Trial Outcomes & Findings for Dose Escalation and Dose Expansion Study of GSK525762 in Combination With Androgen Deprivation Therapy in Participants With Castrate-resistant Prostate Cancer (NCT NCT03150056)
NCT ID: NCT03150056
Last Updated: 2022-08-10
Results Overview
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 defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgement, or is associated with liver injury and impaired liver function.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
73 participants
Primary outcome timeframe
Up to 21.3 months
Results posted on
2022-08-10
Participant Flow
This was an open-label, dose escalation and expansion study to investigate safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in combination with abiraterone or enzalutamide in participants with castrate resistant prostate cancer (CRPC).
This study has been terminated due to meeting protocol defined futility. A total of 73 participants were enrolled in the study.
Participant milestones
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
4
|
10
|
22
|
21
|
|
Overall Study
COMPLETED
|
0
|
1
|
1
|
2
|
9
|
3
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
3
|
8
|
13
|
18
|
Reasons for withdrawal
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Study terminated by Sponsor
|
1
|
3
|
1
|
1
|
5
|
6
|
|
Overall Study
Death
|
9
|
2
|
2
|
7
|
8
|
10
|
Baseline Characteristics
Dose Escalation and Dose Expansion Study of GSK525762 in Combination With Androgen Deprivation Therapy in Participants With Castrate-resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=6 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=22 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=21 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
70.4 Years
STANDARD_DEVIATION 7.69 • n=5 Participants
|
68.0 Years
STANDARD_DEVIATION 9.57 • n=7 Participants
|
76.3 Years
STANDARD_DEVIATION 4.11 • n=5 Participants
|
69.3 Years
STANDARD_DEVIATION 4.72 • n=4 Participants
|
71.0 Years
STANDARD_DEVIATION 6.49 • n=21 Participants
|
69.1 Years
STANDARD_DEVIATION 5.11 • n=8 Participants
|
70.2 Years
STANDARD_DEVIATION 6.32 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
73 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian-East Asian Heritage
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White-Arabic/North African Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European Heritage
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
67 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 21.3 monthsPopulation: All Treated Population consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
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 defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgement, or is associated with liver injury and impaired liver function.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=6 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=22 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=21 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AEs
|
10 Participants
|
6 Participants
|
4 Participants
|
10 Participants
|
22 Participants
|
21 Participants
|
|
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAEs
|
4 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Up to 21.3 monthsPopulation: All Treated Population.
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. Number of participants with AEs leading to any dose reduction or delays have been presented.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=6 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=22 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=21 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants With AEs Leading to Any Dose Reduction or Delays
Dose reduction
|
4 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
10 Participants
|
7 Participants
|
|
Number of Participants With AEs Leading to Any Dose Reduction or Delays
Dose delay
|
5 Participants
|
2 Participants
|
4 Participants
|
8 Participants
|
15 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Up to 21.3 monthsPopulation: All Treated Population.
Number of participants who withdrew due to toxicity and changes in safety assessment including laboratory parameters and vital signs have been presented.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=6 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=22 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=21 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Withdrew Due to Toxicity and Changes in Safety Assessment
|
6 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 21.3 monthsPopulation: Modified All Treated Population comprised of all participants who received at least one dose of GSK525762 plus abiraterone/enzalutamide. Only those participants with data available at the indicated time points were analyzed.
PSA50 response rate is defined as percentage of participants with a decrease of \>=50% in the PSA concentration from the Baseline PSA value determined at least 12 weeks after start of treatment and confirmed \>=4 weeks later by an additional PSA evaluation.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=6 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=19 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=21 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Greater Than or Equals to (>=)50 Percent (%) Decrease in Prostate-specific Antigen From Baseline (PSA50)
|
0 Percentage of participants
Interval 0.0 to 30.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 30.8
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
SECONDARY outcome
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3Population: PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK525762 and GSK3529246 (metabolite of GSK525762). PK parameters were calculated using standard non-compartmental analysis. PK Population consisted of all participants from the All Treated Safety Population for whom a PK sample was obtained and analyzed.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=6 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=21 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=18 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of GSK525762 and Its Active Metabolites GSK3529246
GSK525762:Week1 Day1,n=10,6,4,10,21,18
|
950.319 Nanogram per milliliter
Geometric Coefficient of Variation 19.18
|
993.154 Nanogram per milliliter
Geometric Coefficient of Variation 33.77
|
671.129 Nanogram per milliliter
Geometric Coefficient of Variation 30.44
|
427.580 Nanogram per milliliter
Geometric Coefficient of Variation 31.76
|
333.256 Nanogram per milliliter
Geometric Coefficient of Variation 48.86
|
336.296 Nanogram per milliliter
Geometric Coefficient of Variation 43.28
|
|
Maximum Observed Plasma Concentration (Cmax) of GSK525762 and Its Active Metabolites GSK3529246
GSK525762:Week3 Day1,n=4,3,3,9,17,10
|
891.302 Nanogram per milliliter
Geometric Coefficient of Variation 36.79
|
735.171 Nanogram per milliliter
Geometric Coefficient of Variation 21.63
|
559.711 Nanogram per milliliter
Geometric Coefficient of Variation 40.59
|
284.298 Nanogram per milliliter
Geometric Coefficient of Variation 45.12
|
158.409 Nanogram per milliliter
Geometric Coefficient of Variation 153.45
|
171.527 Nanogram per milliliter
Geometric Coefficient of Variation 47.88
|
|
Maximum Observed Plasma Concentration (Cmax) of GSK525762 and Its Active Metabolites GSK3529246
GSK3529246:Week1 Day1,n=10,6,4,10,21,18
|
280.892 Nanogram per milliliter
Geometric Coefficient of Variation 43.14
|
318.772 Nanogram per milliliter
Geometric Coefficient of Variation 31.13
|
199.456 Nanogram per milliliter
Geometric Coefficient of Variation 32.94
|
408.208 Nanogram per milliliter
Geometric Coefficient of Variation 39.86
|
321.750 Nanogram per milliliter
Geometric Coefficient of Variation 24.24
|
323.685 Nanogram per milliliter
Geometric Coefficient of Variation 25.77
|
|
Maximum Observed Plasma Concentration (Cmax) of GSK525762 and Its Active Metabolites GSK3529246
GSK3529246:Week3 Day1,n=4,3,3,10,17,10
|
447.929 Nanogram per milliliter
Geometric Coefficient of Variation 39.30
|
444.232 Nanogram per milliliter
Geometric Coefficient of Variation 26.74
|
364.151 Nanogram per milliliter
Geometric Coefficient of Variation 15.46
|
449.614 Nanogram per milliliter
Geometric Coefficient of Variation 49.54
|
328.398 Nanogram per milliliter
Geometric Coefficient of Variation 39.74
|
356.615 Nanogram per milliliter
Geometric Coefficient of Variation 18.26
|
SECONDARY outcome
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3Population: PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).
Blood samples were collected at indicated time points for PK analysis of GSK525762 and GSK3529246 (metabolite of GSK525762). PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=6 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=21 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=18 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Time to Cmax (Tmax) of GSK525762 and Its Active Metabolites GSK3529246
GSK3529246:Week1 Day1,n=10,6,4,10,21,18
|
3.000 Hours
Interval 1.18 to 6.0
|
3.000 Hours
Interval 0.53 to 6.0
|
2.042 Hours
Interval 1.0 to 3.08
|
2.067 Hours
Interval 1.0 to 3.0
|
2.917 Hours
Interval 0.53 to 6.05
|
1.817 Hours
Interval 0.95 to 6.0
|
|
Time to Cmax (Tmax) of GSK525762 and Its Active Metabolites GSK3529246
GSK525762:Week1 Day1,n=10,6,4,10,21,18
|
0.800 Hours
Interval 0.5 to 2.92
|
0.558 Hours
Interval 0.5 to 1.0
|
1.000 Hours
Interval 0.58 to 3.08
|
0.508 Hours
Interval 0.4 to 1.08
|
1.000 Hours
Interval 0.45 to 3.0
|
0.742 Hours
Interval 0.5 to 6.0
|
|
Time to Cmax (Tmax) of GSK525762 and Its Active Metabolites GSK3529246
GSK525762:Week3 Day1,n=4,3,3,9,17,10
|
0.500 Hours
Interval 0.5 to 0.5
|
1.000 Hours
Interval 0.5 to 3.0
|
0.950 Hours
Interval 0.5 to 1.0
|
0.583 Hours
Interval 0.47 to 3.0
|
0.933 Hours
Interval 0.0 to 3.03
|
0.517 Hours
Interval 0.5 to 3.08
|
|
Time to Cmax (Tmax) of GSK525762 and Its Active Metabolites GSK3529246
GSK3529246:Week3 Day1,n=4,3,3,10,17,10
|
1.000 Hours
Interval 0.85 to 3.0
|
3.000 Hours
Interval 1.0 to 6.17
|
3.000 Hours
Interval 1.0 to 3.03
|
1.042 Hours
Interval 0.5 to 6.0
|
1.017 Hours
Interval 0.0 to 6.0
|
1.875 Hours
Interval 0.5 to 6.33
|
SECONDARY outcome
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3Population: PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).
Blood samples were collected at indicated time points for PK analysis of GSK525762 and GSK3529246 (metabolite of GSK525762). PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=8 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=2 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=3 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=6 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=12 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=10 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUC[0-tau]) of GSK525762 and Its Active Metabolites GSK3529246
GSK525762:Week1 Day1,n=8,2,2,6,9,8
|
4927.834 Hours*nanogram per milliliter
Geometric Coefficient of Variation 71.78
|
4677.411 Hours*nanogram per milliliter
Geometric Coefficient of Variation 21.59
|
4172.282 Hours*nanogram per milliliter
Geometric Coefficient of Variation 31.08
|
1139.481 Hours*nanogram per milliliter
Geometric Coefficient of Variation 34.32
|
1261.529 Hours*nanogram per milliliter
Geometric Coefficient of Variation 102.14
|
959.452 Hours*nanogram per milliliter
Geometric Coefficient of Variation 60.97
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUC[0-tau]) of GSK525762 and Its Active Metabolites GSK3529246
GSK525762:Week3 Day1,n=4,1,3,5,6,6
|
2697.923 Hours*nanogram per milliliter
Geometric Coefficient of Variation 69.10
|
2580.877 Hours*nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant.
|
1561.908 Hours*nanogram per milliliter
Geometric Coefficient of Variation 13.67
|
674.437 Hours*nanogram per milliliter
Geometric Coefficient of Variation 57.10
|
660.607 Hours*nanogram per milliliter
Geometric Coefficient of Variation 14.41
|
386.950 Hours*nanogram per milliliter
Geometric Coefficient of Variation 37.03
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUC[0-tau]) of GSK525762 and Its Active Metabolites GSK3529246
GSK3529246:Week1 Day1,n=2,1,0,5,9,10
|
3765.196 Hours*nanogram per milliliter
Geometric Coefficient of Variation 0.47
|
4918.549 Hours*nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant.
|
—
|
4379.342 Hours*nanogram per milliliter
Geometric Coefficient of Variation 30.76
|
3373.990 Hours*nanogram per milliliter
Geometric Coefficient of Variation 19.73
|
3306.018 Hours*nanogram per milliliter
Geometric Coefficient of Variation 31.84
|
|
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUC[0-tau]) of GSK525762 and Its Active Metabolites GSK3529246
GSK3529246:Week3 Day1,n=2,2,2,4,12,7
|
4170.516 Hours*nanogram per milliliter
Geometric Coefficient of Variation 6.55
|
5146.749 Hours*nanogram per milliliter
Geometric Coefficient of Variation 9.99
|
4598.235 Hours*nanogram per milliliter
Geometric Coefficient of Variation 16.28
|
3816.407 Hours*nanogram per milliliter
Geometric Coefficient of Variation 37.02
|
3386.702 Hours*nanogram per milliliter
Geometric Coefficient of Variation 30.44
|
3082.516 Hours*nanogram per milliliter
Geometric Coefficient of Variation 33.36
|
SECONDARY outcome
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3Population: PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).
Blood samples were collected at indicated time points for PK analysis of GSK525762 and GSK3529246 (metabolite of GSK525762). PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=8 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=3 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=3 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=9 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=20 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=17 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of GSK525762 and Its Active Metabolites GSK3529246
GSK525762:Week1 Day1,n=8,2,3,1,3,4
|
22.418 Nanogram per milliliter
Geometric Coefficient of Variation 192.37
|
8.696 Nanogram per milliliter
Geometric Coefficient of Variation 72.93
|
13.664 Nanogram per milliliter
Geometric Coefficient of Variation 119.83
|
2.100 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant.
|
5.053 Nanogram per milliliter
Geometric Coefficient of Variation 3035.92
|
1.660 Nanogram per milliliter
Geometric Coefficient of Variation 34.60
|
|
Trough Concentration (Ctrough) of GSK525762 and Its Active Metabolites GSK3529246
GSK525762:Week3 Day1,n=2,2,2,1,0,0
|
8.966 Nanogram per milliliter
Geometric Coefficient of Variation 93.46
|
4.555 Nanogram per milliliter
Geometric Coefficient of Variation 522.90
|
1.410 Nanogram per milliliter
Geometric Coefficient of Variation 48.34
|
3.540 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
|
Trough Concentration (Ctrough) of GSK525762 and Its Active Metabolites GSK3529246
GSK3529246:Week1 Day1,n=8,3,3,9,20,17
|
58.995 Nanogram per milliliter
Geometric Coefficient of Variation 52.50
|
68.379 Nanogram per milliliter
Geometric Coefficient of Variation 47.51
|
42.107 Nanogram per milliliter
Geometric Coefficient of Variation 52.26
|
46.011 Nanogram per milliliter
Geometric Coefficient of Variation 38.73
|
37.765 Nanogram per milliliter
Geometric Coefficient of Variation 56.41
|
38.200 Nanogram per milliliter
Geometric Coefficient of Variation 53.15
|
|
Trough Concentration (Ctrough) of GSK525762 and Its Active Metabolites GSK3529246
GSK3529246:Week3 Day1,n=3,3,2,7,13,8
|
48.223 Nanogram per milliliter
Geometric Coefficient of Variation 99.09
|
48.291 Nanogram per milliliter
Geometric Coefficient of Variation 29.86
|
63.526 Nanogram per milliliter
Geometric Coefficient of Variation 3.90
|
50.882 Nanogram per milliliter
Geometric Coefficient of Variation 77.10
|
32.299 Nanogram per milliliter
Geometric Coefficient of Variation 60.18
|
26.165 Nanogram per milliliter
Geometric Coefficient of Variation 76.95
|
SECONDARY outcome
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3Population: PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).
Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=5 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Cmax of Abiraterone
Week 1 Day 1, n=10,5,4
|
77.962 Nanogram per milliliter
Geometric Coefficient of Variation 57.07
|
63.369 Nanogram per milliliter
Geometric Coefficient of Variation 114.31
|
122.496 Nanogram per milliliter
Geometric Coefficient of Variation 131.30
|
—
|
—
|
—
|
|
Cmax of Abiraterone
Week 3 Day 1, n=4,4,2
|
149.673 Nanogram per milliliter
Geometric Coefficient of Variation 65.39
|
87.554 Nanogram per milliliter
Geometric Coefficient of Variation 110.92
|
146.924 Nanogram per milliliter
Geometric Coefficient of Variation 76.98
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3Population: PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).
Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=5 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Tmax of Abiraterone
Week 1 Day 1, n=10,5,4
|
1.133 Hours
Interval 0.17 to 3.13
|
1.083 Hours
Interval 0.53 to 3.0
|
0.750 Hours
Interval 0.0 to 1.08
|
—
|
—
|
—
|
|
Tmax of Abiraterone
Week 3 Day 1, n=4,4,2
|
1.000 Hours
Interval 0.85 to 1.0
|
2.000 Hours
Interval 0.98 to 3.0
|
3.017 Hours
Interval 3.0 to 3.03
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3Population: PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).
Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=5 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=2 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=1 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
AUC(0-tau) of Abiraterone
Week 1 Day 1, n=5,1,1
|
432.368 Hours*nanogram per milliliter
Geometric Coefficient of Variation 56.74
|
148.871 Hours*nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant.
|
1405.809 Hours*nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
|
AUC(0-tau) of Abiraterone
Week 3 Day 1, n=1,2,1
|
1361.627 Hours*nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant.
|
595.686 Hours*nanogram per milliliter
Geometric Coefficient of Variation 64.72
|
2185.039 Hours*nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3Population: PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).
Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=9 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=4 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=3 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Ctrough of Abiraterone
Week 1 Day 1, n=9,2,3
|
7.603 Nanogram per milliliter
Geometric Coefficient of Variation 93.00
|
4.636 Nanogram per milliliter
Geometric Coefficient of Variation 1802.64
|
11.263 Nanogram per milliliter
Geometric Coefficient of Variation 86.21
|
—
|
—
|
—
|
|
Ctrough of Abiraterone
Week 3 Day 1, n=2,4,1
|
15.114 Nanogram per milliliter
Geometric Coefficient of Variation 9.84
|
7.697 Nanogram per milliliter
Geometric Coefficient of Variation 69.99
|
21.800 Nanogram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Weeks 1, 3, 5, 9, 17 and 25Population: PK Population. Cmax could not be derived as only pre-dose samples were collected.
Blood samples were collected at indicated time points for PK analysis of enzalutamide. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=22 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=21 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Cmax of Enzalutamide
|
NA Microgram per milliliter
Geometric Coefficient of Variation NA
Cmax could not be derived as only pre-dose samples were collected.
|
NA Microgram per milliliter
Geometric Coefficient of Variation NA
Cmax could not be derived as only pre-dose samples were collected.
|
NA Microgram per milliliter
Geometric Coefficient of Variation NA
Cmax could not be derived as only pre-dose samples were collected.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Weeks 1, 3, 5, 9, 17 and 25Population: PK Population. Tmax could not be derived as only pre-dose samples were collected.
Blood samples were collected at indicated time points for PK analysis of enzalutamide. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=22 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=21 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Tmax of Enzalutamide
|
NA Hours
Tmax could not be derived as only pre-dose samples were collected.
|
NA Hours
Tmax could not be derived as only pre-dose samples were collected.
|
NA Hours
Tmax could not be derived as only pre-dose samples were collected.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Weeks 1, 3, 5, 9, 17 and 25Population: PK Population. AUC(0-tau) could not be derived as only pre-dose samples were collected.
Blood samples were collected at indicated time points for PK analysis of enzalutamide. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=22 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=21 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
AUC(0-tau) of Enzalutamide
|
NA Hours*microgram per milliliter
Geometric Coefficient of Variation NA
AUC(0-tau) could not be derived as only pre-dose samples were collected
|
NA Hours*microgram per milliliter
Geometric Coefficient of Variation NA
AUC(0-tau) could not be derived as only pre-dose samples were collected
|
NA Hours*microgram per milliliter
Geometric Coefficient of Variation NA
AUC(0-tau) could not be derived as only pre-dose samples were collected
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Weeks 1, 3, 5, 9, 17 and 25Population: PK Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).
Blood samples were collected at indicated time points for PK analysis of enzalutamide. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=20 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=18 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Ctrough of Enzalutamide
Week 5 Day 1, Pre-dose, n=10,15,18
|
10.026 Microgram per milliliter
Geometric Coefficient of Variation 21.80
|
9.814 Microgram per milliliter
Geometric Coefficient of Variation 44.21
|
12.561 Microgram per milliliter
Geometric Coefficient of Variation 31.27
|
—
|
—
|
—
|
|
Ctrough of Enzalutamide
Week 1 Day 1, Pre-dose, n=9,20,18
|
13.066 Microgram per milliliter
Geometric Coefficient of Variation 21.74
|
13.313 Microgram per milliliter
Geometric Coefficient of Variation 21.70
|
14.546 Microgram per milliliter
Geometric Coefficient of Variation 30.34
|
—
|
—
|
—
|
|
Ctrough of Enzalutamide
Week 3 Day 1, Pre-dose, n=9,19,13
|
10.385 Microgram per milliliter
Geometric Coefficient of Variation 23.30
|
10.902 Microgram per milliliter
Geometric Coefficient of Variation 24.96
|
11.497 Microgram per milliliter
Geometric Coefficient of Variation 27.34
|
—
|
—
|
—
|
|
Ctrough of Enzalutamide
Week 9 Day 1, Pre-dose, n=6,6,13
|
10.021 Microgram per milliliter
Geometric Coefficient of Variation 27.01
|
8.064 Microgram per milliliter
Geometric Coefficient of Variation 85.90
|
12.056 Microgram per milliliter
Geometric Coefficient of Variation 30.12
|
—
|
—
|
—
|
|
Ctrough of Enzalutamide
Week 17 Day 1, Pre-dose, n=4,2,4
|
8.621 Microgram per milliliter
Geometric Coefficient of Variation 22.86
|
12.568 Microgram per milliliter
Geometric Coefficient of Variation 10.14
|
10.267 Microgram per milliliter
Geometric Coefficient of Variation 58.45
|
—
|
—
|
—
|
|
Ctrough of Enzalutamide
Week 25 Day 1, Pre-dose, n=2,2,2
|
10.103 Microgram per milliliter
Geometric Coefficient of Variation 8.13
|
13.069 Microgram per milliliter
Geometric Coefficient of Variation 9.75
|
13.791 Microgram per milliliter
Geometric Coefficient of Variation 5.13
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Modified All Treated Population. Only those participants with data available at the indicated time points were analyzed.
Disease control rate (DCR) is defined as the percentage of participants with \>=1 post-Baseline disease assessment who showed either a confirmed complete response (CR), partial response (PR) or stable disease (SD) observed at \>=24 weeks per prostate cancer working group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; where CR: disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeter 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; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive diseases. Confidence interval (CI) was computed using exact two sided 95% CI.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=9 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=5 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=19 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=21 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Disease Control Rate at Week 24
|
0 Percentage of participants
Interval 0.0 to 33.6
|
40 Percentage of participants
Interval 5.3 to 85.3
|
50 Percentage of participants
Interval 6.8 to 93.2
|
40 Percentage of participants
Interval 12.2 to 73.8
|
11 Percentage of participants
Interval 1.3 to 33.1
|
29 Percentage of participants
Interval 11.3 to 52.2
|
SECONDARY outcome
Timeframe: Up to 21.3 monthsPopulation: Modified All Treated Population.
Composite response rate was defined as the percentage of participants with one of the following: a) Response based on PCWG3-modified RECIST version 1.1, b) PSA decrease of \>=50% from Baseline at Week 12 and thereafter, or c) Circulating Tumor-cell Count Conversion from unfavorable (\>=5/7.5 milliliter \[mL\]) at Baseline to favorable (\<5/7.5 mL) confirmed by a second assessment at least 4 weeks later. If a participant met at least one of the above requirements, then that participant was considered a composite responder. CI was computed using exact two sided 95% CI.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=6 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=22 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=21 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Composite Response Rate
|
0 Percentage of participants
Interval 0.0 to 30.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
0 Percentage of participants
Interval 0.0 to 60.2
|
10 Percentage of participants
Interval 0.3 to 44.5
|
5 Percentage of participants
Interval 0.1 to 22.8
|
0 Percentage of participants
Interval 0.0 to 16.1
|
SECONDARY outcome
Timeframe: Up to 21.3 monthsPopulation: Modified All Treated Population. Only those participants with data available at the indicated time points were analyzed.
Objective response rate (ORR) is defined as the percentage of participants with a confirmed CR or PR at any time as per PCWG3-modified RECIST version 1.1; where CR: Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeter (mm) in the short axis and 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.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=9 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=5 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=19 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=21 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Objective Response Rate
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 21.3 monthsPopulation: Modified All Treated Population. Only those participants with data available at the indicated time points were analyzed. For GSK525762 40 mg+Abiraterone 1000 mg arm, there were no unfavorable values at Baseline, hence CTC response rate (change from unfavorable to favorable) could not be derived for this arm.
CTC response rate is defined as the percentage of participants with a CTC conversion to \<5/7.5 mL blood at nadir (confirmed by a second consecutive value obtained four or more weeks later) for participants with unfavourable CTC (\>=5/7.5 mL) at Baseline. CI was computed using exact two sided 95% CI.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=7 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=3 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=3 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=12 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=11 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Circulating Tumor Cells (CTC) Response Rate
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
33 Percentage of participants
Interval 0.8 to 90.6
|
8 Percentage of participants
Interval 0.2 to 38.5
|
0 Percentage of participants
Interval 0.0 to 28.5
|
SECONDARY outcome
Timeframe: Week 4Population: Modified All Treated Population.
PSA Response Rate is defined as percentage of participants achieving \>=30% decrease from Baseline PSA after 4 weeks of study treatment. The CI was calculated using exact two sided 95% CI for the percentage of participants with Baseline PSA values who show \>=30% reduction in PSA at \>=4 weeks post-Baseline.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=6 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=22 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=21 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Prostate-specific Antigen (PSA) Response Rate at Week 4
|
0 Percentage of participants
Interval 0.0 to 30.8
|
17 Percentage of participants
Interval 0.4 to 64.1
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 30.8
|
0 Percentage of participants
Interval 0.0 to 17.6
|
0 Percentage of participants
Interval 0.0 to 16.1
|
SECONDARY outcome
Timeframe: Up to 21.3 monthsPopulation: Modified All Treated Population.
Time to disease progression is defined as the time from date of first dose of study treatment to date of disease progression defined as one or more of the following criteria: 1. Radiographic progression by PCWG3-modified RECIST version 1.1 for participants with measurable disease, 2. Bone progression on bone scan according to the PCGW3 criteria, 3. PSA progression according to the PCWG3 criteria accompanied by any one of the following: investigator-defined clinical progression or either of the above RECIST version 1.1 radiographic progression or bone progression.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=6 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=22 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=21 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Time to Disease Progression
|
88.0 Days
Interval 36.0 to 88.0
|
NA Days
Interval 86.0 to
\<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.
|
NA Days
Interval 36.0 to
\<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.
|
87.0 Days
Interval 85.0 to 112.0
|
86.0 Days
Interval 56.0 to
\<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.
|
84.0 Days
Interval 52.0 to 330.0
|
SECONDARY outcome
Timeframe: Up to 21.3 montthsPopulation: Modified All Treated Population.
rPFS is defined as the time from study treatment start until the first date of either disease progression or death due to any cause. The date of disease progression is defined as the earliest date of disease progression as assessed by the investigator using PCWG3-modified RECIST, version 1.1 or progression on bone scan. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=6 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=22 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=21 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Radiographic Progression-free Survival (rPFS)
|
53.0 Days
Interval 29.5 to 165.0
|
NA Days
\<25% of participants experienced the event within the treatment arm. Hence, median and inter-quartile range could not be derived.
|
NA Days
Interval 36.0 to
\<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.
|
416.0 Days
Interval 165.0 to 421.0
|
141.0 Days
Interval 56.0 to 220.0
|
330.0 Days
Interval 52.0 to 333.0
|
SECONDARY outcome
Timeframe: Up to 21.3 monthsPopulation: All Treated Population. Only those participants with data available at the indicated time points were analyzed.
Performance status assessments were based on 6-point ECOG scale (from 0 to 5), where 0=fully active, able to carry on all pre-disease performance without restriction; 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g., light house work, office work); 2=ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3=capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed or chair; and 5=dead. Data for worst case post-Baseline is presented.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=6 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=21 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=21 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Worst-Case Post Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst-Case Post Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
7 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
16 Participants
|
13 Participants
|
|
Number of Participants With Worst-Case Post Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Worst-Case Post Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst-Case Post Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst-Case Post Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 1 Day 1, pre-dose) and on Day 1 of Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61Population: Modified All Treated Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).
EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included 5 functional scales (physical functioning, role functioning, cognitive functioning, emotional functioning and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss and financial difficulties). Response options for GHS/QoL range from 1 to 4, where 1=not at all and 4=very much. Scores were averaged and transformed to a 0 to 100 scale, with higher scores representing a high QoL. Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose. Change from Baseline was calculated as post-Baseline visit value minus Baseline value.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=6 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=1 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=2 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=6 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=10 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
Week 1 Day 1,n=1,0,0,0,2,0
|
8.3 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
4.2 Scores on a scale
Standard Deviation 5.89
|
—
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
Week 2 Day 1,n=6,1,2,4,4,8
|
-8.3 Scores on a scale
Standard Deviation 12.91
|
16.7 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
-12.5 Scores on a scale
Standard Deviation 29.46
|
-2.1 Scores on a scale
Standard Deviation 4.17
|
0.0 Scores on a scale
Standard Deviation 13.61
|
-1.0 Scores on a scale
Standard Deviation 12.94
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
Week 3 Day 1,n=6,0,1,4,3,7
|
-8.3 Scores on a scale
Standard Deviation 23.57
|
—
|
-16.7 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
-4.2 Scores on a scale
Standard Deviation 8.33
|
2.8 Scores on a scale
Standard Deviation 4.81
|
-1.2 Scores on a scale
Standard Deviation 3.15
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
Week 4 Day 1,n=6,1,2,3,6,10
|
-8.3 Scores on a scale
Standard Deviation 10.54
|
16.7 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
0.0 Scores on a scale
Standard Deviation 11.79
|
5.6 Scores on a scale
Standard Deviation 9.62
|
1.4 Scores on a scale
Standard Deviation 9.74
|
2.5 Scores on a scale
Standard Deviation 16.22
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
Week 5 Day 1,n=3,0,1,3,5,9
|
-8.3 Scores on a scale
Standard Deviation 14.43
|
—
|
8.3 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
-5.6 Scores on a scale
Standard Deviation 9.62
|
0.0 Scores on a scale
Standard Deviation 11.79
|
-0.0 Scores on a scale
Standard Deviation 11.02
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
Week 9 Day 1,n=2,0,1,2,3,6
|
-12.5 Scores on a scale
Standard Deviation 17.68
|
—
|
-8.3 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
-20.8 Scores on a scale
Standard Deviation 5.89
|
-30.6 Scores on a scale
Standard Deviation 12.73
|
-12.5 Scores on a scale
Standard Deviation 10.21
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
Week 13 Day 1,n=1,1,1,1,2,3
|
-25.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
8.3 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
0.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
0.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
-8.3 Scores on a scale
Standard Deviation 11.79
|
0.0 Scores on a scale
Standard Deviation 0.00
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
Week 17 Day 1,n=1,1,1,1,1,3
|
-25.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
-16.7 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
16.7 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
0.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
0.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
-11.1 Scores on a scale
Standard Deviation 19.25
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
Week 21 Day 1,n=0,0,1,1,0,2
|
—
|
—
|
16.7 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
0.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
-4.2 Scores on a scale
Standard Deviation 5.89
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
Week 25 Day 1,n=0,0,1,0,0,1
|
—
|
—
|
0.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
-8.3 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
Week 29 Day 1,n=0,0,0,0,0,2
|
—
|
—
|
—
|
—
|
—
|
-8.3 Scores on a scale
Standard Deviation 11.79
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
Week 33 Day 1,n=0,0,1,0,1,2
|
—
|
—
|
8.3 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
0.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
-8.3 Scores on a scale
Standard Deviation 11.79
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
Week 37 Day 1,n=0,0,1,0,0,3
|
—
|
—
|
0.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
-2.8 Scores on a scale
Standard Deviation 4.81
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
Week 41 Day 1,n=0,0,1,0,0,0
|
—
|
—
|
8.3 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
Week 45 Day 1,n=0,0,1,0,0,1
|
—
|
—
|
-8.3 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
0.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
Week 49 Day 1,n=0,0,1,0,0,2
|
—
|
—
|
16.7 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
-8.3 Scores on a scale
Standard Deviation 0.00
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
Week 61 Day 1,n=0,0,1,0,0,1
|
—
|
—
|
16.7 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
—
|
-16.7 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose on Week 1 Day 1) and on Day 1 of Weeks 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61, 73, 85, 97Population: Modified All Treated Population. Only those participants with data available at the indicated time points were analyzed (indicated by n=X in category titles).
BPI-SF is 9-item self-administered questionnaire. Pain intensity score was calculated from the four items (items 3, 4, 5 and 6) for worst pain, least pain, average pain and current pain. Worst pain in last 24 hours was rated from 0 (no pain) to 10 (pain as bad as you can imagine). Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose (latest up to Week 1 Day 1). Change from Baseline was calculated as post-Baseline visit value minus Baseline value.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=9 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=5 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=19 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=17 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
Week 45 Day 1,n=0,0,1,2,1,3
|
—
|
—
|
1.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
2.5 Scores on a scale
Standard Deviation 2.12
|
-1.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
1.7 Scores on a scale
Standard Deviation 1.15
|
|
Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
Week 2 Day 1,n=9,5,4,9,14,13
|
0.1 Scores on a scale
Standard Deviation 2.62
|
0.8 Scores on a scale
Standard Deviation 2.86
|
-2.3 Scores on a scale
Standard Deviation 1.71
|
0.0 Scores on a scale
Standard Deviation 1.12
|
0.0 Scores on a scale
Standard Deviation 2.91
|
0.2 Scores on a scale
Standard Deviation 1.48
|
|
Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
Week 3 Day 1,n=8,3,4,10,16,15
|
0.5 Scores on a scale
Standard Deviation 1.77
|
-1.7 Scores on a scale
Standard Deviation 1.53
|
-1.8 Scores on a scale
Standard Deviation 1.89
|
-1.0 Scores on a scale
Standard Deviation 2.05
|
0.3 Scores on a scale
Standard Deviation 3.26
|
0.0 Scores on a scale
Standard Deviation 1.51
|
|
Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
Week 4 Day 1,n=8,4,3,8,16,15
|
0.4 Scores on a scale
Standard Deviation 1.92
|
0.5 Scores on a scale
Standard Deviation 1.91
|
-1.3 Scores on a scale
Standard Deviation 1.15
|
-0.8 Scores on a scale
Standard Deviation 1.28
|
0.2 Scores on a scale
Standard Deviation 2.81
|
0.4 Scores on a scale
Standard Deviation 1.76
|
|
Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
Week 5 Day 1,n=6,4,4,10,19,17
|
-0.8 Scores on a scale
Standard Deviation 3.06
|
-0.3 Scores on a scale
Standard Deviation 1.26
|
-1.0 Scores on a scale
Standard Deviation 0.82
|
-0.9 Scores on a scale
Standard Deviation 2.13
|
0.7 Scores on a scale
Standard Deviation 3.38
|
-0.2 Scores on a scale
Standard Deviation 1.78
|
|
Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
Week 9 Day 1,n=3,4,3,8,10,13
|
1.3 Scores on a scale
Standard Deviation 1.53
|
1.3 Scores on a scale
Standard Deviation 0.96
|
-0.3 Scores on a scale
Standard Deviation 2.52
|
-0.5 Scores on a scale
Standard Deviation 2.07
|
0.2 Scores on a scale
Standard Deviation 2.49
|
-0.4 Scores on a scale
Standard Deviation 2.40
|
|
Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
Week 13 Day 1,n=2,3,1,5,7,7
|
0.5 Scores on a scale
Standard Deviation 0.71
|
2.0 Scores on a scale
Standard Deviation 3.00
|
2.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
0.2 Scores on a scale
Standard Deviation 1.92
|
-1.7 Scores on a scale
Standard Deviation 2.21
|
-0.4 Scores on a scale
Standard Deviation 2.15
|
|
Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
Week 17 Day 1,n=2,4,2,5,3,8
|
2.5 Scores on a scale
Standard Deviation 7.78
|
3.5 Scores on a scale
Standard Deviation 4.36
|
-0.5 Scores on a scale
Standard Deviation 4.95
|
-0.8 Scores on a scale
Standard Deviation 3.11
|
-1.3 Scores on a scale
Standard Deviation 1.15
|
-0.5 Scores on a scale
Standard Deviation 2.20
|
|
Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
Week 21 Day 1,n=1,2,2,5,3,6
|
2.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
0.5 Scores on a scale
Standard Deviation 0.71
|
-2.5 Scores on a scale
Standard Deviation 0.71
|
-0.2 Scores on a scale
Standard Deviation 2.49
|
-2.3 Scores on a scale
Standard Deviation 4.04
|
1.0 Scores on a scale
Standard Deviation 1.79
|
|
Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
Week 25 Day 1,n=0,0,1,2,3,4
|
—
|
—
|
3.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
0.0 Scores on a scale
Standard Deviation 0.00
|
-1.3 Scores on a scale
Standard Deviation 5.69
|
-1.0 Scores on a scale
Standard Deviation 1.15
|
|
Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
Week 29 Day 1,n=0,0,1,3,2,4
|
—
|
—
|
-3.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
-0.7 Scores on a scale
Standard Deviation 1.15
|
-3.5 Scores on a scale
Standard Deviation 0.71
|
0.8 Scores on a scale
Standard Deviation 4.19
|
|
Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
Week 33 Day 1,n=0,0,1,3,2,2
|
—
|
—
|
1.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
0.7 Scores on a scale
Standard Deviation 1.15
|
-1.5 Scores on a scale
Standard Deviation 2.12
|
-1.0 Scores on a scale
Standard Deviation 1.41
|
|
Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
Week 37 Day 1,n=0,0,1,3,0,4
|
—
|
—
|
0.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
1.7 Scores on a scale
Standard Deviation 2.08
|
—
|
0.0 Scores on a scale
Standard Deviation 1.41
|
|
Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
Week 41 Day 1,n=0,0,1,3,1,1
|
—
|
—
|
-1.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
1.3 Scores on a scale
Standard Deviation 1.53
|
-3.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
-1.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
|
Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
Week 49 Day 1,n=0,0,1,3,1,3
|
—
|
—
|
2.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
0.3 Scores on a scale
Standard Deviation 1.53
|
-3.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
2.7 Scores on a scale
Standard Deviation 2.52
|
|
Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
Week 61 Day 1,n=0,0,1,1,1,1
|
—
|
—
|
-2.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
0.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
-3.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
3.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
|
Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
Week 73 Day 1,n=0,0,0,1,1,0
|
—
|
—
|
—
|
0.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
-2.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
|
Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
Week 85 Day 1,n=0,0,0,1,1,0
|
—
|
—
|
—
|
3.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
-3.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
|
Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
Week 97 Day 1,n=0,0,0,0,1,0
|
—
|
—
|
—
|
—
|
-3.0 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 years and 11 monthsPopulation: All Treated Population
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 defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgement, or is associated with liver injury and impaired liver function. Number of Participants With any AEs and SAEs collected from start of the treatment until end of the study were reported.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=6 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=22 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=21 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Until End of the Study
Any AEs
|
10 Participants
|
6 Participants
|
4 Participants
|
10 Participants
|
22 Participants
|
21 Participants
|
|
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Until End of the Study
Any SAEs
|
4 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 years and 11 monthsPopulation: All Treated Population
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. Number of Participants with AEs leading to any dose reduction or delays from start of the treatment until end of the study were reported.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=6 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=22 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=21 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants With AEs Leading to Any Dose Reduction or Delays Until End of the Study
Dose delay
|
5 Participants
|
2 Participants
|
4 Participants
|
8 Participants
|
15 Participants
|
12 Participants
|
|
Number of Participants With AEs Leading to Any Dose Reduction or Delays Until End of the Study
Dose reduction
|
4 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
10 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 years and 11 monthsPopulation: All Treated Population
Number of participants who withdrew due to toxicity and changes in safety assessment including laboratory parameters and vital signs from start of the treatment until end of the study were reported.
Outcome measures
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=6 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 Participants
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=10 Participants
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=22 Participants
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=21 Participants
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Withdrew Due to Toxicity and Changes in Safety Assessment Until End of the Study
|
6 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
Adverse Events
GSK525762 60 mg+Abiraterone 1000 mg
Serious events: 4 serious events
Other events: 10 other events
Deaths: 9 deaths
GSK525762 60 mg Alternate+Abiraterone 1000 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
GSK525762 40 mg+Abiraterone 1000 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 2 deaths
GSK525762 80 mg+Enzalutamide 160 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 7 deaths
GSK525762 60 mg+Enzalutamide 160 mg
Serious events: 6 serious events
Other events: 22 other events
Deaths: 8 deaths
GSK525762 60 mg Alternate+Enzalutamide 160 mg
Serious events: 7 serious events
Other events: 21 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 participants at risk
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=6 participants at risk
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 participants at risk
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=10 participants at risk
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=22 participants at risk
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=21 participants at risk
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.8%
1/21 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.5%
1/22 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.8%
1/21 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.8%
1/21 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.8%
1/21 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.8%
1/21 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.8%
1/21 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.5%
1/22 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
General disorders
Fatigue
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.5%
1/22 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.8%
1/21 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.5%
1/22 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Infections and infestations
Myelitis
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.8%
1/21 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.8%
1/21 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.8%
1/21 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.5%
1/22 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.5%
1/22 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.8%
1/21 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Renal and urinary disorders
Renal impairment
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.5%
1/22 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.5%
1/22 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
Other adverse events
| Measure |
GSK525762 60 mg+Abiraterone 1000 mg
n=10 participants at risk
Participants received once daily oral dose of GSK525762 60 milligram (mg) in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 60 mg Alternate+Abiraterone 1000 mg
n=6 participants at risk
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + abiraterone 1000 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 40 mg+Abiraterone 1000 mg
n=4 participants at risk
Participants received once daily oral dose of GSK525762 40 mg in combination with abiraterone 1000 mg up to maximum of 21.3 months. Participants received prednisone 5 mg orally twice daily as per abiraterone label.
|
GSK525762 80 mg+Enzalutamide 160 mg
n=10 participants at risk
Participants received once daily oral dose of GSK525762 80 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg+Enzalutamide 160 mg
n=22 participants at risk
Participants received once daily oral dose of GSK525762 60 mg in combination with enzalutamide 160 mg up to maximum of 21.3 months.
|
GSK525762 60 mg Alternate+Enzalutamide 160 mg
n=21 participants at risk
Participants received an alternate dosing schedule- once daily GSK525762 60 mg + enzalutamide 160 mg tablets via the oral route for 2 weeks followed by 1 week off-treatment up to maximum of 21.3 months.
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.5%
1/22 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.8%
1/21 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Investigations
International normalised ratio increased
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.8%
1/21 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.0%
4/10 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
66.7%
4/6 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
100.0%
4/4 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
40.0%
4/10 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
40.9%
9/22 • Number of events 15 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
61.9%
13/21 • Number of events 15 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Gastrointestinal disorders
Nausea
|
70.0%
7/10 • Number of events 9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
50.0%
3/6 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
60.0%
6/10 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
36.4%
8/22 • Number of events 9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
52.4%
11/21 • Number of events 17 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
General disorders
Fatigue
|
70.0%
7/10 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
30.0%
3/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
50.0%
11/22 • Number of events 18 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
33.3%
7/21 • Number of events 9 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Nervous system disorders
Dysgeusia
|
50.0%
5/10 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
50.0%
2/4 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
20.0%
2/10 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
31.8%
7/22 • Number of events 11 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
47.6%
10/21 • Number of events 11 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
General disorders
Asthenia
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
50.0%
3/6 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
100.0%
4/4 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
20.0%
2/10 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
36.4%
8/22 • Number of events 11 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
52.4%
11/21 • Number of events 14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Gastrointestinal disorders
Diarrhoea
|
30.0%
3/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
50.0%
2/4 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
20.0%
2/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
27.3%
6/22 • Number of events 10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
33.3%
7/21 • Number of events 10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
5/10 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
27.3%
6/22 • Number of events 11 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
33.3%
7/21 • Number of events 10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Blood and lymphatic system disorders
Anaemia
|
40.0%
4/10 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
30.0%
3/10 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
31.8%
7/22 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
14.3%
3/21 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Investigations
Platelet count decreased
|
40.0%
4/10 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
33.3%
2/6 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
40.0%
4/10 • Number of events 17 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
18.2%
4/22 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
19.0%
4/21 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
30.0%
3/10 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
40.9%
9/22 • Number of events 14 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
19.0%
4/21 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
40.0%
4/10 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
13.6%
3/22 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
28.6%
6/21 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
40.0%
4/10 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
50.0%
3/6 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
40.0%
4/10 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
19.0%
4/21 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
50.0%
2/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
30.0%
3/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
18.2%
4/22 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
19.0%
4/21 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
30.0%
3/10 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
40.0%
4/10 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
13.6%
3/22 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
19.0%
4/21 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
40.0%
4/10 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
13.6%
3/22 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
14.3%
3/21 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Investigations
Amylase increased
|
30.0%
3/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
50.0%
2/4 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
20.0%
2/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.5%
1/22 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
9.5%
2/21 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
9.1%
2/22 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
14.3%
3/21 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
13.6%
3/22 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
9.5%
2/21 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
20.0%
2/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
13.6%
3/22 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
9.5%
2/21 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
30.0%
3/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
9.1%
2/22 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
9.5%
2/21 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
9.1%
2/22 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.8%
1/21 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
9.1%
2/22 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
14.3%
3/21 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
30.0%
3/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.5%
1/22 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
9.5%
2/21 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
30.0%
3/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
14.3%
3/21 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.5%
1/22 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.5%
1/22 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.8%
1/21 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Investigations
Blood bilirubin increased
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.5%
1/22 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Renal and urinary disorders
Haematuria
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.5%
1/22 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
9.5%
2/21 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.5%
1/22 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.8%
1/21 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
40.0%
4/10 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Investigations
Lipase increased
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
30.0%
3/10 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.8%
1/21 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Investigations
Blood creatinine increased
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
9.1%
2/22 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.5%
1/22 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
9.5%
2/21 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Vascular disorders
Haematoma
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.5%
1/22 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
9.5%
2/21 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Investigations
Troponin I increased
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
13.6%
3/22 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.8%
1/21 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
9.1%
2/22 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/21 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
|
Investigations
Weight decreased
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
0.00%
0/22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
4.8%
1/21 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 3 years and 11 months
All-cause mortality, non-SAES and SAEs were assessed using All Treated Population which consisted of all participants who received at least one dose of GSK525762 or abiraterone or enzalutamide.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER