Trial Outcomes & Findings for A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis (NCT NCT01519089)
NCT ID: NCT01519089
Last Updated: 2015-08-13
Results Overview
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at Week 16 relative to Baseline.
COMPLETED
PHASE3
95 participants
Week 16
2015-08-13
Participant Flow
Participant milestones
| Measure |
CP-690,550 5 mg BID
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
48
|
|
Overall Study
Received Treatment
|
47
|
47
|
|
Overall Study
COMPLETED
|
40
|
33
|
|
Overall Study
NOT COMPLETED
|
7
|
15
|
Reasons for withdrawal
| Measure |
CP-690,550 5 mg BID
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
4
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Other
|
2
|
6
|
|
Overall Study
Not received study drug
|
0
|
1
|
Baseline Characteristics
A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis
Baseline characteristics by cohort
| Measure |
CP-690,550 5 mg BID
n=47 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=47 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.9 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
48.7 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at Week 16 relative to Baseline.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=43 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=44 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=87 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16
|
62.8 Percentage of participants
|
72.7 Percentage of participants
|
67.8 Percentage of participants
|
PRIMARY outcome
Timeframe: Week 16Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=43 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=44 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=87 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16
|
67.4 Percentage of participants
|
68.2 Percentage of participants
|
67.8 Percentage of participants
|
PRIMARY outcome
Timeframe: Week 16Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=4 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=8 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=12 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16
|
100 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline to Follow-upPopulation: Participants treated with at least 1 dose of study drugs.
Adjudicated cardiovascular events were assessed by investigators as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; specific requirements vary with the event requiring adjudication.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=47 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=47 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=94 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Number of Participants With Adjudicated Cardiovacular Events
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to Follow-upPopulation: Participants treated with at least 1 dose of study drugs.
For all biopsies of potentially malignant tumors, suspicious lymphadenopathy, or possible extranodal LPD, the study site requested the pathologist to send the original slides used to make the definitive diagnosis, ancillary study reports, and the pathologist's report to the central laboratory for a blinded review by a central pathologist.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=47 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=47 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=94 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Number of Participants With Malignancy Events _Week 0 Through Follow-up
Number of participants with any malignancy events
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Malignancy Events _Week 0 Through Follow-up
Malignancy excluding non-melanoma skin cancer
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Malignancy Events _Week 0 Through Follow-up
Lymphoma/Lymphoproliferative disorders (LPD)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Malignancy Events _Week 0 Through Follow-up
Melanoma
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Malignancy Events _Week 0 Through Follow-up
Non-melanoma skin cancer
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 20, 28, 40, 52Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at the each visit relative to Baseline.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=43 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=44 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=87 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response
Week 2
|
2.3 Percentage of participants
|
4.5 Percentage of participants
|
3.4 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response
Week 4
|
7.0 Percentage of participants
|
22.7 Percentage of participants
|
14.9 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response
Week 8
|
41.9 Percentage of participants
|
54.5 Percentage of participants
|
48.3 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response
Week 12
|
60.5 Percentage of participants
|
70.5 Percentage of participants
|
65.5 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response
Week 20
|
67.4 Percentage of participants
|
63.6 Percentage of participants
|
65.5 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response
Week 28
|
69.8 Percentage of participants
|
65.9 Percentage of participants
|
67.8 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response
Week 40
|
69.8 Percentage of participants
|
63.6 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response
Week 52
|
62.8 Percentage of participants
|
63.6 Percentage of participants
|
63.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 40, 52Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI50 response was defined as at least a 50 percent (%) reduction in PASI at the each visit relative to Baseline.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=43 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=44 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=87 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response
Week 8
|
60.5 Percentage of participants
|
81.8 Percentage of participants
|
71.3 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response
Week 2
|
9.3 Percentage of participants
|
22.7 Percentage of participants
|
16.1 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response
Week 4
|
34.9 Percentage of participants
|
56.8 Percentage of participants
|
46.0 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response
Week 12
|
81.4 Percentage of participants
|
84.1 Percentage of participants
|
82.8 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response
Week 16
|
76.7 Percentage of participants
|
79.5 Percentage of participants
|
78.2 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response
Week 20
|
79.1 Percentage of participants
|
75.0 Percentage of participants
|
77.0 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response
Week 28
|
90.7 Percentage of participants
|
72.7 Percentage of participants
|
81.6 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response
Week 40
|
88.4 Percentage of participants
|
79.5 Percentage of participants
|
83.9 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response
Week 52
|
90.7 Percentage of participants
|
68.2 Percentage of participants
|
79.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 40, 52Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least a 90 percent (%) reduction in PASI at the each visit relative to Baseline.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=43 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=44 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=87 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response
Week 8
|
16.3 Percentage of participants
|
29.5 Percentage of participants
|
23.0 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response
Week 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response
Week 4
|
4.7 Percentage of participants
|
13.6 Percentage of participants
|
9.2 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response
Week 12
|
37.2 Percentage of participants
|
45.5 Percentage of participants
|
41.4 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response
Week 16
|
37.2 Percentage of participants
|
54.5 Percentage of participants
|
46.0 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response
Week 20
|
58.1 Percentage of participants
|
56.8 Percentage of participants
|
57.5 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response
Week 28
|
55.8 Percentage of participants
|
45.5 Percentage of participants
|
50.6 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response
Week 40
|
58.1 Percentage of participants
|
47.7 Percentage of participants
|
52.9 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response
Week 52
|
51.2 Percentage of participants
|
47.7 Percentage of participants
|
49.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=43 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=44 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=87 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
|
8.0 Week
Interval 8.0 to 12.0
|
8.0 Week
Interval 4.0 to 12.0
|
8.0 Week
The 95 percent confidence interval could not be constructed.
|
SECONDARY outcome
Timeframe: Week 16Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=43 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=44 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=87 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response
|
12.0 Week
Interval 8.0 to 16.0
|
8.0 Week
Interval 8.0 to 12.0
|
12.0 Week
Interval 8.0 to 12.0
|
SECONDARY outcome
Timeframe: Week 16Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=43 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=44 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=87 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Time to Achieve a Psoriasis Area and Severity Index 50 (PASI50) Response
|
8.0 Week
Interval 4.0 to 12.0
|
4.0 Week
Interval 4.0 to 8.0
|
8.0 Week
Interval 4.0 to 8.0
|
SECONDARY outcome
Timeframe: Week 16Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least 90% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=43 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=44 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=87 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Time to Achieve a Psoriasis Area and Severity Index 90 (PASI90) Response
|
NA Week
Interval 12.0 to
The median time could not be computed because fewer than half of the subjects achieved a PASI90 response.
|
12.0 Week
Interval 12.0 to 16.0
|
16.0 Week
Interval 12.0 to
The 95 percent upper limit could not be computed due to the limited analysis duration up to Week 16.
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 40, 52Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=43 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=44 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=87 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score
Week 8 (n=43, 41, 84)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score
Week 2
|
2.3 Percentage of participants
|
0.0 Percentage of participants
|
1.1 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score
Week 4
|
0.0 Percentage of participants
|
2.3 Percentage of participants
|
1.1 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score
Week 12 (n=43, 41, 84)
|
0.0 Percentage of participants
|
2.4 Percentage of participants
|
1.2 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score
Week 16 (n=43, 40, 83)
|
0.0 Percentage of participants
|
2.5 Percentage of participants
|
1.2 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score
Week 20 (n=43, 39, 82)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score
Week 28 (n=43, 39, 82)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score
Week 40 (n=41, 38, 79)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score
Week 52 (n=39, 32, 71)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 40, 52Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=43 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=44 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=87 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Week 28 (n=43, 39, 82)
|
-21.77 Units on a scale
Standard Deviation 10.196
|
-21.46 Units on a scale
Standard Deviation 10.503
|
-21.62 Units on a scale
Standard Deviation 10.280
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Week 2
|
-5.18 Units on a scale
Standard Deviation 5.898
|
-7.36 Units on a scale
Standard Deviation 6.428
|
-6.28 Units on a scale
Standard Deviation 6.232
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Week 4
|
-10.40 Units on a scale
Standard Deviation 7.518
|
-13.16 Units on a scale
Standard Deviation 8.739
|
-11.79 Units on a scale
Standard Deviation 8.229
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Week 8 (n=43, 41, 84)
|
-15.95 Units on a scale
Standard Deviation 8.392
|
-19.90 Units on a scale
Standard Deviation 10.741
|
-17.88 Units on a scale
Standard Deviation 9.756
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Week 12 (n=43, 41, 84)
|
-18.91 Units on a scale
Standard Deviation 8.918
|
-21.68 Units on a scale
Standard Deviation 11.598
|
-20.26 Units on a scale
Standard Deviation 10.344
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Week 16 (n=43, 40, 83)
|
-19.53 Units on a scale
Standard Deviation 9.094
|
-22.06 Units on a scale
Standard Deviation 12.606
|
-20.75 Units on a scale
Standard Deviation 10.935
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Week 20 (n=43, 39, 82)
|
-20.95 Units on a scale
Standard Deviation 9.239
|
-22.18 Units on a scale
Standard Deviation 12.045
|
-21.53 Units on a scale
Standard Deviation 10.617
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Week 40 (n=41, 38, 79)
|
-22.20 Units on a scale
Standard Deviation 10.181
|
-21.18 Units on a scale
Standard Deviation 10.229
|
-21.71 Units on a scale
Standard Deviation 10.151
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Week 52 (n=39, 32, 71)
|
-21.96 Units on a scale
Standard Deviation 9.621
|
-22.11 Units on a scale
Standard Deviation 10.598
|
-22.03 Units on a scale
Standard Deviation 10.000
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 40, 52Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=43 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=44 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=87 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 8: Erythema (Upper Limbs) (n=43, 41, 84)
|
-1.5 Units on a scale
Standard Deviation 0.93
|
-1.6 Units on a scale
Standard Deviation 0.98
|
-1.5 Units on a scale
Standard Deviation 0.95
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 52: Scaling (Head/Neck) (n=39, 32, 71)
|
-1.8 Units on a scale
Standard Deviation 0.98
|
-1.6 Units on a scale
Standard Deviation 1.08
|
-1.7 Units on a scale
Standard Deviation 1.02
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 4: Induration (Head/Neck)
|
-0.7 Units on a scale
Standard Deviation 0.89
|
-1.2 Units on a scale
Standard Deviation 1.09
|
-1.0 Units on a scale
Standard Deviation 1.02
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 4: Induration (Upper Limbs)
|
-1.1 Units on a scale
Standard Deviation 0.86
|
-1.0 Units on a scale
Standard Deviation 0.85
|
-1.0 Units on a scale
Standard Deviation 0.85
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 4: Induration (Lower Limbs)
|
-1.0 Units on a scale
Standard Deviation 0.90
|
-1.2 Units on a scale
Standard Deviation 0.98
|
-1.1 Units on a scale
Standard Deviation 0.94
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 4: Scaling (Head/Neck)
|
-0.8 Units on a scale
Standard Deviation 0.86
|
-1.2 Units on a scale
Standard Deviation 0.99
|
-1.0 Units on a scale
Standard Deviation 0.95
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 4: Scaling (Upper Limbs)
|
-0.9 Units on a scale
Standard Deviation 0.70
|
-1.2 Units on a scale
Standard Deviation 0.86
|
-1.0 Units on a scale
Standard Deviation 0.79
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 4: Scaling (Trunk)
|
-0.9 Units on a scale
Standard Deviation 0.71
|
-1.3 Units on a scale
Standard Deviation 0.95
|
-1.1 Units on a scale
Standard Deviation 0.87
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 4: Scaling (Lower Limbs)
|
-0.8 Units on a scale
Standard Deviation 0.72
|
-1.3 Units on a scale
Standard Deviation 0.96
|
-1.1 Units on a scale
Standard Deviation 0.89
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 8: Erythema (Head/Neck) (n=43, 41, 84)
|
-1.4 Units on a scale
Standard Deviation 1.13
|
-1.6 Units on a scale
Standard Deviation 1.03
|
-1.5 Units on a scale
Standard Deviation 1.08
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 8: Erythema (Trunk) (n=43, 41, 84)
|
-1.7 Units on a scale
Standard Deviation 0.91
|
-1.9 Units on a scale
Standard Deviation 0.93
|
-1.8 Units on a scale
Standard Deviation 0.92
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 8: Erythema (Lower Limbs) (n=43, 41, 84)
|
-1.5 Units on a scale
Standard Deviation 0.91
|
-1.7 Units on a scale
Standard Deviation 0.91
|
-1.6 Units on a scale
Standard Deviation 0.91
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 8: Induration (Upper Limbs) (n=43, 41, 84)
|
-1.6 Units on a scale
Standard Deviation 0.93
|
-1.6 Units on a scale
Standard Deviation 0.89
|
-1.6 Units on a scale
Standard Deviation 0.91
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 8: Scaling (Head/Neck) (n=43, 41, 84)
|
-1.3 Units on a scale
Standard Deviation 0.90
|
-1.5 Units on a scale
Standard Deviation 1.03
|
-1.4 Units on a scale
Standard Deviation 0.96
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 12: Induration (Upper Limbs) (n=43, 41, 84)
|
-1.7 Units on a scale
Standard Deviation 0.94
|
-1.8 Units on a scale
Standard Deviation 0.99
|
-1.7 Units on a scale
Standard Deviation 0.96
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 12: Induration (Trunk) (n=43, 41, 84)
|
-2.0 Units on a scale
Standard Deviation 1.01
|
-2.0 Units on a scale
Standard Deviation 1.00
|
-2.0 Units on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 12: Induration (Lower Limbs) (n=43, 41, 84)
|
-1.9 Units on a scale
Standard Deviation 0.91
|
-1.9 Units on a scale
Standard Deviation 1.06
|
-1.9 Units on a scale
Standard Deviation 0.98
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 16: Erythema (Trunk) (n=43, 40, 83)
|
-2.1 Units on a scale
Standard Deviation 1.10
|
-2.0 Units on a scale
Standard Deviation 1.07
|
-2.0 Units on a scale
Standard Deviation 1.08
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 16: Erythema (Lower Limbs) (n=43, 40, 83)
|
-2.0 Units on a scale
Standard Deviation 1.03
|
-1.9 Units on a scale
Standard Deviation 0.94
|
-2.0 Units on a scale
Standard Deviation 0.99
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 16: Scaling (Upper Limbs) (n=43, 40, 83)
|
-1.5 Units on a scale
Standard Deviation 0.93
|
-1.7 Units on a scale
Standard Deviation 1.05
|
-1.6 Units on a scale
Standard Deviation 0.99
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 16: Scaling (Trunk) (n=43, 40, 83)
|
-1.6 Units on a scale
Standard Deviation 0.96
|
-1.8 Units on a scale
Standard Deviation 1.09
|
-1.7 Units on a scale
Standard Deviation 1.02
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 16: Scaling (Lower Limbs) (n=43, 40, 83)
|
-1.6 Units on a scale
Standard Deviation 0.93
|
-1.8 Units on a scale
Standard Deviation 1.06
|
-1.7 Units on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 20: Erythema (Head/Neck) (n=43, 39, 82)
|
-1.8 Units on a scale
Standard Deviation 1.15
|
-1.6 Units on a scale
Standard Deviation 0.96
|
-1.7 Units on a scale
Standard Deviation 1.07
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 20: Erythema (Upper Limbs) (n=43, 39, 82)
|
-1.9 Units on a scale
Standard Deviation 0.97
|
-1.9 Units on a scale
Standard Deviation 1.26
|
-1.9 Units on a scale
Standard Deviation 1.11
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 20: Erythema (Trunk) (n=43, 39, 82)
|
-2.2 Units on a scale
Standard Deviation 1.04
|
-2.1 Units on a scale
Standard Deviation 1.04
|
-2.1 Units on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 20: Erythema (Lower Limbs) (n=43, 39, 82)
|
-2.1 Units on a scale
Standard Deviation 1.04
|
-2.1 Units on a scale
Standard Deviation 1.09
|
-2.1 Units on a scale
Standard Deviation 1.05
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 20: Induration (Head/Neck) (n=43, 39, 82)
|
-1.6 Units on a scale
Standard Deviation 1.00
|
-1.5 Units on a scale
Standard Deviation 1.12
|
-1.6 Units on a scale
Standard Deviation 1.06
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 20: Induration (Upper Limbs) (n=43, 39, 82)
|
-1.9 Units on a scale
Standard Deviation 0.97
|
-1.7 Units on a scale
Standard Deviation 1.14
|
-1.8 Units on a scale
Standard Deviation 1.05
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 20: Induration (Trunk) (n=43, 39, 82)
|
-2.1 Units on a scale
Standard Deviation 1.01
|
-1.9 Units on a scale
Standard Deviation 1.07
|
-2.0 Units on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 20: Induration (Lower Limbs) (n=43, 39, 82)
|
-2.2 Units on a scale
Standard Deviation 0.95
|
-2.0 Units on a scale
Standard Deviation 1.06
|
-2.1 Units on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 20: Scaling (Head/Neck) (n=43, 39, 82)
|
-1.7 Units on a scale
Standard Deviation 0.94
|
-1.5 Units on a scale
Standard Deviation 1.05
|
-1.6 Units on a scale
Standard Deviation 0.99
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 20: Scaling (Upper Limbs) (n=43, 39, 82)
|
-1.5 Units on a scale
Standard Deviation 0.96
|
-1.6 Units on a scale
Standard Deviation 1.14
|
-1.5 Units on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 20: Scaling (Trunk) (n=43, 39, 82)
|
-1.7 Units on a scale
Standard Deviation 0.93
|
-1.8 Units on a scale
Standard Deviation 1.05
|
-1.8 Units on a scale
Standard Deviation 0.99
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 20: Scaling (Lower Limbs) (n=43, 39, 82)
|
-1.7 Units on a scale
Standard Deviation 0.92
|
-1.8 Units on a scale
Standard Deviation 1.16
|
-1.8 Units on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 28: Erythema (Head/Neck) (n=43, 39, 82)
|
-1.8 Units on a scale
Standard Deviation 1.11
|
-1.6 Units on a scale
Standard Deviation 0.81
|
-1.7 Units on a scale
Standard Deviation 0.98
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 28: Erythema (Upper Limbs) (n=43, 39, 82)
|
-2.1 Units on a scale
Standard Deviation 1.09
|
-1.8 Units on a scale
Standard Deviation 1.07
|
-2.0 Units on a scale
Standard Deviation 1.08
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 28: Erythema (Trunk) (n=43, 39, 82)
|
-2.1 Units on a scale
Standard Deviation 1.13
|
-2.0 Units on a scale
Standard Deviation 0.99
|
-2.1 Units on a scale
Standard Deviation 1.06
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 28: Erythema (Lower Limbs) (n=43, 39, 82)
|
-2.3 Units on a scale
Standard Deviation 1.05
|
-1.9 Units on a scale
Standard Deviation 0.99
|
-2.1 Units on a scale
Standard Deviation 1.03
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 28: Induration (Head/Neck) (n=43, 39, 82)
|
-1.7 Units on a scale
Standard Deviation 0.97
|
-1.6 Units on a scale
Standard Deviation 0.99
|
-1.6 Units on a scale
Standard Deviation 0.98
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 28: Induration (Upper Limbs) (n=43, 39, 82)
|
-2.0 Units on a scale
Standard Deviation 1.12
|
-1.7 Units on a scale
Standard Deviation 1.10
|
-1.9 Units on a scale
Standard Deviation 1.12
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 28: Induration (Trunk) (n=43, 39, 82)
|
-2.0 Units on a scale
Standard Deviation 1.12
|
-1.8 Units on a scale
Standard Deviation 1.16
|
-1.9 Units on a scale
Standard Deviation 1.14
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 28: Induration (Lower Limbs) (n=43, 39, 82)
|
-2.2 Units on a scale
Standard Deviation 1.03
|
-1.8 Units on a scale
Standard Deviation 1.14
|
-2.0 Units on a scale
Standard Deviation 1.09
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 28: Scaling (Head/Neck) (n=43, 39, 82)
|
-1.7 Units on a scale
Standard Deviation 1.01
|
-1.4 Units on a scale
Standard Deviation 1.07
|
-1.6 Units on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 28: Scaling (Upper Limbs) (n=43, 39, 82)
|
-1.8 Units on a scale
Standard Deviation 1.05
|
-1.6 Units on a scale
Standard Deviation 1.02
|
-1.7 Units on a scale
Standard Deviation 1.03
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 28: Scaling (Lower Limbs) (n=43, 39, 82)
|
-1.8 Units on a scale
Standard Deviation 1.09
|
-1.7 Units on a scale
Standard Deviation 1.02
|
-1.7 Units on a scale
Standard Deviation 1.05
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 40: Erythema (Head/Neck) (n=41, 38, 79)
|
-1.9 Units on a scale
Standard Deviation 1.10
|
-1.7 Units on a scale
Standard Deviation 0.90
|
-1.8 Units on a scale
Standard Deviation 1.01
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 40: Erythema (Upper Limbs) (n=41, 38, 79)
|
-2.1 Units on a scale
Standard Deviation 1.05
|
-1.9 Units on a scale
Standard Deviation 1.06
|
-2.0 Units on a scale
Standard Deviation 1.06
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 40: Erythema (Trunk) (n=41, 38, 79)
|
-2.1 Units on a scale
Standard Deviation 1.04
|
-2.2 Units on a scale
Standard Deviation 0.87
|
-2.2 Units on a scale
Standard Deviation 0.95
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 40: Erythema (Lower Limbs) (n=41, 38, 79)
|
-2.4 Units on a scale
Standard Deviation 1.05
|
-2.0 Units on a scale
Standard Deviation 1.03
|
-2.2 Units on a scale
Standard Deviation 1.05
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 40: Induration (Head/Neck) (n=41, 38, 79)
|
-1.7 Units on a scale
Standard Deviation 1.05
|
-1.5 Units on a scale
Standard Deviation 1.08
|
-1.6 Units on a scale
Standard Deviation 1.07
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 40: Induration (Upper Limbs) (n=41, 38, 79)
|
-2.0 Units on a scale
Standard Deviation 1.18
|
-1.8 Units on a scale
Standard Deviation 0.98
|
-1.9 Units on a scale
Standard Deviation 1.09
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 40: Induration (Trunk) (n=41, 38, 79)
|
-1.9 Units on a scale
Standard Deviation 1.26
|
-2.1 Units on a scale
Standard Deviation 0.93
|
-2.1 Units on a scale
Standard Deviation 1.11
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 40: Induration (Lower Limbs) (n=41, 38, 79)
|
-2.2 Units on a scale
Standard Deviation 1.14
|
-1.9 Units on a scale
Standard Deviation 1.03
|
-2.1 Units on a scale
Standard Deviation 1.10
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 40: Scaling (Head/Neck) (n=41, 38, 79)
|
-1.8 Units on a scale
Standard Deviation 0.97
|
-1.4 Units on a scale
Standard Deviation 1.00
|
-1.6 Units on a scale
Standard Deviation 0.99
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 40: Scaling (Upper Limbs) (n=41, 38, 79)
|
-1.7 Units on a scale
Standard Deviation 1.10
|
-1.8 Units on a scale
Standard Deviation 0.94
|
-1.7 Units on a scale
Standard Deviation 1.02
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 40: Scaling (Trunk) (n=41, 38, 79)
|
-1.7 Units on a scale
Standard Deviation 0.93
|
-1.9 Units on a scale
Standard Deviation 1.03
|
-1.8 Units on a scale
Standard Deviation 0.98
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 40: Scaling (Lower Limbs) (n=41, 38, 79)
|
-1.9 Units on a scale
Standard Deviation 1.11
|
-1.8 Units on a scale
Standard Deviation 1.06
|
-1.8 Units on a scale
Standard Deviation 1.08
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 52: Erythema (Head/Neck) (n=39, 32, 71)
|
-1.9 Units on a scale
Standard Deviation 1.17
|
-1.6 Units on a scale
Standard Deviation 1.24
|
-1.8 Units on a scale
Standard Deviation 1.20
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 52: Erythema (Upper Limbs) (n=39, 32, 71)
|
-2.0 Units on a scale
Standard Deviation 1.15
|
-2.0 Units on a scale
Standard Deviation 0.90
|
-2.0 Units on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 52: Erythema (Trunk) (n=39, 32, 71)
|
-2.2 Units on a scale
Standard Deviation 1.01
|
-2.2 Units on a scale
Standard Deviation 0.93
|
-2.2 Units on a scale
Standard Deviation 0.97
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 52: Erythema (Lower Limbs) (n=39, 32, 71)
|
-2.1 Units on a scale
Standard Deviation 1.11
|
-2.2 Units on a scale
Standard Deviation 0.94
|
-2.1 Units on a scale
Standard Deviation 1.03
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 52: Induration (Head/Neck) (n=39, 32, 71)
|
-1.7 Units on a scale
Standard Deviation 1.06
|
-1.5 Units on a scale
Standard Deviation 1.22
|
-1.6 Units on a scale
Standard Deviation 1.13
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 52: Induration (Upper Limbs) (n=39, 32, 71)
|
-1.9 Units on a scale
Standard Deviation 1.21
|
-2.0 Units on a scale
Standard Deviation 0.97
|
-1.9 Units on a scale
Standard Deviation 1.10
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 52: Induration (Trunk) (n=39, 32, 71)
|
-1.8 Units on a scale
Standard Deviation 1.39
|
-2.1 Units on a scale
Standard Deviation 1.03
|
-2.0 Units on a scale
Standard Deviation 1.24
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 52: Induration (Lower Limbs) (n=39, 32, 71)
|
-2.0 Units on a scale
Standard Deviation 1.29
|
-2.2 Units on a scale
Standard Deviation 0.97
|
-2.1 Units on a scale
Standard Deviation 1.15
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 52: Scaling (Upper Limbs) (n=39, 32, 71)
|
-1.6 Units on a scale
Standard Deviation 1.02
|
-1.9 Units on a scale
Standard Deviation 0.98
|
-1.7 Units on a scale
Standard Deviation 1.01
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 52: Scaling (Trunk) (n=39, 32, 71)
|
-1.6 Units on a scale
Standard Deviation 0.96
|
-1.9 Units on a scale
Standard Deviation 1.01
|
-1.7 Units on a scale
Standard Deviation 0.98
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 52: Scaling (Lower Limbs) (n=39, 32, 71)
|
-1.7 Units on a scale
Standard Deviation 1.15
|
-2.0 Units on a scale
Standard Deviation 1.03
|
-1.8 Units on a scale
Standard Deviation 1.10
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 28: Scaling (Trunk) (n=43, 39, 82)
|
-1.7 Units on a scale
Standard Deviation 0.99
|
-1.8 Units on a scale
Standard Deviation 1.11
|
-1.7 Units on a scale
Standard Deviation 1.05
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 8: Induration (Head/Neck) (n=43, 41, 84)
|
-1.3 Units on a scale
Standard Deviation 0.91
|
-1.6 Units on a scale
Standard Deviation 1.10
|
-1.4 Units on a scale
Standard Deviation 1.01
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 8: Induration (Trunk) (n=43, 41, 84)
|
-1.6 Units on a scale
Standard Deviation 0.98
|
-1.7 Units on a scale
Standard Deviation 1.03
|
-1.7 Units on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 8: Induration (Lower Limbs) (n=43, 41, 84)
|
-1.6 Units on a scale
Standard Deviation 0.91
|
-1.7 Units on a scale
Standard Deviation 0.98
|
-1.7 Units on a scale
Standard Deviation 0.94
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 8: Scaling (Upper Limbs) (n=43, 41, 84)
|
-1.3 Units on a scale
Standard Deviation 0.80
|
-1.6 Units on a scale
Standard Deviation 0.86
|
-1.5 Units on a scale
Standard Deviation 0.84
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 8: Scaling (Trunk) (n=43, 41, 84)
|
-1.4 Units on a scale
Standard Deviation 0.82
|
-1.8 Units on a scale
Standard Deviation 1.00
|
-1.6 Units on a scale
Standard Deviation 0.93
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 8: Scaling (Lower Limbs) (n=43, 41, 84)
|
-1.3 Units on a scale
Standard Deviation 0.82
|
-1.8 Units on a scale
Standard Deviation 0.88
|
-1.5 Units on a scale
Standard Deviation 0.88
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 12: Erythema (Head/Neck) (n=43, 41, 84)
|
-1.7 Units on a scale
Standard Deviation 1.10
|
-1.7 Units on a scale
Standard Deviation 0.98
|
-1.7 Units on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 12: Erythema (Upper Limbs) (n=43, 41, 84)
|
-1.9 Units on a scale
Standard Deviation 0.99
|
-1.8 Units on a scale
Standard Deviation 1.13
|
-1.8 Units on a scale
Standard Deviation 1.05
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 12: Erythema (Trunk) (n=43, 41, 84)
|
-2.1 Units on a scale
Standard Deviation 1.08
|
-2.0 Units on a scale
Standard Deviation 0.95
|
-2.0 Units on a scale
Standard Deviation 1.01
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 12: Erythema (Lower Limbs) (n=43, 41, 84)
|
-1.9 Units on a scale
Standard Deviation 0.92
|
-1.9 Units on a scale
Standard Deviation 0.94
|
-1.9 Units on a scale
Standard Deviation 0.92
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 12: Induration (Head/Neck) (n=43, 41, 84)
|
-1.5 Units on a scale
Standard Deviation 0.94
|
-1.6 Units on a scale
Standard Deviation 1.12
|
-1.6 Units on a scale
Standard Deviation 1.02
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 12: Scaling (Head/Neck) (n=43, 41, 84)
|
-1.7 Units on a scale
Standard Deviation 0.92
|
-1.6 Units on a scale
Standard Deviation 1.02
|
-1.6 Units on a scale
Standard Deviation 0.96
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 12: Scaling (Upper Limbs) (n=43, 41, 84)
|
-1.4 Units on a scale
Standard Deviation 0.91
|
-1.7 Units on a scale
Standard Deviation 0.95
|
-1.6 Units on a scale
Standard Deviation 0.94
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 12: Scaling (Trunk) (n=43, 41, 84)
|
-1.6 Units on a scale
Standard Deviation 1.05
|
-1.9 Units on a scale
Standard Deviation 1.00
|
-1.7 Units on a scale
Standard Deviation 1.03
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 12: Scaling (Lower Limbs) (n=43, 41, 84)
|
-1.5 Units on a scale
Standard Deviation 0.85
|
-1.9 Units on a scale
Standard Deviation 1.00
|
-1.7 Units on a scale
Standard Deviation 0.95
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 16: Erythema (Head/Neck) (n=43, 40, 83)
|
-1.7 Units on a scale
Standard Deviation 1.14
|
-1.7 Units on a scale
Standard Deviation 1.07
|
-1.7 Units on a scale
Standard Deviation 1.10
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 16: Erythema (Upper Limbs) (n=43, 40, 83)
|
-1.9 Units on a scale
Standard Deviation 1.13
|
-1.9 Units on a scale
Standard Deviation 1.12
|
-1.9 Units on a scale
Standard Deviation 1.12
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 16: Induration (Head/Neck) (n=43, 40, 83)
|
-1.5 Units on a scale
Standard Deviation 0.96
|
-1.6 Units on a scale
Standard Deviation 1.17
|
-1.6 Units on a scale
Standard Deviation 1.06
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 16: Scaling (Head/Neck) (n=43, 40, 83)
|
-1.6 Units on a scale
Standard Deviation 0.95
|
-1.6 Units on a scale
Standard Deviation 1.08
|
-1.6 Units on a scale
Standard Deviation 1.01
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 16: Induration (Upper Limbs) (n=43, 40, 83)
|
-1.8 Units on a scale
Standard Deviation 0.96
|
-1.8 Units on a scale
Standard Deviation 1.01
|
-1.8 Units on a scale
Standard Deviation 0.98
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 16: Induration (Trunk) (n=43, 40, 83)
|
-2.1 Units on a scale
Standard Deviation 1.01
|
-2.0 Units on a scale
Standard Deviation 1.01
|
-2.0 Units on a scale
Standard Deviation 1.01
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 16: Induration (Lower Limbs) (n=43, 40, 83)
|
-2.1 Units on a scale
Standard Deviation 0.95
|
-2.0 Units on a scale
Standard Deviation 1.08
|
-2.0 Units on a scale
Standard Deviation 1.01
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 2: Erythema (Head/Neck)
|
-0.5 Units on a scale
Standard Deviation 0.83
|
-0.9 Units on a scale
Standard Deviation 0.82
|
-0.7 Units on a scale
Standard Deviation 0.84
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 2: Erythema (Upper Limbs)
|
-0.5 Units on a scale
Standard Deviation 0.67
|
-0.8 Units on a scale
Standard Deviation 0.72
|
-0.6 Units on a scale
Standard Deviation 0.70
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 2: Erythema (Trunk)
|
-0.6 Units on a scale
Standard Deviation 0.67
|
-0.8 Units on a scale
Standard Deviation 0.69
|
-0.7 Units on a scale
Standard Deviation 0.69
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 2: Erythema (Lower Limbs)
|
-0.7 Units on a scale
Standard Deviation 0.69
|
-0.8 Units on a scale
Standard Deviation 0.71
|
-0.7 Units on a scale
Standard Deviation 0.70
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 2: Induration (Head/Neck)
|
-0.4 Units on a scale
Standard Deviation 0.70
|
-0.8 Units on a scale
Standard Deviation 0.89
|
-0.6 Units on a scale
Standard Deviation 0.82
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 2: Induration (Upper Limbs)
|
-0.5 Units on a scale
Standard Deviation 0.63
|
-0.6 Units on a scale
Standard Deviation 0.75
|
-0.6 Units on a scale
Standard Deviation 0.69
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 2: Induration (Trunk)
|
-0.5 Units on a scale
Standard Deviation 0.63
|
-0.7 Units on a scale
Standard Deviation 0.59
|
-0.6 Units on a scale
Standard Deviation 0.62
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 2: Induration (Lower Limbs)
|
-0.5 Units on a scale
Standard Deviation 0.67
|
-0.7 Units on a scale
Standard Deviation 0.71
|
-0.6 Units on a scale
Standard Deviation 0.69
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 2: Scaling (Head/Neck)
|
-0.4 Units on a scale
Standard Deviation 0.66
|
-0.9 Units on a scale
Standard Deviation 0.91
|
-0.7 Units on a scale
Standard Deviation 0.83
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 2: Scaling (Upper Limbs)
|
-0.4 Units on a scale
Standard Deviation 0.59
|
-0.8 Units on a scale
Standard Deviation 0.74
|
-0.6 Units on a scale
Standard Deviation 0.69
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 2: Scaling (Trunk)
|
-0.3 Units on a scale
Standard Deviation 0.57
|
-0.8 Units on a scale
Standard Deviation 0.76
|
-0.6 Units on a scale
Standard Deviation 0.71
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 2: Scaling (Lower Limbs)
|
-0.4 Units on a scale
Standard Deviation 0.70
|
-0.7 Units on a scale
Standard Deviation 0.73
|
-0.6 Units on a scale
Standard Deviation 0.73
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 4: Erythema (Head/Neck)
|
-0.8 Units on a scale
Standard Deviation 1.02
|
-1.3 Units on a scale
Standard Deviation 0.99
|
-1.0 Units on a scale
Standard Deviation 1.02
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 4: Erythema (Upper Limbs)
|
-1.1 Units on a scale
Standard Deviation 0.81
|
-1.2 Units on a scale
Standard Deviation 0.94
|
-1.1 Units on a scale
Standard Deviation 0.87
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 4: Erythema (Trunk)
|
-1.0 Units on a scale
Standard Deviation 0.64
|
-1.3 Units on a scale
Standard Deviation 0.79
|
-1.1 Units on a scale
Standard Deviation 0.72
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 4: Erythema (Lower Limbs)
|
-1.1 Units on a scale
Standard Deviation 0.91
|
-1.2 Units on a scale
Standard Deviation 0.79
|
-1.2 Units on a scale
Standard Deviation 0.85
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
Week 4: Induration (Trunk)
|
-0.9 Units on a scale
Standard Deviation 0.80
|
-1.3 Units on a scale
Standard Deviation 0.82
|
-1.1 Units on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 20, 28, 40, 52Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=43 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=44 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=87 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
Week 2
|
7.0 Percentage of participants
|
15.9 Percentage of participants
|
11.5 Percentage of participants
|
|
Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
Week 4
|
30.2 Percentage of participants
|
38.6 Percentage of participants
|
34.5 Percentage of participants
|
|
Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
Week 8
|
58.1 Percentage of participants
|
61.4 Percentage of participants
|
59.8 Percentage of participants
|
|
Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
Week 12
|
72.1 Percentage of participants
|
75.0 Percentage of participants
|
73.6 Percentage of participants
|
|
Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
Week 28
|
67.4 Percentage of participants
|
54.5 Percentage of participants
|
60.9 Percentage of participants
|
|
Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
Week 40
|
67.4 Percentage of participants
|
54.5 Percentage of participants
|
60.9 Percentage of participants
|
|
Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
Week 52
|
58.1 Percentage of participants
|
56.8 Percentage of participants
|
57.5 Percentage of participants
|
|
Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
Week 20
|
72.1 Percentage of participants
|
59.1 Percentage of participants
|
65.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 40, 52Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=43 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=44 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=87 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 2: Clear
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 2: Mild
|
39.5 Percentage of participants
|
43.2 Percentage of participants
|
41.4 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 2: Moderate
|
46.5 Percentage of participants
|
34.1 Percentage of participants
|
40.2 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 2: Severe
|
7.0 Percentage of participants
|
6.8 Percentage of participants
|
6.9 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 4: Clear
|
0 Percentage of participants
|
11.4 Percentage of participants
|
5.7 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 4: Mild
|
44.2 Percentage of participants
|
40.9 Percentage of participants
|
42.5 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 4: Moderate
|
18.6 Percentage of participants
|
20.5 Percentage of participants
|
19.5 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 4: Severe
|
7.0 Percentage of participants
|
0 Percentage of participants
|
3.4 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 8: Moderate (n=43, 41, 84)
|
14.0 Percentage of participants
|
9.8 Percentage of participants
|
11.9 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 8: Severe (n=43, 41, 84)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 12: Clear (n=43, 41, 84)
|
14.0 Percentage of participants
|
36.6 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 12: Almost Clear (n=43, 41, 84)
|
58.1 Percentage of participants
|
43.9 Percentage of participants
|
51.2 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 12: Mild (n=43, 41, 84)
|
20.9 Percentage of participants
|
9.8 Percentage of participants
|
15.5 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 12: Moderate (n=43, 41, 84)
|
7.0 Percentage of participants
|
9.8 Percentage of participants
|
8.3 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 12: Severe (n=43, 41, 84)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 16: Clear (n=43, 40, 83)
|
27.9 Percentage of participants
|
40.0 Percentage of participants
|
33.7 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 16: Almost Clear (n=43, 40, 83)
|
39.5 Percentage of participants
|
35.0 Percentage of participants
|
37.3 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 28: Clear (n=43, 39, 82)
|
37.2 Percentage of participants
|
33.3 Percentage of participants
|
35.4 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 28: Almost Clear (n=43, 39, 82)
|
30.2 Percentage of participants
|
28.2 Percentage of participants
|
29.3 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 40: Mild (n=41, 38, 79)
|
24.4 Percentage of participants
|
28.9 Percentage of participants
|
26.6 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 52: Severe (n=39, 32, 71)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 8: Almost Clear (n=43, 41, 84)
|
51.2 Percentage of participants
|
39.0 Percentage of participants
|
45.2 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 8: Mild (n=43, 41, 84)
|
27.9 Percentage of participants
|
24.4 Percentage of participants
|
26.2 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 16: Mild (n=43, 40, 83)
|
25.6 Percentage of participants
|
17.5 Percentage of participants
|
21.7 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 16: Moderate (n=43, 40, 83)
|
7.0 Percentage of participants
|
5.0 Percentage of participants
|
6.0 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 16: Severe (n=43, 40, 83)
|
0 Percentage of participants
|
2.5 Percentage of participants
|
1.2 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 20: Clear (n=43, 39, 82)
|
27.9 Percentage of participants
|
38.5 Percentage of participants
|
32.9 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 20: Almost Clear (n=43, 39, 82)
|
44.2 Percentage of participants
|
28.2 Percentage of participants
|
36.6 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 20: Mild (n=43, 39, 82)
|
18.6 Percentage of participants
|
25.6 Percentage of participants
|
22.0 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 20: Moderate (n=43, 39, 82)
|
9.3 Percentage of participants
|
7.7 Percentage of participants
|
8.5 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 20: Severe(n=43, 39, 82)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 28: Mild (n=43, 39, 82)
|
27.9 Percentage of participants
|
30.8 Percentage of participants
|
29.3 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 28: Moderate (n=43, 39, 82)
|
4.7 Percentage of participants
|
7.7 Percentage of participants
|
6.1 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 28: Severe (n=43, 39, 82)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 40: Clear (n=41, 38, 79)
|
43.9 Percentage of participants
|
34.2 Percentage of participants
|
39.2 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 40: Almost Clear (n=41, 38, 79)
|
26.8 Percentage of participants
|
28.9 Percentage of participants
|
27.8 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 40: Moderate (n=41, 38, 79)
|
4.9 Percentage of participants
|
7.9 Percentage of participants
|
6.3 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 40: Severe (n=41, 38, 79)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 52: Clear (n=39, 32, 71)
|
41.0 Percentage of participants
|
43.8 Percentage of participants
|
42.3 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 52: Almost Clear (n=39, 32, 71)
|
23.1 Percentage of participants
|
34.4 Percentage of participants
|
28.2 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 52: Mild (n=39, 32, 71)
|
30.8 Percentage of participants
|
18.8 Percentage of participants
|
25.4 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 52: Moderate (n=39, 32, 71)
|
5.1 Percentage of participants
|
3.1 Percentage of participants
|
4.2 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 2: Almost Clear
|
7.0 Percentage of participants
|
15.9 Percentage of participants
|
11.5 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 4: Almost Clear
|
30.2 Percentage of participants
|
27.3 Percentage of participants
|
28.7 Percentage of participants
|
|
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
Week 8: Clear (n=43, 41, 84)
|
7.0 Percentage of participants
|
26.8 Percentage of participants
|
16.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 20, 28, 40, 52Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. Maintenance of PASI75 response at Week 52 among participants achieving PASI75 response at Week 16 is reported.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=28 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=35 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=63 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16
Week 20
|
96.3 Percentage of participants
|
87.5 Percentage of participants
|
91.5 Percentage of participants
|
|
Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16
Week 28
|
92.6 Percentage of participants
|
78.1 Percentage of participants
|
84.7 Percentage of participants
|
|
Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16
Week 40
|
81.5 Percentage of participants
|
71.9 Percentage of participants
|
76.3 Percentage of participants
|
|
Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16
Week 52
|
70.4 Percentage of participants
|
62.5 Percentage of participants
|
66.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 20, 28, 40, 52Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=30 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=31 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=61 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
Week 20
|
100 Percentage of participants
|
83.3 Percentage of participants
|
91.5 Percentage of participants
|
|
Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
Week 28
|
93.1 Percentage of participants
|
73.3 Percentage of participants
|
83.1 Percentage of participants
|
|
Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
Week 40
|
82.8 Percentage of participants
|
66.7 Percentage of participants
|
74.6 Percentage of participants
|
|
Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
Week 52
|
65.5 Percentage of participants
|
60.0 Percentage of participants
|
62.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 8, 16, 20, 28, 40, 52Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 \[absence of psoriasis\] to 4 \[presence of psoriasis in all 4 quadrants\]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=32 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=30 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=62 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
Week 28 (n=32, 27, 59)
|
-21.1 Units on a scale
Standard Deviation 15.83
|
-16.4 Units on a scale
Standard Deviation 15.27
|
-18.9 Units on a scale
Standard Deviation 15.62
|
|
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
Week 8 (n=32, 28, 60)
|
-3.3 Units on a scale
Standard Deviation 9.63
|
-1.8 Units on a scale
Standard Deviation 7.72
|
-2.6 Units on a scale
Standard Deviation 8.75
|
|
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
Week 16 (n=32, 28, 60)
|
-11.2 Units on a scale
Standard Deviation 15.27
|
-9.4 Units on a scale
Standard Deviation 12.66
|
-10.4 Units on a scale
Standard Deviation 14.02
|
|
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
Week 20 (n=32, 27, 59)
|
-15.0 Units on a scale
Standard Deviation 15.29
|
-14.1 Units on a scale
Standard Deviation 13.03
|
-14.6 Units on a scale
Standard Deviation 14.18
|
|
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
Week 40 (n=31, 26, 57)
|
-22.2 Units on a scale
Standard Deviation 16.18
|
-16.2 Units on a scale
Standard Deviation 14.13
|
-19.5 Units on a scale
Standard Deviation 15.45
|
|
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
Week 52 (n=30, 22, 52)
|
-20.6 Units on a scale
Standard Deviation 15.16
|
-16.2 Units on a scale
Standard Deviation 15.62
|
-18.7 Units on a scale
Standard Deviation 15.36
|
SECONDARY outcome
Timeframe: Baseline, Week 8, 16, 20, 28, 40, 52Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop \[salmon patch dyschromia\]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=32 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=30 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=62 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Number of Affected Nails
Baseline
|
7.94 nails
Standard Deviation 2.82
|
7.13 nails
Standard Deviation 3.07
|
7.55 nails
Standard Deviation 2.95
|
|
Number of Affected Nails
Week 8 (n=32, 28, 60)
|
7.66 nails
Standard Deviation 3.17
|
7.11 nails
Standard Deviation 3.02
|
7.40 nails
Standard Deviation 3.09
|
|
Number of Affected Nails
Week 16 (n=32, 28, 60)
|
6.91 nails
Standard Deviation 3.43
|
5.75 nails
Standard Deviation 3.56
|
6.37 nails
Standard Deviation 3.51
|
|
Number of Affected Nails
Week 20 (n=32, 27, 59)
|
6.16 nails
Standard Deviation 3.60
|
4.59 nails
Standard Deviation 4.02
|
5.44 nails
Standard Deviation 3.85
|
|
Number of Affected Nails
Week 28 (n=32, 27, 59)
|
4.53 nails
Standard Deviation 3.87
|
3.59 nails
Standard Deviation 3.96
|
4.10 nails
Standard Deviation 3.91
|
|
Number of Affected Nails
Week 40 (n=31, 26, 57)
|
3.32 nails
Standard Deviation 3.94
|
3.77 nails
Standard Deviation 3.81
|
3.53 nails
Standard Deviation 3.85
|
|
Number of Affected Nails
Week 52 (n=30, 22, 52)
|
3.73 nails
Standard Deviation 4.25
|
2.50 nails
Standard Deviation 3.07
|
3.21 nails
Standard Deviation 3.81
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=43 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=44 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=87 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Itch Severity Item (ISI) Score
Week 2
|
5.19 Units on a scale
Standard Deviation 2.797
|
3.30 Units on a scale
Standard Deviation 2.530
|
4.23 Units on a scale
Standard Deviation 2.815
|
|
Itch Severity Item (ISI) Score
Week 4
|
3.65 Units on a scale
Standard Deviation 2.379
|
2.27 Units on a scale
Standard Deviation 2.472
|
2.95 Units on a scale
Standard Deviation 2.510
|
|
Itch Severity Item (ISI) Score
Week 8 (n=43, 41, 84)
|
2.26 Units on a scale
Standard Deviation 2.381
|
1.22 Units on a scale
Standard Deviation 1.739
|
1.75 Units on a scale
Standard Deviation 2.145
|
|
Itch Severity Item (ISI) Score
Week 12 (n=43, 41, 84)
|
1.77 Units on a scale
Standard Deviation 2.379
|
1.20 Units on a scale
Standard Deviation 1.833
|
1.49 Units on a scale
Standard Deviation 2.137
|
|
Itch Severity Item (ISI) Score
Week 20 (n=43, 39, 82)
|
0.95 Units on a scale
Standard Deviation 1.618
|
1.28 Units on a scale
Standard Deviation 1.589
|
1.11 Units on a scale
Standard Deviation 1.603
|
|
Itch Severity Item (ISI) Score
Week 40 (n=41, 38, 79)
|
0.90 Units on a scale
Standard Deviation 1.814
|
1.13 Units on a scale
Standard Deviation 1.848
|
1.01 Units on a scale
Standard Deviation 1.822
|
|
Itch Severity Item (ISI) Score
Baseline
|
6.16 Units on a scale
Standard Deviation 2.669
|
5.32 Units on a scale
Standard Deviation 2.967
|
5.74 Units on a scale
Standard Deviation 2.839
|
|
Itch Severity Item (ISI) Score
Week 16 (n=43, 40, 83)
|
1.67 Units on a scale
Standard Deviation 2.378
|
0.90 Units on a scale
Standard Deviation 1.257
|
1.30 Units on a scale
Standard Deviation 1.949
|
|
Itch Severity Item (ISI) Score
Week 28 (n=43, 39, 82)
|
1.12 Units on a scale
Standard Deviation 1.651
|
1.62 Units on a scale
Standard Deviation 2.196
|
1.35 Units on a scale
Standard Deviation 1.933
|
|
Itch Severity Item (ISI) Score
Week 52 (n=39, 32, 71)
|
1.15 Units on a scale
Standard Deviation 2.084
|
0.91 Units on a scale
Standard Deviation 1.329
|
1.04 Units on a scale
Standard Deviation 1.776
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=43 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=44 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=87 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Dermatology Life Quality Index (DLQI) Score
Week 4 (n=43, 43, 86)
|
5.9 Units on a scale
Standard Deviation 5.07
|
4.2 Units on a scale
Standard Deviation 4.63
|
5.1 Units on a scale
Standard Deviation 4.90
|
|
Dermatology Life Quality Index (DLQI) Score
Week 20 (n=43, 39, 82)
|
1.9 Units on a scale
Standard Deviation 3.13
|
1.8 Units on a scale
Standard Deviation 2.54
|
1.9 Units on a scale
Standard Deviation 2.84
|
|
Dermatology Life Quality Index (DLQI) Score
Week 28 (n=43, 39, 82)
|
1.7 Units on a scale
Standard Deviation 2.66
|
2.9 Units on a scale
Standard Deviation 3.68
|
2.3 Units on a scale
Standard Deviation 3.23
|
|
Dermatology Life Quality Index (DLQI) Score
Baseline
|
11.3 Units on a scale
Standard Deviation 6.25
|
8.6 Units on a scale
Standard Deviation 5.91
|
9.9 Units on a scale
Standard Deviation 6.19
|
|
Dermatology Life Quality Index (DLQI) Score
Week 2
|
7.8 Units on a scale
Standard Deviation 5.20
|
5.8 Units on a scale
Standard Deviation 5.32
|
6.8 Units on a scale
Standard Deviation 5.32
|
|
Dermatology Life Quality Index (DLQI) Score
Week 8 (n=43, 41, 84)
|
4.0 Units on a scale
Standard Deviation 3.95
|
2.8 Units on a scale
Standard Deviation 3.30
|
3.4 Units on a scale
Standard Deviation 3.67
|
|
Dermatology Life Quality Index (DLQI) Score
Week 12 (n=43, 41, 84)
|
2.6 Units on a scale
Standard Deviation 2.86
|
1.8 Units on a scale
Standard Deviation 2.68
|
2.2 Units on a scale
Standard Deviation 2.79
|
|
Dermatology Life Quality Index (DLQI) Score
Week 16 (n=43, 40, 83)
|
2.2 Units on a scale
Standard Deviation 3.04
|
1.9 Units on a scale
Standard Deviation 2.73
|
2.1 Units on a scale
Standard Deviation 2.88
|
|
Dermatology Life Quality Index (DLQI) Score
Week 40 (n=41, 38, 79)
|
1.8 Units on a scale
Standard Deviation 2.81
|
2.3 Units on a scale
Standard Deviation 4.11
|
2.0 Units on a scale
Standard Deviation 3.48
|
|
Dermatology Life Quality Index (DLQI) Score
Week 52 (n=39, 32, 71)
|
1.6 Units on a scale
Standard Deviation 2.42
|
2.2 Units on a scale
Standard Deviation 4.00
|
1.9 Units on a scale
Standard Deviation 3.22
|
SECONDARY outcome
Timeframe: Week (W) 16, 28, 52Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=43 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=44 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=87 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W16: Bodily Pain Domain (n=43, 40, 83)
|
11.808 Units on a scale
Standard Deviation 13.8431
|
10.663 Units on a scale
Standard Deviation 12.2936
|
11.256 Units on a scale
Standard Deviation 13.0524
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W52: Social Function Domain (n=39, 32, 71)
|
8.411 Units on a scale
Standard Deviation 9.4598
|
8.402 Units on a scale
Standard Deviation 9.2577
|
8.407 Units on a scale
Standard Deviation 9.3024
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W52: Bodily Pain Domain (n=39, 32, 71)
|
12.335 Units on a scale
Standard Deviation 12.1413
|
10.673 Units on a scale
Standard Deviation 9.7128
|
11.586 Units on a scale
Standard Deviation 11.0678
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W52: General Health Domain (n=39, 32, 71)
|
2.758 Units on a scale
Standard Deviation 6.0866
|
4.888 Units on a scale
Standard Deviation 6.8235
|
3.718 Units on a scale
Standard Deviation 6.4707
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W52: Vitality Domain (n=39, 32, 71)
|
4.068 Units on a scale
Standard Deviation 10.5612
|
5.052 Units on a scale
Standard Deviation 8.5160
|
4.511 Units on a scale
Standard Deviation 9.6390
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W52: Role-Emotional Domain (n=39, 32, 71)
|
8.445 Units on a scale
Standard Deviation 11.0018
|
5.915 Units on a scale
Standard Deviation 10.3091
|
7.305 Units on a scale
Standard Deviation 10.6949
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W52: Mental Health Domain (n=39, 32, 71)
|
7.317 Units on a scale
Standard Deviation 11.6243
|
6.926 Units on a scale
Standard Deviation 12.6861
|
7.141 Units on a scale
Standard Deviation 12.0276
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W16: Physical Functioning Domain (n=43, 40, 83)
|
1.951 Units on a scale
Standard Deviation 5.1880
|
4.809 Units on a scale
Standard Deviation 9.1822
|
3.329 Units on a scale
Standard Deviation 7.4800
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W16: Role-Physical Domain (n=43, 40, 83)
|
6.160 Units on a scale
Standard Deviation 9.3615
|
5.130 Units on a scale
Standard Deviation 11.1600
|
5.664 Units on a scale
Standard Deviation 10.2172
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W16: General Health Domain (n=43, 40, 83)
|
2.392 Units on a scale
Standard Deviation 7.0933
|
4.333 Units on a scale
Standard Deviation 7.0145
|
3.328 Units on a scale
Standard Deviation 7.0799
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W16: Vitality Domain (n=43, 40, 83)
|
4.664 Units on a scale
Standard Deviation 9.5406
|
3.517 Units on a scale
Standard Deviation 11.4421
|
4.112 Units on a scale
Standard Deviation 10.4509
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W16: Social Function Domain (n=43, 40, 83)
|
7.629 Units on a scale
Standard Deviation 9.9734
|
7.932 Units on a scale
Standard Deviation 8.8645
|
7.775 Units on a scale
Standard Deviation 9.3992
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W16: Role-Emotional Domain (n=43, 40, 83)
|
7.219 Units on a scale
Standard Deviation 11.5898
|
5.584 Units on a scale
Standard Deviation 11.5654
|
6.431 Units on a scale
Standard Deviation 11.5365
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W16: Mental Health Domain (n=43, 40, 83)
|
5.928 Units on a scale
Standard Deviation 12.8757
|
5.125 Units on a scale
Standard Deviation 13.3613
|
5.541 Units on a scale
Standard Deviation 13.0378
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W28: Physical Functioning Domain (n=43, 39, 82)
|
1.571 Units on a scale
Standard Deviation 6.3446
|
4.303 Units on a scale
Standard Deviation 10.3695
|
2.870 Units on a scale
Standard Deviation 8.5558
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W28: Role-Physical Domain (n=43, 39, 82)
|
5.882 Units on a scale
Standard Deviation 10.6375
|
5.017 Units on a scale
Standard Deviation 11.4671
|
5.471 Units on a scale
Standard Deviation 10.9795
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W28: Bodily Pain Domain (n=43, 39, 82)
|
10.113 Units on a scale
Standard Deviation 15.9485
|
8.394 Units on a scale
Standard Deviation 12.5405
|
9.295 Units on a scale
Standard Deviation 14.3670
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W28: General Health Domain (n=43, 39, 82)
|
2.644 Units on a scale
Standard Deviation 5.9230
|
3.517 Units on a scale
Standard Deviation 7.1375
|
3.059 Units on a scale
Standard Deviation 6.5025
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W28: Vitality Domain (n=43, 39, 82)
|
4.038 Units on a scale
Standard Deviation 10.0116
|
3.608 Units on a scale
Standard Deviation 10.0742
|
3.833 Units on a scale
Standard Deviation 9.9815
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W28: Social Function Domain (n=43, 39, 82)
|
6.628 Units on a scale
Standard Deviation 11.3068
|
6.205 Units on a scale
Standard Deviation 10.4347
|
6.427 Units on a scale
Standard Deviation 10.8358
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W28: Role-Emotional Domain (n=43, 39, 82)
|
7.395 Units on a scale
Standard Deviation 11.8846
|
6.310 Units on a scale
Standard Deviation 12.9504
|
6.879 Units on a scale
Standard Deviation 12.3375
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W28: Mental Health Domain (n=43, 39, 82)
|
6.701 Units on a scale
Standard Deviation 12.4375
|
5.328 Units on a scale
Standard Deviation 12.8129
|
6.048 Units on a scale
Standard Deviation 12.5580
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W52: Physical Functioning Domain (n=39,32,71)
|
2.151 Units on a scale
Standard Deviation 5.6134
|
3.773 Units on a scale
Standard Deviation 7.3533
|
2.882 Units on a scale
Standard Deviation 6.4585
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
W52: Role-Physical Domain (n=39, 32, 71)
|
6.669 Units on a scale
Standard Deviation 10.0520
|
4.623 Units on a scale
Standard Deviation 9.7340
|
5.747 Units on a scale
Standard Deviation 9.8926
|
SECONDARY outcome
Timeframe: Week 16, 28, 52Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=43 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=44 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=87 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score
Week 16: Physical Health Score (n=43, 40, 83)
|
4.719 Units on a scale
Standard Deviation 6.6806
|
6.146 Units on a scale
Standard Deviation 8.5192
|
5.407 Units on a scale
Standard Deviation 7.6087
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score
Week 16: Mental Health Score (n=43, 40, 83)
|
6.767 Units on a scale
Standard Deviation 11.0945
|
5.029 Units on a scale
Standard Deviation 11.4967
|
5.929 Units on a scale
Standard Deviation 11.2548
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score
Week 28: Physical Health Score (n=43, 39, 82)
|
3.770 Units on a scale
Standard Deviation 7.7829
|
4.799 Units on a scale
Standard Deviation 8.8893
|
4.259 Units on a scale
Standard Deviation 8.2914
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score
Week 28: Mental Health Score (n=43, 39, 82)
|
7.085 Units on a scale
Standard Deviation 11.3660
|
5.364 Units on a scale
Standard Deviation 10.9089
|
6.266 Units on a scale
Standard Deviation 11.1159
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score
Week 52: Physical Health Score (n=39, 32, 71)
|
4.676 Units on a scale
Standard Deviation 5.7405
|
5.250 Units on a scale
Standard Deviation 5.7614
|
4.935 Units on a scale
Standard Deviation 5.7159
|
|
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score
Week 52: Mental Health Score (n=39, 32, 71)
|
7.878 Units on a scale
Standard Deviation 10.1983
|
6.826 Units on a scale
Standard Deviation 10.5988
|
7.404 Units on a scale
Standard Deviation 10.3192
|
SECONDARY outcome
Timeframe: Baseline (BL), Week (W) 4, 16, 28, 52Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands Scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 \[no loss\] to 100 \[complete loss of work\]).
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=43 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=44 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=87 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Work Limitation Questionnaire (WLQ)
W28:Mental/Interpersonal Demands Scale(n=33,35,68)
|
16.84 Units on a scale
Standard Deviation 28.242
|
16.39 Units on a scale
Standard Deviation 27.736
|
16.61 Units on a scale
Standard Deviation 27.774
|
|
Work Limitation Questionnaire (WLQ)
BL: Mental/Interpersonal Demands Scale(n=34,38,72)
|
28.61 Units on a scale
Standard Deviation 29.012
|
31.52 Units on a scale
Standard Deviation 30.930
|
30.15 Units on a scale
Standard Deviation 29.865
|
|
Work Limitation Questionnaire (WLQ)
BL: Output Demands scale (n=33, 37, 70)
|
22.61 Units on a scale
Standard Deviation 26.832
|
30.27 Units on a scale
Standard Deviation 35.295
|
26.66 Units on a scale
Standard Deviation 31.602
|
|
Work Limitation Questionnaire (WLQ)
BL: WLQ Index Score (n=34, 38, 72)
|
9.55 Units on a scale
Standard Deviation 6.716
|
10.74 Units on a scale
Standard Deviation 8.045
|
10.18 Units on a scale
Standard Deviation 7.420
|
|
Work Limitation Questionnaire (WLQ)
BL: Time Management scale (n=34, 37, 71)
|
44.49 Units on a scale
Standard Deviation 37.783
|
42.36 Units on a scale
Standard Deviation 33.716
|
43.38 Units on a scale
Standard Deviation 35.479
|
|
Work Limitation Questionnaire (WLQ)
BL: Physical Demands scale (n=33, 35, 68)
|
66.67 Units on a scale
Standard Deviation 33.522
|
78.40 Units on a scale
Standard Deviation 31.122
|
72.71 Units on a scale
Standard Deviation 32.606
|
|
Work Limitation Questionnaire (WLQ)
W4: Time Management scale (n=31, 36, 67)
|
35.32 Units on a scale
Standard Deviation 42.425
|
31.39 Units on a scale
Standard Deviation 36.715
|
33.21 Units on a scale
Standard Deviation 39.203
|
|
Work Limitation Questionnaire (WLQ)
W4: Physical Demands scale (n=29, 36, 65)
|
77.16 Units on a scale
Standard Deviation 33.013
|
83.59 Units on a scale
Standard Deviation 29.593
|
80.72 Units on a scale
Standard Deviation 31.083
|
|
Work Limitation Questionnaire (WLQ)
W4:Mental/Interpersonal Demands Scale(n=32,36,68)
|
17.94 Units on a scale
Standard Deviation 26.979
|
23.39 Units on a scale
Standard Deviation 32.878
|
20.82 Units on a scale
Standard Deviation 30.149
|
|
Work Limitation Questionnaire (WLQ)
W4: Output Demands scale (n=30, 36, 66)
|
13.50 Units on a scale
Standard Deviation 21.978
|
20.14 Units on a scale
Standard Deviation 33.306
|
17.12 Units on a scale
Standard Deviation 28.704
|
|
Work Limitation Questionnaire (WLQ)
W4: WLQ Index Score (n=32, 37, 69)
|
7.23 Units on a scale
Standard Deviation 5.591
|
8.66 Units on a scale
Standard Deviation 7.754
|
8.00 Units on a scale
Standard Deviation 6.827
|
|
Work Limitation Questionnaire (WLQ)
W16: Time Management scale (n=31, 35, 66)
|
35.07 Units on a scale
Standard Deviation 38.894
|
33.29 Units on a scale
Standard Deviation 39.182
|
34.12 Units on a scale
Standard Deviation 38.756
|
|
Work Limitation Questionnaire (WLQ)
W16: Physical Demands scale (n=30, 32, 62)
|
81.60 Units on a scale
Standard Deviation 26.982
|
86.52 Units on a scale
Standard Deviation 25.548
|
84.14 Units on a scale
Standard Deviation 26.153
|
|
Work Limitation Questionnaire (WLQ)
W16:Mental/Interpersonal Demands Scale(n=31,35,66)
|
13.33 Units on a scale
Standard Deviation 21.038
|
20.28 Units on a scale
Standard Deviation 33.419
|
17.01 Units on a scale
Standard Deviation 28.296
|
|
Work Limitation Questionnaire (WLQ)
W16: Output Demands scale (n=32, 33, 65)
|
11.88 Units on a scale
Standard Deviation 20.111
|
19.55 Units on a scale
Standard Deviation 32.485
|
15.77 Units on a scale
Standard Deviation 27.175
|
|
Work Limitation Questionnaire (WLQ)
W16: WLQ Index Score (n=32, 35, 67)
|
6.88 Units on a scale
Standard Deviation 4.715
|
8.35 Units on a scale
Standard Deviation 7.425
|
7.65 Units on a scale
Standard Deviation 6.276
|
|
Work Limitation Questionnaire (WLQ)
W28: Time Management scale (n=34, 34, 68)
|
38.68 Units on a scale
Standard Deviation 40.100
|
29.78 Units on a scale
Standard Deviation 39.092
|
34.23 Units on a scale
Standard Deviation 39.557
|
|
Work Limitation Questionnaire (WLQ)
W28: Physical Demands scale (n=32, 34, 66)
|
76.02 Units on a scale
Standard Deviation 31.041
|
85.42 Units on a scale
Standard Deviation 24.730
|
80.86 Units on a scale
Standard Deviation 28.151
|
|
Work Limitation Questionnaire (WLQ)
W28: Output Demands scale (n=33, 34, 67)
|
13.94 Units on a scale
Standard Deviation 27.408
|
14.71 Units on a scale
Standard Deviation 28.761
|
14.33 Units on a scale
Standard Deviation 27.892
|
|
Work Limitation Questionnaire (WLQ)
W28: WLQ Index Score (n=34, 36, 70)
|
7.43 Units on a scale
Standard Deviation 6.493
|
7.26 Units on a scale
Standard Deviation 6.829
|
7.34 Units on a scale
Standard Deviation 6.620
|
|
Work Limitation Questionnaire (WLQ)
W52: Time Management scale (n=31, 31, 62)
|
50.32 Units on a scale
Standard Deviation 43.683
|
31.88 Units on a scale
Standard Deviation 40.686
|
41.10 Units on a scale
Standard Deviation 42.883
|
|
Work Limitation Questionnaire (WLQ)
W52: Physical Demands scale (n=29, 29, 58)
|
78.16 Units on a scale
Standard Deviation 30.205
|
89.74 Units on a scale
Standard Deviation 24.410
|
83.95 Units on a scale
Standard Deviation 27.838
|
|
Work Limitation Questionnaire (WLQ)
W52:Mental/Interpersonal Demands Scale(n=30,30,60)
|
25.56 Units on a scale
Standard Deviation 36.007
|
16.89 Units on a scale
Standard Deviation 27.293
|
21.22 Units on a scale
Standard Deviation 31.977
|
|
Work Limitation Questionnaire (WLQ)
W52: Output Demands scale (n=30, 29, 59)
|
22.63 Units on a scale
Standard Deviation 33.750
|
12.24 Units on a scale
Standard Deviation 24.589
|
17.52 Units on a scale
Standard Deviation 29.813
|
|
Work Limitation Questionnaire (WLQ)
W52: WLQ Index Score (n=32, 31, 63)
|
9.44 Units on a scale
Standard Deviation 8.127
|
7.34 Units on a scale
Standard Deviation 6.429
|
8.41 Units on a scale
Standard Deviation 7.358
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52Population: Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear \[no psoriasis\]; 1=almost clear; 2=mild; 3=moderate; 4=severe).
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=43 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=44 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=87 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 40: Mild (n=41, 38, 79)
|
19.5 Percentage of participants
|
18.4 Percentage of participants
|
19.0 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Baseline: Clear
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Baseline: Almost Clear
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Baseline: Mild
|
0 Percentage of participants
|
2.3 Percentage of participants
|
1.1 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Baseline: Moderate
|
41.9 Percentage of participants
|
43.2 Percentage of participants
|
42.5 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Baseline: Severe
|
58.1 Percentage of participants
|
54.5 Percentage of participants
|
56.3 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 2: Clear
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 2: Almost Clear
|
2.3 Percentage of participants
|
0 Percentage of participants
|
1.1 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 2: Mild
|
2.3 Percentage of participants
|
29.5 Percentage of participants
|
16.1 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 2: Moderate
|
60.5 Percentage of participants
|
36.4 Percentage of participants
|
48.3 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 2: Severe
|
34.9 Percentage of participants
|
34.1 Percentage of participants
|
34.5 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 4: Clear (n=43, 43, 86)
|
0 Percentage of participants
|
2.3 Percentage of participants
|
1.2 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 4: Almost Clear (n=43, 43, 86)
|
4.7 Percentage of participants
|
9.3 Percentage of participants
|
7.0 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 4: Mild (n=43, 43, 86)
|
18.6 Percentage of participants
|
25.6 Percentage of participants
|
22.1 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 4: Moderate (n=43, 43, 86)
|
53.5 Percentage of participants
|
48.8 Percentage of participants
|
51.2 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 4: Severe (n=43, 43, 86)
|
23.3 Percentage of participants
|
14.0 Percentage of participants
|
18.6 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 8: Clear (n=43, 41, 84)
|
4.7 Percentage of participants
|
7.3 Percentage of participants
|
6.0 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 8: Almost Clear (n=43, 41, 84)
|
14.0 Percentage of participants
|
17.1 Percentage of participants
|
15.5 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 8: Mild (n=43, 41, 84)
|
32.6 Percentage of participants
|
34.1 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 8: Moderate (n=43, 41, 84)
|
39.5 Percentage of participants
|
34.1 Percentage of participants
|
36.9 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 8: Severe (n=43, 41, 84)
|
9.3 Percentage of participants
|
7.3 Percentage of participants
|
8.3 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 12: Clear (n=43, 41, 84)
|
2.3 Percentage of participants
|
7.3 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 12: Almost Clear (n=43, 41, 84)
|
20.9 Percentage of participants
|
26.8 Percentage of participants
|
23.8 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 12: Mild (n=43, 41, 84)
|
34.9 Percentage of participants
|
41.5 Percentage of participants
|
38.1 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 12: Moderate (n=43, 41, 84)
|
34.9 Percentage of participants
|
17.1 Percentage of participants
|
26.2 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 12: Severe (n=43, 41, 84)
|
7.0 Percentage of participants
|
7.3 Percentage of participants
|
7.1 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 16: Clear (n=43, 40, 83)
|
4.7 Percentage of participants
|
10.0 Percentage of participants
|
7.2 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 16: Almost Clear (n=43, 40, 83)
|
32.6 Percentage of participants
|
22.5 Percentage of participants
|
27.7 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 16: Mild (n=43, 40, 83)
|
23.3 Percentage of participants
|
35.0 Percentage of participants
|
28.9 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 16: Moderate (n=43, 40, 83)
|
32.6 Percentage of participants
|
22.5 Percentage of participants
|
27.7 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 16: Severe (n=43, 40, 83)
|
7.0 Percentage of participants
|
10.0 Percentage of participants
|
8.4 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 20: Clear (n=43, 39, 82)
|
7.0 Percentage of participants
|
12.8 Percentage of participants
|
9.8 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 20: Almost Clear (n=43, 39, 82)
|
37.2 Percentage of participants
|
23.1 Percentage of participants
|
30.5 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 20: Mild (n=43, 39, 82)
|
25.6 Percentage of participants
|
33.3 Percentage of participants
|
29.3 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 20: Moderate (n=43, 39, 82)
|
23.3 Percentage of participants
|
25.6 Percentage of participants
|
24.4 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 20: Severe (n=43, 39, 82)
|
7.0 Percentage of participants
|
5.1 Percentage of participants
|
6.1 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 28: Clear (n=43, 39, 82)
|
11.6 Percentage of participants
|
5.1 Percentage of participants
|
8.5 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 28: Almost Clear (n=43, 39, 82)
|
37.2 Percentage of participants
|
35.9 Percentage of participants
|
36.6 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 28: Mild (n=43, 39, 82)
|
23.3 Percentage of participants
|
20.5 Percentage of participants
|
22.0 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 28: Moderate (n=43, 39, 82)
|
20.9 Percentage of participants
|
33.3 Percentage of participants
|
26.8 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 28: Severe (n=43, 39, 82)
|
7.0 Percentage of participants
|
5.1 Percentage of participants
|
6.1 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 40: Clear (n=41, 38, 79)
|
7.3 Percentage of participants
|
18.4 Percentage of participants
|
12.7 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 40: Almost Clear (n=41, 38, 79)
|
46.3 Percentage of participants
|
31.6 Percentage of participants
|
39.2 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 40: Moderate (n=41, 38, 79)
|
22.0 Percentage of participants
|
26.3 Percentage of participants
|
24.1 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 40: Severe (n=41, 38, 79)
|
4.9 Percentage of participants
|
5.3 Percentage of participants
|
5.1 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 52: Clear (n=39, 32, 71)
|
20.5 Percentage of participants
|
18.8 Percentage of participants
|
19.7 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 52: Almost Clear (n=39, 32, 71)
|
20.5 Percentage of participants
|
31.3 Percentage of participants
|
25.4 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 52: Mild (n=39, 32, 71)
|
28.2 Percentage of participants
|
25.0 Percentage of participants
|
26.8 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 52: Moderate (n=39, 32, 71)
|
15.4 Percentage of participants
|
21.9 Percentage of participants
|
18.3 Percentage of participants
|
|
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
Week 52: Severe (n=39, 32, 71)
|
15.4 Percentage of participants
|
3.1 Percentage of participants
|
9.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 16, 28, 52Population: The subjects with a medical history of ongoing psoriatic arthritis (that was defined as the MedDRA preferred term for psoriatic arthropathy regardless of meeting the inclusion criteria for the psoriatic arthritis) in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to "select the number that best describes any joint pain that participant may have experienced over the past 24 hours" with response options ranging from "0-no joint pain" to "10-worst possible joint pain."
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=8 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=15 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=23 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Joint Pain Assessment (JPA)
Baseline
|
5.25 Units on a scale
Standard Deviation 3.327
|
4.60 Units on a scale
Standard Deviation 2.558
|
4.83 Units on a scale
Standard Deviation 2.790
|
|
Joint Pain Assessment (JPA)
Week 4 (n=8, 14, 22)
|
4.00 Units on a scale
Standard Deviation 2.726
|
1.36 Units on a scale
Standard Deviation 1.008
|
2.32 Units on a scale
Standard Deviation 2.191
|
|
Joint Pain Assessment (JPA)
Week 16 (n=8, 15, 23)
|
1.88 Units on a scale
Standard Deviation 2.295
|
0.60 Units on a scale
Standard Deviation 0.737
|
1.04 Units on a scale
Standard Deviation 1.551
|
|
Joint Pain Assessment (JPA)
Week 28 (n=8, 14, 22)
|
1.75 Units on a scale
Standard Deviation 1.753
|
0.86 Units on a scale
Standard Deviation 0.949
|
1.18 Units on a scale
Standard Deviation 1.332
|
|
Joint Pain Assessment (JPA)
Week 52 (n=4, 13, 17)
|
0.50 Units on a scale
Standard Deviation 0.577
|
0.54 Units on a scale
Standard Deviation 0.660
|
0.53 Units on a scale
Standard Deviation 0.624
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 20, 28, 40, 52Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=4 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=8 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=12 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Week 2
|
0.0 Percentage of participants
|
62.5 Percentage of participants
|
41.7 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Week 4
|
50.0 Percentage of participants
|
75.0 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Week 8
|
75.0 Percentage of participants
|
100 Percentage of participants
|
91.7 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Week 12
|
100 Percentage of participants
|
87.5 Percentage of participants
|
91.7 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Week 20
|
100 Percentage of participants
|
87.5 Percentage of participants
|
91.7 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Week 28
|
100 Percentage of participants
|
100 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Week 52
|
50.0 Percentage of participants
|
100 Percentage of participants
|
83.3 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Week 40
|
75.0 Percentage of participants
|
100 Percentage of participants
|
91.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 40, 52Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
ACR50 response: greater than or equal to (\>=) 50 percent (%) improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=4 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=8 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=12 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Week 2
|
0.0 Percentage of participants
|
25.0 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Week 4
|
25.0 Percentage of participants
|
50.0 Percentage of participants
|
41.7 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Week 8
|
50.0 Percentage of participants
|
62.5 Percentage of participants
|
58.3 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Week 12
|
75.0 Percentage of participants
|
75.0 Percentage of participants
|
75.0 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Week 16
|
75.0 Percentage of participants
|
87.5 Percentage of participants
|
83.3 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Week 20
|
100 Percentage of participants
|
87.5 Percentage of participants
|
91.7 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Week 28
|
100 Percentage of participants
|
75.0 Percentage of participants
|
83.3 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Week 40
|
75.0 Percentage of participants
|
87.5 Percentage of participants
|
83.3 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Week 52
|
50.0 Percentage of participants
|
87.5 Percentage of participants
|
75.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 40, 52Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.
ACR70 response: greater than or equal to (\>=) 70 percent (%) improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=4 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=8 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=12 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Week 12
|
50.0 Percentage of participants
|
62.5 Percentage of participants
|
58.3 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Week 20
|
75.0 Percentage of participants
|
75.0 Percentage of participants
|
75.0 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Week 28
|
75.0 Percentage of participants
|
50.0 Percentage of participants
|
58.3 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Week 40
|
50.0 Percentage of participants
|
75.0 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Week 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Week 4
|
0.0 Percentage of participants
|
37.5 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Week 8
|
25.0 Percentage of participants
|
62.5 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Week 16
|
50.0 Percentage of participants
|
62.5 Percentage of participants
|
58.3 Percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Week 52
|
50.0 Percentage of participants
|
75.0 Percentage of participants
|
66.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 40, 52Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Sixty eight (68) joints were assessed by a rheumatologist investigator to determine the number of joints that were considered tender or painful. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=4 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=8 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=12 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count
Week 2
|
-1.8 Tender/painful joints
Standard Deviation 1.50
|
-3.5 Tender/painful joints
Standard Deviation 2.78
|
-2.9 Tender/painful joints
Standard Deviation 2.50
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count
Week 4
|
-6.3 Tender/painful joints
Standard Deviation 6.70
|
-9.3 Tender/painful joints
Standard Deviation 11.37
|
-8.3 Tender/painful joints
Standard Deviation 9.84
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count
Week 16
|
-13.0 Tender/painful joints
Standard Deviation 9.59
|
-13.0 Tender/painful joints
Standard Deviation 12.17
|
-13.0 Tender/painful joints
Standard Deviation 10.92
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count
Week 20
|
-14.3 Tender/painful joints
Standard Deviation 9.11
|
-12.4 Tender/painful joints
Standard Deviation 12.87
|
-13.0 Tender/painful joints
Standard Deviation 11.35
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count
Week 28
|
-14.0 Tender/painful joints
Standard Deviation 9.38
|
-12.4 Tender/painful joints
Standard Deviation 12.52
|
-12.9 Tender/painful joints
Standard Deviation 11.16
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count
Week 40
|
-14.3 Tender/painful joints
Standard Deviation 10.14
|
-13.4 Tender/painful joints
Standard Deviation 12.09
|
-13.7 Tender/painful joints
Standard Deviation 11.02
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count
Week 52 (n=3, 8, 11)
|
-11.3 Tender/painful joints
Standard Deviation 9.24
|
-13.5 Tender/painful joints
Standard Deviation 12.08
|
-12.9 Tender/painful joints
Standard Deviation 10.97
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count
Week 8
|
-11.5 Tender/painful joints
Standard Deviation 10.08
|
-11.6 Tender/painful joints
Standard Deviation 10.24
|
-11.6 Tender/painful joints
Standard Deviation 9.72
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count
Week 12
|
-13.8 Tender/painful joints
Standard Deviation 10.78
|
-12.5 Tender/painful joints
Standard Deviation 11.95
|
-12.9 Tender/painful joints
Standard Deviation 11.09
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 40, 52Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Sixty six (66) joints were assessed for swelling by a rheumatologist investigator to determine the number of joints that were considered swelling. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=4 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=8 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=12 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count
Week 2
|
-1.8 Swollen joints
Standard Deviation 2.22
|
-3.8 Swollen joints
Standard Deviation 5.55
|
-3.1 Swollen joints
Standard Deviation 4.68
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count
Week 12
|
-6.5 Swollen joints
Standard Deviation 6.35
|
-7.0 Swollen joints
Standard Deviation 4.44
|
-6.8 Swollen joints
Standard Deviation 4.86
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count
Week 16
|
-7.3 Swollen joints
Standard Deviation 7.85
|
-7.8 Swollen joints
Standard Deviation 3.85
|
-7.6 Swollen joints
Standard Deviation 5.12
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count
Week 40
|
-7.3 Swollen joints
Standard Deviation 7.85
|
-8.8 Swollen joints
Standard Deviation 4.20
|
-8.3 Swollen joints
Standard Deviation 5.34
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count
Week 52 (n=3, 8, 11)
|
-3.0 Swollen joints
Standard Deviation 0.00
|
-8.8 Swollen joints
Standard Deviation 4.13
|
-7.2 Swollen joints
Standard Deviation 4.38
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count
Week 4
|
-5.0 Swollen joints
Standard Deviation 4.69
|
-5.3 Swollen joints
Standard Deviation 5.80
|
-5.2 Swollen joints
Standard Deviation 5.24
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count
Week 8
|
-6.0 Swollen joints
Standard Deviation 7.35
|
-6.4 Swollen joints
Standard Deviation 4.37
|
-6.3 Swollen joints
Standard Deviation 5.19
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count
Week 20
|
-7.0 Swollen joints
Standard Deviation 8.00
|
-8.9 Swollen joints
Standard Deviation 4.42
|
-8.3 Swollen joints
Standard Deviation 5.55
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count
Week 28
|
-7.3 Swollen joints
Standard Deviation 7.85
|
-7.6 Swollen joints
Standard Deviation 4.03
|
-7.5 Swollen joints
Standard Deviation 5.21
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 40, 52Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Subjects assessed the severity of their arthritis pain with a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (the most severe pain), which corresponded to the magnitude of their pain.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=4 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=8 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=12 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain
Week 4
|
-13.0 Units on a scale
Standard Deviation 23.41
|
-41.4 Units on a scale
Standard Deviation 25.29
|
-31.9 Units on a scale
Standard Deviation 27.42
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain
Week 12
|
-34.5 Units on a scale
Standard Deviation 19.71
|
-46.0 Units on a scale
Standard Deviation 23.42
|
-42.2 Units on a scale
Standard Deviation 22.07
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain
Week 28
|
-45.8 Units on a scale
Standard Deviation 23.26
|
-45.8 Units on a scale
Standard Deviation 20.46
|
-45.8 Units on a scale
Standard Deviation 20.34
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain
Week 40
|
-20.0 Units on a scale
Standard Deviation 54.86
|
-46.9 Units on a scale
Standard Deviation 22.66
|
-37.9 Units on a scale
Standard Deviation 36.37
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain
Week 52 (n=3, 8, 11)
|
-33.0 Units on a scale
Standard Deviation 31.19
|
-48.4 Units on a scale
Standard Deviation 22.14
|
-44.2 Units on a scale
Standard Deviation 24.28
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain
Week 2
|
-13.3 Units on a scale
Standard Deviation 8.30
|
-29.5 Units on a scale
Standard Deviation 23.40
|
-24.1 Units on a scale
Standard Deviation 20.77
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain
Week 8
|
-16.0 Units on a scale
Standard Deviation 19.78
|
-43.6 Units on a scale
Standard Deviation 22.68
|
-34.4 Units on a scale
Standard Deviation 24.88
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain
Week 16
|
-27.3 Units on a scale
Standard Deviation 15.22
|
-46.0 Units on a scale
Standard Deviation 22.44
|
-39.8 Units on a scale
Standard Deviation 21.65
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain
Week 20
|
-44.0 Units on a scale
Standard Deviation 22.82
|
-45.3 Units on a scale
Standard Deviation 21.53
|
-44.8 Units on a scale
Standard Deviation 20.91
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 40, 52Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
Subjects answered the following question, "Considering the possible effects of the arthritis, how are you feeling today?" The subject's response was recorded with a 100 mm visual analog scale (VAS), where 0 = very well and 100 = very poorly.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=4 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=8 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=12 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis
Week 2
|
-8.0 Units on a scale
Standard Deviation 8.87
|
-32.6 Units on a scale
Standard Deviation 27.55
|
-24.4 Units on a scale
Standard Deviation 25.53
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis
Week 4
|
-20.5 Units on a scale
Standard Deviation 11.27
|
-43.4 Units on a scale
Standard Deviation 27.47
|
-35.8 Units on a scale
Standard Deviation 25.33
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis
Week 8
|
-23.3 Units on a scale
Standard Deviation 19.69
|
-51.3 Units on a scale
Standard Deviation 20.53
|
-41.9 Units on a scale
Standard Deviation 23.75
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis
Week 12
|
-45.0 Units on a scale
Standard Deviation 8.83
|
-52.1 Units on a scale
Standard Deviation 21.35
|
-49.8 Units on a scale
Standard Deviation 17.99
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis
Week 16
|
-40.0 Units on a scale
Standard Deviation 13.64
|
-53.0 Units on a scale
Standard Deviation 20.96
|
-48.7 Units on a scale
Standard Deviation 19.27
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis
Week 20
|
-49.5 Units on a scale
Standard Deviation 20.09
|
-49.6 Units on a scale
Standard Deviation 20.26
|
-49.6 Units on a scale
Standard Deviation 19.27
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis
Week 28
|
-52.3 Units on a scale
Standard Deviation 11.18
|
-46.3 Units on a scale
Standard Deviation 26.67
|
-48.3 Units on a scale
Standard Deviation 22.26
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis
Week 40
|
-20.8 Units on a scale
Standard Deviation 30.24
|
-50.8 Units on a scale
Standard Deviation 20.78
|
-40.8 Units on a scale
Standard Deviation 27.24
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis
Week 52 (n=3, 8, 11)
|
-40.7 Units on a scale
Standard Deviation 16.80
|
-55.3 Units on a scale
Standard Deviation 20.51
|
-51.3 Units on a scale
Standard Deviation 19.94
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 40, 52Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
The rheumatologist investigator assessed how the subject's overall arthritis appeared at the time of the visit. This was an evaluation based on the subject's disease signs, functional capacity and physical examination, and was independent of the PGA of arthritis. The rheumatologist investigator's response was recorded a 100 mm visual analog scale (VAS), where 0 = very good and 100 = very poor.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=4 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=8 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=12 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis
Week 8
|
-29.5 Units on a scale
Standard Deviation 30.01
|
-41.8 Units on a scale
Standard Deviation 21.87
|
-37.7 Units on a scale
Standard Deviation 24.21
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis
Week 12
|
-39.8 Units on a scale
Standard Deviation 21.00
|
-45.8 Units on a scale
Standard Deviation 22.76
|
-43.8 Units on a scale
Standard Deviation 21.42
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis
Week 2
|
-15.3 Units on a scale
Standard Deviation 18.01
|
-28.5 Units on a scale
Standard Deviation 18.60
|
-24.1 Units on a scale
Standard Deviation 18.74
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis
Week 4
|
-32.5 Units on a scale
Standard Deviation 22.28
|
-34.6 Units on a scale
Standard Deviation 19.39
|
-33.9 Units on a scale
Standard Deviation 19.38
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis
Week 16
|
-49.8 Units on a scale
Standard Deviation 23.34
|
-47.9 Units on a scale
Standard Deviation 20.09
|
-48.5 Units on a scale
Standard Deviation 20.16
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis
Week 28
|
-49.5 Units on a scale
Standard Deviation 25.96
|
-42.8 Units on a scale
Standard Deviation 22.79
|
-45.0 Units on a scale
Standard Deviation 22.92
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis
Week 40
|
-38.5 Units on a scale
Standard Deviation 39.03
|
-49.5 Units on a scale
Standard Deviation 18.54
|
-45.8 Units on a scale
Standard Deviation 25.76
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis
Week 52 (n=3, 8, 11)
|
-29.0 Units on a scale
Standard Deviation 20.30
|
-46.8 Units on a scale
Standard Deviation 25.08
|
-41.9 Units on a scale
Standard Deviation 24.32
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis
Week 20
|
-50.8 Units on a scale
Standard Deviation 25.29
|
-45.3 Units on a scale
Standard Deviation 26.81
|
-47.1 Units on a scale
Standard Deviation 25.28
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 40, 52Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
The blood samples were collected at each visit for analysis of CRP with an assay analyzed by the central laboratory.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=4 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=8 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=12 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)
Week 2
|
-1.20 mg/dL
Standard Deviation 2.137
|
-1.68 mg/dL
Standard Deviation 2.231
|
-1.52 mg/dL
Standard Deviation 2.114
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)
Week 40 (n=4, 7, 11)
|
-1.15 mg/dL
Standard Deviation 2.037
|
-1.84 mg/dL
Standard Deviation 2.461
|
-1.59 mg/dL
Standard Deviation 2.236
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)
Week 4
|
-1.20 mg/dL
Standard Deviation 2.267
|
-1.69 mg/dL
Standard Deviation 2.272
|
-1.53 mg/dL
Standard Deviation 2.178
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)
Week 8
|
-1.28 mg/dL
Standard Deviation 2.354
|
-1.70 mg/dL
Standard Deviation 2.222
|
-1.56 mg/dL
Standard Deviation 2.167
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)
Week 12
|
-1.28 mg/dL
Standard Deviation 2.351
|
-1.68 mg/dL
Standard Deviation 2.235
|
-1.54 mg/dL
Standard Deviation 2.174
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)
Week 16
|
-1.30 mg/dL
Standard Deviation 2.337
|
-1.69 mg/dL
Standard Deviation 2.189
|
-1.56 mg/dL
Standard Deviation 2.139
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)
Week 20
|
-1.33 mg/dL
Standard Deviation 2.387
|
-1.59 mg/dL
Standard Deviation 2.336
|
-1.50 mg/dL
Standard Deviation 2.246
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)
Week 28
|
-1.30 mg/dL
Standard Deviation 2.337
|
-1.15 mg/dL
Standard Deviation 2.770
|
-1.20 mg/dL
Standard Deviation 2.526
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)
Week 52 (n=3, 8, 11)
|
-0.03 mg/dL
Standard Deviation 0.058
|
-1.65 mg/dL
Standard Deviation 2.295
|
-1.21 mg/dL
Standard Deviation 2.064
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 40, 52Population: Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.
Outcome measures
| Measure |
CP-690,550 5 mg BID
n=4 Participants
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=8 Participants
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=12 Participants
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)
Week 4
|
-0.28 Units on a scale
Standard Deviation 0.329
|
-0.36 Units on a scale
Standard Deviation 0.381
|
-0.33 Units on a scale
Standard Deviation 0.351
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)
Week 8
|
-0.28 Units on a scale
Standard Deviation 0.359
|
-0.42 Units on a scale
Standard Deviation 0.433
|
-0.38 Units on a scale
Standard Deviation 0.399
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)
Week 12
|
-0.28 Units on a scale
Standard Deviation 0.359
|
-0.42 Units on a scale
Standard Deviation 0.433
|
-0.38 Units on a scale
Standard Deviation 0.399
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)
Week 16
|
-0.31 Units on a scale
Standard Deviation 0.375
|
-0.42 Units on a scale
Standard Deviation 0.433
|
-0.39 Units on a scale
Standard Deviation 0.400
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)
Week 20
|
-0.28 Units on a scale
Standard Deviation 0.359
|
-0.42 Units on a scale
Standard Deviation 0.433
|
-0.38 Units on a scale
Standard Deviation 0.399
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)
Week 28
|
-0.34 Units on a scale
Standard Deviation 0.400
|
-0.42 Units on a scale
Standard Deviation 0.433
|
-0.40 Units on a scale
Standard Deviation 0.405
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)
Week 40
|
-0.09 Units on a scale
Standard Deviation 0.640
|
-0.42 Units on a scale
Standard Deviation 0.433
|
-0.31 Units on a scale
Standard Deviation 0.507
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)
Week 52 (n=3, 8, 11)
|
-0.13 Units on a scale
Standard Deviation 0.573
|
-0.42 Units on a scale
Standard Deviation 0.433
|
-0.34 Units on a scale
Standard Deviation 0.465
|
|
Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)
Week 2
|
-0.19 Units on a scale
Standard Deviation 0.239
|
-0.28 Units on a scale
Standard Deviation 0.376
|
-0.25 Units on a scale
Standard Deviation 0.329
|
Adverse Events
CP-690,550 5 mg BID
CP-690,550 10 mg BID
Total
Serious adverse events
| Measure |
CP-690,550 5 mg BID
n=47 participants at risk
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=47 participants at risk
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=94 participants at risk
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Herpes zoster
|
6.4%
3/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.2%
3/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Impetigo
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Erythrodermic psoriasis
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
| Measure |
CP-690,550 5 mg BID
n=47 participants at risk
CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
CP-690,550 10 mg BID
n=47 participants at risk
CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
|
Total
n=94 participants at risk
(=sum across Arm/Groups)
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Anaemia
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Lymphadenitis
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Vertigo
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
2/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Cataract
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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 deposit
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Eyelid oedema
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Presbyopia
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.2%
3/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Colitis
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
2/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
6.4%
3/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
4/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
2/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Lip erosion
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Toothache
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
2/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Malaise
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Oedema
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Oedema peripheral
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.2%
3/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Pyrexia
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.4%
3/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.2%
3/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
4/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Enteritis infectious
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
4/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Furuncle
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
2/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
6.4%
3/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.2%
3/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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 norovirus
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
2/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Herpes zoster
|
6.4%
3/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
21.3%
10/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
13.8%
13/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
6.4%
3/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.4%
3/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.4%
6/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
29.8%
14/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
29.8%
14/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
29.8%
28/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Otitis media acute
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
2/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Periodontitis
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Pertussis
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
2/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Pneumonia
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
2/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Salpingitis
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Subcutaneous abscess
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Tinea infection
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
2/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Tinea pedis
|
8.5%
4/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.8%
6/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.6%
10/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Tinea versicolour
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
2/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Vaginitis gardnerella
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Arthropod bite
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Arthropod sting
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Epicondylitis
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Excoriation
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Fall
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Hand fracture
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Thermal burn
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Traumatic haematoma
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.4%
3/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
4/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.2%
3/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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 bilirubin increased
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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 creatine phosphokinase increased
|
6.4%
3/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.3%
5/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Gamma-glutamyltransferase increased
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.4%
3/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.2%
3/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Haemoglobin decreased
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.5%
4/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.3%
5/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Liver function test abnormal
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
2/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Occult blood positive
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Platelet count decreased
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Weight decreased
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Weight increased
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
White blood cell count decreased
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Diabetes mellitus
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
2/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
2/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Hyperlipidaemia
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.2%
3/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.2%
3/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Joint swelling
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Cervicobrachial syndrome
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
2/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.4%
3/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
4/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Hypoaesthesia
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Neuropathy peripheral
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Post herpetic neuralgia
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.4%
3/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.2%
3/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Pollakiuria
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
2/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Atrophic vulvovaginitis
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Cervical polyp
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Endometriosis
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Prostatitis
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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 inflammation
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.4%
3/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.2%
3/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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 contact
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.2%
3/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Dyshidrotic eczema
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
2/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Hirsutism
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
8.5%
4/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.8%
6/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.6%
10/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Purpura
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Seborrhoeic dermatitis
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.1%
1/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
Solar dermatitis
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
2/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
2.1%
1/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.2%
3/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
|
0.00%
0/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.3%
2/47
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.1%
2/94
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). An event may be categorized as serious 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
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