Trial Outcomes & Findings for A Dose Ranging Placebo-Controlled Double-Blind Study to Evaluate the Safety and Efficacy of Tezepelumab in Atopic Dermatitis (NCT NCT03809663)
NCT ID: NCT03809663
Last Updated: 2022-03-10
Results Overview
The IGA allows investigators to assess overall disease severity at 1 given time point and consists of a 6-point severity scale from clear to severe disease * 0 = clear * 1 = almost clear * 2 = mild disease * 3 = moderate disease * 4 = severe disease * 5 = very severe disease The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment (Breuer et al, 2004). Participants who took rescue medication between Day 29 to Week 16 were considered non-responders.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
251 participants
Primary outcome timeframe
Week 16
Results posted on
2022-03-10
Participant Flow
Participants were enrolled in 78 centers in 14 countries including Australia, Canada, Czech Republic, Estonia, Germany, Hungary, Japan, Latvia, Poland, Republic of Korea, Spain, Ukraine, the United Kingdom, and the United States.
Enrollment of Part A of this study was completed as of 27 July 2020. The study was terminated prior to the enrollment of any participants into Part B.
Participant milestones
| Measure |
Part A: Placebo
Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index \[EASI\] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 210 mg Q4W
Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 280 mg Q2W
Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 420 mg Q2W
Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part B: Placebo and Topical Corticosteroids Regimen
Matching placebo was planned to be administered via SC injection Q2W with topical corticosteroids (TCS) for a maximum of 52 weeks.
The study was terminated prior to the start of Part 2 and no participants were enrolled.
|
Part B: Tezepelumab 420 mg Q2W and Topical Corticosteroids Regimen
Tezepelumab 420 mg was planned to be administered via SC injection Q2W with TCS for a maximum of 52 weeks.
The study was terminated prior to the start of Part 2 and no participants were enrolled.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
63
|
62
|
63
|
63
|
0
|
0
|
|
Overall Study
Participants Who Received Investigational Product
|
63
|
61
|
63
|
63
|
0
|
0
|
|
Overall Study
EASI 50 Non-responder at Week 16
|
40
|
26
|
30
|
38
|
0
|
0
|
|
Overall Study
Switched to Tezepelumab 420 mg Q2W After Week 16
|
39
|
24
|
30
|
38
|
0
|
0
|
|
Overall Study
COMPLETED
|
12
|
18
|
15
|
16
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
51
|
44
|
48
|
47
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A: Placebo
Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index \[EASI\] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 210 mg Q4W
Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 280 mg Q2W
Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 420 mg Q2W
Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part B: Placebo and Topical Corticosteroids Regimen
Matching placebo was planned to be administered via SC injection Q2W with topical corticosteroids (TCS) for a maximum of 52 weeks.
The study was terminated prior to the start of Part 2 and no participants were enrolled.
|
Part B: Tezepelumab 420 mg Q2W and Topical Corticosteroids Regimen
Tezepelumab 420 mg was planned to be administered via SC injection Q2W with TCS for a maximum of 52 weeks.
The study was terminated prior to the start of Part 2 and no participants were enrolled.
|
|---|---|---|---|---|---|---|
|
Overall Study
Decision by sponsor
|
24
|
18
|
20
|
20
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
26
|
22
|
27
|
26
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
1
|
1
|
0
|
0
|
Baseline Characteristics
A Dose Ranging Placebo-Controlled Double-Blind Study to Evaluate the Safety and Efficacy of Tezepelumab in Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Part A: Placebo
n=63 Participants
Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index \[EASI\] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 210 mg Q4W
n=62 Participants
Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 280 mg Q2W
n=63 Participants
Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 420 mg Q2W
n=63 Participants
Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.7 Years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
38.5 Years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
36.9 Years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
40.7 Years
STANDARD_DEVIATION 14.3 • n=4 Participants
|
37.9 Years
STANDARD_DEVIATION 14.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
109 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
142 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
236 Participants
n=21 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
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 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
|
|
Race/Ethnicity, Customized
White
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
175 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
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
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Investigator's Global Assessment Score
IGA Score of 3
|
26 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
126 Participants
n=21 Participants
|
|
Investigator's Global Assessment Score
IGA Score of 4
|
32 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
|
Investigator's Global Assessment Score
IGA Score of 5
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Eczema Area and Severity Index (EASI)
|
32.0 Score on a scale
STANDARD_DEVIATION 11.1 • n=5 Participants
|
28.4 Score on a scale
STANDARD_DEVIATION 13.2 • n=7 Participants
|
30.3 Score on a scale
STANDARD_DEVIATION 10.7 • n=5 Participants
|
28.6 Score on a scale
STANDARD_DEVIATION 12.4 • n=4 Participants
|
29.8 Score on a scale
STANDARD_DEVIATION 11.9 • n=21 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: FAS: All randomized participants.
The IGA allows investigators to assess overall disease severity at 1 given time point and consists of a 6-point severity scale from clear to severe disease * 0 = clear * 1 = almost clear * 2 = mild disease * 3 = moderate disease * 4 = severe disease * 5 = very severe disease The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment (Breuer et al, 2004). Participants who took rescue medication between Day 29 to Week 16 were considered non-responders.
Outcome measures
| Measure |
Part A: Placebo
n=63 Participants
Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index \[EASI\] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 210 mg Q4W
n=62 Participants
Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 280 mg Q2W
n=63 Participants
Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 420 mg Q2W
n=63 Participants
Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
|---|---|---|---|---|
|
Number of Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) (IGA 0/1) at Week 16
|
2 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: FAS: All randomized participants.
The EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on key acute and chronic signs of inflammation (ie, erythema, induration/papulation, excoriation, and lichenification). A reduction in the EASI score indicates an improvement in severity. Participants who took rescue medication between Day 29 to Week 16 were considered non-responders.
Outcome measures
| Measure |
Part A: Placebo
n=63 Participants
Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index \[EASI\] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 210 mg Q4W
n=62 Participants
Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 280 mg Q2W
n=63 Participants
Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 420 mg Q2W
n=63 Participants
Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16
|
8 Participants
|
9 Participants
|
10 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS: All randomized participants.
The EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on key acute and chronic signs of inflammation (ie, erythema, induration/papulation, excoriation, and lichenification). A reduction in the EASI score indicates an improvement in severity. Participants who took rescue medication between Day 29 to Week 16 were considered non-responders.
Outcome measures
| Measure |
Part A: Placebo
n=56 Participants
Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index \[EASI\] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 210 mg Q4W
n=58 Participants
Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 280 mg Q2W
n=58 Participants
Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 420 mg Q2W
n=56 Participants
Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced a 50% or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI 50/90) at Week 16
EASI 50
|
11 Participants
|
21 Participants
|
18 Participants
|
11 Participants
|
|
Number of Participants Who Experienced a 50% or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI 50/90) at Week 16
EASI 90
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to End of Study Visit (Week 70)Population: FAS: All randomized participants.
Outcome measures
| Measure |
Part A: Placebo
n=63 Participants
Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index \[EASI\] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 210 mg Q4W
n=62 Participants
Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 280 mg Q2W
n=63 Participants
Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 420 mg Q2W
n=63 Participants
Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
|---|---|---|---|---|
|
Time to Achievement of 50%, 75% or 90% Reduction From Day 1 in Eczema Area and Severity Index (EASI 50/75/90)
Time to EASI 50
|
6.143 Weeks
Interval 4.14 to 19.57
|
8.143 Weeks
Interval 3.86 to 16.14
|
6.286 Weeks
Interval 3.86 to 22.14
|
5.857 Weeks
Interval 3.86 to 16.14
|
|
Time to Achievement of 50%, 75% or 90% Reduction From Day 1 in Eczema Area and Severity Index (EASI 50/75/90)
Time to EASI 75
|
6.143 Weeks
Interval 4.14 to 19.57
|
6.286 Weeks
Interval 4.0 to 16.43
|
6.714 Weeks
Interval 4.14 to 22.14
|
6.429 Weeks
Interval 4.14 to 16.14
|
|
Time to Achievement of 50%, 75% or 90% Reduction From Day 1 in Eczema Area and Severity Index (EASI 50/75/90)
Time to EASI 90
|
8.286 Weeks
Interval 4.43 to 19.57
|
10.929 Weeks
Interval 4.0 to 16.14
|
10.071 Weeks
Interval 6.14 to 16.14
|
7.286 Weeks
Interval 4.14 to 16.29
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS: All randomized participants.
