A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail
Sponsor
Viamet (Industry)
Overall Status
Completed
CT.gov ID
NCT02267356
Collaborator
(none)
259
33
5
28.6
7.8
0.3
Study Details
Study Description
Brief Summary
Several properties of VT-1161 suggest that it might be a safer and more effective treatment for onychomycosis of the toenail (also known as toenail fungus) than other oral antifungal medicines.
This study will evaluate the effectiveness and safety of VT-1161 for the treatment of toenail onychomycosis and consists of a screening phase, a 24-week treatment phase in which the patient will take either active drug, placebo or a combination of the 2 (according to random assignment), an initial observational phase of 36 weeks and an additional observational study extension of 9 months.
The additional 9-month observational study extension was added with a protocol amendment and patient participation was optional.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
259 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients With Distal Lateral Subungual Onychomycosis of the Toenail
Actual Study Start Date
:
Feb 17, 2015
Actual Primary Completion Date
:
Oct 18, 2016
Actual Study Completion Date
:
Jul 7, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Low dose 12-week 2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks |
Drug: VT-1161
|
| Experimental: Low dose 24-week 2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks |
Drug: VT-1161
|
| Experimental: High dose 12-week 4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks |
Drug: VT-1161
|
| Experimental: High dose 24-week 4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks |
Drug: VT-1161
|
| Placebo Comparator: Placebo 4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- The Proportion of Subjects in the Intent-to-treat Population With Complete Cure, Defined as Clinical AND Mycological Cure, at Week 48 [48 weeks]
Complete cure was defined as 0% nail involvement and an Investigator Global Assessment (IGA) score of 0. Mycological cure was defined as negative potassium hydroxide (KOH) and negative dermatophyte culture. Investigator Global Assessment (IGA) scoring: 0: 0% nail involvement >0% to ≤10% nail involvement >10% to <25% nail involvement ≥25% to ≤50% nail involvement >50% to ≤75% nail involvement >75% nail involvement
- Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities [9 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
Distal subungual onychomycosis of the great toenail, affecting at least ≥25 to ≤75% of nail.
Positive culture for dermatophytes and positive KOH.
Nail ≤ 3 mm thick at the distal end.
At least ≥ 2 mm of the proximal end of the great toenail must be free of infection.
Subjects must be able to swallow tablets.
Women of childbearing potential and males must use acceptable birth control methods throughout the study.
Key Exclusion Criteria:
Presence of subungual hematoma or melanonychia.
Presence of dermatophytoma/nail streaks and severe onychorrhexis.
Significant dystrophy or anatomic abnormalities of the great toenail.
Presence of any other infections of the foot.
Evidence of clinically significant major organ disease.
Poorly controlled diabetes mellitus.
Onychomycosis involving more than 8 toe nails.
Recent use of systemic antifungal therapy.
Recent of any topical antifungal nail therapy.
Recent use of systemic corticosteroid therapy.
Recent use of immunosuppressive medication.
History of prolonged QT intervals.
Known human immunodeficiency virus (HIV) infection.
Known significant renal or hepatic impairment.
Known history of intolerance or hypersensitivity to azole antifungal drugs.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Kirklin Clinic of UAB Hospital | Birmingham | Alabama | United States | 35233 |
| 2 | Radiant Research | Tucson | Arizona | United States | 85712 |
| 3 | Dermatology Specialists, Inc | Oceanside | California | United States | 92056 |
| 4 | Therapeutics Clinical Research | San Diego | California | United States | 92123 |
| 5 | Center For Clinical Research | San Francisco | California | United States | 94115 |
| 6 | Radiant Research | Santa Rosa | California | United States | 95405 |
| 7 | International Dermatology Research | Miami | Florida | United States | 33144 |
| 8 | Radiant Research | Pinellas Park | Florida | United States | 33781 |
| 9 | Northwest Clinical Trials | Boise | Idaho | United States | 83704 |
| 10 | Gateway Health Center | Newburgh | Indiana | United States | 47630 |
| 11 | Mid Atlantic Research Center for Health | Baltimore | Maryland | United States | 21214 |
| 12 | Associated Skin Care Specialist Minnesota Clinical Study Center | Minneapolis | Minnesota | United States | 55432 |
| 13 | Skin Specialists, PC | Omaha | Nebraska | United States | 68144 |
| 14 | Academic Dermatology Associates | Albuquerque | New Mexico | United States | 87106 |
| 15 | Forest Hills Dermatology Group | Forest Hills | New York | United States | 11395 |
| 16 | Skin Search of Rochester | Rochester | New York | United States | 14623 |
| 17 | Radiant Research | Akron | Ohio | United States | 44311 |
| 18 | Radiant Research | Cincinnati | Ohio | United States | 45249 |
| 19 | Radiant Research | Columbus | Ohio | United States | 43212 |
| 20 | Oregon Dermatology & Research Center | Portland | Oregon | United States | 97210 |
| 21 | Oregon Medical Research Center | Portland | Oregon | United States | 97223 |
| 22 | Paddington Testing Company | Philadelphia | Pennsylvania | United States | 19103 |
| 23 | Martin Foot and Ankle | York | Pennsylvania | United States | 17402 |
| 24 | Radiant Research | Greer | South Carolina | United States | 29621 |
| 25 | Coastal Carolina Research Center | Mount Pleasant | South Carolina | United States | 29464 |
| 26 | The Skin Wellness Center | Knoxville | Tennessee | United States | 37922 |
| 27 | Tennessee Clinical Research Center | Nashville | Tennessee | United States | 37215 |
| 28 | DermResearch | Austin | Texas | United States | 78759 |
| 29 | J&S Clinical Studies | College Station | Texas | United States | 77845 |
| 30 | Ashton Podiatry Associates, PA | Dallas | Texas | United States | 75243 |
| 31 | Endeavor Clinical Trials | San Antonio | Texas | United States | 78229 |
| 32 | The Education And Research Foundation, Inc. | Lynchburg | Virginia | United States | 24501 |
| 33 | Virginia Clinical Research, Inc. | Norfolk | Virginia | United States | 23507 |
Sponsors and Collaborators
- Viamet
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Viamet
ClinicalTrials.gov Identifier:
NCT02267356
Other Study ID Numbers:
- VMT-VT-1161-CL-005
First Posted:
Oct 17, 2014
Last Update Posted:
Nov 4, 2020
Last Verified:
Oct 1, 2020
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Low Dose 12-week | Low Dose 24-week | High Dose 12-week | High Dose 24-week | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | 2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks | 2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks | 4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks | 4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks | 4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks |
| Period Title: Initial Study | |||||
| STARTED | 53 | 53 | 52 | 54 | 47 |
| COMPLETED | 47 | 48 | 42 | 43 | 42 |
| NOT COMPLETED | 6 | 5 | 10 | 11 | 5 |
| Period Title: Initial Study | |||||
| STARTED | 33 | 37 | 30 | 32 | 26 |
| COMPLETED | 32 | 37 | 29 | 30 | 26 |
| NOT COMPLETED | 1 | 0 | 1 | 2 | 0 |
Baseline Characteristics
| Arm/Group Title | Low Dose 12-week | Low Dose 24-week | High Dose 12-week | High Dose 24-week | Placebo | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | 2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks | 2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks | 4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks | 4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks | 4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks | Total of all reporting groups |
| Overall Participants | 53 | 53 | 52 | 54 | 47 | 259 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
48.8
(9.41)
|
50.4
(10.28)
|
49.4
(12.79)
|
49.0
(10.45)
|
52.7
(11.69)
|
50.0
(10.96)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
12
22.6%
|
8
15.1%
|
13
25%
|
9
16.7%
|
9
19.1%
|
51
19.7%
|
| Male |
41
77.4%
|
45
84.9%
|
39
75%
|
45
83.3%
|
38
80.9%
|
208
80.3%
|
Outcome Measures
| Title | The Proportion of Subjects in the Intent-to-treat Population With Complete Cure, Defined as Clinical AND Mycological Cure, at Week 48 |
|---|---|
| Description | Complete cure was defined as 0% nail involvement and an Investigator Global Assessment (IGA) score of 0. Mycological cure was defined as negative potassium hydroxide (KOH) and negative dermatophyte culture. Investigator Global Assessment (IGA) scoring: 0: 0% nail involvement >0% to ≤10% nail involvement >10% to <25% nail involvement ≥25% to ≤50% nail involvement >50% to ≤75% nail involvement >75% nail involvement |
| Time Frame | 48 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Initial 60-week study data. Study extension data not applicable. |
| Arm/Group Title | Low Dose 12-week | Low Dose 24-week | High Dose 12-week | High Dose 24-week | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | 2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks | 2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks | 4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks | 4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks | 4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks |
| Measure Participants | 53 | 53 | 52 | 54 | 47 |
| Count of Participants [Participants] |
17
32.1%
|
19
35.8%
|
22
42.3%
|
18
33.3%
|
0
0%
|
| Title | Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities |
|---|---|
| Description | |
| Time Frame | 9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Low Dose 12-week | Low Dose 24-week | High Dose 12-week | High Dose 24-week | Placebo |
|---|---|---|---|---|---|
| Arm/Group Description | 2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks | 2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks | 4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks | 4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks | 4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks |
| Measure Participants | 33 | 37 | 30 | 32 | 26 |
| Count of Participants [Participants] |
8
15.1%
|
5
9.4%
|
7
13.5%
|
9
16.7%
|
6
12.8%
|
Adverse Events
| Time Frame | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Reported non-serious adverse event data do not include events reported during the study extension. No serious adverse events were reported during the study extension. 35 subjects experienced non-serious adverse events, as follows: Low-dose 12-week: 8 subjects; Low-dose 24-week: 5 subjects; High-dose 12-week: 7 subjects; High-dose 24-week: 9 subjects; Placebo: 6 subjects. | |||||||||
| Arm/Group Title | Low Dose 12-week | Low Dose 24-week | High Dose 12-week | High Dose 24-week | Placebo | |||||
| Arm/Group Description | Loading doses of VT-1161 300mg once daily for 2 weeks, then 300mg once weekly for 10 weeks, followed by placebo for 12 weeks | Loading doses of VT-1161 300mg once daily for 2 weeks, then 300mg once weekly for 22 weeks | Loading doses of VT-1161 600mg once daily for 2 weeks, then 600mg once weekly for 10 weeks, followed by placebo for 12 weeks | Loading doses of VT-1161 600mg once daily for 2 weeks, then 600mg once weekly for 22 weeks | Matching placebo tablets for 24 weeks | |||||
All Cause Mortality |
||||||||||
| Low Dose 12-week | Low Dose 24-week | High Dose 12-week | High Dose 24-week | 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 |
||||||||||
| Low Dose 12-week | Low Dose 24-week | High Dose 12-week | High Dose 24-week | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/53 (1.9%) | 1/53 (1.9%) | 2/52 (3.8%) | 5/54 (9.3%) | 2/47 (4.3%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Hemorrhagic anemia | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Enterovesical fistula | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| General disorders | ||||||||||
| Chest pain | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Pyrexia | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Infections and infestations | ||||||||||
| Appendicitis | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Lower limb fracture | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Osteoarthritis | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Acoustic neuroma | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Breast cancer | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Psychiatric disorders | ||||||||||
| Depression | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Nephrolithiasis | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Renal failure acute | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Reproductive system and breast disorders | ||||||||||
| Postmenopausal hemmorage | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Pulmonary embolism | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Vascular disorders | ||||||||||
| Artery dissection | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Low Dose 12-week | Low Dose 24-week | High Dose 12-week | High Dose 24-week | Placebo | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 29/53 (54.7%) | 26/53 (49.1%) | 31/52 (59.6%) | 36/54 (66.7%) | 26/47 (55.3%) | |||||
| Cardiac disorders | ||||||||||
| Tachycardia | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Ventricular extrasystoles | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Congenital, familial and genetic disorders | ||||||||||
| Congenital aural fistula | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Ear and labyrinth disorders | ||||||||||
| Ear discomfort | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Middle ear inflammation | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Tinnitus | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Vertigo | 0/53 (0%) | 0/53 (0%) | 2/52 (3.8%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Endocrine disorders | ||||||||||
| Autoimmune thyroiditis | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Eye disorders | ||||||||||
| Conjunctivitis | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Dry eye | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Meibomian gland dysfunction | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Vision blurred | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal discomfort | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 1/47 (2.1%) | |||||
| Abdominal hernia | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Abdominal mass | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Abdominal pain | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 1/47 (2.1%) | |||||
| Abdominal pain lower | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Abdominal pain upper | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Colonic polyp | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Constipation | 2/53 (3.8%) | 2/53 (3.8%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Dental caries | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Diarrhea | 1/53 (1.9%) | 1/53 (1.9%) | 2/52 (3.8%) | 2/54 (3.7%) | 2/47 (4.3%) | |||||
| Diverticulum | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Duodenogastric reflux | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Dyspepsia | 0/53 (0%) | 1/53 (1.9%) | 1/52 (1.9%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Gastroesophageal reflux disease | 2/53 (3.8%) | 2/53 (3.8%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Hemorrhoids | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Hiatus hernia | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Inguinal hernia | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Mallory-Weiss syndrome | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Nausea | 2/53 (3.8%) | 0/53 (0%) | 4/52 (7.7%) | 4/54 (7.4%) | 0/47 (0%) | |||||
| Esophagitis | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Rectal hemorrhage | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Salivary hypersecretion | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Toothache | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Vomiting | 3/53 (5.7%) | 0/53 (0%) | 1/52 (1.9%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| General disorders | ||||||||||
| Asthenia | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Chest discomfort | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Chest pain | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Fatigue | 1/53 (1.9%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Edema peripheral | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Pain | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Pyrexia | 1/53 (1.9%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Hepatobiliary disorders | ||||||||||
| Cholelithiasis | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Immune system disorders | ||||||||||
| Hypersensitivity | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Seasonal allergy | 1/53 (1.9%) | 0/53 (0%) | 1/52 (1.9%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Infections and infestations | ||||||||||
| Acute sinusitis | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Bronchitis | 0/53 (0%) | 1/53 (1.9%) | 1/52 (1.9%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Cystitis | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Diverticulitis | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Folliculitis | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Gastroenteritis | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 1/54 (1.9%) | 1/47 (2.1%) | |||||
| Gastroenteritis viral | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Helicobacter infection | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Influenza | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Nasopharyngitis | 5/53 (9.4%) | 0/53 (0%) | 4/52 (7.7%) | 2/54 (3.7%) | 2/47 (4.3%) | |||||
| Otitis externa | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Otitis media | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Paronychia | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Pharyngitis streptococcal | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Pneumonia | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Pneumonia primary atypical | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Respiratory tract infection | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Sinusitis | 0/53 (0%) | 1/53 (1.9%) | 4/52 (7.7%) | 4/54 (7.4%) | 1/47 (2.1%) | |||||
| Subcutaneous abscess | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Tinea pedis | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Tooth abscess | 0/53 (0%) | 0/53 (0%) | 2/52 (3.8%) | 0/54 (0%) | 0/47 (0%) | |||||
| Upper respiratory tract infection | 4/53 (7.5%) | 3/53 (5.7%) | 5/52 (9.6%) | 5/54 (9.3%) | 4/47 (8.5%) | |||||
| Urinary tract infection | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Viral infection | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Arthropod bite | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Back injury | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Burns second degree | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Contusion | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Excoriation | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Eye injury | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Face injury | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Injury | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Joint sprain | 1/53 (1.9%) | 1/53 (1.9%) | 2/52 (3.8%) | 0/54 (0%) | 0/47 (0%) | |||||
| Laceration | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 2/54 (3.7%) | 0/47 (0%) | |||||
| Ligament injury | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Ligament rupture | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Limb injury | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Meniscus lesion | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Multiple fractures | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Muscle injury | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Muscle strain | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Nail injury | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Post concussion syndrome | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Procedural nausea | 0/53 (0%) | 0/53 (0%) | 2/52 (3.8%) | 0/54 (0%) | 0/47 (0%) | |||||
| Procedural pain | 2/53 (3.8%) | 0/53 (0%) | 2/52 (3.8%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Tendon injury | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Tooth avulsion | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Tooth fracture | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Traumatic hematoma | 3/53 (5.7%) | 1/53 (1.9%) | 0/52 (0%) | 1/54 (1.9%) | 1/47 (2.1%) | |||||
| Investigations | ||||||||||
| Blood cholesterol increased | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Blood creatine phosphokinase increased | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Blood pressure increased | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Blood testosterone decreased | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Electrocardiogram abnormal | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Electrocardiogram change | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Weight decreased | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Decreased appetite | 0/53 (0%) | 0/53 (0%) | 2/52 (3.8%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Gout | 0/53 (0%) | 1/53 (1.9%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Hypercholesterolemia | 1/53 (1.9%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Hyperglycemia | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Hyperlipidemia | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Hypertriglyceridemia | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthralgia | 2/53 (3.8%) | 1/53 (1.9%) | 0/52 (0%) | 1/54 (1.9%) | 1/47 (2.1%) | |||||
| Back pain | 1/53 (1.9%) | 1/53 (1.9%) | 3/52 (5.8%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Bunion | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Bursitis | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Flank pain | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Gouty arthritis | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Intervertebral disc protrusion | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Joint range of motion decreased | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Muscle spasms | 1/53 (1.9%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Muscle tightness | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Muscular weakness | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Musculoskeletal pain | 1/53 (1.9%) | 0/53 (0%) | 2/52 (3.8%) | 1/54 (1.9%) | 1/47 (2.1%) | |||||
| Musculoskeletal stiffness | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Myalgia | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Neck pain | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Osteoarthritis | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Osteopenia | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Pain in extremity | 2/53 (3.8%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Plantar fasciitis | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Sacroiliitis | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Spinal column stenosis | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Tendonitis | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Basal cell carcinoma | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Dysplastic naevus | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Lung neoplasm | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Melanocytic naevus | 1/53 (1.9%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Skin papilloma | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Thyroid neoplasm | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Uterine leiomyoma | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Nervous system disorders | ||||||||||
| 7th nerve paralysis | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Autonomic nervous system imbalance | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Balance disorder | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Disturbance in attention | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Dizziness | 1/53 (1.9%) | 1/53 (1.9%) | 0/52 (0%) | 1/54 (1.9%) | 2/47 (4.3%) | |||||
| Dysgeusia | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 3/54 (5.6%) | 0/47 (0%) | |||||
| Dyskinesia | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Headache | 2/53 (3.8%) | 2/53 (3.8%) | 1/52 (1.9%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Hyperesthesia | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Lethargy | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Migraine | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Neuropathy peripheral | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Paresthesia | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Polyneuropathy | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Sinus headache | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Somnolence | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Tremor | 0/53 (0%) | 1/53 (1.9%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Depression | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Hematuria | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 1/54 (1.9%) | 1/47 (2.1%) | |||||
| Nephrolithiasis | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 2/47 (4.3%) | |||||
| Pollakiuria | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Polyuria | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Urinary incontinence | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Urine abnormality | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Reproductive system and breast disorders | ||||||||||
| Benign prostatic hyperplasia | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Prostatomegaly | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Uterine polyp | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Cough | 0/53 (0%) | 1/53 (1.9%) | 2/52 (3.8%) | 1/54 (1.9%) | 1/47 (2.1%) | |||||
| Dyspnea | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 0/54 (0%) | 0/47 (0%) | |||||
| Nasal congestion | 2/53 (3.8%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Nasal obstruction | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Nasal turbinate hypertrophy | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Oropharyngeal pain | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Pleurisy | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Rhinitis seasonal | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Rhinorrhea | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Sinus congestion | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Sleep apnea syndrome | 0/53 (0%) | 0/53 (0%) | 1/52 (1.9%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Actinic keratosis | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Blister | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Dermatitis | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 2/54 (3.7%) | 0/47 (0%) | |||||
| Dermatitis allergic | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Dermatitis atopic | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Dermatitis contact | 2/53 (3.8%) | 0/53 (0%) | 1/52 (1.9%) | 1/54 (1.9%) | 1/47 (2.1%) | |||||
| Dry skin | 1/53 (1.9%) | 0/53 (0%) | 2/52 (3.8%) | 0/54 (0%) | 0/47 (0%) | |||||
| Eczema asteatotic | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Hyperkeratosis | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Ingrowing nail | 3/53 (5.7%) | 2/53 (3.8%) | 5/52 (9.6%) | 3/54 (5.6%) | 0/47 (0%) | |||||
| Neurodermatitis | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Onychoclasis | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Onycholysis | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 1/47 (2.1%) | |||||
| Rash | 0/53 (0%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Rosacea | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 1/54 (1.9%) | 0/47 (0%) | |||||
| Scar | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Skin exfoliation | 1/53 (1.9%) | 0/53 (0%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Vascular disorders | ||||||||||
| Hot flush | 0/53 (0%) | 1/53 (1.9%) | 0/52 (0%) | 0/54 (0%) | 0/47 (0%) | |||||
| Hypertension | 2/53 (3.8%) | 1/53 (1.9%) | 0/52 (0%) | 3/54 (5.6%) | 2/47 (4.3%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Neither Institution nor Principal Investigator shall publish the results of the Trial without the prior written consent of Sponsor, which it may withhold in its sole discretion.
Results Point of Contact
| Name/Title | Sr Vice President, Clinical Development |
|---|---|
| Organization | Mycovia Pharmaceuticals |
| Phone | (919) 467-8539 |
| info@viamet.com |
Responsible Party:
Viamet
ClinicalTrials.gov Identifier:
NCT02267356
Other Study ID Numbers:
- VMT-VT-1161-CL-005
First Posted:
Oct 17, 2014
Last Update Posted:
Nov 4, 2020
Last Verified:
Oct 1, 2020