Trial Outcomes & Findings for ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer (NCT NCT00544076)
NCT ID: NCT00544076
Last Updated: 2019-01-02
Results Overview
Potency rates (ability to obtain an erection sufficient for penetration) without assistance in those patients receiving maintenance Viagra compared to non-pharmacology controls was compared at 12 months from start of treatment using the fisher's exact test
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
110 participants
Primary outcome timeframe
12 months following BNS-RAP
Results posted on
2019-01-02
Participant Flow
10 patients were not randomized, for the following reasons: 1. ineligible upon surgery - 4 patients 2. patient withdrew or not returning to COH - 2 patients 3. did not have BNS procedure -- 2 patients (5) deemed to have sensitivity to MUSE -- 2 patients
Participant milestones
| Measure |
Sildenafil Citrate/Mo+Aprostadil/Day
Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
alprostadil: Given intraurethrally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
Sildenafil Citrate Monthly
Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
Daily Sildenafil Citrate
P atients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
|---|---|---|---|
|
Overall Study
STARTED
|
34
|
35
|
31
|
|
Overall Study
COMPLETED
|
17
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
17
|
16
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer
Baseline characteristics by cohort
| Measure |
Sildenafil Citrate/Mo+Aprostadil/Day
n=34 Participants
Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
alprostadil: Given intraurethrally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
Sildenafil Citrate Monthly
n=35 Participants
Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
Sildenafil Citrate Monthly Daily Sildenafil Citrate
n=31 Participants
Patients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
58 years
n=7 Participants
|
59 years
n=5 Participants
|
58 years
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
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 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
|
1 Participants
n=5 Participants
|
1 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 months following BNS-RAPPopulation: These are the patients who remained on treatment for the duration of the 12 months and were evaluable at that time point.
Potency rates (ability to obtain an erection sufficient for penetration) without assistance in those patients receiving maintenance Viagra compared to non-pharmacology controls was compared at 12 months from start of treatment using the fisher's exact test
Outcome measures
| Measure |
Sildenafil Citrate/Mo+Aprostadil/Day
n=17 Participants
Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
alprostadil: Given intraurethrally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
Sildenafil Citrate Monthly
n=19 Participants
Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
Daily Sildenafil Citrate
n=20 Participants
Patients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
|---|---|---|---|
|
Potency Rates (Ability to Obtain an Erection Sufficient for Penetration) Without Assistance Compared Between Patients in All Three Arms of the Study at 12 Months
|
13 Participants
|
16 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: At 6 and 18 monthsPopulation: patients who were evaluated at 6 months, 18 months
Potency rates with or without assistance in the control group versus maintenance MUSE or maintenance Viagra were compared at each of 6 and 18 months
Outcome measures
| Measure |
Sildenafil Citrate/Mo+Aprostadil/Day
n=17 Participants
Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
alprostadil: Given intraurethrally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
Sildenafil Citrate Monthly
n=19 Participants
Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
Daily Sildenafil Citrate
n=20 Participants
Patients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
|---|---|---|---|
|
Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra
6 month potency
|
10 Participants
|
11 Participants
|
17 Participants
|
|
Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra
18 month potency
|
14 Participants
|
16 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: At 1, 3, 6, 9, 12, and 18 monthsPopulation: patients with shim scores at 1 month
Median and range of SHIM scores evaluated at 1, 3, 6, 9, 12, and 18 months. SHIMS-5 is the Sexual Health Inventory for Men, which includes 5 questions that are scored from 1 to 5 each. The total score is obtained by adding all five response scores, and can range from 5 to 25 when all 5 questions are answered. Questions that are left unanswered are scored as a 0, and can result in an overall score lower than 5 (as low as 0). Higher scores are more desirable. A Score of 22-25 = no ED, 17-21=Mild ED, 12-16=Mild to moderate ED, 8-11=Moderate ED, and 5-7 =Severe ED (ED=Erectile Dysfunction). There are no sub-scale scores within this questionnaire.
Outcome measures
| Measure |
Sildenafil Citrate/Mo+Aprostadil/Day
n=16 Participants
Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
alprostadil: Given intraurethrally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
Sildenafil Citrate Monthly
n=18 Participants
Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
Daily Sildenafil Citrate
n=19 Participants
Patients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
|---|---|---|---|
|
SHIMS-5 Scores in the Control Groups Versus Maintenance MUSE or Maintenance Viagra Groups
SHIM score 1 month
|
9.5 units on a scale
Interval 1.0 to 24.0
|
3 units on a scale
Interval 0.0 to 25.0
|
12 units on a scale
Interval 1.0 to 25.0
|
|
SHIMS-5 Scores in the Control Groups Versus Maintenance MUSE or Maintenance Viagra Groups
SHIM score 3 months
|
14 units on a scale
Interval 1.0 to 21.0
|
14 units on a scale
Interval 1.0 to 25.0
|
18 units on a scale
Interval 1.0 to 25.0
|
|
SHIMS-5 Scores in the Control Groups Versus Maintenance MUSE or Maintenance Viagra Groups
SHIM score 6 months
|
18 units on a scale
Interval 4.0 to 25.0
|
18.5 units on a scale
Interval 4.0 to 25.0
|
20 units on a scale
Interval 2.0 to 25.0
|
|
SHIMS-5 Scores in the Control Groups Versus Maintenance MUSE or Maintenance Viagra Groups
SHIM score 9 months
|
18.5 units on a scale
Interval 1.0 to 25.0
|
17.5 units on a scale
Interval 1.0 to 25.0
|
19 units on a scale
Interval 2.0 to 25.0
|
|
SHIMS-5 Scores in the Control Groups Versus Maintenance MUSE or Maintenance Viagra Groups
SHIM score 12 months
|
20 units on a scale
Interval 1.0 to 25.0
|
19 units on a scale
Interval 1.0 to 25.0
|
18 units on a scale
Interval 3.0 to 25.0
|
|
SHIMS-5 Scores in the Control Groups Versus Maintenance MUSE or Maintenance Viagra Groups
SHIM score 18 months
|
19.5 units on a scale
Interval 1.0 to 25.0
|
20 units on a scale
Interval 2.0 to 25.0
|
20.5 units on a scale
Interval 2.0 to 25.0
|
SECONDARY outcome
Timeframe: At pre-treatment and 18 monthsPopulation: patients who were willing to have penile measurements taken at baseline
measurement of penile length in centimeters
Outcome measures
| Measure |
Sildenafil Citrate/Mo+Aprostadil/Day
n=27 Participants
Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
alprostadil: Given intraurethrally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
Sildenafil Citrate Monthly
n=26 Participants
Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
Daily Sildenafil Citrate
n=25 Participants
Patients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
|---|---|---|---|
|
Penile Length
Month 18 Penile Measurement
|
12.5 centimeters
Interval 8.3 to 14.5
|
11 centimeters
Interval 3.0 to 14.0
|
12 centimeters
Interval 5.5 to 15.5
|
|
Penile Length
Baseline Penile Measurement
|
11 centimeters
Interval 5.0 to 15.0
|
12 centimeters
Interval 6.0 to 16.0
|
10.2 centimeters
Interval 6.4 to 15.0
|
Adverse Events
Sildenafil Citrate/Mo+Aprostadil/Day
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Sildenafil Citrate Monthly
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Daily Sildenafil Citrate
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sildenafil Citrate/Mo+Aprostadil/Day
n=34 participants at risk
Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
alprostadil: Given intraurethrally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
Sildenafil Citrate Monthly
n=35 participants at risk
Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
Daily Sildenafil Citrate
n=31 participants at risk
Patients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.
sildenafil citrate: Given orally
robotic-assisted laparoscopic surgery: Undergo prostatectomy
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
14.7%
5/34 • Number of events 5 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
20.0%
7/35 • Number of events 7 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
9.7%
3/31 • Number of events 3 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Eye disorders
Cataract
|
2.9%
1/34 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Eye disorders
Eye disorders - Other, specify
|
5.9%
2/34 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
5.7%
2/35 • Number of events 6 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Eye disorders
Eye pain
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Eye disorders
Photophobia
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
5.7%
2/35 • Number of events 5 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
12.9%
4/31 • Number of events 7 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
2/34 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
8.6%
3/35 • Number of events 3 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Gastrointestinal disorders
Cheilitis
|
2.9%
1/34 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
1/34 • Number of events 3 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
9.7%
3/31 • Number of events 10 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Gastrointestinal disorders
Fecal incontinence
|
2.9%
1/34 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
5.9%
2/34 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/34 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
5.7%
2/35 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
6.5%
2/31 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
General disorders
Chills
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
General disorders
Edema trunk
|
5.9%
2/34 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
General disorders
Fatigue
|
11.8%
4/34 • Number of events 4 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
5.7%
2/35 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
12.9%
4/31 • Number of events 5 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
General disorders
Pain
|
11.8%
4/34 • Number of events 7 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Infections and infestations
Bladder infection
|
2.9%
1/34 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.9%
1/34 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Injury, poisoning and procedural complications
Bladder anastomotic leak
|
2.9%
1/34 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.9%
1/34 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Investigations
Cholesterol high
|
2.9%
1/34 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Investigations
Creatinine increased
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
5.7%
2/35 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.9%
1/34 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
5.7%
2/35 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
2.9%
1/34 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
5.7%
2/35 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.9%
1/34 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Nervous system disorders
Dizziness
|
2.9%
1/34 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Nervous system disorders
Headache
|
14.7%
5/34 • Number of events 7 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
25.7%
9/35 • Number of events 29 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
32.3%
10/31 • Number of events 24 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Nervous system disorders
Syncope
|
2.9%
1/34 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Psychiatric disorders
Libido decreased
|
2.9%
1/34 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
6.5%
2/31 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Renal and urinary disorders
Hematuria
|
11.8%
4/34 • Number of events 5 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
5.7%
2/35 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Renal and urinary disorders
Urinary frequency
|
8.8%
3/34 • Number of events 3 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
6.5%
2/31 • Number of events 6 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Renal and urinary disorders
Urinary incontinence
|
8.8%
3/34 • Number of events 3 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
8.6%
3/35 • Number of events 8 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
9.7%
3/31 • Number of events 8 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Renal and urinary disorders
Urinary retention
|
2.9%
1/34 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.9%
1/34 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Renal and urinary disorders
Urinary tract pain
|
29.4%
10/34 • Number of events 17 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
5.7%
2/35 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
6.5%
2/31 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Renal and urinary disorders
Urine discoloration
|
2.9%
1/34 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.9%
1/34 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
5.7%
2/35 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Reproductive system and breast disorders
Penile pain
|
23.5%
8/34 • Number of events 13 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
8.6%
3/35 • Number of events 3 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
6.5%
2/31 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
2.9%
1/34 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
6.5%
2/31 • Number of events 3 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
2.9%
1/35 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Reproductive system and breast disorders
Testicular pain
|
8.8%
3/34 • Number of events 4 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.9%
1/34 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
22.9%
8/35 • Number of events 27 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
16.1%
5/31 • Number of events 19 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
3.2%
1/31 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/34 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
5.7%
2/35 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
6.5%
2/31 • Number of events 2 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Vascular disorders
Flushing
|
5.9%
2/34 • Number of events 4 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
22.9%
8/35 • Number of events 17 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
16.1%
5/31 • Number of events 12 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
|
Vascular disorders
Hypotension
|
2.9%
1/34 • Number of events 1 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/35 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
0.00%
0/31 • The time frame was over 1 year.
The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place