Trial Outcomes & Findings for Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1) (NCT NCT03131648)
NCT ID: NCT03131648
Last Updated: 2025-03-11
Results Overview
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
802 participants
Primary outcome timeframe
At Week 16
Results posted on
2025-03-11
Participant Flow
The screening period was 2 to 6 weeks and included 1 or 2 visits. The exact duration depended on the wash-out period defined by the exclusion criteria. If no wash-out or only a 2-week wash-out was required, screening Visits 1 and 2 were combined. Eligibility was assessed at the (first) screening visit and on Day 0 prior to randomisation.
Participant milestones
| Measure |
Initial Treatment Period - Tralokinumab 300 mg Q2W
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for SC administration
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Initial Treatment Period - Placebo Q2W
Week 0 to Week 16:
Placebo Q2W
Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Maintenance Treatment Period - Tralokinumab 300 mg Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomised to tralokinumab re-randomised to tralokinumab 300 mg Q2W maintenance dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg tralokinumab.
|
Maintenance Treatment Period - Tralokinumab 300 mg Q4W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomised to tralokinumab re-randomised to tralokinumab 300 mg Q4W maintenance dosing regimen.
At each visit, subject received alternating dose administrations: 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab and 2 SC injections (each 1.0 mL) of placebo.
|
Maintenance Treatment Period - Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomised to tralokinumab re-randomised to placebo Q2W dosing regimen.
At each visit, each subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
Maintenance Treatment Period- Placebo Q2W - Tralokinumab Naive
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to placebo re-assigned to placebo Q2W.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS
Week 16 to Week 52:
Subjects receiving initial treatment with tralokinumab/placebo Q2W who did not achieve protocol-defined clinical response assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 300 mg Q2W/Q4W or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if
* IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16 OR
* IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16 OR
* Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16
At each visit, subjects received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
|
Open-label Treatment - Tralokinumab 300 mg Q2W + Optional TCS
Week 52 to Week 66 \[Short term extension (Japan only)\]:
Japanese subjects who did not achieve protocol-defined clinical response assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) continued an additional 16 weeks (Week 52 to Week 66) of open-label treatment to receive 52 weeks of active therapy.
At each visit, subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
|
|---|---|---|---|---|---|---|---|---|
|
Initial Treatment Period
STARTED
|
603
|
199
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period
COMPLETED
|
550
|
179
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period
NOT COMPLETED
|
53
|
20
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-label Treatment
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
564
|
0
|
|
Open-label Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
446
|
0
|
|
Open-label Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
118
|
0
|
|
Maintenance Treatment Period
STARTED
|
0
|
0
|
71
|
78
|
36
|
29
|
0
|
0
|
|
Maintenance Treatment Period
COMPLETED
|
0
|
0
|
44
|
53
|
21
|
15
|
0
|
0
|
|
Maintenance Treatment Period
NOT COMPLETED
|
0
|
0
|
27
|
25
|
15
|
14
|
0
|
0
|
|
Open-label (Short Term Extension)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
65
|
|
Open-label (Short Term Extension)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
62
|
|
Open-label (Short Term Extension)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Initial Treatment Period - Tralokinumab 300 mg Q2W
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for SC administration
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Initial Treatment Period - Placebo Q2W
Week 0 to Week 16:
Placebo Q2W
Placebo: Placebo contains the same excipients, in the same concentration, only lacking tralokinumab.
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Maintenance Treatment Period - Tralokinumab 300 mg Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomised to tralokinumab re-randomised to tralokinumab 300 mg Q2W maintenance dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg tralokinumab.
|
Maintenance Treatment Period - Tralokinumab 300 mg Q4W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomised to tralokinumab re-randomised to tralokinumab 300 mg Q4W maintenance dosing regimen.
At each visit, subject received alternating dose administrations: 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab and 2 SC injections (each 1.0 mL) of placebo.
|
Maintenance Treatment Period - Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomised to tralokinumab re-randomised to placebo Q2W dosing regimen.
At each visit, each subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
Maintenance Treatment Period- Placebo Q2W - Tralokinumab Naive
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to placebo re-assigned to placebo Q2W.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
Open-label Treatment -Tralokinumab 300 mg Q2W + Optional TCS
Week 16 to Week 52:
Subjects receiving initial treatment with tralokinumab/placebo Q2W who did not achieve protocol-defined clinical response assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 300 mg Q2W/Q4W or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if
* IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16 OR
* IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16 OR
* Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16
At each visit, subjects received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
|
Open-label Treatment - Tralokinumab 300 mg Q2W + Optional TCS
Week 52 to Week 66 \[Short term extension (Japan only)\]:
Japanese subjects who did not achieve protocol-defined clinical response assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) continued an additional 16 weeks (Week 52 to Week 66) of open-label treatment to receive 52 weeks of active therapy.
At each visit, subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
|
|---|---|---|---|---|---|---|---|---|
|
Initial Treatment Period
Not dosed
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initial Treatment Period
Discontinued IMP before Week 16
|
51
|
18
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-label Treatment
Discontinued IMP
|
0
|
0
|
0
|
0
|
0
|
0
|
112
|
0
|
|
Open-label Treatment
Completed Week 50
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
|
Maintenance Treatment Period
Not dosed
|
0
|
0
|
3
|
2
|
1
|
0
|
0
|
0
|
|
Maintenance Treatment Period
Discontinued IMP
|
0
|
0
|
3
|
5
|
4
|
4
|
0
|
0
|
|
Maintenance Treatment Period
Transfer to open-label treatment
|
0
|
0
|
21
|
18
|
9
|
10
|
0
|
0
|
|
Maintenance Treatment Period
Completed Week 50
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Open-label (Short Term Extension)
Discontinued IMP
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Number of subjects analysed = subjects with available data for the baseline parameter.
Baseline characteristics by cohort
| Measure |
Initial Treatment Period - Tralokinumab 300 mg Q2W
n=603 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Initial Treatment Period - Placebo Q2W
n=199 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Total
n=802 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
351 Participants
n=603 Participants
|
123 Participants
n=199 Participants
|
474 Participants
n=802 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
53 Participants
n=603 Participants
|
17 Participants
n=199 Participants
|
70 Participants
n=802 Participants
|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 13.7 • n=603 Participants
|
39.4 years
STANDARD_DEVIATION 15.2 • n=199 Participants
|
38.8 years
STANDARD_DEVIATION 14.1 • n=802 Participants
|
|
Age, Customized
18-64 years
|
574 Participants
n=603 Participants
|
185 Participants
n=199 Participants
|
759 Participants
n=802 Participants
|
|
Age, Customized
65-84 years
|
28 Participants
n=603 Participants
|
14 Participants
n=199 Participants
|
42 Participants
n=802 Participants
|
|
Age, Customized
>=85 years
|
1 Participants
n=603 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=802 Participants
|
|
Sex: Female, Male
Female
|
252 Participants
n=603 Participants
|
76 Participants
n=199 Participants
|
328 Participants
n=802 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
548 Participants
n=603 Participants
|
179 Participants
n=199 Participants
|
727 Participants
n=802 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=603 Participants
|
3 Participants
n=199 Participants
|
5 Participants
n=802 Participants
|
|
Race/Ethnicity, Customized
White
|
426 Participants
n=603 Participants
|
138 Participants
n=199 Participants
|
564 Participants
n=802 Participants
|
|
Race/Ethnicity, Customized
Black or african american
|
41 Participants
n=603 Participants
|
18 Participants
n=199 Participants
|
59 Participants
n=802 Participants
|
|
Race/Ethnicity, Customized
Asian
|
120 Participants
n=603 Participants
|
40 Participants
n=199 Participants
|
160 Participants
n=802 Participants
|
|
Race/Ethnicity, Customized
American indian or alaska native
|
1 Participants
n=603 Participants
|
0 Participants
n=199 Participants
|
1 Participants
n=802 Participants
|
|
Race/Ethnicity, Customized
Native hawaiian or other pacific islander
|
5 Participants
n=603 Participants
|
0 Participants
n=199 Participants
|
5 Participants
n=802 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=603 Participants
|
0 Participants
n=199 Participants
|
8 Participants
n=802 Participants
|
|
Race/Ethnicity, Customized
Missing
|
2 Participants
n=603 Participants
|
3 Participants
n=199 Participants
|
5 Participants
n=802 Participants
|
|
Region of Enrollment
United States
|
149 participants
n=603 Participants
|
49 participants
n=199 Participants
|
198 participants
n=802 Participants
|
|
Region of Enrollment
Japan
|
96 participants
n=603 Participants
|
31 participants
n=199 Participants
|
127 participants
n=802 Participants
|
|
Region of Enrollment
France
|
85 participants
n=603 Participants
|
23 participants
n=199 Participants
|
108 participants
n=802 Participants
|
|
Region of Enrollment
Germany
|
200 participants
n=603 Participants
|
73 participants
n=199 Participants
|
273 participants
n=802 Participants
|
|
Region of Enrollment
Spain
|
73 participants
n=603 Participants
|
23 participants
n=199 Participants
|
96 participants
n=802 Participants
|
|
Investigator's Global Assessment
Clear
|
0 Participants
n=603 Participants
|
0 Participants
n=199 Participants
|
0 Participants
n=802 Participants
|
|
Investigator's Global Assessment
Almost clear
|
0 Participants
n=603 Participants
|
0 Participants
n=199 Participants
|
0 Participants
n=802 Participants
|
|
Investigator's Global Assessment
Mild
|
0 Participants
n=603 Participants
|
0 Participants
n=199 Participants
|
0 Participants
n=802 Participants
|
|
Investigator's Global Assessment
Moderate
|
296 Participants
n=603 Participants
|
95 Participants
n=199 Participants
|
391 Participants
n=802 Participants
|
|
Investigator's Global Assessment
Severe
|
305 Participants
n=603 Participants
|
102 Participants
n=199 Participants
|
407 Participants
n=802 Participants
|
|
Investigator's Global Assessment
Missing
|
2 Participants
n=603 Participants
|
2 Participants
n=199 Participants
|
4 Participants
n=802 Participants
|
|
Eczema Area and Severity Index
|
32.2 units on a scale
STANDARD_DEVIATION 13.7 • n=601 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
32.9 units on a scale
STANDARD_DEVIATION 13.9 • n=197 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
32.4 units on a scale
STANDARD_DEVIATION 13.8 • n=798 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
|
Scoring Atopic Dermatitis
|
70.3 units on a scale
STANDARD_DEVIATION 13.0 • n=601 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
71.7 units on a scale
STANDARD_DEVIATION 12.5 • n=197 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
70.6 units on a scale
STANDARD_DEVIATION 12.9 • n=798 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
|
Dermatology Life Quality Index
|
16.8 units on a scale
STANDARD_DEVIATION 7.1 • n=591 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
17.0 units on a scale
STANDARD_DEVIATION 6.6 • n=194 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
16.9 units on a scale
STANDARD_DEVIATION 7.0 • n=785 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
|
Worst Daily Pruritus NRS (weekly average)
|
7.7 units on a scale
STANDARD_DEVIATION 1.4 • n=598 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
7.7 units on a scale
STANDARD_DEVIATION 1.4 • n=195 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
7.7 units on a scale
STANDARD_DEVIATION 1.4 • n=793 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
|
Body surface area affected by atopic dermatitis (AD)
|
52.7 percentage affected
STANDARD_DEVIATION 24.1 • n=603 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
54.2 percentage affected
STANDARD_DEVIATION 25.6 • n=198 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
53.1 percentage affected
STANDARD_DEVIATION 24.5 • n=801 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
|
Age of onset of atopic dermatitis (AD)
|
3.0 years
n=603 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
3.0 years
n=198 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
3.0 years
n=801 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
|
Duration of atopic dermatitis (AD)
|
27.9 years
STANDARD_DEVIATION 14.5 • n=603 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
29.6 years
STANDARD_DEVIATION 15.1 • n=198 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
28.3 years
STANDARD_DEVIATION 14.7 • n=801 Participants • Number of subjects analysed = subjects with available data for the baseline parameter.
|
PRIMARY outcome
Timeframe: At Week 16Population: The full analysis set (FAS: all subjects randomised to initial treatment who were exposed to IMP) was used for the primary analysis; 802 subjects were randomised to initial treatment and 798 received IMP, thus the FAS comprised of 798 subjects.
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=601 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Placebo Q2W
n=197 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
|
95 Participants
|
14 Participants
|
—
|
PRIMARY outcome
Timeframe: At Week 16Population: Full analysis set
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=601 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Placebo Q2W
n=197 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Subjects Achieving at Least 75% Reduction in Eczema Area and Severity Index [EASI] at Week 16
|
150 Participants
|
25 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: Full analysis set (FAS). Number of subjects analysed = subjects with baseline pruritus NRS weekly average ≥4.
Subjects will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=594 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Placebo Q2W
n=194 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Reduction of Worst Daily Pruritus Numeric Rating Scale (Weekly Average) of at Least 4 From Baseline to Week 16.
|
119 Participants
|
20 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: Full analysis set
The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with higher values indicating a more extensive and/or severe condition.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=601 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Placebo Q2W
n=197 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16
|
-25.2 units on a scale
Standard Error 0.94
|
-14.7 units on a scale
Standard Error 1.80
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: Full analysis set.
The Dermatology Life Quality Index (DLQI) is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life (QoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4 point Likert scale (0 = not at all ⁄not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor QoL.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=601 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Placebo Q2W
n=197 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16
|
-7.1 units on a scale
Standard Error 0.31
|
-5.0 units on a scale
Standard Error 0.59
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: Maintenance analysis set - Subjects who achieved IGA 0/1 at Week 16 after initial treatment with tralokinumab without use of rescue medication. Subjects who were treated with placebo during initial treatment period (tralokinumab naïve arm) and who continued to the maintenance period were not part of the analysis of maintenance endpoints and therefore this arm is not included for outcome measures.
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=39 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Placebo Q2W
n=36 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Placebo Q2W
n=19 Participants
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA of 0/1 at Week 16
|
20 Participants
|
14 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: At Week 52Population: Maintenance analysis set: Subjects who achieved EASI75 at Week 16 after inital treatment with tralokinumab without use of rescue medication. Subjects who were treated with placebo during initial treatment period (tralokinumab naïve arm) and who continued to the maintenance period were not part of the analysis of maintenance endpoints and therefore this arm is not included for outcome measures.
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=47 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Placebo Q2W
n=57 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Placebo Q2W
n=30 Participants
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Subjects With at Least 75% Reduction in Eczema Area and Severity Index [EASI] at Week 52 Among Subjects With EASI75 at Week 16
|
28 Participants
|
28 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: The analysis was performed on the safety analysis set. The safety analysis set comprised of participants who received at least 1 dose of IMP during the trial.
Overall summary of AEs and SAEs during the Initial treatment period is presented. For list of AEs and SAEs by MedDRA system organ class (SOC) and preferred term (PT) during the entire trial period (including safety follow-up), see Adverse Events Overview section.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=602 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Placebo Q2W
n=196 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Safety and Tolerability: Adverse Event (AE) /Serious Adverse Event (SAE) Frequency
AEs
|
411 Participants
|
133 Participants
|
—
|
|
Safety and Tolerability: Adverse Event (AE) /Serious Adverse Event (SAE) Frequency
SAEs
|
23 Participants
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: All subjects in the safety analysis set are included
Anti-tralokinumab antibody levels were analysed using a validated bioanalytical method.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=602 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Placebo Q2W
n=196 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Frequency of Anti-drug Antibodies
Treatment emergent
|
10 Participants
|
1 Participants
|
—
|
|
Frequency of Anti-drug Antibodies
Perishing
|
5 Participants
|
3 Participants
|
—
|
|
Frequency of Anti-drug Antibodies
Negative
|
564 Participants
|
177 Participants
|
—
|
|
Frequency of Anti-drug Antibodies
No post-baseline anti-drug antibody assessment
|
23 Participants
|
13 Participants
|
—
|
|
Frequency of Anti-drug Antibodies
Treatment-boosted
|
0 Participants
|
0 Participants
|
—
|
|
Frequency of Anti-drug Antibodies
Total positive
|
10 Participants
|
3 Participants
|
—
|
|
Frequency of Anti-drug Antibodies
Pre-existing
|
0 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: At Week 16Population: Full analysis set
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=601 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Placebo Q2W
n=197 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Subjects Achieving at Least 50% Reduction in Eczema Area and Severity Index [EASI] at Week 16
|
250 Participants
|
42 Participants
|
—
|
SECONDARY outcome
Timeframe: At Week 16Population: Full analysis set
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=601 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Placebo Q2W
n=197 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Subjects Achieving at Least 90% Reduction in Eczema Area and Severity Index [EASI] at Week 16
|
87 Participants
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: Full analysis set
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=601 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Placebo Q2W
n=197 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Change From Baseline to Week 16 in Eczema Area and Severity Index [EASI] Score
|
-15.5 units on a scale
Interval -16.6 to -14.4
|
-9.0 units on a scale
Interval -11.1 to -7.0
|
—
|
SECONDARY outcome
Timeframe: At Week 16Population: Full analysis set
The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with a higher values indicating a more extensive and/or severe condition.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=601 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Placebo Q2W
n=197 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Subjects Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16
|
53 Participants
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: At Week 16Population: Full analysis set
The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with higher values indicating a more extensive and/or severe condition.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=601 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Placebo Q2W
n=197 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Subjects Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16
|
156 Participants
|
23 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: Full analysis set
Subjects will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=598 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Placebo Q2W
n=195 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Change From Baseline to Week 16 in Worst Daily Pruritus NRS (Weekly Average)
|
-2.6 units on a scale
Interval -2.8 to -2.4
|
-1.7 units on a scale
Interval -2.1 to -1.3
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: Full analysis set. Number of subjects analysed = subjects with baseline Pruritus NRS weekly average of at least 3
Subjects will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=597 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Placebo Q2W
n=195 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Reduction of Worst Daily Pruritus NRS (Weekly Average) ≥3 From Baseline to Week 16
|
177 Participants
|
28 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: Full analysis set. Number of subjects analysed = subjects with baseline DLQI ≥4.
The DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their QoL over the last week such as dermatology related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4 point Likert scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor QoL.
Outcome measures
| Measure |
Tralokinumab 300 mg Q2W
n=578 Participants
Week 0 to Week 16:
Tralokinumab 300 mg Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Placebo Q2W
n=190 Participants
Week 0 to Week 16:
Placebo Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Placebo Q2W
Week 16 to Week 52:
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
|---|---|---|---|
|
Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of ≥4 Points Among Subjects With Baseline DLQI ≥4
|
258 Participants
|
60 Participants
|
—
|
Adverse Events
Initial Period - Tralokinumab Q2W
Serious events: 23 serious events
Other events: 351 other events
Deaths: 0 deaths
Initial Period - Placebo
Serious events: 8 serious events
Other events: 114 other events
Deaths: 0 deaths
Maintenance Period - Tralokinumab Q2W
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Maintenance Period - Tralokinumab Q4W
Serious events: 3 serious events
Other events: 39 other events
Deaths: 0 deaths
Maintenance Period - Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Maintenance Period - Placebo - Tralokinumab Naive
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Open-label Period - Tralokinumab Q2W + Optional TCS
Serious events: 27 serious events
Other events: 304 other events
Deaths: 0 deaths
Safety Follow-up
Serious events: 16 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Initial Period - Tralokinumab Q2W
n=602 participants at risk
Initial Period - Tralokinumab Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Initial Period - Placebo
n=196 participants at risk
Initial Period - Placebo
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Maintenance Period - Tralokinumab Q2W
n=68 participants at risk
Maintenance Period - Tralokinumab Q2W
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to tralokinumab 300 mg Q2W maintenance dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg tralokinumab.
|
Maintenance Period - Tralokinumab Q4W
n=76 participants at risk
Maintenance Period - Tralokinumab Q4W
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to tralokinumab 300 mg Q4W maintenance dosing regimen.
At each visit, subject received alternating dose administrations: 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab and 2 SC injections (each 1.0 mL) of placebo.
|
Maintenance Period - Placebo
n=35 participants at risk
Maintenance Period - Placebo
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
Maintenance Period - Placebo - Tralokinumab Naive
n=29 participants at risk
Maintenance Period - Placebo - Tralokinumab Naive
Subjects achieving a clinical response at Week 16 and initially randomized to placebo re-assigned to placebo Q2W.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
Open-label Period - Tralokinumab Q2W + Optional TCS
n=563 participants at risk
Open-label Period - Tralokinumab Q2W + Optional TCS
Subjects receiving initial treatment with tralokinumab/placebo Q2W who did not achieve protocol-defined clinical response assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 300 mg Q2W/Q4W or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16 OR IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16 OR Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16 At each visit, subjects received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
|
Safety Follow-up
n=595 participants at risk
Subjects who spent any amount of time in the safety follow-up period, independently of the treatment(s) received before. No treatment was administered to the subjects during the safety follow-up period. Eligible participants who completed treatment could transfer to an open-label long-term extension trial (conducted under a separate protocol) at any any time during the safety follow-up period.
|
|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.17%
1/595 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Renal and urinary disorders
Stag horn calculus
|
0.17%
1/602 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.17%
1/602 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Cardiac disorders
Accessory cardiac pathway
|
0.17%
1/602 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Cardiac disorders
Acute left ventricular failure
|
0.17%
1/602 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.53%
3/563 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.17%
1/595 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Cardiac disorders
Atrial fibrillation
|
0.17%
1/602 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.17%
1/595 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Eye disorders
Lens dislocation
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.17%
1/602 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
General disorders
Granuloma
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
General disorders
Injection site reaction
|
0.17%
1/602 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
General disorders
Strangulated hernia
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.17%
1/595 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.17%
1/595 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Infections and infestations
Bronchitis
|
0.17%
1/602 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.51%
1/196 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Infections and infestations
Cellulitis
|
0.17%
1/602 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.36%
2/563 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Infections and infestations
Cystitis
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
1.5%
1/68 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Infections and infestations
Endocarditis
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.17%
1/595 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Infections and infestations
Erysipelas
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.51%
1/196 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Infections and infestations
Furuncle
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Infections and infestations
Keratitis bacterial
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.17%
1/595 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Infections and infestations
Keratitis viral
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.17%
1/595 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Infections and infestations
Leishmaniasis
|
0.17%
1/602 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
1.3%
1/76 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.17%
1/602 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.17%
1/602 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.17%
1/595 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.17%
1/602 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Investigations
Troponin increased
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.17%
1/595 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
1.3%
1/76 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.51%
1/196 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.51%
1/196 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.51%
1/196 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.36%
2/563 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Nervous system disorders
Ataxia
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.17%
1/595 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.17%
1/602 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Nervous system disorders
Syncope
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.17%
1/602 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.51%
1/196 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
1.3%
1/76 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
3.4%
1/29 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.17%
1/595 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.51%
1/196 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.17%
1/602 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
1.3%
1/76 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.66%
4/602 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.51%
1/196 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.36%
2/563 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.50%
3/595 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
0.33%
2/602 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.51%
1/196 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.34%
2/595 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.17%
1/602 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.17%
1/595 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.51%
1/196 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.51%
1/196 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Vascular disorders
Peripheral artery stenosis
|
0.17%
1/602 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/563 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/602 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
Other adverse events
| Measure |
Initial Period - Tralokinumab Q2W
n=602 participants at risk
Initial Period - Tralokinumab Q2W
At Day 0, each subject received 4 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total loading dose of 600 mg tralokinumab (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab.
|
Initial Period - Placebo
n=196 participants at risk
Initial Period - Placebo
At Day 0, each subject received 4 SC injections (each 1.0 mL) of placebo to receive a total loading dose (4.0 mL). At subsequent visits (Q2W) each subject received 2 SC injections (each 1.0 mL) of placebo.
|
Maintenance Period - Tralokinumab Q2W
n=68 participants at risk
Maintenance Period - Tralokinumab Q2W
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to tralokinumab 300 mg Q2W maintenance dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg tralokinumab.
|
Maintenance Period - Tralokinumab Q4W
n=76 participants at risk
Maintenance Period - Tralokinumab Q4W
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to tralokinumab 300 mg Q4W maintenance dosing regimen.
At each visit, subject received alternating dose administrations: 2 SC injections (each 1.0 mL) of 150 mg tralokinumab to receive a total dose of 300 mg tralokinumab and 2 SC injections (each 1.0 mL) of placebo.
|
Maintenance Period - Placebo
n=35 participants at risk
Maintenance Period - Placebo
Subjects achieving a clinical response at Week 16 and initially randomized to tralokinumab re-randomized to placebo Q2W dosing regimen.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
Maintenance Period - Placebo - Tralokinumab Naive
n=29 participants at risk
Maintenance Period - Placebo - Tralokinumab Naive
Subjects achieving a clinical response at Week 16 and initially randomized to placebo re-assigned to placebo Q2W.
At each visit, subject received 2 SC injections (each 1.0 mL) of placebo Q2W to receive a total dose of placebo.
|
Open-label Period - Tralokinumab Q2W + Optional TCS
n=563 participants at risk
Open-label Period - Tralokinumab Q2W + Optional TCS
Subjects receiving initial treatment with tralokinumab/placebo Q2W who did not achieve protocol-defined clinical response assigned to open-label treatment at Week 16 with tralokinumab 300 mg Q2W regimen + optional topical corticosteroids (TCS) OR Subjects receiving maintenance treatment with tralokinumab 300 mg Q2W/Q4W or placebo Q2W assigned to open-label treatment after Week 16 with tralokinumab 300 mg Q2W regimen + optional TCS if IGA of at least 2 and not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA=0 at Week 16 OR IGA of at least 3 and not achieving EASI75 over at least a 4-week period (i.e. over 3 consecutive visits) for subjects with IGA=1 at Week 16 OR Not achieving EASI75 over at least a 4-week period (over 3 consecutive visits) for subjects with IGA\>1 at Week 16 At each visit, subjects received 2 SC injections (each 1.0 mL) of 150 mg tralokinumab Q2W to receive a total dose of 300 mg.
|
Safety Follow-up
n=595 participants at risk
Subjects who spent any amount of time in the safety follow-up period, independently of the treatment(s) received before. No treatment was administered to the subjects during the safety follow-up period. Eligible participants who completed treatment could transfer to an open-label long-term extension trial (conducted under a separate protocol) at any any time during the safety follow-up period.
|
|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Conjunctivitis allergic
|
2.7%
16/602 • Number of events 16 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
1.5%
3/196 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
4.4%
3/68 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
1.3%
1/76 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
5.7%
2/35 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
2.3%
13/563 • Number of events 14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.34%
2/595 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
General disorders
Injection site reaction
|
4.0%
24/602 • Number of events 47 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
7.4%
5/68 • Number of events 13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
9.2%
7/76 • Number of events 21 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
2.9%
1/35 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
5.0%
28/563 • Number of events 60 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Infections and infestations
Bronchitis
|
1.8%
11/602 • Number of events 12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
2.0%
4/196 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
4.4%
3/68 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
9.2%
7/76 • Number of events 8 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
5.7%
2/35 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
3.4%
1/29 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
2.5%
14/563 • Number of events 15 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.17%
1/595 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Infections and infestations
Conjunctivitis
|
7.1%
43/602 • Number of events 50 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
2.0%
4/196 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
4.4%
3/68 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
5.3%
4/76 • Number of events 6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
7.3%
41/563 • Number of events 52 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.67%
4/595 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Infections and infestations
Influenza
|
3.0%
18/602 • Number of events 18 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
2.6%
5/196 • Number of events 5 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
5.9%
4/68 • Number of events 5 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
3.9%
3/76 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
2.9%
1/35 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
1.2%
7/563 • Number of events 7 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.34%
2/595 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
15/602 • Number of events 16 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
1.0%
2/196 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
3.9%
3/76 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
5.7%
2/35 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.89%
5/563 • Number of events 5 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.17%
1/595 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
23.1%
139/602 • Number of events 172 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
20.9%
41/196 • Number of events 54 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
20.6%
14/68 • Number of events 17 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
23.7%
18/76 • Number of events 26 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
11.4%
4/35 • Number of events 5 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
6.9%
2/29 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
25.4%
143/563 • Number of events 201 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
2.0%
12/595 • Number of events 12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Injury, poisoning and procedural complications
Wrong patient received medication
|
1.3%
8/602 • Number of events 13 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.51%
1/196 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
6.9%
2/29 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.36%
2/563 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Investigations
Liver function test increased
|
0.66%
4/602 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
5.7%
2/35 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.18%
1/563 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.83%
5/602 • Number of events 5 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
1.0%
2/196 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
4.4%
3/68 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
5.3%
4/76 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
3.4%
1/29 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
3.2%
18/563 • Number of events 19 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.50%
3/602 • Number of events 3 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/196 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/68 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
6.9%
2/29 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
1.1%
6/563 • Number of events 6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Nervous system disorders
Headache
|
4.7%
28/602 • Number of events 50 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
5.1%
10/196 • Number of events 16 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
8.8%
6/68 • Number of events 12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
2.6%
2/76 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
8.6%
3/35 • Number of events 6 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
3.9%
22/563 • Number of events 29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.17%
1/595 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.7%
10/602 • Number of events 11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.51%
1/196 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
5.9%
4/68 • Number of events 4 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/35 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.89%
5/563 • Number of events 5 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.17%
1/595 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.7%
10/602 • Number of events 11 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.51%
1/196 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
1.5%
1/68 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/76 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
5.7%
2/35 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/29 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
1.8%
10/563 • Number of events 10 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
25.2%
152/602 • Number of events 198 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
38.3%
75/196 • Number of events 123 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
16.2%
11/68 • Number of events 14 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
18.4%
14/76 • Number of events 22 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
37.1%
13/35 • Number of events 18 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
20.7%
6/29 • Number of events 10 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
21.8%
123/563 • Number of events 201 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
1.7%
10/595 • Number of events 12 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
32/602 • Number of events 41 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
5.1%
10/196 • Number of events 15 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
2.9%
2/68 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
5.3%
4/76 • Number of events 5 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
2.9%
1/35 • Number of events 1 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
6.9%
2/29 • Number of events 2 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
3.6%
20/563 • Number of events 27 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
0.00%
0/595 • Initial Treatment Period: Week 0 to Week 16, Maintenance Treatment Period: Week 16 to Week 52, Open-label Treatment: Week 16 to Week 52; Safety Follow-up Period: Week 52 to Week 66 and Week 68 to Week 82 (for selected Japanese subjects).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee LEO Pharma seeks publication of all Phase 3 clinical trials in peer-reviewed journals within 18 months of trial completion, regardless of whether the findings are positive or negative. If there is no multi-centre publication within 18 months after the clinical trial has been completed or terminated at all trial sites, the investigator has the right to publish the results from the clinical trial generated by the investigator.
- Publication restrictions are in place
Restriction type: OTHER