Trial Outcomes & Findings for Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects (NCT NCT01445301)
NCT ID: NCT01445301
Last Updated: 2018-04-27
Results Overview
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from post-randomization value at Week 12.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
800 participants
Primary outcome timeframe
Baseline (Day 1) and Week 12
Results posted on
2018-04-27
Participant Flow
A total of 800 Japanese participants across 26 investigational centers in Japan, with Acne Vulgaris were enrolled in this study. The study was conducted from 27 September 2011 - 02 August 2012.
Participant milestones
| Measure |
GSK2585823 Once Daily
Participants were instructed to apply GSK2585823 (Topical gel in 1 gram (g) containing clindamycin (CLDM) 10 milligram (mg) and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU (Finger Tip Unit).
|
GSK2585823 Twice Daily
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
CLDM Twice Daily
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
|---|---|---|---|
|
Overall Study
STARTED
|
204
|
297
|
299
|
|
Overall Study
COMPLETED
|
183
|
262
|
290
|
|
Overall Study
NOT COMPLETED
|
21
|
35
|
9
|
Reasons for withdrawal
| Measure |
GSK2585823 Once Daily
Participants were instructed to apply GSK2585823 (Topical gel in 1 gram (g) containing clindamycin (CLDM) 10 milligram (mg) and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU (Finger Tip Unit).
|
GSK2585823 Twice Daily
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
CLDM Twice Daily
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
15
|
25
|
4
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Protocol-Defined Stopping Criteria
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
4
|
Baseline Characteristics
Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects
Baseline characteristics by cohort
| Measure |
GSK2585823 Once Daily
n=204 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
GSK2585823 Twice Daily
n=296 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
CLDM Twice Daily
n=299 Participants
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
Total
n=799 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
20.4 Years
STANDARD_DEVIATION 6.06 • n=5 Participants
|
20.7 Years
STANDARD_DEVIATION 6.33 • n=7 Participants
|
21.1 Years
STANDARD_DEVIATION 6.55 • n=5 Participants
|
20.8 Years
STANDARD_DEVIATION 6.34 • n=4 Participants
|
|
Sex: Female, Male
Female
|
139 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
528 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
271 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
204 Participants
n=5 Participants
|
296 Participants
n=7 Participants
|
299 Participants
n=5 Participants
|
799 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: ITT population. Only those participants available at the indicated time points were analyzed.
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from post-randomization value at Week 12.
Outcome measures
| Measure |
GSK2585823 Once Daily
n=201 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
GSK2585823 Twice Daily
n=289 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
CLDM Twice Daily
n=299 Participants
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
|---|---|---|---|
|
Absolute Change From Baseline to Week 12 in Total Lesion Counts.
|
-57.2 lesion count
Standard Error 1.94
|
-60.8 lesion count
Standard Error 1.53
|
-49.8 lesion count
Standard Error 1.52
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 1, 2, 4, and 8Population: ITT population. Only those participants available at the specified time points were analyzed.
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.
Outcome measures
| Measure |
GSK2585823 Once Daily
n=204 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
GSK2585823 Twice Daily
n=296 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
CLDM Twice Daily
n=299 Participants
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
|---|---|---|---|
|
Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts
WEEK 1
|
-22.9 lesion count
Standard Deviation 19.81
|
-25.6 lesion count
Standard Deviation 24.91
|
-16.9 lesion count
Standard Deviation 24.40
|
|
Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts
WEEK 2
|
-32.9 lesion count
Standard Deviation 29.18
|
-37.9 lesion count
Standard Deviation 28.91
|
-26.6 lesion count
Standard Deviation 30.00
|
|
Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts
WEEK 4
|
-41.4 lesion count
Standard Deviation 27.41
|
-47.3 lesion count
Standard Deviation 31.04
|
-34.8 lesion count
Standard Deviation 30.92
|
|
Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts
WEEK 8
|
-49.1 lesion count
Standard Deviation 28.97
|
-54.4 lesion count
Standard Deviation 34.65
|
-42.7 lesion count
Standard Deviation 33.49
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12Population: ITT population. Only those participants available at the specified time points were analyzed.
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.
Outcome measures
| Measure |
GSK2585823 Once Daily
n=204 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
GSK2585823 Twice Daily
n=296 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
CLDM Twice Daily
n=299 Participants
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
|---|---|---|---|
|
Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts
Inflammatory lesions,Week 1
|
-11.5 Lesion count
Standard Error 0.60
|
-11.1 Lesion count
Standard Error 0.54
|
-8.5 Lesion count
Standard Error 0.50
|
|
Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts
Inflammatory lesions,Week 2
|
-14.8 Lesion count
Standard Error 0.90
|
-16.4 Lesion count
Standard Error 0.61
|
-13.1 Lesion count
Standard Error 0.76
|
|
Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts
Inflammatory lesions,Week 4
|
-18.3 Lesion count
Standard Error 0.93
|
-19.1 Lesion count
Standard Error 0.62
|
-16.3 Lesion count
Standard Error 0.78
|
|
Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts
Inflammatory lesions,Week 8
|
-21.0 Lesion count
Standard Error 0.98
|
-21.3 Lesion count
Standard Error 0.69
|
-18.3 Lesion count
Standard Error 0.82
|
|
Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts
Inflammatory lesions,Week 12
|
-22.9 Lesion count
Standard Error 0.99
|
-23.3 Lesion count
Standard Error 0.69
|
-20.3 Lesion count
Standard Error 0.83
|
|
Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts
Non-Inflammatory lesions,Week 1
|
-13.1 Lesion count
Standard Error 1.26
|
-15.6 Lesion count
Standard Error 1.08
|
-9.7 Lesion count
Standard Error 1.06
|
|
Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts
Non-Inflammatory lesions,Week 2
|
-20.3 Lesion count
Standard Error 1.53
|
-22.8 Lesion count
Standard Error 1.28
|
-14.9 Lesion count
Standard Error 1.29
|
|
Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts
Non-Inflammatory lesions,Week 4
|
-25.2 Lesion count
Standard Error 1.58
|
-28.9 Lesion count
Standard Error 1.33
|
-19.4 Lesion count
Standard Error 1.32
|
|
Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts
Non-Inflammatory lesions,Week 8
|
-30.4 Lesion count
Standard Error 1.62
|
-33.9 Lesion count
Standard Error 1.36
|
-24.9 Lesion count
Standard Error 1.36
|
|
Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts
Non-Inflammatory lesions,Week 12
|
-34.3 Lesion count
Standard Error 1.60
|
-37.5 Lesion count
Standard Error 1.31
|
-28.7 Lesion count
Standard Error 1.34
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12Population: ITT population. Only those participants available at the specified time points were analyzed.
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.( Weeks 1, 2, 4, 8 and 12)
Outcome measures
| Measure |
GSK2585823 Once Daily
n=204 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
GSK2585823 Twice Daily
n=296 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
CLDM Twice Daily
n=299 Participants
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
|---|---|---|---|
|
Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts
Total lesions,Week 1
|
-32.42 Percent change
Standard Error 1.478
|
-33.29 Percent change
Standard Error 1.312
|
-24.71 Percent change
Standard Error 1.247
|
|
Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts
Total lesions,Week 2
|
-46.87 Percent change
Standard Error 1.953
|
-49.29 Percent change
Standard Error 1.544
|
-38.36 Percent change
Standard Error 1.644
|
|
Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts
Total lesions,Week 4
|
-57.15 Percent change
Standard Error 1.848
|
-59.98 Percent change
Standard Error 1.454
|
-48.26 Percent change
Standard Error 1.556
|
|
Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts
Total lesions,Week 8
|
-66.33 Percent change
Standard Error 1.935
|
-68.49 Percent change
Standard Error 1.551
|
-57.20 Percent change
Standard Error 1.630
|
|
Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts
Total lesions,Week 12
|
-73.85 Percent change
Standard Error 1.929
|
-75.57 Percent change
Standard Error 1.512
|
-64.42 Percent change
Standard Error 1.625
|
|
Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts
Inflammatory lesions, Week 1
|
-41.87 Percent change
Standard Error 1.885
|
-39.76 Percent change
Standard Error 1.704
|
-31.32 Percent change
Standard Error 1.590
|
|
Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts
Inflammatory lesions, Week 2
|
-55.64 Percent change
Standard Error 2.277
|
-58.31 Percent change
Standard Error 1.641
|
-48.43 Percent change
Standard Error 1.917
|
|
Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts
Inflammatory lesions, Week 4
|
-66.51 Percent change
Standard Error 2.181
|
-66.89 Percent change
Standard Error 1.617
|
-58.87 Percent change
Standard Error 1.837
|
|
Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts
Inflammatory lesions, Week 8
|
-74.86 Percent change
Standard Error 2.256
|
-74.37 Percent change
Standard Error 1.750
|
-66.13 Percent change
Standard Error 1.899
|
|
Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts
Inflammatory lesions, Week 12
|
-80.84 Percent change
Standard Error 2.120
|
-81.14 Percent change
Standard Error 1.598
|
-72.64 Percent change
Standard Error 1.785
|
|
Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts
Non-Inflammatory lesions, Week 1
|
-26.49 Percent change
Standard Error 1.846
|
-29.20 Percent change
Standard Error 1.697
|
-20.69 Percent change
Standard Error 1.558
|
|
Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts
Non-Inflammatory lesions, Week 2
|
-41.26 Percent change
Standard Error 2.392
|
-43.43 Percent change
Standard Error 2.022
|
-32.96 Percent change
Standard Error 2.014
|
|
Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts
Non-Inflammatory lesions, Week 4
|
-51.12 Percent change
Standard Error 2.246
|
-55.40 Percent change
Standard Error 1.847
|
-41.85 Percent change
Standard Error 1.891
|
|
Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts
Non-Inflammatory lesions, Week 8
|
-60.59 Percent change
Standard Error 2.247
|
-64.83 Percent change
Standard Error 1.844
|
-51.75 Percent change
Standard Error 1.892
|
|
Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts
Non-Inflammatory lesions, Week 12
|
-69.01 Percent change
Standard Error 2.219
|
-71.90 Percent change
Standard Error 1.804
|
-59.33 Percent change
Standard Error 1.869
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: ITT population. Only those participants available at the indicated time points were analyzed.
Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5(very severe): many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face.
Outcome measures
| Measure |
GSK2585823 Once Daily
n=184 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
GSK2585823 Twice Daily
n=262 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
CLDM Twice Daily
n=290 Participants
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
|---|---|---|---|
|
Percentage of Participants With a Minimum 2-grade Improvement From Baseline to Week 12 in Investigator's Static Global Assessment (ISGA) Score
|
30 Percentage of Participants
Interval 23.4 to 37.1
|
31 Percentage of Participants
Interval 25.7 to 37.3
|
14 Percentage of Participants
Interval 10.6 to 19.1
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 8, and 12Population: ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles).
Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5 (very severe): many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face.
Outcome measures
| Measure |
GSK2585823 Once Daily
n=204 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
GSK2585823 Twice Daily
n=296 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
CLDM Twice Daily
n=299 Participants
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
|---|---|---|---|
|
Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12
Week 1
|
2 Percentage of participants
Interval 0.5 to 5.0
|
2 Percentage of participants
Interval 0.8 to 4.5
|
1 Percentage of participants
Interval 0.4 to 3.4
|
|
Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12
Week 2
|
7 Percentage of participants
Interval 3.9 to 11.6
|
5 Percentage of participants
Interval 2.5 to 7.8
|
5 Percentage of participants
Interval 2.9 to 8.2
|
|
Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12
Week 4
|
11 Percentage of participants
Interval 6.9 to 16.3
|
13 Percentage of participants
Interval 9.2 to 17.6
|
7 Percentage of participants
Interval 4.7 to 11.0
|
|
Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12
Week 8
|
22 Percentage of participants
Interval 15.8 to 28.1
|
20 Percentage of participants
Interval 15.3 to 25.4
|
9 Percentage of participants
Interval 5.9 to 12.8
|
|
Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12
Week 12
|
30 Percentage of participants
Interval 23.4 to 37.1
|
34 Percentage of participants
Interval 27.9 to 39.7
|
20 Percentage of participants
Interval 15.2 to 24.7
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 1, 2, 4, 8, and 12Population: ITT population. Only those participants available at the indicated time points were analyzed.
The percentage of participants who had reduction in total lesions (inflammatory and non-inflammatory) of at least 50 percent from Baseline at Weeks 1, 2, 4, 8, and 12 was measured.
Outcome measures
| Measure |
GSK2585823 Once Daily
n=204 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
GSK2585823 Twice Daily
n=296 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
CLDM Twice Daily
n=299 Participants
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
|---|---|---|---|
|
Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions
Week 12
|
85 Percentage of participants
Interval 79.4 to 89.7
|
89 Percentage of participants
Interval 84.3 to 92.0
|
79 Percentage of participants
Interval 73.5 to 83.1
|
|
Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions
Week 1
|
18 Percentage of participants
Interval 12.5 to 23.5
|
24 Percentage of participants
Interval 19.5 to 29.8
|
15 Percentage of participants
Interval 11.1 to 19.5
|
|
Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions
Week 2
|
47 Percentage of participants
Interval 40.2 to 54.4
|
51 Percentage of participants
Interval 44.9 to 56.8
|
32 Percentage of participants
Interval 26.5 to 37.4
|
|
Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions
Week 4
|
63 Percentage of participants
Interval 55.6 to 69.4
|
71 Percentage of participants
Interval 65.3 to 76.1
|
52 Percentage of participants
Interval 45.7 to 57.3
|
|
Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions
Week 8
|
79 Percentage of participants
Interval 72.8 to 84.5
|
82 Percentage of participants
Interval 77.1 to 86.3
|
69 Percentage of participants
Interval 63.0 to 73.8
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week12Population: ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles).
MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism). MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism) for the susceptibility of clinical isolates (Propionibacterium acnes before and after application of the CLDM and NDFX was reported. MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis.
Outcome measures
| Measure |
GSK2585823 Once Daily
n=204 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
GSK2585823 Twice Daily
n=296 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
CLDM Twice Daily
n=299 Participants
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
|---|---|---|---|
|
Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX)
CLDM,Baseline,MIC50
|
0.12 Micrograms/milliliter
|
0.12 Micrograms/milliliter
|
0.12 Micrograms/milliliter
|
|
Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX)
CLDM,Baseline,MIC90
|
1 Micrograms/milliliter
|
4 Micrograms/milliliter
|
4 Micrograms/milliliter
|
|
Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX)
CLDM, Week 12,MIC50
|
0.25 Micrograms/milliliter
|
0.5 Micrograms/milliliter
|
0.5 Micrograms/milliliter
|
|
Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX)
CLDM, Week 12,MIC90
|
128 Micrograms/milliliter
|
128 Micrograms/milliliter
|
128 Micrograms/milliliter
|
|
Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX)
NDFX,Baseline,MIC50
|
0.25 Micrograms/milliliter
|
0.25 Micrograms/milliliter
|
0.25 Micrograms/milliliter
|
|
Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX)
NDFX,Baseline,MIC90
|
0.5 Micrograms/milliliter
|
0.5 Micrograms/milliliter
|
0.5 Micrograms/milliliter
|
|
Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX)
NDFX, Week 12,MIC50
|
0.25 Micrograms/milliliter
|
0.25 Micrograms/milliliter
|
0.25 Micrograms/milliliter
|
|
Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX)
NDFX, Week 12,MIC90
|
0.5 Micrograms/milliliter
|
0.5 Micrograms/milliliter
|
0.5 Micrograms/milliliter
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 1, 2, 4, 8, and 12Population: ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles).
Erythema (redness), dryness, and peeling, were evaluated independently by the investigator on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12).
Outcome measures
| Measure |
GSK2585823 Once Daily
n=204 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
GSK2585823 Twice Daily
n=296 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
CLDM Twice Daily
n=299 Participants
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
|---|---|---|---|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12
Erythema score-Week 1
|
-0.11 Score on scale
Standard Deviation 0.58
|
-0.00 Score on scale
Standard Deviation 0.63
|
-0.11 Score on scale
Standard Deviation 0.52
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12
Erythema score-Week 2
|
-0.16 Score on scale
Standard Deviation 0.76
|
-0.02 Score on scale
Standard Deviation 0.82
|
-0.19 Score on scale
Standard Deviation 0.58
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12
Erythema score-Week 4
|
-0.30 Score on scale
Standard Deviation 0.72
|
-0.24 Score on scale
Standard Deviation 0.75
|
-0.27 Score on scale
Standard Deviation 0.62
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12
Erythema score-Week 8
|
-0.43 Score on scale
Standard Deviation 0.82
|
-0.33 Score on scale
Standard Deviation 0.78
|
-0.31 Score on scale
Standard Deviation 0.67
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12
Erythema score-Week 12
|
-0.49 Score on scale
Standard Deviation 0.82
|
-0.45 Score on scale
Standard Deviation 0.87
|
-0.38 Score on scale
Standard Deviation 0.75
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12
Dryness yscore-Week 1
|
0.10 Score on scale
Standard Deviation 0.65
|
0.29 Score on scale
Standard Deviation 0.76
|
-0.04 Score on scale
Standard Deviation 0.47
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12
Dryness score-Week 2
|
0.04 Score on scale
Standard Deviation 0.65
|
0.23 Score on scale
Standard Deviation 0.80
|
-0.11 Score on scale
Standard Deviation 0.51
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12
Dryness score-Week 4
|
-0.06 Score on scale
Standard Deviation 0.57
|
0.00 Score on scale
Standard Deviation 0.65
|
-0.15 Score on scale
Standard Deviation 0.53
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12
Dryness score-Week 8
|
-0.11 Score on scale
Standard Deviation 0.61
|
-0.00 Score on scale
Standard Deviation 0.67
|
-0.13 Score on scale
Standard Deviation 0.50
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12
Dryness score-Week 12
|
-0.18 Score on scale
Standard Deviation 0.62
|
-0.10 Score on scale
Standard Deviation 0.61
|
-0.17 Score on scale
Standard Deviation 0.52
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12
Peeling score-Week 1
|
0.09 Score on scale
Standard Deviation 0.50
|
0.19 Score on scale
Standard Deviation 0.68
|
-0.04 Score on scale
Standard Deviation 0.39
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12
Peeling score-Week 2
|
0.02 Score on scale
Standard Deviation 0.49
|
0.17 Score on scale
Standard Deviation 0.68
|
-0.10 Score on scale
Standard Deviation 0.39
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12
Peeling score-Week 4
|
-0.05 Score on scale
Standard Deviation 0.44
|
0.04 Score on scale
Standard Deviation 0.54
|
-0.14 Score on scale
Standard Deviation 0.43
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12
Peeling score-Week 8
|
-0.08 Score on scale
Standard Deviation 0.46
|
0.03 Score on scale
Standard Deviation 0.56
|
-0.13 Score on scale
Standard Deviation 0.43
|
|
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12
Peeling score-Week 12
|
-0.08 Score on scale
Standard Deviation 0.49
|
-0.07 Score on scale
Standard Deviation 0.51
|
-0.13 Score on scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 1, 2, 4, 8 and 12Population: ITT population. Only those participants available at the specified time points were analyzed (represented by n=X. X, X in the category titles).
Burning/stinging, itching were evaluated independently by the participant on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12).
Outcome measures
| Measure |
GSK2585823 Once Daily
n=204 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
GSK2585823 Twice Daily
n=296 Participants
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
CLDM Twice Daily
n=299 Participants
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
|---|---|---|---|
|
Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12
Burning/Stinging Score, Week 1
|
0.08 Score on scale
Standard Deviation 0.55
|
0.26 Score on scale
Standard Deviation 0.76
|
-0.02 Score on scale
Standard Deviation 0.45
|
|
Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12
Burning/Stinging Score, Week 2
|
0.02 Score on scale
Standard Deviation 0.45
|
0.11 Score on scale
Standard Deviation 0.61
|
-0.06 Score on scale
Standard Deviation 0.37
|
|
Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12
Itching Score, Week 1
|
-0.02 Score on scale
Standard Deviation 0.53
|
0.07 Score on scale
Standard Deviation 0.61
|
-0.08 Score on scale
Standard Deviation 0.53
|
|
Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12
Itching Score, Week 2
|
-0.06 Score on scale
Standard Deviation 0.58
|
0.12 Score on scale
Standard Deviation 0.73
|
-0.13 Score on scale
Standard Deviation 0.48
|
|
Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12
Itching Score, Week 4
|
-0.10 Score on scale
Standard Deviation 0.51
|
-0.02 Score on scale
Standard Deviation 0.48
|
-0.14 Score on scale
Standard Deviation 0.51
|
|
Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12
Itching Score, Week 8
|
-0.15 Score on scale
Standard Deviation 0.50
|
-0.06 Score on scale
Standard Deviation 0.43
|
-0.14 Score on scale
Standard Deviation 0.55
|
|
Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12
Itching Score, Week 12
|
-0.10 Score on scale
Standard Deviation 0.59
|
-0.08 Score on scale
Standard Deviation 0.53
|
-0.12 Score on scale
Standard Deviation 0.52
|
|
Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12
Burning/Stinging Score, Week 4
|
-0.02 Score on scale
Standard Deviation 0.43
|
-0.02 Score on scale
Standard Deviation 0.48
|
-0.07 Score on scale
Standard Deviation 0.39
|
|
Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12
Burning/Stinging Score, Week 8
|
-0.02 Score on scale
Standard Deviation 0.44
|
-0.04 Score on scale
Standard Deviation 0.47
|
-0.08 Score on scale
Standard Deviation 0.39
|
|
Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12
Burning/Stinging Score, Week 12
|
-0.06 Score on scale
Standard Deviation 0.38
|
-0.08 Score on scale
Standard Deviation 0.38
|
-0.08 Score on scale
Standard Deviation 0.37
|
Adverse Events
GSK2585823 Once Daily
Serious events: 0 serious events
Other events: 108 other events
Deaths: 0 deaths
GSK2585823 Twice Daily
Serious events: 0 serious events
Other events: 163 other events
Deaths: 0 deaths
CLDM Twice Daily
Serious events: 0 serious events
Other events: 110 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GSK2585823 Once Daily
n=204 participants at risk
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
GSK2585823 Twice Daily
n=296 participants at risk
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
CLDM Twice Daily
n=299 participants at risk
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
17/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
11.8%
35/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
2.7%
8/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.9%
14/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
8.1%
24/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
1.7%
5/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.9%
8/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
7.4%
22/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
2.7%
8/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.4%
9/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
5.7%
17/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
2.0%
6/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
2.0%
4/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
8.4%
25/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.67%
2/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.0%
4/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
3.4%
10/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
2.3%
7/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
2.0%
4/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
2.0%
6/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
1.3%
4/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
1.5%
3/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
2.7%
8/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.67%
2/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.5%
3/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
1.4%
4/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.67%
2/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.5%
3/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
1.0%
3/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
1.0%
3/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
1.0%
3/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.67%
2/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Dyshidrosis
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Solar dermatitis
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Pityriasis
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Infections and infestations
Nasopharyngitis
|
13.7%
28/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
16.2%
48/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
13.0%
39/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Infections and infestations
Influenza
|
2.0%
4/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
3.0%
9/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
2.3%
7/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Infections and infestations
Gastroenteritis
|
1.5%
3/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.68%
2/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Infections and infestations
Oral herpes
|
0.98%
2/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.98%
2/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Infections and infestations
Infected dermal cyst
|
0.98%
2/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Infections and infestations
Bronchitis
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Infections and infestations
Impetigo
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Infections and infestations
Pericoronitis
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Infections and infestations
Rhinitis
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Infections and infestations
Skin infection
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Infections and infestations
Varicella
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Investigations
Alanine aminotransferase increased
|
1.5%
3/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
1.7%
5/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Investigations
Aspartate aminotransferase increased
|
1.5%
3/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
1.3%
4/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Investigations
Blood bilirubin increased
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.68%
2/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
1.7%
5/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Investigations
White blood cell count increased
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
1.0%
3/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
1.3%
4/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Investigations
Glucose urine present
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.67%
2/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Investigations
Protein urine present
|
0.98%
2/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.67%
2/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Nervous system disorders
Burning sensation
|
2.9%
6/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
4.1%
12/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
1.3%
4/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Nervous system disorders
Headache
|
0.98%
2/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
1.0%
3/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Nervous system disorders
Dizziness postural
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
General disorders
Facial pain
|
4.4%
9/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
3.0%
9/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
1.3%
4/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
General disorders
Pyrexia
|
0.98%
2/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
General disorders
Feeling hot
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
General disorders
Nodule
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.98%
2/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.68%
2/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.67%
2/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
1.0%
3/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
1.0%
3/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.67%
2/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.67%
2/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.98%
2/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.67%
2/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.67%
2/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.67%
2/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.68%
2/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Gastrointestinal disorders
Dental caries
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Gastrointestinal disorders
Proctitis
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Gastrointestinal disorders
Radicular cyst
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Gastrointestinal disorders
Vomiting
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Eye disorders
Eyelid oedema
|
0.98%
2/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.68%
2/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Eye disorders
Erythema of eyelid
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.68%
2/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Eye disorders
Blepharitis
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Eye disorders
Eyelid irritation
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.68%
2/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Eye disorders
Eczema eyelids
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Eye disorders
Eyelids pruritus
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.67%
2/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.49%
1/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.33%
1/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/204 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.34%
1/296 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
0.00%
0/299 • Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
|
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