Trial Outcomes & Findings for A Study to Evaluate Safety and Efficacy of PF-06826647 For Moderate To Severe Plaque Psoriasis (NCT NCT03895372)
NCT ID: NCT03895372
Last Updated: 2021-08-27
Results Overview
The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage 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. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. The statistical analysis was for the data at Week 16.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
179 participants
Primary outcome timeframe
Baseline up to Week 16
Results posted on
2021-08-27
Participant Flow
This study included 2 treatment periods (16-week investigational treatment period and 24-week extension treatment period) followed by a 4-week follow-up. A total of 179 participants were enrolled and 178 participants were treated in investigational treatment period and 153 participants completed this period and entered the extension treatment period. A total of 130 participants completed the extension treatment period.
This was a Phase 2b, randomized, double blind, placebo controlled, parallel group, and multicenter study in participants with moderate to severe plaque psoriasis.
Participant milestones
| Measure |
Placebo QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.
|
Placebo QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.
|
PF-06826647 50 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.
|
PF-06826647 50 mg QD->PF-06826647 400 mg QD Group
This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.
|
PF-06826647 100 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Investigational Treatment Period
STARTED
|
23
|
22
|
11
|
11
|
12
|
11
|
45
|
43
|
|
Investigational Treatment Period
COMPLETED
|
19
|
19
|
10
|
9
|
12
|
9
|
37
|
38
|
|
Investigational Treatment Period
NOT COMPLETED
|
4
|
3
|
1
|
2
|
0
|
2
|
8
|
5
|
|
Extension Treatment Period
STARTED
|
19
|
19
|
10
|
9
|
12
|
9
|
37
|
38
|
|
Extension Treatment Period
COMPLETED
|
16
|
14
|
10
|
8
|
9
|
8
|
33
|
32
|
|
Extension Treatment Period
NOT COMPLETED
|
3
|
5
|
0
|
1
|
3
|
1
|
4
|
6
|
Reasons for withdrawal
| Measure |
Placebo QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.
|
Placebo QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.
|
PF-06826647 50 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.
|
PF-06826647 50 mg QD->PF-06826647 400 mg QD Group
This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.
|
PF-06826647 100 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Investigational Treatment Period
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
4
|
3
|
|
Investigational Treatment Period
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Investigational Treatment Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Investigational Treatment Period
Other
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
|
Investigational Treatment Period
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Investigational Treatment Period
Withdrawal by Subject
|
2
|
3
|
1
|
1
|
0
|
1
|
3
|
0
|
|
Extension Treatment Period
Adverse Event
|
0
|
1
|
0
|
1
|
0
|
0
|
3
|
3
|
|
Extension Treatment Period
Other
|
1
|
3
|
0
|
0
|
1
|
0
|
0
|
2
|
|
Extension Treatment Period
Pregnancy
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Extension Treatment Period
Withdrawal by Subject
|
2
|
1
|
0
|
0
|
1
|
1
|
1
|
1
|
Baseline Characteristics
A Study to Evaluate Safety and Efficacy of PF-06826647 For Moderate To Severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo QD->PF-06826647 200 mg QD Group
n=23 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.
|
Placebo QD->PF-06826647 400 mg QD Group
n=22 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.
|
PF-06826647 50 mg QD->PF-06826647 200 mg QD Group
n=11 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.
|
PF-06826647 50 mg QD->PF-06826647 400 mg QD Group
n=11 Participants
This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.
|
PF-06826647 100 mg QD->PF-06826647 200 mg QD Group
n=12 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
n=11 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
n=43 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18-44 Years
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
20 Participants
n=24 Participants
|
86 Participants
n=42 Participants
|
|
Age, Customized
45-64 Years
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
20 Participants
n=24 Participants
|
80 Participants
n=42 Participants
|
|
Age, Customized
>=65 Years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
8 Participants
n=24 Participants
|
56 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
35 Participants
n=24 Participants
|
122 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
44 Participants
n=115 Participants
|
39 Participants
n=24 Participants
|
169 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
37 Participants
n=115 Participants
|
40 Participants
n=24 Participants
|
158 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 16Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed).
The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage 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. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. The statistical analysis was for the data at Week 16.
Outcome measures
| Measure |
Placebo QD Group
n=42 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=22 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=21 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=41 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period
Week 16
|
4.8 Percentage of participants
Interval 1.27 to 13.53
|
13.6 Percentage of participants
Interval 5.12 to 31.13
|
9.5 Percentage of participants
Interval 2.56 to 24.5
|
37.8 Percentage of participants
Interval 25.96 to 50.95
|
51.2 Percentage of participants
Interval 37.44 to 64.86
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period
Week 2
|
0 Percentage of participants
Interval 0.0 to 6.41
|
0 Percentage of participants
Interval 0.0 to 12.6
|
0 Percentage of participants
Interval 0.0 to 12.33
|
2.2 Percentage of participants
Interval 0.23 to 9.17
|
0 Percentage of participants
Interval 0.0 to 6.57
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period
Week 4
|
0 Percentage of participants
Interval 0.0 to 6.41
|
0 Percentage of participants
Interval 0.0 to 12.6
|
0 Percentage of participants
Interval 0.0 to 12.33
|
11.1 Percentage of participants
Interval 5.5 to 21.8
|
7.3 Percentage of participants
Interval 2.72 to 17.32
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period
Week 8
|
2.4 Percentage of participants
Interval 0.25 to 9.85
|
4.5 Percentage of participants
Interval 0.48 to 19.56
|
4.8 Percentage of participants
Interval 0.5 to 20.57
|
24.4 Percentage of participants
Interval 15.47 to 35.88
|
34.1 Percentage of participants
Interval 23.04 to 46.94
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period
Week 12
|
2.4 Percentage of participants
Interval 0.25 to 9.85
|
13.6 Percentage of participants
Interval 5.12 to 31.13
|
9.5 Percentage of participants
Interval 2.56 to 24.5
|
37.8 Percentage of participants
Interval 25.96 to 50.95
|
48.8 Percentage of participants
Interval 35.14 to 62.56
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period
Week 1
|
0 Percentage of participants
Interval 0.0 to 6.41
|
0 Percentage of participants
Interval 0.0 to 12.6
|
0 Percentage of participants
Interval 0.0 to 12.33
|
0 Percentage of participants
Interval 0.0 to 5.97
|
0 Percentage of participants
Interval 0.0 to 6.57
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period
Week 6
|
0 Percentage of participants
Interval 0.0 to 6.41
|
4.5 Percentage of participants
Interval 0.48 to 19.56
|
4.8 Percentage of participants
Interval 0.5 to 20.57
|
20.0 Percentage of participants
Interval 11.72 to 31.73
|
26.8 Percentage of participants
Interval 17.12 to 39.77
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Week 16 to Week 40Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who were treated in the extension treatment period.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time.
Outcome measures
| Measure |
Placebo QD Group
n=19 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=18 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=10 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=9 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=12 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
n=9 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
n=37 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
n=38 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period
Participants discontinued study drug due to AE and continue study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period
Participants discontinued from study due to AEs
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period
Participants with AEs
|
11 Participants
|
8 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
7 Participants
|
24 Participants
|
26 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period
Participants with SAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period
Participants with severe AEs
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period
Participants with dose reduced or temporary discontinuation due to AEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From Week 16 to Week 40Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who entered the extension treatment period.
Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time. Relatedness to investigational product (PF-06826647 or placebo) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Outcome measures
| Measure |
Placebo QD Group
n=19 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=18 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=10 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=9 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=12 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
n=9 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
n=37 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
n=38 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period
Participants with AEs
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
10 Participants
|
5 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period
Participants with SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period
Participants with severe AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period
Participants discontinued from study due to AEs
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period
Participants discontinued study drug due to AE and continue study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period
Participants with dose reduced or temporary discontinuation due to AEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Week 16 to Week 40Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who were treated in the extension treatment period, with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time from week 16 to week 40.
Following hematology parameters were analyzed for laboratory examination: hemoglobin (HGB), hematocrit, erythrocytes (Ery.), reticulocytes, Ery. mean corpuscular volume, Ery. mean corpuscular HGB, Ery. mean corpuscular HGB concentration, platelets, reticulocytes/erythrocytes, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, activated partial thromboplastin time, prothrombin time, prothrombin international (Intl.) normalized ratio, neutrophils total count, and lymphocytes total count. LLN=lower limit of normal; ULN=upper limit of normal.
Outcome measures
| Measure |
Placebo QD Group
n=19 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=18 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=10 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=9 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=12 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
n=9 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
n=37 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
n=38 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Platelets (10^3/mm^3) <0.5*LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
HGB (g/dL) <0.8*LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Hematocrit (%) <0.8*LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Erythrocytes (10^6/mm^3) <0.8*LLN
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Reticulocytes (10^3/mm^3) <0.5*LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Reticulocytes (10^3/mm^3) >1.5*ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Ery. Mean Corpuscular Volume (um^3) <0.9*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Ery. Mean Corpuscular Volume (um^3) >1.1*ULN
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Ery. Mean Corpuscular HGB (pg/cell) <0.9*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Ery. Mean Corpuscular HGB (pg/cell) >1.1*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Platelets (10^3/mm^3) >1.75*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Reticulocytes/Erythrocytes (%) <0.5*LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Reticulocytes/Erythrocytes (%) >1.5*ULN
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Leukocytes(10^3/mm^3) <0.6*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Leukocytes(10^3/mm^3) >1.5*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Lymphocytes/Leukocytes (%) <0.8*LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Lymphocytes/Leukocytes (%) >1.2*ULN
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Neutrophils/Leukocytes (%) <0.8*LLN
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Neutrophils/Leukocytes (%) >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Basophils (10^3/mm^3) >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Basophils/Leukocytes (%) >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Eosinophils (10^3/mm^3) >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Eosinophils/Leukocytes (%) >1.2*ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Monocytes (10^3/mm^3) >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Monocytes/Leukocytes (%) >1.2*ULN
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Activated Partial Thromboplastin Time (sec) >1.1 x ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Prothrombin Time (sec) >1.1*ULN
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Prothrombin Intl. Normalized Ratio >1.1*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Neutrophils total count (10^3/mm^3) <0.8*LLN
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
7 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Neutrophils total count (10^3/mm^3) >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Lymphocytes total count (10^3/mm^3) <0.8*LLN
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Lymphocytes total count (10^3/mm^3) >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Week 16 to Week 40Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who were treated in the extension treatment period, with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time from week 16 to week 40.
Following clinical chemistry parameters were analyzed for laboratory examination: bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, and cholesterol.
Outcome measures
| Measure |
Placebo QD Group
n=19 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=18 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=10 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=9 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=12 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
n=9 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
n=37 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
n=38 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Direct Bilirubin (mg/dL) >1.5*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Sodium (Meq/L) <0.95*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Creatine Kinase (U/L) >2.0*ULN
|
2 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
12 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Cholesterol (mg/dL) >1.3*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Bilirubin (mg/dL) >1.5*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Indirect Bilirubin (mg/dL) >1.5*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Aspartate Aminotransferase (U/L) > 3.0*ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Alanine Aminotransferase (U/L) > 3.0*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Gamma Glutamyl Transferase (U/L) > 3.0*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Alkaline Phosphatase (U/L) > 3.0*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Protein (g/dL) <0.8*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Protein (g/dL) >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Albumin (g/dL) <0.8*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Albumin (g/dL) >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Blood Urea Nitrogen (mg/dL) >1.3*ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Urea (mg/dL) >1.3*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Creatinine (mg/dL) >1.3*ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Urate (mg/dL) >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
HDL Cholesterol (mg/dL) <0.8*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
LDL Cholesterol (mg/dL) >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Triglycerides (mg/dL) >1.3*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Sodium (Meq/L) >1.05*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Potassium (Meq/L) <0.9*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Potassium (Meq/L) >1.1*ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Chloride (Meq/L) <0.9*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Chloride (Meq/L) >1.1*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Calcium (mg/dL) <0.9*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Calcium (mg/dL) >1.1*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Bicarbonate (Meq/L) <0.9*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Bicarbonate (Meq/L) >1.1*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Glucose (mg/dL) <0.6*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Glucose (mg/dL) >1.5*ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From Week 16 to Week 40Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who were treated in the extension treatment period, with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time from week 16 to week 40.
Following urinalysis parameters were analyzed for laboratory examination: urine pH, urine glucose, urine ketones, urine protein, urine hemoglobin, urine urobilinogen, urine bilirubin, urine nitrite, urine leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline, and urine bacteria.
Outcome measures
| Measure |
Placebo QD Group
n=19 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=18 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=10 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=9 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=12 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
n=9 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
n=37 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
n=38 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Urine Protein >=1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Urine Hemoglobin (Scalar) >=1
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Urine pH (Scalar) <4.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Urine pH (Scalar) >8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Urine Glucose >=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Urine Ketones (Scalar) >=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Urine Urobilinogen (EU/dL) >=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Urine Bilirubin (Scalar) >=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Urine Nitrite (Scalar) >=1
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Urine Leukocyte Esterase (Scalar) >=1
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Urine Erythrocytes (Scalar) >=20
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Urine Leukocytes (/HPF) >=20
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Urine Hyaline Casts (/LPF) >1
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Urine Bacteria (/LPF) >20
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From Week 16 to Week 40Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and were treated in the extension treatment period and evaluated against criteria.
Criteria for ECG abnormalities: maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) \>=25 percent (%) for baseline value of \>200 milliseconds (msec) and Pctchg\>=50% for baseline value of \<=200 msec for PR interval, a maximum IFB: Pctchg\>=50%, maximum QTcF interval (Fridericia's Correction) of 450 msec to \<=480 msec, 480 msec to \<=500 msec and a maximum change of \<30 change =\<60 or \>60 msec from baseline.
Outcome measures
| Measure |
Placebo QD Group
n=17 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=17 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=10 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=9 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=11 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
n=8 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
n=37 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
n=36 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
QTcF - Fridericia's correction formula (msec) change >60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
PR interval, single beat (msec) Pctchg >=25/50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
QRS duration, singe beat (msec) Pctchg >=50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
QT interval, single beat (msec) >500
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
450< QTcF - Fridericia's correction formula (msec) <=480
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
480< QTcF - Fridericia's correction formula (msec) <=500
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
30< QTcF - Fridericia's correction formula (msec) change <=60
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From Week 16 to Week 40Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who entered the extension treatment period.
The vital signs were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Criteria for vital signs abnormalities: sitting diastolic blood pressure (BP) \< 50 millimeter of mercury (mmHg), sitting diastolic BP change \>= 20 mmHg increase, sitting diastolic BP change \>= 20 mmHg decrease, sitting systolic BP \< 90 mmHg, sitting systolic BP change \>= 30 mmHg increase, and sitting systolic BP change \>= 30 mmHg decrease.
Outcome measures
| Measure |
Placebo QD Group
n=19 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=18 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=10 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=9 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=12 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
n=9 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
n=37 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
n=38 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
Sitting diastolic BP (mmHg) <50
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
Sitting diastolic BP (mmHg) change >= 20 increase
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
Sitting diastolic BP (mmHg) change >= 20 decrease
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
Sitting systolic BP (mmHg) <90
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
Sitting systolic BP (mmHg) change >= 30 increase
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
Sitting systolic BP (mmHg) change >= 30 decrease
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed).
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. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. The statistical analysis was for the data at Week 16.
Outcome measures
| Measure |
Placebo QD Group
n=42 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=22 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=21 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=41 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period
Week 1
|
0 Percentage of participants
Interval 0.0 to 6.41
|
0 Percentage of participants
Interval 0.0 to 12.6
|
0 Percentage of participants
Interval 0.0 to 12.33
|
2.2 Percentage of participants
Interval 0.23 to 9.17
|
0 Percentage of participants
Interval 0.0 to 6.57
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period
Week 2
|
4.8 Percentage of participants
Interval 1.27 to 13.53
|
0 Percentage of participants
Interval 0.0 to 12.6
|
0 Percentage of participants
Interval 0.0 to 12.33
|
8.9 Percentage of participants
Interval 3.93 to 18.01
|
2.4 Percentage of participants
Interval 0.26 to 10.1
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period
Week 4
|
7.1 Percentage of participants
Interval 2.56 to 17.39
|
4.5 Percentage of participants
Interval 0.48 to 19.56
|
0 Percentage of participants
Interval 0.0 to 12.33
|
24.4 Percentage of participants
Interval 15.47 to 35.88
|
31.7 Percentage of participants
Interval 19.88 to 44.52
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period
Week 6
|
7.1 Percentage of participants
Interval 2.56 to 17.39
|
13.6 Percentage of participants
Interval 5.12 to 31.13
|
4.8 Percentage of participants
Interval 0.5 to 20.57
|
33.3 Percentage of participants
Interval 21.8 to 46.08
|
43.9 Percentage of participants
Interval 31.18 to 57.87
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period
Week 8
|
4.8 Percentage of participants
Interval 1.27 to 15.53
|
13.6 Percentage of participants
Interval 5.12 to 31.13
|
14.3 Percentage of participants
Interval 5.37 to 32.81
|
40.0 Percentage of participants
Interval 28.66 to 52.89
|
61.0 Percentage of participants
Interval 46.94 to 73.77
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period
Week 12
|
9.5 Percentage of participants
Interval 4.22 to 19.38
|
13.6 Percentage of participants
Interval 5.12 to 31.13
|
9.5 Percentage of participants
Interval 2.56 to 24.5
|
51.1 Percentage of participants
Interval 38.26 to 64.12
|
70.7 Percentage of participants
Interval 57.87 to 82.16
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period
Week 16
|
14.3 Percentage of participants
Interval 6.41 to 25.56
|
18.2 Percentage of participants
Interval 8.17 to 35.25
|
9.5 Percentage of participants
Interval 2.56 to 24.5
|
46.7 Percentage of participants
Interval 33.79 to 59.13
|
73.2 Percentage of participants
Interval 60.23 to 82.88
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed).
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). The statistical analysis was for the data at Week 16.
Outcome measures
| Measure |
Placebo QD Group
n=42 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=22 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=21 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=41 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear" and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period
Week 1
|
2.4 Percentage of participants
Interval 0.25 to 9.85
|
0 Percentage of participants
Interval 0.0 to 12.6
|
4.8 Percentage of participants
Interval 0.5 to 20.57
|
4.4 Percentage of participants
Interval 1.19 to 12.58
|
4.9 Percentage of participants
Interval 1.3 to 13.87
|
—
|
—
|
—
|
|
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear" and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period
Week 2
|
2.4 Percentage of participants
Interval 0.25 to 9.85
|
0 Percentage of participants
Interval 0.0 to 12.6
|
4.8 Percentage of participants
Interval 0.5 to 20.57
|
11.1 Percentage of participants
Interval 5.5 to 21.8
|
7.3 Percentage of participants
Interval 2.72 to 17.32
|
—
|
—
|
—
|
|
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear" and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period
Week 4
|
9.5 Percentage of participants
Interval 4.22 to 19.38
|
9.1 Percentage of participants
Interval 2.44 to 23.6
|
4.8 Percentage of participants
Interval 0.5 to 20.57
|
35.6 Percentage of participants
Interval 23.73 to 48.68
|
36.6 Percentage of participants
Interval 24.57 to 50.0
|
—
|
—
|
—
|
|
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear" and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period
Week 6
|
14.3 Percentage of participants
Interval 6.41 to 25.56
|
13.6 Percentage of participants
Interval 5.12 to 31.13
|
14.3 Percentage of participants
Interval 5.37 to 32.81
|
46.7 Percentage of participants
Interval 33.79 to 59.13
|
53.7 Percentage of participants
Interval 39.77 to 66.11
|
—
|
—
|
—
|
|
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear" and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period
Week 8
|
14.3 Percentage of participants
Interval 6.41 to 25.56
|
18.2 Percentage of participants
Interval 8.17 to 35.25
|
14.3 Percentage of participants
Interval 5.37 to 32.81
|
44.4 Percentage of participants
Interval 31.73 to 56.75
|
63.4 Percentage of participants
Interval 50.0 to 75.43
|
—
|
—
|
—
|
|
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear" and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period
Week 12
|
14.3 Percentage of participants
Interval 6.41 to 25.56
|
18.2 Percentage of participants
Interval 8.17 to 35.25
|
19.0 Percentage of participants
Interval 8.58 to 37.19
|
46.7 Percentage of participants
Interval 33.79 to 59.13
|
78.0 Percentage of participants
Interval 64.86 to 87.04
|
—
|
—
|
—
|
|
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear" and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period
Week 16
|
16.7 Percentage of participants
Interval 9.06 to 27.68
|
18.2 Percentage of participants
Interval 8.17 to 35.25
|
14.3 Percentage of participants
Interval 5.37 to 32.81
|
44.4 Percentage of participants
Interval 31.73 to 56.75
|
70.7 Percentage of participants
Interval 57.87 to 82.16
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed).
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). The statistical analysis was for the data at Week 16.
Outcome measures
| Measure |
Placebo QD Group
n=42 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=22 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=21 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=41 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear", Up to Week 16 - Investigational Treatment Period
Week 1
|
2.4 Percentage of participants
Interval 0.25 to 9.85
|
0 Percentage of participants
Interval 0.0 to 12.6
|
4.8 Percentage of participants
Interval 0.5 to 20.57
|
4.4 Percentage of participants
Interval 1.19 to 12.58
|
4.9 Percentage of participants
Interval 1.3 to 13.87
|
—
|
—
|
—
|
|
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear", Up to Week 16 - Investigational Treatment Period
Week 2
|
2.4 Percentage of participants
Interval 0.25 to 9.85
|
0 Percentage of participants
Interval 0.0 to 12.6
|
4.8 Percentage of participants
Interval 0.5 to 20.57
|
11.1 Percentage of participants
Interval 5.5 to 21.8
|
7.3 Percentage of participants
Interval 2.72 to 17.32
|
—
|
—
|
—
|
|
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear", Up to Week 16 - Investigational Treatment Period
Week 4
|
9.5 Percentage of participants
Interval 4.22 to 19.38
|
9.1 Percentage of participants
Interval 2.44 to 23.6
|
4.8 Percentage of participants
Interval 0.5 to 20.57
|
35.6 Percentage of participants
Interval 23.73 to 48.68
|
36.6 Percentage of participants
Interval 24.57 to 50.0
|
—
|
—
|
—
|
|
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear", Up to Week 16 - Investigational Treatment Period
Week 6
|
14.3 Percentage of participants
Interval 6.41 to 25.56
|
13.6 Percentage of participants
Interval 5.12 to 31.13
|
14.3 Percentage of participants
Interval 5.37 to 32.81
|
46.7 Percentage of participants
Interval 33.79 to 59.13
|
53.7 Percentage of participants
Interval 39.77 to 66.11
|
—
|
—
|
—
|
|
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear", Up to Week 16 - Investigational Treatment Period
Week 8
|
14.3 Percentage of participants
Interval 6.41 to 25.56
|
18.2 Percentage of participants
Interval 8.17 to 35.25
|
14.3 Percentage of participants
Interval 5.37 to 32.81
|
44.4 Percentage of participants
Interval 31.73 to 56.75
|
63.4 Percentage of participants
Interval 50.0 to 75.43
|
—
|
—
|
—
|
|
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear", Up to Week 16 - Investigational Treatment Period
Week 12
|
14.3 Percentage of participants
Interval 6.41 to 25.56
|
18.2 Percentage of participants
Interval 8.17 to 35.25
|
19.0 Percentage of participants
Interval 8.58 to 37.19
|
46.7 Percentage of participants
Interval 33.79 to 59.13
|
78.0 Percentage of participants
Interval 64.86 to 87.04
|
—
|
—
|
—
|
|
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear", Up to Week 16 - Investigational Treatment Period
Week 16
|
16.7 Percentage of participants
Interval 9.06 to 27.68
|
18.2 Percentage of participants
Interval 8.17 to 35.25
|
14.3 Percentage of participants
Interval 5.37 to 32.81
|
44.4 Percentage of participants
Interval 31.73 to 56.75
|
70.7 Percentage of participants
Interval 57.87 to 82.16
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who were evaluated against criteria.
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. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline.
Outcome measures
| Measure |
Placebo QD Group
n=42 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=22 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=21 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=41 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period
Week 4
|
22.5 Percentage of participants
|
19.0 Percentage of participants
|
14.3 Percentage of participants
|
50.0 Percentage of participants
|
65.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period
Week 6
|
28.9 Percentage of participants
|
33.3 Percentage of participants
|
30.0 Percentage of participants
|
59.1 Percentage of participants
|
69.2 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period
Week 8
|
32.4 Percentage of participants
|
35.0 Percentage of participants
|
25.0 Percentage of participants
|
70.7 Percentage of participants
|
75.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period
Week 12
|
38.9 Percentage of participants
|
45.0 Percentage of participants
|
38.1 Percentage of participants
|
73.2 Percentage of participants
|
92.5 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period
Week 16
|
41.7 Percentage of participants
|
45.0 Percentage of participants
|
45.0 Percentage of participants
|
68.4 Percentage of participants
|
94.9 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period
Week 1
|
2.4 Percentage of participants
|
0 Percentage of participants
|
4.8 Percentage of participants
|
11.4 Percentage of participants
|
5.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period
Week 2
|
7.1 Percentage of participants
|
13.6 Percentage of participants
|
4.8 Percentage of participants
|
28.9 Percentage of participants
|
22.0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who were evaluated against criteria.
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. PASI 100 response was defined as at least a 100 percent (%) reduction in PASI relative to Baseline.
Outcome measures
| Measure |
Placebo QD Group
n=42 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=22 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=21 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=41 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period
Week 1
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period
Week 2
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.2 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period
Week 4
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
4.5 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period
Week 6
|
0 Percentage of participants
|
4.8 Percentage of participants
|
0 Percentage of participants
|
9.1 Percentage of participants
|
7.7 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period
Week 8
|
0 Percentage of participants
|
5.0 Percentage of participants
|
0 Percentage of participants
|
17.1 Percentage of participants
|
15.0 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period
Week 12
|
0 Percentage of participants
|
5.0 Percentage of participants
|
4.8 Percentage of participants
|
12.2 Percentage of participants
|
22.5 Percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period
Week 16
|
0 Percentage of participants
|
15.0 Percentage of participants
|
5.0 Percentage of participants
|
15.8 Percentage of participants
|
20.5 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who had observed data.
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. The statistical analysis was for the data at Week 16.
Outcome measures
| Measure |
Placebo QD Group
n=42 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=22 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=21 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=41 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Week 1
|
-1.88 Units on a scale
Standard Error 0.697
|
-2.82 Units on a scale
Standard Error 0.969
|
-1.96 Units on a scale
Standard Error 0.984
|
-4.32 Units on a scale
Standard Error 0.676
|
-3.00 Units on a scale
Standard Error 0.708
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Week 2
|
-3.44 Units on a scale
Standard Error 0.959
|
-3.83 Units on a scale
Standard Error 1.330
|
-3.24 Units on a scale
Standard Error 1.356
|
-0.804 Units on a scale
Standard Error 0.926
|
-7.40 Units on a scale
Standard Error 0.970
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Week 4
|
-5.08 Units on a scale
Standard Error 1.108
|
-5.16 Units on a scale
Standard Error 1.528
|
-4.68 Units on a scale
Standard Error 1.553
|
-12.25 Units on a scale
Standard Error 1.065
|
-12.16 Units on a scale
Standard Error 1.114
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Week 6
|
-6.02 Units on a scale
Standard Error 1.268
|
-6.96 Units on a scale
Standard Error 1.737
|
-7.53 Units on a scale
Standard Error 1.769
|
-14.45 Units on a scale
Standard Error 1.212
|
-14.78 Units on a scale
Standard Error 1.268
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Week 8
|
-7.43 Units on a scale
Standard Error 1.333
|
-7.55 Units on a scale
Standard Error 1.827
|
-9.29 Units on a scale
Standard Error 1.847
|
-15.74 Units on a scale
Standard Error 1.274
|
-17.12 Units on a scale
Standard Error 1.324
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Week 12
|
-8.09 Units on a scale
Standard Error 1.364
|
-8.58 Units on a scale
Standard Error 1.863
|
-10.02 Units on a scale
Standard Error 1.861
|
-16.79 Units on a scale
Standard Error 1.300
|
-19.69 Units on a scale
Standard Error 1.340
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Week 16
|
-7.88 Units on a scale
Standard Error 1.417
|
-9.34 Units on a scale
Standard Error 1.932
|
-11.42 Units on a scale
Standard Error 1.928
|
-17.68 Units on a scale
Standard Error 1.354
|
-20.21 Units on a scale
Standard Error 1.387
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who had observed data.
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. The statistical analysis was for the data at Week 16.
Outcome measures
| Measure |
Placebo QD Group
n=42 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=22 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=21 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=41 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Week 1
|
-5.63 Percent change
Standard Error 2.858
|
-9.42 Percent change
Standard Error 3.975
|
-8.93 Percent change
Standard Error 4.039
|
-17.41 Percent change
Standard Error 2.774
|
-12.55 Percent change
Standard Error 2.908
|
—
|
—
|
—
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Week 2
|
-16.18 Percent change
Standard Error 3.809
|
-14.80 Percent change
Standard Error 5.283
|
-14.37 Percent change
Standard Error 5.385
|
-33.65 Percent change
Standard Error 3.677
|
-30.58 Percent change
Standard Error 3.851
|
—
|
—
|
—
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Week 4
|
-22.66 Percent change
Standard Error 4.437
|
-20.88 Percent change
Standard Error 6.107
|
-22.70 Percent change
Standard Error 6.205
|
-51.26 Percent change
Standard Error 4.259
|
-53.81 Percent change
Standard Error 4.449
|
—
|
—
|
—
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Week 6
|
-27.07 Percent change
Standard Error 4.833
|
-30.25 Percent change
Standard Error 6.619
|
-33.79 Percent change
Standard Error 6.739
|
-60.63 Percent change
Standard Error 4.620
|
-64.03 Percent change
Standard Error 4.828
|
—
|
—
|
—
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Week 8
|
-31.16 Percent change
Standard Error 4.983
|
-33.27 Percent change
Standard Error 6.831
|
-39.81 Percent change
Standard Error 6.909
|
-66.51 Percent change
Standard Error 4.763
|
-72.81 Percent change
Standard Error 4.954
|
—
|
—
|
—
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Week 12
|
-32.66 Percent change
Standard Error 5.137
|
-37.24 Percent change
Standard Error 7.010
|
-42.25 Percent change
Standard Error 6.996
|
-70.28 Percent change
Standard Error 4.886
|
-84.17 Percent change
Standard Error 5.039
|
—
|
—
|
—
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Week 16
|
-33.29 Percent change
Standard Error 5.369
|
-41.92 Percent change
Standard Error 7.304
|
-46.31 Percent change
Standard Error 7.271
|
-74.03 Percent change
Standard Error 5.122
|
-86.33 Percent change
Standard Error 5.236
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who had observed data.
The intensity of pruritus was assessed by a PP-NRS, an 11-category numeric rating scale from 0 to 10, which was participant reported. Participants were asked to assess their itch over the past 24 hours, anchored by the terms "no itch" (0) and "worst itch imaginable" (10) at the ends. The statistical analysis was for the data at Week 16.
Outcome measures
| Measure |
Placebo QD Group
n=38 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=17 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=20 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=42 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=38 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
Study Day 2, Week 1
|
-0.60 Units on a scale
Standard Error 0.238
|
0.05 Units on a scale
Standard Error 0.355
|
-0.64 Units on a scale
Standard Error 0.331
|
-0.76 Units on a scale
Standard Error 0.229
|
-0.41 Units on a scale
Standard Error 0.241
|
—
|
—
|
—
|
|
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
Study Day 3, Week 1
|
-0.71 Units on a scale
Standard Error 0.239
|
-0.65 Units on a scale
Standard Error 0.354
|
-0.90 Units on a scale
Standard Error 0.325
|
-0.83 Units on a scale
Standard Error 0.230
|
-0.88 Units on a scale
Standard Error 0.239
|
—
|
—
|
—
|
|
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
Study Day 4, Week 1
|
-0.76 Units on a scale
Standard Error 0.234
|
-0.83 Units on a scale
Standard Error 0.348
|
-0.89 Units on a scale
Standard Error 0.323
|
-1.24 Units on a scale
Standard Error 0.224
|
-1.04 Units on a scale
Standard Error 0.236
|
—
|
—
|
—
|
|
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
Study Day 5, Week 1
|
-0.63 Units on a scale
Standard Error 0.233
|
-0.91 Units on a scale
Standard Error 0.348
|
-1.12 Units on a scale
Standard Error 0.324
|
-1.26 Units on a scale
Standard Error 0.223
|
-1.08 Units on a scale
Standard Error 0.237
|
—
|
—
|
—
|
|
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
Study Day 6, Week 1
|
-0.82 Units on a scale
Standard Error 0.246
|
-0.94 Units on a scale
Standard Error 0.362
|
-0.81 Units on a scale
Standard Error 0.336
|
-1.49 Units on a scale
Standard Error 0.235
|
-1.34 Units on a scale
Standard Error 0.250
|
—
|
—
|
—
|
|
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
Study Day 7, Week 1
|
-0.72 Units on a scale
Standard Error 0.272
|
-1.11 Units on a scale
Standard Error 0.399
|
-0.86 Units on a scale
Standard Error 0.372
|
-1.75 Units on a scale
Standard Error 0.261
|
-1.11 Units on a scale
Standard Error 0.273
|
—
|
—
|
—
|
|
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
Study Day 8, Week 1
|
-0.83 Units on a scale
Standard Error 0.274
|
-1.26 Units on a scale
Standard Error 0.403
|
-0.92 Units on a scale
Standard Error 0.371
|
-1.65 Units on a scale
Standard Error 0.261
|
-1.21 Units on a scale
Standard Error 0.276
|
—
|
—
|
—
|
|
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
Study Day 9, Week 1
|
-0.79 Units on a scale
Standard Error 0.289
|
-1.32 Units on a scale
Standard Error 0.425
|
-1.08 Units on a scale
Standard Error 0.394
|
-1.50 Units on a scale
Standard Error 0.278
|
-1.43 Units on a scale
Standard Error 0.292
|
—
|
—
|
—
|
|
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
Study Day 10, Week 1
|
-0.85 Units on a scale
Standard Error 0.284
|
-1.48 Units on a scale
Standard Error 0.420
|
-1.01 Units on a scale
Standard Error 0.384
|
-1.63 Units on a scale
Standard Error 0.272
|
-1.46 Units on a scale
Standard Error 0.286
|
—
|
—
|
—
|
|
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
Study Day 11, Week 1
|
-0.70 Units on a scale
Standard Error 0.291
|
-1.55 Units on a scale
Standard Error 0.429
|
-1.11 Units on a scale
Standard Error 0.392
|
-1.67 Units on a scale
Standard Error 0.278
|
-1.27 Units on a scale
Standard Error 0.291
|
—
|
—
|
—
|
|
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
Study Day 12, Week 2
|
-0.63 Units on a scale
Standard Error 0.289
|
-1.67 Units on a scale
Standard Error 0.424
|
-0.92 Units on a scale
Standard Error 0.390
|
-1.93 Units on a scale
Standard Error 0.275
|
-1.39 Units on a scale
Standard Error 0.289
|
—
|
—
|
—
|
|
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
Study Day 13, Week 2
|
-0.78 Units on a scale
Standard Error 0.294
|
-1.49 Units on a scale
Standard Error 0.433
|
-1.15 Units on a scale
Standard Error 0.397
|
-2.18 Units on a scale
Standard Error 0.280
|
-1.61 Units on a scale
Standard Error 0.296
|
—
|
—
|
—
|
|
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
Study Day 14, Week 2
|
-0.82 Units on a scale
Standard Error 0.317
|
-1.66 Units on a scale
Standard Error 0.464
|
-1.21 Units on a scale
Standard Error 0.426
|
-2.15 Units on a scale
Standard Error 0.302
|
-1.81 Units on a scale
Standard Error 0.317
|
—
|
—
|
—
|
|
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
Study Day 15, Week 2
|
-0.75 Units on a scale
Standard Error 0.308
|
-1.48 Units on a scale
Standard Error 0.454
|
-1.18 Units on a scale
Standard Error 0.417
|
-2.20 Units on a scale
Standard Error 0.294
|
-1.83 Units on a scale
Standard Error 0.309
|
—
|
—
|
—
|
|
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
Study Day 16, Week 2
|
-0.73 Units on a scale
Standard Error 0.314
|
-1.52 Units on a scale
Standard Error 0.462
|
-1.13 Units on a scale
Standard Error 0.426
|
-2.29 Units on a scale
Standard Error 0.301
|
-1.80 Units on a scale
Standard Error 0.314
|
—
|
—
|
—
|
|
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
Week 4
|
-0.54 Units on a scale
Standard Error 0.354
|
-1.74 Units on a scale
Standard Error 0.517
|
-1.64 Units on a scale
Standard Error 0.477
|
-2.90 Units on a scale
Standard Error 0.337
|
-2.57 Units on a scale
Standard Error 0.354
|
—
|
—
|
—
|
|
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
Week 8
|
-1.24 Units on a scale
Standard Error 0.391
|
-1.10 Units on a scale
Standard Error 0.561
|
-1.93 Units on a scale
Standard Error 0.517
|
-4.10 Units on a scale
Standard Error 0.374
|
-4.12 Units on a scale
Standard Error 0.381
|
—
|
—
|
—
|
|
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
Week 12
|
-0.84 Units on a scale
Standard Error 0.455
|
-1.66 Units on a scale
Standard Error 0.651
|
-2.18 Units on a scale
Standard Error 0.599
|
-3.92 Units on a scale
Standard Error 0.433
|
-4.27 Units on a scale
Standard Error 0.442
|
—
|
—
|
—
|
|
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
Week 16
|
-0.93 Units on a scale
Standard Error 0.453
|
-2.15 Units on a scale
Standard Error 0.645
|
-2.14 Units on a scale
Standard Error 0.604
|
-4.40 Units on a scale
Standard Error 0.435
|
-4.59 Units on a scale
Standard Error 0.440
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed).
The Psoriasis Symptom Inventory (PSI) is a self administered 8-item questionnaire that measures the severity of psoriasis symptoms over the past 24 hours and the past 7 days. The measure includes concepts of itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Participants were asked to respond to each item using a 5-point Likert response scale: 0: not all severe, 1: mild, 2: moderate, 3: severe and 4: very severe. The statistical analysis was for the data at Week 16.
Outcome measures
| Measure |
Placebo QD Group
n=42 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=22 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=21 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=41 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
Study Day 2, Week 1
|
7.1 Percentage of participants
Interval 2.65 to 17.39
|
0 Percentage of participants
Interval 0.0 to 12.6
|
4.8 Percentage of participants
Interval 0.5 to 20.57
|
6.7 Percentage of participants
Interval 2.47 to 16.17
|
12.2 Percentage of participants
Interval 6.05 to 23.04
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
Study Day 3, Week 1
|
7.1 Percentage of participants
Interval 2.65 to 17.39
|
0 Percentage of participants
Interval 0.0 to 12.6
|
19.0 Percentage of participants
Interval 8.58 to 37.19
|
6.7 Percentage of participants
Interval 2.47 to 16.17
|
12.2 Percentage of participants
Interval 6.05 to 23.04
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
Study Day 4, Week 1
|
9.5 Percentage of participants
Interval 4.22 to 19.38
|
4.5 Percentage of participants
Interval 0.48 to 19.56
|
14.3 Percentage of participants
Interval 5.37 to 32.81
|
13.3 Percentage of participants
Interval 5.97 to 23.73
|
14.6 Percentage of participants
Interval 6.57 to 26.23
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
Study Day 5, Week 1
|
7.1 Percentage of participants
Interval 2.65 to 17.39
|
9.1 Percentage of participants
Interval 2.44 to 23.6
|
14.3 Percentage of participants
Interval 5.37 to 32.81
|
15.6 Percentage of participants
Interval 8.42 to 25.96
|
19.5 Percentage of participants
Interval 10.1 to 31.18
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
Study Day 6, Week 1
|
4.8 Percentage of participants
Interval 1.27 to 13.53
|
13.6 Percentage of participants
Interval 5.12 to 31.13
|
19.0 Percentage of participants
Interval 8.58 to 37.19
|
20.0 Percentage of participants
Interval 11.72 to 31.73
|
19.5 Percentage of participants
Interval 10.1 to 31.18
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
Study Day 7, Week 1
|
9.5 Percentage of participants
Interval 4.22 to 19.38
|
9.1 Percentage of participants
Interval 2.44 to 23.6
|
19.0 Percentage of participants
Interval 8.58 to 37.19
|
17.8 Percentage of participants
Interval 9.17 to 29.7
|
19.5 Percentage of participants
Interval 10.1 to 31.18
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
Study Day 8, Week 1
|
11.9 Percentage of participants
Interval 5.91 to 22.74
|
9.1 Percentage of participants
Interval 2.44 to 23.6
|
14.3 Percentage of participants
Interval 5.37 to 32.81
|
20.0 Percentage of participants
Interval 11.72 to 31.73
|
19.5 Percentage of participants
Interval 10.1 to 31.18
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
Study Day 9, Week 1
|
9.5 Percentage of participants
Interval 4.22 to 19.38
|
9.1 Percentage of participants
Interval 2.44 to 23.6
|
9.5 Percentage of participants
Interval 2.56 to 24.5
|
20.0 Percentage of participants
Interval 11.72 to 31.73
|
22.0 Percentage of participants
Interval 12.96 to 35.14
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
Study Day 10, Week 1
|
11.9 Percentage of participants
Interval 5.91 to 22.74
|
4.5 Percentage of participants
Interval 0.48 to 19.56
|
19.0 Percentage of participants
Interval 8.58 to 37.19
|
24.4 Percentage of participants
Interval 15.47 to 35.88
|
19.5 Percentage of participants
Interval 10.1 to 31.18
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
Study Day 11, Week 1
|
9.5 Percentage of participants
Interval 4.22 to 19.38
|
4.5 Percentage of participants
Interval 0.48 to 19.56
|
19.0 Percentage of participants
Interval 8.58 to 37.19
|
20.0 Percentage of participants
Interval 11.72 to 31.73
|
26.8 Percentage of participants
Interval 17.12 to 39.77
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
Study Day 12, Week 2
|
4.8 Percentage of participants
Interval 1.27 to 13.53
|
4.5 Percentage of participants
Interval 0.48 to 19.56
|
19.0 Percentage of participants
Interval 8.58 to 37.19
|
22.2 Percentage of participants
Interval 12.58 to 33.79
|
29.3 Percentage of participants
Interval 17.84 to 42.13
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
Study Day 13, Week 2
|
11.9 Percentage of participants
Interval 5.91 to 22.74
|
18.2 Percentage of participants
Interval 8.17 to 32.25
|
14.3 Percentage of participants
Interval 5.37 to 32.81
|
40.0 Percentage of participants
Interval 28.66 to 52.89
|
26.8 Percentage of participants
Interval 17.12 to 39.77
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
Study Day 14, Week 2
|
11.9 Percentage of participants
Interval 5.91 to 22.74
|
22.7 Percentage of participants
Interval 11.49 to 39.52
|
14.3 Percentage of participants
Interval 5.37 to 32.81
|
33.3 Percentage of participants
Interval 21.8 to 46.08
|
34.1 Percentage of participants
Interval 23.04 to 46.94
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
Study Day 15, Week 2
|
4.8 Percentage of participants
Interval 1.27 to 13.53
|
9.1 Percentage of participants
Interval 2.44 to 23.6
|
14.3 Percentage of participants
Interval 5.37 to 32.81
|
33.3 Percentage of participants
Interval 21.8 to 46.08
|
29.3 Percentage of participants
Interval 17.84 to 42.13
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
Study Day 16, Week 2
|
14.3 Percentage of participants
Interval 6.41 to 25.56
|
13.6 Percentage of participants
Interval 5.12 to 31.13
|
9.5 Percentage of participants
Interval 2.56 to 24.5
|
24.4 Percentage of participants
Interval 15.47 to 35.88
|
39.0 Percentage of participants
Interval 26.23 to 53.06
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
Week 4
|
14.3 Percentage of participants
Interval 6.41 to 25.56
|
13.6 Percentage of participants
Interval 5.12 to 31.13
|
28.6 Percentage of participants
Interval 13.24 to 46.41
|
44.4 Percentage of participants
Interval 31.73 to 56.75
|
43.9 Percentage of participants
Interval 31.18 to 57.87
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
Week 8
|
11.9 Percentage of participants
Interval 5.91 to 22.74
|
22.7 Percentage of participants
Interval 11.49 to 39.52
|
23.8 Percentage of participants
Interval 12.06 to 41.72
|
53.3 Percentage of participants
Interval 40.87 to 66.21
|
63.4 Percentage of participants
Interval 50.0 to 75.43
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
Week 12
|
7.1 Percentage of participants
Interval 2.65 to 17.39
|
31.8 Percentage of participants
Interval 18.11 to 50.0
|
28.6 Percentage of participants
Interval 13.24 to 46.41
|
55.6 Percentage of participants
Interval 43.25 to 68.27
|
63.4 Percentage of participants
Interval 50.0 to 75.43
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
Week 16
|
14.3 Percentage of participants
Interval 6.41 to 25.56
|
27.3 Percentage of participants
Interval 12.6 to 44.36
|
38.1 Percentage of participants
Interval 20.57 to 58.28
|
55.6 Percentage of participants
Interval 43.25 to 68.27
|
63.4 Percentage of participants
Interval 50.0 to 75.43
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who had observed data.
The Psoriasis Symptom Inventory (PSI) is a self administered 8-item questionnaire that measures the severity of psoriasis symptoms over the past 24 hours and the past 7 days. The measure includes concepts of itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Participants were asked to respond to each item using a 5-point Likert response scale: 0: not all severe, 1: mild, 2: moderate, 3: severe and 4: very severe. The outcome of PSI is the sum of the scores for the 8 items. The total score range of PSI is 0-32. A negative change from baseline means a better outcome and the bigger score decrease means a better outcome. The statistical analysis was for the data at Week 16.
Outcome measures
| Measure |
Placebo QD Group
n=38 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=18 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=21 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=42 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=39 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
Study Day 12, Week 2
|
-3.04 Unit on a scale
Standard Error 0.763
|
-4.54 Unit on a scale
Standard Error 1.118
|
-4.65 Unit on a scale
Standard Error 1.027
|
-7.10 Unit on a scale
Standard Error 0.726
|
-6.62 Unit on a scale
Standard Error 0.753
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
Study Day 13, Week 2
|
-2.94 Unit on a scale
Standard Error 0.781
|
-5.61 Unit on a scale
Standard Error 1.149
|
-4.79 Unit on a scale
Standard Error 1.055
|
-7.94 Unit on a scale
Standard Error 0.742
|
-7.16 Unit on a scale
Standard Error 0.776
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
Week 12
|
-2.27 Unit on a scale
Standard Error 1.208
|
-5.65 Unit on a scale
Standard Error 1.722
|
-7.35 Unit on a scale
Standard Error 1.572
|
-11.50 Unit on a scale
Standard Error 1.146
|
-13.42 Unit on a scale
Standard Error 1.145
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
Week 16
|
-1.87 Unit on a scale
Standard Error 1.260
|
-6.07 Unit on a scale
Standard Error 1.782
|
-8.31 Unit on a scale
Standard Error 1.661
|
-12.38 Unit on a scale
Standard Error 1.205
|
-12.68 Unit on a scale
Standard Error 1.191
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
Study Day 2, Week 1
|
-1.51 Unit on a scale
Standard Error 0.636
|
-0.89 Unit on a scale
Standard Error 0.927
|
-1.98 Unit on a scale
Standard Error 0.880
|
-2.54 Unit on a scale
Standard Error 0.605
|
-1.25 Unit on a scale
Standard Error 0.639
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
Study Day 3, Week 1
|
-2.70 Unit on a scale
Standard Error 0.653
|
-1.95 Unit on a scale
Standard Error 0.952
|
-3.65 Unit on a scale
Standard Error 0.879
|
-3.45 Unit on a scale
Standard Error 0.624
|
-2.79 Unit on a scale
Standard Error 0.650
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
Study Day 4, Week 1
|
-2.88 Unit on a scale
Standard Error 0.666
|
-3.05 Unit on a scale
Standard Error 0.985
|
-3.95 Unit on a scale
Standard Error 0.915
|
-4.61 Unit on a scale
Standard Error 0.637
|
-4.28 Unit on a scale
Standard Error 0.665
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
Study Day 5, Week 1
|
-2.55 Unit on a scale
Standard Error 0.692
|
-3.18 Unit on a scale
Standard Error 1.032
|
-3.87 Unit on a scale
Standard Error 0.959
|
-5.40 Unit on a scale
Standard Error 0.661
|
-3.93 Unit on a scale
Standard Error 0.696
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
Study Day 6, Week 1
|
-3.01 Unit on a scale
Standard Error 0.716
|
-3.98 Unit on a scale
Standard Error 1.058
|
-3.94 Unit on a scale
Standard Error 0.981
|
-5.43 Unit on a scale
Standard Error 0.684
|
-4.77 Unit on a scale
Standard Error 0.717
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
Study Day 7, Week 1
|
-3.23 Unit on a scale
Standard Error 0.770
|
-4.34 Unit on a scale
Standard Error 1.134
|
-4.08 Unit on a scale
Standard Error 1.059
|
-6.42 Unit on a scale
Standard Error 0.740
|
-4.90 Unit on a scale
Standard Error 0.763
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
Study Day 8, Week 1
|
-3.27 Unit on a scale
Standard Error 0.768
|
-4.38 Unit on a scale
Standard Error 1.137
|
-4.65 Unit on a scale
Standard Error 1.042
|
-6.23 Unit on a scale
Standard Error 0.731
|
-5.67 Unit on a scale
Standard Error 0.762
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
Study Day 9, Week 1
|
-3.11 Unit on a scale
Standard Error 0.788
|
-3.95 Unit on a scale
Standard Error 1.159
|
-4.54 Unit on a scale
Standard Error 1.078
|
-5.71 Unit on a scale
Standard Error 0.756
|
-5.70 Unit on a scale
Standard Error 0.782
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
Study Day 10, Week 1
|
-3.29 Unit on a scale
Standard Error 0.781
|
-4.24 Unit on a scale
Standard Error 1.150
|
-4.15 Unit on a scale
Standard Error 1.055
|
-6.22 Unit on a scale
Standard Error 0.747
|
-6.02 Unit on a scale
Standard Error 0.776
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
Study Day 11, Week 1
|
-2.89 Unit on a scale
Standard Error 0.825
|
-4.72 Unit on a scale
Standard Error 1.216
|
-4.41 Unit on a scale
Standard Error 1.111
|
-7.06 Unit on a scale
Standard Error 0.787
|
-6.03 Unit on a scale
Standard Error 0.812
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
Study Day 14, Week 2
|
-3.25 Unit on a scale
Standard Error 0.793
|
-5.84 Unit on a scale
Standard Error 1.162
|
-5.22 Unit on a scale
Standard Error 1.065
|
-8.12 Unit on a scale
Standard Error 0.757
|
-7.09 Unit on a scale
Standard Error 0.784
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
Study Day 15, Week 2
|
-2.71 Unit on a scale
Standard Error 0.830
|
-4.98 Unit on a scale
Standard Error 1.227
|
-5.23 Unit on a scale
Standard Error 1.123
|
-7.84 Unit on a scale
Standard Error 0.793
|
-7.47 Unit on a scale
Standard Error 0.821
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
Study Day 16, Week 2
|
-3.27 Unit on a scale
Standard Error 0.847
|
-5.03 Unit on a scale
Standard Error 1.250
|
-4.83 Unit on a scale
Standard Error 1.150
|
-8.12 Unit on a scale
Standard Error 0.810
|
-7.45 Unit on a scale
Standard Error 0.836
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
Week 4
|
-2.53 Unit on a scale
Standard Error 0.990
|
-4.83 Unit on a scale
Standard Error 1.449
|
-6.58 Unit on a scale
Standard Error 1.338
|
-9.14 Unit on a scale
Standard Error 0.943
|
-9.02 Unit on a scale
Standard Error 0.978
|
—
|
—
|
—
|
|
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
Week 8
|
-3.45 Unit on a scale
Standard Error 1.069
|
-4.09 Unit on a scale
Standard Error 1.536
|
-7.30 Unit on a scale
Standard Error 1.407
|
-11.63 Unit on a scale
Standard Error 1.022
|
-12.19 Unit on a scale
Standard Error 1.026
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo).
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time.
Outcome measures
| Measure |
Placebo QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=22 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=23 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=43 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period
Participants with AEs
|
23 Participants
|
13 Participants
|
16 Participants
|
28 Participants
|
29 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period
Participants with SAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period
Participants with severe AEs
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period
Participants discontinued from study due to AEs
|
1 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period
Participants discontinued study drug due to AE and continue study
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period
Participants with dose reduced or temporary discontinuation due to AEs
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo).
Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug ((PF-06826647 or placebo). Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time. Relatedness to investigational product (PF-06826647 or placebo) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Outcome measures
| Measure |
Placebo QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=22 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=23 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=43 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period
Participants with AEs
|
4 Participants
|
0 Participants
|
4 Participants
|
11 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period
Participants with SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period
Participants with severe AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period
Participants discontinued from study due to AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period
Participants discontinued study drug due to AE and continue study
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period
Participants with dose reduced or temporary discontinuation due to AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who had at least 1 ECG assessment.
Criteria for ECG abnormalities: Criteria for ECG abnormalities: maximum PR interval \>=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) \>=25 percent (%) for baseline value of \>200 msec and Pctchg\>=50% for baseline value of \<=200 msec for PR interval, maximum QRS interval \>=140 msec and a maximum IFB: Pctchg\>=50%, maximum QTcF interval (Fridericia's Correction) of 450 msec to \<=480 msec, 480 msec to \<=500 msec and a maximum change of \<30change\<=60 or \>60 msec from baseline.
Outcome measures
| Measure |
Placebo QD Group
n=44 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=22 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=23 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=44 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=43 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
PR interval, single beat (msec) >=300
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
PR interval, single beat (msec) Pctchg >=25/50%
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
QRS duration, single beat (msec) >=140
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
QRS duration, single beat (msec) Pctchg >=50%
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
450< QTcF- Fridericia's correction formula (msec) <=480
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
480< QTcF- Fridericia's correction formula (msec) <=500
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
30< QTcF- Fridericia's correction formula (msec) change <=60
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
QTcF- Fridericia's correction formula (msec) change >60
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and were evaluated against the criteria.
The vital signs were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Criteria for vital signs abnormalities: pulse rate \>120 beats per minute (BPM), sitting diastolic blood pressure (BP) change \>=20 millimeter of mercury (mmHg) increase, sitting diastolic BP change \>=20 mmHg decrease, sitting systolic BP \<90 mmHg, sitting systolic BP change \>=30 mmHg increase, and sitting systolic BP change \>=30 mmHg decrease.
Outcome measures
| Measure |
Placebo QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=22 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=23 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=43 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
Pulse rate (BMP) >120
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
Sitting diastolic BP (mmHg) change >=20 increase
|
4 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
Sitting diastolic BP (mmHg) change >=20 decrease
|
4 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
Sitting systolic BP (mmHg) <90 increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
Sitting systolic BP (mmHg) change >=30 increase
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
Sitting systolic BP (mmHg) change >=30 decrease
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo), with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time up to week 16.
Following hematology parameters were analyzed for laboratory examination: hemoglobin (HGB), hematocrit, erythrocytes (Ery.), reticulocytes, Ery. mean corpuscular volume, Ery. mean corpuscular HGB, Ery. mean corpuscular HGB concentration, platelets, reticulocytes/erythrocytes, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, activated partial thromboplastin time, prothrombin time, neutrophils total count, and lymphocytes total count. LLN=lower limit of normal; ULN=upper limit of normal.
Outcome measures
| Measure |
Placebo QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=22 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=23 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=43 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Neutrophils/Leukocytes (%) >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Basophils (10^3/mm^3) >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Basophils/Leukocytes (%) >1.2*ULN
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Eosinophils (10^3/mm^3) >1.2*ULN
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Eosinophils/Leukocytes (%) >1.2*ULN
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Ery. Mean Corpuscular Volume (um^3) >1.1*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Monocytes (10^3/mm^3) >1.2*ULN
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Monocytes/Leukocytes (%) >1.2*ULN
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
HGB (g/dL) <0.8*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Hematocrit (%) <0.8*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Erythrocytes (10^6/mm^3) <0.8*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Reticulocytes (10^3/mm^3) <0.5*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Reticulocytes (10^3/mm^3) >1.5*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Ery. Mean Corpuscular Volume (um^3) <0.9*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Ery. Mean Corpuscular HGB (pg/cell) <0.9*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Platelets (10^3/mm^3) <0.5*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Platelets (10^3/mm^3) >1.75*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Reticulocytes/Erythrocytes (%) <0.5*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Reticulocytes/Erythrocytes (%) >1.5*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Leukocytes(10^3/mm^3) <0.6*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Leukocytes(10^3/mm^3) >1.5*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Lymphocytes/Leukocytes (%) <0.8*LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Lymphocytes/Leukocytes (%) >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Neutrophils/Leukocytes (%) <0.8*LLN
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Activated Partial Thromboplastin Time (sec) >1.1*ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Prothrombin Time (sec) >1.1*ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Neutrophils total count (10^3/mm^3) <0.8*LLN
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Neutrophils total count (10^3/mm^3) >1.2*ULN
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Lymphocytes total count (10^3/mm^3) <0.8*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Lymphocytes total count (10^3/mm^3) >1.2*ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 16.Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo), with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time up to week 16.
Following clinical chemistry parameters were analyzed for laboratory examination: bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, high-density lipoprotein (HDL) cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, and cholesterol. LLN=lower limit of normal; ULN=upper limit of normal.
Outcome measures
| Measure |
Placebo QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=22 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=23 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=43 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Calcium (mg/dL) >1.1*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Bicarbonate (Meq/L) <0.9*LLN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Bicarbonate (Meq/L) >1.1*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Glucose (mg/dL) <0.6*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Glucose (mg/dL) >1.5*ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Creatine Kinase (U/L) >2.0*ULN
|
3 Participants
|
3 Participants
|
2 Participants
|
9 Participants
|
15 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Cholesterol (mg/dL) >1.3*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Sodium (Meq/L) >1.05*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Potassium (Meq/L) <0.9*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Potassium (Meq/L) >1.1*ULN
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Alanine Aminotransferase (U/L) > 3.0*ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Bilirubin (mg/dL) >1.5*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Indirect Bilirubin (mg/dL) >1.5*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Aspartate Aminotransferase (U/L) > 3.0*ULN
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Gamma Glutamyl Transferase (U/L) > 3.0*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Alkaline Phosphatase (U/L) > 3.0*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Protein (g/dL) <0.8*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Protein (g/dL) >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Albumin (g/dL) <0.8*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Albumin (g/dL) >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Blood Urea Nitrogen (mg/dL) >1.3*ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Urea (mg/dL) >1.3*ULN
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Creatinine (mg/dL) >1.3*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Urate (mg/dL) >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
HDL Cholesterol (mg/dL) <0.8*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Triglycerides (mg/dL) >1.3*ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Sodium (Meq/L) <0.95*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Chloride (Meq/L) <0.9*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Chloride (Meq/L) >1.1*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Calcium (mg/dL) <0.9*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo), with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time up to week 16.
Following urinalysis parameters were analyzed for laboratory examination: urine pH, urine glucose, urine ketones, urine protein, urine hemoglobin, urine urobilinogen, urine bilirubin, urine nitrite, urine leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline, and urine bacteria.
Outcome measures
| Measure |
Placebo QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
|
PF-06826647 50 mg QD Group
n=22 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD Group
n=23 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
|
PF-06826647 200 mg QD Group
n=45 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
|
PF-06826647 400 mg QD Group
n=43 Participants
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Urine pH (Scalar) <4.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Urine pH (Scalar) >8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Urine Glucose >=1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Urine Ketones (Scalar) >=1
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Urine Protein >=1
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Urine Hemoglobin (Scalar) >=1
|
3 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Urine Urobilinogen (EU/dL) >=1
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Urine Bilirubin (Scalar) >=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Urine Nitrite (Scalar) >=1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Urine Leukocyte Esterase (Scalar) >=1
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Urine Erythrocytes (Scalar) >=20
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Urine Leukocytes (/HPF) >=20
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Urine Hyaline Casts (/LPF) >1
|
1 Participants
|
1 Participants
|
—
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Urine Bacteria (/LPF) >20
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo QD->PF-06826647 200 mg QD Group
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo QD->PF-06826647 400 mg QD Group
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
PF-06826647 50 mg QD->PF-06826647 200 mg QD Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
PF-06826647 50 mg QD->PF-06826647 400 mg QD Group
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
PF-06826647 100 mg QD->PF-06826647 200 mg QD Group
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo QD->PF-06826647 200 mg QD Group
n=23 participants at risk
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.
|
Placebo QD->PF-06826647 400 mg QD Group
n=22 participants at risk
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.
|
PF-06826647 50 mg QD->PF-06826647 200 mg QD Group
n=11 participants at risk
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.
|
PF-06826647 50 mg QD->PF-06826647 400 mg QD Group
n=11 participants at risk
This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.
|
PF-06826647 100 mg QD->PF-06826647 200 mg QD Group
n=12 participants at risk
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
n=11 participants at risk
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
n=45 participants at risk
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
n=43 participants at risk
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
General disorders
Chest pain
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.2%
1/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Infections and infestations
Viral sepsis
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.2%
1/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Vascular disorders
Hypertension
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.5%
1/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.2%
1/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
Other adverse events
| Measure |
Placebo QD->PF-06826647 200 mg QD Group
n=23 participants at risk
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.
|
Placebo QD->PF-06826647 400 mg QD Group
n=22 participants at risk
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.
|
PF-06826647 50 mg QD->PF-06826647 200 mg QD Group
n=11 participants at risk
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.
|
PF-06826647 50 mg QD->PF-06826647 400 mg QD Group
n=11 participants at risk
This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.
|
PF-06826647 100 mg QD->PF-06826647 200 mg QD Group
n=12 participants at risk
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.
|
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
n=11 participants at risk
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
|
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
n=45 participants at risk
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
|
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
n=43 participants at risk
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
18.2%
2/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.2%
1/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
7.0%
3/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.2%
1/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
8.7%
2/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.2%
1/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.7%
2/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.3%
1/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
6.7%
3/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.7%
2/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Cardiac disorders
Atrial fibrillation
|
4.3%
1/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.3%
1/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Ear and labyrinth disorders
Vertigo
|
4.3%
1/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Eye disorders
Diplopia
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Eye disorders
Strabismus
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.4%
2/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.3%
1/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
2/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
7.0%
3/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Gastrointestinal disorders
Constipation
|
4.3%
1/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.3%
1/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.3%
1/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.2%
1/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.5%
1/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.3%
1/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.4%
2/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.3%
1/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.3%
1/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.3%
1/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.7%
2/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
General disorders
Asthenia
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
General disorders
Fatigue
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.5%
1/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.4%
2/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.7%
2/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
General disorders
Feeling hot
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
General disorders
Oedema peripheral
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.5%
1/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
General disorders
Peripheral swelling
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
General disorders
Pyrexia
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.3%
1/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
6.7%
3/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.3%
1/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Infections and infestations
Erythema migrans
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Infections and infestations
Folliculitis
|
8.7%
2/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.2%
1/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.5%
1/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.3%
1/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.2%
1/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.3%
1/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Infections and infestations
Nasopharyngitis
|
26.1%
6/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.5%
1/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
27.3%
3/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
25.0%
3/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
18.2%
2/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
13.3%
6/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
27.9%
12/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.5%
1/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.3%
1/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.3%
1/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.3%
1/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.3%
1/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
1/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.5%
1/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
18.2%
2/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
18.2%
2/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
6.7%
3/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.3%
4/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Infections and infestations
Urinary tract infection
|
4.3%
1/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.5%
1/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.2%
1/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.7%
2/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
4.3%
1/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
16.7%
2/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.2%
1/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.3%
1/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
18.2%
2/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.2%
1/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
7.0%
3/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Injury, poisoning and procedural complications
Diffuse axonal injury
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.5%
1/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.3%
1/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.3%
1/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Investigations
Alanine aminotransferase increased
|
4.3%
1/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.4%
2/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
7.0%
3/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.7%
2/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Investigations
Blood creatine phosphokinase increased
|
4.3%
1/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.5%
1/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
11.1%
5/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
14.0%
6/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.3%
1/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Investigations
Blood pressure increased
|
4.3%
1/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.3%
1/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
18.2%
2/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.9%
4/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.3%
4/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
7.0%
3/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Investigations
Prothrombin time prolonged
|
4.3%
1/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.4%
2/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Investigations
Serum ferritin increased
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Investigations
Transaminases increased
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.7%
2/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.5%
1/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
18.2%
2/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.7%
2/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
1/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.3%
1/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.2%
1/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
7.0%
3/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.3%
1/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.3%
1/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.3%
1/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.3%
1/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Nervous system disorders
Circadian rhythm sleep disorder
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.3%
1/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.3%
1/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.2%
1/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.5%
1/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.4%
2/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
14.0%
6/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.3%
1/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Nervous system disorders
Syncope
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.3%
1/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Psychiatric disorders
Depression
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.3%
1/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
2.2%
1/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal hypertrophy
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Skin and subcutaneous tissue disorders
Pseudofolliculitis
|
0.00%
0/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
4.3%
1/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
|
Vascular disorders
Hypertension
|
4.3%
1/23 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.5%
1/22 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
9.1%
1/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
8.3%
1/12 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
0.00%
0/11 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
4.4%
2/45 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
11.6%
5/43 • From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
|
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