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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01587703
Recruitment Status : Completed
First Posted : April 30, 2012
Results First Posted : March 16, 2020
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Midline
Intervention Drug: GSK525762
Enrollment 196
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 Details 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
Hide 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
Reason Not Completed
Physician Decision             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Lost to Follow-up             0             0             0             0             0             1             0             2             0             0             0             0             0             0             0             0             0             0             0
Site closed             0             0             0             0             0             0             2             0             0             0             0             0             0             0             0             0             0             0             0
Death             2             4             1             3             4             7             30             7             0             0             0             0             0             0             0             0             0             0             0
Period Title: Part1 BID(Median Exposure of 1.41months)
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
Reason Not Completed
Death             0             0             0             0             0             0             0             0             1             9             3             0             0             0             0             0             0             0             0
Withdrawal by Subject             0             0             0             0             0             0             0             0             1             0             1             0             0             0             0             0             0             0             0
Site closed             0             0             0             0             0             0             0             0             0             1             1             0             0             0             0             0             0             0             0
Lost to Follow-up             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0             0             0             0             0
Period Title: Substudy-Period(P)1, Week1(Day1 to Day3)
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: Substudy-P2, Week1Day3 to Week2Day1
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: Substudy-P3, Week2Day1 to Week2Day3
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: Substudy-P4,Maximum Exposure of 5.5month
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
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1
Death             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             5             4
Period Title: Part2(Median Exposure of 1.41 Months)
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
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             0             1             0             0             2             0             0             0             0
Site closed             0             0             0             0             0             0             0             0             0             0             0             2             2             1             1             3             8             0             0
Death             0             0             0             0             0             0             0             0             0             0             0             8             12             21             16             17             5             0             0
Physician Decision             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0             0
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
Hide 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 Number of Baseline Participants 4 1 3 4 9 32 9 4 10 5 10 12 14 23 3 19 21 13 196
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants 4 participants 10 participants 5 participants 10 participants 12 participants 14 participants 23 participants 3 participants 19 participants 21 participants 13 participants 196 participants
47.0  (19.44) 39.0 [1]   (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)
[1]
Standard deviation could not be calculated as only one participant was analyzed
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants 4 participants 10 participants 5 participants 10 participants 12 participants 14 participants 23 participants 3 participants 19 participants 21 participants 13 participants 196 participants
Female
3
  75.0%
1
 100.0%
3
 100.0%
1
  25.0%
6
  66.7%
14
  43.8%
2
  22.2%
2
  50.0%
4
  40.0%
1
  20.0%
5
  50.0%
7
  58.3%
9
  64.3%
0
   0.0%
1
  33.3%
19
 100.0%
21
 100.0%
6
  46.2%
105
  53.6%
Male
1
  25.0%
0
   0.0%
0
   0.0%
3
  75.0%
3
  33.3%
18
  56.3%
7
  77.8%
2
  50.0%
6
  60.0%
4
  80.0%
5
  50.0%
5
  41.7%
5
  35.7%
23
 100.0%
2
  66.7%
0
   0.0%
0
   0.0%
7
  53.8%
91
  46.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants 4 participants 10 participants 5 participants 10 participants 12 participants 14 participants 23 participants 3 participants 19 participants 21 participants 13 participants 196 participants
American Indian or Alaska Native
0
   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
   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
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
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
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  16.7%
3
  21.4%
0
   0.0%
0
   0.0%
1
   5.3%
0
   0.0%
1
   7.7%
9
   4.6%
Black or African American
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
1
  11.1%
2
   6.3%
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
2
  14.3%
0
   0.0%
0
   0.0%
2
  10.5%
1
   4.8%
1
   7.7%
12
   6.1%
White
3
  75.0%
0
   0.0%
2
  66.7%
4
 100.0%
7
  77.8%
30
  93.8%
8
  88.9%
3
  75.0%
10
 100.0%
5
 100.0%
9
  90.0%
6
  50.0%
8
  57.1%
23
 100.0%
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
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  25.0%
1
   7.1%
0
   0.0%
0
   0.0%
1
   5.3%
2
   9.5%
1
   7.7%
8
   4.1%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QD
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 3 4 1 3 4 9 32 9
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
3
 100.0%
4
 100.0%
1
 100.0%
3
 100.0%
3
  75.0%
9
 100.0%
31
  96.9%
9
 100.0%
Any SAE
0
   0.0%
2
  50.0%
0
   0.0%
0
   0.0%
1
  25.0%
2
  22.2%
21
  65.6%
3
  33.3%
2.Primary Outcome
Title Number of Participants With AEs and SAEs-Part 1 BID
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 4 10 5
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
4
 100.0%
10
 100.0%
5
 100.0%
Any SAE
0
   0.0%
4
  40.0%
2
  40.0%
3.Primary Outcome
Title Number of Participants With AEs and SAEs-Part 2
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 12 14 23 19 21 13
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
11
  91.7%
14
 100.0%
23
 100.0%
19
 100.0%
21
 100.0%
13
 100.0%
Any SAE
6
  50.0%
9
  64.3%
16
  69.6%
11
  57.9%
15
  71.4%
8
  61.5%
4.Primary Outcome
Title Number of Participants With Dose Reductions or Delays-Part 1 QD
Hide Description The number of participants who had any dose reductions or delays is presented.
Time Frame Median of 1.38 months of drug exposure
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 3 4 1 3 4 9 32 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  22.2%
8
  25.0%
7
  77.8%
5.Primary Outcome
Title Number of Participants With Dose Reductions or Delays-Part 1 BID
Hide Description The number of participants who had any dose reductions or delays is presented.
Time Frame Median of 1.41 months of drug exposure
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 4 10 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3
  30.0%
1
  20.0%
6.Primary Outcome
Title Number of Participants With Dose Reductions or Delays-Part 2
Hide Description The number of participants who had any dose reductions or delays is presented.
Time Frame Median of 1.41 months of drug exposure
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 12 14 23 19 21 13
Measure Type: Count of Participants
Unit of Measure: Participants
7
  58.3%
4
  28.6%
11
  47.8%
6
  31.6%
6
  28.6%
4
  30.8%
7.Primary Outcome
Title Number of Participants With Dose Reductions or Delays-Besylate Sub-study
Hide Description The number of participants who had any dose reductions or delays is presented.
Time Frame Median of 1.87 months of drug exposure
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 5 5
Measure Type: Count of Participants
Unit of Measure: Participants
3
  60.0%
1
  20.0%
8.Primary Outcome
Title Number of Participants Withdrawn Due to Toxicities-Part 1 QD
Hide Description Number of participants withdrawn due to toxicities is presented.
Time Frame Median of 1.38 months of drug exposure
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 3 4 1 3 4 9 32 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  22.2%
7
  21.9%
2
  22.2%
9.Primary Outcome
Title Number of Participants Withdrawn Due to Toxicities-Part 1 BID
Hide Description Number of participants withdrawn due to toxicities is presented.
Time Frame Median of 1.41 months of drug exposure
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 4 10 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
  20.0%
2
  40.0%
10.Primary Outcome
Title Number of Participants Withdrawn Due to Toxicities-Part 2
Hide Description Number of participants withdrawn due to toxicities is presented.
Time Frame Median of 1.41 months of drug exposure
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 12 14 23 19 21 13
Measure Type: Count of Participants
Unit of Measure: Participants
1
   8.3%
3
  21.4%
6
  26.1%
4
  21.1%
6
  28.6%
2
  15.4%
11.Primary Outcome
Title Number of Participants Withdrawn Due to Toxicities-Besylate Sub-study
Hide Description Number of participants withdrawn due to toxicities is presented.
Time Frame Median of 1.87 months of drug exposure
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 5 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
12.Primary Outcome
Title Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 3 4 1 3 4 9 32 9
Measure Type: Count of Participants
Unit of Measure: Participants
Glucose; Any grade increase; n=2,4,1,3,4,9,32,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
2
  50.0%
1
 100.0%
3
 100.0%
2
  50.0%
7
  77.8%
24
  75.0%
8
  88.9%
Glucose; Increase to Grade 3; n=2,4,1,3,4,9,32,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   6.3%
3
  33.3%
Glucose; Increase to Grade 4; n=2,4,1,3,4,9,32,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
2
  50.0%
0
   0.0%
0
   0.0%
1
  25.0%
3
  33.3%
12
  37.5%
1
  11.1%
Albumin; Increase to Grade 3; n=2,4,1,3,4,9,32,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
7
  22.6%
0
   0.0%
ALP; Increase to Grade 3; n=2,4,1,3,4,9,31,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.2%
0
   0.0%
ALP; Increase to Grade 4; n=2,4,1,3,4,9,31,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
1
 100.0%
0
   0.0%
1
  25.0%
1
  11.1%
9
  28.1%
2
  22.2%
ALT; Increase to Grade 3; n=2,4,1,3,4,9,32,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
1
  50.0%
1
  25.0%
0
   0.0%
1
  33.3%
2
  50.0%
0
   0.0%
10
  31.3%
1
  11.1%
Amylase; Increase to Grade 3; n=2,4,1,3,4,9,32,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.1%
1
  11.1%
Amylase; Increase to Grade 4; n=2,4,1,3,4,9,32,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.1%
0
   0.0%
AST; Any grade increase; n=2,4,1,3,4,9,32,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
2
 100.0%
1
  25.0%
1
 100.0%
0
   0.0%
2
  50.0%
1
  11.1%
14
  43.8%
3
  33.3%
AST; Increase to Grade 3; n=2,4,1,3,4,9,32,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
AST; Increase to Grade 4; n=2,4,1,3,4,9,32,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 30 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 30 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 30 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
1
 100.0%
0
   0.0%
1
  25.0%
1
  11.1%
15
  46.9%
8
  88.9%
Bilirubin; Increase to Grade 3; n=2,4,1,3,4,9,32,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
5
  15.6%
1
  11.1%
Bilirubin; Increase to Grade 4; n=2,4,1,3,4,9,32,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 30 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 30 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 30 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
1
  50.0%
1
  25.0%
0
   0.0%
1
  33.3%
2
  50.0%
1
  11.1%
17
  53.1%
3
  33.3%
Calcium; Increase to Grade 3; n=2,4,1,3,4,9,32,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
1
  50.0%
0
   0.0%
0
   0.0%
0
   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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 7 participants 29 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
11
  37.9%
1
  11.1%
Cholesterol;Increase to Grade 3;n=2,4,1,3,4,7,29,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 7 participants 29 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 7 participants 29 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 3 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 9 participants
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
11
  35.5%
5
  55.6%
CK; Increase to Grade 3; n=3, 4, 1, 3, 4, 9, 31, 9 Number Analyzed 3 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   6.5%
0
   0.0%
CK; Increase to Grade 4; n=3, 4, 1, 3, 4, 9, 31, 9 Number Analyzed 3 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
7
  21.9%
3
  33.3%
Creatinine;Increase to Grade 3;n=2,4,1,3,4,9,32,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.1%
0
   0.0%
Creatinine;Increase to Grade 4;n=2,4,1,3,4,9,32,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 7 participants
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
11
  35.5%
1
  14.3%
GGT;Increase to Grade 3; n=2,4,1,3,4,9,31,7 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 7 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   6.5%
0
   0.0%
GGT; Increase to Grade 4; n=2,4,1,3,4,9,31,7 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 7 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.2%
0
   0.0%
HDL; Any grade increase; n=2, 4, 1, 3, 4, 7, 28, 9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 7 participants 28 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 7 participants 28 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 7 participants 28 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 3 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
2
  66.7%
2
  50.0%
0
   0.0%
3
 100.0%
0
   0.0%
2
  22.2%
13
  40.6%
3
  33.3%
Potassium;Increase to Grade 3;n=3,4,1,3,4,9,32,9 Number Analyzed 3 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.1%
1
  11.1%
Potassium;Increase to Grade 4;n=3,4,1,3,4,9,32,9 Number Analyzed 3 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.1%
0
   0.0%
LDH; Any grade increase; n=0, 0, 0, 0, 0, 1, 0, 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
0
   0.0%
LDH; Increase to Grade 3; n=0, 0, 0, 0, 0, 1, 0, 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
0
   0.0%
LDH; Increase to Grade 4; n=0, 0, 0, 0, 0, 1, 0, 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
0
   0.0%
LDL; Any grade increase; n=2, 4, 1, 3, 4, 7, 28, 8 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 7 participants 28 participants 8 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 7 participants 28 participants 8 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 7 participants 28 participants 8 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 9 participants
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8
  25.8%
2
  22.2%
Lipase;Increase to Grade 3; n=2,4,1,3,4,9,31,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
   9.7%
0
   0.0%
Lipase;Increase to Grade 4; n=2,4,1,3,4,9,31,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 9 participants
1
  50.0%
0
   0.0%
0
   0.0%
0
   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 Number Analyzed 3 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
2
  50.0%
1
 100.0%
1
  33.3%
1
  25.0%
0
   0.0%
9
  28.1%
2
  22.2%
Magnesium;Increase to Grade 3;n=3,4,1,3,4,9,32,9 Number Analyzed 3 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 3 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 3 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
1
  33.3%
3
  75.0%
0
   0.0%
1
  33.3%
2
  50.0%
3
  33.3%
16
  50.0%
4
  44.4%
Sodium;Increase to Grade 3; n=3,4,1,3,4,9,32,9 Number Analyzed 3 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
4
  12.5%
0
   0.0%
Sodium;Increase to Grade 4; n=3,4,1,3,4,9,32,9 Number Analyzed 3 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 7 participants 29 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 7 participants 29 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 7 participants 29 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 1 participants 0 participants 0 participants 0 participants 3 participants 3 participants 14 participants 7 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Testosterone;Increase to Grade3;n=1,0,0,0,3,3,14,7 Number Analyzed 1 participants 0 participants 0 participants 0 participants 3 participants 3 participants 14 participants 7 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Testosterone;Increase to Grade4;n=1,0,0,0,3,3,14,7 Number Analyzed 1 participants 0 participants 0 participants 0 participants 3 participants 3 participants 14 participants 7 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Triglyc;Any grade increase;n=2,4,1,3,4,7,29,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 7 participants 29 participants 9 participants
0
   0.0%
2
  50.0%
0
   0.0%
0
   0.0%
2
  50.0%
2
  28.6%
17
  58.6%
6
  66.7%
Triglyc;Increase to Grade 3;n=2,4,1,3,4,7,29,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 7 participants 29 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 7 participants 29 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
Troponin I;Any grade increase;n=0,0,0,0, 2,5,24,5 Number Analyzed 0 participants 0 participants 0 participants 0 participants 2 participants 5 participants 24 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Troponin I;Increase to Grade 3;n=0,0,0,0,2,5,24,5 Number Analyzed 0 participants 0 participants 0 participants 0 participants 2 participants 5 participants 24 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Troponin I;Increase to Grade 4; n=0,0,0,0,2,5,24,5 Number Analyzed 0 participants 0 participants 0 participants 0 participants 2 participants 5 participants 24 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Troponin T;Any grade increase;n=3,4,1,3,4,9,31,9 Number Analyzed 3 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 3 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 3 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
1
   3.1%
0
   0.0%
Urate; Increase to Grade 3; n=2,4,1,3,4,9,32,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 32 participants 9 participants
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
1
   3.1%
0
   0.0%
Urea; Any grade increase; n=2,4,1,3,4,9,31,9 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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 Number Analyzed 2 participants 4 participants 1 participants 3 participants 4 participants 9 participants 31 participants 9 participants
0
   0.0%
0
   0.0%
0
   0.0%
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 4 10 5
Measure Type: Count of Participants
Unit of Measure: Participants
Glucose; Any grade increase; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
1
  25.0%
9
  90.0%
5
 100.0%
Glucose; Increase to Grade 3; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
1
  25.0%
3
  30.0%
1
  20.0%
Glucose; Increase to Grade 4; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Albumin; Any grade increase; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
4
  40.0%
1
  20.0%
Albumin; Increase to Grade 3; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Albumin; Increase to Grade 4; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
ALP; Any grade increase; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
4
  40.0%
2
  40.0%
ALP; Increase to Grade 3; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
2
  20.0%
0
   0.0%
ALP; Increase to Grade 4; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
ALT; Any grade increase; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
5
  50.0%
1
  20.0%
ALT; Increase to Grade 3; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
1
  10.0%
0
   0.0%
ALT; Increase to Grade 4; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Amylase; Any grade increase; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
2
  20.0%
2
  40.0%
Amylase; Increase to Grade 3; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Amylase; Increase to Grade 4; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
AST; Any grade increase; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
2
  50.0%
6
  60.0%
1
  20.0%
AST; Increase to Grade 3; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
2
  20.0%
0
   0.0%
AST; Increase to Grade 4; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Dir bil; Any grade increase; n=4, 9, 4 Number Analyzed 4 participants 9 participants 4 participants
0
   0.0%
0
   0.0%
0
   0.0%
Dir bil; Increase to Grade 3; n=4, 9, 4 Number Analyzed 4 participants 9 participants 4 participants
0
   0.0%
0
   0.0%
0
   0.0%
Dir bil; Increase to Grade 4; n=4, 9, 4 Number Analyzed 4 participants 9 participants 4 participants
0
   0.0%
0
   0.0%
0
   0.0%
Bilirubin; Any grade increase; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
1
  25.0%
7
  70.0%
2
  40.0%
Bilirubin; Increase to Grade 3; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
1
  25.0%
1
  10.0%
1
  20.0%
Bilirubin; Increase to Grade 4; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
1
  10.0%
0
   0.0%
NT-BNP; Any grade increase; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
NT-BNP; Increase to Grade 3; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
NT-BNP; Increase to Grade 4; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Calcium; Any grade increase; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
1
  25.0%
2
  20.0%
1
  20.0%
Calcium; Increase to Grade 3; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Calcium; Increase to Grade 4; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Cholesterol; Any grade increase; n=2, 9, 5 Number Analyzed 2 participants 9 participants 5 participants
0
   0.0%
2
  22.2%
0
   0.0%
Cholesterol; Increase to Grade 3; n=2, 9, 5 Number Analyzed 2 participants 9 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Cholesterol; Increase to Grade 4; n=2, 9, 5 Number Analyzed 2 participants 9 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
CK; Any grade increase; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
3
  30.0%
2
  40.0%
CK; Increase to Grade 3; n=n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
CK; Increase to Grade 4; n=n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Chloride; Any grade increase; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Chloride; Increase to Grade 3; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Chloride; Increase to Grade 4; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
CO2; Any grade increase; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
CO2; Increase to Grade 3; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
CO2; Increase to Grade 4; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine; Any grade increase; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
2
  20.0%
2
  40.0%
Creatinine; Increase to Grade 3; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine; Increase to Grade 4; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
GGT; Any grade increase; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
4
  40.0%
1
  20.0%
GGT; Increase to Grade 3; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
1
  10.0%
0
   0.0%
GGT; Increase to Grade 4; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
1
  10.0%
0
   0.0%
HDL; Any grade increase; n=2, 9, 5 Number Analyzed 2 participants 9 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
HDL; Increase to Grade 3; n=2, 9, 5 Number Analyzed 2 participants 9 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
HDL; Increase to Grade 4; n=2, 9, 5 Number Analyzed 2 participants 9 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Insulin; Any grade increase; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Insulin; Increase to Grade 3; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Insulin; Increase to Grade 4; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Potassium; Any grade increase; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
1
  25.0%
5
  50.0%
2
  40.0%
Potassium; Increase to Grade 3; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Potassium; Increase to Grade 4; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
LDL; Any grade increase; n=2, 9, 5 Number Analyzed 2 participants 9 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
LDL; Increase to Grade 3; n=2, 9, 5 Number Analyzed 2 participants 9 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
LDL; Increase to Grade 4; n=2, 9, 5 Number Analyzed 2 participants 9 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Lipase; Any grade increase; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
2
  20.0%
3
  60.0%
Lipase; Increase to Grade 3; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
1
  10.0%
0
   0.0%
Lipase; Increase to Grade 4; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Magnesium; Any grade increase; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
2
  20.0%
2
  40.0%
Magnesium; Increase to Grade 3; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Magnesium; Increase to Grade 4; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
1
  10.0%
0
   0.0%
Protein; Any grade increase; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Protein; Increase to Grade 3; n=4, 10, 5 Number Analyzed 4 participants 10 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Protein; Increase to Grade 4; n=4, 10, 5