Trial Outcomes & Findings for A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer (NCT NCT00924469)

Last Updated: 2013-04-17

Results Overview

Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Abiraterone acetate affects sources of testosterone in the body (ie, adrendal gland and prostate tumor). Testosterone concentration was measured in prostate tissues after exposure to study treatments at Week 12.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

58 participants

Primary outcome timeframe

Week 12

Results posted on

2013-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	Abiraterone Plus Leuprolide Plus Prednisone Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.	Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
Overall Study STARTED	30	28
Overall Study COMPLETED	28	26
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Abiraterone Plus Leuprolide Plus Prednisone Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.	Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
Overall Study Adverse Event	2	0
Overall Study Withdrawal by Subject	0	1
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abiraterone Plus Leuprolide Plus Prednisone n=30 Participants Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.	Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone n=28 Participants Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.	Total n=58 Participants Total of all reporting groups
Age Continuous	61.0 years STANDARD_DEVIATION 6.67 • n=5 Participants	56.9 years STANDARD_DEVIATION 5.30 • n=7 Participants	59.0 years STANDARD_DEVIATION 6.35 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	28 Participants n=7 Participants	58 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Intent-to-treat (ITT) population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.

Outcome measures

Outcome measures
Measure	Abiraterone Plus Leuprolide Plus Prednisone n=28 Participants Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.	Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone n=27 Participants Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
Testosterone Concentration in Prostate Tissue	0.089 Picogram per milligram (pg/mg) Standard Deviation 0.0637	0.228 Picogram per milligram (pg/mg) Standard Deviation 0.3788

PRIMARY outcome

Timeframe: Week 12

The DHT is a potent androgenic metabolite of testosterone and the concentration of DHT was measured in prostate tissues after exposure to study treatments at Week 12.

Outcome measures

Outcome measures
Measure	Abiraterone Plus Leuprolide Plus Prednisone n=28 Participants Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.	Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone n=27 Participants Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
Dihydrotestosterone (DHT) Concentration in Prostate Tissue	4.311 Picogram per milligram (pg/mg) Standard Deviation 21.6213	2.170 Picogram per milligram (pg/mg) Standard Deviation 3.4589

SECONDARY outcome

Timeframe: Week 24

Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Dihydrotestosterone (DHT) is a potent androgenic metabolite of testosterone. Testosterone and DHT concentration was measured in prostate tissues after exposure to study treatments at Week 24.

Outcome measures

Outcome measures
Measure	Abiraterone Plus Leuprolide Plus Prednisone n=28 Participants Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.	Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone n=26 Participants Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue Testosterone	0.216 Picogram per milligram (pg/mg) Standard Deviation 0.6707	0.062 Picogram per milligram (pg/mg) Standard Deviation 0.0340
Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue DHT	1.340 Picogram per milligram (pg/mg) Standard Deviation 3.5099	2.456 Picogram per milligram (pg/mg) Standard Deviation 6.3901

SECONDARY outcome

Timeframe: Week 12 and 24

Population: ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure and "n" signifies those participants who were evaluated for this measure at the specified time point.

Androstenedione is a steroid (a group of polycyclic compounds closely related biochemically to terpenes, for example, cholesterol, numerous hormones), that is produced in the testis, ovary and the adrenal cortex, and depending on the tissue type, androstenedione can serve as a precursor to testosterone, estrone and estradiol. The DHEA is a major steroid produced by the adrenal cortex. It is also produced in small quantities in the testis and the ovary. Androstenedione and DHEA concentration was measured in prostate tissues at Week 12 and 24.

Outcome measures

Outcome measures
Measure	Abiraterone Plus Leuprolide Plus Prednisone n=28 Participants Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.	Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone n=27 Participants Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue Androstenedione: Week 12 (n=28,27)	0.082 Picogram per milligram (pg/mg) Standard Deviation 0.0525	0.277 Picogram per milligram (pg/mg) Standard Deviation 0.1729
Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue Androstenedione: Week 24 (n=28,26)	0.090 Picogram per milligram (pg/mg) Standard Deviation 0.0879	0.070 Picogram per milligram (pg/mg) Standard Deviation 0.0403
Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue DHEA: Week 12 (n=28,27)	1.994 Picogram per milligram (pg/mg) Standard Deviation 5.0266	29.241 Picogram per milligram (pg/mg) Standard Deviation 26.9800
Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue DHEA: Week 24 (n=28,26)	3.138 Picogram per milligram (pg/mg) Standard Deviation 8.6692	2.170 Picogram per milligram (pg/mg) Standard Deviation 3.7095

SECONDARY outcome

Timeframe: Week 12 and 24

Serum concentrations of testosterone, DHT, androsterone, DHEA, DHEA-Sulfate, DHEA-Glucuronide and delta-4-androstenedione were measured at Weeks 12 and 24.

Outcome measures

Outcome measures
Measure	Abiraterone Plus Leuprolide Plus Prednisone n=29 Participants Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.	Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone n=28 Participants Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
Serum Levels of Androgens Testosterone: Week 12 (n=28,28)	1.049 Nanogram per deciliter (ng/dL) Standard Deviation 1.0374	10.014 Nanogram per deciliter (ng/dL) Standard Deviation 12.5981
Serum Levels of Androgens Testosterone: Week 24 (n=25,25)	0.648 Nanogram per deciliter (ng/dL) Standard Deviation 0.4975	3.122 Nanogram per deciliter (ng/dL) Standard Deviation 12.6460
Serum Levels of Androgens DHT: Week 12 (n=28,28)	6.143 Nanogram per deciliter (ng/dL) Standard Deviation 8.9868	5.797 Nanogram per deciliter (ng/dL) Standard Deviation 5.9816
Serum Levels of Androgens DHT: Week 24 (n=26,26)	5.932 Nanogram per deciliter (ng/dL) Standard Deviation 9.1599	6.730 Nanogram per deciliter (ng/dL) Standard Deviation 15.7929
Serum Levels of Androgens Androsterone: Week 12 (n=28,28)	0.619 Nanogram per deciliter (ng/dL) Standard Deviation 0.4473	3.100 Nanogram per deciliter (ng/dL) Standard Deviation 5.8891
Serum Levels of Androgens Androsterone: Week 24 (26,26)	1.752 Nanogram per deciliter (ng/dL) Standard Deviation 6.3226	0.500 Nanogram per deciliter (ng/dL) Standard Deviation 0.0000
Serum Levels of Androgens DHEA: Week 12 (n=28,28)	10.684 Nanogram per deciliter (ng/dL) Standard Deviation 27.2814	180.307 Nanogram per deciliter (ng/dL) Standard Deviation 133.6277
Serum Levels of Androgens DHEA: Week 24 (n=26,26)	20.922 Nanogram per deciliter (ng/dL) Standard Deviation 64.2594	7.617 Nanogram per deciliter (ng/dL) Standard Deviation 14.5386
Serum Levels of Androgens DHEA-Glucuronide: Week 12 (n=29,28)	69.724 Nanogram per deciliter (ng/dL) Standard Deviation 184.2399	583.036 Nanogram per deciliter (ng/dL) Standard Deviation 879.7514
Serum Levels of Androgens DHEA-Glucuronide: Week 24 (n=27,27)	51.675 Nanogram per deciliter (ng/dL) Standard Deviation 148.9412	51.759 Nanogram per deciliter (ng/dL) Standard Deviation 95.0666
Serum Levels of Androgens DHEA-Sulfate: Week 12 (n=28,28)	7156.270 Nanogram per deciliter (ng/dL) Standard Deviation 22406.7048	133338.875 Nanogram per deciliter (ng/dL) Standard Deviation 108819.6403
Serum Levels of Androgens DHEA-Sulfate: Week 24 (n=26,26)	9047.406 Nanogram per deciliter (ng/dL) Standard Deviation 27844.7883	9207.345 Nanogram per deciliter (ng/dL) Standard Deviation 30897.5488
Serum Levels of Androgens Delta-4-Androstenedione:Week 12(n=28,28)	3.315 Nanogram per deciliter (ng/dL) Standard Deviation 3.3858	33.330 Nanogram per deciliter (ng/dL) Standard Deviation 26.8110
Serum Levels of Androgens Delta-4-Androstenedione:Week 24(n=26,26)	5.192 Nanogram per deciliter (ng/dL) Standard Deviation 10.8654	2.831 Nanogram per deciliter (ng/dL) Standard Deviation 1.1596

SECONDARY outcome

Timeframe: Weeks 12 and 24

Population: ITT population included all the participants who were randomly assigned to the study treatment.

The PSA response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criterion which is, percentage of participants with PSA less than or equal to 0.2 nanogram/milliliter at Weeks 12 and 24 after androgen deprivation.

Outcome measures

Outcome measures
Measure	Abiraterone Plus Leuprolide Plus Prednisone n=30 Participants Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.	Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone n=28 Participants Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
Percentage of Participants With Prostate-specific Antigen (PSA) Response Week 24	86.7 Percentage of participants	82.1 Percentage of participants
Percentage of Participants With Prostate-specific Antigen (PSA) Response Week 12	86.7 Percentage of participants 0.0637	3.6 Percentage of participants 0.3788

SECONDARY outcome

Timeframe: Week 24

Complete response is defined as a disappearance of all target lesions and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criterion.

Outcome measures

Outcome measures
Measure	Abiraterone Plus Leuprolide Plus Prednisone n=29 Participants Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.	Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone n=27 Participants Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
Percentage of Participants With Pathologic Complete Response (CR)	10.3 Percentage of participants 0.0637	3.7 Percentage of participants 0.3788

SECONDARY outcome

Timeframe: Week 24

Population: Resullts were not reported due to insufficient data in this outcome measure.

Tumor expression of AR regulated genes determined by real-time polymerase chain reaction (RT PCR). PCR is an in vitro method for producing large amounts of specific deoxyribonucleic acid (DNA) or ribonucleic acid fragments of defined length and sequence from small amounts of short oligonucleotide flanking sequences (primers). RT PCR is a method used for detecting the amplified DNA products from the PCR as they accumulate instead of at the end of the reaction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 24

Population: Resullts were not reported due to insufficient data in this outcome measure.

Molecular and protein expression was correlated with intracellular androgen levels and pathologic response to study treatment.

Outcome measures

Outcome data not reported

Adverse Events

Abiraterone Plus Leuprolide Plus Prednisone

Serious events: 6 serious events

Other events: 30 other events

Deaths: 0 deaths

Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone

Serious events: 7 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Director, Clinical Research

Janssen Research & Development, LLC 10990 Wilshire Blvd, Suite 1200 Los Angeles, CA 90024

Phone: (310) 914-2917

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor will retain the right to review all material prior to presentation or submission for publication and neither institution(s) nor Study Co-Chairs/Principal Investigator(s) is/are permitted to publish/present the results of the study, in part or in their entirety, without the written authorization of the Sponsor. The review is aimed at complying with 21CFR312.7 (non promotion of investigational drugs) as well as the intellectual property rights and commercial interests of the Sponsor.
Publication restrictions are in place

Restriction type: OTHER

Measure	Abiraterone Plus Leuprolide Plus Prednisone n=30 participants at risk Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.	Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone n=28 participants at risk Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
Endocrine disorders Pituitary infarction	0.00% 0/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.6% 1/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Gastrointestinal perforation	0.00% 0/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.6% 1/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Ileus	0.00% 0/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.6% 1/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Vomiting	0.00% 0/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.6% 1/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
General disorders Hernia obstructive	0.00% 0/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.6% 1/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
General disorders Pyrexia	0.00% 0/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.6% 1/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Infections and infestations Infected lymphocele	3.3% 1/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.6% 1/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Infections and infestations Infection	0.00% 0/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.6% 1/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Infections and infestations Staphylococcal infection	0.00% 0/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.6% 1/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Infections and infestations Urinary tract infection	0.00% 0/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.6% 1/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Injury, poisoning and procedural complications Renal injury	0.00% 0/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.6% 1/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Investigations Alanine aminotransferase increased	6.7% 2/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.6% 1/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Investigations Aspartate aminotransferase increased	0.00% 0/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.6% 1/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Investigations Blood alkaline phosphatase increased	3.3% 1/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Metabolism and nutrition disorders Dehydration	0.00% 0/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.6% 1/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.6% 1/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	3.3% 1/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 0/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.6% 1/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Psychiatric disorders Depression	3.3% 1/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Psychiatric disorders Mental status changes	0.00% 0/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.6% 1/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Renal and urinary disorders Renal failure	0.00% 0/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.6% 1/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.6% 1/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Vascular disorders Deep vein thrombosis	0.00% 0/30 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.6% 1/28 • Baseline up to Week 32 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.