=3,4,1,3,4,9,32,9	168.6 (44.5)	357.5 (34.8)	431.1 (NA)	877.7 (39.4)	4147.8 (54.3)	4304.1 (40.7)	5667.3 (61.5)	7218.4 (45.1)
AUC (0 to t); Week3;n=1,2,1,3,4,6,16,6	152.8 (NA)	334.3 (60.3)	330.6 (NA)	672.3 (21.5)	3164.3 (54.7)	2576.9 (47.3)	2953.8 (49.0)	3819.9 (35.9)

69. Secondary Outcome

Title	Maximum Observed Concentration for GSK525762-Part 1 QD
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.
Time Frame	pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily oral dose of 2 mg GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762.	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	3	4	1	3	4	9	32	9
Week1;n=3,4,1,3,4,9,32,9	50.95 (41.5)	70.46 (29.2)	120.35 (NA)	179.45 (39.9)	603.92 (30.3)	889.52 (24.5)	1099.81 (62.7)	1080.49 (38.8)
Week3;n=1,2,1,3,4,6,16,6	52.04 (NA)	53.37 (16.3)	103.18 (NA)	137.57 (25.1)	602.70 (17.2)	633.71 (52.6)	815.40 (41.1)	918.56 (41.4)

70. Secondary Outcome

Title	Lambda z for GSK525762-Part 1 QD
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.
Time Frame	pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily oral dose of 2 mg GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762.	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	3	4	1	3	4	9	32	9
Week1;n=3,4,1,3,4,9,32,9	0.21411 (98.4)	0.13554 (37.4)	0.23126 (NA)	0.09903 (43.5)	0.07863 (53.1)	0.12468 (28.2)	0.15613 (34.1)	0.10992 (16.0)
Week3;n=1,2,1,3,4,6,16,6	0.15579 (NA)	0.15472 (11.2)	0.14087 (NA)	0.15599 (21.7)	0.12513 (12.7)	0.17629 (26.3)	0.16667 (30.6)	0.17560 (21.1)

71. Secondary Outcome

Title	Tmax for GSK525762-Part 1 QD
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.
Time Frame	pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily oral dose of 2 mg GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762.	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	3	4	1	3	4	9	32	9
Week1;n=3,4,1,3,4,9,32,9	0.5833	1.2250	1.1000	2.0167	2.0083	1.0000	1.0000	1.0000
Week3;n=1,2,1,3,4,6,16,6	1.0000	2.5083	0.5000	1.0500	0.9000	1.0583	0.5667	1.5000

72. Secondary Outcome

Title	Apparent Clearance of GSK525762-Part 1 QD
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.
Time Frame	pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily oral dose of 2 mg GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762.	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	3	4	1	3	4	9	32	9
Week1;n=3,4,1,3,4,9,32,9	11.467 (44.3)	11.085 (35.1)	18.470 (NA)	18.036 (39.1)	6.720 (62.9)	13.769 (42.1)	13.589 (62.8)	13.707 (45.2)
Week3;n=1,2,1,3,4,6,16,6	13.082 (NA)	11.955 (60.5)	24.277 (NA)	23.823 (21.4)	9.535 (54.5)	23.296 (47.3)	27.029 (48.4)	26.188 (35.8)

73. Secondary Outcome

Title	Volume of Distribution of GSK525762-Part 1 QD
Description	Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.
Time Frame	pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Arm/Group Title	Part 1: GSK525762 2 mg QD	Part 1: GSK525762 4 mg QD	Part 1: GSK525762 8 mg QD	Part 1: GSK525762 16 mg QD	Part 1: GSK525762 30 mg QD	Part 1: GSK525762 60 mg QD	Part 1: GSK525762 80 mg QD	Part 1: GSK525762 100 mg QD
Arm/Group Description	Participants were administered once daily oral dose of 2 mg GSK525762.	Participants were administered once daily oral dose of 4 mg GSK525762.	Participants were administered once daily oral dose of 8 mg GSK525762.	Participants were administered once daily oral dose of 16 mg GSK525762.	Participants were administered once daily oral dose of 30 mg GSK525762.	Participants were administered once daily oral dose of 60 mg GSK525762.	Participants were administered once daily oral dose of 80 mg GSK525762.	Participants were administered once daily oral dose of 100 mg GSK525762.
Measure Participants	3	4	1	3	4	9	32	9
Week1;n=3,4,1,3,4,9,32,9	53.56 (65.9)	81.79 (34.7)	79.87 (NA)	182.13 (92.7)	85.46 (30.3)	110.44 (23.5)	87.03 (56.4)	124.70 (42.6)
Week3;n=1,2,1,3,4,6,16,6	83.97 (NA)	77.27 (47.0)	172.33 (NA)	152.72 (44.5)	76.20 (44.0)	132.14 (34.7)	162.17 (40.6)	149.14 (26.9)

74. Secondary Outcome

Title	AUC (0 to Inf), AUC (0 to 24) and AUC (0 to t) of GSK525762-Part 1 BID
Description	Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.
Time Frame	pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.
Measure Participants	4	10	5
AUC (0 to 24); Week1 AM dose;n=3,10,5	856.1 (123.7)	3067.0 (43.9)	2794.4 (31.8)
AUC (0 to 24); Week1 PM dose;n=4,7,5	981.4 (84.8)	3261.1 (59.9)	2607.6 (36.2)
AUC (0 to 24); Week3 AM dose;n=3,7,3	1279.0 (116.2)	2725.3 (92.4)	1184.6 (17.8)
AUC (0 to 24); Week3 PM dose;n=3,5,3	1155.8 (102.4)	1662.1 (29.2)	1131.6 (28.5)
AUC (0 to inf); Week1 AM dose;n=3,10,5	860.4 (124.4)	3118.3 (45.3)	2825.8 (32.8)
AUC (0 to t); Week1 AM dose;n=4,10,5	932.2 (97.6)	2727.2 (40.8)	2579.0 (28.0)
AUC (0 to t); Week1 PM dose;n=4,9,5	927.5 (82.5)	2840.4 (43.4)	2446.7 (34.2)
AUC (0 to t); Week3 AM dose;n=3,7,3	1194.6 (110.1)	2472.4 (89.8)	1140.9 (16.9)
AUC (0 to t); Week3 PM dose;n=3,6,3	1053.6 (96.6)	1490.8 (23.3)	1073.6 (29.2)

75. Secondary Outcome

Title	Maximum Observed Concentration of GSK525762-Part 1 BID
Description	Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.
Time Frame	pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.
Measure Participants	4	10	5
Week1 AM dose;n=4,10,5	231.68 (70.6)	628.01 (40.0)	703.31 (34.2)
Week1 PM dose;n=4,9,5	166.62 (62.0)	445.17 (27.6)	425.76 (29.3)
Week3 AM dose;n=3,7,3	284.71 (87.1)	604.38 (66.4)	419.15 (18.1)
Week3 PM dose;n=3,6,3	256.08 (94.0)	263.72 (41.3)	229.91 (34.8)

76. Secondary Outcome

Title	Lambda z for GSK525762-Part 1 BID
Description	Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.
Time Frame	pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.
Measure Participants	4	10	5
Week1 AM dose;n=3,10,5	0.23463 (19.4)	0.19989 (29.6)	0.23721 (39.4)
Week1 PM dose;n=3,7,3	0.21171 (23.1)	0.14307 (36.6)	0.18789 (25.2)
Week3 AM dose;n=3,7,3	0.23565 (27.2)	0.21751 (27.7)	0.30868 (19.6)
Week3 PM dose;n=3,5,3	0.20507 (21.5)	0.19263 (27.7)	0.29133 (15.8)

77. Secondary Outcome

Title	Tmax for GSK525762-Part 1 BID
Description	Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.
Time Frame	pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.
Measure Participants	4	10	5
Week1 AM dose;n=4,10,5	1.5500	0.9667	0.5500
Week1 PM dose;n=4,9,5	1.9583	1.9667	1.9833
Week3 AM dose;n=3,7,3	1.1833	1.0667	0.5833
Week3 PM dose;n=3,6,3	1.0000	1.4500	2.0667

78. Secondary Outcome

Title	Apparent Clearance of GSK525762-Part 1 BID
Description	Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.
Time Frame	pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.
Measure Participants	4	10	5
Week1 AM dose;n=3,10,5	23.246 (124.4)	9.621 (45.3)	14.155 (32.8)
Week1 PM dose;n=4,7,5	21.745 (82.7)	11.057 (48.1)	16.382 (34.6)
Week3 AM dose;n=3,7,3	16.731 (110.1)	11.949 (86.1)	34.623 (18.7)
Week3 PM dose;n=3,5,3	18.867 (96.0)	20.133 (26.2)	37.097 (29.4)

79. Secondary Outcome

Title	Volume of Distribution of GSK525762-Part 1 BID
Description	Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.
Time Frame	pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4

Outcome Measure Data

Analysis Population Description

PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title	Part 1: GSK525762 20 mg BID	Part 1: GSK525762 30 mg BID	Part 1: GSK525762 40 mg BID
Arm/Group Description	Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.	Participants were administered twice daily oral dose of 30 mg GSK525762.	Participants were administered twice daily oral dose of 40 mg GSK525762.
Measure Participants	4	10	5
Week1 AM dose;n=3,10,5	99.07 (91.0)	48.13 (40.8)	59.67 (35.0)
Week1 PM dose;n=3,7,3	116.52 (66.0)	77.28 (16.6)	81.11 (52.6)
Week3 AM dose;n=3,7,3	71.00 (72.8)	54.94 (61.4)	112.17 (37.6)
Week3 PM dose;n=3,5,3	92.00 (65.3)	104.52 (29.5)	127.34 (41.7)

80. Primary Outcome

Title	Number of Participants With Non-serious AEs and SAEs-Besylate Sub-study
Description	An AE is any untoward medical occurrence in a participant 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 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; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment
Time Frame	Median of 1.87 months of drug exposure

Outcome Measure Data

Analysis Population Description

All Treated Population

Arm/Group Title	80mg Amor+6mg Iso/80mg Bes+6mg Iso/30mg Bes+6mg Iso/80mg Bes	80mg Bes+6mg Iso/80mg Amor+6mg Iso/30mg Bes+6mg Iso/80mg Bes
Arm/Group Description	Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.	Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
Measure Participants	5	5
Any non-serious AE	5 125%	5 500%
Any SAE	3 75%	3 300%

Adverse Events

Time Frame	Adverse events and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (Median of 1.38 months of drug exposure-Part 1 QD, Median of 1.41 months of drug exposure-Part 1 BID and Part 2 and Median of 1.87 months of drug exposure-Besylate sub-study).
Adverse Event Reporting Description	Adverse events were collected in the All Treated Population.
Arm/Group Title	Part1: GSK525762 4 mg QD		Part 1: GSK525762 8 mg QD		Part 1: GSK525762 16 mg QD		Part 1: GSK525762 30 mg QD		Part 1: GSK525762 60 mg QD		Part 1: GSK525762 80 mg QD		Part 1: GSK525762 100 mg QD		Part 1: GSK525762 20 mg BID		Part 1: GSK525762 30 mg BID		Part 1: GSK525762 40 mg BID		Part 2: Participants With NMC		Part 2: Participants With SCLC		Part 2: Participants With CRPC		Part1: GSK525762 2 mg QD		Part 2: Participants With TNBC		Part 2: Participants With ER+BC		Part 2: Participants With GIST		80mg Amor+6mg Iso/80mg Bes+6mg		80mg Bes+6mg Iso/80mg Amor+6mg
Arm/Group Description	Participants were administered once daily oral dose of 4 mg GSK525762.		Participants were administered once daily oral dose of 8 mg GSK525762.		Participants were administered once daily oral dose of 16 mg GSK525762.		Participants were administered once daily oral dose of 30 mg GSK525762.		Participants were administered once daily oral dose of 60 mg GSK525762.		Participants were administered once daily oral dose of 80 mg GSK525762.		Participants were administered once daily oral dose of 100 mg GSK525762.		Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.		Participants were administered twice daily oral dose of 30 mg GSK525762.		Participants were administered twice daily oral dose of 40 mg GSK525762.		Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762.		Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762.		Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762.		Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.		Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762.		Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762.		Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762.		Participants received GSK525762 80 mg amorphous (amor) free-base tablet along with 6 mg stable isotope (iso) in solution in the fasted state in Period 1 followed by administration of GSK525762 80 mg besylate (bes) tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with Food and Drug Administration (FDA) recommended high fat breakfast in Period 4.		Participants received GSK525762 80 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 1 followed by administration GSK525762 80 mg amor free-base tablet along with 6 mg stable iso in solution in the fasted state in Period 2. Participants were then administered GSK525762 30 mg bes tablet along with 6 mg stable iso in solution in the fasted state in Period 3 and GSK525762 80 mg bes tablet was administered with FDA recommended high fat breakfast in Period 4.
All Cause Mortality
	Part1: GSK525762 4 mg QD		Part 1: GSK525762 8 mg QD		Part 1: GSK525762 16 mg QD		Part 1: GSK525762 30 mg QD		Part 1: GSK525762 60 mg QD		Part 1: GSK525762 80 mg QD		Part 1: GSK525762 100 mg QD		Part 1: GSK525762 20 mg BID		Part 1: GSK525762 30 mg BID		Part 1: GSK525762 40 mg BID		Part 2: Participants With NMC		Part 2: Participants With SCLC		Part 2: Participants With CRPC		Part1: GSK525762 2 mg QD		Part 2: Participants With TNBC		Part 2: Participants With ER+BC		Part 2: Participants With GIST		80mg Amor+6mg Iso/80mg Bes+6mg		80mg Bes+6mg Iso/80mg Amor+6mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/4 (100%)		1/1 (100%)		3/3 (100%)		4/4 (100%)		7/9 (77.8%)		30/32 (93.8%)		7/9 (77.8%)		1/4 (25%)		9/10 (90%)		3/5 (60%)		8/12 (66.7%)		12/14 (85.7%)		21/23 (91.3%)		2/3 (66.7%)		16/19 (84.2%)		17/21 (81%)		5/13 (38.5%)		1/5 (20%)		0/5 (0%)
Serious Adverse Events
	Part1: GSK525762 4 mg QD		Part 1: GSK525762 8 mg QD		Part 1: GSK525762 16 mg QD		Part 1: GSK525762 30 mg QD		Part 1: GSK525762 60 mg QD		Part 1: GSK525762 80 mg QD		Part 1: GSK525762 100 mg QD		Part 1: GSK525762 20 mg BID		Part 1: GSK525762 30 mg BID		Part 1: GSK525762 40 mg BID		Part 2: Participants With NMC		Part 2: Participants With SCLC		Part 2: Participants With CRPC		Part1: GSK525762 2 mg QD		Part 2: Participants With TNBC		Part 2: Participants With ER+BC		Part 2: Participants With GIST		80mg Amor+6mg Iso/80mg Bes+6mg		80mg Bes+6mg Iso/80mg Amor+6mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/4 (50%)		0/1 (0%)		0/3 (0%)		1/4 (25%)		2/9 (22.2%)		21/32 (65.6%)		3/9 (33.3%)		0/4 (0%)		4/10 (40%)		2/5 (40%)		6/12 (50%)		9/14 (64.3%)		16/23 (69.6%)		0/3 (0%)		11/19 (57.9%)		15/21 (71.4%)		8/13 (61.5%)		3/5 (60%)		3/5 (60%)
Blood and lymphatic system disorders
Anaemia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	2/32 (6.3%)	2	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	1/5 (20%)	1	2/12 (16.7%)	3	0/14 (0%)	0	3/23 (13%)	3	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	1/13 (7.7%)	2	0/5 (0%)	0	0/5 (0%)	0
Histiocytosis haematophagic	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Leukopenia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Thrombocytopenia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	8/32 (25%)	10	2/9 (22.2%)	2	0/4 (0%)	0	0/10 (0%)	0	1/5 (20%)	1	3/12 (25%)	5	4/14 (28.6%)	5	9/23 (39.1%)	10	0/3 (0%)	0	4/19 (21.1%)	4	2/21 (9.5%)	2	0/13 (0%)	0	3/5 (60%)	3	1/5 (20%)	1
Thrombotic microangiopathy	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Cardiac disorders
Atrial fibrillation	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Cardiotoxicity	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Pericardial effusion	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Thyrotoxic cardiomyopathy	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Gastrointestinal disorders
Abdominal pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	2/21 (9.5%)	2	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Colitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Diarrhoea	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	2	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Dysphagia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Gastric haemorrhage	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Gastrointestinal toxicity	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Intestinal perforation	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Large intestinal haemorrhage	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Nausea	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	4/32 (12.5%)	4	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	3/23 (13%)	3	0/3 (0%)	0	2/19 (10.5%)	2	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Oesophagitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Peritoneal haemorrhage	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Rectal haemorrhage	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	2	0/5 (0%)	0	0/5 (0%)	0
Stomatitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Upper gastrointestinal haemorrhage	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Varices oesophageal	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Vomiting	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	3/32 (9.4%)	3	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	4/23 (17.4%)	4	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
General disorders
Asthenia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	2/32 (6.3%)	2	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	1/5 (20%)	1	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	2/21 (9.5%)	2	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Chest pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Fatigue	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	2/21 (9.5%)	2	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
General physical health deterioration	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Malaise	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Mucosal inflammation	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Oedema peripheral	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Pyrexia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Sudden death	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hepatobiliary disorders
Hepatic haemorrhage	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hepatitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hepatocellular injury	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hyperbilirubinaemia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	2/10 (20%)	2	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Infections and infestations
Anal abscess	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Catheter site infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Cellulitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Clostridium difficile colitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Device related infection	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Escherichia urinary tract infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Herpes zoster	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Oral herpes	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Pneumonia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	1/21 (4.8%)	1	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Respiratory tract infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Sepsis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	2	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Upper respiratory tract infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Urinary tract infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	1/5 (20%)	1
Urosepsis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	2/23 (8.7%)	2	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Injury, poisoning and procedural complications
Post procedural haematoma	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Investigations
Alanine aminotransferase increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Amylase increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Blood creatinine increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Coagulation factor VII level decreased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	2/5 (40%)	3	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	2/21 (9.5%)	2	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Ejection fraction decreased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Lipase increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Prothrombin time prolonged	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	2	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Troponin I increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Metabolism and nutrition disorders
Decreased appetite	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	2/32 (6.3%)	2	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Dehydration	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	1/4 (25%)	1	0/9 (0%)	0	1/32 (3.1%)	2	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	1/14 (7.1%)	1	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Failure to thrive	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hypercalcaemia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hyperglycaemia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Hypokalaemia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	2	0/5 (0%)	0	0/5 (0%)	0
Hyponatraemia	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Osteonecrosis of jaw	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Nervous system disorders
Haemorrhage intracranial	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Ischaemic stroke	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Loss of consciousness	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Psychiatric disorders
Confusional state	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Delirium	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	1/4 (25%)	1	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Suicidal ideation	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Renal and urinary disorders
Acute kidney injury	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Haematuria	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	2/32 (6.3%)	2	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	3/23 (13%)	3	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Renal failure	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Urinary retention	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Reproductive system and breast disorders
Vaginal haemorrhage	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Epistaxis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Haemothorax	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Paranasal sinus haemorrhage	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Pleural effusion	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Pneumothorax	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Pulmonary embolism	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Respiratory failure	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Vascular disorders
Hypertension	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hypotension	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Superior vena cava syndrome	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Other (Not Including Serious) Adverse Events
	Part1: GSK525762 4 mg QD		Part 1: GSK525762 8 mg QD		Part 1: GSK525762 16 mg QD		Part 1: GSK525762 30 mg QD		Part 1: GSK525762 60 mg QD		Part 1: GSK525762 80 mg QD		Part 1: GSK525762 100 mg QD		Part 1: GSK525762 20 mg BID		Part 1: GSK525762 30 mg BID		Part 1: GSK525762 40 mg BID		Part 2: Participants With NMC		Part 2: Participants With SCLC		Part 2: Participants With CRPC		Part1: GSK525762 2 mg QD		Part 2: Participants With TNBC		Part 2: Participants With ER+BC		Part 2: Participants With GIST		80mg Amor+6mg Iso/80mg Bes+6mg		80mg Bes+6mg Iso/80mg Amor+6mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/4 (100%)		1/1 (100%)		3/3 (100%)		3/4 (75%)		9/9 (100%)		31/32 (96.9%)		9/9 (100%)		4/4 (100%)		10/10 (100%)		5/5 (100%)		11/12 (91.7%)		14/14 (100%)		23/23 (100%)		3/3 (100%)		19/19 (100%)		21/21 (100%)		12/13 (92.3%)		5/5 (100%)		5/5 (100%)
Blood and lymphatic system disorders
Anaemia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	1/4 (25%)	2	1/9 (11.1%)	1	11/32 (34.4%)	14	5/9 (55.6%)	5	2/4 (50%)	2	4/10 (40%)	4	1/5 (20%)	2	3/12 (25%)	3	6/14 (42.9%)	6	13/23 (56.5%)	14	0/3 (0%)	0	7/19 (36.8%)	7	9/21 (42.9%)	11	2/13 (15.4%)	2	4/5 (80%)	4	3/5 (60%)	3
Haemorrhagic diathesis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	2/23 (8.7%)	2	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Increased tendency to bruise	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Leukocytosis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	1/4 (25%)	1	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Leukopenia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	2/32 (6.3%)	2	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	3/5 (60%)	3	1/5 (20%)	1
Lymphopenia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	4/32 (12.5%)	7	0/9 (0%)	0	0/4 (0%)	0	2/10 (20%)	4	1/5 (20%)	1	1/12 (8.3%)	1	0/14 (0%)	0	3/23 (13%)	3	0/3 (0%)	0	2/19 (10.5%)	2	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Neutropenia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	2/32 (6.3%)	3	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	2/12 (16.7%)	2	3/14 (21.4%)	3	1/23 (4.3%)	2	0/3 (0%)	0	1/19 (5.3%)	1	4/21 (19%)	4	1/13 (7.7%)	1	1/5 (20%)	1	0/5 (0%)	0
Thrombocytopenia	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	1/4 (25%)	1	2/9 (22.2%)	2	18/32 (56.3%)	39	5/9 (55.6%)	8	1/4 (25%)	1	7/10 (70%)	8	5/5 (100%)	5	3/12 (25%)	5	7/14 (50%)	12	12/23 (52.2%)	23	0/3 (0%)	0	13/19 (68.4%)	15	13/21 (61.9%)	18	3/13 (23.1%)	3	4/5 (80%)	4	3/5 (60%)	3
Cardiac disorders
Atrial fibrillation	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Nodal rhythm	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Palpitations	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	2	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Pericardial effusion	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Sinus tachycardia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	2/32 (6.3%)	2	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	2	1/3 (33.3%)	1	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Supraventricular tachycardia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Tachycardia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	2/32 (6.3%)	2	0/9 (0%)	0	0/4 (0%)	0	2/10 (20%)	3	1/5 (20%)	1	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	1/3 (33.3%)	1	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	1/5 (20%)	1
Congenital, familial and genetic disorders
Factor V deficiency	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Ear and labyrinth disorders
Ear haemorrhage	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Hypoacusis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	1/3 (33.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Vertigo	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	1/21 (4.8%)	2	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Endocrine disorders
Hyperthyroidism	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Eye disorders
Cataract	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Diplopia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Dry eye	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Eye pruritus	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Keratitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Optic neuropathy	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Orbital oedema	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Vision blurred	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	3/32 (9.4%)	4	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	1/5 (20%)	1	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Visual acuity reduced	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Vitreous floaters	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Xerophthalmia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Gastrointestinal disorders
Abdominal discomfort	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Abdominal distension	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Abdominal hernia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Abdominal pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	4/32 (12.5%)	4	0/9 (0%)	0	0/4 (0%)	0	2/10 (20%)	2	2/5 (40%)	2	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	1/3 (33.3%)	1	1/19 (5.3%)	1	1/21 (4.8%)	1	2/13 (15.4%)	3	1/5 (20%)	2	1/5 (20%)	1
Abdominal pain lower	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Abdominal pain upper	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	2/12 (16.7%)	2	0/14 (0%)	0	1/23 (4.3%)	2	0/3 (0%)	0	0/19 (0%)	0	5/21 (23.8%)	6	0/13 (0%)	0	2/5 (40%)	2	0/5 (0%)	0
Abdominal tenderness	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Anal fissure	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Anal inflammation	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Anorectal discomfort	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Ascites	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Chapped lips	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	1/5 (20%)	1	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Cheilitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	2	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Colitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Constipation	3/4 (75%)	3	0/1 (0%)	0	1/3 (33.3%)	1	1/4 (25%)	1	2/9 (22.2%)	2	1/32 (3.1%)	1	3/9 (33.3%)	3	1/4 (25%)	1	2/10 (20%)	3	0/5 (0%)	0	3/12 (25%)	3	1/14 (7.1%)	1	5/23 (21.7%)	5	0/3 (0%)	0	5/19 (26.3%)	6	1/21 (4.8%)	2	2/13 (15.4%)	2	4/5 (80%)	4	0/5 (0%)	0
Diarrhoea	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	2	11/32 (34.4%)	16	4/9 (44.4%)	5	0/4 (0%)	0	6/10 (60%)	10	5/5 (100%)	8	6/12 (50%)	8	4/14 (28.6%)	6	12/23 (52.2%)	24	1/3 (33.3%)	1	7/19 (36.8%)	7	8/21 (38.1%)	11	4/13 (30.8%)	5	3/5 (60%)	5	1/5 (20%)	1
Dry mouth	1/4 (25%)	1	0/1 (0%)	0	2/3 (66.7%)	2	2/4 (50%)	2	0/9 (0%)	0	3/32 (9.4%)	4	0/9 (0%)	0	0/4 (0%)	0	3/10 (30%)	3	1/5 (20%)	1	2/12 (16.7%)	2	0/14 (0%)	0	3/23 (13%)	3	0/3 (0%)	0	1/19 (5.3%)	1	3/21 (14.3%)	4	1/13 (7.7%)	1	0/5 (0%)	0	1/5 (20%)	1
Dyspepsia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	1/3 (33.3%)	1	1/19 (5.3%)	1	1/21 (4.8%)	1	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Dysphagia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Eructation	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Faeces discoloured	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Faeces soft	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Flatulence	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	1/23 (4.3%)	1	1/3 (33.3%)	1	1/19 (5.3%)	1	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Frequent bowel movements	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Gastric haemorrhage	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Gastric ulcer	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	1/4 (25%)	1	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Gastrointestinal fistula	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Gastrointestinal haemorrhage	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Gastrooesophageal reflux disease	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Gingival bleeding	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	2/32 (6.3%)	6	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Gingival pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Glossitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Haematemesis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	1/4 (25%)	1	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Haemorrhoids	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hypoaesthesia oral	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Impaired gastric emptying	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	1/3 (33.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Lip dry	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Mouth ulceration	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Nausea	1/4 (25%)	1	1/1 (100%)	2	1/3 (33.3%)	1	3/4 (75%)	3	2/9 (22.2%)	2	15/32 (46.9%)	19	7/9 (77.8%)	10	2/4 (50%)	2	6/10 (60%)	9	1/5 (20%)	2	5/12 (41.7%)	6	8/14 (57.1%)	8	11/23 (47.8%)	16	0/3 (0%)	0	8/19 (42.1%)	12	9/21 (42.9%)	12	5/13 (38.5%)	5	3/5 (60%)	4	1/5 (20%)	1
Odynophagia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Oesophagitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Perianal erythema	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Rectal haemorrhage	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Stomatitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	2/32 (6.3%)	2	0/9 (0%)	0	0/4 (0%)	0	3/10 (30%)	3	0/5 (0%)	0	1/12 (8.3%)	1	2/14 (14.3%)	3	1/23 (4.3%)	1	0/3 (0%)	0	1/19 (5.3%)	1	3/21 (14.3%)	3	1/13 (7.7%)	1	1/5 (20%)	1	0/5 (0%)	0
Toothache	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Vomiting	1/4 (25%)	1	0/1 (0%)	0	2/3 (66.7%)	2	1/4 (25%)	1	2/9 (22.2%)	2	11/32 (34.4%)	20	4/9 (44.4%)	5	3/4 (75%)	3	3/10 (30%)	6	1/5 (20%)	1	4/12 (33.3%)	5	4/14 (28.6%)	4	9/23 (39.1%)	18	0/3 (0%)	0	8/19 (42.1%)	11	6/21 (28.6%)	8	2/13 (15.4%)	2	3/5 (60%)	3	1/5 (20%)	1
General disorders
Asthenia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	10/32 (31.3%)	13	0/9 (0%)	0	1/4 (25%)	1	7/10 (70%)	8	3/5 (60%)	4	5/12 (41.7%)	6	4/14 (28.6%)	5	6/23 (26.1%)	6	0/3 (0%)	0	7/19 (36.8%)	9	11/21 (52.4%)	12	3/13 (23.1%)	3	0/5 (0%)	0	0/5 (0%)	0
Axillary pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Catheter site inflammation	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Catheter site pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Chest discomfort	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Chest pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	2/12 (16.7%)	2	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Chills	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	1/9 (11.1%)	1	1/4 (25%)	1	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	2/21 (9.5%)	2	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Face oedema	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	3/19 (15.8%)	3	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Facial pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Fatigue	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	1/4 (25%)	1	3/9 (33.3%)	3	11/32 (34.4%)	12	5/9 (55.6%)	6	1/4 (25%)	1	1/10 (10%)	1	1/5 (20%)	1	4/12 (33.3%)	4	5/14 (35.7%)	5	12/23 (52.2%)	15	1/3 (33.3%)	1	7/19 (36.8%)	7	4/21 (19%)	4	3/13 (23.1%)	3	3/5 (60%)	3	3/5 (60%)	3
Gait disturbance	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Influenza like illness	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	2/19 (10.5%)	2	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Localised oedema	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Malaise	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	2	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	2/21 (9.5%)	2	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Mucosal inflammation	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	3/32 (9.4%)	3	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	1/14 (7.1%)	1	2/23 (8.7%)	2	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	1/5 (20%)	1
Non-cardiac chest pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	3/32 (9.4%)	3	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	1/3 (33.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Oedema peripheral	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	2/32 (6.3%)	2	1/9 (11.1%)	1	0/4 (0%)	0	1/10 (10%)	1	1/5 (20%)	1	1/12 (8.3%)	1	1/14 (7.1%)	1	3/23 (13%)	3	0/3 (0%)	0	3/19 (15.8%)	3	2/21 (9.5%)	4	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Pain	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Pyrexia	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	6/32 (18.8%)	8	0/9 (0%)	0	0/4 (0%)	0	2/10 (20%)	3	0/5 (0%)	0	0/12 (0%)	0	4/14 (28.6%)	6	1/23 (4.3%)	1	1/3 (33.3%)	1	4/19 (21.1%)	4	2/21 (9.5%)	2	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Xerosis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hepatobiliary disorders
Cholangitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hepatic pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hyperbilirubinaemia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	9/32 (28.1%)	11	5/9 (55.6%)	6	1/4 (25%)	1	4/10 (40%)	4	2/5 (40%)	3	6/12 (50%)	8	4/14 (28.6%)	5	7/23 (30.4%)	9	0/3 (0%)	0	2/19 (10.5%)	3	9/21 (42.9%)	12	2/13 (15.4%)	2	2/5 (40%)	2	2/5 (40%)	2
Liver disorder	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Portal vein thrombosis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Immune system disorders
Seasonal allergy	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Infections and infestations
Anal abscess	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Angular cheilitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Bronchitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Catheter site infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Cellulitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Conjunctivitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Cystitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Device related infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	2/10 (20%)	2	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Ear infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Endometritis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Folliculitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Fungal skin infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Genital herpes simplex	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Gingivitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Herpes dermatitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Herpes virus infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Herpes zoster	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	1/32 (3.1%)	2	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	2/21 (9.5%)	2	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Infected cyst	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Infected skin ulcer	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Lip infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Lower respiratory tract infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Lung infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Nail infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Nasopharyngitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Oral candidiasis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	2/32 (6.3%)	2	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Oral herpes	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	3/32 (9.4%)	4	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	1/5 (20%)	1	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	1/19 (5.3%)	1	1/21 (4.8%)	1	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Otitis media	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Pharyngitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Pneumonia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Respiratory tract infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Rhinitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	1/5 (20%)	1	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Rhinovirus infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Sepsis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Skin candida	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Skin infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Subcutaneous abscess	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Upper respiratory tract infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Urinary tract infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	3/32 (9.4%)	3	1/9 (11.1%)	1	1/4 (25%)	1	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	4/23 (17.4%)	7	0/3 (0%)	0	3/19 (15.8%)	3	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Vaginal infection	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Injury, poisoning and procedural complications
Allergic transfusion reaction	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Animal bite	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Contusion	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	2/32 (6.3%)	2	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	3/12 (25%)	5	0/14 (0%)	0	5/23 (21.7%)	5	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	2/5 (40%)	2
Cystitis radiation	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Eye contusion	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Fall	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Genital contusion	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Limb injury	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Postoperative wound complication	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Procedural pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	1/5 (20%)	1	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Radiation oesophagitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Transfusion reaction	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Investigations
Activated partial thromboplastin time prolonged	0/4 (0%)	0	0/1 (0%)	0	1/3 (33.3%)	1	0/4 (0%)	0	0/9 (0%)	0	2/32 (6.3%)	3	1/9 (11.1%)	1	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	3/21 (14.3%)	3	0/13 (0%)	0	4/5 (80%)	4	1/5 (20%)	1
Alanine aminotransferase increased	0/4 (0%)	0	1/1 (100%)	1	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	4/32 (12.5%)	5	2/9 (22.2%)	2	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	2/14 (14.3%)	2	3/23 (13%)	3	0/3 (0%)	0	4/19 (21.1%)	5	4/21 (19%)	4	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Amylase increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	1/14 (7.1%)	2	2/23 (8.7%)	2	0/3 (0%)	0	1/19 (5.3%)	1	1/21 (4.8%)	1	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Aspartate aminotransferase increased	0/4 (0%)	0	1/1 (100%)	1	0/3 (0%)	0	1/4 (25%)	1	1/9 (11.1%)	1	5/32 (15.6%)	6	2/9 (22.2%)	2	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	2/12 (16.7%)	3	2/14 (14.3%)	2	6/23 (26.1%)	8	0/3 (0%)	0	4/19 (21.1%)	4	6/21 (28.6%)	7	2/13 (15.4%)	2	2/5 (40%)	6	0/5 (0%)	0
Bacterial test positive	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Bilirubin conjugated increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	2/9 (22.2%)	2	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	3/21 (14.3%)	3	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Blood albumin increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Blood alkaline phosphatase increased	0/4 (0%)	0	1/1 (100%)	1	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Blood bilirubin unconjugated increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Blood chloride decreased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Blood creatine phosphokinase MB increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Blood creatine phosphokinase increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	1/4 (25%)	1	0/9 (0%)	0	1/32 (3.1%)	1	1/9 (11.1%)	2	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	3/21 (14.3%)	3	5/13 (38.5%)	6	1/5 (20%)	1	0/5 (0%)	0
Blood creatinine increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	3/32 (9.4%)	3	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	2/12 (16.7%)	2	3/14 (21.4%)	3	3/23 (13%)	3	0/3 (0%)	0	0/19 (0%)	0	4/21 (19%)	5	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Blood fibrinogen decreased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Blood fibrinogen increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Blood insulin increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Blood thyroid stimulating hormone decreased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	1/5 (20%)	1	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Blood triglycerides increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	1/5 (20%)	1	2/12 (16.7%)	2	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	2/19 (10.5%)	2	2/21 (9.5%)	2	1/13 (7.7%)	1	1/5 (20%)	1	1/5 (20%)	1
Blood uric acid increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Brain natriuretic peptide increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Coagulation factor VII level decreased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	3/10 (30%)	3	1/5 (20%)	1	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	3/19 (15.8%)	3	4/21 (19%)	6	3/13 (23.1%)	3	0/5 (0%)	0	0/5 (0%)	0
Ejection fraction decreased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	2/21 (9.5%)	2	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Electrocardiogram QRS complex prolonged	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Electrocardiogram QT prolonged	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	2/9 (22.2%)	2	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Gamma-glutamyltransferase increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
International normalised ratio increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	7/32 (21.9%)	7	2/9 (22.2%)	2	1/4 (25%)	1	0/10 (0%)	0	0/5 (0%)	0	4/12 (33.3%)	4	0/14 (0%)	0	5/23 (21.7%)	5	1/3 (33.3%)	1	3/19 (15.8%)	3	4/21 (19%)	4	4/13 (30.8%)	4	4/5 (80%)	4	1/5 (20%)	1
Lipase increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	2/32 (6.3%)	2	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	2/14 (14.3%)	2	2/23 (8.7%)	3	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	2/13 (15.4%)	2	0/5 (0%)	0	0/5 (0%)	0
N-terminal prohormone brain natriuretic peptide increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Occult blood positive	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Oxygen saturation decreased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Protein urine present	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Prothrombin time prolonged	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	4/32 (12.5%)	5	0/9 (0%)	0	0/4 (0%)	0	3/10 (30%)	4	2/5 (40%)	2	3/12 (25%)	3	0/14 (0%)	0	4/23 (17.4%)	4	0/3 (0%)	0	2/19 (10.5%)	3	4/21 (19%)	7	4/13 (30.8%)	4	1/5 (20%)	1	2/5 (40%)	2
Prothrombin time ratio decreased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Thyroxine free decreased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Thyroxine free increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	2/23 (8.7%)	2	0/3 (0%)	0	1/19 (5.3%)	1	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Transaminases increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Tri-iodothyronine free decreased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Troponin T increased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Weight decreased	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	3/32 (9.4%)	3	4/9 (44.4%)	5	0/4 (0%)	0	3/10 (30%)	4	1/5 (20%)	2	3/12 (25%)	4	0/14 (0%)	0	2/23 (8.7%)	2	0/3 (0%)	0	2/19 (10.5%)	3	5/21 (23.8%)	5	2/13 (15.4%)	2	0/5 (0%)	0	1/5 (20%)	1
White blood cells urine positive	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Metabolism and nutrition disorders
Decreased appetite	2/4 (50%)	2	0/1 (0%)	0	0/3 (0%)	0	1/4 (25%)	1	2/9 (22.2%)	2	15/32 (46.9%)	19	6/9 (66.7%)	8	1/4 (25%)	1	7/10 (70%)	10	4/5 (80%)	5	4/12 (33.3%)	4	5/14 (35.7%)	5	15/23 (65.2%)	16	0/3 (0%)	0	8/19 (42.1%)	8	10/21 (47.6%)	11	6/13 (46.2%)	6	1/5 (20%)	1	2/5 (40%)	2
Dehydration	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	2/32 (6.3%)	2	2/9 (22.2%)	2	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	3/14 (21.4%)	3	2/23 (8.7%)	2	0/3 (0%)	0	0/19 (0%)	0	2/21 (9.5%)	2	1/13 (7.7%)	1	1/5 (20%)	1	0/5 (0%)	0
Hypercalcaemia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hypercholesterolaemia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	2/32 (6.3%)	2	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	2/21 (9.5%)	2	1/13 (7.7%)	1	1/5 (20%)	1	0/5 (0%)	0
Hyperglycaemia	0/4 (0%)	0	1/1 (100%)	1	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	6/32 (18.8%)	6	1/9 (11.1%)	1	1/4 (25%)	1	4/10 (40%)	7	1/5 (20%)	1	2/12 (16.7%)	2	1/14 (7.1%)	1	2/23 (8.7%)	2	0/3 (0%)	0	3/19 (15.8%)	4	6/21 (28.6%)	7	5/13 (38.5%)	5	1/5 (20%)	1	2/5 (40%)	2
Hyperkalaemia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Hypermagnesaemia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hyperphosphataemia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	2/32 (6.3%)	2	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	1/14 (7.1%)	1	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	1/13 (7.7%)	1	0/5 (0%)	0	1/5 (20%)	1
Hypertriglyceridaemia	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hypoalbuminaemia	2/4 (50%)	2	0/1 (0%)	0	1/3 (33.3%)	1	0/4 (0%)	0	0/9 (0%)	0	2/32 (6.3%)	3	0/9 (0%)	0	0/4 (0%)	0	2/10 (20%)	2	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	1/23 (4.3%)	1	1/3 (33.3%)	1	3/19 (15.8%)	3	2/21 (9.5%)	3	0/13 (0%)	0	2/5 (40%)	2	0/5 (0%)	0
Hypocalcaemia	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	2/32 (6.3%)	2	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Hypocholesterolaemia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	1/5 (20%)	1	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hypokalaemia	1/4 (25%)	1	0/1 (0%)	0	1/3 (33.3%)	1	0/4 (0%)	0	0/9 (0%)	0	5/32 (15.6%)	6	1/9 (11.1%)	1	1/4 (25%)	1	4/10 (40%)	4	0/5 (0%)	0	0/12 (0%)	0	2/14 (14.3%)	2	3/23 (13%)	4	0/3 (0%)	0	1/19 (5.3%)	1	1/21 (4.8%)	1	1/13 (7.7%)	1	1/5 (20%)	1	0/5 (0%)	0
Hypomagnesaemia	2/4 (50%)	2	1/1 (100%)	1	0/3 (0%)	0	1/4 (25%)	1	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	1/21 (4.8%)	1	0/13 (0%)	0	2/5 (40%)	2	0/5 (0%)	0
Hyponatraemia	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	4/32 (12.5%)	4	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	1/12 (8.3%)	1	1/14 (7.1%)	1	1/23 (4.3%)	1	1/3 (33.3%)	1	2/19 (10.5%)	2	2/21 (9.5%)	2	1/13 (7.7%)	1	1/5 (20%)	1	0/5 (0%)	0
Hypophosphataemia	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Iron deficiency	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Metabolic acidosis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	3/32 (9.4%)	3	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	2/12 (16.7%)	2	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Arthritis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Back pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	4/32 (12.5%)	6	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	4/23 (17.4%)	4	0/3 (0%)	0	0/19 (0%)	0	2/21 (9.5%)	2	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Bone pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	2/12 (16.7%)	2	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Connective tissue disorder	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Groin pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Joint swelling	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Muscle spasms	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	1/5 (20%)	1	1/12 (8.3%)	2	0/14 (0%)	0	3/23 (13%)	3	0/3 (0%)	0	1/19 (5.3%)	1	3/21 (14.3%)	3	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Musculoskeletal chest pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	3/32 (9.4%)	4	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Musculoskeletal disorder	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Musculoskeletal pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	1/5 (20%)	1	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	2/21 (9.5%)	2	0/13 (0%)	0	1/5 (20%)	1	1/5 (20%)	1
Myalgia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	4/23 (17.4%)	4	0/3 (0%)	0	3/19 (15.8%)	3	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	1/5 (20%)	1
Pain in extremity	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	2/32 (6.3%)	2	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Pain in jaw	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Tumour pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	2/23 (8.7%)	2	0/3 (0%)	0	2/19 (10.5%)	2	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Nervous system disorders
Ageusia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Aphasia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Balance disorder	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	1/5 (20%)	1	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Cervical radiculopathy	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Dizziness	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	1/4 (25%)	1	0/9 (0%)	0	3/32 (9.4%)	3	2/9 (22.2%)	3	0/4 (0%)	0	1/10 (10%)	2	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	1/19 (5.3%)	1	4/21 (19%)	4	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Drug withdrawal headache	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Dysaesthesia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	1/5 (20%)	1	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Dysgeusia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	1/4 (25%)	1	3/9 (33.3%)	5	8/32 (25%)	9	5/9 (55.6%)	6	1/4 (25%)	1	4/10 (40%)	4	2/5 (40%)	2	4/12 (33.3%)	4	2/14 (14.3%)	2	10/23 (43.5%)	12	0/3 (0%)	0	5/19 (26.3%)	6	7/21 (33.3%)	8	5/13 (38.5%)	5	2/5 (40%)	2	3/5 (60%)	3
Headache	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	3/32 (9.4%)	5	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	3/12 (25%)	4	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	4/19 (21.1%)	4	2/21 (9.5%)	2	3/13 (23.1%)	3	0/5 (0%)	0	1/5 (20%)	1
Intercostal neuralgia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Lethargy	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Loss of consciousness	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Neuralgia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Neuropathy peripheral	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Paraesthesia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Post herpetic neuralgia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Presyncope	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Sciatica	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Somnolence	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	3/32 (9.4%)	3	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	1/5 (20%)	1	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Syncope	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Tension headache	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Tremor	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Psychiatric disorders
Agitation	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Anhedonia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Anxiety	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	1/4 (25%)	1	0/9 (0%)	0	2/32 (6.3%)	2	1/9 (11.1%)	2	0/4 (0%)	0	1/10 (10%)	2	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	2/3 (66.7%)	2	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	2/5 (40%)	2	0/5 (0%)	0
Confusional state	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Delirium	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Depression	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	2/9 (22.2%)	2	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Disorientation	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hallucination	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hallucination, visual	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Insomnia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	1/14 (7.1%)	1	0/23 (0%)	0	1/3 (33.3%)	1	1/19 (5.3%)	1	4/21 (19%)	4	1/13 (7.7%)	1	2/5 (40%)	2	1/5 (20%)	1
Mental status changes	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Mood altered	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Renal and urinary disorders
Acute kidney injury	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	3/32 (9.4%)	3	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Anuria	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Chromaturia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	1/5 (20%)	1
Dysuria	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	3/32 (9.4%)	3	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	1/14 (7.1%)	1	2/23 (8.7%)	2	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Haematuria	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	1/4 (25%)	1	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	7/23 (30.4%)	10	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hydronephrosis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Hypertonic bladder	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Neurogenic bladder	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Nocturia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Proteinuria	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Urinary hesitation	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	1/4 (25%)	1	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Urinary retention	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Urinary tract disorder	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	2	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Urine odour abnormal	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Reproductive system and breast disorders
Benign prostatic hyperplasia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Breast pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Metrorrhagia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Pelvic haematoma	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Pelvic pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Perineal pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Vaginal discharge	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Vaginal odour	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Vulvovaginal pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Cough	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	3/9 (33.3%)	3	4/32 (12.5%)	4	1/9 (11.1%)	2	0/4 (0%)	0	3/10 (30%)	3	1/5 (20%)	1	3/12 (25%)	3	1/14 (7.1%)	1	2/23 (8.7%)	2	0/3 (0%)	0	1/19 (5.3%)	1	2/21 (9.5%)	2	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Dysphonia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	1/4 (25%)	1	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	2/21 (9.5%)	2	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Dyspnoea	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	5/32 (15.6%)	7	5/9 (55.6%)	6	0/4 (0%)	0	3/10 (30%)	4	1/5 (20%)	1	2/12 (16.7%)	2	4/14 (28.6%)	4	5/23 (21.7%)	5	0/3 (0%)	0	4/19 (21.1%)	4	8/21 (38.1%)	8	4/13 (30.8%)	4	1/5 (20%)	1	2/5 (40%)	2
Dyspnoea exertional	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	2/23 (8.7%)	2	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Epistaxis	0/4 (0%)	0	0/1 (0%)	0	1/3 (33.3%)	1	0/4 (0%)	0	0/9 (0%)	0	5/32 (15.6%)	5	2/9 (22.2%)	2	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	5/12 (41.7%)	6	0/14 (0%)	0	6/23 (26.1%)	6	0/3 (0%)	0	1/19 (5.3%)	1	1/21 (4.8%)	1	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Haemoptysis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	2/32 (6.3%)	3	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Laryngeal pain	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Nasal congestion	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Nasal dryness	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Nocturnal dyspnoea	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Oropharyngeal pain	0/4 (0%)	0	0/1 (0%)	0	1/3 (33.3%)	1	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Orthopnoea	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Pharyngeal oedema	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Pleural effusion	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Pneumonia aspiration	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Productive cough	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Pulmonary alveolar haemorrhage	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Pulmonary embolism	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Pulmonary haemorrhage	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Respiratory symptom	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Rhinitis allergic	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Rhinorrhoea	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Sputum discoloured	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Throat clearing	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Upper-airway cough syndrome	0/4 (0%)	0	0/1 (0%)	0	1/3 (33.3%)	1	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Wheezing	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Skin and subcutaneous tissue disorders
Alopecia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Blister	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Dermatitis acneiform	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	3/32 (9.4%)	3	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	2/21 (9.5%)	2	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Dermatitis bullous	1/4 (25%)	1	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Dermatitis contact	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Dry skin	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	2/32 (6.3%)	2	1/9 (11.1%)	1	0/4 (0%)	0	2/10 (20%)	2	1/5 (20%)	1	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	1/3 (33.3%)	1	3/19 (15.8%)	3	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Ecchymosis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Erythema	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	1/14 (7.1%)	1	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Guttate psoriasis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Hair colour changes	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hidradenitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hyperhidrosis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Ingrowing nail	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Leukoplakia	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Madarosis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	2	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Night sweats	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Onycholysis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Palmar-plantar erythrodysaesthesia syndrome	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Petechiae	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Pigmentation disorder	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Pruritus	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	2/32 (6.3%)	2	1/9 (11.1%)	1	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	1/12 (8.3%)	1	3/14 (21.4%)	4	0/23 (0%)	0	1/3 (33.3%)	1	4/19 (21.1%)	5	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Purpura	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Rash	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	2/9 (22.2%)	2	5/32 (15.6%)	5	2/9 (22.2%)	2	0/4 (0%)	0	2/10 (20%)	3	0/5 (0%)	0	5/12 (41.7%)	5	4/14 (28.6%)	5	1/23 (4.3%)	1	0/3 (0%)	0	1/19 (5.3%)	1	3/21 (14.3%)	4	0/13 (0%)	0	1/5 (20%)	1	1/5 (20%)	1
Rash erythematous	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Rash macular	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Rash maculo-papular	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	2/14 (14.3%)	2	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Rash papular	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Rash pruritic	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	1/5 (20%)	1	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Scab	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	0/5 (0%)	0	0/5 (0%)	0
Seborrhoeic dermatitis	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Skin burning sensation	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	1/5 (20%)	1
Skin fissures	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Skin hyperpigmentation	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	1/9 (11.1%)	1	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Skin lesion	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Skin ulcer	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	1/3 (33.3%)	1	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Urticaria	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Vascular disorders
Flushing	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	0/13 (0%)	0	1/5 (20%)	1	0/5 (0%)	0
Haematoma	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	1/32 (3.1%)	1	0/9 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	1/23 (4.3%)	1	0/3 (0%)	0	0/19 (0%)	0	2/21 (9.5%)	2	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hypertension	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	2/32 (6.3%)	2	1/9 (11.1%)	1	0/4 (0%)	0	1/10 (10%)	1	0/5 (0%)	0	1/12 (8.3%)	1	0/14 (0%)	0	0/23 (0%)	0	1/3 (33.3%)	1	0/19 (0%)	0	1/21 (4.8%)	1	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0
Hypotension	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	0/19 (0%)	0	0/21 (0%)	0	1/13 (7.7%)	1	2/5 (40%)	2	0/5 (0%)	0
Lymphoedema	0/4 (0%)	0	0/1 (0%)	0	0/3 (0%)	0	0/4 (0%)	0	0/9 (0%)	0	0/32 (0%)	0	0/9 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/5 (0%)	0	0/12 (0%)	0	0/14 (0%)	0	0/23 (0%)	0	0/3 (0%)	0	1/19 (5.3%)	1	0/21 (0%)	0	0/13 (0%)	0	0/5 (0%)	0	0/5 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.