Trial Outcomes & Findings for Effectiveness and Safety of 3 Dosing Regimens of CP-690,550 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis (NCT NCT00678210)

NCT ID: NCT00678210

Last Updated: 2012-12-19

Results Overview

Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

197 participants

Primary outcome timeframe

Week 12

Results posted on

2012-12-19

Participant Flow

Participant milestones

Participant milestones
Measure
CP-690,550 2 mg
CP-690,550 tablets equivalent to CP-690,550 2 milligram (mg) orally twice daily for 12 weeks.
CP-690,550 5 mg
CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
CP-690,550 15 mg
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
Placebo
Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
Overall Study
STARTED
49
49
49
50
Overall Study
COMPLETED
38
38
43
30
Overall Study
NOT COMPLETED
11
11
6
20

Reasons for withdrawal

Reasons for withdrawal
Measure
CP-690,550 2 mg
CP-690,550 tablets equivalent to CP-690,550 2 milligram (mg) orally twice daily for 12 weeks.
CP-690,550 5 mg
CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
CP-690,550 15 mg
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
Placebo
Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
Overall Study
Adverse Event
1
2
3
3
Overall Study
Lack of Efficacy
2
3
1
9
Overall Study
Lost to Follow-up
4
2
0
1
Overall Study
Withdrawal by Subject
3
4
1
7
Overall Study
Other
1
0
1
0

Baseline Characteristics

Effectiveness and Safety of 3 Dosing Regimens of CP-690,550 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
CP-690,550 2 mg
n=49 Participants
CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
CP-690,550 5 mg
n=49 Participants
CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
CP-690,550 15 mg
n=49 Participants
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
Placebo
n=50 Participants
Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
Total
n=197 Participants
Total of all reporting groups
Age, Customized
18 to 44 years
23 participants
n=5 Participants
25 participants
n=7 Participants
28 participants
n=5 Participants
20 participants
n=4 Participants
96 participants
n=21 Participants
Age, Customized
45 to 54 years
13 participants
n=5 Participants
14 participants
n=7 Participants
10 participants
n=5 Participants
18 participants
n=4 Participants
55 participants
n=21 Participants
Age, Customized
54 to 64 years
9 participants
n=5 Participants
9 participants
n=7 Participants
6 participants
n=5 Participants
10 participants
n=4 Participants
34 participants
n=21 Participants
Age, Customized
Greater than or equal to 65 years
4 participants
n=5 Participants
1 participants
n=7 Participants
5 participants
n=5 Participants
2 participants
n=4 Participants
12 participants
n=21 Participants
Sex: Female, Male
Female
20 Participants
n=5 Participants
20 Participants
n=7 Participants
18 Participants
n=5 Participants
14 Participants
n=4 Participants
72 Participants
n=21 Participants
Sex: Female, Male
Male
29 Participants
n=5 Participants
29 Participants
n=7 Participants
31 Participants
n=5 Participants
36 Participants
n=4 Participants
125 Participants
n=21 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Full analysis set (FAS) included all randomized participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values were imputed using last observation carried forward (LOCF).

Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

Outcome measures

Outcome measures
Measure
CP-690,550 2 mg
n=48 Participants
CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
CP-690,550 5 mg
n=49 Participants
CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
CP-690,550 15 mg
n=48 Participants
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
Placebo
n=50 Participants
Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12
25.00 percentage of participants
40.82 percentage of participants
66.67 percentage of participants
2.00 percentage of participants

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, 14, 16

Population: FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values imputed using LOCF for week 2, 4, 8, 12 and no imputation done for week 14, 16. n=participants evaluable for this measure at specified time points for each arm group respectively.

Physician global assessment of psoriasis is global consideration of the erythema, induration and scaling across all psoriatic lesions, rated separately over the whole body according to a 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the treatment area overall severity of psoriasis score and category. The score of 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.

Outcome measures

Outcome measures
Measure
CP-690,550 2 mg
n=49 Participants
CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
CP-690,550 5 mg
n=49 Participants
CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
CP-690,550 15 mg
n=48 Participants
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
Placebo
n=50 Participants
Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
Percentage of Participants Achieving Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear"
Week 2 (n=48, 48, 48, 49)
8.33 percentage of participants
12.50 percentage of participants
16.67 percentage of participants
4.08 percentage of participants
Percentage of Participants Achieving Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear"
Week 12 (n=49, 49, 48, 50)
24.49 percentage of participants
40.82 percentage of participants
72.92 percentage of participants
10.00 percentage of participants
Percentage of Participants Achieving Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear"
Week 14 (n=38, 37, 37, 33)
23.68 percentage of participants
35.14 percentage of participants
56.76 percentage of participants
9.09 percentage of participants
Percentage of Participants Achieving Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear"
Week 4 (n=49, 49, 48, 50)
18.37 percentage of participants
28.57 percentage of participants
33.33 percentage of participants
4.00 percentage of participants
Percentage of Participants Achieving Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear"
Week 8 (n=49, 49, 48, 50)
24.49 percentage of participants
44.90 percentage of participants
56.25 percentage of participants
14.00 percentage of participants
Percentage of Participants Achieving Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear"
Week 16 (n=37, 37, 41, 30)
24.32 percentage of participants
18.92 percentage of participants
41.46 percentage of participants
10.00 percentage of participants

SECONDARY outcome

Timeframe: Week 2, 4, 8, 14, 16

Population: FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values imputed using LOCF for week 2, 4, 8 and no imputation done for week 14, 16. n=participants evaluable for this measure at specified time points for each arm group respectively.

Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

Outcome measures

Outcome measures
Measure
CP-690,550 2 mg
n=48 Participants
CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
CP-690,550 5 mg
n=49 Participants
CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
CP-690,550 15 mg
n=48 Participants
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
Placebo
n=50 Participants
Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score
Week 8 (n=48, 49, 48, 50)
20.83 percentage of participants
40.82 percentage of participants
62.50 percentage of participants
2.00 percentage of participants
Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score
Week 2 (n=47, 48, 48, 49)
0.00 percentage of participants
2.08 percentage of participants
2.08 percentage of participants
0.00 percentage of participants
Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score
Week 4 (n=48, 49, 48, 50)
8.33 percentage of participants
14.29 percentage of participants
20.83 percentage of participants
0.00 percentage of participants
Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score
Week 14 (n=38, 37, 37, 33)
23.68 percentage of participants
37.84 percentage of participants
59.46 percentage of participants
6.06 percentage of participants
Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score
Week 16 (n=37, 36, 41, 30)
24.32 percentage of participants
22.22 percentage of participants
39.02 percentage of participants
6.67 percentage of participants

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12, 14, 16

Population: FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values imputed using LOCF for week 2, 4, 8, 12 and no imputation done for week 14, 16. n=participants evaluable for this measure at specified time points for each arm group respectively.

Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

Outcome measures

Outcome measures
Measure
CP-690,550 2 mg
n=48 Participants
CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
CP-690,550 5 mg
n=49 Participants
CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
CP-690,550 15 mg
n=48 Participants
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
Placebo
n=50 Participants
Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Week 2 (n=47, 48, 48, 49)
10.64 percentage of participants
14.58 percentage of participants
25.00 percentage of participants
0.00 percentage of participants
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Week 4 (n=48, 49, 48, 50)
29.17 percentage of participants
44.90 percentage of participants
62.50 percentage of participants
6.00 percentage of participants
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Week 8 (n=48, 49, 48, 50)
41.67 percentage of participants
55.10 percentage of participants
79.17 percentage of participants
14.00 percentage of participants
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Week 12 (n=48, 49, 48, 50)
39.58 percentage of participants
65.31 percentage of participants
87.50 percentage of participants
20.00 percentage of participants
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Week 14 (n=38, 37, 37, 33)
42.11 percentage of participants
59.46 percentage of participants
86.49 percentage of participants
24.24 percentage of participants
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Week 16 (n=37, 36, 41, 30)
40.54 percentage of participants
47.22 percentage of participants
68.29 percentage of participants
23.33 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values imputed using LOCF.

Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

Outcome measures

Outcome measures
Measure
CP-690,550 2 mg
n=48 Participants
CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
CP-690,550 5 mg
n=49 Participants
CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
CP-690,550 15 mg
n=48 Participants
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
Placebo
n=50 Participants
Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
Percentage of Participants Achieving a 90% Improvement in Psoriasis Area and Severity Index (PASI 90) Score
14.58 percentage of participants
18.37 percentage of participants
33.33 percentage of participants
0.00 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 14, 16

Population: FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. No imputation was done. n=participants evaluable for this measure at specified time points for each arm group respectively.

Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

Outcome measures

Outcome measures
Measure
CP-690,550 2 mg
n=48 Participants
CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
CP-690,550 5 mg
n=49 Participants
CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
CP-690,550 15 mg
n=48 Participants
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
Placebo
n=50 Participants
Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 8: Trunk Erythema (n=43, 40, 47, 39)
1.5 units on a scale
Standard Error 0.16
1.3 units on a scale
Standard Error 0.16
1.2 units on a scale
Standard Error 0.16
2.3 units on a scale
Standard Error 0.13
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Baseline: Head/Neck Induration (n=48, 49, 48, 50)
2.0 units on a scale
Standard Error 0.14
1.8 units on a scale
Standard Error 0.13
2.1 units on a scale
Standard Error 0.15
2.0 units on a scale
Standard Error 0.13
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 2: Trunk Induration (n=47, 47, 48, 46)
2.1 units on a scale
Standard Error 0.15
1.7 units on a scale
Standard Error 0.15
2.0 units on a scale
Standard Error 0.13
2.4 units on a scale
Standard Error 0.11
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 14: Lower Limbs Induration (n=38, 37, 37, 33)
1.9 units on a scale
Standard Error 0.16
1.5 units on a scale
Standard Error 0.17
1.3 units on a scale
Standard Error 0.18
2.2 units on a scale
Standard Error 0.14
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 14: Trunk Scaling (n=38, 37, 37, 33)
1.5 units on a scale
Standard Error 0.18
1.3 units on a scale
Standard Error 0.18
1.1 units on a scale
Standard Error 0.18
1.8 units on a scale
Standard Error 0.18
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 2: Upper Limbs Induration(n=47, 48, 48, 49)
2.0 units on a scale
Standard Error 0.13
2.1 units on a scale
Standard Error 0.12
1.9 units on a scale
Standard Error 0.13
2.4 units on a scale
Standard Error 0.10
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 12: Lower Limbs Scaling (n=38, 39, 43, 34)
1.8 units on a scale
Standard Error 0.18
1.4 units on a scale
Standard Error 0.14
0.9 units on a scale
Standard Error 0.13
2.3 units on a scale
Standard Error 0.18
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 14: Head/Neck Scaling (n=38, 37, 37, 33)
1.2 units on a scale
Standard Error 0.18
1.1 units on a scale
Standard Error 0.19
0.9 units on a scale
Standard Error 0.18
1.7 units on a scale
Standard Error 0.18
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 14: Upper Limbs Scaling (n=38, 37, 37, 33)
1.8 units on a scale
Standard Error 0.16
1.6 units on a scale
Standard Error 0.15
1.3 units on a scale
Standard Error 0.17
2.1 units on a scale
Standard Error 0.17
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Baseline: Head/Neck Erythema (n=48, 49, 48, 50)
2.1 units on a scale
Standard Error 0.13
2.1 units on a scale
Standard Error 0.14
2.4 units on a scale
Standard Error 0.15
2.4 units on a scale
Standard Error 0.12
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Baseline: Upper Limbs Erythema (n=48, 49, 48, 50)
2.8 units on a scale
Standard Error 0.09
2.7 units on a scale
Standard Error 0.11
2.8 units on a scale
Standard Error 0.10
2.9 units on a scale
Standard Error 0.07
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Baseline: Trunk Erythema (n=48, 49, 48, 50)
2.6 units on a scale
Standard Error 0.13
2.6 units on a scale
Standard Error 0.14
2.9 units on a scale
Standard Error 0.10
2.8 units on a scale
Standard Error 0.09
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Baseline: Lower Limbs Erythema (n=48, 49, 48, 50)
3.0 units on a scale
Standard Error 0.08
2.9 units on a scale
Standard Error 0.11
3.0 units on a scale
Standard Error 0.11
3.1 units on a scale
Standard Error 0.08
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 2: Head/Neck Erythema (n=47, 48, 48, 49)
1.8 units on a scale
Standard Error 0.15
1.4 units on a scale
Standard Error 0.14
1.4 units on a scale
Standard Error 0.15
2.2 units on a scale
Standard Error 0.12
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 2: Upper Limbs Erythema (n=47, 48, 48, 49)
2.2 units on a scale
Standard Error 0.12
2.2 units on a scale
Standard Error 0.13
2.0 units on a scale
Standard Error 0.10
2.7 units on a scale
Standard Error 0.09
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 2: Trunk Erythema (n=47, 48, 48, 49)
2.1 units on a scale
Standard Error 0.14
2.0 units on a scale
Standard Error 0.17
2.1 units on a scale
Standard Error 0.14
2.7 units on a scale
Standard Error 0.09
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 2: Lower Limbs Erythema (n=47, 48, 48, 49)
2.6 units on a scale
Standard Error 0.11
2.4 units on a scale
Standard Error 0.13
2.3 units on a scale
Standard Error 0.14
2.9 units on a scale
Standard Error 0.11
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 4: Head/Neck Erythema (n=47, 47, 48, 46)
1.5 units on a scale
Standard Error 0.14
1.1 units on a scale
Standard Error 0.15
1.0 units on a scale
Standard Error 0.14
2.1 units on a scale
Standard Error 0.15
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 4: Upper Limbs Erythema (n=47, 47, 48, 46)
1.9 units on a scale
Standard Error 0.13
1.7 units on a scale
Standard Error 0.14
1.5 units on a scale
Standard Error 0.09
2.5 units on a scale
Standard Error 0.11
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 4: Trunk Erythema (n= 47, 47, 48, 46)
1.8 units on a scale
Standard Error 0.15
1.7 units on a scale
Standard Error 0.17
1.6 units on a scale
Standard Error 0.13
2.5 units on a scale
Standard Error 0.11
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 4: Lower Limbs Erythema (n= 47, 47, 48, 46)
2.3 units on a scale
Standard Error 0.13
2.0 units on a scale
Standard Error 0.15
1.8 units on a scale
Standard Error 0.13
2.8 units on a scale
Standard Error 0.11
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 8: Head/Neck Erythema (n=43, 40, 47, 39)
1.2 units on a scale
Standard Error 0.15
0.8 units on a scale
Standard Error 0.16
0.6 units on a scale
Standard Error 0.13
1.8 units on a scale
Standard Error 0.18
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 8: Upper Limbs Erythema (n=43, 40, 47, 39)
1.6 units on a scale
Standard Error 0.15
1.4 units on a scale
Standard Error 0.14
1.1 units on a scale
Standard Error 0.12
2.3 units on a scale
Standard Error 0.12
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 8: Lower Limbs Erythema (n=43, 40, 47, 39)
1.8 units on a scale
Standard Error 0.14
1.4 units on a scale
Standard Error 0.16
1.2 units on a scale
Standard Error 0.14
2.5 units on a scale
Standard Error 0.11
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 12: Head/Neck Erythema (n=38, 39, 43, 34)
1.1 units on a scale
Standard Error 0.17
0.8 units on a scale
Standard Error 0.15
0.4 units on a scale
Standard Error 0.11
1.7 units on a scale
Standard Error 0.19
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 12: Upper Limbs Erythema (n=38, 39, 43, 34)
1.5 units on a scale
Standard Error 0.17
1.3 units on a scale
Standard Error 0.12
1.0 units on a scale
Standard Error 0.12
2.3 units on a scale
Standard Error 0.15
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 12: Trunk Erythema (n=38, 39, 43, 34)
1.5 units on a scale
Standard Error 0.18
1.1 units on a scale
Standard Error 0.17
0.9 units on a scale
Standard Error 0.16
2.4 units on a scale
Standard Error 0.17
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 12: Lower Limbs Erythema (n=38, 39, 43, 34)
1.8 units on a scale
Standard Error 0.17
1.3 units on a scale
Standard Error 0.13
1.2 units on a scale
Standard Error 0.15
2.6 units on a scale
Standard Error 0.13
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 14: Head/Neck Erythema (n=38, 37, 37, 33)
1.2 units on a scale
Standard Error 0.18
1.1 units on a scale
Standard Error 0.14
0.9 units on a scale
Standard Error 0.17
1.7 units on a scale
Standard Error 0.20
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 14: Upper Limbs Erythema (n=38, 37, 37, 33)
1.8 units on a scale
Standard Error 0.17
1.5 units on a scale
Standard Error 0.16
1.3 units on a scale
Standard Error 0.16
2.3 units on a scale
Standard Error 0.14
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 14: Trunk Erythema (n=38, 37, 37, 33)
1.6 units on a scale
Standard Error 0.19
1.4 units on a scale
Standard Error 0.18
1.2 units on a scale
Standard Error 0.20
2.4 units on a scale
Standard Error 0.18
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 14: Lower Limbs Erythema (n=38, 37, 37, 33)
2.0 units on a scale
Standard Error 0.17
1.6 units on a scale
Standard Error 0.17
1.4 units on a scale
Standard Error 0.18
2.6 units on a scale
Standard Error 0.11
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 16: Head/Neck Erythema (n=37, 36, 41, 30)
1.3 units on a scale
Standard Error 0.20
1.5 units on a scale
Standard Error 0.16
1.0 units on a scale
Standard Error 0.18
1.8 units on a scale
Standard Error 0.22
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 16: Upper Limbs Erythema (n=37, 36, 41, 30)
1.9 units on a scale
Standard Error 0.21
1.8 units on a scale
Standard Error 0.14
1.7 units on a scale
Standard Error 0.15
2.3 units on a scale
Standard Error 0.14
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 16: Trunk Erythema (n=37, 36, 41, 30)
1.8 units on a scale
Standard Error 0.21
1.8 units on a scale
Standard Error 0.17
1.8 units on a scale
Standard Error 0.18
2.3 units on a scale
Standard Error 0.18
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 16: Lower Limbs Erythema (n=37, 36, 41, 30)
2.2 units on a scale
Standard Error 0.18
1.8 units on a scale
Standard Error 0.15
1.7 units on a scale
Standard Error 0.18
2.7 units on a scale
Standard Error 0.13
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Baseline: Upper Limbs Induration(n=48, 49, 48, 50)
2.5 units on a scale
Standard Error 0.11
2.6 units on a scale
Standard Error 0.11
2.7 units on a scale
Standard Error 0.11
2.5 units on a scale
Standard Error 0.10
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Baseline: Trunk Induration (n=48, 49, 48, 50)
2.4 units on a scale
Standard Error 0.12
2.3 units on a scale
Standard Error 0.12
2.6 units on a scale
Standard Error 0.12
2.7 units on a scale
Standard Error 0.09
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Baseline: Lower Limbs Induration(n=48, 49, 48, 50)
2.8 units on a scale
Standard Error 0.09
2.7 units on a scale
Standard Error 0.10
2.8 units on a scale
Standard Error 0.12
2.7 units on a scale
Standard Error 0.09
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 2: Head/Neck Induration (n=47, 48, 48, 49)
1.4 units on a scale
Standard Error 0.15
1.4 units on a scale
Standard Error 0.14
1.3 units on a scale
Standard Error 0.15
1.9 units on a scale
Standard Error 0.12
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 2: Lower Limbs Induration(n=47, 48, 48, 49)
2.5 units on a scale
Standard Error 0.12
2.4 units on a scale
Standard Error 0.12
2.1 units on a scale
Standard Error 0.14
2.6 units on a scale
Standard Error 0.09
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 4: Head/Neck Induration (n=47, 47, 48, 46)
1.2 units on a scale
Standard Error 0.14
0.8 units on a scale
Standard Error 0.13
0.8 units on a scale
Standard Error 0.14
1.7 units on a scale
Standard Error 0.14
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 4: Upper Limbs Induration (n=47, 47, 48, 46)
1.9 units on a scale
Standard Error 0.13
1.7 units on a scale
Standard Error 0.13
1.4 units on a scale
Standard Error 0.14
2.2 units on a scale
Standard Error 0.12
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 4: Trunk Induration (n=47, 47, 48, 46)
1.7 units on a scale
Standard Error 0.15
1.5 units on a scale
Standard Error 0.15
1.4 units on a scale
Standard Error 0.14
2.3 units on a scale
Standard Error 0.11
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 4: Lower Limbs Induration (n=47, 47, 48, 46)
2.2 units on a scale
Standard Error 0.14
1.9 units on a scale
Standard Error 0.13
1.6 units on a scale
Standard Error 0.14
2.3 units on a scale
Standard Error 0.11
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 8: Head/Neck Induration (n=43, 40, 47, 39)
1.0 units on a scale
Standard Error 0.14
0.6 units on a scale
Standard Error 0.14
0.5 units on a scale
Standard Error 0.13
1.5 units on a scale
Standard Error 0.14
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 8: Upper Limbs Induration (n=43, 40, 47, 39)
1.7 units on a scale
Standard Error 0.16
1.4 units on a scale
Standard Error 0.14
1.2 units on a scale
Standard Error 0.15
2.2 units on a scale
Standard Error 0.12
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 8: Trunk Induration (n=43, 40, 47, 39)
1.5 units on a scale
Standard Error 0.17
1.1 units on a scale
Standard Error 0.17
1.1 units on a scale
Standard Error 0.16
2.0 units on a scale
Standard Error 0.13
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 8: Lower Limbs Induration (n=43, 40, 47, 39)
1.8 units on a scale
Standard Error 0.17
1.3 units on a scale
Standard Error 0.15
1.2 units on a scale
Standard Error 0.16
2.2 units on a scale
Standard Error 0.12
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 12: Head/Neck Induration (n=38, 39, 43, 34)
1.0 units on a scale
Standard Error 0.17
0.5 units on a scale
Standard Error 0.12
0.3 units on a scale
Standard Error 0.10
1.5 units on a scale
Standard Error 0.18
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 12: Upper Limbs Induration (n=38, 37, 37, 33)
1.4 units on a scale
Standard Error 0.17
1.2 units on a scale
Standard Error 0.12
1.0 units on a scale
Standard Error 0.14
2.0 units on a scale
Standard Error 0.16
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 12: Trunk Induration (n=38, 39, 43, 34)
1.4 units on a scale
Standard Error 0.18
0.9 units on a scale
Standard Error 0.16
0.8 units on a scale
Standard Error 0.15
2.0 units on a scale
Standard Error 0.17
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 12: Lower limbs induration (n=38, 39, 43, 34)
1.7 units on a scale
Standard Error 0.17
1.2 units on a scale
Standard Error 0.14
1.0 units on a scale
Standard Error 0.14
2.2 units on a scale
Standard Error 0.14
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 14: Head/Neck Induration (n=38, 37, 37, 33)
1.0 units on a scale
Standard Error 0.16
0.9 units on a scale
Standard Error 0.15
0.7 units on a scale
Standard Error 0.16
1.4 units on a scale
Standard Error 0.17
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 14: Upper Limbs Induration (n=38, 37, 37, 33)
1.8 units on a scale
Standard Error 0.18
1.4 units on a scale
Standard Error 0.16
1.3 units on a scale
Standard Error 0.16
2.1 units on a scale
Standard Error 0.14
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 14: Trunk Induration (n=38, 37, 37, 33)
1.4 units on a scale
Standard Error 0.18
1.3 units on a scale
Standard Error 0.18
1.1 units on a scale
Standard Error 0.18
1.9 units on a scale
Standard Error 0.17
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 16: Head/Neck Induration (n=37, 36, 41, 30)
1.1 units on a scale
Standard Error 0.18
1.2 units on a scale
Standard Error 0.17
0.8 units on a scale
Standard Error 0.15
1.6 units on a scale
Standard Error 0.18
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 16: Upper Limbs Induration (n=37, 36, 41, 30)
1.8 units on a scale
Standard Error 0.20
1.9 units on a scale
Standard Error 0.16
1.5 units on a scale
Standard Error 0.16
2.2 units on a scale
Standard Error 0.15
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 16: Trunk Induration (n=37, 36, 41, 30)
1.5 units on a scale
Standard Error 0.20
1.6 units on a scale
Standard Error 0.18
1.5 units on a scale
Standard Error 0.17
2.1 units on a scale
Standard Error 0.18
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 16: Lower Limbs Induration (n=37, 36, 41, 30)
1.9 units on a scale
Standard Error 0.19
1.8 units on a scale
Standard Error 0.15
1.4 units on a scale
Standard Error 0.17
2.4 units on a scale
Standard Error 0.14
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 14: Lower Limbs Scaling (n=38, 37, 37, 33)
1.9 units on a scale
Standard Error 0.18
1.5 units on a scale
Standard Error 0.16
1.3 units on a scale
Standard Error 0.20
2.2 units on a scale
Standard Error 0.19
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Baseline: Head/Neck Scaling (n=48, 49, 48, 50)
2.1 units on a scale
Standard Error 0.16
2.2 units on a scale
Standard Error 0.13
2.3 units on a scale
Standard Error 0.14
2.2 units on a scale
Standard Error 0.14
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Baseline: Upper Limbs Scaling (n=48, 49, 48, 50)
2.5 units on a scale
Standard Error 0.10
2.8 units on a scale
Standard Error 0.11
2.6 units on a scale
Standard Error 0.09
2.6 units on a scale
Standard Error 0.10
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Baseline: Trunk Scaling (n=48, 49, 48, 50)
2.4 units on a scale
Standard Error 0.14
2.4 units on a scale
Standard Error 0.14
2.5 units on a scale
Standard Error 0.12
2.6 units on a scale
Standard Error 0.11
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Baseline: Lower Limbs Scaling (n=48, 49, 48, 50)
3.1 units on a scale
Standard Error 0.10
2.9 units on a scale
Standard Error 0.11
2.7 units on a scale
Standard Error 0.12
2.9 units on a scale
Standard Error 0.09
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 2: Head/Neck Scaling (n=47, 48, 48, 49)
1.7 units on a scale
Standard Error 0.16
1.6 units on a scale
Standard Error 0.16
1.4 units on a scale
Standard Error 0.16
1.9 units on a scale
Standard Error 0.13
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 2: Upper Limbs Scaling (n=48, 49, 48, 50)
2.1 units on a scale
Standard Error 0.13
2.2 units on a scale
Standard Error 0.13
2.0 units on a scale
Standard Error 0.12
2.4 units on a scale
Standard Error 0.11
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 2: Trunk Scaling (n=47, 48, 48, 49)
2.1 units on a scale
Standard Error 0.14
1.8 units on a scale
Standard Error 0.16
1.9 units on a scale
Standard Error 0.12
2.3 units on a scale
Standard Error 0.12
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 2: Lower Limbs Scaling (n=47, 48, 48, 49)
2.6 units on a scale
Standard Error 0.12
2.5 units on a scale
Standard Error 0.14
2.1 units on a scale
Standard Error 0.13
2.7 units on a scale
Standard Error 0.11
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 4: Head/Neck Scaling (n=47, 47, 48, 46)
1.5 units on a scale
Standard Error 0.16
1.1 units on a scale
Standard Error 0.15
0.9 units on a scale
Standard Error 0.14
1.8 units on a scale
Standard Error 0.16
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 4: Upper Limbs Scaling (n=47, 47, 48, 46)
2.0 units on a scale
Standard Error 0.12
1.9 units on a scale
Standard Error 0.16
1.6 units on a scale
Standard Error 0.14
2.3 units on a scale
Standard Error 0.11
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 4: Trunk Scaling (n=47, 47, 48, 46)
1.8 units on a scale
Standard Error 0.15
1.5 units on a scale
Standard Error 0.16
1.4 units on a scale
Standard Error 0.12
2.4 units on a scale
Standard Error 0.12
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 4: Lower Limbs Scaling (n=47, 47, 48, 46)
2.4 units on a scale
Standard Error 0.11
2.0 units on a scale
Standard Error 0.15
1.8 units on a scale
Standard Error 0.14
2.5 units on a scale
Standard Error 0.12
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 8: Head/Neck Scaling (n=43, 40, 47, 39)
1.2 units on a scale
Standard Error 0.15
0.8 units on a scale
Standard Error 0.16
0.7 units on a scale
Standard Error 0.14
1.6 units on a scale
Standard Error 0.16
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 8: Upper Limbs Scaling (n=43, 40, 47, 39)
1.7 units on a scale
Standard Error 0.14
1.5 units on a scale
Standard Error 0.16
1.3 units on a scale
Standard Error 0.14
2.2 units on a scale
Standard Error 0.15
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 8: Trunk Scaling (n=43, 40, 47, 39)
1.4 units on a scale
Standard Error 0.16
1.2 units on a scale
Standard Error 0.19
1.0 units on a scale
Standard Error 0.14
2.1 units on a scale
Standard Error 0.13
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 8: Lower Limbs Scaling (n=43, 40, 47, 39)
1.9 units on a scale
Standard Error 0.16
1.5 units on a scale
Standard Error 0.16
1.3 units on a scale
Standard Error 0.15
2.4 units on a scale
Standard Error 0.15
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 12: Head/Neck Scaling (n=38, 39, 43, 34)
1.0 units on a scale
Standard Error 0.17
0.8 units on a scale
Standard Error 0.14
0.5 units on a scale
Standard Error 0.12
1.6 units on a scale
Standard Error 0.18
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 12: Upper Limbs Scaling (n=38, 39, 43, 34)
1.5 units on a scale
Standard Error 0.16
1.4 units on a scale
Standard Error 0.13
1.1 units on a scale
Standard Error 0.14
2.0 units on a scale
Standard Error 0.18
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 12: Trunk Scaling (n=38, 39, 43, 34)
1.3 units on a scale
Standard Error 0.18
1.0 units on a scale
Standard Error 0.18
0.7 units on a scale
Standard Error 0.12
1.9 units on a scale
Standard Error 0.19
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 16: Head/Neck Scaling (n=37, 36, 41, 30)
1.2 units on a scale
Standard Error 0.19
1.6 units on a scale
Standard Error 0.20
1.0 units on a scale
Standard Error 0.17
1.7 units on a scale
Standard Error 0.22
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 16: Upper Limbs Scaling (n=37, 36, 41, 30)
1.9 units on a scale
Standard Error 0.19
1.7 units on a scale
Standard Error 0.16
1.7 units on a scale
Standard Error 0.16
2.3 units on a scale
Standard Error 0.18
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 16: Trunk Scaling (n=37, 36, 41, 30)
1.7 units on a scale
Standard Error 0.20
1.5 units on a scale
Standard Error 0.18
1.4 units on a scale
Standard Error 0.16
2.0 units on a scale
Standard Error 0.20
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 16: Lower Limbs Scaling (n=37, 36, 41, 30)
2.2 units on a scale
Standard Error 0.19
1.8 units on a scale
Standard Error 0.17
1.5 units on a scale
Standard Error 0.17
2.4 units on a scale
Standard Error 0.19
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Baseline: PASI Total Score
21.5 units on a scale
Standard Error 0.97
21.2 units on a scale
Standard Error 1.15
22.6 units on a scale
Standard Error 1.49
21.5 units on a scale
Standard Error 1.01
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 2: PASI Total Score
17.0 units on a scale
Standard Error 0.97
16.3 units on a scale
Standard Error 1.39
15.3 units on a scale
Standard Error 1.27
20.4 units on a scale
Standard Error 1.23
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 4: PASI Total Score
14.0 units on a scale
Standard Error 0.98
12.3 units on a scale
Standard Error 1.46
10.4 units on a scale
Standard Error 1.13
19.1 units on a scale
Standard Error 1.50
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 8: PASI Total Score
10.7 units on a scale
Standard Error 1.02
8.1 units on a scale
Standard Error 1.45
6.9 units on a scale
Standard Error 1.14
17.3 units on a scale
Standard Error 1.31
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 12: PASI Total Score
9.6 units on a scale
Standard Error 1.18
5.7 units on a scale
Standard Error 0.73
5.0 units on a scale
Standard Error 0.87
15.8 units on a scale
Standard Error 1.30
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 14: PASI Total Score
10.8 units on a scale
Standard Error 1.18
7.6 units on a scale
Standard Error 1.06
6.7 units on a scale
Standard Error 1.37
16.1 units on a scale
Standard Error 1.39
Psoriasis Area and Severity Index (PASI) Component Scores and Total Score
Week 16: PASI Total Score
11.9 units on a scale
Standard Error 1.33
9.1 units on a scale
Standard Error 0.91
8.8 units on a scale
Standard Error 1.26
16.4 units on a scale
Standard Error 1.66

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 14, 16

Population: FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. No imputation was done. n=participants evaluable for this measure at specified time points for each arm group respectively.

Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

Outcome measures

Outcome measures
Measure
CP-690,550 2 mg
n=48 Participants
CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
CP-690,550 5 mg
n=49 Participants
CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
CP-690,550 15 mg
n=48 Participants
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
Placebo
n=50 Participants
Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 14: Head/Neck Erythema (n=38, 37, 37, 33)
-1.0 units on a scale
Standard Error 0.18
-1.0 units on a scale
Standard Error 0.19
-1.5 units on a scale
Standard Error 0.21
-0.6 units on a scale
Standard Error 0.19
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 14: Upper Limbs Erythema (n=38, 37, 37, 33)
-1.1 units on a scale
Standard Error 0.17
-1.0 units on a scale
Standard Error 0.17
-1.5 units on a scale
Standard Error 0.18
-0.7 units on a scale
Standard Error 0.13
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 14: Lower Limbs Erythema (n=38, 37, 37, 33)
-1.1 units on a scale
Standard Error 0.16
-1.2 units on a scale
Standard Error 0.17
-1.6 units on a scale
Standard Error 0.20
-0.4 units on a scale
Standard Error 0.14
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 16: Head/Neck Erythema (n=37, 36, 41, 30)
-0.9 units on a scale
Standard Error 0.19
-0.5 units on a scale
Standard Error 0.18
-1.3 units on a scale
Standard Error 0.21
-0.5 units on a scale
Standard Error 0.22
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 16: Trunk Erythema (n=37, 36, 41, 30)
-0.9 units on a scale
Standard Error 0.22
-0.6 units on a scale
Standard Error 0.17
-1.1 units on a scale
Standard Error 0.20
-0.6 units on a scale
Standard Error 0.19
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 2: Upper Limbs Induration (n=47, 48, 48, 49)
-0.5 units on a scale
Standard Error 0.09
-0.5 units on a scale
Standard Error 0.08
-0.8 units on a scale
Standard Error 0.11
-0.1 units on a scale
Standard Error 0.09
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 12: Trunk Scaling (n=38, 39, 43, 34)
-1.2 units on a scale
Standard Error 0.19
-1.4 units on a scale
Standard Error 0.17
-1.8 units on a scale
Standard Error 0.16
-0.7 units on a scale
Standard Error 0.17
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 2: Trunk Induration (n=47, 48, 48, 49)
-0.4 units on a scale
Standard Error 0.10
-0.6 units on a scale
Standard Error 0.11
-0.6 units on a scale
Standard Error 0.11
-0.3 units on a scale
Standard Error 0.07
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 2: Lower Limbs Induration (n=47, 48, 48, 49)
-0.3 units on a scale
Standard Error 0.08
-0.4 units on a scale
Standard Error 0.08
-0.7 units on a scale
Standard Error 0.12
-0.2 units on a scale
Standard Error 0.09
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 4: Upper Limbs Induration (n=47, 47, 48, 46)
-0.6 units on a scale
Standard Error 0.12
-0.8 units on a scale
Standard Error 0.12
-1.3 units on a scale
Standard Error 0.13
-0.3 units on a scale
Standard Error 0.10
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 4: Trunk Induration (n=47, 47, 48, 46)
-0.8 units on a scale
Standard Error 0.12
-0.7 units on a scale
Standard Error 0.13
-1.2 units on a scale
Standard Error 0.12
-0.4 units on a scale
Standard Error 0.10
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 8: Upper Limbs Induration (n=43, 40, 47, 39)
-0.9 units on a scale
Standard Error 0.15
-1.1 units on a scale
Standard Error 0.13
-1.5 units on a scale
Standard Error 0.16
-0.3 units on a scale
Standard Error 0.12
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 8: Lower Limbs Induration (n=43, 40, 47, 39)
-1.0 units on a scale
Standard Error 0.15
-1.3 units on a scale
Standard Error 0.16
-1.6 units on a scale
Standard Error 0.17
-0.5 units on a scale
Standard Error 0.10
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 12: Trunk Induration (n=38, 39, 43, 34)
-1.1 units on a scale
Standard Error 0.18
-1.2 units on a scale
Standard Error 0.14
-1.8 units on a scale
Standard Error 0.16
-0.7 units on a scale
Standard Error 0.15
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 12: Lower Limbs Induration (n=38, 39, 43, 34)
-1.2 units on a scale
Standard Error 0.16
-1.4 units on a scale
Standard Error 0.15
-1.7 units on a scale
Standard Error 0.15
-0.5 units on a scale
Standard Error 0.11
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 14: Head/Neck Induration (n=38, 37, 37, 33)
-1.1 units on a scale
Standard Error 0.15
-0.8 units on a scale
Standard Error 0.16
-1.4 units on a scale
Standard Error 0.20
-0.5 units on a scale
Standard Error 0.17
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 14: Upper Limbs Induration (n=38, 37, 37, 33)
-0.8 units on a scale
Standard Error 0.15
-1.0 units on a scale
Standard Error 0.16
-1.4 units on a scale
Standard Error 0.18
-0.5 units on a scale
Standard Error 0.16
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 14: Trunk Induration (n=38, 37, 37, 33)
-1.0 units on a scale
Standard Error 0.18
-0.9 units on a scale
Standard Error 0.15
-1.5 units on a scale
Standard Error 0.20
-0.7 units on a scale
Standard Error 0.17
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 16: Head/Neck Induration (n=37, 36, 41, 30)
-1.1 units on a scale
Standard Error 0.15
-0.4 units on a scale
Standard Error 0.18
-1.3 units on a scale
Standard Error 0.20
-0.3 units on a scale
Standard Error 0.19
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 16: Upper Limbs Induration (n=37, 36, 41, 30)
-0.8 units on a scale
Standard Error 0.17
-0.6 units on a scale
Standard Error 0.16
-1.2 units on a scale
Standard Error 0.18
-0.4 units on a scale
Standard Error 0.18
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 4: Trunk Scaling (n=47, 47, 48, 46)
-0.6 units on a scale
Standard Error 0.13
-0.9 units on a scale
Standard Error 0.13
-1.1 units on a scale
Standard Error 0.14
-0.2 units on a scale
Standard Error 0.09
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 8: Upper Limbs Scaling (n=43, 40, 47, 39)
-0.8 units on a scale
Standard Error 0.16
-1.2 units on a scale
Standard Error 0.13
-1.3 units on a scale
Standard Error 0.16
-0.4 units on a scale
Standard Error 0.14
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 8: Trunk Scaling (n=43, 40, 47, 39)
-1.0 units on a scale
Standard Error 0.18
-1.2 units on a scale
Standard Error 0.16
-1.5 units on a scale
Standard Error 0.17
-0.5 units on a scale
Standard Error 0.12
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 8: Lower Limbs Scaling (n=43, 40, 47, 39)
-1.1 units on a scale
Standard Error 0.14
-1.3 units on a scale
Standard Error 0.15
-1.4 units on a scale
Standard Error 0.15
-0.5 units on a scale
Standard Error 0.13
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 12: Head/Neck Scaling (n=38, 39, 43, 34)
-1.2 units on a scale
Standard Error 0.19
-1.4 units on a scale
Standard Error 0.19
-1.8 units on a scale
Standard Error 0.18
-0.3 units on a scale
Standard Error 0.20
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 12: Upper Limbs Scaling (n=38, 39, 43, 34)
-1.0 units on a scale
Standard Error 0.18
-1.3 units on a scale
Standard Error 0.14
-1.5 units on a scale
Standard Error 0.17
-0.6 units on a scale
Standard Error 0.17
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 12: Lower Limbs Scaling (n=38, 39, 43, 34)
-1.3 units on a scale
Standard Error 0.15
-1.4 units on a scale
Standard Error 0.15
-1.7 units on a scale
Standard Error 0.15
-0.6 units on a scale
Standard Error 0.15
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 14: Head/Neck Scaling (n=38, 37, 37, 33)
-1.0 units on a scale
Standard Error 0.19
-1.0 units on a scale
Standard Error 0.19
-1.4 units on a scale
Standard Error 0.20
-0.3 units on a scale
Standard Error 0.18
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 14: Trunk Scaling (n=38, 37, 37, 33)
-0.8 units on a scale
Standard Error 0.18
-1.0 units on a scale
Standard Error 0.16
-1.4 units on a scale
Standard Error 0.20
-0.8 units on a scale
Standard Error 0.17
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 14: Lower Limbs Scaling (n=38, 37, 37, 33)
-1.2 units on a scale
Standard Error 0.17
-1.2 units on a scale
Standard Error 0.17
-1.4 units on a scale
Standard Error 0.19
-0.7 units on a scale
Standard Error 0.16
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 16: Head/Neck Scaling (n=37, 36, 41, 30)
-1.0 units on a scale
Standard Error 0.18
-0.5 units on a scale
Standard Error 0.18
-1.4 units on a scale
Standard Error 0.20
-0.2 units on a scale
Standard Error 0.22
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 16: Trunk Scaling (n=37, 36, 41, 30)
-0.8 units on a scale
Standard Error 0.20
-0.8 units on a scale
Standard Error 0.15
-1.2 units on a scale
Standard Error 0.19
-0.7 units on a scale
Standard Error 0.19
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 2: PASI Total Score (n=47, 48, 48, 49)
-4.7 units on a scale
Standard Error 0.81
-4.7 units on a scale
Standard Error 0.62
-7.3 units on a scale
Standard Error 0.86
-0.8 units on a scale
Standard Error 0.69
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 4: PASI Total Score (n=47, 47, 48, 46)
-7.5 units on a scale
Standard Error 1.05
-8.6 units on a scale
Standard Error 0.93
-12.2 units on a scale
Standard Error 1.18
-2.7 units on a scale
Standard Error 0.86
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 8: PASI Total Score (n=43, 40, 47, 39)
-10.9 units on a scale
Standard Error 1.41
-11.6 units on a scale
Standard Error 1.09
-15.8 units on a scale
Standard Error 1.38
-3.7 units on a scale
Standard Error 0.96
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 12: PASI Total Score (n=38, 39, 43, 34)
-12.1 units on a scale
Standard Error 1.59
-13.1 units on a scale
Standard Error 1.05
-17.9 units on a scale
Standard Error 1.59
-5.1 units on a scale
Standard Error 1.16
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 14: PASI Total Score (n=38, 37, 37, 33)
-10.9 units on a scale
Standard Error 1.58
-11.4 units on a scale
Standard Error 1.13
-16.5 units on a scale
Standard Error 1.95
-4.4 units on a scale
Standard Error 1.32
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 2: Head/Neck Erythema (n=47, 48, 48, 49)
-0.4 units on a scale
Standard Error 0.10
-0.7 units on a scale
Standard Error 0.13
-1.0 units on a scale
Standard Error 0.15
-0.2 units on a scale
Standard Error 0.08
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 2: Upper Limbs Erythema (n=47, 48, 48, 49)
-0.6 units on a scale
Standard Error 0.11
-0.5 units on a scale
Standard Error 0.09
-0.8 units on a scale
Standard Error 0.10
-0.2 units on a scale
Standard Error 0.09
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 2: Trunk Erythema (n=47, 48, 48, 49)
-0.6 units on a scale
Standard Error 0.12
-0.6 units on a scale
Standard Error 0.12
-0.8 units on a scale
Standard Error 0.13
-0.2 units on a scale
Standard Error 0.10
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 2: Lower Limbs Erythema (n=47, 48, 48, 49)
-0.4 units on a scale
Standard Error 0.11
-0.6 units on a scale
Standard Error 0.11
-0.8 units on a scale
Standard Error 0.11
-0.2 units on a scale
Standard Error 0.09
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 4: Head/Neck Erythema (n=47, 47, 48, 46)
-0.7 units on a scale
Standard Error 0.13
-1.0 units on a scale
Standard Error 0.15
-1.4 units on a scale
Standard Error 0.16
-0.3 units on a scale
Standard Error 0.15
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 4: Upper Limbs Erythema (n=47, 47, 48, 46)
-0.9 units on a scale
Standard Error 0.14
-1.0 units on a scale
Standard Error 0.11
-1.3 units on a scale
Standard Error 0.12
-0.5 units on a scale
Standard Error 0.09
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 4: Trunk Erythema (n=47, 47, 48, 46)
-0.9 units on a scale
Standard Error 0.14
-0.8 units on a scale
Standard Error 0.12
-1.3 units on a scale
Standard Error 0.12
-0.4 units on a scale
Standard Error 0.07
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 4: Lower Limbs Erythema (n=47, 47, 48, 46)
-0.7 units on a scale
Standard Error 0.13
-0.9 units on a scale
Standard Error 0.11
-1.3 units on a scale
Standard Error 0.12
-0.4 units on a scale
Standard Error 0.09
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 8: Head/Neck Erythema (n=43, 40, 47, 39)
-1.0 units on a scale
Standard Error 0.14
-1.3 units on a scale
Standard Error 0.19
-1.7 units on a scale
Standard Error 0.18
-0.6 units on a scale
Standard Error 0.18
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 8: Upper Limbs Erythema (n=43, 40, 47, 39)
-1.2 units on a scale
Standard Error 0.16
-1.2 units on a scale
Standard Error 0.14
-1.7 units on a scale
Standard Error 0.14
-0.6 units on a scale
Standard Error 0.10
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 8: Trunk Erythema (n=43, 40, 47, 39)
-1.1 units on a scale
Standard Error 0.18
-1.2 units on a scale
Standard Error 0.15
-1.7 units on a scale
Standard Error 0.17
-0.5 units on a scale
Standard Error 0.12
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 8: Lower Limbs Erythema (n=43, 40, 47, 39)
-1.1 units on a scale
Standard Error 0.16
-1.4 units on a scale
Standard Error 0.16
-1.8 units on a scale
Standard Error 0.16
-0.5 units on a scale
Standard Error 0.10
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 12: Head/Neck Erythema (n=38, 39, 43, 34)
-1.1 units on a scale
Standard Error 0.17
-1.2 units on a scale
Standard Error 0.18
-2.0 units on a scale
Standard Error 0.19
-0.6 units on a scale
Standard Error 0.20
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 12: Upper Limbs Erythema (n=38, 39, 43, 34)
-1.3 units on a scale
Standard Error 0.17
-1.3 units on a scale
Standard Error 0.14
-1.8 units on a scale
Standard Error 0.15
-0.7 units on a scale
Standard Error 0.14
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 12: Trunk Erythema (n=38, 39, 43, 34)
-1.2 units on a scale
Standard Error 0.20
-1.3 units on a scale
Standard Error 0.19
-1.9 units on a scale
Standard Error 0.18
-0.5 units on a scale
Standard Error 0.18
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 12: Lower Limbs Erythema (n=38, 39, 43, 34)
-1.2 units on a scale
Standard Error 0.18
-1.5 units on a scale
Standard Error 0.14
-1.9 units on a scale
Standard Error 0.17
-0.4 units on a scale
Standard Error 0.12
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 14: Trunk Erythema (n=38, 37, 37, 33)
-1.1 units on a scale
Standard Error 0.19
-1.0 units on a scale
Standard Error 0.20
-1.6 units on a scale
Standard Error 0.20
-0.5 units on a scale
Standard Error 0.18
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 16: Upper Limbs Erythema (n=37, 36, 41, 30)
-0.8 units on a scale
Standard Error 0.19
-0.7 units on a scale
Standard Error 0.16
-1.0 units on a scale
Standard Error 0.17
-0.6 units on a scale
Standard Error 0.14
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 16: Lower Limbs Erythema (n=37, 36, 41, 30)
-0.7 units on a scale
Standard Error 0.18
-1.0 units on a scale
Standard Error 0.18
-1.3 units on a scale
Standard Error 0.18
-0.4 units on a scale
Standard Error 0.13
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 2: Head/Neck Induration (n=47, 48, 48, 49)
-0.6 units on a scale
Standard Error 0.11
-0.4 units on a scale
Standard Error 0.11
-0.8 units on a scale
Standard Error 0.13
-0.2 units on a scale
Standard Error 0.09
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 4: Head/Neck Induration (n=47, 47, 48, 46)
-0.8 units on a scale
Standard Error 0.11
-0.9 units on a scale
Standard Error 0.13
-1.3 units on a scale
Standard Error 0.16
-0.3 units on a scale
Standard Error 0.15
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 4: Lower Limbs Induration (n=47, 47, 48, 46)
-0.6 units on a scale
Standard Error 0.12
-0.8 units on a scale
Standard Error 0.12
-1.2 units on a scale
Standard Error 0.13
-0.5 units on a scale
Standard Error 0.10
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 8: Head/Neck Induration (n=43, 40, 47, 39)
-1.0 units on a scale
Standard Error 0.13
-1.1 units on a scale
Standard Error 0.16
-1.5 units on a scale
Standard Error 0.18
-0.5 units on a scale
Standard Error 0.14
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 8: Trunk Induration (n=43, 40, 47, 39)
-1.0 units on a scale
Standard Error 0.16
-1.1 units on a scale
Standard Error 0.16
-1.5 units on a scale
Standard Error 0.15
-0.6 units on a scale
Standard Error 0.13
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 12: Head/Neck Induration (n=38, 39, 43, 34)
-1.2 units on a scale
Standard Error 0.16
-1.2 units on a scale
Standard Error 0.15
-1.7 units on a scale
Standard Error 0.18
-0.4 units on a scale
Standard Error 0.17
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 12: Upper Limbs Induration (n=38, 39, 43, 34)
-1.2 units on a scale
Standard Error 0.15
-1.2 units on a scale
Standard Error 0.13
-1.6 units on a scale
Standard Error 0.17
-0.5 units on a scale
Standard Error 0.16
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 14: Lower Limbs Induration (n=38, 37, 37, 33)
-1.1 units on a scale
Standard Error 0.16
-1.1 units on a scale
Standard Error 0.18
-1.4 units on a scale
Standard Error 0.20
-0.5 units on a scale
Standard Error 0.13
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 16: Trunk Induration (n=37, 36, 41, 30)
-0.9 units on a scale
Standard Error 0.20
-0.6 units on a scale
Standard Error 0.14
-1.1 units on a scale
Standard Error 0.19
-0.6 units on a scale
Standard Error 0.18
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 16: Lower Limbs Induration (n=37, 36, 41, 30)
-1.0 units on a scale
Standard Error 0.19
-0.8 units on a scale
Standard Error 0.16
-1.4 units on a scale
Standard Error 0.18
-0.4 units on a scale
Standard Error 0.14
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 2: Head/Neck Scaling (n=47, 48, 48, 49)
-0.5 units on a scale
Standard Error 0.12
-0.6 units on a scale
Standard Error 0.13
-0.9 units on a scale
Standard Error 0.13
-0.3 units on a scale
Standard Error 0.09
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 2: Upper Limbs Scaling (n=47, 48, 48, 49)
-0.4 units on a scale
Standard Error 0.10
-0.6 units on a scale
Standard Error 0.10
-0.6 units on a scale
Standard Error 0.10
-0.2 units on a scale
Standard Error 0.08
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 2: Trunk Scaling (n=47, 48, 48, 49)
-0.3 units on a scale
Standard Error 0.12
-0.6 units on a scale
Standard Error 0.13
-0.7 units on a scale
Standard Error 0.11
-0.2 units on a scale
Standard Error 0.10
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 2: Lower Limbs Scaling (n=47, 48, 48, 49)
-0.4 units on a scale
Standard Error 0.10
-0.4 units on a scale
Standard Error 0.09
-0.6 units on a scale
Standard Error 0.11
-0.2 units on a scale
Standard Error 0.09
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 4: Head/Neck Scaling (n=47, 47, 48, 46)
-0.7 units on a scale
Standard Error 0.14
-1.0 units on a scale
Standard Error 0.15
-1.4 units on a scale
Standard Error 0.15
-0.4 units on a scale
Standard Error 0.14
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 4: Upper Limbs Scaling (n=47, 47, 48, 46)
-0.5 units on a scale
Standard Error 0.14
-0.8 units on a scale
Standard Error 0.12
-1.0 units on a scale
Standard Error 0.13
-0.3 units on a scale
Standard Error 0.10
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 4: Lower Limbs Scaling (n=47, 47, 48, 46)
-0.7 units on a scale
Standard Error 0.09
-0.9 units on a scale
Standard Error 0.12
-0.9 units on a scale
Standard Error 0.14
-0.4 units on a scale
Standard Error 0.11
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 8: Head/Neck Scaling (n=43, 40, 47, 39)
-1.0 units on a scale
Standard Error 0.19
-1.4 units on a scale
Standard Error 0.19
-1.6 units on a scale
Standard Error 0.18
-0.4 units on a scale
Standard Error 0.16
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 14: Upper Limbs Scaling (n=38, 37, 37, 33)
-0.7 units on a scale
Standard Error 0.16
-1.1 units on a scale
Standard Error 0.17
-1.3 units on a scale
Standard Error 0.18
-0.6 units on a scale
Standard Error 0.16
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 16: Upper Limbs Scaling (n=37, 36, 41, 30)
-0.7 units on a scale
Standard Error 0.16
-1.0 units on a scale
Standard Error 0.14
-1.0 units on a scale
Standard Error 0.16
-0.5 units on a scale
Standard Error 0.18
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 16: Lower Limbs Scaling (n=37, 36, 41, 30)
-0.9 units on a scale
Standard Error 0.16
-0.9 units on a scale
Standard Error 0.18
-1.2 units on a scale
Standard Error 0.19
-0.6 units on a scale
Standard Error 0.17
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16
Week 16: PASI Total Score (n=37, 36, 41, 30)
-9.7 units on a scale
Standard Error 1.57
-9.3 units on a scale
Standard Error 1.09
-14.0 units on a scale
Standard Error 1.77
-5.1 units on a scale
Standard Error 1.42

Adverse Events

CP-690,550 2 mg

Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths

CP-690,550 5 mg

Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths

CP-690,550 15 mg

Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
CP-690,550 2 mg
n=49 participants at risk
CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
CP-690,550 5 mg
n=49 participants at risk
CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
CP-690,550 15 mg
n=49 participants at risk
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
Placebo
n=50 participants at risk
Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
Cardiac disorders
Angina pectoris
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders
Atrial fibrillation
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Pyelonephritis
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Urinary tract infection
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Urosepsis
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure
CP-690,550 2 mg
n=49 participants at risk
CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
CP-690,550 5 mg
n=49 participants at risk
CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
CP-690,550 15 mg
n=49 participants at risk
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
Placebo
n=50 participants at risk
Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
Blood and lymphatic system disorders
Anaemia
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders
Lymphopenia
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders
Ear congestion
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders
Tinnitus
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders
Asthenopia
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders
Conjunctival hyperaemia
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders
Eye pruritus
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders
Lacrimation increased
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Abdominal pain lower
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Constipation
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Dental caries
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
4.1%
2/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Diarrhoea
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
6.0%
3/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Dry mouth
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Dyspepsia
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Gastritis
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Nausea
4.1%
2/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
4.1%
2/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
4.0%
2/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Vomiting
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders
Chest pain
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders
Fatigue
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
4.0%
2/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders
Hernia
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders
Therapeutic response unexpected
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Bronchitis
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Cellulitis
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Ear infection
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Folliculitis
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Gastroenteritis
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
4.1%
2/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
4.0%
2/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Gastroenteritis viral
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
4.0%
2/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Hordeolum
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Influenza
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Laryngitis
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Lower respiratory tract infection
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Nasopharyngitis
4.1%
2/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
6.1%
3/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
10.0%
5/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Oral herpes
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Pharyngitis
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
4.1%
2/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Rhinitis
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Sinusitis
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
10.2%
5/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Skin infection
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Staphylococcal infection
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Tooth abscess
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
4.1%
2/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Upper respiratory tract infection
8.2%
4/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
8.2%
4/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
4.1%
2/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
10.0%
5/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Urinary tract infection
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Viral upper respiratory tract infection
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations
Vulvovaginal mycotic infection
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications
Accidental overdose
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications
Contusion
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications
Eye injury
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications
Foot fracture
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications
Intentional overdose
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications
Limb injury
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications
Medication error
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
4.1%
2/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications
Meniscus lesion
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications
Muscle strain
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications
Overdose
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications
Road traffic accident
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications
Skeletal injury
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications
Skin laceration
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications
Tibia fracture
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations
Alanine aminotransferase increased
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations
Aspartate aminotransferase increased
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations
Blood cholesterol increased
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations
Blood pressure increased
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations
Blood triglycerides increased
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations
Blood uric acid increased
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations
Cardiac murmur
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations
Cytomegalovirus test positive
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations
Electrocardiogram QT prolonged
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations
Low density lipoprotein increased
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations
Neutrophil count decreased
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations
Vitamin D decreased
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders
Dyslipidaemia
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders
Hypercholesterolaemia
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders
Hypertriglyceridaemia
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders
Arthralgia
4.1%
2/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders
Back pain
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
6.1%
3/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders
Neck pain
4.1%
2/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
4.0%
2/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders
Pain in jaw
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders
Burning sensation
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders
Dizziness
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders
Headache
8.2%
4/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
6.1%
3/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
6.1%
3/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders
Migraine
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders
Syncope
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders
Ejaculation disorder
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders
Oligomenorrhoea
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Cough
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
4.1%
2/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Throat irritation
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Acne
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Dermatitis
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Dermatitis acneiform
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
4.1%
2/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Guttate psoriasis
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Hyperhidrosis
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Psoriasis
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
4.1%
2/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
8.0%
4/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Seborrhoea
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures
Endodontic procedure
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders
Hypertension
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
2.0%
1/49
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
0.00%
0/50
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

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