Trial Outcomes & Findings for RElugolix VErsus LeUprolide Cardiac Trial (NCT NCT05320406)
NCT ID: NCT05320406
Last Updated: 2025-10-06
Results Overview
Using cardiac computed tomography angiography (CCTA), total coronary plaque volume will be determined using an artificial intelligence-enabled quantitative coronary plaque analysis (AI-QCPA) through a commercially available and validated software service (HeartFlow, Inc). Each coronary artery (right coronary, left main, left anterior descending, and left circumflex) will be scored, and plaque volumes were summed over all segments.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
94 participants
Primary outcome timeframe
From baseline to 12 months post-treatment initiation
Results posted on
2025-10-06
Participant Flow
Participant milestones
| Measure |
Arm I (Radiation Therapy Alone)
Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
|
Arm II (Radiation Therapy Plus Leuprolide)
Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Leuprolide: Given IM or SC
|
Arm III (Radiation Therapy Plus Relugolix)
Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Relugolix: Given PO
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
34
|
31
|
|
Overall Study
COMPLETED
|
28
|
28
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RElugolix VErsus LeUprolide Cardiac Trial
Baseline characteristics by cohort
| Measure |
Arm I (Radiation Therapy Alone)
n=29 Participants
Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
|
Arm II (Radiation Therapy Plus Leuprolide)
n=34 Participants
Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Leuprolide: Given IM or SC
|
Arm III (Radiation Therapy Plus Relugolix)
n=31 Participants
Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Relugolix: Given PO
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Age, Continuous
|
65.79 Years
STANDARD_DEVIATION 6.75 • n=5 Participants
|
68.85 Years
STANDARD_DEVIATION 8.12 • n=7 Participants
|
68.81 Years
STANDARD_DEVIATION 8.83 • n=5 Participants
|
67.89 Years
STANDARD_DEVIATION 8.02 • n=4 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
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
34 participants
n=7 Participants
|
31 participants
n=5 Participants
|
94 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline to 12 months post-treatment initiationUsing cardiac computed tomography angiography (CCTA), total coronary plaque volume will be determined using an artificial intelligence-enabled quantitative coronary plaque analysis (AI-QCPA) through a commercially available and validated software service (HeartFlow, Inc). Each coronary artery (right coronary, left main, left anterior descending, and left circumflex) will be scored, and plaque volumes were summed over all segments.
Outcome measures
| Measure |
Arm I (Radiation Therapy Alone)
n=28 Participants
Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
|
Arm II (Radiation Therapy Plus Leuprolide)
n=31 Participants
Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Leuprolide: Given IM or SC
|
Arm III (Radiation Therapy Plus Relugolix)
n=31 Participants
Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Relugolix: Given PO
|
|---|---|---|---|
|
Total Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries)
Baseline
|
103.0 mm3
Interval 79.0 to 182.0
|
204.0 mm3
Interval 73.0 to 556.5
|
272.0 mm3
Interval 65.0 to 766.0
|
|
Total Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries)
Month 12
|
130.0 mm3
Interval 55.0 to 265.0
|
290.0 mm3
Interval 153.0 to 655.5
|
265.0 mm3
Interval 100.0 to 807.0
|
SECONDARY outcome
Timeframe: From baseline to 12 months post-treatment initiationUsing cardiac computed tomography angiography (CCTA), total coronary plaque volume will be determined using an artificial intelligence-enabled quantitative coronary plaque analysis (AI-QCPA) through a commercially available and validated software service (HeartFlow, Inc). Each coronary artery (right coronary, left main, left anterior descending, and left circumflex) will be scored, and plaque volumes were summed over all segments.
Outcome measures
| Measure |
Arm I (Radiation Therapy Alone)
n=28 Participants
Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
|
Arm II (Radiation Therapy Plus Leuprolide)
n=31 Participants
Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Leuprolide: Given IM or SC
|
Arm III (Radiation Therapy Plus Relugolix)
n=31 Participants
Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Relugolix: Given PO
|
|---|---|---|---|
|
Non-calcified Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries)
Baseline
|
98.0 mm3
Interval 74.0 to 167.0
|
157.0 mm3
Interval 65.5 to 464.5
|
206.0 mm3
Interval 56.0 to 620.0
|
|
Non-calcified Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries)
Month 12
|
112.0 mm3
Interval 42.0 to 215.0
|
252.0 mm3
Interval 133.0 to 511.0
|
236.0 mm3
Interval 92.0 to 613.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to 12 months post-treatment initiationUsing cardiac computed tomography angiography (CCTA), total coronary plaque volume will be determined using an artificial intelligence-enabled quantitative coronary plaque analysis (AI-QCPA) through a commercially available and validated software service (HeartFlow, Inc). Each coronary artery (right coronary, left main, left anterior descending, and left circumflex) will be scored, and plaque volumes were summed over all segments.
Outcome measures
| Measure |
Arm I (Radiation Therapy Alone)
n=28 Participants
Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
|
Arm II (Radiation Therapy Plus Leuprolide)
n=31 Participants
Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Leuprolide: Given IM or SC
|
Arm III (Radiation Therapy Plus Relugolix)
n=31 Participants
Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Relugolix: Given PO
|
|---|---|---|---|
|
Calcified and Low-attenuation Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries)
Baseline
|
11.5 mm3
Interval 2.3 to 25.8
|
34.0 mm3
Interval 5.8 to 98.8
|
41.0 mm3
Interval 9.0 to 175.0
|
|
Calcified and Low-attenuation Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries)
Month 12
|
13.0 mm3
Interval 4.0 to 38.8
|
44.0 mm3
Interval 12.3 to 109.0
|
46.0 mm3
Interval 16.0 to 185.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to 12 months post-treatment initiationThe CACS will be measured by the Agatston score (range 0-400, with higher scores indicating more coronary artery calcium) on precontrast cardiac computed tomography anigiography (CCTA) scans by two blinded, board-certified cardiologists.
Outcome measures
| Measure |
Arm I (Radiation Therapy Alone)
n=28 Participants
Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
|
Arm II (Radiation Therapy Plus Leuprolide)
n=31 Participants
Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Leuprolide: Given IM or SC
|
Arm III (Radiation Therapy Plus Relugolix)
n=31 Participants
Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Relugolix: Given PO
|
|---|---|---|---|
|
Coronary Artery Calcium Score (CACS)
Baseline
|
24.9 Agatston score (range 0-400)
Interval 5.3 to 91.3
|
106.6 Agatston score (range 0-400)
Interval 4.5 to 249.6
|
96.0 Agatston score (range 0-400)
Interval 14.0 to 390.1
|
|
Coronary Artery Calcium Score (CACS)
Month 12
|
36.0 Agatston score (range 0-400)
Interval 6.8 to 101.8
|
102.7 Agatston score (range 0-400)
Interval 19.9 to 262.5
|
109.8 Agatston score (range 0-400)
Interval 31.8 to 509.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to 12 months post-treatment initiationCoronary computed tomographic angiography post-contrast images were used for vessel stenosis, using an artificial intelligence-informed coronary stenosis quantification tool (AI-CSQ, Roadmap Analysis, Heart flow, Mountain View CA). Stenoses regions are defined in ranges of 0-29%, 30-49%, 50-69%, and \>70%. The number of participants within each treatment meeting these stenosis thresholds were quantified at baseline and month 12.
Outcome measures
| Measure |
Arm I (Radiation Therapy Alone)
n=28 Participants
Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
|
Arm II (Radiation Therapy Plus Leuprolide)
n=31 Participants
Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Leuprolide: Given IM or SC
|
Arm III (Radiation Therapy Plus Relugolix)
n=31 Participants
Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Relugolix: Given PO
|
|---|---|---|---|
|
Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12
Baseline · <30%
|
5 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12
Baseline · 30% - 49%
|
12 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12
Baseline · 50% - 69%
|
9 Participants
|
15 Participants
|
16 Participants
|
|
Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12
Baseline · 70% - 99%
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12
Month 12 · <30%
|
6 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12
Month 12 · 30% - 49%
|
10 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12
Month 12 · 50% - 69%
|
10 Participants
|
17 Participants
|
15 Participants
|
|
Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12
Month 12 · 70% - 99%
|
2 Participants
|
4 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to at least 2 years post-treatment initiationIncidence of myocardial infarction, need for coronary revascularization, and/or sudden cardiac death will be measured for up to 2 years following enrollment.
Outcome measures
| Measure |
Arm I (Radiation Therapy Alone)
n=28 Participants
Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
|
Arm II (Radiation Therapy Plus Leuprolide)
n=31 Participants
Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Leuprolide: Given IM or SC
|
Arm III (Radiation Therapy Plus Relugolix)
n=31 Participants
Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Relugolix: Given PO
|
|---|---|---|---|
|
Major Adverse Cardiovascular Events
|
1 Participants
|
3 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and month 0, 3, 6, 12Change in total testosterone levels (ng/dL) will be measured at baseline and month 0, 3, 6, and 12 between treatment arms. Testosterone change over time will be summarized and plotted over time for each treatment arm.
Outcome measures
| Measure |
Arm I (Radiation Therapy Alone)
n=28 Participants
Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
|
Arm II (Radiation Therapy Plus Leuprolide)
n=31 Participants
Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Leuprolide: Given IM or SC
|
Arm III (Radiation Therapy Plus Relugolix)
n=31 Participants
Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Relugolix: Given PO
|
|---|---|---|---|
|
Testosterone Kinetics
0
|
254.433 ng/mL
Standard Error 16.365
|
292.735 ng/mL
Standard Error 15.114
|
254.548 ng/mL
Standard Error 15.828
|
|
Testosterone Kinetics
3
|
266.358 ng/mL
Standard Error 16.633
|
37.483 ng/mL
Standard Error 10.254
|
26.468 ng/mL
Standard Error 7.325
|
|
Testosterone Kinetics
6
|
260.606 ng/mL
Standard Error 17.815
|
31.063 ng/mL
Standard Error 8.018
|
25.538 ng/mL
Standard Error 5.325
|
|
Testosterone Kinetics
12
|
253.631 ng/mL
Standard Error 18.149
|
142.007 ng/mL
Standard Error 18.503
|
199.673 ng/mL
Standard Error 16.573
|
Adverse Events
Arm I (Radiation Therapy Alone)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Arm II (Radiation Therapy Plus Leuprolide)
Serious events: 1 serious events
Other events: 27 other events
Deaths: 1 deaths
Arm III (Radiation Therapy Plus Relugolix)
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Radiation Therapy Alone)
n=28 participants at risk
Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
|
Arm II (Radiation Therapy Plus Leuprolide)
n=31 participants at risk
Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Leuprolide: Given IM or SC
|
Arm III (Radiation Therapy Plus Relugolix)
n=31 participants at risk
Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Relugolix: Given PO
|
|---|---|---|---|
|
Infections and infestations
sepsis
|
0.00%
0/28 • 12 months
|
3.2%
1/31 • Number of events 1 • 12 months
|
0.00%
0/31 • 12 months
|
Other adverse events
| Measure |
Arm I (Radiation Therapy Alone)
n=28 participants at risk
Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
|
Arm II (Radiation Therapy Plus Leuprolide)
n=31 participants at risk
Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Leuprolide: Given IM or SC
|
Arm III (Radiation Therapy Plus Relugolix)
n=31 participants at risk
Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Radiation therapy: Undergo radiation therapy
Relugolix: Given PO
|
|---|---|---|---|
|
Renal and urinary disorders
Cystitis noninfective
|
21.4%
6/28 • Number of events 6 • 12 months
|
41.9%
13/31 • Number of events 16 • 12 months
|
38.7%
12/31 • Number of events 14 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
1/28 • Number of events 1 • 12 months
|
32.3%
10/31 • Number of events 14 • 12 months
|
45.2%
14/31 • Number of events 24 • 12 months
|
|
General disorders
Fatigue
|
32.1%
9/28 • Number of events 13 • 12 months
|
71.0%
22/31 • Number of events 33 • 12 months
|
83.9%
26/31 • Number of events 29 • 12 months
|
|
Vascular disorders
Hot flashes
|
0.00%
0/28 • 12 months
|
58.1%
18/31 • Number of events 27 • 12 months
|
64.5%
20/31 • Number of events 24 • 12 months
|
|
Renal and urinary disorders
Urinary frequency
|
42.9%
12/28 • Number of events 14 • 12 months
|
71.0%
22/31 • Number of events 24 • 12 months
|
77.4%
24/31 • Number of events 29 • 12 months
|
|
Renal and urinary disorders
Urinary retention
|
32.1%
9/28 • Number of events 11 • 12 months
|
45.2%
14/31 • Number of events 19 • 12 months
|
19.4%
6/31 • Number of events 6 • 12 months
|
|
Renal and urinary disorders
Urinary urgency
|
35.7%
10/28 • Number of events 11 • 12 months
|
48.4%
15/31 • Number of events 19 • 12 months
|
61.3%
19/31 • Number of events 20 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place