Trial Outcomes & Findings for Tadalafil in Preventing Erectile Dysfunction in Patients With Prostate Cancer Treated With Radiation Therapy (NCT NCT00931528)

NCT ID: NCT00931528

Last Updated: 2018-02-14

Results Overview

EF is measured by Question 1 of the International Index of Erectile Function (IIEF). The IIEF is a validated 15-item for measuring patient-reported erectile function. Question 1 asks "How often were you able to get an erection during sexual activity?" Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5 on IIEF Q1. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders (maintaining). Patient-related predictors of at erectile function at this time point are also reported with this outcome measure.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 242 participants
• Primary outcome timeframe: Baseline and 30 weeks from the start of radiation therapy
• Results posted on: 2018-02-14

Participant Flow

Participant milestones

Measure	Tadalafil Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.	Placebo Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Overall Study STARTED	121	121
Overall Study COMPLETED	80	61
Overall Study NOT COMPLETED	41	60

Reasons for withdrawal

Measure	Tadalafil Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.	Placebo Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Overall Study Protocol Violation	9	12
Overall Study Withdrawal by Subject	4	12
Overall Study Lost to Follow-up	6	13
Overall Study Assessment outside of Time Frame	22	23

Baseline Characteristics

Tadalafil in Preventing Erectile Dysfunction in Patients With Prostate Cancer Treated With Radiation Therapy

Baseline characteristics by cohort

Measure	Tadalafil n=112 Participants Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.	Placebo n=109 Participants Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.	Total n=221 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	63 years n=7 Participants	63 years 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	112 Participants n=5 Participants	109 Participants n=7 Participants	221 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 30 weeks from the start of radiation therapy

Population: All randomized eligible patients with IIEF at both baseline and 30 week time point.

EF is measured by Question 1 of the International Index of Erectile Function (IIEF). The IIEF is a validated 15-item for measuring patient-reported erectile function. Question 1 asks "How often were you able to get an erection during sexual activity?" Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5 on IIEF Q1. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders (maintaining). Patient-related predictors of at erectile function at this time point are also reported with this outcome measure.

Outcome measures

Measure	Tadalafil n=80 Participants Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.	Placebo n=61 Participants Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Percentage of Patients Maintaining Spontaneous (Off-drug) Erectile Function (EF) at Weeks 28-30 After Initiation of Radiation Therapy (RT)	79 percentage of participants Interval 70.0 to 88.0	74 percentage of participants Interval 63.0 to 85.0

SECONDARY outcome

Timeframe: Baseline, 1 and 2 years from the start of tadalafil or placebo

Population: All randomized eligible patients with IIEF at both baseline and corresponding time point.

The International Index of Erectile Function (IIEF) is a validated 15-item for measuring patient-reported erectile function. Question 1 asks "How often were you able to get an erection during sexual activity?" Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders (maintaining). Patient-related predictors of at erectile function at Years 1 and 2 are also reported with this outcome measure.

Outcome measures

Measure	Tadalafil n=109 Participants Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.	Placebo n=108 Participants Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Percentage of Patients Maintaining Spontaneous (Off-drug) EF at Years 1 and 2 After Initiation of RT Year 1	72.2 percentage of participants Interval 60.3 to 84.1	71.4 percentage of participants Interval 58.7 to 84.1
Percentage of Patients Maintaining Spontaneous (Off-drug) EF at Years 1 and 2 After Initiation of RT Year 2	68.4 percentage of participants Interval 56.3 to 80.5	63.3 percentage of participants Interval 49.8 to 76.8

SECONDARY outcome

Timeframe: Baseline, week 30, and years 1 and 2 from start of treatment

Population: Eligible patients with IIEF at baseline and corresponding time points.

The IIEF is a validated 15-item for measuring patient-reported erectile function. A score of 0-5 is given to each of the 15 questions that examine 5 main domains of male sexual function: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Domain scores are the sum of each item. The erectile function domain has 5 items with a score range of 1-30, orgasmic function has 2 items with a score range of 0-10, sexual desire has 2 items with a score range of 0-10, intercourse satisfaction has 3 items with a score range of 0-15, and overall satisfaction has 2 items with a score range of 2-10. Total score ranges from 0-70, with higher scores indicated better functioning. Change from baseline is calculated by subtracting baseline score from score at the time point of interest.

Outcome measures

Measure	Tadalafil n=109 Participants Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.	Placebo n=108 Participants Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Overall Sexual Function as Measured by Change From Baseline in the International Index of Erectile Function (IIEF) Week 30	-8.2 change in total IIEF Standard Deviation 15.4	-9.0 change in total IIEF Standard Deviation 17.0
Overall Sexual Function as Measured by Change From Baseline in the International Index of Erectile Function (IIEF) Year 1	-9.5 change in total IIEF Standard Deviation 14.8	-10.5 change in total IIEF Standard Deviation 18.4
Overall Sexual Function as Measured by Change From Baseline in the International Index of Erectile Function (IIEF) Year 2	-9.7 change in total IIEF Standard Deviation 15.7	-14.1 change in total IIEF Standard Deviation 20.1

SECONDARY outcome

Timeframe: Baseline, week 30 and years 1 and 2 after the start of treatment

Population: Eligible patients with data at baseline and corresponding time point

The Sexual Adjustment Questionnaire (SAQ) is a 20-item questionnaire with an overall score range between 8 and 100 including the following domains: desire, ranging between 5 and 30; dysfunction, 0 and 25; activity, 0 and 10; satisfaction, 1 and 10; and fatigue, 1 and 5. The change in SAQ score is calculated by subtracting the baseline score from the follow-up score. A positive change indicates an improvement in sexual well-being.

Outcome measures

Measure	Tadalafil n=63 Participants Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.	Placebo n=51 Participants Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Overall Patient Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire (SAQ) Score Week 30	-2.0 change in SAQ score Standard Deviation 11.3	-2.9 change in SAQ score Standard Deviation 8.0
Overall Patient Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire (SAQ) Score Year 1	-3.7 change in SAQ score Standard Deviation 9.7	-4.9 change in SAQ score Standard Deviation 9.9
Overall Patient Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire (SAQ) Score Year 2	-3.4 change in SAQ score Standard Deviation 9.3	-4.6 change in SAQ score Standard Deviation 14.8

SECONDARY outcome

Timeframe: Baseline, week 30 and years 1 and 2 after the start of treatment

Population: Consenting partners of randomized eligible patients with data at baseline and corresponding time point

The SAQ-P is an 18-item questionnaire with an overall score range between 0 and 90 including the following domains: desire, dysfunction, activity, satisfaction, and fatigue. The change in SAQ score is calculated by subtracting the baseline score from the follow-up score. A positive change indicates an improvement in sexual well-being.

Outcome measures

Measure	Tadalafil n=42 Participants Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.	Placebo n=40 Participants Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Overall Partner Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire-Partner (SAQ-P) Score Week 30	-4.9 change in SAQ score Standard Deviation 7.5	-1.8 change in SAQ score Standard Deviation 8.2
Overall Partner Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire-Partner (SAQ-P) Score Year 1	-3.9 change in SAQ score Standard Deviation 6.4	-2.5 change in SAQ score Standard Deviation 7.1
Overall Partner Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire-Partner (SAQ-P) Score Year 2	1.5 change in SAQ score Standard Deviation 5.5	5.1 change in SAQ score Standard Deviation 9.6

SECONDARY outcome

Timeframe: Baseline, week 30 and years 1 and 2 after the start of treatment

Population: Eligible patients with data at baseline and time point of interest.

The Locke Marital Adjustment Test (LMAT) is a 16-item questionnaire with scores ranging from 48 to 138 for participants. Higher scores indicate greater sexual function, sexual wellbeing, or marital adjustment. The change in LMAT score is calculated by subtracting the baseline score from the follow-up score.

Outcome measures

Measure	Tadalafil n=61 Participants Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.	Placebo n=60 Participants Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Patient Marital Adjustment as Measured by the Locke's Marital Adjustment Test Week 30	-3.5 change in LMAT score Standard Deviation 7.7	-2.6 change in LMAT score Standard Deviation 10.4
Patient Marital Adjustment as Measured by the Locke's Marital Adjustment Test Year 1	-1.9 change in LMAT score Standard Deviation 7.2	-1.9 change in LMAT score Standard Deviation 6.3
Patient Marital Adjustment as Measured by the Locke's Marital Adjustment Test Year 2	-1.3 change in LMAT score Standard Deviation 9.87	-1.4 change in LMAT score Standard Deviation 5.4

SECONDARY outcome

Timeframe: Baseline, week 30 and years 1 and 2 after the start of treatment

Population: Consenting spouses of randomized, eligible patients with data at baseline and time point of interest

The Locke Marital Adjustment Test (LMAT) is a 16-item questionnaire with scores ranging from 48 to 138 for participants. Higher scores indicate greater sexual function, sexual wellbeing, or marital adjustment. The change in LMAT score is calculated by subtracting the baseline score from the follow-up score.

Outcome measures

Measure	Tadalafil n=34 Participants Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.	Placebo n=27 Participants Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Partner Marital Adjustment as Measured by the Locke's Marital Adjustment Test Week 30	-1.5 change in LMAT score Standard Error 6.3	-2.6 change in LMAT score Standard Error 6.4
Partner Marital Adjustment as Measured by the Locke's Marital Adjustment Test Year 1	-2.3 change in LMAT score Standard Error 5.1	1.2 change in LMAT score Standard Error 7.3
Partner Marital Adjustment as Measured by the Locke's Marital Adjustment Test Year 2	-2.8 change in LMAT score Standard Error 5.8	-4.7 change in LMAT score Standard Error 7.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, week 30 and years 1 and 2 after the start of treatment

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, week 30 and years 1 and 2 after the start of treatment

Outcome measures

Outcome data not reported

Adverse Events

Tadalafil

Serious events: 3 serious events

Other events: 85 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 76 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tadalafil n=111 participants at risk Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.	Placebo n=108 participants at risk Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Gastrointestinal disorders Abdominal pain	0.90% 1/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.93% 1/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Gastrointestinal disorders Gastritis	0.90% 1/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Gastrointestinal disorders Nausea	0.90% 1/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.93% 1/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Gastrointestinal disorders Vomiting	0.90% 1/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
General disorders Chills	0.90% 1/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Infections and infestations Sepsis	0.90% 1/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Investigations Investigations - Other	0.90% 1/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Investigations Lymphocyte count decreased	0.90% 1/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Investigations Platelet count decreased	0.90% 1/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Investigations Weight loss	0.90% 1/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Metabolism and nutrition disorders Dehydration	0.90% 1/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Metabolism and nutrition disorders Hyperglycemia	0.90% 1/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Metabolism and nutrition disorders Hyponatremia	0.90% 1/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Nervous system disorders Presyncope	0.00% 0/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.93% 1/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Renal and urinary disorders Urinary retention	0.90% 1/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Vascular disorders Hypotension	0.90% 1/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.93% 1/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Vascular disorders Thromboembolic event	0.00% 0/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.93% 1/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Vascular disorders Visceral arterial ischemia	0.00% 0/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.93% 1/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.

Other adverse events

Measure	Tadalafil n=111 participants at risk Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.	Placebo n=108 participants at risk Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
Gastrointestinal disorders Diarrhea	16.2% 18/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	9.3% 10/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Gastrointestinal disorders Gastrointestinal disorders - Other	6.3% 7/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	1.9% 2/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
General disorders Fatigue	27.0% 30/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	25.9% 28/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Musculoskeletal and connective tissue disorders Back pain	5.4% 6/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	3.7% 4/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Nervous system disorders Headache	8.1% 9/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	3.7% 4/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Renal and urinary disorders Cystitis noninfective	6.3% 7/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	9.3% 10/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Renal and urinary disorders Renal and urinary disorders - Other	19.8% 22/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	19.4% 21/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Renal and urinary disorders Urinary frequency	49.5% 55/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	46.3% 50/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Renal and urinary disorders Urinary retention	15.3% 17/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	17.6% 19/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Renal and urinary disorders Urinary tract pain	13.5% 15/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	13.0% 14/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Renal and urinary disorders Urinary urgency	32.4% 36/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	20.4% 22/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Reproductive system and breast disorders Ejaculation disorder	6.3% 7/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	5.6% 6/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Reproductive system and breast disorders Erectile dysfunction	30.6% 34/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	28.7% 31/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Reproductive system and breast disorders Reproductive system and breast disorders - Other	5.4% 6/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Vascular disorders Hypertension	5.4% 6/111 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	1.9% 2/108 Adverse event (AE) data is reported for eligible patients with adverse event data. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.

Additional Information

Wendy Seiferheld

NRG Onoclogy

Email: seiferheldw@nrg.oncology.org

Results disclosure agreements

• Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
• Publication restrictions are in place

Restriction type: OTHER