Trial Outcomes & Findings for Abiraterone Acetate Dose-Escalation Study in Hormone Refractory Prostate Cancer (NCT NCT00473746)
NCT ID: NCT00473746
Last Updated: 2014-04-29
Results Overview
The MTD is the highest dose of a drug or treatment that does not cause unacceptable side effects.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Up to Cycle 12
Results posted on
2014-04-29
Participant Flow
The study was conducted between 10 July 2006 and 22 December 2012.
66 participants participated in the study, including 33 participants enrolled in Phase 1 of the study, and 33 participants enrolled in Phase 2 of the study.
Participant milestones
| Measure |
Phase 1 250 MG/DAY
Abiraterone acetate
|
Phase 1 500 MG/DAY
Abiraterone acetate
|
Phase 1 750 MG/DAY
Abiraterone acetate
|
Phase 1 1000 MG/DAY
Abiraterone acetate
|
Phase 2 1000 MG/DAY
Abiraterone acetate
|
|---|---|---|---|---|---|
|
Period 1 (Phase 1)
STARTED
|
6
|
9
|
6
|
12
|
0
|
|
Period 1 (Phase 1)
COMPLETED
|
0
|
0
|
0
|
2
|
0
|
|
Period 1 (Phase 1)
NOT COMPLETED
|
6
|
9
|
6
|
10
|
0
|
|
Period 2 (Phase 2)
STARTED
|
0
|
0
|
0
|
0
|
33
|
|
Period 2 (Phase 2)
COMPLETED
|
0
|
0
|
0
|
0
|
6
|
|
Period 2 (Phase 2)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
27
|
Reasons for withdrawal
| Measure |
Phase 1 250 MG/DAY
Abiraterone acetate
|
Phase 1 500 MG/DAY
Abiraterone acetate
|
Phase 1 750 MG/DAY
Abiraterone acetate
|
Phase 1 1000 MG/DAY
Abiraterone acetate
|
Phase 2 1000 MG/DAY
Abiraterone acetate
|
|---|---|---|---|---|---|
|
Period 1 (Phase 1)
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
|
Period 1 (Phase 1)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
|
Period 1 (Phase 1)
Progressive Disease
|
5
|
6
|
6
|
10
|
0
|
|
Period 1 (Phase 1)
Symptomatic Deterioration
|
0
|
1
|
0
|
0
|
0
|
|
Period 1 (Phase 1)
Reason not specified
|
0
|
1
|
0
|
0
|
0
|
|
Period 2 (Phase 2)
Adverse Event
|
0
|
0
|
0
|
0
|
3
|
|
Period 2 (Phase 2)
Death
|
0
|
0
|
0
|
0
|
1
|
|
Period 2 (Phase 2)
Progressive Disease
|
0
|
0
|
0
|
0
|
20
|
|
Period 2 (Phase 2)
Reason not specified
|
0
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Abiraterone Acetate Dose-Escalation Study in Hormone Refractory Prostate Cancer
Baseline characteristics by cohort
| Measure |
Phase 1 250 MG/DAY
n=6 Participants
Abiraterone acetate
|
Phase 1 500 MG/DAY
n=9 Participants
Abiraterone acetate
|
Phase 1 750 MG/DAY
n=6 Participants
Abiraterone acetate
|
Phase 1 1000 MG/DAY
n=12 Participants
Abiraterone acetate
|
Phase 2 1000 MG/DAY
n=33 Participants
Abiraterone acetate
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 6.19 • n=5 Participants
|
67.6 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
73.2 years
STANDARD_DEVIATION 8.18 • n=5 Participants
|
72.9 years
STANDARD_DEVIATION 8.3 • n=4 Participants
|
70.3 years
STANDARD_DEVIATION 8.51 • n=21 Participants
|
70.3 years
STANDARD_DEVIATION 8.05 • 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
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
66 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
6 participants
n=5 Participants
|
12 participants
n=4 Participants
|
33 participants
n=21 Participants
|
66 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to Cycle 12Population: Safety population included all enrolled participants who received any study drug. MTD of abiraterone acetate was not reached because the doses administered appear to be well tolerated with no Dose Limiting Toxicity (DLT) even at 1000 milligram per day (mg/day \[recommended maximum dose for phase 1\]) and 1000 mg/day was taken as test dose in phase 2.
The MTD is the highest dose of a drug or treatment that does not cause unacceptable side effects.
Outcome measures
| Measure |
Phase I Dose Escalation
n=33 Participants
The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
|
Phase I Dose Escalation (500mg)
The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (750mg)
The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (1000mg)
The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
|---|---|---|---|---|
|
Phase 1: Maximum Tolerated Dose (MTD) of Abiraterone Acetate
|
NA mg/day
0
MTD of abiraterone acetate was not reached because the doses administered appear to be well tolerated with no Dose Limiting Toxicity (DLT) even at 1000 milligram per day.
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12 weeks from start of treatmentPopulation: Intent-to-treat (ITT) population included all participants who were enrolled into the study.
Number of participants with greater than or equal to 50 percent decrease in PSA levels were assessed. PSA decline was evaluated according to (Prostate Specific Antigen Working Group) PSAWG criteria. Decrease in PSA levels represented improvement.
Outcome measures
| Measure |
Phase I Dose Escalation
n=33 Participants
The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
|
Phase I Dose Escalation (500mg)
The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (750mg)
The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (1000mg)
The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
|---|---|---|---|---|
|
Phase 2: Participants With Greater Than or Equal to 50 Percent Decline in Prostate Specific Antigen (PSA)
Confirmed
|
26 participants
|
—
|
—
|
—
|
|
Phase 2: Participants With Greater Than or Equal to 50 Percent Decline in Prostate Specific Antigen (PSA)
Not Confirmed
|
2 participants
|
—
|
—
|
—
|
|
Phase 2: Participants With Greater Than or Equal to 50 Percent Decline in Prostate Specific Antigen (PSA)
Total
|
28 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3.Population: ITT population included all participants who were enrolled into the study.
Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).
Outcome measures
| Measure |
Phase I Dose Escalation
n=6 Participants
The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
|
Phase I Dose Escalation (500mg)
n=9 Participants
The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (750mg)
n=6 Participants
The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (1000mg)
n=12 Participants
The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
|---|---|---|---|---|
|
Phase 1: Maximum Plasma Concentration (Cmax) of Abiraterone Acetate
Fasted
|
283.000 nanomoles per liter (nmol/L)
Standard Deviation 142.265
|
330.633 nanomoles per liter (nmol/L)
Standard Deviation 204.889
|
289.533 nanomoles per liter (nmol/L)
Standard Deviation 126.646
|
509.500 nanomoles per liter (nmol/L)
Standard Deviation 366.452
|
|
Phase 1: Maximum Plasma Concentration (Cmax) of Abiraterone Acetate
Fed
|
421.000 nanomoles per liter (nmol/L)
Standard Deviation 75.809
|
676.000 nanomoles per liter (nmol/L)
Standard Deviation 147.866
|
1552.000 nanomoles per liter (nmol/L)
Standard Deviation 458.082
|
2194.250 nanomoles per liter (nmol/L)
Standard Deviation 1096.914
|
SECONDARY outcome
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3Population: ITT population included all participants who were enrolled into the study.
Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose)
Outcome measures
| Measure |
Phase I Dose Escalation
n=6 Participants
The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
|
Phase I Dose Escalation (500mg)
n=9 Participants
The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (750mg)
n=6 Participants
The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (1000mg)
n=12 Participants
The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
|---|---|---|---|---|
|
Phase 1: Time to Reach the Maximum Plasma Concentration (Tmax) of Abiraterone Acetate
Fed
|
2.044 hour (hr)
Standard Deviation 0.077
|
2.667 hour (hr)
Standard Deviation 1.155
|
2.000 hour (hr)
Standard Deviation 0.000
|
4.000 hour (hr)
Standard Deviation 0.000
|
|
Phase 1: Time to Reach the Maximum Plasma Concentration (Tmax) of Abiraterone Acetate
Fasted
|
2.000 hour (hr)
Standard Deviation 0.000
|
1.500 hour (hr)
Standard Deviation 0.548
|
2.033 hour (hr)
Standard Deviation 0.058
|
1.833 hour (hr)
Standard Deviation 0.408
|
SECONDARY outcome
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3Population: ITT population included all participants who were enrolled into the study.
Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).
Outcome measures
| Measure |
Phase I Dose Escalation
n=6 Participants
The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
|
Phase I Dose Escalation (500mg)
n=9 Participants
The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (750mg)
n=6 Participants
The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (1000mg)
n=12 Participants
The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
|---|---|---|---|---|
|
Phase 1: Area Under the Plasma-Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Abiraterone Acetate
Fasted
|
1329.178 hr*nmol/L
Standard Deviation 699.977
|
1625.059 hr*nmol/L
Standard Deviation 930.364
|
1565.659 hr*nmol/L
Standard Deviation 661.289
|
3039.937 hr*nmol/L
Standard Deviation 1902.697
|
|
Phase 1: Area Under the Plasma-Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Abiraterone Acetate
Fed
|
1310.715 hr*nmol/L
Standard Deviation 311.041
|
3624.781 hr*nmol/L
Standard Deviation 1041.927
|
8920.790 hr*nmol/L
Standard Deviation 3060.457
|
13695.482 hr*nmol/L
Standard Deviation 5623.185
|
SECONDARY outcome
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3Population: ITT population included all participants who were enrolled into the study.
Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).
Outcome measures
| Measure |
Phase I Dose Escalation
n=6 Participants
The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
|
Phase I Dose Escalation (500mg)
n=9 Participants
The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (750mg)
n=6 Participants
The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (1000mg)
n=12 Participants
The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
|---|---|---|---|---|
|
Phase 1: Area Under the Plasma-Concentration-time Curve From Time 0 to Infinite Time (AUCINF_obs) of Abiraterone Acetate
Fasted
|
1411.268 hr*nmol/L
Standard Deviation 697.183
|
1781.374 hr*nmol/L
Standard Deviation 986.770
|
1665.454 hr*nmol/L
Standard Deviation 704.551
|
3478.385 hr*nmol/L
Standard Deviation 2012.176
|
|
Phase 1: Area Under the Plasma-Concentration-time Curve From Time 0 to Infinite Time (AUCINF_obs) of Abiraterone Acetate
Fed
|
1386.939 hr*nmol/L
Standard Deviation 290.240
|
3839.804 hr*nmol/L
Standard Deviation 1080.853
|
9358.743 hr*nmol/L
Standard Deviation 3338.601
|
14404.387 hr*nmol/L
Standard Deviation 5971.041
|
SECONDARY outcome
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3Population: ITT population included all participants who were enrolled into the study.
Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).
Outcome measures
| Measure |
Phase I Dose Escalation
n=6 Participants
The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
|
Phase I Dose Escalation (500mg)
n=9 Participants
The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (750mg)
n=6 Participants
The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (1000mg)
n=12 Participants
The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
|---|---|---|---|---|
|
Phase 1: Terminal Half-life (HL_Lambda_z) of Abiraterone Acetate
Fasted
|
5.284 hour (hr)
Standard Deviation 1.676
|
10.591 hour (hr)
Standard Deviation 6.337
|
7.066 hour (hr)
Standard Deviation 3.431
|
14.361 hour (hr)
Standard Deviation 7.655
|
|
Phase 1: Terminal Half-life (HL_Lambda_z) of Abiraterone Acetate
Fed
|
5.125 hour (hr)
Standard Deviation 1.039
|
6.913 hour (hr)
Standard Deviation 5.720
|
7.939 hour (hr)
Standard Deviation 2.633
|
12.454 hour (hr)
Standard Deviation 1.218
|
SECONDARY outcome
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3Population: ITT population included all participants who were enrolled into the study.
Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).
Outcome measures
| Measure |
Phase I Dose Escalation
n=6 Participants
The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
|
Phase I Dose Escalation (500mg)
n=9 Participants
The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (750mg)
n=6 Participants
The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (1000mg)
n=12 Participants
The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
|---|---|---|---|---|
|
Phase 1: Total Body Clearance (Cl_F_obs) of Abiraterone Acetate
Fasted
|
4288.456 liter per hour (l/hr)
Standard Deviation 1319.322
|
5440.949 liter per hour (l/hr)
Standard Deviation 4844.515
|
1518.748 liter per hour (l/hr)
Standard Deviation 822.714
|
2649.954 liter per hour (l/hr)
Standard Deviation 4617.049
|
|
Phase 1: Total Body Clearance (Cl_F_obs) of Abiraterone Acetate
Fed
|
529.606 liter per hour (l/hr)
Standard Deviation 99.532
|
391.046 liter per hour (l/hr)
Standard Deviation 99.118
|
246.643 liter per hour (l/hr)
Standard Deviation 72.970
|
231.383 liter per hour (l/hr)
Standard Deviation 97.746
|
SECONDARY outcome
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3Population: ITT population included all participants who were enrolled into the study.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Volume of distribution is normally calculated by using equation volume of distribution =dose/initial concentration. Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).
Outcome measures
| Measure |
Phase I Dose Escalation
n=6 Participants
The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
|
Phase I Dose Escalation (500mg)
n=9 Participants
The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (750mg)
n=6 Participants
The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (1000mg)
n=12 Participants
The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
|---|---|---|---|---|
|
Phase 1: Volume of Distribution (Vz_F_obs) of Abiraterone Acetate
Fed
|
3940.400 Liter (L)
Standard Deviation 1275.408
|
3418.280 Liter (L)
Standard Deviation 1934.384
|
2739.655 Liter (L)
Standard Deviation 1084.694
|
4068.885 Liter (L)
Standard Deviation 1462.613
|
|
Phase 1: Volume of Distribution (Vz_F_obs) of Abiraterone Acetate
Fasted
|
653.745 Liter (L)
Standard Deviation 447.316
|
10252.077 Liter (L)
Standard Deviation 12268.787
|
13688.367 Liter (L)
Standard Deviation 4265.429
|
25494.398 Liter (L)
Standard Deviation 18670.215
|
SECONDARY outcome
Timeframe: Up to 12 weeks from start of treatmentPopulation: ITT population included all participants who were enrolled into the study. RAD-PFS was not analyzed because of insufficient data to provide a meaningful estimate of the median and associated confidence interval (CI)
RAD-PFS is the time interval from the date of first dose of abiraterone acetate therapy to the date of death or radiographic disease progression according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Phase I Dose Escalation
n=13 Participants
The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
|
Phase I Dose Escalation (500mg)
The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (750mg)
The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (1000mg)
The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
|---|---|---|---|---|
|
Phase 2: Radiographic Progression Free Survival (RAD-PFS)
|
NA days
The median survival is not reached and the confidence interval was not estimable
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 weeks from start of treatmentPopulation: ITT population included all participants who were enrolled into the study.
PSA-PFS is the time interval from the date of first dose of abiraterone acetate therapy to the date of death or the PSA progression as defined by the Prostate Specific Antigen Working Group (PSAWG) criteria.
Outcome measures
| Measure |
Phase I Dose Escalation
n=33 Participants
The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
|
Phase I Dose Escalation (500mg)
The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (750mg)
The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (1000mg)
The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
|---|---|---|---|---|
|
Phase 2: PSA Progression Free Survival (PSA-PFS)
|
473 days
Interval 281.0 to
The median survival is not reached and the confidence interval was not estimable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 weeks from start of treatmentPopulation: Thirteen evaluable participants with measurable disease at baseline were evaluated for radiographic objective response rate.
The objective response rate is defined as the proportion of participants with measurable lesions achieving a Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Phase I Dose Escalation
n=13 Participants
The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
|
Phase I Dose Escalation (500mg)
The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (750mg)
The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (1000mg)
The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
|---|---|---|---|---|
|
Phase 2: Radiographic Objective Response Rate (RAD-ORR)
Confirmed
|
9 participants
Interval 38.6 to 90.9
|
—
|
—
|
—
|
|
Phase 2: Radiographic Objective Response Rate (RAD-ORR)
Not Confirmed
|
1 participants
Interval 0.2 to 36.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 weeks from start of treatmentPopulation: ITT population included all participants who were enrolled into the study.
The time interval from the date of first dose of abiraterone acetate therapy to the date of the PSA progression as defined by the PSAWG criteria.
Outcome measures
| Measure |
Phase I Dose Escalation
n=33 Participants
The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
|
Phase I Dose Escalation (500mg)
The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (750mg)
The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (1000mg)
The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
|---|---|---|---|---|
|
Phase 2: Time to PSA Progression
|
497 days
Interval 281.0 to
The median survival is not reached and the confidence interval was not estimable
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 weeks from start of treatmentPopulation: ITT population included all participants who were enrolled into the study.
Duration of PSA response was defined as the duration between the date of confirmed PSA response and subsequent PSA progression date as defined by the PSAWG criteria.
Outcome measures
| Measure |
Phase I Dose Escalation
n=33 Participants
The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
|
Phase I Dose Escalation (500mg)
The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (750mg)
The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (1000mg)
The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
|---|---|---|---|---|
|
Phase 2: Duration of PSA Response
|
477 days
Interval 283.0 to
The median survival is not reached and the confidence interval was not estimable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 weeks from start of treatmentPopulation: ITT population included all participants who were enrolled into the study.
ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction. 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3=capable of limited self-care, confined to bed or chair \>50% of waking hours. 4=completely disabled, not capable of any self-care, totally confined to bed or chair. 5=dead.
Outcome measures
| Measure |
Phase I Dose Escalation
n=33 Participants
The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
|
Phase I Dose Escalation (500mg)
The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (750mg)
The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (1000mg)
The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
|---|---|---|---|---|
|
Phase 2: Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline ECOG 0
|
20 participants
|
—
|
—
|
—
|
|
Phase 2: Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline ECOG 1
|
13 participants
|
—
|
—
|
—
|
|
Phase 2: Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline ECOG 2
|
0 participants
|
—
|
—
|
—
|
|
Phase 2: Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline ECOG 3
|
0 participants
|
—
|
—
|
—
|
|
Phase 2: Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Baseline ECOG 4
|
0 participants
|
—
|
—
|
—
|
|
Phase 2: Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Best Post-Baseline ECOG 0
|
28 participants
|
—
|
—
|
—
|
|
Phase 2: Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Best Post-Baseline ECOG 1
|
5 participants
|
—
|
—
|
—
|
|
Phase 2: Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Best Post-Baseline ECOG 2
|
0 participants
|
—
|
—
|
—
|
|
Phase 2: Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Best Post-Baseline ECOG 3
|
0 participants
|
—
|
—
|
—
|
|
Phase 2: Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Best Post-Baseline ECOG 4
|
0 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Month 60Population: ITT population included all participants who were enrolled into the study.
Overall survival is the time interval from the date of first dose (cycle 1 day 1) of abiraterone acetate therapy to the date of death from any cause.
Outcome measures
| Measure |
Phase I Dose Escalation
n=33 Participants
The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
|
Phase I Dose Escalation (500mg)
The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (750mg)
The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (1000mg)
The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
|---|---|---|---|---|
|
Phase 2: Overall Survival
|
NA days
The median survival is not reached and the confidence interval was not estimable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 weeks from start of treatmentPopulation: Thirteen evaluable participants with measurable disease at baseline were evaluated for radiographic duration of objective response.
Duration of objective response was assessed only in participants who achieved a CR or PR, and measured from the first documented date of response to the first documented date of disease progression according to the RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Phase I Dose Escalation
n=13 Participants
The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
|
Phase I Dose Escalation (500mg)
The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (750mg)
The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
Phase I Dose Escalation (1000mg)
The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
|
|---|---|---|---|---|
|
Phase 2: Duration of Objective Response
|
NA days
Interval 253.0 to
The median survival is not reached and the confidence interval was not estimable.
|
—
|
—
|
—
|
Adverse Events
Phase 1 250 MG/DAY
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1 500 MG/DAY
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Phase 1 750 MG/DAY
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1 1000 MG/DAY
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Phase 2 1000 MG/DAY
Serious events: 10 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 250 MG/DAY
n=6 participants at risk
Abiraterone acetate
|
Phase 1 500 MG/DAY
n=9 participants at risk
Abiraterone acetate
|
Phase 1 750 MG/DAY
n=6 participants at risk
Abiraterone acetate
|
Phase 1 1000 MG/DAY
n=12 participants at risk
Abiraterone acetate
|
Phase 2 1000 MG/DAY
n=33 participants at risk
Abiraterone acetate
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Cardiac disorders
Arrhythmia Supraventricular
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
General disorders
Oedema Peripheral
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
General disorders
Pyrexia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Infections and infestations
Cystitis
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Infections and infestations
Infection
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Infections and infestations
Urosepsis
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Investigations
Troponin Increased
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Nervous system disorders
Syncope
|
16.7%
1/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Renal and urinary disorders
Calculus Bladder
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Renal and urinary disorders
Urinary Bladder Haemorrhage
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Vascular disorders
Hypotension
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
Other adverse events
| Measure |
Phase 1 250 MG/DAY
n=6 participants at risk
Abiraterone acetate
|
Phase 1 500 MG/DAY
n=9 participants at risk
Abiraterone acetate
|
Phase 1 750 MG/DAY
n=6 participants at risk
Abiraterone acetate
|
Phase 1 1000 MG/DAY
n=12 participants at risk
Abiraterone acetate
|
Phase 2 1000 MG/DAY
n=33 participants at risk
Abiraterone acetate
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Gastrointestinal disorders
Lip Dry
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
11.1%
1/9
|
33.3%
2/6
|
25.0%
3/12
|
21.2%
7/33
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
3.0%
1/33
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Ear and labyrinth disorders
Cerumen Impaction
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Endocrine disorders
Gynaecomastia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
9.1%
3/33
|
|
Eye disorders
Cataract
|
16.7%
1/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
3.0%
1/33
|
|
Eye disorders
Ocular Discomfort
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Eye disorders
Ocular Hyperaemia
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
6.1%
2/33
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6
|
22.2%
2/9
|
33.3%
2/6
|
16.7%
2/12
|
9.1%
3/33
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6
|
33.3%
3/9
|
33.3%
2/6
|
16.7%
2/12
|
21.2%
7/33
|
|
Gastrointestinal disorders
Defaecation Urgency
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6
|
44.4%
4/9
|
50.0%
3/6
|
33.3%
4/12
|
21.2%
7/33
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/6
|
22.2%
2/9
|
33.3%
2/6
|
8.3%
1/12
|
6.1%
2/33
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6
|
33.3%
3/9
|
33.3%
2/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
3.0%
1/33
|
|
Gastrointestinal disorders
Gingival Pain
|
16.7%
1/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6
|
33.3%
3/9
|
16.7%
1/6
|
50.0%
6/12
|
15.2%
5/33
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
9.1%
3/33
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6
|
11.1%
1/9
|
16.7%
1/6
|
25.0%
3/12
|
21.2%
7/33
|
|
General disorders
Asthenia
|
16.7%
1/6
|
33.3%
3/9
|
33.3%
2/6
|
16.7%
2/12
|
6.1%
2/33
|
|
General disorders
Chills
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
8.3%
1/12
|
0.00%
0/33
|
|
General disorders
Fatigue
|
50.0%
3/6
|
77.8%
7/9
|
66.7%
4/6
|
66.7%
8/12
|
48.5%
16/33
|
|
General disorders
Irritability
|
16.7%
1/6
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/33
|
|
General disorders
Mucosal Dryness
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/33
|
|
General disorders
Oedema
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/33
|
|
General disorders
Oedema Peripheral
|
16.7%
1/6
|
44.4%
4/9
|
0.00%
0/6
|
50.0%
6/12
|
27.3%
9/33
|
|
General disorders
Pain
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/33
|
|
General disorders
Pyrexia
|
0.00%
0/6
|
11.1%
1/9
|
16.7%
1/6
|
8.3%
1/12
|
3.0%
1/33
|
|
General disorders
Tenderness
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
General disorders
Thirst
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
15.2%
5/33
|
|
Infections and infestations
Infection
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
9.1%
3/33
|
|
Infections and infestations
Influenza
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
3.0%
1/33
|
|
Infections and infestations
Tinea Versicolour
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
16.7%
1/6
|
11.1%
1/9
|
16.7%
1/6
|
8.3%
1/12
|
15.2%
5/33
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
2/12
|
9.1%
3/33
|
|
Injury, poisoning and procedural complications
Contrast Media Reaction
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
25.0%
3/12
|
15.2%
5/33
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
9.1%
3/33
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Muscle Injury
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
12.1%
4/33
|
|
Investigations
Aspartate Aminotransferase Increased
|
16.7%
1/6
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
2/12
|
9.1%
3/33
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
16.7%
1/6
|
0.00%
0/9
|
16.7%
1/6
|
8.3%
1/12
|
6.1%
2/33
|
|
Investigations
Blood Bicarbonate Decreased
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
3.0%
1/33
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Investigations
Weight Decreased
|
16.7%
1/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Investigations
Weight Increased
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6
|
22.2%
2/9
|
16.7%
1/6
|
25.0%
3/12
|
3.0%
1/33
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
9.1%
3/33
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6
|
11.1%
1/9
|
33.3%
2/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6
|
11.1%
1/9
|
0.00%
0/6
|
16.7%
2/12
|
15.2%
5/33
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
8.3%
1/12
|
6.1%
2/33
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
9.1%
3/33
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6
|
11.1%
1/9
|
66.7%
4/6
|
33.3%
4/12
|
30.3%
10/33
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
15.2%
5/33
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6
|
0.00%
0/9
|
33.3%
2/6
|
0.00%
0/12
|
15.2%
5/33
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6
|
11.1%
1/9
|
33.3%
2/6
|
16.7%
2/12
|
27.3%
9/33
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.7%
1/6
|
11.1%
1/9
|
16.7%
1/6
|
16.7%
2/12
|
24.2%
8/33
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
8.3%
1/12
|
30.3%
10/33
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
Muscle Fatigue
|
16.7%
1/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/6
|
11.1%
1/9
|
16.7%
1/6
|
0.00%
0/12
|
18.2%
6/33
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
33.3%
2/6
|
11.1%
1/9
|
33.3%
2/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
2/12
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
15.2%
5/33
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/6
|
0.00%
0/9
|
33.3%
2/6
|
0.00%
0/12
|
12.1%
4/33
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
3.0%
1/33
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Nervous system disorders
Aphasia
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Nervous system disorders
Dizziness Postural
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Nervous system disorders
Headache
|
0.00%
0/6
|
33.3%
3/9
|
33.3%
2/6
|
58.3%
7/12
|
9.1%
3/33
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
6.1%
2/33
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Psychiatric disorders
Depression
|
16.7%
1/6
|
11.1%
1/9
|
16.7%
1/6
|
0.00%
0/12
|
9.1%
3/33
|
|
Psychiatric disorders
Euphoric Mood
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
9.1%
3/33
|
|
Psychiatric disorders
Mood Altered
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Psychiatric disorders
Personality Change
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Psychiatric disorders
Stress
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Renal and urinary disorders
Haematuria
|
16.7%
1/6
|
11.1%
1/9
|
0.00%
0/6
|
8.3%
1/12
|
6.1%
2/33
|
|
Renal and urinary disorders
Micturition Urgency
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
9.1%
3/33
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
16.7%
2/12
|
0.00%
0/33
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
9.1%
3/33
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
3.0%
1/33
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Reproductive system and breast disorders
Testicular Pain
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6
|
22.2%
2/9
|
66.7%
4/6
|
8.3%
1/12
|
15.2%
5/33
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
8.3%
1/12
|
12.1%
4/33
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
33.3%
2/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
16.7%
1/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/6
|
11.1%
1/9
|
16.7%
1/6
|
0.00%
0/12
|
3.0%
1/33
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6
|
8.3%
1/12
|
24.2%
8/33
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
6.1%
2/33
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/12
|
9.1%
3/33
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6
|
0.00%
0/9
|
0.00%
0/6
|
8.3%
1/12
|
3.0%
1/33
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/12
|
12.1%
4/33
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
0.00%
0/6
|
11.1%
1/9
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/33
|
|
Vascular disorders
Hot Flush
|
0.00%
0/6
|
22.2%
2/9
|
33.3%
2/6
|
25.0%
3/12
|
30.3%
10/33
|
|
Vascular disorders
Hypertension
|
33.3%
2/6
|
22.2%
2/9
|
50.0%
3/6
|
41.7%
5/12
|
21.2%
7/33
|
|
Vascular disorders
Hypotension
|
16.7%
1/6
|
22.2%
2/9
|
0.00%
0/6
|
0.00%
0/12
|
9.1%
3/33
|
Additional Information
Sr. Director, Clinical Research
Janssen R&D US
Phone: (310)914-2917
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60