The SCORAD is a clinical tool for assessing the severity (ie, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with subjective symptoms (Kunz et al, 1997). The total score ranges from 0 to 103, with higher values indicating more severe disease. A negative change from baseline indicates an improvement in severity of disease.
Outcome measures
| Measure |
Part A: Placebo
n=63 Participants
Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index \[EASI\] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 210 mg Q4W
n=62 Participants
Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 280 mg Q2W
n=63 Participants
Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 420 mg Q2W
n=63 Participants
Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
|---|---|---|---|---|
|
Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 16
|
-8.00 Score on a scale
Standard Error 2.55
|
-16.75 Score on a scale
Standard Error 2.40
|
-11.87 Score on a scale
Standard Error 2.49
|
-9.32 Score on a scale
Standard Error 2.48
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS: All randomized participants.
Pruritus was assessed using an NRS (0-10) with 0 = no itch and 10 = worst imaginable itch. A negative change from baseline indicates an improvement in symptoms.
Outcome measures
| Measure |
Part A: Placebo
n=63 Participants
Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index \[EASI\] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 210 mg Q4W
n=62 Participants
Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 280 mg Q2W
n=63 Participants
Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 420 mg Q2W
n=63 Participants
Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
|---|---|---|---|---|
|
Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16
|
-0.71 Score on a scale
Standard Error 0.30
|
-1.40 Score on a scale
Standard Error 0.27
|
-0.94 Score on a scale
Standard Error 0.28
|
-0.38 Score on a scale
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1, Week 2, 4, 12, 16, 24, 32, 40, 48, 50, 52, 58 and 70Population: All randomized participants who received at least 1 dose of investigational product with analyzable samples at each time point. Participants were analyzed according to the highest dose of actual treatment received after initial first dose or only dose received. Switchers were included up to Week 16 and were then excluded from the analysis after switching at Week 16.
Switchers were included up to Week 16 and were then excluded from the analysis after switching. All Tezepelumab participants received 420 mg of Tezepelumab on Day 1.
Outcome measures
| Measure |
Part A: Placebo
n=58 Participants
Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index \[EASI\] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 210 mg Q4W
n=58 Participants
Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 280 mg Q2W
n=66 Participants
Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 420 mg Q2W
Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
|---|---|---|---|---|
|
Serum Trough Concentrations of Tezepelumab After Q2W or Q4W Administration
Day 1
|
0.00031 µg/mL
Standard Deviation 0.00236
|
0.00 µg/mL
Standard Deviation 0.00
|
0.00 µg/mL
Standard Deviation 0.00
|
—
|
|
Serum Trough Concentrations of Tezepelumab After Q2W or Q4W Administration
Week 2
|
34.9 µg/mL
Standard Deviation 10.9
|
36.3 µg/mL
Standard Deviation 12.9
|
34.8 µg/mL
Standard Deviation 12.9
|
—
|
|
Serum Trough Concentrations of Tezepelumab After Q2W or Q4W Administration
Week 4
|
23.4 µg/mL
Standard Deviation 9.03
|
48.8 µg/mL
Standard Deviation 16.0
|
58.9 µg/mL
Standard Deviation 21.4
|
—
|
|
Serum Trough Concentrations of Tezepelumab After Q2W or Q4W Administration
Week 12
|
21.7 µg/mL
Standard Deviation 8.47
|
66.7 µg/mL
Standard Deviation 22.9
|
97.0 µg/mL
Standard Deviation 35.0
|
—
|
|
Serum Trough Concentrations of Tezepelumab After Q2W or Q4W Administration
Week 16
|
22.2 µg/mL
Standard Deviation 9.42
|
77.4 µg/mL
Standard Deviation 33.0
|
98.0 µg/mL
Standard Deviation 37.8
|
—
|
|
Serum Trough Concentrations of Tezepelumab After Q2W or Q4W Administration
Week 24
|
23.2 µg/mL
Standard Deviation 10.6
|
83.6 µg/mL
Standard Deviation 31.2
|
107 µg/mL
Standard Deviation 29.5
|
—
|
|
Serum Trough Concentrations of Tezepelumab After Q2W or Q4W Administration
Week 32
|
25.4 µg/mL
Standard Deviation 17.0
|
75.1 µg/mL
Standard Deviation 36.3
|
81.4 µg/mL
Standard Deviation 26.4
|
—
|
|
Serum Trough Concentrations of Tezepelumab After Q2W or Q4W Administration
Week 40
|
22.9 µg/mL
Standard Deviation 12.7
|
76.8 µg/mL
Standard Deviation 19.7
|
112 µg/mL
Standard Deviation 63.3
|
—
|
|
Serum Trough Concentrations of Tezepelumab After Q2W or Q4W Administration
Week 48
|
18.2 µg/mL
Standard Deviation 6.49
|
76.4 µg/mL
Standard Deviation 26.4
|
118 µg/mL
Standard Deviation 48.3
|
—
|
|
Serum Trough Concentrations of Tezepelumab After Q2W or Q4W Administration
Week 50
|
29.2 µg/mL
Standard Deviation 9.11
|
86.8 µg/mL
Standard Deviation 27.7
|
113 µg/mL
Standard Deviation 44.4
|
—
|
|
Serum Trough Concentrations of Tezepelumab After Q2W or Q4W Administration
Week 52
|
18.3 µg/mL
Standard Deviation 7.24
|
67.2 µg/mL
Standard Deviation 33.2
|
102 µg/mL
Standard Deviation 31.2
|
—
|
|
Serum Trough Concentrations of Tezepelumab After Q2W or Q4W Administration
Week 58
|
5.41 µg/mL
Standard Deviation 2.56
|
18.0 µg/mL
Standard Deviation 7.09
|
20.9 µg/mL
Standard Deviation NA
Insufficient samples to measure standard deviation.
|
—
|
|
Serum Trough Concentrations of Tezepelumab After Q2W or Q4W Administration
Week 70
|
0.699 µg/mL
Standard Deviation 0.380
|
1.87 µg/mL
Standard Deviation 1.74
|
5.36 µg/mL
Standard Deviation 3.20
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Week 24, 32, 40, 48, 50, 52, 58 and 70Population: All randomized participants who received at least 1 dose of investigational product who were assessed as EASI non-responders at Week 16 and switched to 420 mg Q2W, with analyzable samples at each time point.
Outcome measures
| Measure |
Part A: Placebo
n=30 Participants
Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index \[EASI\] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 210 mg Q4W
n=22 Participants
Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 280 mg Q2W
n=21 Participants
Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
Part A: Tezepelumab 420 mg Q2W
n=25 Participants
Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.
|
|---|---|---|---|---|
|
Serum Trough Concentrations of Tezepelumab After Switching to 420 mg Q2W Administration After Week 16
Week 24
|
70.5 µg/mL
Standard Deviation 28.3
|
87.2 µg/mL
Standard Deviation 24.0
|
96.6 µg/mL
Standard Deviation 29.2
|
100 µg/mL
Standard Deviation 38.2
|
|
Serum Trough Concentrations of Tezepelumab After Switching to 420 mg Q2W Administration After Week 16
Week 32
|
91.0 µg/mL
Standard Deviation 38.7
|
104 µg/mL
Standard Deviation 38.8
|
97.8 µg/mL
Standard Deviation 39.3
|
105 µg/mL
Standard Deviation 39.1
|
|
Serum Trough Concentrations of Tezepelumab After Switching to 420 mg Q2W Administration After Week 16
Week 40
|
117 µg/mL
Standard Deviation 42.7
|
93.8 µg/mL
Standard Deviation 35.5
|
113 µg/mL
Standard Deviation 31.1
|
101 µg/mL
Standard Deviation 37.7
|
|
Serum Trough Concentrations of Tezepelumab After Switching to 420 mg Q2W Administration After Week 16
Week 48
|
134 µg/mL
Standard Deviation 60.2
|
121 µg/mL
Standard Deviation 29.1
|
89.6 µg/mL
Standard Deviation 35.1
|
103 µg/mL
Standard Deviation 29.9
|
|
Serum Trough Concentrations of Tezepelumab After Switching to 420 mg Q2W Administration After Week 16
Week 50
|
115 µg/mL
Standard Deviation 39.0
|
125 µg/mL
Standard Deviation 42.2
|
79.1 µg/mL
Standard Deviation 38.6
|
106 µg/mL
Standard Deviation 27.0
|
|
Serum Trough Concentrations of Tezepelumab After Switching to 420 mg Q2W Administration After Week 16
Week 52
|
125 µg/mL
Standard Deviation 30.8
|
113 µg/mL
Standard Deviation 45.0
|
88.3 µg/mL
Standard Deviation 33.0
|
105 µg/mL
Standard Deviation 30.2
|
|
Serum Trough Concentrations of Tezepelumab After Switching to 420 mg Q2W Administration After Week 16
Week 58
|
26.0 µg/mL
Standard Deviation 21.6
|
52.6 µg/mL
Standard Deviation NA
Insufficient number of samples to calculate standard deviation.
|
36.7 µg/mL
Standard Deviation NA
Insufficient number of samples to calculate standard deviation.
|
17.6 µg/mL
Standard Deviation 9.28
|
|
Serum Trough Concentrations of Tezepelumab After Switching to 420 mg Q2W Administration After Week 16
Week 70
|
5.07 µg/mL
Standard Deviation 5.10
|
4.47 µg/mL
Standard Deviation 3.39
|
2.60 µg/mL
Standard Deviation 1.72
|
3.49 µg/mL
Standard Deviation 2.42
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Tezepelumab 210 mg Q4W
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Tezepelumab 280 mg Q2W
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Tezepelumab 420 mg Q2W
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo - Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Tezepelumab 210 mg Q4W - 210 mg Q4W
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Tezepelumab 280 mg Q2W - 280 mg Q2W
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Tezepelumab 420 mg Q2W - 420 mg Q2W
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo- Tezepelumab 420 mg Q2W
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Tezepelumab 210 mg Q4W-420 mg Q2W
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Tezepelumab 280 mg Q2W-420 mg Q2W
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Tezepelumab 420 mg Q2W-420 mg Q2W
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=63 participants at risk
Participants who took placebo from Week 1 to Week 16.
|
Tezepelumab 210 mg Q4W
n=59 participants at risk
Participants who took 210 mg Q4W from Week 1 to Week 16.
|
Tezepelumab 280 mg Q2W
n=58 participants at risk
Participants who took 280 mg Q2W from Week 1 to Week 16.
|
Tezepelumab 420 mg Q2W
n=70 participants at risk
Participants who took 420 mg Q2W from Week 1 to Week 16.
Includes 7 subjects randomized to the lower doses of Tezepelumab but received only the first dose of Tezepelumab 420 mg SC and early discontinued.
|
Placebo - Placebo
n=12 participants at risk
Non-switching participants who took placebo from Week 16 to Week 52.
|
Tezepelumab 210 mg Q4W - 210 mg Q4W
n=25 participants at risk
Non-switching participants who took 210 mg Q4W from Week 16 to Week 52.
|
Tezepelumab 280 mg Q2W - 280 mg Q2W
n=20 participants at risk
Non-switching participants who took 280 mg Q2W from Week 16 to Week 52.
|
Tezepelumab 420 mg Q2W - 420 mg Q2W
n=22 participants at risk
Non-switching participants who continued to take 420 mg Q2W from Week 16 to Week 52.
Includes 6 participants who were randomized to placebo (n=2), 210 mg Q4W (n=3) and 280 mg Q2W (n=1) but switched to Tezepelumab 420 mg SC Q2W in error after Week 16.
|
Placebo- Tezepelumab 420 mg Q2W
n=39 participants at risk
Participants who switched after Week 16 to take 420 mg Q2W.
|
Tezepelumab 210 mg Q4W-420 mg Q2W
n=24 participants at risk
Participants who switched after Week 16 to take 420 mg Q2W.
|
Tezepelumab 280 mg Q2W-420 mg Q2W
n=30 participants at risk
Participants who switched after Week 16 to take 420 mg Q2W.
|
Tezepelumab 420 mg Q2W-420 mg Q2W
n=38 participants at risk
Participants who switched after week 16 who continued to take 420 mg Q2W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Eye disorders
Corneal degeneration
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
3.3%
1/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Product Issues
Device failure
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.3%
2/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Skin and subcutaneous tissue disorders
Dermatitis herpetiformis
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Vascular disorders
Hypertension
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.4%
1/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
Other adverse events
| Measure |
Placebo
n=63 participants at risk
Participants who took placebo from Week 1 to Week 16.
|
Tezepelumab 210 mg Q4W
n=59 participants at risk
Participants who took 210 mg Q4W from Week 1 to Week 16.
|
Tezepelumab 280 mg Q2W
n=58 participants at risk
Participants who took 280 mg Q2W from Week 1 to Week 16.
|
Tezepelumab 420 mg Q2W
n=70 participants at risk
Participants who took 420 mg Q2W from Week 1 to Week 16.
Includes 7 subjects randomized to the lower doses of Tezepelumab but received only the first dose of Tezepelumab 420 mg SC and early discontinued.
|
Placebo - Placebo
n=12 participants at risk
Non-switching participants who took placebo from Week 16 to Week 52.
|
Tezepelumab 210 mg Q4W - 210 mg Q4W
n=25 participants at risk
Non-switching participants who took 210 mg Q4W from Week 16 to Week 52.
|
Tezepelumab 280 mg Q2W - 280 mg Q2W
n=20 participants at risk
Non-switching participants who took 280 mg Q2W from Week 16 to Week 52.
|
Tezepelumab 420 mg Q2W - 420 mg Q2W
n=22 participants at risk
Non-switching participants who continued to take 420 mg Q2W from Week 16 to Week 52.
Includes 6 participants who were randomized to placebo (n=2), 210 mg Q4W (n=3) and 280 mg Q2W (n=1) but switched to Tezepelumab 420 mg SC Q2W in error after Week 16.
|
Placebo- Tezepelumab 420 mg Q2W
n=39 participants at risk
Participants who switched after Week 16 to take 420 mg Q2W.
|
Tezepelumab 210 mg Q4W-420 mg Q2W
n=24 participants at risk
Participants who switched after Week 16 to take 420 mg Q2W.
|
Tezepelumab 280 mg Q2W-420 mg Q2W
n=30 participants at risk
Participants who switched after Week 16 to take 420 mg Q2W.
|
Tezepelumab 420 mg Q2W-420 mg Q2W
n=38 participants at risk
Participants who switched after week 16 who continued to take 420 mg Q2W.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Eye disorders
Chalazion
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.3%
2/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.1%
2/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.4%
1/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.3%
2/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.3%
3/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.3%
2/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.2%
1/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
3.4%
2/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.9%
2/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
3.3%
1/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.3%
2/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
General disorders
Application site pain
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
General disorders
Condition aggravated
|
1.6%
1/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
8.3%
1/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
General disorders
Injection site reaction
|
3.2%
2/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.0%
1/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.1%
2/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
3.3%
1/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
General disorders
Oedema peripheral
|
1.6%
1/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.4%
1/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
General disorders
Temperature intolerance
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Immune system disorders
Food allergy
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.0%
1/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
8.0%
2/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
8.3%
1/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.1%
2/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.2%
1/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
3.4%
2/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.9%
2/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
8.3%
2/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.3%
2/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Eczema herpeticum
|
3.2%
2/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
8.3%
1/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
3.3%
1/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Erysipelas
|
1.6%
1/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.4%
1/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.1%
2/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.2%
1/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
3.3%
1/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.9%
2/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
7.9%
3/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.3%
3/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
3.3%
1/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
7.9%
3/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
3.4%
2/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.0%
1/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.3%
2/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Nasopharyngitis
|
9.5%
6/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
8.5%
5/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
17.2%
10/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
8.6%
6/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
12.0%
3/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
15.0%
3/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
13.6%
3/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
7.7%
3/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
10.0%
3/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
7.9%
3/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.4%
1/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
3.3%
1/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Otitis media
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
8.3%
2/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Pharyngitis
|
4.8%
3/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.9%
2/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.0%
1/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.1%
2/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.2%
1/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Pyoderma
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
8.3%
1/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.4%
1/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
8.3%
1/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.4%
1/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
8.3%
1/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
8.0%
2/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.5%
1/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Skin infection
|
1.6%
1/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.0%
1/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.3%
4/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.1%
3/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
3.4%
2/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.4%
1/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.0%
1/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
10.0%
2/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.1%
2/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.2%
1/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
3.4%
2/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.4%
1/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
9.1%
2/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.2%
1/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.4%
1/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.0%
1/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
8.3%
2/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
3.3%
1/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.9%
2/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.2%
1/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.3%
2/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Investigations
Blood pressure increased
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
8.0%
2/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Investigations
SARS-CoV-2 antibody test positive
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.3%
2/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
1/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.5%
1/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
3.3%
1/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.3%
2/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
1/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.0%
1/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.5%
1/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
3.2%
2/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
8.3%
1/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.2%
1/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.4%
1/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.3%
2/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.9%
2/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.3%
2/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Nervous system disorders
Headache
|
4.8%
3/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.7%
4/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
10.3%
4/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.2%
1/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.3%
2/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Psychiatric disorders
Insomnia
|
1.6%
1/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.4%
1/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.3%
2/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.6%
1/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.4%
1/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
8.3%
1/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.0%
1/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.2%
1/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
6.7%
2/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.5%
1/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
3.3%
1/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.3%
2/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.5%
1/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
8.3%
2/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.6%
1/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.3%
2/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
19.0%
12/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
15.3%
9/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
22.4%
13/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
18.6%
13/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
16.7%
2/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
20.0%
5/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
10.0%
2/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
13.6%
3/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
23.1%
9/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
8.3%
2/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
13.3%
4/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
15.8%
6/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
3.4%
2/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.4%
1/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.0%
1/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.2%
1/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
7.9%
3/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
8.3%
1/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
2/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.2%
3/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Skin and subcutaneous tissue disorders
Skin striae
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Vascular disorders
Hypertension
|
1.6%
1/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.2%
3/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.9%
2/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
4.2%
1/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
2.6%
1/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Vascular disorders
Hypotension
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/63 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/59 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
1.7%
1/58 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/70 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/12 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/25 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
5.0%
1/20 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/22 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/39 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/24 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/30 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
0.00%
0/38 • Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12
Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER