Trial Outcomes & Findings for Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis (NCT NCT03066609)
NCT ID: NCT03066609
Last Updated: 2019-12-30
Results Overview
Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. 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
543 participants
Primary outcome timeframe
Week 12
Results posted on
2019-12-30
Participant Flow
A total of 664 patients were screened and 543 patients were randomized to one of three treatment groups in the induction period: secukinumab 300 mg (n=272), secukinumab 150 mg (n=136), and placebo (n=135)
Participant milestones
| Measure |
Secukinumab 150mg
Secukinumab 150mg s.c.
|
Secukinumab 300mg
Secukinumab 300mg s.c.
|
Placebo
Placebo
|
Placebo - Secukinumab 300mg
patients switched to AIN457 at week 12
|
|---|---|---|---|---|
|
INDUCTION
STARTED
|
136
|
272
|
135
|
0
|
|
INDUCTION
COMPLETED
|
134
|
270
|
133
|
0
|
|
INDUCTION
NOT COMPLETED
|
2
|
2
|
2
|
0
|
|
MAINTENANCE
STARTED
|
134
|
270
|
4
|
129
|
|
MAINTENANCE
COMPLETED
|
127
|
266
|
2
|
126
|
|
MAINTENANCE
NOT COMPLETED
|
7
|
4
|
2
|
3
|
|
OVERALL STUDY
STARTED
|
136
|
272
|
6
|
129
|
|
OVERALL STUDY
COMPLETED
|
126
|
264
|
2
|
124
|
|
OVERALL STUDY
NOT COMPLETED
|
10
|
8
|
4
|
5
|
Reasons for withdrawal
| Measure |
Secukinumab 150mg
Secukinumab 150mg s.c.
|
Secukinumab 300mg
Secukinumab 300mg s.c.
|
Placebo
Placebo
|
Placebo - Secukinumab 300mg
patients switched to AIN457 at week 12
|
|---|---|---|---|---|
|
INDUCTION
Pregnancy
|
0
|
0
|
1
|
0
|
|
INDUCTION
Lack of Efficacy
|
0
|
0
|
1
|
0
|
|
INDUCTION
Adverse Event
|
2
|
2
|
0
|
0
|
|
MAINTENANCE
Adverse Event
|
0
|
0
|
0
|
1
|
|
MAINTENANCE
Withdrawal by Subject
|
4
|
2
|
1
|
1
|
|
MAINTENANCE
Lost to Follow-up
|
0
|
1
|
1
|
0
|
|
MAINTENANCE
Pregnancy
|
1
|
0
|
0
|
0
|
|
MAINTENANCE
Lack of Efficacy
|
2
|
1
|
0
|
1
|
|
OVERALL STUDY
Adverse Event
|
2
|
2
|
0
|
1
|
|
OVERALL STUDY
Withdrawal by Subject
|
4
|
2
|
1
|
2
|
|
OVERALL STUDY
Lost to Follow-up
|
1
|
1
|
1
|
1
|
|
OVERALL STUDY
Pregnancy
|
1
|
0
|
1
|
0
|
|
OVERALL STUDY
Lack of Efficacy
|
2
|
1
|
1
|
1
|
|
OVERALL STUDY
discontinued follow up
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Baseline characteristics by cohort
| Measure |
Secukinumab 150mg
n=136 Participants
Secukinumab 150mg s.c.
|
Secukinumab 300mg
n=272 Participants
Secukinumab 300mg s.c.
|
Placebo
n=135 Participants
Placebo
|
Total
n=543 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 11.39 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 12.35 • n=7 Participants
|
40.1 years
STANDARD_DEVIATION 11.01 • n=5 Participants
|
40.2 years
STANDARD_DEVIATION 11.78 • n=4 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
412 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
109 Participants
n=5 Participants
|
220 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
438 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Southeast Asian
|
19 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
West Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
other
|
6 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
not reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
129 Participants
n=5 Participants
|
252 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
506 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: full analysis set
Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Outcome measures
| Measure |
Secukinumab 150mg
n=136 Participants
Secukinumab 150mg s.c.
|
Secukinumab 300mg
n=272 Participants
Secukinumab 300mg s.c.
|
Placebo
n=135 Participants
Placebo
|
Placebo - AIN457 300 mg
patients switched to AIN457 at week 12
|
|---|---|---|---|---|
|
Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation)
|
112 Participants
|
254 Participants
|
6 Participants
|
—
|
PRIMARY outcome
Timeframe: Week 12Population: full analysis set
Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
Outcome measures
| Measure |
Secukinumab 150mg
n=136 Participants
Secukinumab 150mg s.c.
|
Secukinumab 300mg
n=272 Participants
Secukinumab 300mg s.c.
|
Placebo
n=135 Participants
Placebo
|
Placebo - AIN457 300 mg
patients switched to AIN457 at week 12
|
|---|---|---|---|---|
|
Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation)
|
92 Participants
|
214 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: full analysis set
Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Outcome measures
| Measure |
Secukinumab 150mg
n=136 Participants
Secukinumab 150mg s.c.
|
Secukinumab 300mg
n=272 Participants
Secukinumab 300mg s.c.
|
Placebo
n=135 Participants
Placebo
|
Placebo - AIN457 300 mg
patients switched to AIN457 at week 12
|
|---|---|---|---|---|
|
Psoriasis Area and Severity Index (PASI) 90 (Multiple Imputation)
|
85 Participants
|
210 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: full analysis set with measure
Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Outcome measures
| Measure |
Secukinumab 150mg
n=112 Participants
Secukinumab 150mg s.c.
|
Secukinumab 300mg
n=254 Participants
Secukinumab 300mg s.c.
|
Placebo
Placebo
|
Placebo - AIN457 300 mg
patients switched to AIN457 at week 12
|
|---|---|---|---|---|
|
Efficacy of Secukinumab in Maintaining PASI 75 Response at Week 52 in Subjects Who Were PASI 75 Responders at Week 12 (Multiple Imputation)
|
94 Participants
|
235 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: full analysis set with measure
Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
Outcome measures
| Measure |
Secukinumab 150mg
n=92 Participants
Secukinumab 150mg s.c.
|
Secukinumab 300mg
n=214 Participants
Secukinumab 300mg s.c.
|
Placebo
Placebo
|
Placebo - AIN457 300 mg
patients switched to AIN457 at week 12
|
|---|---|---|---|---|
|
Efficacy of Secukinumab in Maintaining IGA Mod 2011 0 or 1 Response at Week 52 in Subjects Who Were IGA Mod 2011 0 or 1 Responders at Week 12 (Multiple Imputation)
|
65 Participants
|
162 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: week 1, week 12, week 24, week 52Population: full analysis set
Number (%) of subjects with PASI 50, PASI 75, PASI 90, PASI 100 and IGA mod 2011 0 or 1 response
Outcome measures
| Measure |
Secukinumab 150mg
n=136 Participants
Secukinumab 150mg s.c.
|
Secukinumab 300mg
n=272 Participants
Secukinumab 300mg s.c.
|
Placebo
n=135 Participants
Placebo
|
Placebo - AIN457 300 mg
n=129 Participants
patients switched to AIN457 at week 12
|
|---|---|---|---|---|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 1 IGA 0/1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 1 PASI 50
|
5 Participants
|
25 Participants
|
1 Participants
|
0 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 1 PASI 75
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 1 PASI 90
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 1 PASI 100
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 12 IGA 0/1
|
92 Participants
|
214 Participants
|
4 Participants
|
0 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 12 PASI 50
|
130 Participants
|
267 Participants
|
16 Participants
|
0 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 12 PASI 75
|
112 Participants
|
254 Participants
|
6 Participants
|
0 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 12 PASI 90
|
85 Participants
|
210 Participants
|
2 Participants
|
0 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 12 PASI 100
|
28 Participants
|
81 Participants
|
1 Participants
|
0 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 16 IGA 0/1
|
100 Participants
|
219 Participants
|
2 Participants
|
32 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 16 PASI 50
|
134 Participants
|
270 Participants
|
4 Participants
|
108 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 16 PASI 75
|
124 Participants
|
261 Participants
|
3 Participants
|
72 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 16 PASI 90
|
98 Participants
|
233 Participants
|
2 Participants
|
22 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 16 PASI 100
|
39 Participants
|
99 Participants
|
0 Participants
|
3 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 24 IGA 0/1
|
91 Participants
|
217 Participants
|
1 Participants
|
88 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 24 PASI 50
|
135 Participants
|
271 Participants
|
4 Participants
|
123 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 24 PASI 75
|
123 Participants
|
257 Participants
|
2 Participants
|
113 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 24 PASI 90
|
93 Participants
|
230 Participants
|
2 Participants
|
94 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 24 PASI 100
|
47 Participants
|
107 Participants
|
0 Participants
|
31 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 52 IGA 0/1
|
79 Participants
|
194 Participants
|
0 Participants
|
96 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 52 PASI 50
|
128 Participants
|
269 Participants
|
4 Participants
|
126 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 52 PASI 75
|
111 Participants
|
259 Participants
|
4 Participants
|
119 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 52 PASI 90
|
86 Participants
|
218 Participants
|
1 Participants
|
101 Participants
|
|
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Week 52 PASI 100
|
42 Participants
|
110 Participants
|
1 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: week 12, week 24, week 52Population: full analysis set
Percentage of patients who achieved ACR 20/50/70 at Week 12 and up to Week 52. The subset of patients who had active PsA at baseline included 7 patients in the secukinumab 150 mg group, 17 patients in the secukinumab 300 mg group and 4 patients in the placebo group. ACR 20, 50 or 70 responses correspond, respectively, to at least 20%, 50% or 70% improvement in comparison with baseline in the number of tender and swollen joint counts, in addition to similar improvements in at least three of five other measure of disability or disease activity
Outcome measures
| Measure |
Secukinumab 150mg
n=7 Participants
Secukinumab 150mg s.c.
|
Secukinumab 300mg
n=17 Participants
Secukinumab 300mg s.c.
|
Placebo
n=4 Participants
Placebo
|
Placebo - AIN457 300 mg
n=4 Participants
patients switched to AIN457 at week 12
|
|---|---|---|---|---|
|
American Collage of Rheumatology (ACR) Response 20/50/70
Week 12 ACR 20
|
4 Participants
|
13 Participants
|
0 Participants
|
0 Participants
|
|
American Collage of Rheumatology (ACR) Response 20/50/70
Week 12 ACR 50
|
3 Participants
|
12 Participants
|
0 Participants
|
0 Participants
|
|
American Collage of Rheumatology (ACR) Response 20/50/70
Week 12 ACR 70
|
2 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
American Collage of Rheumatology (ACR) Response 20/50/70
Week 24 ACR 20
|
5 Participants
|
14 Participants
|
0 Participants
|
2 Participants
|
|
American Collage of Rheumatology (ACR) Response 20/50/70
Week 24 ACR 50
|
4 Participants
|
10 Participants
|
0 Participants
|
1 Participants
|
|
American Collage of Rheumatology (ACR) Response 20/50/70
Week 24 ACR 70
|
2 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
|
American Collage of Rheumatology (ACR) Response 20/50/70
Week 52 ACR 20
|
4 Participants
|
13 Participants
|
0 Participants
|
3 Participants
|
|
American Collage of Rheumatology (ACR) Response 20/50/70
Week 52 ACR 50
|
3 Participants
|
11 Participants
|
0 Participants
|
2 Participants
|
|
American Collage of Rheumatology (ACR) Response 20/50/70
Week 52 ACR 70
|
2 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: week 12Population: full analysis set
Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Outcome measures
| Measure |
Secukinumab 150mg
n=136 Participants
Secukinumab 150mg s.c.
|
Secukinumab 300mg
n=272 Participants
Secukinumab 300mg s.c.
|
Placebo
Placebo
|
Placebo - AIN457 300 mg
patients switched to AIN457 at week 12
|
|---|---|---|---|---|
|
Time to PASI 75 Response up to Week 12
|
57 days
Interval 51.0 to 57.0
|
55 days
Interval 29.0 to 57.0
|
—
|
—
|
Adverse Events
AIN457 150 mg
Serious events: 5 serious events
Other events: 115 other events
Deaths: 0 deaths
AIN457 300 mg
Serious events: 9 serious events
Other events: 221 other events
Deaths: 0 deaths
Any AIN457 300 mg
Serious events: 14 serious events
Other events: 312 other events
Deaths: 0 deaths
Any AIN457 Dose
Serious events: 19 serious events
Other events: 427 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AIN457 150 mg
n=136 participants at risk
AIN457 150 mg
|
AIN457 300 mg
n=272 participants at risk
AIN457 300 mg
|
Any AIN457 300 mg
n=401 participants at risk
Any AIN457 300 mg
|
Any AIN457 Dose
n=537 participants at risk
Any AIN457 dose
|
Placebo
n=135 participants at risk
Placebo
|
|---|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.74%
1/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.74%
1/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.37%
2/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.37%
1/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.74%
1/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.37%
1/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.74%
1/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Hepatobiliary disorders
Hepatic mass
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.74%
2/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.50%
2/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.37%
2/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.37%
1/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.37%
1/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.37%
1/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Infections and infestations
Tonsillitis
|
0.74%
1/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.37%
1/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.37%
1/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.37%
1/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.74%
1/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.74%
1/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.37%
1/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Renal and urinary disorders
Glomerulonephritis chronic
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.37%
1/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.37%
1/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.37%
1/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Skin and subcutaneous tissue disorders
Erythrodermic psoriasis
|
0.74%
1/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.74%
1/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Vascular disorders
Diabetic vascular disorder
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.25%
1/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.19%
1/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
Other adverse events
| Measure |
AIN457 150 mg
n=136 participants at risk
AIN457 150 mg
|
AIN457 300 mg
n=272 participants at risk
AIN457 300 mg
|
Any AIN457 300 mg
n=401 participants at risk
Any AIN457 300 mg
|
Any AIN457 Dose
n=537 participants at risk
Any AIN457 dose
|
Placebo
n=135 participants at risk
Placebo
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
9.6%
13/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
11.4%
31/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
10.5%
42/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
10.2%
55/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
8.9%
12/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
General disorders
Pyrexia
|
2.9%
4/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
5.1%
14/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
4.5%
18/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
4.1%
22/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.74%
1/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
6.6%
9/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
6.6%
18/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
5.5%
22/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
5.8%
31/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
3.0%
4/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Infections and infestations
Folliculitis
|
4.4%
6/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
6.6%
18/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
6.5%
26/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
6.0%
32/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Infections and infestations
Influenza
|
12.5%
17/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
10.3%
28/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
9.5%
38/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
10.2%
55/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
3.0%
4/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Infections and infestations
Nasopharyngitis
|
11.0%
15/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
16.2%
44/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
14.2%
57/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
13.4%
72/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
3.7%
5/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Infections and infestations
Pharyngitis
|
10.3%
14/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
8.8%
24/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
8.7%
35/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
9.1%
49/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
5.2%
7/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Infections and infestations
Rhinitis
|
1.5%
2/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
5.1%
14/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
4.0%
16/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
3.4%
18/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.74%
1/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Infections and infestations
Tinea pedis
|
3.7%
5/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
7.4%
20/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
6.2%
25/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
5.6%
30/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.74%
1/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Infections and infestations
Tonsillitis
|
3.7%
5/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
5.1%
14/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
4.0%
16/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
3.9%
21/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.74%
1/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Infections and infestations
Upper respiratory tract infection
|
30.1%
41/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
24.6%
67/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
24.2%
97/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
25.7%
138/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
9.6%
13/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Investigations
Blood uric acid increased
|
2.9%
4/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
1.5%
4/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
1.5%
6/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
1.9%
10/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
3.7%
5/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Investigations
C-reactive protein increased
|
5.1%
7/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
4.0%
11/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
3.2%
13/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
3.7%
20/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
2.2%
3/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.5%
2/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
3.7%
10/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
3.0%
12/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
2.6%
14/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.74%
1/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.74%
2/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.50%
2/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.37%
2/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
3.7%
5/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
8.1%
11/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
8.1%
22/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
5.7%
23/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
6.3%
34/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
8.1%
11/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
18.4%
25/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
20.6%
56/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
19.0%
76/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
18.8%
101/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
12.6%
17/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
4/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
4.0%
11/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
3.0%
12/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
3.0%
16/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
2.2%
3/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Nervous system disorders
Headache
|
2.9%
4/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
3.7%
10/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
2.5%
10/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
2.6%
14/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
1.5%
2/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.6%
13/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
6.2%
17/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
6.2%
25/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
7.1%
38/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
1.5%
2/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.8%
16/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
9.2%
25/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
8.0%
32/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
8.9%
48/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
2.2%
3/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.4%
10/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
7.4%
20/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
6.2%
25/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
6.5%
35/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.8%
12/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
11.8%
32/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
9.0%
36/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
8.9%
48/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
8.1%
11/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
4.4%
6/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
1.1%
3/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.75%
3/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
1.7%
9/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
8.8%
12/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
8.8%
24/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
7.5%
30/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
7.8%
42/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
0.00%
0/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
|
Vascular disorders
Hypertension
|
3.7%
5/136 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
7.0%
19/272 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
5.5%
22/401 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
5.0%
27/537 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
3.0%
4/135 • 12 months
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
|
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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER