Trial Outcomes & Findings for Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis (NCT NCT00730405)
NCT ID: NCT00730405
Last Updated: 2018-03-12
Results Overview
At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Effective treatment was defined as a mycological cure and clear or almost clear nail (distal subungual hyperkeratosis and/or onycholysis leaving less than 10% of nail plate effected). Comparisons were carried out in a sequential step-down fashion, combined with the Holm procedure at step 2. P-value was based on a sequential step-down combined with the Holm procedure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
582 participants
Primary outcome timeframe
Week 52
Results posted on
2018-03-12
Participant Flow
From 16 July 2008 to 19 February 2010, total of 582 participants with onychomycosis were randomized in 5 different arms at 26 centres in the United States, 3 centres in the Canada and 1 centre in the Iceland.
Participant milestones
| Measure |
Albaconazole 400 mg (36 Weeks) Oral Weekly
Participants received 4 capsules containing 100 milligrams (mg) of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 400 mg (24 Weeks) Oral Weekly
Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 200 mg (36 Weeks) Oral Weekly
Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 100 mg (36 Weeks) Oral Weekly
Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Placebo
Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
|---|---|---|---|---|---|
|
Overall Study-Treatment Phase
STARTED
|
116
|
117
|
117
|
117
|
115
|
|
Overall Study-Treatment Phase
COMPLETED
|
97
|
96
|
96
|
98
|
95
|
|
Overall Study-Treatment Phase
NOT COMPLETED
|
19
|
21
|
21
|
19
|
20
|
|
Overall Study-follow-up Phase
STARTED
|
116
|
117
|
117
|
117
|
115
|
|
Overall Study-follow-up Phase
COMPLETED
|
95
|
96
|
94
|
100
|
93
|
|
Overall Study-follow-up Phase
NOT COMPLETED
|
21
|
21
|
23
|
17
|
22
|
Reasons for withdrawal
| Measure |
Albaconazole 400 mg (36 Weeks) Oral Weekly
Participants received 4 capsules containing 100 milligrams (mg) of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 400 mg (24 Weeks) Oral Weekly
Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 200 mg (36 Weeks) Oral Weekly
Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 100 mg (36 Weeks) Oral Weekly
Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Placebo
Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
|---|---|---|---|---|---|
|
Overall Study-Treatment Phase
Adverse Event
|
5
|
10
|
4
|
8
|
4
|
|
Overall Study-Treatment Phase
Lost to Follow-up
|
4
|
5
|
6
|
4
|
4
|
|
Overall Study-Treatment Phase
Non-compliance with Study Treatment
|
1
|
0
|
5
|
0
|
1
|
|
Overall Study-Treatment Phase
Withdrawal by Subject
|
7
|
1
|
2
|
5
|
8
|
|
Overall Study-Treatment Phase
Did not met eligibility
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study-Treatment Phase
Participant meets exclusion
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study-Treatment Phase
Prohibited concomitant medication
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study-Treatment Phase
Withdrew from study treatment
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study-Treatment Phase
Use of prohibited medication
|
0
|
1
|
0
|
0
|
2
|
|
Overall Study-Treatment Phase
Human immunodeficiency virus positive
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study-Treatment Phase
Misrandomized
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study-Treatment Phase
Study drug interrupted
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study-Treatment Phase
Due to in-vitro fertilization
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study-Treatment Phase
Protocol violation due to eligibility
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study-Treatment Phase
Change of location
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study-Treatment Phase
Pregnancy
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study-Treatment Phase
QTCF: 454 millisecond, withdrew consent
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study-Treatment Phase
Atrial fibrillation history
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study-follow-up Phase
Adverse Event
|
2
|
6
|
2
|
3
|
4
|
|
Overall Study-follow-up Phase
Lost to Follow-up
|
7
|
6
|
8
|
4
|
6
|
|
Overall Study-follow-up Phase
Withdrawal by Subject
|
7
|
3
|
3
|
6
|
10
|
|
Overall Study-follow-up Phase
Death
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study-follow-up Phase
Change of location
|
1
|
1
|
0
|
1
|
0
|
|
Overall Study-follow-up Phase
Did not met eligibility
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study-follow-up Phase
Non-compliance with study treatment
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study-follow-up Phase
Participant meets exclusion criteria
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study-follow-up Phase
Terminated due to adverse event (AE)
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study-follow-up Phase
Prohibited concomitant medication
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study-follow-up Phase
Refused follow-up due to AE
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study-follow-up Phase
Requested to withdraw from follow-up
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study-follow-up Phase
Declined to continue with follow-up
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study-follow-up Phase
Use of restricted medication
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study-follow-up Phase
Non-compliance
|
1
|
0
|
2
|
0
|
0
|
|
Overall Study-follow-up Phase
Missing
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study-follow-up Phase
Use an exclusionary medication
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study-follow-up Phase
Human immunodeficiency virus positive
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study-follow-up Phase
Mis-randomized
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study-follow-up Phase
Other Protocol violation
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study-follow-up Phase
discontinued AE, investigator discretion
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study-follow-up Phase
Atrial fibrillation history
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis
Baseline characteristics by cohort
| Measure |
Albaconazole 400 mg (36 Weeks) Oral Weekly
n=116 Participants
Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 400 mg (24 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 200 mg (36 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 100 mg (36 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Placebo
n=115 Participants
Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Total
n=582 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.3 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
49.2 Years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
49.0 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
46.8 Years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
48.5 Years
STANDARD_DEVIATION 12.3 • n=21 Participants
|
48.6 Years
STANDARD_DEVIATION 11.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
141 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
441 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
66 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
95 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
481 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: The intent-to-treat (ITT) analysis set consists of all randomized participants who receive study product. All participants were available at the time of assessment.
At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Effective treatment was defined as a mycological cure and clear or almost clear nail (distal subungual hyperkeratosis and/or onycholysis leaving less than 10% of nail plate effected). Comparisons were carried out in a sequential step-down fashion, combined with the Holm procedure at step 2. P-value was based on a sequential step-down combined with the Holm procedure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.
Outcome measures
| Measure |
Albaconazole 400 mg (36 Weeks) Oral Weekly
n=116 Participants
Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 400 mg (24 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 200 mg (36 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 100 mg (36 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Placebo
n=115 Participants
Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
|---|---|---|---|---|---|
|
The Percentage of Participants Who Achieve Effective Treatment at Week 52
|
54 Percentage of participants
Interval 45.2 to 63.4
|
38 Percentage of participants
Interval 28.8 to 46.4
|
29 Percentage of participants
Interval 20.8 to 37.3
|
21 Percentage of participants
Interval 13.2 to 27.8
|
1 Percentage of participants
Interval 0.0 to 2.6
|
SECONDARY outcome
Timeframe: Week 52Population: ITT analysis set. All participants were available at the time of assessment.
At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Clinical cure was defined as 100% clear nail. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.
Outcome measures
| Measure |
Albaconazole 400 mg (36 Weeks) Oral Weekly
n=116 Participants
Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 400 mg (24 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 200 mg (36 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 100 mg (36 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Placebo
n=115 Participants
Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
|---|---|---|---|---|---|
|
The Percentage of Participants Who Achieve Clinical Cure at Week 52
|
34 Percentage of participants
Interval 25.0 to 42.2
|
32 Percentage of participants
Interval 23.2 to 40.0
|
30 Percentage of participants
Interval 21.6 to 38.2
|
16 Percentage of participants
Interval 9.6 to 22.9
|
1 Percentage of participants
Interval 0.0 to 2.6
|
SECONDARY outcome
Timeframe: Week 52Population: ITT analysis set. All participants were available at the time of assessment.
At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Mycological cure was defined as negative potassium hydroxide (KOH) and negative cultures for dermatophytes. It was assessed on Week 12, 16, 20, 24, 30, 36, 44 and 52.
Outcome measures
| Measure |
Albaconazole 400 mg (36 Weeks) Oral Weekly
n=116 Participants
Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 400 mg (24 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 200 mg (36 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 100 mg (36 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Placebo
n=115 Participants
Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
|---|---|---|---|---|---|
|
The Percentage of Participants Who Achieve Mycological Cure at Week 52
|
71 Percentage of participants
Interval 62.4 to 79.0
|
54 Percentage of participants
Interval 44.8 to 62.9
|
43 Percentage of participants
Interval 33.8 to 51.7
|
34 Percentage of participants
Interval 25.6 to 42.8
|
6 Percentage of participants
Interval 1.7 to 10.5
|
SECONDARY outcome
Timeframe: Week 52Population: ITT analysis set. All participants were available at the time of assessment.
At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Complete cure was defined as mycological cure plus clinical cure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.
Outcome measures
| Measure |
Albaconazole 400 mg (36 Weeks) Oral Weekly
n=116 Participants
Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 400 mg (24 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 200 mg (36 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 100 mg (36 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Placebo
n=115 Participants
Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
|---|---|---|---|---|---|
|
The Percentage of Participants Who Achieve Complete Cure at Week 52
|
33 Percentage of participants
Interval 24.2 to 41.3
|
26 Percentage of participants
Interval 17.7 to 33.6
|
21 Percentage of participants
Interval 13.2 to 27.8
|
12 Percentage of participants
Interval 6.1 to 17.8
|
0 Percentage of participants
95% confidence interval not derived, as no participant achieved complete response.
|
SECONDARY outcome
Timeframe: Baseline (Week 0/Day 1 or before) and up to Week 52Population: ITT analysis set. All participants were available at the time of assessment.
Length of the unaffected part of the target nail was measured in millimeters along the midpoint from the nail fold to the proximal border of the affected part (lowest point affected) along the midpoint of the target nail. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52. Baseline values were the observations at Week 0/Day 1 or before. Change from Baseline was a Baseline value subtracted from Week 52 value. P-value was based on analysis of variance (ANOVA) with treatment and pooled center. Statistics is provided for adjusted least square mean.
Outcome measures
| Measure |
Albaconazole 400 mg (36 Weeks) Oral Weekly
n=116 Participants
Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 400 mg (24 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 200 mg (36 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 100 mg (36 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Placebo
n=115 Participants
Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
|---|---|---|---|---|---|
|
Absolute Change in Unaffected Part of Target Nail From Baseline to Week 52
|
6.47 Millimeters
Standard Deviation 4.62
|
6.21 Millimeters
Standard Deviation 4.51
|
4.75 Millimeters
Standard Deviation 4.58
|
3.78 Millimeters
Standard Deviation 4.94
|
0.40 Millimeters
Standard Deviation 3.14
|
SECONDARY outcome
Timeframe: Week 52Population: ITT analysis set. All participants were available at the time of assessment.
A count of the number of toenails affected, using visual examination, was performed at all study visits (Week 12, 24, 30, 36, 44 and 52). The investigator given a global evaluation of the toenails condition, based on the investigator's assessment of the reduction in extent of nail involvement and improvement in clinical signs as compared with the status at the Baseline visit. The 0-5 rating scale was used: 0: cleared, 1: much improved, 2: minimally improved, 3: unchanged, 4: minimally worse and 5: much worse; where higher score indicates worse condition and lower score indicates clear toenail.
Outcome measures
| Measure |
Albaconazole 400 mg (36 Weeks) Oral Weekly
n=116 Participants
Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 400 mg (24 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 200 mg (36 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 100 mg (36 Weeks) Oral Weekly
n=117 Participants
Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Placebo
n=115 Participants
Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
|---|---|---|---|---|---|
|
The Percentage of Participants With a Global Change Score of Cleared or Much Improved at Week 52
|
71 Percentage of participants
Interval 62.4 to 79.0
|
62 Percentage of participants
Interval 53.6 to 71.2
|
61 Percentage of participants
Interval 51.8 to 69.5
|
45 Percentage of participants
Interval 36.3 to 54.3
|
10 Percentage of participants
Interval 4.2 to 14.9
|
Adverse Events
Albaconazole 400 mg (36 Weeks) Oral Weekly
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Albaconazole 400 mg (24 Weeks) Oral Weekly
Serious events: 7 serious events
Other events: 0 other events
Deaths: 1 deaths
Albaconazole 200 mg (36 Weeks) Oral Weekly
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Albaconazole 100 mg (36 Weeks) Oral Weekly
Serious events: 6 serious events
Other events: 0 other events
Deaths: 1 deaths
Placebo
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Albaconazole 400 mg (36 Weeks) Oral Weekly
n=116 participants at risk
Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 400 mg (24 Weeks) Oral Weekly
n=117 participants at risk
Participants received 4 capsules containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 24 weeks followed by 4 placebo capsules every week for 12 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 200 mg (36 Weeks) Oral Weekly
n=117 participants at risk
Participants received 4 capsules (2 active + 2 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Albaconazole 100 mg (36 Weeks) Oral Weekly
n=117 participants at risk
Participants received 4 capsules (1 active + 3 placebo) containing 100 mg of albaconazole in combination with amino methacrylate copolymer as film coated microcrystalline cellulose spheres once every week for 36 weeks. Albaconazole film-coated spheres are filled in size 1, off white, hard gelatin capsules. Placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
Placebo
n=115 participants at risk
Participants received 4 placebo capsules with identical ingredients and packaging as albaconazole capsules but without the active ingredient albaconazole. The capsules were swallowed whole with water, not chewed or crushed. Study product was administered every 7 days. Visits were scheduled on dosing days; dosing on visit dates was administered at the site.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.85%
1/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.85%
1/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.85%
1/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.85%
1/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.85%
1/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.85%
1/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.85%
1/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.85%
1/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Infections and infestations
Urosepsis
|
1.7%
2/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Infections and infestations
Wound infection
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.85%
1/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.87%
1/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.85%
1/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.86%
1/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.85%
1/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.85%
1/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.85%
1/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.85%
1/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.85%
1/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Pregnancy, puerperium and perinatal conditions
Peripartum cardiomyopathy
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.85%
1/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Psychiatric disorders
Depression
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.87%
1/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.85%
1/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.85%
1/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.86%
1/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.85%
1/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/116 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.85%
1/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/117 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
0.00%
0/115 • Serious adverse events (SAE) and AEs were collected throughout the study (approximately up to Week 62). SAEs were reported for 62 weeks and non-SAEs reported for treatment period only (36 weeks).
ITT analysis set was used for reporting AE and SAE. The datasets for adverse events could not be located to generate separate non-SAE table.
|
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER