Trial Outcomes & Findings for A Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer (NCT NCT02737332)

NCT ID: NCT02737332

Last Updated: 2021-11-22

Results Overview

Blood Sample tested for Serum Testosterone Levels

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

53 participants

Primary outcome timeframe

Average of Day 9 and 10

Results posted on

2021-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	Zytiga® (Abiraterone Acetate) Zytiga® 1,000 mg (4 x 250 mg qd) tablets	SoluMatrix™ (Abiraterone Acetate) SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
Overall Study STARTED	29	24
Overall Study COMPLETED	28	23
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zytiga® (Abiraterone Acetate) n=29 Participants Zytiga® 1,000 mg (4 x 250 mg qd) tablets	SoluMatrix™ (Abiraterone Acetate) n=24 Participants SoluMatrix™ 500 mg (4 x 125 mg qd) tablets	Total n=53 Participants Total of all reporting groups
Age, Continuous	73.5 years STANDARD_DEVIATION 9.4 • n=5 Participants	77 years STANDARD_DEVIATION 8.9 • n=7 Participants	75.1 years STANDARD_DEVIATION 9.3 • 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	29 Participants n=5 Participants	24 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	20 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	24 participants n=7 Participants	53 participants n=5 Participants

PRIMARY outcome

Timeframe: Average of Day 9 and 10

Population: Analysis of serum T levels in the ITT population

Blood Sample tested for Serum Testosterone Levels

Outcome measures

Outcome measures
Measure	Zytiga® (Abiraterone Acetate) n=29 Participants Zytiga® 1,000 mg (4 x 250 mg qd) tablets	SoluMatrix™ (Abiraterone Acetate) n=24 Participants SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
Testosterone Levels	1.02 ng/dL Standard Error 0.03	1.05 ng/dL Standard Error 0.04

SECONDARY outcome

Timeframe: Day 28, Day 56, and Day 84

Population: ITT population:The intention-to-treat (ITT) population is defined as all subjects who are randomized to one of the two treatment groups. The ITT population is the primary population for PD evaluation. The ITT population will be identified and finalized before the database is locked.

All patients randomized to one of the two treatment groups, round about level of PSA. These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint

Outcome measures

Outcome measures
Measure	Zytiga® (Abiraterone Acetate) n=29 Participants Zytiga® 1,000 mg (4 x 250 mg qd) tablets	SoluMatrix™ (Abiraterone Acetate) n=24 Participants SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
PSA Levels Day 28	37.5 ng/mL Standard Error 11.33	22.37 ng/mL Standard Error 12.02
PSA Levels Day 56	40.84 ng/mL Standard Error 12.58	25.29 ng/mL Standard Error 13.68
PSA Levels Day 84	33.88 ng/mL Standard Error 13.43	26.46 ng/mL Standard Error 15.41

SECONDARY outcome

Timeframe: Day 28, Day 56, and Day 84

Proportion of patients with complete suppression of PSA-50 were reported by treatment and compared for between-group differences. These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.

Outcome measures

Outcome measures
Measure	Zytiga® (Abiraterone Acetate) n=27 Participants Zytiga® 1,000 mg (4 x 250 mg qd) tablets	SoluMatrix™ (Abiraterone Acetate) n=24 Participants SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
Percent of Subjects With PSA-50 Response Day 28	70.4 percentage of Participants	66.7 percentage of Participants
Percent of Subjects With PSA-50 Response Day 56	65.4 percentage of Participants	63.6 percentage of Participants
Percent of Subjects With PSA-50 Response Day 84	72.0 percentage of Participants	68.4 percentage of Participants

SECONDARY outcome

Timeframe: Day 28, Day 56, and Day 84

These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.

Outcome measures

Outcome measures
Measure	Zytiga® (Abiraterone Acetate) n=29 Participants Zytiga® 1,000 mg (4 x 250 mg qd) tablets	SoluMatrix™ (Abiraterone Acetate) n=24 Participants SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
Serum Testosterone Levels Day 28	1.01 ng/dL Standard Error 0.01	1.01 ng/dL Standard Error 0.01
Serum Testosterone Levels Day 56	1.01 ng/dL Standard Error 1.03	2.56 ng/dL Standard Error 1.07
Serum Testosterone Levels Day 84	1 ng/dL Standard Error 0	1 ng/dL Standard Error 0

SECONDARY outcome

Timeframe: Day 09, Day 28, Day 56, and Day 84

Population: Safety Population

These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.

Outcome measures

Outcome measures
Measure	Zytiga® (Abiraterone Acetate) n=28 Participants Zytiga® 1,000 mg (4 x 250 mg qd) tablets	SoluMatrix™ (Abiraterone Acetate) n=23 Participants SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
Steady State Trough Concentration of Arbiraterone Day 09	20.938 ng/dL Standard Error 7.044	27.259 ng/dL Standard Error 7.772
Steady State Trough Concentration of Arbiraterone Day 28	56.721 ng/dL Standard Error 23.104	18.662 ng/dL Standard Error 24.18
Steady State Trough Concentration of Arbiraterone Day 56	29.978 ng/dL Standard Error 8.117	18.707 ng/dL Standard Error 9.175
Steady State Trough Concentration of Arbiraterone Day 84	18.263 ng/dL Standard Error 3.087	13.819 ng/dL Standard Error 3.381

SECONDARY outcome

Timeframe: 60 to 30 minutes prior to dosing and over 24 Hours post-dose

Steady state systemic exposure parameters

Outcome measures

Outcome measures
Measure	Zytiga® (Abiraterone Acetate) n=8 Participants Zytiga® 1,000 mg (4 x 250 mg qd) tablets	SoluMatrix™ (Abiraterone Acetate) n=4 Participants SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
AUC (0-inf)	1020.218 ng*hr/mL Standard Error 154.549	326.458 ng*hr/mL Standard Error 218.565

SECONDARY outcome

Timeframe: 60 to 30 minutes prior to dosing and over 24 Hours post-dose

Population: Overall, 14 subjects were analyzed in the PK population, amongst which, 8 were in the Zytiga group and 5 were in the SoluMatrix group.

Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).

Outcome measures

Outcome measures
Measure	Zytiga® (Abiraterone Acetate) n=8 Participants Zytiga® 1,000 mg (4 x 250 mg qd) tablets	SoluMatrix™ (Abiraterone Acetate) n=5 Participants SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
AUC (0-24 hr)	870.859 ng*hr/mL Standard Error 221.709	626.066 ng*hr/mL Standard Error 280.443

SECONDARY outcome

Timeframe: 60 to 30 minutes prior to dosing and over 24 Hours post-dose

Population: Overall, 14 subjects were analyzed in the PK population, amongst which, 8 were in the Zytiga group and 5 were in the SoluMatrix group.

Outcome measures

Outcome measures
Measure	Zytiga® (Abiraterone Acetate) n=8 Participants Zytiga® 1,000 mg (4 x 250 mg qd) tablets	SoluMatrix™ (Abiraterone Acetate) n=5 Participants SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
AUC (0-t)	870.859 ng*hr/mL Standard Error 221.709	626.066 ng*hr/mL Standard Error 280.443

SECONDARY outcome

Timeframe: 60 to 30 minutes prior to dosing and over 24 Hours post-dose

Population: Overall, 14 subjects were analyzed in the PK population, amongst which, 8 were in the Zytiga group and 5 were in the SoluMatrix group.

Outcome measures

Outcome measures
Measure	Zytiga® (Abiraterone Acetate) n=8 Participants Zytiga® 1,000 mg (4 x 250 mg qd) tablets	SoluMatrix™ (Abiraterone Acetate) n=5 Participants SoluMatrix™ 500 mg (4 x 125 mg qd) tablets
Cmax	268.261 ng/mL Standard Error 69.967	111.316 ng/mL Standard Error 88.503

Adverse Events

Zytiga® (Abiraterone Acetate)

Serious events: 2 serious events

Other events: 22 other events

Deaths: 2 deaths

SoluMatrix™ (Abiraterone Acetate)

Serious events: 5 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Zytiga® (Abiraterone Acetate) n=29 participants at risk 1,000 MG (4 x 250 mg qd) Zytiga® (Abiraterone Acetate): Zytiga® 1,000 mg (4 x 250 mg qd) Compared to SoluMatrix™ Abiraterone Acetate 500 mg	SoluMatrix™ (Abiraterone Acetate) n=24 participants at risk 500 mg (4 x 125 mg qd) SoluMatrix™ (Abiraterone Acetate): SoluMatrix™ Abiraterone Acetate 500 mg Compared to Zytiga® 1,000 mg (4 x 250 mg qd)
Cardiac disorders Corornary artery disease	0.00% 0/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	4.2% 1/24 • Number of events 1 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
Infections and infestations Sepsis	0.00% 0/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	4.2% 1/24 • Number of events 1 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
Infections and infestations Pyelonephritis	0.00% 0/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	4.2% 1/24 • Number of events 1 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Progression of prostate cancer	3.4% 1/29 • Number of events 1 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	0.00% 0/24 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
Cardiac disorders Myocardial infarction	3.4% 1/29 • Number of events 1 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	0.00% 0/24 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
Infections and infestations Vertigo	0.00% 0/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	4.2% 1/24 • Number of events 1 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
Renal and urinary disorders Worsening of left hydroureteronephrosis	0.00% 0/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	4.2% 1/24 • Number of events 1 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.

Other adverse events

Additional Information

Head, Clinical Development

SPARC

Phone: 912266455645

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Zytiga® (Abiraterone Acetate) n=29 participants at risk 1,000 MG (4 x 250 mg qd) Zytiga® (Abiraterone Acetate): Zytiga® 1,000 mg (4 x 250 mg qd) Compared to SoluMatrix™ Abiraterone Acetate 500 mg	SoluMatrix™ (Abiraterone Acetate) n=24 participants at risk 500 mg (4 x 125 mg qd) SoluMatrix™ (Abiraterone Acetate): SoluMatrix™ Abiraterone Acetate 500 mg Compared to Zytiga® 1,000 mg (4 x 250 mg qd)
Gastrointestinal disorders Abdominal pain	0.00% 0/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	8.3% 2/24 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
Gastrointestinal disorders Nausea	10.3% 3/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	0.00% 0/24 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
Gastrointestinal disorders Vomiting	6.9% 2/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	0.00% 0/24 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
General disorders Asthenia	6.9% 2/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	0.00% 0/24 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
General disorders Oedema peripheral	0.00% 0/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	8.3% 2/24 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
Infections and infestations Urinary tract infections	10.3% 3/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	16.7% 4/24 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
Investigations Blood creatiineincreased	6.9% 2/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	0.00% 0/24 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
Musculoskeletal and connective tissue disorders Back pain	13.8% 4/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	4.2% 1/24 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
Musculoskeletal and connective tissue disorders Muscle spasms	13.8% 4/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	4.2% 1/24 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
Musculoskeletal and connective tissue disorders Muscular weakness	6.9% 2/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	0.00% 0/24 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
Nervous system disorders Dizziness	13.8% 4/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	0.00% 0/24 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
Vascular disorders Hypertension	6.9% 2/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	4.2% 1/24 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	4.2% 1/24 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
Gastrointestinal disorders Gastroesophgeal reflux disease	0.00% 0/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	4.2% 1/24 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
General disorders Thirst	0.00% 0/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	4.2% 1/24 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
Infections and infestations Bacteriuria	0.00% 0/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	4.2% 1/24 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.
Infections and infestations Cellulitis	0.00% 0/29 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.	4.2% 1/24 • AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF. The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.