Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00283842
Collaborator
(none)
408
51
5
27
8
0.3
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of DVS SR in the treatment of neuropathic pain associated with diabetic peripheral neuropathy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
408 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, 13-Week, Adaptive-Design Study of 4 Fixed Oral Doses of DVS SR in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
Study Start Date
:
Mar 1, 2006
Actual Primary Completion Date
:
Jun 1, 2008
Actual Study Completion Date
:
Jun 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: desvenlafaxine succinate sustained-release (DVS SR) 50mg
|
Drug: DVS SR
|
| Experimental: desvenlafaxine succinate sustained-release (DVS SR) 100mg
|
Drug: DVS SR
|
| Experimental: desvenlafaxine succinate sustained-release (DVS SR) 200mg
|
Drug: DVS SR
|
| Experimental: desvenlafaxine succinate sustained-release (DVS SR) 400mg
|
Drug: DVS SR
|
| Placebo Comparator: Placebo
|
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Change in Mean Pain Severity Score From Baseline to 13 Weeks [Baseline and 13 weeks]
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.
Secondary Outcome Measures
- Number of Patients With ≥50% Reduction in Mean Pain Severity Score. [Baseline and 13 weeks]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diabetes type 1 or 2
-
Painful symptoms of diabetic neuropathy in the lower extremities extremities for at least 6 months
Exclusion Criteria:
-
Major Depression
-
Uncontrolled diabetes
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mesa | Arizona | United States | 85210 | |
| 2 | Peoria | Arizona | United States | 85381 | |
| 3 | Phoenix | Arizona | United States | 85016 | |
| 4 | Encino | California | United States | 91316 | |
| 5 | Newport Beach | California | United States | 92660 | |
| 6 | Walnut Creek | California | United States | 94598 | |
| 7 | Pueblo | Colorado | United States | 81001 | |
| 8 | New Britain | Connecticut | United States | 06050 | |
| 9 | Stratford | Connecticut | United States | 06615 | |
| 10 | Waterbury | Connecticut | United States | 06708 | |
| 11 | Ft. Myers | Florida | United States | 33907 | |
| 12 | Palm Beach Gardens | Florida | United States | 33418 | |
| 13 | Pembroke Pines | Florida | United States | 33026 | |
| 14 | St. Petersburg | Florida | United States | 33709 | |
| 15 | West Palm Beach | Florida | United States | 33401 | |
| 16 | Lawrenceville | Georgia | United States | 30045 | |
| 17 | Roswell | Georgia | United States | 30076 | |
| 18 | Coeur D'Alene | Idaho | United States | 83814 | |
| 19 | Chicago | Illinois | United States | 60610 | |
| 20 | Evansville | Indiana | United States | 47714 | |
| 21 | Des Moines | Iowa | United States | 50314 | |
| 22 | Madisonville | Kentucky | United States | 42431 | |
| 23 | Springfield | Massachusetts | United States | 01199 | |
| 24 | Ann Arbor | Michigan | United States | 48106 | |
| 25 | Kansas City | Missouri | United States | 64114 | |
| 26 | St. Louis | Missouri | United States | 63117 | |
| 27 | St. Louis | Missouri | United States | 63141 | |
| 28 | Billings | Montana | United States | 59101 | |
| 29 | Omaha | Nebraska | United States | 88131 | |
| 30 | Albany | New York | United States | 12205 | |
| 31 | Flushing | New York | United States | 11365 | |
| 32 | New York | New York | United States | 10024 | |
| 33 | Rochester | New York | United States | 14621 | |
| 34 | Staten Island | New York | United States | 10312 | |
| 35 | Fargo | North Dakota | United States | 58104 | |
| 36 | Cincinnati | Ohio | United States | 45236 | |
| 37 | Dayton | Ohio | United States | 45432 | |
| 38 | Toledo | Ohio | United States | 43623 | |
| 39 | Collegeville | Pennsylvania | United States | 19426 | |
| 40 | Feasterville | Pennsylvania | United States | 19053 | |
| 41 | Harleysville | Pennsylvania | United States | 19438 | |
| 42 | Warwick | Rhode Island | United States | 02886 | |
| 43 | Austin | Texas | United States | 78705 | |
| 44 | Dallas | Texas | United States | 75246 | |
| 45 | San Antonio | Texas | United States | 78229 | |
| 46 | Midvale | Utah | United States | 84047 | |
| 47 | Salt Lake City | Utah | United States | 84106 | |
| 48 | Virginia Beach | Virginia | United States | 23451 | |
| 49 | Lakewood | Washington | United States | 98499 | |
| 50 | Tacoma | Washington | United States | 98405 | |
| 51 | Milwaukee | Wisconsin | United States | 53209 |
Sponsors and Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
- Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00283842
Other Study ID Numbers:
- 3151A5-322
First Posted:
Jan 30, 2006
Last Update Posted:
Oct 24, 2011
Last Verified:
Oct 1, 2011
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were recruited January 2006 to February 2008 |
|---|---|
| Pre-assignment Detail | Participants were screened during a 7- to 28-day period, a treatment period. |
| Arm/Group Title | Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | 50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | 100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | 200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | 400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | |
| Period Title: Overall Study | |||||
| STARTED | 63 | 87 | 99 | 69 | 90 |
| COMPLETED | 51 | 69 | 68 | 42 | 75 |
| NOT COMPLETED | 12 | 18 | 31 | 27 | 15 |
Baseline Characteristics
| Arm/Group Title | Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg | Placebo | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | 50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | 100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | 200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | 400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | Total of all reporting groups | |
| Overall Participants | 63 | 87 | 99 | 69 | 90 | 408 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
61.62
(8.59)
|
60.66
(9.23)
|
59.80
(9.38)
|
61.14
(10.03)
|
58.98
(8.51)
|
60.31
(9.16)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
16
25.4%
|
20
23%
|
30
30.3%
|
17
24.6%
|
25
27.8%
|
108
26.5%
|
| Male |
47
74.6%
|
67
77%
|
69
69.7%
|
52
75.4%
|
65
72.2%
|
300
73.5%
|
Outcome Measures
| Title | Change in Mean Pain Severity Score From Baseline to 13 Weeks |
|---|---|
| Description | 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. |
| Time Frame | Baseline and 13 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population was the intent to treat. |
| Arm/Group Title | Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | 50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | 100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | 200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | 400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | |
| Measure Participants | 49 | 65 | 70 | 40 | 72 |
| Mean (Standard Error) [units on scale] |
-2.41
(0.26)
|
-2.42
(0.23)
|
-2.93
(0.22)
|
-2.74
(0.27)
|
-1.83
(0.22)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg |
|---|---|---|
| Comments | Statistical analysis provided for 50mg. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.084 |
| Comments | ||
| Method | Hochberg | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg |
|---|---|---|
| Comments | Statistical analysis provided for 100mg. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.084 |
| Comments | ||
| Method | Hochberg | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg |
|---|---|---|
| Comments | Statistical analysis provided for 200mg. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | Hochberg | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg |
|---|---|---|
| Comments | Statistical analysis provided for 400mg. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.027 |
| Comments | ||
| Method | Hochberg | |
| Comments | ||
| Title | Number of Patients With ≥50% Reduction in Mean Pain Severity Score. |
|---|---|
| Description | 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. |
| Time Frame | Baseline and 13 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is the intent to treat. |
| Arm/Group Title | Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | 50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | 100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | 200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | 400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | |
| Measure Participants | 63 | 86 | 99 | 68 | 89 |
| Number [patients] |
22
|
32
|
36
|
22
|
23
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg |
|---|---|---|
| Comments | Statistical analysis provided for 50mg. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.375 |
| Comments | ||
| Method | Hochberg | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg |
|---|---|---|
| Comments | Statistical analysis provided for 100mg. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.342 |
| Comments | ||
| Method | Hochberg | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg |
|---|---|---|
| Comments | Statistical analysis provided for 200mg. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.342 |
| Comments | ||
| Method | Hochberg | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg |
|---|---|---|
| Comments | Statistical analysis provided for 400mg. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.375 |
| Comments | ||
| Method | Hochberg | |
| Comments | ||
Adverse Events
| Time Frame | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg | Placebo | |||||
| Arm/Group Description | 50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | 100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | 200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | 400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | ||||||
All Cause Mortality |
||||||||||
| Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/ (NaN) | 1/ (NaN) | 1/ (NaN) | 3/ (NaN) | 6/ (NaN) | |||||
| Cardiac disorders | ||||||||||
| Angina pectoris | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Ventricular tachycardia | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Gastrointestinal hemorrhage | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Infections and infestations | ||||||||||
| Pneumonia | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Ankle fracture | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Overdose | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Stress fracture | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Investigations | ||||||||||
| Blood glucose increased | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Anaplastic thyroid cancer | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Colon cancer | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Esophageal cancer | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Mental status changes | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Urinary retention | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Vascular disorders | ||||||||||
| Orthostatic hypotension | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg | Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 47/ (NaN) | 65/ (NaN) | 82/ (NaN) | 63/ (NaN) | 68/ (NaN) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anemia | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Ecchymosis | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Leukopenia | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Lymphadenopathy | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Cardiac disorders | ||||||||||
| Angina pectoris | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Arrhythmia | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Atrial flutter | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| AV block first degree | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Bundle branck block | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Cardiovascular physical finding | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Coronary artery disorder | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Electrocardiogram abnormal | 1/63 (1.6%) | 0/87 (0%) | 2/99 (2%) | 0/69 (0%) | 0/90 (0%) | |||||
| Palpitation | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| QRS prolongation | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| QT interval prolonged | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 2/90 (2.2%) | |||||
| Sinus bradycardia | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Syncope | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Tachycardia | 1/63 (1.6%) | 1/87 (1.1%) | 0/99 (0%) | 5/69 (7.2%) | 0/90 (0%) | |||||
| Ventricular extrasystoles | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Ventricular tachycardia | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Ear and labyrinth disorders | ||||||||||
| Ear disorder | 1/63 (1.6%) | 0/87 (0%) | 1/99 (1%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Ear pain | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Otitis media | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Taste perversion | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Tinnitus | 1/63 (1.6%) | 0/87 (0%) | 1/99 (1%) | 3/69 (4.3%) | 0/90 (0%) | |||||
| Endocrine disorders | ||||||||||
| Thyroid carcinoma | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Thyroid disorder | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Eye disorders | ||||||||||
| Abnormal vision | 0/63 (0%) | 1/87 (1.1%) | 1/99 (1%) | 2/69 (2.9%) | 0/90 (0%) | |||||
| Conjunctivitis | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Eye pain | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Mydriasis | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 2/69 (2.9%) | 0/90 (0%) | |||||
| Refraction disorder | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Retinal disorder | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal distension | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Anorexia | 2/63 (3.2%) | 3/87 (3.4%) | 5/99 (5.1%) | 3/69 (4.3%) | 2/90 (2.2%) | |||||
| Colitis | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Constipation | 3/63 (4.8%) | 4/87 (4.6%) | 6/99 (6.1%) | 6/69 (8.7%) | 0/90 (0%) | |||||
| Diarrhea | 5/63 (7.9%) | 6/87 (6.9%) | 7/99 (7.1%) | 6/69 (8.7%) | 9/90 (10%) | |||||
| Dry mouth | 2/63 (3.2%) | 4/87 (4.6%) | 5/99 (5.1%) | 9/69 (13%) | 2/90 (2.2%) | |||||
| Dyspepsia | 1/63 (1.6%) | 3/87 (3.4%) | 3/99 (3%) | 1/69 (1.4%) | 3/90 (3.3%) | |||||
| Dysphagia | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Eructation | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 2/90 (2.2%) | |||||
| Flatulence | 2/63 (3.2%) | 2/87 (2.3%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Gastroenteritis | 1/63 (1.6%) | 1/87 (1.1%) | 2/99 (2%) | 2/69 (2.9%) | 1/90 (1.1%) | |||||
| Gastroesophageal reflux disease | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Gastrointestinal carcinoma | 1/63 (1.6%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Gastrointestinal disorder | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Gastrointestinal hemorrhage | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Hiatal hernia | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Increased appetite | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Nausea | 9/63 (14.3%) | 11/87 (12.6%) | 27/99 (27.3%) | 12/69 (17.4%) | 2/90 (2.2%) | |||||
| Periodontal abscess | 0/63 (0%) | 2/87 (2.3%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Retching | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Tenesmus | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Tooth disorder | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Vomiting | 3/63 (4.8%) | 3/87 (3.4%) | 10/99 (10.1%) | 2/69 (2.9%) | 2/90 (2.2%) | |||||
| General disorders | ||||||||||
| Abdominal pain | 3/63 (4.8%) | 2/87 (2.3%) | 1/99 (1%) | 1/69 (1.4%) | 1/90 (1.1%) | |||||
| Abscess | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Accidental injury | 3/63 (4.8%) | 5/87 (5.7%) | 7/99 (7.1%) | 8/69 (11.6%) | 6/90 (6.7%) | |||||
| Allergic reaction | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Asthenia | 4/63 (6.3%) | 8/87 (9.2%) | 9/99 (9.1%) | 10/69 (14.5%) | 4/90 (4.4%) | |||||
| Back pain | 2/63 (3.2%) | 0/87 (0%) | 3/99 (3%) | 1/69 (1.4%) | 5/90 (5.6%) | |||||
| Cellulitis | 1/63 (1.6%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Chest pain | 0/63 (0%) | 2/87 (2.3%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Chills | 1/63 (1.6%) | 0/87 (0%) | 3/99 (3%) | 0/69 (0%) | 0/90 (0%) | |||||
| Cyst | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Face edema | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Fever | 0/63 (0%) | 1/87 (1.1%) | 1/99 (1%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Flu syndrome | 1/63 (1.6%) | 3/87 (3.4%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Generalized edema | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Headache | 5/63 (7.9%) | 7/87 (8%) | 9/99 (9.1%) | 5/69 (7.2%) | 9/90 (10%) | |||||
| Infection | 3/63 (4.8%) | 7/87 (8%) | 7/99 (7.1%) | 3/69 (4.3%) | 1/90 (1.1%) | |||||
| Malaise | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Medication error | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Mucous membrane disorder | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Neck pain | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 2/69 (2.9%) | 0/90 (0%) | |||||
| Neoplasm | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 2/90 (2.2%) | |||||
| Overdose | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Pain | 5/63 (7.9%) | 3/87 (3.4%) | 4/99 (4%) | 3/69 (4.3%) | 2/90 (2.2%) | |||||
| Photosensitivity reaction | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 2/69 (2.9%) | 0/90 (0%) | |||||
| Withdrawal syndrome | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Allergic reaction other than drug | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Local reaction to procedure | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Positive event | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Creatinine increased | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Gout | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 1/69 (1.4%) | 1/90 (1.1%) | |||||
| Healing abnormal | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Hypercholesteremia | 2/63 (3.2%) | 3/87 (3.4%) | 3/99 (3%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Hyperglycemia | 2/63 (3.2%) | 1/87 (1.1%) | 1/99 (1%) | 0/69 (0%) | 2/90 (2.2%) | |||||
| Hyperkalemia | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Hyperlipemia | 4/63 (6.3%) | 6/87 (6.9%) | 7/99 (7.1%) | 5/69 (7.2%) | 8/90 (8.9%) | |||||
| Hyperuricemia | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Hypoglycemia | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 3/69 (4.3%) | 0/90 (0%) | |||||
| Hypokalemia | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Hyponatremia | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Peripheral edema | 2/63 (3.2%) | 2/87 (2.3%) | 0/99 (0%) | 0/69 (0%) | 2/90 (2.2%) | |||||
| Weight gain | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Weight loss | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 4/69 (5.8%) | 0/90 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthralgia | 1/63 (1.6%) | 2/87 (2.3%) | 2/99 (2%) | 2/69 (2.9%) | 6/90 (6.7%) | |||||
| Arthritis | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Joint disorder | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Leg cramps | 4/63 (6.3%) | 3/87 (3.4%) | 3/99 (3%) | 2/69 (2.9%) | 2/90 (2.2%) | |||||
| Muscle cramp | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 2/69 (2.9%) | 1/90 (1.1%) | |||||
| Muscle spasms | 1/63 (1.6%) | 1/87 (1.1%) | 1/99 (1%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Musculoskeletal stiffness | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Myalgia | 1/63 (1.6%) | 2/87 (2.3%) | 1/99 (1%) | 1/69 (1.4%) | 1/90 (1.1%) | |||||
| Myasthenia | 1/63 (1.6%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Tendon disorder | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Nervous system disorders | ||||||||||
| Abnormal dreams | 1/63 (1.6%) | 2/87 (2.3%) | 3/99 (3%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Anxiety | 3/63 (4.8%) | 0/87 (0%) | 3/99 (3%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Apathy | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Ataxia | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Carpal tunnel syndrome | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Confusion | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Depersonalization | 0/63 (0%) | 0/87 (0%) | 2/99 (2%) | 0/69 (0%) | 0/90 (0%) | |||||
| Depression | 0/63 (0%) | 2/87 (2.3%) | 0/99 (0%) | 1/69 (1.4%) | 1/90 (1.1%) | |||||
| Dizziness | 1/63 (1.6%) | 7/87 (8%) | 18/99 (18.2%) | 18/69 (26.1%) | 9/90 (10%) | |||||
| Emotional liability | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 3/90 (3.3%) | |||||
| Euphoria | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Hostility | 2/63 (3.2%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Hyperkinesia | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Hypertonia | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Hypesthesia | 0/63 (0%) | 1/87 (1.1%) | 3/99 (3%) | 0/69 (0%) | 2/90 (2.2%) | |||||
| Incoordination | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Insomnia | 3/63 (4.8%) | 1/87 (1.1%) | 4/99 (4%) | 7/69 (10.1%) | 1/90 (1.1%) | |||||
| Libido decreased | 0/63 (0%) | 1/87 (1.1%) | 3/99 (3%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Memory impairment | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Mental status changes | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Motion sickness | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Movement disorder | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Nervousness | 1/63 (1.6%) | 1/87 (1.1%) | 3/99 (3%) | 2/69 (2.9%) | 0/90 (0%) | |||||
| Neuralgia | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Paresthesia | 0/63 (0%) | 0/87 (0%) | 2/99 (2%) | 0/69 (0%) | 0/90 (0%) | |||||
| Reflexes decreased | 2/63 (3.2%) | 0/87 (0%) | 0/99 (0%) | 2/69 (2.9%) | 2/90 (2.2%) | |||||
| Reflexes increased | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Restless legs syndrome | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Somnolence | 3/63 (4.8%) | 9/87 (10.3%) | 9/99 (9.1%) | 7/69 (10.1%) | 2/90 (2.2%) | |||||
| Thinking abnormal | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 2/69 (2.9%) | 0/90 (0%) | |||||
| Tremor | 1/63 (1.6%) | 0/87 (0%) | 2/99 (2%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Twitching | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Vertigo | 1/63 (1.6%) | 2/87 (2.3%) | 2/99 (2%) | 0/69 (0%) | 0/90 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Creatine clearance decreased | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Cystitis | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Dysuria | 1/63 (1.6%) | 1/87 (1.1%) | 2/99 (2%) | 0/69 (0%) | 0/90 (0%) | |||||
| Hematuria | 3/63 (4.8%) | 0/87 (0%) | 1/99 (1%) | 1/69 (1.4%) | 1/90 (1.1%) | |||||
| Impotence | 1/63 (1.6%) | 4/87 (4.6%) | 2/99 (2%) | 3/69 (4.3%) | 1/90 (1.1%) | |||||
| Kidney function abnormal | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Nocturia | 0/63 (0%) | 1/87 (1.1%) | 1/99 (1%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Pyuria | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Urinary frequency | 2/63 (3.2%) | 0/87 (0%) | 2/99 (2%) | 1/69 (1.4%) | 1/90 (1.1%) | |||||
| Urinary hesitation | 0/63 (0%) | 1/87 (1.1%) | 1/99 (1%) | 2/69 (2.9%) | 0/90 (0%) | |||||
| Urinary incontinence | 0/63 (0%) | 1/87 (1.1%) | 1/99 (1%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Urinary retention | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Urinary tract infection | 1/63 (1.6%) | 2/87 (2.3%) | 1/99 (1%) | 0/69 (0%) | 3/90 (3.3%) | |||||
| Urination impaired | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 3/69 (4.3%) | 0/90 (0%) | |||||
| Urine abnormality | 1/63 (1.6%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Albuminuria | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Reproductive system and breast disorders | ||||||||||
| Abnormal ejaculation/orgasm | 0/63 (0%) | 0/87 (0%) | 2/99 (2%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Anorgasmia | 0/63 (0%) | 1/87 (1.1%) | 2/99 (2%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Breast disorder | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Cervix disorder | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Prostatic disorder | 0/63 (0%) | 3/87 (3.4%) | 2/99 (2%) | 4/69 (5.8%) | 1/90 (1.1%) | |||||
| Prostatic specific antigen increase | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Sexual function abnormal | 0/63 (0%) | 2/87 (2.3%) | 1/99 (1%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Testis disorder | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Vulvovaginal disorder | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Bronchitis | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 3/69 (4.3%) | 0/90 (0%) | |||||
| Chronic obstructive airways disease | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Cough increased | 1/63 (1.6%) | 4/87 (4.6%) | 1/99 (1%) | 2/69 (2.9%) | 6/90 (6.7%) | |||||
| Dyspnea | 0/63 (0%) | 2/87 (2.3%) | 1/99 (1%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Epistaxis | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Lung disorder | 0/63 (0%) | 1/87 (1.1%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Nose dryness | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Pharyngitis | 0/63 (0%) | 0/87 (0%) | 2/99 (2%) | 1/69 (1.4%) | 3/90 (3.3%) | |||||
| Pneumonia | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Pulmonary physical finding | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Rhinitis | 0/63 (0%) | 2/87 (2.3%) | 3/99 (3%) | 1/69 (1.4%) | 1/90 (1.1%) | |||||
| Sinusittis | 0/63 (0%) | 3/87 (3.4%) | 4/99 (4%) | 1/69 (1.4%) | 1/90 (1.1%) | |||||
| Upper respiratory infection | 2/63 (3.2%) | 3/87 (3.4%) | 2/99 (2%) | 1/69 (1.4%) | 7/90 (7.8%) | |||||
| Voice alteration | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Yawn | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Acne | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 3/90 (3.3%) | |||||
| Alopecia | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Contact dermatitis | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Dry skin | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Eczema | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Exfoliative dermatitis | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Folliculitis | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Fungal dermatitis | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 2/69 (2.9%) | 0/90 (0%) | |||||
| Furunculosis | 0/63 (0%) | 0/87 (0%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Herpes simplex | 2/63 (3.2%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Herpes zoster | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Maculopapular rash | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Nail disorder | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Night sweats | 1/63 (1.6%) | 1/87 (1.1%) | 1/99 (1%) | 0/69 (0%) | 0/90 (0%) | |||||
| Pruritus | 0/63 (0%) | 0/87 (0%) | 3/99 (3%) | 3/69 (4.3%) | 2/90 (2.2%) | |||||
| Rash | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 4/69 (5.8%) | 3/90 (3.3%) | |||||
| Seborrhea | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Skin benign neoplasm | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Skin discoloration | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Skin disorder | 2/63 (3.2%) | 0/87 (0%) | 2/99 (2%) | 0/69 (0%) | 0/90 (0%) | |||||
| Skin hypertrophy | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 0/69 (0%) | 2/90 (2.2%) | |||||
| Sweating | 3/63 (4.8%) | 2/87 (2.3%) | 7/99 (7.1%) | 5/69 (7.2%) | 1/90 (1.1%) | |||||
| Urticaria | 0/63 (0%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 0/90 (0%) | |||||
| Vesiculobullous rash | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 1/90 (1.1%) | |||||
| Vascular disorders | ||||||||||
| Hemorrhage | 0/63 (0%) | 1/87 (1.1%) | 0/99 (0%) | 0/69 (0%) | 0/90 (0%) | |||||
| Hypertension | 2/63 (3.2%) | 6/87 (6.9%) | 11/99 (11.1%) | 9/69 (13%) | 7/90 (7.8%) | |||||
| Hypotension | 1/63 (1.6%) | 0/87 (0%) | 0/99 (0%) | 1/69 (1.4%) | 1/90 (1.1%) | |||||
| Peripheral vascular disorder | 1/63 (1.6%) | 0/87 (0%) | 2/99 (2%) | 2/69 (2.9%) | 0/90 (0%) | |||||
| Postural hypotension | 1/63 (1.6%) | 2/87 (2.3%) | 5/99 (5.1%) | 4/69 (5.8%) | 1/90 (1.1%) | |||||
| Vasodilatation | 1/63 (1.6%) | 1/87 (1.1%) | 4/99 (4%) | 2/69 (2.9%) | 0/90 (0%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Results Point of Contact
| Name/Title | U.S. Contact Center |
|---|---|
| Organization | Wyeth |
| Phone | |
| clintrialresults@wyeth.com |
Responsible Party:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00283842
Other Study ID Numbers:
- 3151A5-322
First Posted:
Jan 30, 2006
Last Update Posted:
Oct 24, 2011
Last Verified:
Oct 1, 2011