Trial Outcomes & Findings for Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis (NCT NCT00936065)
NCT ID: NCT00936065
Last Updated: 2012-04-09
Results Overview
Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section \* area score \* weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
COMPLETED
PHASE4
60 participants
Week 24
2012-04-09
Participant Flow
Participant milestones
| Measure |
Etanercept
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
19
|
|
Overall Study
Received Treatment
|
21
|
20
|
18
|
|
Overall Study
Study Assessments Performed
|
21
|
19
|
18
|
|
Overall Study
COMPLETED
|
17
|
16
|
12
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
7
|
Reasons for withdrawal
| Measure |
Etanercept
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
4
|
Baseline Characteristics
Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis
Baseline characteristics by cohort
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
38.57 years
STANDARD_DEVIATION 9.53 • n=5 Participants
|
35.5 years
STANDARD_DEVIATION 8.75 • n=7 Participants
|
42.39 years
STANDARD_DEVIATION 11.95 • n=5 Participants
|
38.78 years
STANDARD_DEVIATION 10.31 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Modified intent to treat (mITT) population: randomized participants who took at least 1 dose of test article and had both baseline and on-therapy PASI evaluations; Last Observation Carried Forward (LOCF)
Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section \* area score \* weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24
|
52.38 percentage of participants
Interval 29.78 to 74.29
|
57.89 percentage of participants
Interval 33.5 to 79.75
|
22.22 percentage of participants
Interval 6.41 to 47.64
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 18, and 24Population: mITT; LOCF
Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section \* area score \* weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Week 2
|
4.76 percentage of participants
Interval 0.12 to 23.82
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Week 8
|
71.43 percentage of participants
Interval 47.82 to 88.72
|
57.89 percentage of participants
Interval 33.5 to 79.75
|
27.78 percentage of participants
Interval 9.69 to 53.48
|
|
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Week 12
|
76.19 percentage of participants
Interval 52.83 to 91.78
|
78.95 percentage of participants
Interval 54.43 to 93.95
|
22.22 percentage of participants
Interval 6.41 to 47.64
|
|
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Week 18
|
76.19 percentage of participants
Interval 52.83 to 91.78
|
84.21 percentage of participants
Interval 60.42 to 96.62
|
38.89 percentage of participants
Interval 17.3 to 64.25
|
|
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Week 24
|
71.43 percentage of participants
Interval 47.82 to 88.72
|
84.21 percentage of participants
Interval 60.42 to 96.62
|
44.44 percentage of participants
Interval 21.53 to 69.24
|
|
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Week 4
|
47.62 percentage of participants
Interval 25.71 to 70.22
|
15.79 percentage of participants
Interval 3.38 to 39.58
|
11.11 percentage of participants
Interval 1.38 to 34.71
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear = PGA score of 0 (no evidence).
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
Baseline
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
Week 4
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
Week 18
|
9.52 Percentage of participants
Interval 1.17 to 30.38
|
5.26 Percentage of participants
Interval 0.13 to 26.03
|
5.56 Percentage of participants
Interval 0.14 to 27.29
|
|
Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
Week 24
|
9.52 Percentage of participants
Interval 1.17 to 30.38
|
10.53 Percentage of participants
Interval 1.3 to 33.14
|
5.56 Percentage of participants
Interval 0.14 to 27.29
|
|
Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
Week 2
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
Week 8
|
4.76 Percentage of participants
Interval 0.12 to 23.82
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
Week 12
|
9.52 Percentage of participants
Interval 1.17 to 30.38
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
Baseline
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
Week 2
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
5.56 percentage of participants
Interval 0.14 to 27.29
|
|
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
Week 4
|
19.05 percentage of participants
Interval 5.45 to 41.91
|
5.26 percentage of participants
Interval 0.13 to 26.03
|
11.11 percentage of participants
Interval 1.38 to 34.71
|
|
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
Week 8
|
28.57 percentage of participants
Interval 11.28 to 52.18
|
21.05 percentage of participants
Interval 6.05 to 45.57
|
5.56 percentage of participants
Interval 0.14 to 27.29
|
|
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
Week 12
|
42.86 percentage of participants
Interval 21.82 to 65.98
|
21.05 percentage of participants
Interval 6.05 to 45.57
|
5.56 percentage of participants
Interval 0.14 to 27.29
|
|
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
Week 18
|
33.33 percentage of participants
Interval 14.59 to 56.97
|
31.58 percentage of participants
Interval 12.58 to 56.55
|
16.67 percentage of participants
Interval 3.58 to 41.42
|
|
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
Week 24
|
52.38 percentage of participants
Interval 29.78 to 74.29
|
52.63 percentage of participants
Interval 28.86 to 75.55
|
16.67 percentage of participants
Interval 3.58 to 41.42
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), 2 (mild).
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
Baseline
|
14.29 percentage of participants
Interval 3.05 to 36.34
|
5.26 percentage of participants
Interval 0.13 to 26.03
|
16.67 percentage of participants
Interval 3.58 to 41.42
|
|
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
Week 2
|
33.33 percentage of participants
Interval 14.59 to 56.97
|
26.32 percentage of participants
Interval 9.15 to 51.2
|
11.11 percentage of participants
Interval 1.38 to 34.71
|
|
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
Week 4
|
42.86 percentage of participants
Interval 21.82 to 65.98
|
47.37 percentage of participants
Interval 24.45 to 74.14
|
16.67 percentage of participants
Interval 3.58 to 41.42
|
|
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
Week 8
|
61.90 percentage of participants
Interval 38.44 to 81.89
|
42.11 percentage of participants
Interval 20.25 to 66.5
|
27.78 percentage of participants
Interval 9.69 to 53.48
|
|
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
Week 12
|
76.19 percentage of participants
Interval 52.83 to 91.78
|
78.95 percentage of participants
Interval 54.43 to 93.95
|
33.33 percentage of participants
Interval 13.34 to 59.01
|
|
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
Week 18
|
80.95 percentage of participants
Interval 58.09 to 94.55
|
84.21 percentage of participants
Interval 60.42 to 96.62
|
38.89 percentage of participants
Interval 17.3 to 64.25
|
|
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
Week 24
|
76.19 percentage of participants
Interval 52.83 to 91.78
|
84.21 percentage of participants
Interval 60.42 to 96.62
|
33.33 percentage of participants
Interval 13.34 to 59.01
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: mITT
PASI 50 defined as a 50% or greater improvement in PASI score from Baseline
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Time to Achieve a PASI 50 Score
|
56 days
Interval 28.0 to 56.0
|
56 days
Interval 54.0 to 84.0
|
126 days
Interval 56.0 to
Not Available (NA): The number of events to observe the upper limit of 95% Confidence Interval (CI) did not occur during the specified period.
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: mITT
PASI 75 defined as a 75% or greater improvement in PASI score from Baseline
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Time to Achieve a PASI 75 Score
|
126 days
Interval 56.0 to 146.0
|
146 days
Interval 124.0 to
The number of events to observe the upper limit of 95% CI did not occur during the specified period.
|
NA days
Interval 127.0 to
The number of events to observe the median time to PASI 75 did not occur during the specified period.
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: mITT
PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), or 2 (mild).
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
|
57 days
Interval 19.0 to 84.0
|
57 days
Interval 14.0 to 84.0
|
169 days
Interval 56.0 to
The number of events to observe the upper limit of 95% CI did not occur during the specified period.
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: mITT
PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear
|
167 days
Interval 55.0 to 172.0
|
165 days
Interval 59.0 to
The number of events to observe the upper limit of 95% CI did not occur during the specified period.
|
NA days
Interval 87.0 to
The number of events to observe the median time to achieve PGA of Clear or Almost Clear did not occur during the specified period.
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18, and 24Population: mITT; LOCF
PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear = PGA score of 0 (no evidence). Change = Week x, minus Baseline, where smaller scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in the PGA of Psoriasis
Change at Week 8
|
-1.34 units on a scale
Standard Deviation 1.07
|
-1.09 units on a scale
Standard Deviation 0.86
|
-0.43 units on a scale
Standard Deviation 0.91
|
|
Change From Baseline in the PGA of Psoriasis
Change at Week 12
|
-1.62 units on a scale
Standard Deviation 1.33
|
-1.42 units on a scale
Standard Deviation 0.69
|
-0.48 units on a scale
Standard Deviation 0.98
|
|
Change From Baseline in the PGA of Psoriasis
Baseline
|
3.40 units on a scale
Standard Deviation 0.82
|
3.38 units on a scale
Standard Deviation 0.59
|
3.50 units on a scale
Standard Deviation 0.92
|
|
Change From Baseline in the PGA of Psoriasis
Change at Week 2
|
-0.51 units on a scale
Standard Deviation 0.71
|
-0.35 units on a scale
Standard Deviation 0.58
|
0.02 units on a scale
Standard Deviation 0.56
|
|
Change From Baseline in the PGA of Psoriasis
Change at Week 4
|
-1.00 units on a scale
Standard Deviation 1.03
|
-0.84 units on a scale
Standard Deviation 0.60
|
-0.26 units on a scale
Standard Deviation 0.74
|
|
Change From Baseline in the PGA of Psoriasis
Change at Week 18
|
-1.58 units on a scale
Standard Deviation 1.33
|
-1.68 units on a scale
Standard Deviation 1.00
|
-0.69 units on a scale
Standard Deviation 1.35
|
|
Change From Baseline in the PGA of Psoriasis
Change at Week 24
|
-1.67 units on a scale
Standard Deviation 1.47
|
-1.86 units on a scale
Standard Deviation 1.06
|
-0.71 units on a scale
Standard Deviation 1.37
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
Combined assessment of lesion severity, area affected into single score; range:0(no disease) to 72(maximal disease).Body divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated:0(0%) to 6(90-100%), severity estimated by clinical signs: erythema, induration, desquamation; scale: 0(none) to 4(maximum). Final PASI = sum of severity parameters for each section \* area score \* weight of section(head:0.1,arm:0.2,body: 0.3, leg:0.4). Change=Week X-Baseline, smaller scores show improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in the PASI Score
Change at Week 24
|
-12.16 units on a scale
Standard Deviation 12.15
|
-13.92 units on a scale
Standard Deviation 5.75
|
-9.62 units on a scale
Standard Deviation 10.10
|
|
Change From Baseline in the PASI Score
Baseline
|
20.83 units on a scale
Standard Deviation 14.02
|
19.75 units on a scale
Standard Deviation 9.85
|
26.31 units on a scale
Standard Deviation 13.63
|
|
Change From Baseline in the PASI Score
Change at Week 2
|
-5.38 units on a scale
Standard Deviation 7.13
|
-3.27 units on a scale
Standard Deviation 1.88
|
-3.17 units on a scale
Standard Deviation 5.60
|
|
Change From Baseline in the PASI Score
Change at Week 4
|
-9.98 units on a scale
Standard Deviation 10.64
|
-6.45 units on a scale
Standard Deviation 3.19
|
-4.06 units on a scale
Standard Deviation 5.68
|
|
Change From Baseline in the PASI Score
Change at Week 8
|
-11.11 units on a scale
Standard Deviation 10.89
|
-9.96 units on a scale
Standard Deviation 3.73
|
-6.84 units on a scale
Standard Deviation 9.57
|
|
Change From Baseline in the PASI Score
Change at Week 12
|
-11.97 units on a scale
Standard Deviation 11.63
|
-11.39 units on a scale
Standard Deviation 4.72
|
-6.71 units on a scale
Standard Deviation 6.81
|
|
Change From Baseline in the PASI Score
Change at Week 18
|
-12.13 units on a scale
Standard Deviation 11.67
|
-13.54 units on a scale
Standard Deviation 6.80
|
-8.77 units on a scale
Standard Deviation 8.54
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
Change from Baseline in the percentage of the surface area of the body affected by psoriasis. Change = Week x minus Baseline, where smaller scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
Baseline
|
32.98 percentage of BSA
Standard Deviation 20.21
|
32.50 percentage of BSA
Standard Deviation 24.15
|
39.75 percentage of BSA
Standard Deviation 22.96
|
|
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
|
-2.64 percentage of BSA
Standard Deviation 6.69
|
-1.55 percentage of BSA
Standard Deviation 5.07
|
-0.36 percentage of BSA
Standard Deviation 5.54
|
|
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
|
-12.67 percentage of BSA
Standard Deviation 13.17
|
-7.97 percentage of BSA
Standard Deviation 9.27
|
-5.14 percentage of BSA
Standard Deviation 16.96
|
|
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
|
-15.43 percentage of BSA
Standard Deviation 14.90
|
-10.29 percentage of BSA
Standard Deviation 9.19
|
-5.08 percentage of BSA
Standard Deviation 11.89
|
|
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
|
-16.57 percentage of BSA
Standard Deviation 14.70
|
-14.76 percentage of BSA
Standard Deviation 11.61
|
-9.25 percentage of BSA
Standard Deviation 16.72
|
|
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
|
-7.36 percentage of BSA
Standard Deviation 10.89
|
-4.50 percentage of BSA
Standard Deviation 6.48
|
-0.75 percentage of BSA
Standard Deviation 7.66
|
|
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
|
-17.52 percentage of BSA
Standard Deviation 14.91
|
-16.87 percentage of BSA
Standard Deviation 10.79
|
-10.30 percentage of BSA
Standard Deviation 18.86
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data
Participants were asked to rate the severity of their joint pain on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=18 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
Baseline
|
0.67 units on a scale
Standard Deviation 1.43
|
0.56 units on a scale
Standard Deviation 1.15
|
0.94 units on a scale
Standard Deviation 1.73
|
|
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 4
|
0.29 units on a scale
Standard Deviation 1.19
|
-0.06 units on a scale
Standard Deviation 0.42
|
-0.72 units on a scale
Standard Deviation 1.81
|
|
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 8
|
0.19 units on a scale
Standard Deviation 0.81
|
-0.22 units on a scale
Standard Deviation 0.88
|
-0.56 units on a scale
Standard Deviation 1.72
|
|
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 12
|
0.00 units on a scale
Standard Deviation 0.63
|
-0.28 units on a scale
Standard Deviation 0.96
|
-0.44 units on a scale
Standard Deviation 2.36
|
|
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 18
|
-0.05 units on a scale
Standard Deviation 0.67
|
-0.28 units on a scale
Standard Deviation 1.02
|
-0.44 units on a scale
Standard Deviation 1.85
|
|
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 2
|
0.00 units on a scale
Standard Deviation 0.71
|
0.00 units on a scale
Standard Deviation 0.49
|
-0.44 units on a scale
Standard Deviation 1.10
|
|
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 24
|
0.29 units on a scale
Standard Deviation 1.06
|
-0.39 units on a scale
Standard Deviation 0.85
|
-0.61 units on a scale
Standard Deviation 2.03
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12 ,18 and 24Population: mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data
Participants were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=18 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 12
|
-2.67 units on a scale
Standard Deviation 1.56
|
-2.28 units on a scale
Standard Deviation 1.53
|
-1.61 units on a scale
Standard Deviation 1.72
|
|
Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 18
|
-2.57 units on a scale
Standard Deviation 1.99
|
-2.11 units on a scale
Standard Deviation 1.78
|
-1.83 units on a scale
Standard Deviation 1.76
|
|
Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
Baseline
|
3.90 units on a scale
Standard Deviation 1.09
|
3.94 units on a scale
Standard Deviation 1.06
|
4.72 units on a scale
Standard Deviation 0.67
|
|
Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 2
|
-0.90 units on a scale
Standard Deviation 1.58
|
-0.33 units on a scale
Standard Deviation 1.24
|
-0.72 units on a scale
Standard Deviation 1.02
|
|
Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 4
|
-1.86 units on a scale
Standard Deviation 1.28
|
-0.94 units on a scale
Standard Deviation 1.26
|
-0.83 units on a scale
Standard Deviation 1.04
|
|
Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 8
|
-2.29 units on a scale
Standard Deviation 1.79
|
-1.89 units on a scale
Standard Deviation 1.49
|
-1.67 units on a scale
Standard Deviation 1.71
|
|
Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
Change at Week 24
|
-1.81 units on a scale
Standard Deviation 2.20
|
-2.39 units on a scale
Standard Deviation 1.54
|
-1.72 units on a scale
Standard Deviation 1.93
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12 ,18 and 24Population: mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data
Participants were asked to rate the severity of their psoriasis itching on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=18 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in SGA of Itching at Each Visit
Change at Week 4
|
-1.52 units on a scale
Standard Deviation 1.33
|
-0.61 units on a scale
Standard Deviation 1.65
|
-0.39 units on a scale
Standard Deviation 2.03
|
|
Change From Baseline in SGA of Itching at Each Visit
Change at Week 8
|
-1.86 units on a scale
Standard Deviation 2.06
|
-1.06 units on a scale
Standard Deviation 1.76
|
-1.28 units on a scale
Standard Deviation 1.71
|
|
Change From Baseline in SGA of Itching at Each Visit
Change at Week 12
|
-2.10 units on a scale
Standard Deviation 2.07
|
-1.44 units on a scale
Standard Deviation 2.09
|
-1.22 units on a scale
Standard Deviation 1.73
|
|
Change From Baseline in SGA of Itching at Each Visit
Baseline
|
3.33 units on a scale
Standard Deviation 1.35
|
3.11 units on a scale
Standard Deviation 1.81
|
3.72 units on a scale
Standard Deviation 1.45
|
|
Change From Baseline in SGA of Itching at Each Visit
Change at Week 2
|
-0.67 units on a scale
Standard Deviation 1.59
|
0.28 units on a scale
Standard Deviation 1.74
|
-0.39 units on a scale
Standard Deviation 1.29
|
|
Change From Baseline in SGA of Itching at Each Visit
Change at Week 18
|
-1.81 units on a scale
Standard Deviation 2.06
|
-1.83 units on a scale
Standard Deviation 1.76
|
-1.17 units on a scale
Standard Deviation 1.62
|
|
Change From Baseline in SGA of Itching at Each Visit
Change at Week 24
|
-1.19 units on a scale
Standard Deviation 2.23
|
-1.83 units on a scale
Standard Deviation 2.04
|
-1.06 units on a scale
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the overall appearance of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
|
0.81 Units on a scale
Standard Deviation 1.25
|
0.79 Units on a scale
Standard Deviation 1.40
|
0.28 Units on a scale
Standard Deviation 1.41
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
|
1.57 Units on a scale
Standard Deviation 1.16
|
0.95 Units on a scale
Standard Deviation 1.31
|
0.50 Units on a scale
Standard Deviation 1.38
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
|
2.10 Units on a scale
Standard Deviation 1.58
|
1.58 Units on a scale
Standard Deviation 1.71
|
0.78 Units on a scale
Standard Deviation 1.40
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
|
2.10 Units on a scale
Standard Deviation 1.58
|
1.74 Units on a scale
Standard Deviation 1.76
|
0.56 Units on a scale
Standard Deviation 1.38
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
|
2.24 Units on a scale
Standard Deviation 1.87
|
1.95 Units on a scale
Standard Deviation 1.54
|
1.06 Units on a scale
Standard Deviation 1.66
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
|
1.76 Units on a scale
Standard Deviation 1.67
|
2.05 Units on a scale
Standard Deviation 1.18
|
1.11 Units on a scale
Standard Deviation 1.84
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
|
0.67 Units on a scale
Standard Deviation 0.80
|
0.74 Units on a scale
Standard Deviation 0.99
|
0.44 Units on a scale
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the flaking of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
|
1.00 Units on a scale
Standard Deviation 1.30
|
0.84 Units on a scale
Standard Deviation 1.21
|
0.56 Units on a scale
Standard Deviation 0.78
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
|
1.14 Units on a scale
Standard Deviation 1.53
|
1.21 Units on a scale
Standard Deviation 1.51
|
0.39 Units on a scale
Standard Deviation 1.50
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
|
1.57 Units on a scale
Standard Deviation 1.36
|
0.68 Units on a scale
Standard Deviation 1.42
|
0.94 Units on a scale
Standard Deviation 1.66
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
|
2.38 Units on a scale
Standard Deviation 1.83
|
1.53 Units on a scale
Standard Deviation 1.95
|
1.11 Units on a scale
Standard Deviation 1.78
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
|
2.67 Units on a scale
Standard Deviation 1.88
|
1.63 Units on a scale
Standard Deviation 1.46
|
0.83 Units on a scale
Standard Deviation 1.76
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
|
2.33 Units on a scale
Standard Deviation 2.01
|
1.89 Units on a scale
Standard Deviation 1.41
|
1.28 Units on a scale
Standard Deviation 1.84
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
|
1.90 Units on a scale
Standard Deviation 2.17
|
2.21 Units on a scale
Standard Deviation 1.18
|
1.17 Units on a scale
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the redness of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
|
2.00 Units on a scale
Standard Deviation 2.02
|
2.21 Units on a scale
Standard Deviation 1.23
|
1.00 Units on a scale
Standard Deviation 1.41
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
|
0.90 Units on a scale
Standard Deviation 1.18
|
0.63 Units on a scale
Standard Deviation 1.01
|
0.72 Units on a scale
Standard Deviation 0.89
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
|
0.86 Units on a scale
Standard Deviation 1.20
|
1.32 Units on a scale
Standard Deviation 1.34
|
0.17 Units on a scale
Standard Deviation 1.20
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
|
0.95 Units on a scale
Standard Deviation 1.24
|
1.16 Units on a scale
Standard Deviation 1.17
|
0.44 Units on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
|
2.05 Units on a scale
Standard Deviation 2.04
|
1.58 Units on a scale
Standard Deviation 1.71
|
0.83 Units on a scale
Standard Deviation 1.34
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
|
2.19 Units on a scale
Standard Deviation 1.97
|
1.68 Units on a scale
Standard Deviation 1.67
|
0.61 Units on a scale
Standard Deviation 1.38
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
|
2.05 Units on a scale
Standard Deviation 2.20
|
2.16 Units on a scale
Standard Deviation 1.21
|
1.22 Units on a scale
Standard Deviation 1.52
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on tightness in the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
|
2.43 Units on a scale
Standard Deviation 2.34
|
1.32 Units on a scale
Standard Deviation 1.29
|
0.83 Units on a scale
Standard Deviation 1.76
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
|
2.67 Units on a scale
Standard Deviation 2.18
|
1.74 Units on a scale
Standard Deviation 1.48
|
0.61 Units on a scale
Standard Deviation 2.20
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
|
1.90 Units on a scale
Standard Deviation 2.47
|
2.00 Units on a scale
Standard Deviation 1.05
|
0.56 Units on a scale
Standard Deviation 1.62
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
|
1.33 Units on a scale
Standard Deviation 1.28
|
1.11 Units on a scale
Standard Deviation 1.05
|
1.83 Units on a scale
Standard Deviation 1.76
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
|
1.48 Units on a scale
Standard Deviation 1.50
|
0.42 Units on a scale
Standard Deviation 1.61
|
-0.11 Units on a scale
Standard Deviation 1.57
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
|
2.19 Units on a scale
Standard Deviation 1.72
|
0.79 Units on a scale
Standard Deviation 1.13
|
0.44 Units on a scale
Standard Deviation 1.79
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
|
2.48 Units on a scale
Standard Deviation 2.16
|
2.05 Units on a scale
Standard Deviation 1.18
|
0.78 Units on a scale
Standard Deviation 1.77
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on bleeding of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
|
0.57 Units on a scale
Standard Deviation 1.60
|
0.68 Units on a scale
Standard Deviation 1.53
|
0.28 Units on a scale
Standard Deviation 1.74
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
|
1.00 Units on a scale
Standard Deviation 1.95
|
0.74 Units on a scale
Standard Deviation 1.45
|
0.56 Units on a scale
Standard Deviation 2.09
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
|
1.43 Units on a scale
Standard Deviation 1.99
|
1.05 Units on a scale
Standard Deviation 1.22
|
0.44 Units on a scale
Standard Deviation 1.82
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
|
2.81 Units on a scale
Standard Deviation 1.86
|
2.84 Units on a scale
Standard Deviation 1.64
|
2.89 Units on a scale
Standard Deviation 2.14
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
|
1.00 Units on a scale
Standard Deviation 2.32
|
0.84 Units on a scale
Standard Deviation 1.64
|
0.61 Units on a scale
Standard Deviation 2.20
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
|
1.43 Units on a scale
Standard Deviation 2.23
|
0.74 Units on a scale
Standard Deviation 1.28
|
0.78 Units on a scale
Standard Deviation 2.41
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
|
1.38 Units on a scale
Standard Deviation 2.25
|
1.16 Units on a scale
Standard Deviation 1.92
|
0.67 Units on a scale
Standard Deviation 2.09
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on burning sensation of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
|
2.81 Units on a scale
Standard Deviation 1.69
|
2.37 Units on a scale
Standard Deviation 1.86
|
2.28 Units on a scale
Standard Deviation 2.05
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
|
0.57 Units on a scale
Standard Deviation 1.57
|
0.37 Units on a scale
Standard Deviation 1.30
|
-0.44 Units on a scale
Standard Deviation 1.65
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
|
0.76 Units on a scale
Standard Deviation 1.81
|
0.89 Units on a scale
Standard Deviation 1.49
|
-0.06 Units on a scale
Standard Deviation 2.53
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
|
1.24 Units on a scale
Standard Deviation 1.92
|
1.58 Units on a scale
Standard Deviation 1.71
|
0.61 Units on a scale
Standard Deviation 2.33
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
|
0.86 Units on a scale
Standard Deviation 1.98
|
1.37 Units on a scale
Standard Deviation 1.54
|
0.78 Units on a scale
Standard Deviation 1.90
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
|
1.14 Units on a scale
Standard Deviation 1.96
|
1.16 Units on a scale
Standard Deviation 1.86
|
0.56 Units on a scale
Standard Deviation 2.28
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
|
0.67 Units on a scale
Standard Deviation 2.35
|
1.05 Units on a scale
Standard Deviation 1.72
|
0.44 Units on a scale
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on skin pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
|
2.95 Units on a scale
Standard Deviation 1.63
|
2.21 Units on a scale
Standard Deviation 1.78
|
2.72 Units on a scale
Standard Deviation 2.11
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
|
0.90 Units on a scale
Standard Deviation 1.76
|
1.00 Units on a scale
Standard Deviation 1.41
|
0.50 Units on a scale
Standard Deviation 2.26
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
|
1.24 Units on a scale
Standard Deviation 2.00
|
1.32 Units on a scale
Standard Deviation 1.45
|
0.89 Units on a scale
Standard Deviation 2.30
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
|
1.29 Units on a scale
Standard Deviation 2.05
|
1.32 Units on a scale
Standard Deviation 1.45
|
0.78 Units on a scale
Standard Deviation 2.73
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
|
1.10 Units on a scale
Standard Deviation 2.02
|
1.63 Units on a scale
Standard Deviation 1.71
|
1.00 Units on a scale
Standard Deviation 2.45
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
|
0.48 Units on a scale
Standard Deviation 1.75
|
0.89 Units on a scale
Standard Deviation 1.59
|
0.28 Units on a scale
Standard Deviation 1.96
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
|
0.62 Units on a scale
Standard Deviation 2.27
|
1.37 Units on a scale
Standard Deviation 1.89
|
0.67 Units on a scale
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on joint pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
|
4.43 Units on a scale
Standard Deviation 1.16
|
3.79 Units on a scale
Standard Deviation 1.40
|
4.17 Units on a scale
Standard Deviation 1.58
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
|
-0.52 Units on a scale
Standard Deviation 1.21
|
0.05 Units on a scale
Standard Deviation 0.91
|
0.22 Units on a scale
Standard Deviation 1.77
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
|
-0.33 Units on a scale
Standard Deviation 1.20
|
0.21 Units on a scale
Standard Deviation 1.03
|
0.33 Units on a scale
Standard Deviation 1.53
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
|
-0.33 Units on a scale
Standard Deviation 1.11
|
-0.05 Units on a scale
Standard Deviation 1.18
|
0.17 Units on a scale
Standard Deviation 0.99
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
|
-0.29 Units on a scale
Standard Deviation 1.15
|
0.21 Units on a scale
Standard Deviation 1.18
|
0.00 Units on a scale
Standard Deviation 2.35
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
|
-0.14 Units on a scale
Standard Deviation 0.85
|
0.37 Units on a scale
Standard Deviation 1.38
|
-0.28 Units on a scale
Standard Deviation 1.60
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
|
-0.57 Units on a scale
Standard Deviation 1.47
|
0.05 Units on a scale
Standard Deviation 1.22
|
0.17 Units on a scale
Standard Deviation 1.95
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their comfort level with their personal appearance. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
|
1.14 Units on a scale
Standard Deviation 1.56
|
0.79 Units on a scale
Standard Deviation 0.79
|
0.83 Units on a scale
Standard Deviation 1.10
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
|
0.43 Units on a scale
Standard Deviation 1.21
|
0.63 Units on a scale
Standard Deviation 1.46
|
-0.11 Units on a scale
Standard Deviation 1.23
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
|
1.57 Units on a scale
Standard Deviation 2.29
|
2.21 Units on a scale
Standard Deviation 1.13
|
0.78 Units on a scale
Standard Deviation 1.44
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
|
0.90 Units on a scale
Standard Deviation 1.64
|
1.05 Units on a scale
Standard Deviation 1.43
|
-0.11 Units on a scale
Standard Deviation 1.23
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
|
1.48 Units on a scale
Standard Deviation 1.91
|
1.58 Units on a scale
Standard Deviation 1.61
|
0.44 Units on a scale
Standard Deviation 1.29
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
|
1.52 Units on a scale
Standard Deviation 2.18
|
1.89 Units on a scale
Standard Deviation 1.41
|
0.17 Units on a scale
Standard Deviation 1.34
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
|
1.90 Units on a scale
Standard Deviation 2.51
|
1.68 Units on a scale
Standard Deviation 1.29
|
0.72 Units on a scale
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their anxiety. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
|
2.29 Units on a scale
Standard Deviation 1.87
|
1.89 Units on a scale
Standard Deviation 1.73
|
2.22 Units on a scale
Standard Deviation 1.80
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
|
1.05 Units on a scale
Standard Deviation 1.66
|
0.63 Units on a scale
Standard Deviation 1.89
|
-0.39 Units on a scale
Standard Deviation 1.54
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
|
1.24 Units on a scale
Standard Deviation 1.55
|
1.21 Units on a scale
Standard Deviation 1.84
|
-0.61 Units on a scale
Standard Deviation 1.61
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
|
1.57 Units on a scale
Standard Deviation 1.91
|
1.47 Units on a scale
Standard Deviation 1.95
|
0.33 Units on a scale
Standard Deviation 2.06
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
|
1.52 Units on a scale
Standard Deviation 2.14
|
1.68 Units on a scale
Standard Deviation 1.73
|
0.22 Units on a scale
Standard Deviation 2.60
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
|
1.57 Units on a scale
Standard Deviation 2.01
|
1.53 Units on a scale
Standard Deviation 1.87
|
0.56 Units on a scale
Standard Deviation 2.15
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
|
1.24 Units on a scale
Standard Deviation 1.95
|
1.58 Units on a scale
Standard Deviation 1.68
|
0.67 Units on a scale
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their depression. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
|
2.43 Units on a scale
Standard Deviation 1.91
|
1.95 Units on a scale
Standard Deviation 1.72
|
2.33 Units on a scale
Standard Deviation 1.85
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
|
0.95 Units on a scale
Standard Deviation 1.32
|
1.11 Units on a scale
Standard Deviation 1.63
|
-0.11 Units on a scale
Standard Deviation 1.18
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
|
1.33 Units on a scale
Standard Deviation 1.59
|
1.26 Units on a scale
Standard Deviation 1.97
|
-0.22 Units on a scale
Standard Deviation 1.59
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
|
1.19 Units on a scale
Standard Deviation 2.02
|
1.68 Units on a scale
Standard Deviation 1.70
|
0.67 Units on a scale
Standard Deviation 1.50
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
|
1.38 Units on a scale
Standard Deviation 1.83
|
1.47 Units on a scale
Standard Deviation 2.20
|
0.28 Units on a scale
Standard Deviation 1.41
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
|
1.71 Units on a scale
Standard Deviation 2.05
|
1.58 Units on a scale
Standard Deviation 1.64
|
0.17 Units on a scale
Standard Deviation 2.04
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
|
1.57 Units on a scale
Standard Deviation 2.09
|
1.47 Units on a scale
Standard Deviation 1.81
|
0.61 Units on a scale
Standard Deviation 1.58
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their fatigue. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
|
2.95 Units on a scale
Standard Deviation 1.75
|
1.74 Units on a scale
Standard Deviation 1.52
|
2.78 Units on a scale
Standard Deviation 1.73
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
|
0.48 Units on a scale
Standard Deviation 1.86
|
0.89 Units on a scale
Standard Deviation 1.56
|
-0.72 Units on a scale
Standard Deviation 1.99
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
|
0.29 Units on a scale
Standard Deviation 1.82
|
0.95 Units on a scale
Standard Deviation 2.07
|
-0.33 Units on a scale
Standard Deviation 2.35
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
|
0.48 Units on a scale
Standard Deviation 1.89
|
1.37 Units on a scale
Standard Deviation 1.61
|
-0.61 Units on a scale
Standard Deviation 2.06
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
|
0.29 Units on a scale
Standard Deviation 1.76
|
0.68 Units on a scale
Standard Deviation 1.80
|
-0.56 Units on a scale
Standard Deviation 2.01
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
|
0.48 Units on a scale
Standard Deviation 1.89
|
0.95 Units on a scale
Standard Deviation 1.72
|
-0.89 Units on a scale
Standard Deviation 2.42
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
|
0.24 Units on a scale
Standard Deviation 2.02
|
1.21 Units on a scale
Standard Deviation 2.20
|
-0.67 Units on a scale
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how others responded to their personal appearance at work/school. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
|
2.29 Units on a scale
Standard Deviation 1.85
|
1.53 Units on a scale
Standard Deviation 1.02
|
1.83 Units on a scale
Standard Deviation 1.62
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
|
0.00 Units on a scale
Standard Deviation 1.67
|
0.53 Units on a scale
Standard Deviation 1.50
|
-0.39 Units on a scale
Standard Deviation 1.58
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
|
1.00 Units on a scale
Standard Deviation 1.73
|
1.11 Units on a scale
Standard Deviation 1.56
|
-0.22 Units on a scale
Standard Deviation 1.77
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
|
0.95 Units on a scale
Standard Deviation 1.91
|
1.53 Units on a scale
Standard Deviation 1.43
|
-0.33 Units on a scale
Standard Deviation 1.88
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
|
0.95 Units on a scale
Standard Deviation 1.86
|
1.42 Units on a scale
Standard Deviation 1.57
|
0.11 Units on a scale
Standard Deviation 2.14
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
|
0.95 Units on a scale
Standard Deviation 1.99
|
1.63 Units on a scale
Standard Deviation 1.46
|
-0.11 Units on a scale
Standard Deviation 2.05
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
|
1.05 Units on a scale
Standard Deviation 1.69
|
0.74 Units on a scale
Standard Deviation 1.05
|
-0.33 Units on a scale
Standard Deviation 1.91
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how their skin affected social and leisure activities. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
|
0.57 Units on a scale
Standard Deviation 1.36
|
0.74 Units on a scale
Standard Deviation 1.41
|
-0.06 Units on a scale
Standard Deviation 1.43
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
|
1.10 Units on a scale
Standard Deviation 1.64
|
0.89 Units on a scale
Standard Deviation 0.99
|
0.22 Units on a scale
Standard Deviation 1.73
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
|
1.76 Units on a scale
Standard Deviation 1.79
|
1.58 Units on a scale
Standard Deviation 1.61
|
0.28 Units on a scale
Standard Deviation 1.45
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
|
1.90 Units on a scale
Standard Deviation 1.84
|
1.68 Units on a scale
Standard Deviation 1.70
|
0.50 Units on a scale
Standard Deviation 1.82
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
|
0.95 Units on a scale
Standard Deviation 1.02
|
0.89 Units on a scale
Standard Deviation 0.94
|
1.39 Units on a scale
Standard Deviation 1.50
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
|
2.10 Units on a scale
Standard Deviation 2.02
|
1.89 Units on a scale
Standard Deviation 1.52
|
-0.06 Units on a scale
Standard Deviation 1.70
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
|
1.57 Units on a scale
Standard Deviation 2.09
|
1.95 Units on a scale
Standard Deviation 1.61
|
0.28 Units on a scale
Standard Deviation 2.08
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: very dissatisfied (0), dissatisfied (1), neither satisfied nor dissatisfied (2), satisfied (3), very satisfied (4). Change = Week X minus Baseline, where larger scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
|
1.19 Units on a scale
Standard Deviation 1.12
|
1.37 Units on a scale
Standard Deviation 1.21
|
1.41 Units on a scale
Standard Deviation 1.18
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
|
1.24 Units on a scale
Standard Deviation 1.18
|
1.00 Units on a scale
Standard Deviation 1.60
|
0.18 Units on a scale
Standard Deviation 1.55
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
|
1.67 Units on a scale
Standard Deviation 1.20
|
1.00 Units on a scale
Standard Deviation 1.37
|
0.12 Units on a scale
Standard Deviation 1.58
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
|
1.67 Units on a scale
Standard Deviation 1.32
|
1.37 Units on a scale
Standard Deviation 1.83
|
0.53 Units on a scale
Standard Deviation 1.55
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
|
1.90 Units on a scale
Standard Deviation 1.51
|
1.53 Units on a scale
Standard Deviation 1.74
|
0.35 Units on a scale
Standard Deviation 1.87
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
|
1.86 Units on a scale
Standard Deviation 1.56
|
1.74 Units on a scale
Standard Deviation 1.52
|
0.82 Units on a scale
Standard Deviation 1.78
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
|
1.38 Units on a scale
Standard Deviation 1.47
|
1.68 Units on a scale
Standard Deviation 1.60
|
0.76 Units on a scale
Standard Deviation 1.95
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to respond to the statement "I would like to continue with my current psoriasis treatment". Responses were based on a 5-point scale: strongly disagree (0), disagree(1), neither agree nor disagree (2), agree (3), strongly agree (4). Change = Week X minus Baseline, where larger scores indicate improvement.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
|
3.10 Units on a scale
Standard Deviation 1.22
|
3.42 Units on a scale
Standard Deviation 1.02
|
2.82 Units on a scale
Standard Deviation 1.42
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 2
|
0.48 Units on a scale
Standard Deviation 1.17
|
0.11 Units on a scale
Standard Deviation 1.20
|
0.00 Units on a scale
Standard Deviation 1.80
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 18
|
0.48 Units on a scale
Standard Deviation 1.50
|
0.21 Units on a scale
Standard Deviation 1.13
|
-0.29 Units on a scale
Standard Deviation 2.08
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 4
|
0.67 Units on a scale
Standard Deviation 1.24
|
0.05 Units on a scale
Standard Deviation 1.18
|
-0.12 Units on a scale
Standard Deviation 1.93
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 8
|
0.52 Units on a scale
Standard Deviation 1.54
|
0.26 Units on a scale
Standard Deviation 1.05
|
0.06 Units on a scale
Standard Deviation 1.98
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 12
|
0.48 Units on a scale
Standard Deviation 1.50
|
0.16 Units on a scale
Standard Deviation 1.21
|
-0.29 Units on a scale
Standard Deviation 2.14
|
|
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24
Change at Week 24
|
0.14 Units on a scale
Standard Deviation 1.53
|
0.11 Units on a scale
Standard Deviation 1.10
|
-0.18 Units on a scale
Standard Deviation 1.88
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a "yes" or "no", "Taking into account your psoriasis symptoms, the appearance of your skin and all other problems which psoriasis causes, do you consider that your current health state is satisfactory?" Percentage of participants who responded "yes" reported.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
|
9.52 Percentage of participants
Interval 1.17 to 30.38
|
15.79 Percentage of participants
Interval 3.38 to 39.58
|
22.22 Percentage of participants
Interval 6.41 to 47.64
|
|
Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24
Week 4
|
42.86 Percentage of participants
Interval 21.82 to 65.98
|
52.63 Percentage of participants
Interval 28.86 to 75.55
|
33.33 Percentage of participants
Interval 13.34 to 59.01
|
|
Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24
Week 8
|
57.14 Percentage of participants
Interval 34.02 to 78.18
|
57.89 Percentage of participants
Interval 33.5 to 79.75
|
33.33 Percentage of participants
Interval 13.34 to 59.01
|
|
Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24
Week 12
|
71.43 Percentage of participants
Interval 47.82 to 88.72
|
57.89 Percentage of participants
Interval 33.5 to 79.75
|
33.33 Percentage of participants
Interval 13.34 to 59.01
|
|
Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24
Week 18
|
71.43 Percentage of participants
Interval 47.82 to 88.72
|
63.16 Percentage of participants
Interval 38.36 to 83.71
|
38.89 Percentage of participants
Interval 17.3 to 64.25
|
|
Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24
Week 24
|
57.14 Percentage of participants
Interval 34.02 to 78.18
|
73.68 Percentage of participants
Interval 48.8 to 90.85
|
38.89 Percentage of participants
Interval 17.3 to 64.25
|
|
Change From Baseline in the Percentage of Participants Who Responded "Yes" to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24
Week 2
|
14.29 Percentage of participants
Interval 3.05 to 36.34
|
42.11 Percentage of participants
Interval 20.25 to 66.5
|
27.78 Percentage of participants
Interval 9.69 to 53.48
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 18 and 24Population: mITT; LOCF
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a "yes" or "no", "Taking into account your psoriasis symptoms, the appearance of your skin, medicine side effects and medicine ease/difficulty of use, do you consider that your current psoriasis treatment is satisfactory?" Percentage of participants who responded "yes" reported.
Outcome measures
| Measure |
Etanercept
n=21 Participants
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=19 Participants
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 Participants
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24
Week 2
|
80.95 percentage of participants
Interval 58.09 to 94.55
|
78.95 percentage of participants
Interval 54.43 to 93.95
|
50.00 percentage of participants
Interval 26.02 to 73.98
|
|
Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24
Week 4
|
85.71 percentage of participants
Interval 63.66 to 96.95
|
94.74 percentage of participants
Interval 73.97 to 99.87
|
55.56 percentage of participants
Interval 30.76 to 78.47
|
|
Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24
Week 8
|
90.48 percentage of participants
Interval 69.62 to 98.83
|
89.47 percentage of participants
Interval 66.86 to 98.7
|
66.67 percentage of participants
Interval 40.99 to 86.66
|
|
Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24
Week 12
|
95.24 percentage of participants
Interval 76.18 to 99.88
|
73.68 percentage of participants
Interval 48.8 to 90.85
|
61.11 percentage of participants
Interval 35.75 to 82.7
|
|
Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24
Week 18
|
90.48 percentage of participants
Interval 69.62 to 98.83
|
94.74 percentage of participants
Interval 73.97 to 99.87
|
61.11 percentage of participants
Interval 35.75 to 82.7
|
|
Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24
Week 24
|
80.95 percentage of participants
Interval 58.09 to 94.55
|
94.74 percentage of participants
Interval 73.97 to 99.87
|
55.56 percentage of participants
Interval 30.76 to 78.47
|
|
Change From Baseline in the Percentage of Participants Who Responded "Yes" to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24
Baseline
|
38.10 percentage of participants
Interval 18.11 to 61.56
|
42.11 percentage of participants
Interval 20.25 to 66.5
|
33.33 percentage of participants
Interval 14.21 to 61.67
|
Adverse Events
Etanercept
Etanercept and Acitretin
Acitretin
Serious adverse events
| Measure |
Etanercept
n=21 participants at risk
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=20 participants at risk
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 participants at risk
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Etanercept
n=21 participants at risk
Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
|
Etanercept and Acitretin
n=20 participants at risk
Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
|
Acitretin
n=18 participants at risk
Acitretin 10 mg subcutaneous injection BID for 24 weeks
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
3/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
10.0%
2/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
20.0%
4/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
10.0%
2/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
15.0%
3/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
11.1%
2/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
10.0%
2/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
11.1%
2/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
11.1%
2/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
10.0%
2/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
10.0%
2/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Hepatic enzyme increased
|
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Liver function test abnormal
|
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
White blood cell count increased
|
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
2/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
11.1%
2/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Asthenia
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Condition aggravated
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site reaction
|
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
10.0%
2/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Flushing
|
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.6%
1/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
4.8%
1/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Paronychia
|
0.00%
0/21
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/18
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER