Trial Outcomes & Findings for Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy (NCT NCT00283842)
NCT ID: NCT00283842
Last Updated: 2011-10-24
Results Overview
Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Change: score at 13 weeks minus score at baseline.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
408 participants
Primary outcome timeframe
Baseline and 13 weeks
Results posted on
2011-10-24
Participant Flow
Participants were recruited January 2006 to February 2008
Participants were screened during a 7- to 28-day period, a treatment period.
Participant milestones
| Measure |
Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg
50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg
100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg
200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg
400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Placebo
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
63
|
87
|
99
|
69
|
90
|
|
Overall Study
COMPLETED
|
51
|
69
|
68
|
42
|
75
|
|
Overall Study
NOT COMPLETED
|
12
|
18
|
31
|
27
|
15
|
Reasons for withdrawal
| Measure |
Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg
50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg
100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg
200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg
400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Placebo
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
7
|
21
|
21
|
5
|
|
Overall Study
Protocol Violation
|
1
|
5
|
4
|
0
|
0
|
|
Overall Study
Protocol deviation
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
1
|
5
|
4
|
|
Overall Study
Lack of Efficacy
|
1
|
3
|
1
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
4
|
1
|
1
|
Baseline Characteristics
Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
Baseline characteristics by cohort
| Measure |
Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg
n=63 Participants
50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg
n=87 Participants
100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg
n=99 Participants
200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg
n=69 Participants
400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Placebo
n=90 Participants
|
Total
n=408 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
|
61.62 years
STANDARD_DEVIATION 8.59 • n=5 Participants
|
60.66 years
STANDARD_DEVIATION 9.23 • n=7 Participants
|
59.80 years
STANDARD_DEVIATION 9.38 • n=5 Participants
|
61.14 years
STANDARD_DEVIATION 10.03 • n=4 Participants
|
58.98 years
STANDARD_DEVIATION 8.51 • n=21 Participants
|
60.31 years
STANDARD_DEVIATION 9.16 • n=10 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
108 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
300 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and 13 weeksPopulation: The analysis population was the intent to treat.
Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Change: score at 13 weeks minus score at baseline.
Outcome measures
| Measure |
Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg
n=49 Participants
50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg
n=65 Participants
100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg
n=70 Participants
200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg
n=40 Participants
400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Placebo
n=72 Participants
|
|---|---|---|---|---|---|
|
Change in Mean Pain Severity Score From Baseline to 13 Weeks
|
-2.41 units on scale
Standard Error 0.26
|
-2.42 units on scale
Standard Error 0.23
|
-2.93 units on scale
Standard Error 0.22
|
-2.74 units on scale
Standard Error 0.27
|
-1.83 units on scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline and 13 weeksPopulation: The analysis population is the intent to treat.
Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Assessment of reduction based on change in score at 13 weeks compared to baseline.
Outcome measures
| Measure |
Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg
n=63 Participants
50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg
n=86 Participants
100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg
n=99 Participants
200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg
n=68 Participants
400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Placebo
n=89 Participants
|
|---|---|---|---|---|---|
|
Number of Patients With ≥50% Reduction in Mean Pain Severity Score.
|
22 patients
|
32 patients
|
36 patients
|
22 patients
|
23 patients
|
Adverse Events
Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg
Serious events: 1 serious events
Other events: 65 other events
Deaths: 0 deaths
Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg
Serious events: 1 serious events
Other events: 82 other events
Deaths: 0 deaths
Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg
Serious events: 3 serious events
Other events: 63 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg
50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg
100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg
200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg
400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Placebo
|
|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Infections and infestations
Pneumonia
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Investigations
Blood glucose increased
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic thyroid cancer
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Esophageal cancer
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
Other adverse events
| Measure |
Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg
50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg
100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg
200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg
400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
|
Placebo
|
|---|---|---|---|---|---|
|
General disorders
Abdominal pain
|
4.8%
3/63
|
2.3%
2/87
|
1.0%
1/99
|
1.4%
1/69
|
1.1%
1/90
|
|
General disorders
Abscess
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
General disorders
Accidental injury
|
4.8%
3/63
|
5.7%
5/87
|
7.1%
7/99
|
11.6%
8/69
|
6.7%
6/90
|
|
General disorders
Allergic reaction
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
General disorders
Asthenia
|
6.3%
4/63
|
9.2%
8/87
|
9.1%
9/99
|
14.5%
10/69
|
4.4%
4/90
|
|
General disorders
Back pain
|
3.2%
2/63
|
0.00%
0/87
|
3.0%
3/99
|
1.4%
1/69
|
5.6%
5/90
|
|
General disorders
Cellulitis
|
1.6%
1/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
General disorders
Chest pain
|
0.00%
0/63
|
2.3%
2/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
General disorders
Chills
|
1.6%
1/63
|
0.00%
0/87
|
3.0%
3/99
|
0.00%
0/69
|
0.00%
0/90
|
|
General disorders
Cyst
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
General disorders
Face edema
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
1.1%
1/90
|
|
General disorders
Fever
|
0.00%
0/63
|
1.1%
1/87
|
1.0%
1/99
|
1.4%
1/69
|
0.00%
0/90
|
|
General disorders
Flu syndrome
|
1.6%
1/63
|
3.4%
3/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
General disorders
Generalized edema
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
General disorders
Headache
|
7.9%
5/63
|
8.0%
7/87
|
9.1%
9/99
|
7.2%
5/69
|
10.0%
9/90
|
|
General disorders
Infection
|
4.8%
3/63
|
8.0%
7/87
|
7.1%
7/99
|
4.3%
3/69
|
1.1%
1/90
|
|
General disorders
Malaise
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
General disorders
Medication error
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
General disorders
Mucous membrane disorder
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
General disorders
Neck pain
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
2.9%
2/69
|
0.00%
0/90
|
|
General disorders
Neoplasm
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
2.2%
2/90
|
|
General disorders
Overdose
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
General disorders
Pain
|
7.9%
5/63
|
3.4%
3/87
|
4.0%
4/99
|
4.3%
3/69
|
2.2%
2/90
|
|
General disorders
Photosensitivity reaction
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
2.9%
2/69
|
0.00%
0/90
|
|
General disorders
Withdrawal syndrome
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Cardiac disorders
Angina pectoris
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Cardiac disorders
Arrhythmia
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Cardiac disorders
AV block first degree
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Cardiac disorders
Bundle branck block
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Cardiac disorders
Cardiovascular physical finding
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Cardiac disorders
Coronary artery disorder
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Cardiac disorders
Electrocardiogram abnormal
|
1.6%
1/63
|
0.00%
0/87
|
2.0%
2/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Vascular disorders
Hypertension
|
3.2%
2/63
|
6.9%
6/87
|
11.1%
11/99
|
13.0%
9/69
|
7.8%
7/90
|
|
Vascular disorders
Hypotension
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
1.1%
1/90
|
|
Cardiac disorders
Palpitation
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Vascular disorders
Peripheral vascular disorder
|
1.6%
1/63
|
0.00%
0/87
|
2.0%
2/99
|
2.9%
2/69
|
0.00%
0/90
|
|
Vascular disorders
Postural hypotension
|
1.6%
1/63
|
2.3%
2/87
|
5.1%
5/99
|
5.8%
4/69
|
1.1%
1/90
|
|
Cardiac disorders
QRS prolongation
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Cardiac disorders
QT interval prolonged
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
2.2%
2/90
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Cardiac disorders
Syncope
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Cardiac disorders
Tachycardia
|
1.6%
1/63
|
1.1%
1/87
|
0.00%
0/99
|
7.2%
5/69
|
0.00%
0/90
|
|
Vascular disorders
Vasodilatation
|
1.6%
1/63
|
1.1%
1/87
|
4.0%
4/99
|
2.9%
2/69
|
0.00%
0/90
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Gastrointestinal disorders
Anorexia
|
3.2%
2/63
|
3.4%
3/87
|
5.1%
5/99
|
4.3%
3/69
|
2.2%
2/90
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Gastrointestinal disorders
Constipation
|
4.8%
3/63
|
4.6%
4/87
|
6.1%
6/99
|
8.7%
6/69
|
0.00%
0/90
|
|
Gastrointestinal disorders
Diarrhea
|
7.9%
5/63
|
6.9%
6/87
|
7.1%
7/99
|
8.7%
6/69
|
10.0%
9/90
|
|
Gastrointestinal disorders
Dry mouth
|
3.2%
2/63
|
4.6%
4/87
|
5.1%
5/99
|
13.0%
9/69
|
2.2%
2/90
|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
1/63
|
3.4%
3/87
|
3.0%
3/99
|
1.4%
1/69
|
3.3%
3/90
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
2.2%
2/90
|
|
Gastrointestinal disorders
Flatulence
|
3.2%
2/63
|
2.3%
2/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.6%
1/63
|
1.1%
1/87
|
2.0%
2/99
|
2.9%
2/69
|
1.1%
1/90
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Gastrointestinal disorders
Gastrointestinal carcinoma
|
1.6%
1/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Gastrointestinal disorders
Hiatal hernia
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Gastrointestinal disorders
Increased appetite
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Gastrointestinal disorders
Nausea
|
14.3%
9/63
|
12.6%
11/87
|
27.3%
27/99
|
17.4%
12/69
|
2.2%
2/90
|
|
Gastrointestinal disorders
Periodontal abscess
|
0.00%
0/63
|
2.3%
2/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Gastrointestinal disorders
Tenesmus
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
3/63
|
3.4%
3/87
|
10.1%
10/99
|
2.9%
2/69
|
2.2%
2/90
|
|
Endocrine disorders
Thyroid carcinoma
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Blood and lymphatic system disorders
Ecchymosis
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Metabolism and nutrition disorders
Creatinine increased
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
1.4%
1/69
|
1.1%
1/90
|
|
Metabolism and nutrition disorders
Healing abnormal
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Metabolism and nutrition disorders
Hypercholesteremia
|
3.2%
2/63
|
3.4%
3/87
|
3.0%
3/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.2%
2/63
|
1.1%
1/87
|
1.0%
1/99
|
0.00%
0/69
|
2.2%
2/90
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Metabolism and nutrition disorders
Hyperlipemia
|
6.3%
4/63
|
6.9%
6/87
|
7.1%
7/99
|
7.2%
5/69
|
8.9%
8/90
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
4.3%
3/69
|
0.00%
0/90
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Metabolism and nutrition disorders
Peripheral edema
|
3.2%
2/63
|
2.3%
2/87
|
0.00%
0/99
|
0.00%
0/69
|
2.2%
2/90
|
|
Metabolism and nutrition disorders
Weight gain
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Metabolism and nutrition disorders
Weight loss
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
5.8%
4/69
|
0.00%
0/90
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
1/63
|
2.3%
2/87
|
2.0%
2/99
|
2.9%
2/69
|
6.7%
6/90
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
6.3%
4/63
|
3.4%
3/87
|
3.0%
3/99
|
2.9%
2/69
|
2.2%
2/90
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
2.9%
2/69
|
1.1%
1/90
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.6%
1/63
|
1.1%
1/87
|
1.0%
1/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.6%
1/63
|
2.3%
2/87
|
1.0%
1/99
|
1.4%
1/69
|
1.1%
1/90
|
|
Musculoskeletal and connective tissue disorders
Myasthenia
|
1.6%
1/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Nervous system disorders
Abnormal dreams
|
1.6%
1/63
|
2.3%
2/87
|
3.0%
3/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Nervous system disorders
Anxiety
|
4.8%
3/63
|
0.00%
0/87
|
3.0%
3/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Nervous system disorders
Apathy
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Nervous system disorders
Ataxia
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Nervous system disorders
Confusion
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Nervous system disorders
Depersonalization
|
0.00%
0/63
|
0.00%
0/87
|
2.0%
2/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Nervous system disorders
Depression
|
0.00%
0/63
|
2.3%
2/87
|
0.00%
0/99
|
1.4%
1/69
|
1.1%
1/90
|
|
Nervous system disorders
Dizziness
|
1.6%
1/63
|
8.0%
7/87
|
18.2%
18/99
|
26.1%
18/69
|
10.0%
9/90
|
|
Nervous system disorders
Emotional liability
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
3.3%
3/90
|
|
Nervous system disorders
Euphoria
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Nervous system disorders
Hostility
|
3.2%
2/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Nervous system disorders
Hyperkinesia
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Nervous system disorders
Hypertonia
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Nervous system disorders
Hypesthesia
|
0.00%
0/63
|
1.1%
1/87
|
3.0%
3/99
|
0.00%
0/69
|
2.2%
2/90
|
|
Nervous system disorders
Incoordination
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Nervous system disorders
Insomnia
|
4.8%
3/63
|
1.1%
1/87
|
4.0%
4/99
|
10.1%
7/69
|
1.1%
1/90
|
|
Nervous system disorders
Libido decreased
|
0.00%
0/63
|
1.1%
1/87
|
3.0%
3/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Nervous system disorders
Mental status changes
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Nervous system disorders
Motion sickness
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Nervous system disorders
Movement disorder
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Nervous system disorders
Nervousness
|
1.6%
1/63
|
1.1%
1/87
|
3.0%
3/99
|
2.9%
2/69
|
0.00%
0/90
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/63
|
0.00%
0/87
|
2.0%
2/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Nervous system disorders
Reflexes decreased
|
3.2%
2/63
|
0.00%
0/87
|
0.00%
0/99
|
2.9%
2/69
|
2.2%
2/90
|
|
Nervous system disorders
Reflexes increased
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Nervous system disorders
Somnolence
|
4.8%
3/63
|
10.3%
9/87
|
9.1%
9/99
|
10.1%
7/69
|
2.2%
2/90
|
|
Nervous system disorders
Thinking abnormal
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
2.9%
2/69
|
0.00%
0/90
|
|
Nervous system disorders
Tremor
|
1.6%
1/63
|
0.00%
0/87
|
2.0%
2/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Nervous system disorders
Twitching
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Nervous system disorders
Vertigo
|
1.6%
1/63
|
2.3%
2/87
|
2.0%
2/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
4.3%
3/69
|
0.00%
0/90
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Respiratory, thoracic and mediastinal disorders
Cough increased
|
1.6%
1/63
|
4.6%
4/87
|
1.0%
1/99
|
2.9%
2/69
|
6.7%
6/90
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/63
|
2.3%
2/87
|
1.0%
1/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/63
|
1.1%
1/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Respiratory, thoracic and mediastinal disorders
Nose dryness
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/63
|
0.00%
0/87
|
2.0%
2/99
|
1.4%
1/69
|
3.3%
3/90
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary physical finding
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/63
|
2.3%
2/87
|
3.0%
3/99
|
1.4%
1/69
|
1.1%
1/90
|
|
Respiratory, thoracic and mediastinal disorders
Sinusittis
|
0.00%
0/63
|
3.4%
3/87
|
4.0%
4/99
|
1.4%
1/69
|
1.1%
1/90
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
3.2%
2/63
|
3.4%
3/87
|
2.0%
2/99
|
1.4%
1/69
|
7.8%
7/90
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Respiratory, thoracic and mediastinal disorders
Yawn
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
3.3%
3/90
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Skin and subcutaneous tissue disorders
Exfoliative dermatitis
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Skin and subcutaneous tissue disorders
Fungal dermatitis
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
2.9%
2/69
|
0.00%
0/90
|
|
Skin and subcutaneous tissue disorders
Furunculosis
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Skin and subcutaneous tissue disorders
Herpes simplex
|
3.2%
2/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Skin and subcutaneous tissue disorders
Herpes zoster
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.6%
1/63
|
1.1%
1/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/63
|
0.00%
0/87
|
3.0%
3/99
|
4.3%
3/69
|
2.2%
2/90
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
5.8%
4/69
|
3.3%
3/90
|
|
Skin and subcutaneous tissue disorders
Seborrhea
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Skin and subcutaneous tissue disorders
Skin benign neoplasm
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Skin and subcutaneous tissue disorders
Skin discoloration
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
3.2%
2/63
|
0.00%
0/87
|
2.0%
2/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Skin and subcutaneous tissue disorders
Skin hypertrophy
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
2.2%
2/90
|
|
Skin and subcutaneous tissue disorders
Sweating
|
4.8%
3/63
|
2.3%
2/87
|
7.1%
7/99
|
7.2%
5/69
|
1.1%
1/90
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Skin and subcutaneous tissue disorders
Vesiculobullous rash
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Eye disorders
Abnormal vision
|
0.00%
0/63
|
1.1%
1/87
|
1.0%
1/99
|
2.9%
2/69
|
0.00%
0/90
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Ear and labyrinth disorders
Ear disorder
|
1.6%
1/63
|
0.00%
0/87
|
1.0%
1/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Eye disorders
Eye pain
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Eye disorders
Mydriasis
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
2.9%
2/69
|
0.00%
0/90
|
|
Ear and labyrinth disorders
Otitis media
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Eye disorders
Refraction disorder
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Eye disorders
Retinal disorder
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Ear and labyrinth disorders
Taste perversion
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Ear and labyrinth disorders
Tinnitus
|
1.6%
1/63
|
0.00%
0/87
|
1.0%
1/99
|
4.3%
3/69
|
0.00%
0/90
|
|
Reproductive system and breast disorders
Abnormal ejaculation/orgasm
|
0.00%
0/63
|
0.00%
0/87
|
2.0%
2/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Reproductive system and breast disorders
Anorgasmia
|
0.00%
0/63
|
1.1%
1/87
|
2.0%
2/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Reproductive system and breast disorders
Breast disorder
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Reproductive system and breast disorders
Cervix disorder
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Renal and urinary disorders
Creatine clearance decreased
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Renal and urinary disorders
Dysuria
|
1.6%
1/63
|
1.1%
1/87
|
2.0%
2/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Renal and urinary disorders
Hematuria
|
4.8%
3/63
|
0.00%
0/87
|
1.0%
1/99
|
1.4%
1/69
|
1.1%
1/90
|
|
Renal and urinary disorders
Impotence
|
1.6%
1/63
|
4.6%
4/87
|
2.0%
2/99
|
4.3%
3/69
|
1.1%
1/90
|
|
Renal and urinary disorders
Kidney function abnormal
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/63
|
1.1%
1/87
|
1.0%
1/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Reproductive system and breast disorders
Prostatic disorder
|
0.00%
0/63
|
3.4%
3/87
|
2.0%
2/99
|
5.8%
4/69
|
1.1%
1/90
|
|
Reproductive system and breast disorders
Prostatic specific antigen increase
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Renal and urinary disorders
Pyuria
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Reproductive system and breast disorders
Sexual function abnormal
|
0.00%
0/63
|
2.3%
2/87
|
1.0%
1/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Reproductive system and breast disorders
Testis disorder
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Renal and urinary disorders
Urinary frequency
|
3.2%
2/63
|
0.00%
0/87
|
2.0%
2/99
|
1.4%
1/69
|
1.1%
1/90
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/63
|
1.1%
1/87
|
1.0%
1/99
|
2.9%
2/69
|
0.00%
0/90
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/63
|
1.1%
1/87
|
1.0%
1/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
Renal and urinary disorders
Urinary tract infection
|
1.6%
1/63
|
2.3%
2/87
|
1.0%
1/99
|
0.00%
0/69
|
3.3%
3/90
|
|
Renal and urinary disorders
Urination impaired
|
0.00%
0/63
|
0.00%
0/87
|
1.0%
1/99
|
4.3%
3/69
|
0.00%
0/90
|
|
Renal and urinary disorders
Urine abnormality
|
1.6%
1/63
|
0.00%
0/87
|
1.0%
1/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Reproductive system and breast disorders
Vulvovaginal disorder
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
General disorders
Allergic reaction other than drug
|
0.00%
0/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
|
General disorders
Local reaction to procedure
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
1.1%
1/90
|
|
General disorders
Positive event
|
0.00%
0/63
|
1.1%
1/87
|
0.00%
0/99
|
0.00%
0/69
|
0.00%
0/90
|
|
Renal and urinary disorders
Albuminuria
|
1.6%
1/63
|
0.00%
0/87
|
0.00%
0/99
|
1.4%
1/69
|
0.00%
0/90
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication
- Publication restrictions are in place
Restriction type: OTHER