Trial Outcomes & Findings for Study of Secukinumab With 2 mL Pre-filled Syringes (NCT NCT02748863)
NCT ID: NCT02748863
Last Updated: 2019-07-15
Results Overview
Number of participants who achieved ≥ 75% reduction in PASI compared to baseline PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
214 participants
Primary outcome timeframe
12 weeks
Results posted on
2019-07-15
Participant Flow
A total of 251 patients were screened and 214 patients were randomized
Participant milestones
| Measure |
Secukinumab 2 mL PFS
Secukinumab 300 mg in one 2 mL pre-filled syringe
|
Secukinumab 2 x 1 mL PFS
Secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form)
|
Placebo
Placebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe
|
Secukinumab 2 mL PFS Following Placebo
Switched from placebo to secukinumab 300 mg, provided in one 2 mL pre-filled syringe
|
Secukinumab 2 x 1 mL PFS Following Placebo
Switched from placebo to secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg
|
|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
72
|
71
|
71
|
0
|
0
|
|
Treatment Period 1
COMPLETED
|
72
|
69
|
69
|
0
|
0
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
2
|
2
|
0
|
0
|
|
Treatment Period 2
STARTED
|
72
|
69
|
0
|
34
|
34
|
|
Treatment Period 2
COMPLETED
|
67
|
66
|
0
|
32
|
33
|
|
Treatment Period 2
NOT COMPLETED
|
5
|
3
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Secukinumab 2 mL PFS
Secukinumab 300 mg in one 2 mL pre-filled syringe
|
Secukinumab 2 x 1 mL PFS
Secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form)
|
Placebo
Placebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe
|
Secukinumab 2 mL PFS Following Placebo
Switched from placebo to secukinumab 300 mg, provided in one 2 mL pre-filled syringe
|
Secukinumab 2 x 1 mL PFS Following Placebo
Switched from placebo to secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg
|
|---|---|---|---|---|---|
|
Treatment Period 1
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period 1
Lack of Efficacy
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period 1
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
|
Treatment Period 2
Lost to Follow-up
|
2
|
0
|
0
|
0
|
0
|
|
Treatment Period 2
Adverse Event
|
3
|
2
|
0
|
2
|
0
|
|
Treatment Period 2
Lack of Efficacy
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period 2
Pregnancy
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of Secukinumab With 2 mL Pre-filled Syringes
Baseline characteristics by cohort
| Measure |
Secukinumab 2 mL PFS
n=72 Participants
Secukinumab 300 mg in one 2 mL pre-filled syringe
|
Secukinumab 2 x 1 mL PFS
n=71 Participants
Secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form)
|
Placebo
n=71 Participants
Placebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe
|
Total
n=214 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<65 years
|
68 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
|
Age, Customized
>=65 years
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age, Customized
>=75 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
133 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
64 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
194 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.
Number of participants who achieved ≥ 75% reduction in PASI compared to baseline PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Outcome measures
| Measure |
Secukinumab 2 mL PFS
n=72 Participants
Secukinumab 300 mg in one 2 mL pre-filled syringe
|
Placebo
n=71 Participants
Placebo, in a 2 mL pre-filled syringe Placebo, in a 1 mL pre-filled syringe
|
Placebo
Placebo, in a 2 mL pre-filled syringe Placebo, in a 1 mL pre-filled syringe
|
Secukinumab 2 mL PFS Following Placebo
Switched from placebo to secukinumab 300 mg, provided in one 2 mL pre-filled syringe
|
Secukinumab 2 x 1 mL PFS Following Placebo
Switched from placebo to secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg
|
|---|---|---|---|---|---|
|
Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment
|
64 participants
|
1 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.
The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. Number of participants who achieved IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline
Outcome measures
| Measure |
Secukinumab 2 mL PFS
n=72 Participants
Secukinumab 300 mg in one 2 mL pre-filled syringe
|
Placebo
n=71 Participants
Placebo, in a 2 mL pre-filled syringe Placebo, in a 1 mL pre-filled syringe
|
Placebo
Placebo, in a 2 mL pre-filled syringe Placebo, in a 1 mL pre-filled syringe
|
Secukinumab 2 mL PFS Following Placebo
Switched from placebo to secukinumab 300 mg, provided in one 2 mL pre-filled syringe
|
Secukinumab 2 x 1 mL PFS Following Placebo
Switched from placebo to secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg
|
|---|---|---|---|---|---|
|
Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment
|
55 participants
|
1 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.
Number of participants who achieved ≥ 90% and 100% reduction in PASI compared to baseline
Outcome measures
| Measure |
Secukinumab 2 mL PFS
n=72 Participants
Secukinumab 300 mg in one 2 mL pre-filled syringe
|
Placebo
n=71 Participants
Placebo, in a 2 mL pre-filled syringe Placebo, in a 1 mL pre-filled syringe
|
Placebo
Placebo, in a 2 mL pre-filled syringe Placebo, in a 1 mL pre-filled syringe
|
Secukinumab 2 mL PFS Following Placebo
Switched from placebo to secukinumab 300 mg, provided in one 2 mL pre-filled syringe
|
Secukinumab 2 x 1 mL PFS Following Placebo
Switched from placebo to secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg
|
|---|---|---|---|---|---|
|
Participants With PASI 90 After 12 Weeks of Treatment
|
48 participants
|
1 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.
Participants who achieved 100% reduction in PASI compared to baseline
Outcome measures
| Measure |
Secukinumab 2 mL PFS
n=72 Participants
Secukinumab 300 mg in one 2 mL pre-filled syringe
|
Placebo
n=71 Participants
Placebo, in a 2 mL pre-filled syringe Placebo, in a 1 mL pre-filled syringe
|
Placebo
n=71 Participants
Placebo, in a 2 mL pre-filled syringe Placebo, in a 1 mL pre-filled syringe
|
Secukinumab 2 mL PFS Following Placebo
Switched from placebo to secukinumab 300 mg, provided in one 2 mL pre-filled syringe
|
Secukinumab 2 x 1 mL PFS Following Placebo
Switched from placebo to secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg
|
|---|---|---|---|---|---|
|
Number of Participants With PASI 100 Response After 12 Weeks of Treatment
|
28 participants
|
26 participants
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to week 52Population: FAS
PASI response over time up to week 52: Number of participants who achieved ≥ 50%, 75%, 90% and 100% reduction in PASI and achieve IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline
Outcome measures
| Measure |
Secukinumab 2 mL PFS
n=72 Participants
Secukinumab 300 mg in one 2 mL pre-filled syringe
|
Placebo
n=71 Participants
Placebo, in a 2 mL pre-filled syringe Placebo, in a 1 mL pre-filled syringe
|
Placebo
n=71 Participants
Placebo, in a 2 mL pre-filled syringe Placebo, in a 1 mL pre-filled syringe
|
Secukinumab 2 mL PFS Following Placebo
n=34 Participants
Switched from placebo to secukinumab 300 mg, provided in one 2 mL pre-filled syringe
|
Secukinumab 2 x 1 mL PFS Following Placebo
n=34 Participants
Switched from placebo to secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg
|
|---|---|---|---|---|---|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 2 PASI 75
|
4 participants
|
5 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 2 PASI 90
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 1 IGA 0/1
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 2 PASI 100
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 1 PASI 50
|
5 participants
|
5 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 1 PASI 75
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 1 PASI 90
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 1 PASI 100
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 2 IGA 0/1
|
2 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 2 PASI 50
|
18 participants
|
28 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 3 IGA 0/1
|
6 participants
|
11 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 3 PASI 50
|
39 participants
|
40 participants
|
5 participants
|
3 participants
|
1 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 3 PASI 75
|
14 participants
|
17 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 3 PASI 90
|
4 participants
|
4 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 3 PASI 100
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 4 IGA 0/1
|
19 participants
|
23 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 4 PASI 50
|
53 participants
|
52 participants
|
6 participants
|
5 participants
|
1 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 4 PASI 75
|
29 participants
|
32 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 4 PASI 90
|
10 participants
|
13 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 4 PASI 100
|
3 participants
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 8 IGA 0/1
|
43 participants
|
41 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 8 PASI 50
|
66 participants
|
60 participants
|
5 participants
|
3 participants
|
2 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 8 PASI 75
|
53 participants
|
51 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 8 PASI 90
|
35 participants
|
31 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 8 PASI 100
|
8 participants
|
11 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 12 IGA 0/1
|
55 participants
|
49 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 12 PASI 50
|
67 participants
|
61 participants
|
5 participants
|
2 participants
|
2 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 12 PASI 75
|
64 participants
|
58 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 12 PASI 90
|
48 participants
|
50 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 12 PASI 100
|
28 participants
|
26 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 16 IGA 0/1
|
57 participants
|
52 participants
|
0 participants
|
14 participants
|
5 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 16 PASI 50
|
69 participants
|
61 participants
|
0 participants
|
27 participants
|
20 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 16 PASI 75
|
65 participants
|
60 participants
|
0 participants
|
17 participants
|
13 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 16 PASI 90
|
56 participants
|
55 participants
|
0 participants
|
8 participants
|
4 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 16 PASI 100
|
37 participants
|
31 participants
|
0 participants
|
5 participants
|
1 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 28 IGA 0/1
|
64 participants
|
54 participants
|
0 participants
|
30 participants
|
25 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 28 PASI 50
|
71 participants
|
66 participants
|
0 participants
|
33 participants
|
30 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 28 PASI 75
|
69 participants
|
60 participants
|
0 participants
|
32 participants
|
28 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 28 PASI 90
|
62 participants
|
56 participants
|
0 participants
|
26 participants
|
21 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 28 PASI 100
|
44 participants
|
34 participants
|
0 participants
|
16 participants
|
12 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 40 IGA 0/1
|
60 participants
|
55 participants
|
0 participants
|
28 participants
|
25 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 40 PASI 50
|
69 participants
|
67 participants
|
0 participants
|
33 participants
|
33 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 40 PASI 75
|
66 participants
|
63 participants
|
0 participants
|
31 participants
|
31 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 40 PASI 90
|
58 participants
|
57 participants
|
0 participants
|
27 participants
|
24 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 40 PASI 100
|
40 participants
|
37 participants
|
0 participants
|
20 participants
|
17 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 52 IGA 0/1
|
55 participants
|
55 participants
|
0 participants
|
28 participants
|
26 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 52 PASI 50
|
67 participants
|
67 participants
|
0 participants
|
31 participants
|
32 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 52 PASI 75
|
63 participants
|
62 participants
|
0 participants
|
30 participants
|
31 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 52 PASI 90
|
54 participants
|
58 participants
|
0 participants
|
25 participants
|
26 participants
|
|
Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response
Week 52 PASI 100
|
40 participants
|
37 participants
|
0 participants
|
20 participants
|
16 participants
|
Adverse Events
Secukinumab 300 mg (2mL PFS)
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
AIN457 300 mg (2x1mL PFS)
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Any AIN457 300 mg (2mL PFS)
Serious events: 8 serious events
Other events: 60 other events
Deaths: 0 deaths
Any Secukuinumab 300 mg (2x1mL PFS)
Serious events: 5 serious events
Other events: 68 other events
Deaths: 0 deaths
Any Secukinumab 300 mg
Serious events: 13 serious events
Other events: 128 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Secukinumab 300 mg (2mL PFS)
n=72 participants at risk
Treatment period 1 secukinumab 300 mg (2mL pre-filled syringes)
|
AIN457 300 mg (2x1mL PFS)
n=71 participants at risk
Treatment period 1 Secukinumab 300 mg in one 2 mL pre-filled syringe
|
Placebo
n=71 participants at risk
Treatment period 1 Placebo
|
Any AIN457 300 mg (2mL PFS)
n=106 participants at risk
Any AIN457 300 mg (2 mL pre-filled syringes)
|
Any Secukuinumab 300 mg (2x1mL PFS)
n=105 participants at risk
Any AIN457 300 mg (2x1mL pre-filed syringes)
|
Any Secukinumab 300 mg
n=211 participants at risk
Entire Any AIN457 300 mg
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.95%
1/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.47%
1/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.94%
1/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.95%
1/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.95%
2/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.94%
1/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.47%
1/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.94%
1/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.47%
1/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.94%
1/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.47%
1/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.95%
1/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.47%
1/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.94%
1/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.47%
1/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.94%
1/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.47%
1/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.94%
1/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.47%
1/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Infections and infestations
Pharyngitis bacterial
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.95%
1/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.47%
1/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.95%
1/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.47%
1/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.94%
1/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.47%
1/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.94%
1/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.47%
1/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.94%
1/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.47%
1/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.95%
1/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.47%
1/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.95%
1/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.47%
1/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.95%
1/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.47%
1/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.94%
1/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.47%
1/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
Other adverse events
| Measure |
Secukinumab 300 mg (2mL PFS)
n=72 participants at risk
Treatment period 1 secukinumab 300 mg (2mL pre-filled syringes)
|
AIN457 300 mg (2x1mL PFS)
n=71 participants at risk
Treatment period 1 Secukinumab 300 mg in one 2 mL pre-filled syringe
|
Placebo
n=71 participants at risk
Treatment period 1 Placebo
|
Any AIN457 300 mg (2mL PFS)
n=106 participants at risk
Any AIN457 300 mg (2 mL pre-filled syringes)
|
Any Secukuinumab 300 mg (2x1mL PFS)
n=105 participants at risk
Any AIN457 300 mg (2x1mL pre-filed syringes)
|
Any Secukinumab 300 mg
n=211 participants at risk
Entire Any AIN457 300 mg
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
2/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
4.2%
3/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
5.7%
6/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
5.7%
6/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
5.7%
12/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
2/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
2/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
4/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.8%
2/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
2/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
3/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.9%
3/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
6/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Gastrointestinal disorders
Toothache
|
2.8%
2/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
2/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
3/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.95%
1/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
4/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
General disorders
Fatigue
|
2.8%
2/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
5.7%
6/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.9%
3/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
4.3%
9/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
General disorders
Injection site bruising
|
2.8%
2/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
4/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
General disorders
Injection site erythema
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
3/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
3/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
General disorders
Injection site pruritus
|
2.8%
2/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.95%
2/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
General disorders
Injection site swelling
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
2/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.95%
2/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
General disorders
Pyrexia
|
2.8%
2/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
4/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
2/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.94%
1/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
3/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Infections and infestations
Conjunctivitis
|
1.4%
1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
3/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.4%
5/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Infections and infestations
Folliculitis
|
1.4%
1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
3.8%
4/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
6/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Infections and infestations
Hordeolum
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.9%
3/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
3/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
7.6%
8/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
4.7%
10/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Infections and infestations
Nasopharyngitis
|
9.7%
7/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
11.3%
8/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
11.3%
8/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
12.3%
13/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
16.2%
17/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
14.2%
30/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Infections and infestations
Oral herpes
|
4.2%
3/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
2/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
3/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.9%
3/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
6/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
2/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
4.7%
5/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.95%
1/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
6/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Infections and infestations
Respiratory tract infection viral
|
2.8%
2/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
4.8%
5/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
3.3%
7/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Infections and infestations
Rhinitis
|
1.4%
1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
3.8%
4/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
4.8%
5/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
4.3%
9/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
2/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.94%
1/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
3/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
2/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
4/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
2/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
4.7%
5/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
4.8%
5/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
4.7%
10/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
2/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.95%
2/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.4%
1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
2/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.94%
1/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.9%
3/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
4/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
3/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
3/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
2/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
4/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
2/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.94%
1/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.95%
1/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.95%
2/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Investigations
Weight increased
|
2.8%
2/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
3/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
3/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
2/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.95%
2/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
3/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.9%
3/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
6/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
4/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
4.2%
3/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
2/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
5.7%
6/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
3.8%
4/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
4.7%
10/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.8%
2/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
3/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.95%
1/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
4/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Nervous system disorders
Headache
|
8.3%
6/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
8.5%
6/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
4.2%
3/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
9.4%
10/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
7.6%
8/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
8.5%
18/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
2/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
3.8%
4/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.9%
3/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
3.3%
7/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.2%
3/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
3.8%
4/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.95%
1/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.4%
5/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.4%
1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
2/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
2/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.9%
4/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.9%
5/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
4.2%
3/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
4.2%
3/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
9.4%
10/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
3.8%
4/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
6.6%
14/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
2/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
0.00%
0/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.9%
3/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
3/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
1.4%
1/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
4.2%
3/71 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
2.8%
3/106 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
4.8%
5/105 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
3.8%
8/211 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 52 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 52 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER