Trial Outcomes & Findings for Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis (NCT NCT01358578)
NCT ID: NCT01358578
Last Updated: 2021-01-05
Results Overview
A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1306 participants
Primary outcome timeframe
12 wks
Results posted on
2021-01-05
Participant Flow
Participant milestones
| Measure |
AIN457 150mg
s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
AIN457 300mg
s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
Placebo
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Etanercept
Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c.
injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
|
AIN457 150mg From Placebo
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 150 in maintenance
|
AIN457 300mg From Placebo
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 300 in maintenance
|
|---|---|---|---|---|---|---|
|
Induction Period
STARTED
|
327
|
327
|
326
|
326
|
0
|
0
|
|
Induction Period
COMPLETED
|
315
|
312
|
301
|
305
|
0
|
0
|
|
Induction Period
NOT COMPLETED
|
12
|
15
|
25
|
21
|
0
|
0
|
|
Maintenance Period
STARTED
|
315
|
312
|
17
|
305
|
142
|
142
|
|
Maintenance Period
COMPLETED
|
276
|
290
|
15
|
263
|
125
|
131
|
|
Maintenance Period
NOT COMPLETED
|
39
|
22
|
2
|
42
|
17
|
11
|
|
Follow-up Period
STARTED
|
148
|
125
|
26
|
279
|
0
|
0
|
|
Follow-up Period
COMPLETED
|
138
|
119
|
21
|
260
|
0
|
0
|
|
Follow-up Period
NOT COMPLETED
|
10
|
6
|
5
|
19
|
0
|
0
|
Reasons for withdrawal
| Measure |
AIN457 150mg
s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
AIN457 300mg
s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
Placebo
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Etanercept
Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c.
injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
|
AIN457 150mg From Placebo
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 150 in maintenance
|
AIN457 300mg From Placebo
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 300 in maintenance
|
|---|---|---|---|---|---|---|
|
Induction Period
Adverse Event
|
2
|
4
|
2
|
6
|
0
|
0
|
|
Induction Period
Lack of Efficacy
|
0
|
0
|
9
|
1
|
0
|
0
|
|
Induction Period
Lost to Follow-up
|
0
|
0
|
1
|
4
|
0
|
0
|
|
Induction Period
Physician Decision
|
2
|
1
|
2
|
0
|
0
|
0
|
|
Induction Period
Protocol Deviation
|
3
|
5
|
0
|
3
|
0
|
0
|
|
Induction Period
technical problems
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Induction Period
Withdrawal by Subject
|
5
|
5
|
10
|
6
|
0
|
0
|
|
Maintenance Period
Adverse Event
|
2
|
7
|
0
|
6
|
4
|
3
|
|
Maintenance Period
Lack of Efficacy
|
10
|
2
|
0
|
11
|
3
|
0
|
|
Maintenance Period
Lost to Follow-up
|
4
|
0
|
0
|
5
|
1
|
1
|
|
Maintenance Period
Non-compliance with study treatment
|
3
|
1
|
0
|
2
|
1
|
2
|
|
Maintenance Period
Physician Decision
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Maintenance Period
Pregnancy
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period
Protocol deviation
|
7
|
4
|
0
|
2
|
2
|
2
|
|
Maintenance Period
Withdrawal by Subject
|
12
|
7
|
2
|
15
|
6
|
3
|
|
Follow-up Period
Adverse Event
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Follow-up Period
Lack of Efficacy
|
3
|
0
|
4
|
1
|
0
|
0
|
|
Follow-up Period
Lost to Follow-up
|
0
|
1
|
0
|
4
|
0
|
0
|
|
Follow-up Period
non- compliance with study treatment
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Follow-up Period
Pregnancy
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Follow-up Period
Withdrawal by Subject
|
3
|
3
|
1
|
12
|
0
|
0
|
|
Follow-up Period
Physician Decision
|
1
|
1
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis
Baseline characteristics by cohort
| Measure |
AIN457 150mg
n=327 Participants
AIN457 150mg
|
AIN457 300mg
n=327 Participants
AIN457 300mg
|
Placebo
n=326 Participants
Placebo
|
Etanercept
n=326 Participants
Etanercept
|
Total
n=1306 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
304 Participants
n=5 Participants
|
305 Participants
n=7 Participants
|
311 Participants
n=5 Participants
|
308 Participants
n=4 Participants
|
1228 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 12.92 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 13.19 • n=7 Participants
|
44.1 years
STANDARD_DEVIATION 12.64 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 12.95 • n=4 Participants
|
44.4 years
STANDARD_DEVIATION 12.93 • n=21 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
377 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
236 Participants
n=5 Participants
|
224 Participants
n=7 Participants
|
237 Participants
n=5 Participants
|
232 Participants
n=4 Participants
|
929 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
102 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
72 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
291 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
219 Participants
n=5 Participants
|
224 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
219 Participants
n=4 Participants
|
880 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 wksA 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis
Outcome measures
| Measure |
AIN457 150mg
n=327 Participants
s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
AIN457 300mg
n=323 Participants
s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
Placebo
n=324 Participants
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Placebo
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Placebo
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to treatment groups based on their PASI 75 response status at Week 12:
|
Etanercept
Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab
|
|---|---|---|---|---|---|---|
|
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) .
|
219 participants achieving goal
|
249 participants achieving goal
|
16 participants achieving goal
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 wksThe IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.
Outcome measures
| Measure |
AIN457 150mg
n=327 Participants
s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
AIN457 300mg
n=323 Participants
s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
Placebo
n=324 Participants
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Placebo
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Placebo
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to treatment groups based on their PASI 75 response status at Week 12:
|
Etanercept
Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab
|
|---|---|---|---|---|---|---|
|
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12
|
167 participants acheiving goal
|
202 participants acheiving goal
|
9 participants acheiving goal
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 wksPopulation: FAS
A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above current benchmark of primary endpoints for most clinical trials of psoriasis
Outcome measures
| Measure |
AIN457 150mg
n=327 Participants
s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
AIN457 300mg
n=323 Participants
s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
Placebo
n=323 Participants
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Placebo
n=324 Participants
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Placebo
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to treatment groups based on their PASI 75 response status at Week 12:
|
Etanercept
Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab
|
|---|---|---|---|---|---|---|
|
Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12
|
137 participant who acheived goal
|
175 participant who acheived goal
|
67 participant who acheived goal
|
5 participant who acheived goal
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 wksPopulation: FAS
A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis
Outcome measures
| Measure |
AIN457 150mg
n=327 Participants
s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
AIN457 300mg
n=323 Participants
s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
Placebo
n=323 Participants
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Placebo
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Placebo
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to treatment groups based on their PASI 75 response status at Week 12:
|
Etanercept
Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab
|
|---|---|---|---|---|---|---|
|
Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12
|
219 participant who acheived goal
|
249 participant who acheived goal
|
142 participant who acheived goal
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 wksPopulation: FAS
The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.
Outcome measures
| Measure |
AIN457 150mg
n=327 Participants
s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
AIN457 300mg
n=323 Participants
s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
Placebo
n=323 Participants
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Placebo
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Placebo
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to treatment groups based on their PASI 75 response status at Week 12:
|
Etanercept
Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab
|
|---|---|---|---|---|---|---|
|
Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: :IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12
|
167 participant acheiving goal
|
202 participant acheiving goal
|
88 participant acheiving goal
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 52 wksPopulation: Full analysis set
Outcome measures
| Measure |
AIN457 150mg
n=219 Participants
s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
AIN457 300mg
n=249 Participants
s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
Placebo
n=142 Participants
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Placebo
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Placebo
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to treatment groups based on their PASI 75 response status at Week 12:
|
Etanercept
Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab
|
|---|---|---|---|---|---|---|
|
Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation)
|
180 participants who reached goal
|
210 participants who reached goal
|
103 participants who reached goal
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 52 wksPopulation: Full analysis set
Outcome measures
| Measure |
AIN457 150mg
n=167 Participants
s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
AIN457 300mg
n=202 Participants
s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
Placebo
n=88 Participants
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Placebo
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Placebo
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to treatment groups based on their PASI 75 response status at Week 12:
|
Etanercept
Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab
|
|---|---|---|---|---|---|---|
|
Maintenance of IGA Mod 2011 0 or 1 Response After 52 Weeks of Treatment for Subjects Who Were IGA Mod 2011 0 or 1 Responders After 12 Weeks of Treatment
|
113 participants who reached goal
|
161 participants who reached goal
|
50 participants who reached goal
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline to week 12Population: Full analysis set
The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy
Outcome measures
| Measure |
AIN457 150mg
n=117 Participants
s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
AIN457 300mg
n=117 Participants
s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
Placebo
n=109 Participants
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Placebo
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Placebo
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to treatment groups based on their PASI 75 response status at Week 12:
|
Etanercept
Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab
|
|---|---|---|---|---|---|---|
|
Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo
Itching
|
-4.92 units on scale
Standard Error 0.249
|
-4.93 units on scale
Standard Error 0.247
|
-0.54 units on scale
Standard Error 0.201
|
—
|
—
|
—
|
|
Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo
Pain
|
-4.10 units on scale
Standard Error 0.277
|
-4.48 units on scale
Standard Error 0.278
|
-0.33 units on scale
Standard Error 0.216
|
—
|
—
|
—
|
|
Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo
Scaling
|
-4.89 units on scale
Standard Error 0.241
|
-4.93 units on scale
Standard Error 0.258
|
-0.42 units on scale
Standard Error 0.217
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline to week 12Population: Full analysis set
The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy
Outcome measures
| Measure |
AIN457 150mg
n=117 Participants
s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
AIN457 300mg
n=117 Participants
s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
Placebo
n=116 Participants
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Placebo
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Placebo
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to treatment groups based on their PASI 75 response status at Week 12:
|
Etanercept
Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab
|
|---|---|---|---|---|---|---|
|
Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept
Itching
|
-4.92 Units on a scale
Standard Error 0.277
|
-4.93 Units on a scale
Standard Error 0.278
|
-3.80 Units on a scale
Standard Error 0.257
|
—
|
—
|
—
|
|
Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept
Pain
|
-4.10 Units on a scale
Standard Error 0.268
|
-4.48 Units on a scale
Standard Error 0.269
|
-3.48 Units on a scale
Standard Error 0.251
|
—
|
—
|
—
|
|
Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept
Scaling
|
-4.89 Units on a scale
Standard Error 0.241
|
-4.93 Units on a scale
Standard Error 0.258
|
-3.74 Units on a scale
Standard Error 0.260
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 60 weeksPopulation: Full Analysis Set
Describes the number of participants tested positive for anti-secukinumab antibodies. It refers to the number of patients who had no positive values at baseline but developed them only after start of active study treatment (AIN457 or etanercept)
Outcome measures
| Measure |
AIN457 150mg
n=327 Participants
s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
AIN457 300mg
n=327 Participants
s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
|
Placebo
n=142 Participants
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Placebo
n=142 Participants
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
|
Placebo
n=17 Participants
s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to treatment groups based on their PASI 75 response status at Week 12:
|
Etanercept
n=326 Participants
Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab
|
|---|---|---|---|---|---|---|
|
Number of Participants Developing Anti-secukinumab Antibodies
|
2 # participants tested positive
|
3 # participants tested positive
|
0 # participants tested positive
|
0 # participants tested positive
|
0 # participants tested positive
|
6 # participants tested positive
|
Adverse Events
INDUCTION-AIN457 150mg
Serious events: 7 serious events
Other events: 157 other events
Deaths: 0 deaths
INDUCTION-AIN457 300mg
Serious events: 4 serious events
Other events: 145 other events
Deaths: 0 deaths
INDUCTION-Placebo
Serious events: 6 serious events
Other events: 121 other events
Deaths: 0 deaths
INDUCTION-Etanercept
Serious events: 3 serious events
Other events: 130 other events
Deaths: 0 deaths
ENTIRE-AIN457 150mg
Serious events: 18 serious events
Other events: 225 other events
Deaths: 0 deaths
ENTIRE-AIN457 300mg
Serious events: 21 serious events
Other events: 230 other events
Deaths: 0 deaths
ENTIRE-Any AIN457 150mg
Serious events: 24 serious events
Other events: 297 other events
Deaths: 0 deaths
ENTIRE-Any AIN457 300mg
Serious events: 27 serious events
Other events: 316 other events
Deaths: 0 deaths
ENTIRE-Placebo
Serious events: 7 serious events
Other events: 122 other events
Deaths: 0 deaths
ENTIRE-Etanercept
Serious events: 20 serious events
Other events: 213 other events
Deaths: 0 deaths
FOLLOW UP-Any AIN457 150mg
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
FOLLOW UP-Any AIN457 300mg
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
FOLLOW UP-Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
FOLLOW UP-Etanercept
Serious events: 2 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
INDUCTION-AIN457 150mg
n=327 participants at risk
INDUCTION-AIN457 150mg
|
INDUCTION-AIN457 300mg
n=326 participants at risk
INDUCTION-AIN457 300mg
|
INDUCTION-Placebo
n=327 participants at risk
INDUCTION-Placebo
|
INDUCTION-Etanercept
n=323 participants at risk
INDUCTION-Etanercept
|
ENTIRE-AIN457 150mg
n=327 participants at risk
ENTIRE-AIN457 150mg
|
ENTIRE-AIN457 300mg
n=326 participants at risk
ENTIRE-AIN457 300mg
|
ENTIRE-Any AIN457 150mg
n=469 participants at risk
ENTIRE-Any AIN457 150mg
|
ENTIRE-Any AIN457 300mg
n=467 participants at risk
ENTIRE-Any AIN457 300mg
|
ENTIRE-Placebo
n=327 participants at risk
ENTIRE-Placebo
|
ENTIRE-Etanercept
n=323 participants at risk
ENTIRE-Etanercept
|
FOLLOW UP-Any AIN457 150mg
n=148 participants at risk
FOLLOW UP-Any AIN457 150mg
|
FOLLOW UP-Any AIN457 300mg
n=125 participants at risk
FOLLOW UP-Any AIN457 300mg
|
FOLLOW UP-Placebo
n=27 participants at risk
FOLLOW UP-Placebo
|
FOLLOW UP-Etanercept
n=278 participants at risk
FOLLOW UP-Etanercept
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
LACERATION
|
0.31%
1/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Injury, poisoning and procedural complications
LIGAMENT RUPTURE
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.31%
1/327
|
0.31%
1/326
|
0.31%
1/327
|
0.00%
0/323
|
0.31%
1/327
|
0.31%
1/326
|
0.21%
1/469
|
0.21%
1/467
|
0.31%
1/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.36%
1/278
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Cardiac disorders
ARTERIOSCLEROSIS CORONARY ARTERY
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Endocrine disorders
BASEDOW'S DISEASE
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.68%
1/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Endocrine disorders
PARATHYROID GLAND ENLARGEMENT
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Endocrine disorders
THYROTOXIC CRISIS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
0.31%
1/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.31%
1/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Gastrointestinal disorders
OESOPHAGEAL FOOD IMPACTION
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.31%
1/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.36%
1/278
|
|
General disorders
POLYSEROSITIS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.80%
1/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Infections and infestations
ACUTE TONSILLITIS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Infections and infestations
ANAL ABSCESS
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/327
|
0.00%
0/326
|
0.31%
1/327
|
0.00%
0/323
|
0.31%
1/327
|
0.31%
1/326
|
0.21%
1/469
|
0.21%
1/467
|
0.31%
1/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Infections and infestations
HEPATITIS B
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.68%
1/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Infections and infestations
PERIRECTAL ABSCESS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Infections and infestations
PHARYNGOTONSILLITIS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Infections and infestations
TONSILLITIS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.80%
1/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Injury, poisoning and procedural complications
ALCOHOL POISONING
|
0.00%
0/327
|
0.00%
0/326
|
0.31%
1/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.31%
1/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Injury, poisoning and procedural complications
CARTILAGE INJURY
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.31%
1/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HYPOTHYROIDISM
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.68%
1/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE RESPIRATORY DISTRESS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.68%
1/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Injury, poisoning and procedural complications
TENDON INJURY
|
0.00%
0/327
|
0.00%
0/326
|
0.31%
1/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.31%
1/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.31%
1/326
|
0.21%
1/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Musculoskeletal and connective tissue disorders
CHONDROPATHY
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Musculoskeletal and connective tissue disorders
JOINT INSTABILITY
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Musculoskeletal and connective tissue disorders
PSORIATIC ARTHROPATHY
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Nervous system disorders
FACIAL PARESIS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.31%
1/327
|
0.62%
2/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Nervous system disorders
VIITH NERVE PARALYSIS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Nervous system disorders
VITH NERVE PARALYSIS
|
0.31%
1/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Psychiatric disorders
DEPRESSION SUICIDAL
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Psychiatric disorders
DRUG ABUSE
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Psychiatric disorders
INSOMNIA
|
0.31%
1/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Renal and urinary disorders
CALCULUS URETHRAL
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.31%
1/326
|
0.21%
1/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Renal and urinary disorders
RENAL COLIC
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Reproductive system and breast disorders
PROSTATOMEGALY
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.36%
1/278
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.31%
1/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Skin and subcutaneous tissue disorders
DYSHIDROTIC ECZEMA
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Skin and subcutaneous tissue disorders
LICHEN SCLEROSUS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
0.31%
1/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
0.00%
0/326
|
0.21%
1/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.00%
0/327
|
0.00%
0/326
|
0.61%
2/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.61%
2/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Social circumstances
ABSTAINS FROM ALCOHOL
|
0.00%
0/327
|
0.00%
0/326
|
0.31%
1/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.31%
1/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Vascular disorders
ARTERIAL OCCLUSIVE DISEASE
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Vascular disorders
BEHCET'S SYNDROME
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.80%
1/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.21%
1/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.31%
1/326
|
0.00%
0/469
|
0.21%
1/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
Other adverse events
| Measure |
INDUCTION-AIN457 150mg
n=327 participants at risk
INDUCTION-AIN457 150mg
|
INDUCTION-AIN457 300mg
n=326 participants at risk
INDUCTION-AIN457 300mg
|
INDUCTION-Placebo
n=327 participants at risk
INDUCTION-Placebo
|
INDUCTION-Etanercept
n=323 participants at risk
INDUCTION-Etanercept
|
ENTIRE-AIN457 150mg
n=327 participants at risk
ENTIRE-AIN457 150mg
|
ENTIRE-AIN457 300mg
n=326 participants at risk
ENTIRE-AIN457 300mg
|
ENTIRE-Any AIN457 150mg
n=469 participants at risk
ENTIRE-Any AIN457 150mg
|
ENTIRE-Any AIN457 300mg
n=467 participants at risk
ENTIRE-Any AIN457 300mg
|
ENTIRE-Placebo
n=327 participants at risk
ENTIRE-Placebo
|
ENTIRE-Etanercept
n=323 participants at risk
ENTIRE-Etanercept
|
FOLLOW UP-Any AIN457 150mg
n=148 participants at risk
FOLLOW UP-Any AIN457 150mg
|
FOLLOW UP-Any AIN457 300mg
n=125 participants at risk
FOLLOW UP-Any AIN457 300mg
|
FOLLOW UP-Placebo
n=27 participants at risk
FOLLOW UP-Placebo
|
FOLLOW UP-Etanercept
n=278 participants at risk
FOLLOW UP-Etanercept
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/327
|
0.92%
3/326
|
0.31%
1/327
|
0.00%
0/323
|
0.92%
3/327
|
2.8%
9/326
|
0.64%
3/469
|
2.1%
10/467
|
0.31%
1/327
|
0.93%
3/323
|
0.00%
0/148
|
0.80%
1/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.61%
2/327
|
0.92%
3/326
|
1.2%
4/327
|
0.93%
3/323
|
2.1%
7/327
|
1.5%
5/326
|
2.3%
11/469
|
1.3%
6/467
|
1.2%
4/327
|
2.5%
8/323
|
0.68%
1/148
|
0.00%
0/125
|
0.00%
0/27
|
0.72%
2/278
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.2%
4/327
|
0.61%
2/326
|
1.2%
4/327
|
0.31%
1/323
|
3.1%
10/327
|
3.1%
10/326
|
2.6%
12/469
|
3.0%
14/467
|
1.2%
4/327
|
0.93%
3/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Gastrointestinal disorders
DIARRHOEA
|
3.7%
12/327
|
5.2%
17/326
|
1.8%
6/327
|
3.4%
11/323
|
9.2%
30/327
|
10.4%
34/326
|
7.7%
36/469
|
8.1%
38/467
|
2.1%
7/327
|
6.8%
22/323
|
1.4%
2/148
|
0.80%
1/125
|
0.00%
0/27
|
1.1%
3/278
|
|
Gastrointestinal disorders
NAUSEA
|
1.8%
6/327
|
2.5%
8/326
|
2.1%
7/327
|
1.2%
4/323
|
3.1%
10/327
|
2.8%
9/326
|
2.1%
10/469
|
2.4%
11/467
|
2.1%
7/327
|
2.2%
7/323
|
0.68%
1/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.92%
3/327
|
1.8%
6/326
|
1.5%
5/327
|
0.93%
3/323
|
3.1%
10/327
|
3.1%
10/326
|
2.6%
12/469
|
2.8%
13/467
|
1.8%
6/327
|
2.2%
7/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.36%
1/278
|
|
Gastrointestinal disorders
VOMITING
|
0.31%
1/327
|
1.2%
4/326
|
0.31%
1/327
|
1.5%
5/323
|
0.61%
2/327
|
3.1%
10/326
|
0.85%
4/469
|
2.1%
10/467
|
0.31%
1/327
|
2.8%
9/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.36%
1/278
|
|
General disorders
ADVERSE DRUG REACTION
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
3.7%
1/27
|
0.00%
0/278
|
|
General disorders
FATIGUE
|
1.5%
5/327
|
2.1%
7/326
|
0.92%
3/327
|
1.5%
5/323
|
2.8%
9/327
|
4.3%
14/326
|
2.6%
12/469
|
3.4%
16/467
|
0.92%
3/327
|
1.9%
6/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.36%
1/278
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.61%
2/327
|
0.61%
2/326
|
0.31%
1/327
|
0.93%
3/323
|
2.1%
7/327
|
1.5%
5/326
|
1.5%
7/469
|
1.7%
8/467
|
0.31%
1/327
|
2.8%
9/323
|
0.68%
1/148
|
0.80%
1/125
|
0.00%
0/27
|
0.36%
1/278
|
|
General disorders
INJECTION SITE ERYTHEMA
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
5.0%
16/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
5.3%
17/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
General disorders
OEDEMA PERIPHERAL
|
1.5%
5/327
|
0.31%
1/326
|
1.2%
4/327
|
0.31%
1/323
|
2.8%
9/327
|
0.92%
3/326
|
2.1%
10/469
|
0.86%
4/467
|
1.2%
4/327
|
1.5%
5/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.36%
1/278
|
|
General disorders
PYREXIA
|
0.61%
2/327
|
1.5%
5/326
|
0.92%
3/327
|
2.2%
7/323
|
3.1%
10/327
|
3.7%
12/326
|
3.0%
14/469
|
4.1%
19/467
|
0.92%
3/327
|
4.6%
15/323
|
0.68%
1/148
|
0.00%
0/125
|
0.00%
0/27
|
0.36%
1/278
|
|
Infections and infestations
BRONCHITIS
|
1.2%
4/327
|
1.2%
4/326
|
0.61%
2/327
|
1.2%
4/323
|
3.7%
12/327
|
4.6%
15/326
|
3.0%
14/469
|
3.6%
17/467
|
0.61%
2/327
|
2.8%
9/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.72%
2/278
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/327
|
0.31%
1/326
|
0.31%
1/327
|
0.00%
0/323
|
1.2%
4/327
|
2.5%
8/326
|
0.85%
4/469
|
1.7%
8/467
|
0.31%
1/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.36%
1/278
|
|
Infections and infestations
FOLLICULITIS
|
1.2%
4/327
|
0.00%
0/326
|
0.31%
1/327
|
0.93%
3/323
|
2.8%
9/327
|
2.8%
9/326
|
3.0%
14/469
|
2.8%
13/467
|
0.31%
1/327
|
2.5%
8/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Infections and infestations
GASTROENTERITIS
|
0.92%
3/327
|
1.5%
5/326
|
0.61%
2/327
|
0.93%
3/323
|
3.1%
10/327
|
4.6%
15/326
|
2.6%
12/469
|
3.9%
18/467
|
0.92%
3/327
|
2.5%
8/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Infections and infestations
IMPETIGO
|
0.00%
0/327
|
1.2%
4/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
2.1%
7/326
|
0.21%
1/469
|
1.9%
9/467
|
0.00%
0/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Infections and infestations
INFLUENZA
|
1.5%
5/327
|
1.5%
5/326
|
0.92%
3/327
|
0.62%
2/323
|
2.8%
9/327
|
5.5%
18/326
|
2.6%
12/469
|
4.7%
22/467
|
0.92%
3/327
|
3.4%
11/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.72%
2/278
|
|
Infections and infestations
NASOPHARYNGITIS
|
13.5%
44/327
|
10.7%
35/326
|
8.0%
26/327
|
11.5%
37/323
|
25.1%
82/327
|
27.9%
91/326
|
22.8%
107/469
|
26.1%
122/467
|
8.0%
26/327
|
26.9%
87/323
|
4.1%
6/148
|
0.80%
1/125
|
11.1%
3/27
|
5.0%
14/278
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.31%
1/327
|
0.61%
2/326
|
0.00%
0/327
|
0.00%
0/323
|
1.2%
4/327
|
3.1%
10/326
|
1.3%
6/469
|
2.6%
12/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Infections and infestations
ORAL HERPES
|
0.31%
1/327
|
1.5%
5/326
|
0.00%
0/327
|
0.00%
0/323
|
0.31%
1/327
|
2.5%
8/326
|
0.85%
4/469
|
2.1%
10/467
|
0.00%
0/327
|
2.8%
9/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.36%
1/278
|
|
Infections and infestations
PHARYNGITIS
|
1.5%
5/327
|
1.2%
4/326
|
0.00%
0/327
|
0.00%
0/323
|
2.1%
7/327
|
2.8%
9/326
|
2.1%
10/469
|
2.8%
13/467
|
0.00%
0/327
|
1.9%
6/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Infections and infestations
RHINITIS
|
1.2%
4/327
|
2.1%
7/326
|
1.2%
4/327
|
0.93%
3/323
|
2.1%
7/327
|
3.1%
10/326
|
1.7%
8/469
|
3.0%
14/467
|
1.2%
4/327
|
1.9%
6/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Infections and infestations
SINUSITIS
|
1.5%
5/327
|
0.00%
0/326
|
0.31%
1/327
|
0.00%
0/323
|
2.8%
9/327
|
2.5%
8/326
|
2.3%
11/469
|
1.9%
9/467
|
0.31%
1/327
|
1.5%
5/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.36%
1/278
|
|
Infections and infestations
TINEA PEDIS
|
0.92%
3/327
|
0.92%
3/326
|
0.00%
0/327
|
0.00%
0/323
|
1.8%
6/327
|
2.5%
8/326
|
1.5%
7/469
|
2.1%
10/467
|
0.00%
0/327
|
1.2%
4/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Infections and infestations
TONSILLITIS
|
0.92%
3/327
|
0.61%
2/326
|
0.61%
2/327
|
0.00%
0/323
|
2.1%
7/327
|
2.8%
9/326
|
2.1%
10/469
|
2.6%
12/467
|
0.61%
2/327
|
0.93%
3/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/327
|
0.00%
0/326
|
0.31%
1/327
|
0.00%
0/323
|
0.92%
3/327
|
0.31%
1/326
|
0.85%
4/469
|
0.43%
2/467
|
0.31%
1/327
|
0.93%
3/323
|
0.00%
0/148
|
0.00%
0/125
|
3.7%
1/27
|
0.00%
0/278
|
|
Infections and infestations
TRICHOMONIASIS
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
3.7%
1/27
|
0.00%
0/278
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
3.1%
10/327
|
2.1%
7/326
|
0.92%
3/327
|
2.2%
7/323
|
6.4%
21/327
|
5.8%
19/326
|
5.5%
26/469
|
5.6%
26/467
|
0.92%
3/327
|
5.6%
18/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.72%
2/278
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.61%
2/327
|
0.61%
2/326
|
0.92%
3/327
|
1.9%
6/323
|
1.8%
6/327
|
2.5%
8/326
|
1.7%
8/469
|
2.8%
13/467
|
0.92%
3/327
|
2.8%
9/323
|
0.68%
1/148
|
0.00%
0/125
|
0.00%
0/27
|
0.72%
2/278
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.31%
1/327
|
0.31%
1/326
|
0.31%
1/327
|
0.00%
0/323
|
2.1%
7/327
|
2.1%
7/326
|
1.7%
8/469
|
2.4%
11/467
|
0.31%
1/327
|
0.31%
1/323
|
1.4%
2/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Injury, poisoning and procedural complications
MUSCLE RUPTURE
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
3.7%
1/27
|
0.00%
0/278
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
0.61%
2/327
|
0.61%
2/326
|
0.92%
3/327
|
0.00%
0/323
|
2.8%
9/327
|
0.92%
3/326
|
1.9%
9/469
|
0.64%
3/467
|
0.92%
3/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.31%
1/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.61%
2/327
|
0.00%
0/326
|
0.43%
2/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
3.7%
1/27
|
0.00%
0/278
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
1.8%
6/327
|
0.31%
1/326
|
1.5%
5/327
|
1.2%
4/323
|
3.1%
10/327
|
1.5%
5/326
|
2.1%
10/469
|
1.3%
6/467
|
1.5%
5/327
|
2.2%
7/323
|
1.4%
2/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.61%
2/327
|
0.92%
3/326
|
0.61%
2/327
|
0.00%
0/323
|
2.4%
8/327
|
0.92%
3/326
|
1.7%
8/469
|
1.1%
5/467
|
0.61%
2/327
|
1.2%
4/323
|
0.68%
1/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
1.8%
6/327
|
0.31%
1/326
|
0.92%
3/327
|
0.62%
2/323
|
2.4%
8/327
|
0.92%
3/326
|
1.7%
8/469
|
0.64%
3/467
|
0.92%
3/327
|
0.93%
3/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
4.3%
14/327
|
1.5%
5/326
|
3.1%
10/327
|
3.7%
12/323
|
7.6%
25/327
|
5.5%
18/326
|
6.8%
32/469
|
4.9%
23/467
|
3.1%
10/327
|
6.8%
22/323
|
2.0%
3/148
|
0.00%
0/125
|
0.00%
0/27
|
2.2%
6/278
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.4%
8/327
|
2.5%
8/326
|
1.8%
6/327
|
3.1%
10/323
|
5.2%
17/327
|
6.7%
22/326
|
4.3%
20/469
|
6.4%
30/467
|
1.8%
6/327
|
8.4%
27/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.72%
2/278
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.92%
3/327
|
0.61%
2/326
|
0.31%
1/327
|
0.00%
0/323
|
3.1%
10/327
|
0.92%
3/326
|
2.1%
10/469
|
0.86%
4/467
|
0.31%
1/327
|
0.31%
1/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.36%
1/278
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.92%
3/327
|
0.92%
3/326
|
1.2%
4/327
|
0.93%
3/323
|
1.5%
5/327
|
2.1%
7/326
|
1.9%
9/469
|
2.1%
10/467
|
1.2%
4/327
|
2.8%
9/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.61%
2/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
2.4%
8/327
|
0.92%
3/326
|
1.7%
8/469
|
0.86%
4/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.61%
2/327
|
1.5%
5/326
|
1.2%
4/327
|
0.31%
1/323
|
1.5%
5/327
|
3.7%
12/326
|
1.7%
8/469
|
2.8%
13/467
|
1.2%
4/327
|
1.2%
4/323
|
1.4%
2/148
|
0.80%
1/125
|
0.00%
0/27
|
0.36%
1/278
|
|
Nervous system disorders
HEADACHE
|
4.9%
16/327
|
9.2%
30/326
|
7.0%
23/327
|
7.1%
23/323
|
10.4%
34/327
|
14.4%
47/326
|
9.8%
46/469
|
12.6%
59/467
|
7.3%
24/327
|
12.4%
40/323
|
2.0%
3/148
|
1.6%
2/125
|
0.00%
0/27
|
0.72%
2/278
|
|
Nervous system disorders
PARAESTHESIA
|
0.61%
2/327
|
0.31%
1/326
|
0.61%
2/327
|
0.31%
1/323
|
2.1%
7/327
|
1.2%
4/326
|
1.5%
7/469
|
1.1%
5/467
|
0.61%
2/327
|
0.93%
3/323
|
1.4%
2/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Renal and urinary disorders
URETHRAL HAEMORRHAGE
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/327
|
0.00%
0/326
|
0.00%
0/469
|
0.00%
0/467
|
0.00%
0/327
|
0.00%
0/323
|
0.00%
0/148
|
0.00%
0/125
|
3.7%
1/27
|
0.00%
0/278
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
1.8%
6/327
|
3.4%
11/326
|
1.2%
4/327
|
1.2%
4/323
|
4.0%
13/327
|
7.4%
24/326
|
3.4%
16/469
|
6.4%
30/467
|
1.2%
4/327
|
3.7%
12/323
|
0.68%
1/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
1.2%
4/327
|
2.8%
9/326
|
2.1%
7/327
|
1.2%
4/323
|
4.6%
15/327
|
6.4%
21/326
|
4.1%
19/469
|
5.6%
26/467
|
2.1%
7/327
|
3.1%
10/323
|
0.00%
0/148
|
0.80%
1/125
|
0.00%
0/27
|
0.36%
1/278
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.31%
1/327
|
2.1%
7/326
|
0.31%
1/327
|
0.62%
2/323
|
0.92%
3/327
|
2.8%
9/326
|
0.64%
3/469
|
2.1%
10/467
|
0.31%
1/327
|
0.62%
2/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.61%
2/327
|
0.92%
3/326
|
0.00%
0/327
|
0.31%
1/323
|
2.4%
8/327
|
2.8%
9/326
|
2.1%
10/469
|
2.4%
11/467
|
0.00%
0/327
|
0.62%
2/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
1.1%
3/278
|
|
Skin and subcutaneous tissue disorders
ERYTHRODERMIC PSORIASIS
|
0.31%
1/327
|
0.31%
1/326
|
0.00%
0/327
|
0.00%
0/323
|
1.2%
4/327
|
0.31%
1/326
|
0.85%
4/469
|
0.21%
1/467
|
0.00%
0/327
|
0.62%
2/323
|
2.0%
3/148
|
4.0%
5/125
|
0.00%
0/27
|
4.3%
12/278
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
3.7%
12/327
|
2.5%
8/326
|
3.4%
11/327
|
2.8%
9/323
|
5.5%
18/327
|
4.3%
14/326
|
4.5%
21/469
|
3.6%
17/467
|
3.4%
11/327
|
5.0%
16/323
|
1.4%
2/148
|
0.80%
1/125
|
0.00%
0/27
|
0.36%
1/278
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
1.5%
5/327
|
0.31%
1/326
|
2.1%
7/327
|
0.62%
2/323
|
2.8%
9/327
|
1.5%
5/326
|
2.3%
11/469
|
1.5%
7/467
|
2.1%
7/327
|
1.9%
6/323
|
1.4%
2/148
|
0.00%
0/125
|
0.00%
0/27
|
1.8%
5/278
|
|
Skin and subcutaneous tissue disorders
SEBORRHOEIC DERMATITIS
|
0.31%
1/327
|
0.61%
2/326
|
0.00%
0/327
|
0.00%
0/323
|
2.1%
7/327
|
1.5%
5/326
|
1.7%
8/469
|
1.1%
5/467
|
0.00%
0/327
|
0.62%
2/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.36%
1/278
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
1.5%
5/327
|
0.31%
1/326
|
0.00%
0/327
|
0.62%
2/323
|
2.1%
7/327
|
0.92%
3/326
|
1.9%
9/469
|
0.86%
4/467
|
0.00%
0/327
|
0.93%
3/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.00%
0/278
|
|
Vascular disorders
HYPERTENSION
|
3.1%
10/327
|
1.5%
5/326
|
1.2%
4/327
|
1.5%
5/323
|
5.5%
18/327
|
4.9%
16/326
|
4.7%
22/469
|
4.3%
20/467
|
1.2%
4/327
|
4.3%
14/323
|
0.00%
0/148
|
0.00%
0/125
|
0.00%
0/27
|
0.72%
2/278
|
Additional Information
Study Director
Novartis
Phone: 862-778-8300
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