Trial Outcomes & Findings for Plaque Psoriasis Efficacy and Safety With Secukinumab (NCT NCT02409667)
NCT ID: NCT02409667
Last Updated: 2019-05-13
Results Overview
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
16487 participants
Primary outcome timeframe
Week 52
Results posted on
2019-05-13
Participant Flow
The screening period was up to 4 weeks and rescreening was allowed for an unlimited number of times. At the Screening Visit, every patient was registered in an Interactive Response Technology and the Investigator ensured that the patient fulfilled all the inclusion/exclusion criteria
Participant milestones
| Measure |
Treatment Period 1: All Participants
Participants received secukinumab 300 mg subcutaneous (s.c.) every 4 weeks for 24 weeks.
|
Treatment Period 2: Group 1
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 2
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
|
Treatment Period 2: Group 3
Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 4
Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to \<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.
|
|---|---|---|---|---|---|
|
Treatment Period 1, Baseline to Week 24
STARTED
|
1647
|
0
|
0
|
0
|
0
|
|
Treatment Period 1, Baseline to Week 24
COMPLETED
|
1526
|
0
|
0
|
0
|
0
|
|
Treatment Period 1, Baseline to Week 24
NOT COMPLETED
|
121
|
0
|
0
|
0
|
0
|
|
Treatment Period 2, Week 24 to Week 52)
STARTED
|
0
|
644
|
662
|
114
|
93
|
|
Treatment Period 2, Week 24 to Week 52)
COMPLETED
|
0
|
621
|
641
|
106
|
90
|
|
Treatment Period 2, Week 24 to Week 52)
NOT COMPLETED
|
0
|
23
|
21
|
8
|
3
|
Reasons for withdrawal
| Measure |
Treatment Period 1: All Participants
Participants received secukinumab 300 mg subcutaneous (s.c.) every 4 weeks for 24 weeks.
|
Treatment Period 2: Group 1
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 2
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
|
Treatment Period 2: Group 3
Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 4
Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to \<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.
|
|---|---|---|---|---|---|
|
Treatment Period 1, Baseline to Week 24
Withdrawal of informed consent
|
6
|
0
|
0
|
0
|
0
|
|
Treatment Period 1, Baseline to Week 24
Withdrawal by Subject
|
6
|
0
|
0
|
0
|
0
|
|
Treatment Period 1, Baseline to Week 24
Protocol deviation
|
20
|
0
|
0
|
0
|
0
|
|
Treatment Period 1, Baseline to Week 24
Pregnancy
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period 1, Baseline to Week 24
Physician Decision
|
4
|
0
|
0
|
0
|
0
|
|
Treatment Period 1, Baseline to Week 24
Non-compliance with study treatment
|
5
|
0
|
0
|
0
|
0
|
|
Treatment Period 1, Baseline to Week 24
Lost to Follow-up
|
6
|
0
|
0
|
0
|
0
|
|
Treatment Period 1, Baseline to Week 24
Lack of Efficacy
|
48
|
0
|
0
|
0
|
0
|
|
Treatment Period 1, Baseline to Week 24
Adverse Event
|
25
|
0
|
0
|
0
|
0
|
|
Treatment Period 2, Week 24 to Week 52)
Lost to Follow-up
|
0
|
7
|
4
|
3
|
0
|
|
Treatment Period 2, Week 24 to Week 52)
Lack of Efficacy
|
0
|
0
|
0
|
2
|
0
|
|
Treatment Period 2, Week 24 to Week 52)
Adverse Event
|
0
|
7
|
4
|
1
|
2
|
|
Treatment Period 2, Week 24 to Week 52)
Withdrawal of informed consent
|
0
|
5
|
4
|
0
|
0
|
|
Treatment Period 2, Week 24 to Week 52)
Withdrawal by Subject
|
0
|
4
|
5
|
2
|
0
|
|
Treatment Period 2, Week 24 to Week 52)
Pregnancy
|
0
|
0
|
1
|
0
|
1
|
|
Treatment Period 2, Week 24 to Week 52)
Protocol deviation
|
0
|
0
|
3
|
0
|
0
|
Baseline Characteristics
Plaque Psoriasis Efficacy and Safety With Secukinumab
Baseline characteristics by cohort
| Measure |
Treatment Period 1: All Participants
n=1647 Participants
Participants received secukinumab 300 mg subcutaneous (s.c.) every 4 weeks for 24 weeks.
|
|---|---|
|
Age, Continuous
|
43.1 Years
STANDARD_DEVIATION 13.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
476 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1171 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1597 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: Full analysis set for Treatment Period 2 of PASI 90 responders (FAS-P90R): The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
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 |
Treatment Period 2: Group 1
n=644 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 2
n=662 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
|
|---|---|---|
|
Maintenance of PASI 90 Response at Week 52 in Participants With a PASI 90 Response at Week 24
|
552 Participants
|
496 Participants
|
SECONDARY outcome
Timeframe: Week 52Population: FAS for Treatment Period 2 of PASI 75 responders who did not achieve a PASI 90 response (FAS-P75R): All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at the Week 24 visit, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after visit Week 24.
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 |
Treatment Period 2: Group 1
n=114 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 2
n=92 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
|
|---|---|---|
|
Key Secondary: PASI 90 Response Rate at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24
|
53 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: week 52Population: Only participants from the FAS-P90R with evaluable data were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
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). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The 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.
Outcome measures
| Measure |
Treatment Period 2: Group 1
n=644 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 2
n=662 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
|
|---|---|---|
|
PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24
PASI 50
|
608 Participants
|
624 Participants
|
|
PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24
PASI 75
|
597 Participants
|
588 Participants
|
|
PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24
PASI 90
|
553 Participants
|
496 Participants
|
|
PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24
PASI 100
|
378 Participants
|
305 Participants
|
|
PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24
IGA mod 2011
|
564 Participants
|
529 Participants
|
SECONDARY outcome
Timeframe: Week 52Population: Only participants from the FAS-P75R with evaluable data were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at the Week 24 visit, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after visit Week 24.
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). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The 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.
Outcome measures
| Measure |
Treatment Period 2: Group 1
n=104 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 2
n=90 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
|
|---|---|---|
|
PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24
PASI 50
|
98 Participants
|
88 Participants
|
|
PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24
PASI 75
|
74 Participants
|
80 Participants
|
|
PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24
PASI 90
|
53 Participants
|
52 Participants
|
|
PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24
PASI 100
|
12 Participants
|
13 Participants
|
|
PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24
IGA mod 2011 0 or 1
|
64 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52Population: Only participants from the FAS-P90R, who had evaluable data at both baseline and the post-baseline time point, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
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). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Treatment Period 2: Group 1
n=644 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 2
n=662 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
|
|---|---|---|
|
Change From Baseline in PASI in Participants With a PASI 90 Response at Week 24
Week 28
|
-20.7 score on a scale
Standard Deviation 8.471
|
-19.9 score on a scale
Standard Deviation 8.511
|
|
Change From Baseline in PASI in Participants With a PASI 90 Response at Week 24
Week 32
|
-20.7 score on a scale
Standard Deviation 8.581
|
-19.8 score on a scale
Standard Deviation 8.474
|
|
Change From Baseline in PASI in Participants With a PASI 90 Response at Week 24
Week 36
|
-20.6 score on a scale
Standard Deviation 8.439
|
-19.7 score on a scale
Standard Deviation 8.563
|
|
Change From Baseline in PASI in Participants With a PASI 90 Response at Week 24
Week 40
|
-20.5 score on a scale
Standard Deviation 8.392
|
-19.6 score on a scale
Standard Deviation 8.393
|
|
Change From Baseline in PASI in Participants With a PASI 90 Response at Week 24
Week 44
|
-20.5 score on a scale
Standard Deviation 8.384
|
-19.6 score on a scale
Standard Deviation 8.484
|
|
Change From Baseline in PASI in Participants With a PASI 90 Response at Week 24
Week 48
|
-20.5 score on a scale
Standard Deviation 8.472
|
-19.2 score on a scale
Standard Deviation 8.509
|
|
Change From Baseline in PASI in Participants With a PASI 90 Response at Week 24
Week 52
|
-20.4 score on a scale
Standard Deviation 8.301
|
-19.2 score on a scale
Standard Deviation 8.513
|
SECONDARY outcome
Timeframe: Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52Population: Participants from the FAS-P75R, who had evaluable data at both baseline and the post-baseline time point, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.
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). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Treatment Period 2: Group 1
n=114 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 2
n=92 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
|
|---|---|---|
|
Change From Baseline in PASI in Participants With a PASI Response of ≥75 to <90 at Week 24
Week 40
|
-16.1 score on a scale
Standard Deviation 6.908
|
-16.8 score on a scale
Standard Deviation 8.170
|
|
Change From Baseline in PASI in Participants With a PASI Response of ≥75 to <90 at Week 24
Week 44
|
-16.1 score on a scale
Standard Deviation 6.553
|
-16.6 score on a scale
Standard Deviation 8.259
|
|
Change From Baseline in PASI in Participants With a PASI Response of ≥75 to <90 at Week 24
Week 48
|
-15.6 score on a scale
Standard Deviation 6.246
|
-16.8 score on a scale
Standard Deviation 8.307
|
|
Change From Baseline in PASI in Participants With a PASI Response of ≥75 to <90 at Week 24
Week 52
|
-15.5 score on a scale
Standard Deviation 6.371
|
-16.6 score on a scale
Standard Deviation 8.011
|
|
Change From Baseline in PASI in Participants With a PASI Response of ≥75 to <90 at Week 24
Week 28
|
-16.1 score on a scale
Standard Deviation 6.160
|
-16.3 score on a scale
Standard Deviation 8.029
|
|
Change From Baseline in PASI in Participants With a PASI Response of ≥75 to <90 at Week 24
Week 32
|
-15.9 score on a scale
Standard Deviation 6.002
|
-16.6 score on a scale
Standard Deviation 7.941
|
|
Change From Baseline in PASI in Participants With a PASI Response of ≥75 to <90 at Week 24
Week 36
|
-16.1 score on a scale
Standard Deviation 6.356
|
-16.6 score on a scale
Standard Deviation 7.996
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Outcome measures
| Measure |
Treatment Period 2: Group 1
n=605 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 2
n=624 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
|
|---|---|---|
|
Change From Baseline in DLQI in Participants With a PASI 90 Response at Week 24
|
-12.7 score on a scale
Standard Deviation 7.325
|
-11.4 score on a scale
Standard Deviation 7.480
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.
The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Outcome measures
| Measure |
Treatment Period 2: Group 1
n=105 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 2
n=89 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
|
|---|---|---|
|
Change From Baseline in DLQI in Participants With a PASI Response of ≥75 to <90 at Week 24
|
-10.0 score on a scale
Standard Deviation 6.605
|
-9.72 score on a scale
Standard Deviation 6.880
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
The WPAI-PSO is a self-administered questionnaire comprised of 6 questions about effects of psoriasis on the patient's ability to work and perform regular activities based on the previous 7 days. The questionnaire quantifies the number of hours the respondent was unable to work and evaluates how much the respondent's psoriasis affected productivity while working. For respondents who were not in paid employment, the questionnaire evaluated how much the respondent's psoriasis affects their ability to perform regular daily activities. Four outcomes were generated from the WPAI-PSO: % Absenteeism: percent work time missed due to health; % Presenteism: percent impairment while working due to health; % Total work productivity impairment: percent overall work impairment due to health; % Total activity impairment: percent activity impairment due to health for all respondents. First 3 outcomes applied to employed participants only. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Treatment Period 2: Group 1
n=644 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 2
n=662 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
|
|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Psoriasis (WPAI-PSO) Score in Participants With a PASI 90 Response at Week 24
Absenteeism
|
-4.70 score on a scale
Standard Deviation 19.590
|
-1.99 score on a scale
Standard Deviation 19.759
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Psoriasis (WPAI-PSO) Score in Participants With a PASI 90 Response at Week 24
Presenteeism
|
-23.1 score on a scale
Standard Deviation 25.968
|
-23.0 score on a scale
Standard Deviation 26.522
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Psoriasis (WPAI-PSO) Score in Participants With a PASI 90 Response at Week 24
Total activity impairment
|
-24.3 score on a scale
Standard Deviation 27.850
|
-23.2 score on a scale
Standard Deviation 29.861
|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Psoriasis (WPAI-PSO) Score in Participants With a PASI 90 Response at Week 24
Work productivity loss
|
-31.9 score on a scale
Standard Deviation 29.392
|
-28.6 score on a scale
Standard Deviation 27.996
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.
The WPAI-PSO is a self-administered questionnaire comprised of 6 questions about effects of psoriasis on the patient's ability to work and perform regular activities based on the previous 7 days. The questionnaire quantifies the number of hours the respondent was unable to work and evaluates how much the respondent's psoriasis affected productivity while working. For respondents who were not in paid employment, the questionnaire evaluated how much the respondent's psoriasis affects their ability to perform regular daily activities. Four outcomes were generated from the WPAI-PSO: % Absenteeism: percent work time missed due to health; % Presenteism: percent impairment while working due to health; % Total work productivity impairment: percent overall work impairment due to health; % Total activity impairment: percent activity impairment due to health for all respondents. First 3 outcomes applied to employed participants only. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Treatment Period 2: Group 1
n=114 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 2
n=92 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
|
|---|---|---|
|
Change From Baseline in WPAI-PSO Score in Participants With a PASI Response of ≥75 to <90 at Week 24
Absenteeism
|
-2.36 score on a scale
Standard Deviation 12.990
|
-3.45 score on a scale
Standard Deviation 18.698
|
|
Change From Baseline in WPAI-PSO Score in Participants With a PASI Response of ≥75 to <90 at Week 24
Presenteeism
|
-22.9 score on a scale
Standard Deviation 28.377
|
-22.1 score on a scale
Standard Deviation 26.333
|
|
Change From Baseline in WPAI-PSO Score in Participants With a PASI Response of ≥75 to <90 at Week 24
Total activity impairment
|
-23.1 score on a scale
Standard Deviation 28.657
|
-21.7 score on a scale
Standard Deviation 29.905
|
|
Change From Baseline in WPAI-PSO Score in Participants With a PASI Response of ≥75 to <90 at Week 24
Work productivity loss
|
-18.2 score on a scale
Standard Deviation 28.824
|
-22.5 score on a scale
Standard Deviation 25.192
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
Self-administered, 11-point numeric rating scales (NRS, 0-10) were used to evaluate the patients' assessment of their current pain, itching and scaling. Respondents answered the following questions for the assessment: Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours?; Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours?; and Scaling: Overall, how severe was your psoriasis-related scaling over the past 24 hours? Patients had to rate their pain, itching, and scaling from 0 to 10 (11-point scale), with the understanding that the 0 represents the absence or null end of the pain, itching, or scale intensity (i.e. no pain, itching or scaling) and the 10 represents the other extreme of pain, itching, or scaling intensity (i.e. pain, itching or scaling as bad as it could be). The number that the patient selected represents his or her intensity score in the respective category. A negative change from baseline indicates improvement
Outcome measures
| Measure |
Treatment Period 2: Group 1
n=644 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 2
n=662 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
|
|---|---|---|
|
Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI 90 Response at Week 24
Pain
|
-4.56 score on a scale
Standard Deviation 2.771
|
-4.17 score on a scale
Standard Deviation 2.2727
|
|
Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI 90 Response at Week 24
Itching
|
-5.59 score on a scale
Standard Deviation 2.885
|
-5.20 score on a scale
Standard Deviation 2.985
|
|
Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI 90 Response at Week 24
Scaling
|
-6.05 score on a scale
Standard Deviation 2.659
|
-5.73 score on a scale
Standard Deviation 2.757
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.
Self-administered, 11-point numeric rating scales (NRS, 0-10) were used to evaluate the patients' assessment of their current pain, itching and scaling. Respondents answered the following questions for the assessment: Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours?; Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours?; and Scaling: Overall, how severe was your psoriasis-related scaling over the past 24 hours? Patients had to rate their pain, itching, and scaling from 0 to 10 (11-point scale), with the understanding that the 0 represents the absence or null end of the pain, itching, or scale intensity (i.e. no pain, itching or scaling) and the 10 represents the other extreme of pain, itching, or scaling intensity (i.e. pain, itching or scaling as bad as it could be). The number that the patient selected represents his or her intensity score in the respective category. A negative change from baseline indicates improvement
Outcome measures
| Measure |
Treatment Period 2: Group 1
n=114 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 2
n=92 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
|
|---|---|---|
|
Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI Response of ≥75 to <90 at Week 24
Pain
|
-3.59 score on a scale
Standard Deviation 2.754
|
-3.68 score on a scale
Standard Deviation 3.049
|
|
Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI Response of ≥75 to <90 at Week 24
Itching
|
-4.13 score on a scale
Standard Deviation 2.883
|
-4.49 score on a scale
Standard Deviation 3.129
|
|
Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI Response of ≥75 to <90 at Week 24
Scaling
|
-4.66 score on a scale
Standard Deviation 2.960
|
-5.40 score on a scale
Standard Deviation 2.899
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
A visual analogue scale (VAS) was used within the EQ-5D. This scale recorded the respondent's self-rated health on a vertical 20-cm VAS where the endpoints were labeled "best imaginable health state" and "worst imaginable health state." This resulted in a numeric value set ranging from 0 (="worst imaginable health state") up to 100 (="best imaginable health state"). A positive change from baseline indicates improvement.
Outcome measures
| Measure |
Treatment Period 2: Group 1
n=603 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 2
n=620 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
|
|---|---|---|
|
Change From Baseline in the European Quality of Life - 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) in Participants With a PASI 90 Response at Week 24
|
24.34 score on a scale
Standard Deviation 23.296
|
21.24 score on a scale
Standard Deviation 22.074
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.
A visual analogue scale (VAS) was used within the EQ-5D. This scale recorded the respondent's self-rated health on a vertical 20-cm VAS where the endpoints were labeled "best imaginable health state" and "worst imaginable health state." This resulted in a numeric value set ranging from 0 (="worst imaginable health state") up to 100 (="best imaginable health state").
Outcome measures
| Measure |
Treatment Period 2: Group 1
n=103 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 2
n=88 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
|
|---|---|---|
|
Change From Baseline in the EQ-5D VAS in Participants With a PASI Response of ≥75 to <90 at Week 24
|
15.86 score on a scale
Standard Deviation 20.099
|
18.92 score on a scale
Standard Deviation 19.855
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.
The EQ-5D quantifies the health state of a patient for the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort \& anxiety/depression. In this study the EQ-5D-5L version has been used which evaluates each of these dimensions using the following 5 labels: no problems, slight problems, moderate problems, severe problems \& unable to/extreme problems. Based on the 5 dimensions, a summary score (utility index) was derived using country specific value sets evaluating the patient condition described by the outcome in the single dimensions. The EQ-5D-5L (in this trail) utility index based on the crosswalk value sets available from the EuroQol for Germany \& UK (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/) was calculated. A positive change from baseline indicates improvement. A visual analogue scale was used within the EQ-5D measuring the health state of the patients, ranging from 0 (worst imaginable health state) up to 100 (best imaginable health state).
Outcome measures
| Measure |
Treatment Period 2: Group 1
n=605 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 2
n=623 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
|
|---|---|---|
|
Change From Baseline in the EQ-5D Utility Index (Germany, United Kingdom (UK)) in Participants With a PASI 90 Response at Week 24
Germany
|
0.17 score on a scale
Standard Deviation 0.200
|
0.13 score on a scale
Standard Deviation 0.182
|
|
Change From Baseline in the EQ-5D Utility Index (Germany, United Kingdom (UK)) in Participants With a PASI 90 Response at Week 24
UK
|
0.28 score on a scale
Standard Deviation 0.250
|
0.22 score on a scale
Standard Deviation 0.230
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.
The EQ-5D quantifies the health state of a patient for the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. In the current study the EQ-5D-5L version has been used which evaluates each of these dimensions using the following five labels: "no problems", "slight problems", "moderate problems", "severe problems" and "unable to/extreme problems". Based on the five dimensions, a summary score (utility index) was derived using country specific value sets evaluating the patient condition described by the outcome in the single dimensions. For this trial, the EQ-5D-5L utility index based on the crosswalk value sets available from the EuroQol for Germany and for UK (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/) was calculated. A visual analogue scale (VAS) was used within the EQ-5D measuring the health state of the patients, ranging from 0 (="worst imaginable health state") up to 100 (="best imaginable health state").
Outcome measures
| Measure |
Treatment Period 2: Group 1
n=103 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 2
n=89 Participants
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
|
|---|---|---|
|
Change From Baseline in the EQ-5D Utility Index (Germany, UK) in Participants With a PASI Response of ≥75 to <90 at Week 24
Germany
|
0.11 score on a scale
Standard Deviation 0.164
|
0.13 score on a scale
Standard Deviation 0.164
|
|
Change From Baseline in the EQ-5D Utility Index (Germany, UK) in Participants With a PASI Response of ≥75 to <90 at Week 24
UK
|
0.18 score on a scale
Standard Deviation 0.206
|
0.21 score on a scale
Standard Deviation 0.204
|
Adverse Events
Treatment Period 1: All Participants
Serious events: 73 serious events
Other events: 884 other events
Deaths: 1 deaths
Treatment Period 2: Group 1
Serious events: 25 serious events
Other events: 272 other events
Deaths: 0 deaths
Treatment Period 2: Group 2
Serious events: 25 serious events
Other events: 288 other events
Deaths: 0 deaths
Treatment Period 2: Group 3
Serious events: 4 serious events
Other events: 64 other events
Deaths: 0 deaths
Treatment Period 2: Group 4
Serious events: 3 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Period 1: All Participants
n=1647 participants at risk
Participants received secukinumab 300 mg subcutaneous (s.c.) every 4 weeks for 24 weeks.
|
Treatment Period 2: Group 1
n=644 participants at risk
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 2
n=662 participants at risk
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
|
Treatment Period 2: Group 3
n=114 participants at risk
Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 4
n=93 participants at risk
Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to \<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Cardiac disorders
Angina pectoris
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.88%
1/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.30%
2/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Cardiac disorders
Atrial flutter
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Cardiac disorders
Coronary artery disease
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.88%
1/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Gastrointestinal disorders
Crohn's disease
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Gastrointestinal disorders
Haematochezia
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
General disorders
Asthenia
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
General disorders
Oedema peripheral
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.88%
1/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.12%
2/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Abscess jaw
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Appendicitis
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Bronchiolitis
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Endocarditis
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Erysipelas
|
0.12%
2/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Gastroenteritis
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Giardiasis
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Osteomyelitis
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Pilonidal cyst
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.1%
1/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Urinary tract infection
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.88%
1/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Urosepsis
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Viral infection
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.12%
2/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.30%
2/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.12%
2/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Investigations
Alanine aminotransferase increased
|
0.55%
9/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.88%
1/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Investigations
Aspartate aminotransferase increased
|
0.61%
10/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.31%
2/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.88%
1/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Investigations
Blood bilirubin increased
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Investigations
Hepatic enzyme increased
|
0.18%
3/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Investigations
Liver function test increased
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Investigations
Transaminases increased
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.12%
2/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.18%
3/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.88%
1/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.12%
2/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.12%
2/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage II
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral fibroma
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Nervous system disorders
Burning sensation
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.12%
2/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Nervous system disorders
Epilepsy
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Nervous system disorders
Monoplegia
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.1%
1/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Nervous system disorders
Seizure
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Nervous system disorders
Tension headache
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Psychiatric disorders
Alcohol abuse
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Psychiatric disorders
Anxiety disorder
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Psychiatric disorders
Confusional state
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Psychiatric disorders
Depression
|
0.12%
2/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Psychiatric disorders
Schizophrenia
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Renal and urinary disorders
Calculus urethral
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Renal and urinary disorders
Renal colic
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Renal and urinary disorders
Renal failure
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Reproductive system and breast disorders
Peyronie's disease
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.88%
1/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Social circumstances
Alcohol use
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.1%
1/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Vascular disorders
Iliac artery occlusion
|
0.06%
1/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
Other adverse events
| Measure |
Treatment Period 1: All Participants
n=1647 participants at risk
Participants received secukinumab 300 mg subcutaneous (s.c.) every 4 weeks for 24 weeks.
|
Treatment Period 2: Group 1
n=644 participants at risk
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 2
n=662 participants at risk
Participants with moderate to severe plaque psoriasis who had reached PASI 90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 6 weeks.
|
Treatment Period 2: Group 3
n=114 participants at risk
Participants with moderate to severe plaque psoriasis who had reached PASI 75 to \<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks will be treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 4 weeks.
|
Treatment Period 2: Group 4
n=93 participants at risk
Participants with moderate to severe plaque psoriasis, who had reached PASI 75 to \<90 response after 24 weeks of treatment with secukinumab 300 mg s.c. every 4 weeks, were treated with Secukinumab 300 mg s.c. from week 24 until Week 52 every 2 weeks.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.24%
4/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.31%
2/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.30%
2/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.88%
1/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.2%
2/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Eye disorders
Conjunctivitis allergic
|
0.36%
6/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.47%
3/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.88%
1/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.2%
2/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Eye disorders
Eye pruritus
|
0.30%
5/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
3.2%
3/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
74/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.5%
16/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
3.3%
22/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
3.5%
4/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Gastrointestinal disorders
Odynophagia
|
0.43%
7/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.62%
4/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.91%
6/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.88%
1/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
3.2%
3/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Gastrointestinal disorders
Toothache
|
2.1%
34/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.7%
11/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.7%
11/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.6%
3/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.1%
1/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
General disorders
Fatigue
|
2.5%
41/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.78%
5/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.30%
2/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
General disorders
Injection site haematoma
|
1.1%
18/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.31%
2/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.2%
2/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
General disorders
Pyrexia
|
2.2%
36/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.6%
10/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.2%
8/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.8%
2/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.1%
1/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Bronchitis
|
1.4%
23/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.9%
12/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.91%
6/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.88%
1/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
3.2%
3/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Cystitis
|
0.73%
12/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.47%
3/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.45%
3/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.2%
2/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Folliculitis
|
1.9%
31/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.2%
8/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.2%
8/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.88%
1/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.2%
2/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Gastroenteritis
|
1.3%
22/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.6%
10/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.5%
10/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.6%
3/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.2%
2/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Influenza
|
2.2%
36/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.6%
17/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.9%
19/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
3.5%
4/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
4.3%
4/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Nasopharyngitis
|
0.36%
6/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.47%
3/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.91%
6/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.2%
2/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Oral candidiasis
|
1.5%
25/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.4%
9/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.1%
14/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
3.2%
3/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Oral herpes
|
2.5%
41/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.9%
12/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.2%
8/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.6%
3/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Pulpitis dental
|
0.24%
4/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.30%
2/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.8%
2/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.2%
2/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Rhinitis
|
3.2%
52/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.2%
8/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.8%
12/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.6%
3/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Sinusitis
|
1.3%
22/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.2%
8/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.91%
6/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.88%
1/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.2%
2/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Tonsillitis
|
2.1%
34/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.2%
8/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.4%
9/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.8%
2/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
3.2%
3/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Upper respiratory tract infection
|
3.9%
65/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.8%
18/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.4%
16/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
6.1%
7/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
5.4%
5/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Urinary tract infection
|
1.6%
26/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.5%
16/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.2%
8/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.6%
3/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
3.2%
3/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
22.3%
368/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
14.6%
94/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
14.4%
95/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
20.2%
23/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
23.7%
22/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.18%
3/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.62%
4/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.60%
4/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.2%
2/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Investigations
Alanine aminotransferase increased
|
0.61%
10/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.62%
4/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.91%
6/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.8%
2/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
4.3%
4/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Investigations
Aspartate aminotransferase increased
|
0.49%
8/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.62%
4/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.45%
3/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.88%
1/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
3.2%
3/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
50/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.5%
16/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.9%
19/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.6%
3/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
4.3%
4/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.24%
4/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.2%
2/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.9%
64/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.8%
18/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
4.2%
28/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
3.5%
4/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.1%
1/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Nervous system disorders
Headache
|
8.6%
141/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
4.8%
31/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
4.1%
27/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
5.3%
6/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.1%
1/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Nervous system disorders
Migraine
|
0.55%
9/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.16%
1/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.2%
2/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
61/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.7%
11/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.5%
10/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.6%
3/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.8%
46/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.0%
13/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.6%
17/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.6%
3/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.1%
1/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.18%
3/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.31%
2/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.2%
2/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.55%
9/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.62%
4/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.15%
1/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
3.2%
3/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.2%
20/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.2%
8/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.1%
14/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.6%
3/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.1%
1/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Skin and subcutaneous tissue disorders
Erythrodermic psoriasis
|
0.00%
0/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
0.00%
0/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.6%
3/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.1%
1/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.9%
65/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.4%
9/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.7%
11/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.8%
2/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
4.3%
4/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.3%
21/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.9%
12/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
2.4%
16/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
9.6%
11/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
8.6%
8/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
|
Vascular disorders
Hypertension
|
3.3%
55/1647 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.1%
7/644 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
1.5%
10/662 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
3.5%
4/114 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
4.3%
4/93 • Week 52
The Adverse Events (AE) dataset has MedDRA version 19.1 (5345 records) and 20.0 (1272 records).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER