Trial Outcomes & Findings for 16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients (NCT NCT02008916)
NCT ID: NCT02008916
Last Updated: 2019-01-08
Results Overview
ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 was used to assess the efficacy of at least one dose of secukinumab versus placebo.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
226 participants
Primary outcome timeframe
16 weeks
Results posted on
2019-01-08
Participant Flow
Patients were randomized to one of three treatment groups (1:1:1) and planned to be treated for 156 weeks. At Week 16, subjects who were randomized to placebo were re-randomized to secukinumab 150 mg or 300 mg. Patients were enrolled in 54 centers in Germany, Spain, United States, Czech Republic, Belgium, Greece, Mexico, Portugal, Russia and UK.
A screening period (SCR) running up to 10 weeks before randomization was used to assess eligibility.
Participant milestones
| Measure |
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Placebo i.v. and s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, 36 patients were re-randomised to Secukinumab 150mg and 37 patients to Secukinumab 300mg until the end of the study.
|
|---|---|---|---|
|
Primary Assessment (up to Week 16)
STARTED
|
74
|
76
|
76
|
|
Primary Assessment (up to Week 16)
FAS
|
74
|
76
|
76
|
|
Primary Assessment (up to Week 16)
Safety Set
|
74
|
76
|
75
|
|
Primary Assessment (up to Week 16)
COMPLETED
|
74
|
75
|
73
|
|
Primary Assessment (up to Week 16)
NOT COMPLETED
|
0
|
1
|
3
|
|
Week 16 - 156
STARTED
|
74
|
75
|
73
|
|
Week 16 - 156
COMPLETED
|
55
|
62
|
63
|
|
Week 16 - 156
NOT COMPLETED
|
19
|
13
|
10
|
Reasons for withdrawal
| Measure |
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Placebo i.v. and s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, 36 patients were re-randomised to Secukinumab 150mg and 37 patients to Secukinumab 300mg until the end of the study.
|
|---|---|---|---|
|
Primary Assessment (up to Week 16)
Withdrawal by Subject
|
0
|
1
|
3
|
|
Week 16 - 156
Adverse Event
|
4
|
2
|
3
|
|
Week 16 - 156
Withdrawal by Subject
|
7
|
3
|
5
|
|
Week 16 - 156
No longer requires treatment
|
0
|
1
|
0
|
|
Week 16 - 156
Lost to Follow-up
|
5
|
0
|
0
|
|
Week 16 - 156
Lack of Efficacy
|
3
|
5
|
2
|
|
Week 16 - 156
Pregnancy
|
0
|
1
|
0
|
|
Week 16 - 156
Physician Decision
|
0
|
1
|
0
|
Baseline Characteristics
16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients
Baseline characteristics by cohort
| Measure |
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
n=74 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
n=76 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Placebo i.v. and s.c.
n=76 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.
|
Total
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.9 Years
STANDARD_DEVIATION 11.11 • n=99 Participants
|
42.1 Years
STANDARD_DEVIATION 11.81 • n=107 Participants
|
42.7 Years
STANDARD_DEVIATION 11.43 • n=206 Participants
|
42.5 Years
STANDARD_DEVIATION 11.41 • n=7 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
90 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
136 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
54 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
164 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: FAS - Missing ASAS responses were considered as non-responder
ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 was used to assess the efficacy of at least one dose of secukinumab versus placebo.
Outcome measures
| Measure |
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
n=74 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
n=76 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Placebo i.v. and s.c.
n=76 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.
|
|---|---|---|---|
|
Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response
Responder
|
43 Participants
|
46 Participants
|
28 Participants
|
|
Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response
Non-Responder
|
31 Participants
|
30 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: FAS - Missing ASAS responses were considered as non-responder
ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 was used to assess the efficacy of at least one dose of secukinumab versus placebo.
Outcome measures
| Measure |
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
n=74 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
n=76 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Placebo i.v. and s.c.
n=76 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.
|
|---|---|---|---|
|
ASAS 40 Response
Responder
|
30 Participants
|
32 Participants
|
16 Participants
|
|
ASAS 40 Response
Non-Responder
|
44 Participants
|
44 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: FAS
Blood levels of C-reactive protein (CRP), an acute phase reactant, are indicative of inflammation and of its severity, and can be used to monitor treatment response. A high sensitivity CRP (hsCRP) test was implemented in this study, to assess the efficacy of at least one dose of secukinumab versus placebo in reducing AS elicited systemic inflammation over the time.
Outcome measures
| Measure |
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
n=74 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
n=76 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Placebo i.v. and s.c.
n=76 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.
|
|---|---|---|---|
|
Serum hsCRP
Baseline
|
15.79 mg/L
Standard Deviation 21.075
|
11.08 mg/L
Standard Deviation 13.285
|
13.91 mg/L
Standard Deviation 19.999
|
|
Serum hsCRP
Week 16
|
7.68 mg/L
Standard Deviation 13.277
|
4.34 mg/L
Standard Deviation 5.433
|
15.34 mg/L
Standard Deviation 21.694
|
|
Serum hsCRP
Change from Baseline to Week 16
|
-8.06 mg/L
Standard Deviation 21.132
|
-6.75 mg/L
Standard Deviation 13.778
|
0.57 mg/L
Standard Deviation 11.629
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: FAS - Missing ASAS responses were considered as non-responder
ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevant to AS and no worsening in the remaining domain. In this study, ASAS 5/6 was used to assess the efficacy of at least one dose of secukinumab versus placebo.
Outcome measures
| Measure |
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
n=74 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
n=76 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Placebo i.v. and s.c.
n=76 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.
|
|---|---|---|---|
|
ASAS 5/6 Response
Responder
|
31 Participants
|
30 Participants
|
11 Participants
|
|
ASAS 5/6 Response
Non-Responder
|
43 Participants
|
46 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: FAS
BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating "no problem" and 10 indicating "worst problem"), to characterise six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI index was used to assess the efficacy of at least one dose of secukinumab versus placebo.
Outcome measures
| Measure |
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
n=74 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
n=76 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Placebo i.v. and s.c.
n=76 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.
|
|---|---|---|---|
|
Bath Ankylosing Spondylitis Disease Activity Index / BASDAI
Baseline
|
6.958 units on a scale
Standard Deviation 1.3913
|
6.963 units on a scale
Standard Deviation 1.3766
|
6.907 units on a scale
Standard Deviation 1.2600
|
|
Bath Ankylosing Spondylitis Disease Activity Index / BASDAI
Week 16
|
4.451 units on a scale
Standard Deviation 2.5623
|
4.178 units on a scale
Standard Deviation 2.7038
|
5.369 units on a scale
Standard Deviation 2.2574
|
|
Bath Ankylosing Spondylitis Disease Activity Index / BASDAI
Change from Baseline to Week 16
|
-2.548 units on a scale
Standard Deviation 2.4559
|
-2.796 units on a scale
Standard Deviation 2.6374
|
-1.590 units on a scale
Standard Deviation 2.0084
|
SECONDARY outcome
Timeframe: Week 8 and Week 12Population: Safety Set
Successful self-administration is defined as success in steps P8 (Removed Needle Cap from Safety Syringe), P10 (Pinched the Skin at Injection Site), P11 (Inserted the Needle into Skin), P12 (Held onto the Finger Flange), P13 (Fully Depressed Plunger until End Point), and P14 (Held Plunger Down and Syringe in Place) of the Instructions for Use, as observed by the site staff at applicable visits.
Outcome measures
| Measure |
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
n=74 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
n=76 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Placebo i.v. and s.c.
n=75 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.
|
|---|---|---|---|
|
Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe)
Self-administration Week 8 · Missing
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe)
Self-administration Week 8 · Successful Self-administration
|
72 Participants
|
73 Participants
|
71 Participants
|
|
Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe)
Self-administration Week 8 · Unsuccessful Self-administration
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe)
Self-administration Week 12 · Successful Self-administration
|
74 Participants
|
75 Participants
|
72 Participants
|
|
Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe)
Self-administration Week 12 · Unsuccessful Self-administration
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe)
Self-administration Week 12 · Missing
|
0 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 8 and Week 12Population: Safety Set
The number and percentage of subjects who experience any of the defined possible hazards are summarized, as defined in the Possible Hazard assessment check list and as observed by the site staff at applicable visits.
Outcome measures
| Measure |
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
n=74 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
n=76 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Placebo i.v. and s.c.
n=75 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.
|
|---|---|---|---|
|
Pre-filled Syringe Possible Hazard
Week 8:Was needle stick in a critical area? · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8:Was swallowing of debris observed? · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was any other problem observed? · Yes
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8:Was needle stick in a critical area? · No
|
73 Participants
|
73 Participants
|
72 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8:Was needle stick in a critical area? · Missing
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8: Was needle stick in a non-critical area? · Yes
|
2 Participants
|
5 Participants
|
3 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8: Was needle stick in a non-critical area? · No
|
71 Participants
|
68 Participants
|
69 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8: Was needle stick in a non-critical area? · Missing
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8: Was any part of the device swallowed? · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8: Was any part of the device swallowed? · No
|
73 Participants
|
73 Participants
|
72 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8: Was any part of the device swallowed? · Missing
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8: Was allergic reaction to device noticed? · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8: Was allergic reaction to device noticed? · No
|
73 Participants
|
73 Participants
|
72 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8: Was allergic reaction to device noticed? · Missing
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8: Was pain increased due to bent needle? · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8: Was pain increased due to bent needle? · No
|
73 Participants
|
73 Participants
|
72 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8: Was pain increased due to bent needle? · Missing
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8: Was there breakage of device observed? · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8: Was there breakage of device observed? · No
|
73 Participants
|
73 Participants
|
72 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8: Was there breakage of device observed? · Missing
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8:Was swallowing of debris observed? · No
|
73 Participants
|
73 Participants
|
72 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8:Was swallowing of debris observed? · Missing
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8:Was any other problem observed? · Yes
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8:Was any other problem observed? · No
|
72 Participants
|
73 Participants
|
72 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8:Was any other problem observed? · Missing
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8:Was less than the full dose administered · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8:Was less than the full dose administered · No
|
73 Participants
|
73 Participants
|
72 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 8:Was less than the full dose administered · Missing
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was needle stick in a critical area? · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was needle stick in a critical area? · No
|
74 Participants
|
75 Participants
|
72 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was needle stick in a critical area? · Missing
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was needle stick in a non-critical area? · Yes
|
1 Participants
|
4 Participants
|
3 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was needle stick in a non-critical area? · No
|
73 Participants
|
71 Participants
|
69 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was needle stick in a non-critical area? · Missing
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was any part of the device swallowed? · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was any part of the device swallowed? · No
|
74 Participants
|
75 Participants
|
72 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was any part of the device swallowed? · Missing
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was allergic reaction to device noticed? · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was allergic reaction to device noticed? · No
|
74 Participants
|
75 Participants
|
72 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was allergic reaction to device noticed? · Missing
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was pain increased due to bent needle? · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was pain increased due to bent needle? · No
|
74 Participants
|
75 Participants
|
72 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was pain increased due to bent needle? · Missing
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was there breakage of device observed? · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was there breakage of device observed? · No
|
74 Participants
|
75 Participants
|
72 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was there breakage of device observed? · Missing
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was swallowing of debris observed? · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was swallowing of debris observed? · No
|
74 Participants
|
75 Participants
|
72 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was swallowing of debris observed? · Missing
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was any other problem observed? · No
|
73 Participants
|
74 Participants
|
72 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was any other problem observed? · Missing
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was less than the full dose administered? · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was less than the full dose administered? · No
|
74 Participants
|
75 Participants
|
72 Participants
|
|
Pre-filled Syringe Possible Hazard
Week 12: Was less than the full dose administered? · Missing
|
0 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, weeks 8, 12 and 16Population: Safety Set
The self-injection assessment questionnaire (SIAQ) measures overall patient experience with subcutaneous self-injection at applicable visits. Domain scores ranging from 0 (worst experience) to 10 (best experience) are presented: Feeling about injections, Self-confidence, Satisfaction with self-injection.
Outcome measures
| Measure |
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
n=74 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
n=76 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Placebo i.v. and s.c.
n=75 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.
|
|---|---|---|---|
|
Prefilled Syringe Patient Satisfaction Assessment
Week 0: Feeling about injections
|
7.97 Points
Standard Deviation 1.946
|
7.66 Points
Standard Deviation 2.369
|
8.01 Points
Standard Deviation 1.927
|
|
Prefilled Syringe Patient Satisfaction Assessment
Week 8: Feeling about injections
|
7.96 Points
Standard Deviation 2.538
|
7.68 Points
Standard Deviation 2.296
|
8.24 Points
Standard Deviation 2.082
|
|
Prefilled Syringe Patient Satisfaction Assessment
Week 12: Feeling about injections
|
8.45 Points
Standard Deviation 1.968
|
7.93 Points
Standard Deviation 2.201
|
8.25 Points
Standard Deviation 1.997
|
|
Prefilled Syringe Patient Satisfaction Assessment
Week 16: Feeling about injections
|
8.15 Points
Standard Deviation 2.337
|
7.99 Points
Standard Deviation 2.269
|
8.41 Points
Standard Deviation 2.037
|
|
Prefilled Syringe Patient Satisfaction Assessment
Week 0: Self-confidence
|
6.27 Points
Standard Deviation 2.811
|
6.66 Points
Standard Deviation 2.315
|
6.52 Points
Standard Deviation 2.273
|
|
Prefilled Syringe Patient Satisfaction Assessment
Week 8: Self-confidence
|
7.08 Points
Standard Deviation 2.520
|
6.66 Points
Standard Deviation 2.855
|
7.41 Points
Standard Deviation 2.198
|
|
Prefilled Syringe Patient Satisfaction Assessment
Week 12: Self-confidence
|
7.01 Points
Standard Deviation 2.603
|
7.28 Points
Standard Deviation 2.231
|
7.42 Points
Standard Deviation 2.230
|
|
Prefilled Syringe Patient Satisfaction Assessment
Week 16: Self-confidence
|
7.51 Points
Standard Deviation 2.388
|
7.23 Points
Standard Deviation 2.566
|
7.64 Points
Standard Deviation 2.192
|
|
Prefilled Syringe Patient Satisfaction Assessment
Week 0: Satisfaction with self-injection
|
5.34 Points
Standard Deviation 2.692
|
6.12 Points
Standard Deviation 2.429
|
5.30 Points
Standard Deviation 2.694
|
|
Prefilled Syringe Patient Satisfaction Assessment
Week 8: Satisfaction with self-injection
|
7.67 Points
Standard Deviation 1.734
|
7.50 Points
Standard Deviation 1.667
|
7.39 Points
Standard Deviation 2.002
|
|
Prefilled Syringe Patient Satisfaction Assessment
Week 12: Satisfaction with self-injection
|
7.68 Points
Standard Deviation 1.483
|
7.50 Points
Standard Deviation 1.816
|
7.46 Points
Standard Deviation 1.780
|
|
Prefilled Syringe Patient Satisfaction Assessment
Week 16: Satisfaction with self-injection
|
7.57 Points
Standard Deviation 1.741
|
7.82 Points
Standard Deviation 1.933
|
7.67 Points
Standard Deviation 1.577
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: FAS - Missing ASAS responses were considered as non-responder
ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale of 10. In this study, ASAS partial remission was used to assess the efficacy of at least one dose of secukinumab versus placebo.
Outcome measures
| Measure |
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
n=74 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Secukinumab 10 mg/kg i.v. / 300 mg s.c.
n=76 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
|
Placebo i.v. and s.c.
n=76 Participants
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.
|
|---|---|---|---|
|
ASAS Partial Remission
Responder
|
7 Participants
|
16 Participants
|
1 Participants
|
|
ASAS Partial Remission
Non-Responder
|
67 Participants
|
60 Participants
|
75 Participants
|
Adverse Events
Any Secukinumab 150 mg
Serious events: 11 serious events
Other events: 86 other events
Deaths: 0 deaths
Any Secukinumab 300 mg
Serious events: 11 serious events
Other events: 89 other events
Deaths: 0 deaths
Any Secukinumab
Serious events: 22 serious events
Other events: 175 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Any Secukinumab 150 mg
n=110 participants at risk
Includes Patients randomized to Secukinumab 150 mg at baseline + patients re-randomized to Secukinumab 150 mg at week 16 (for AEs occurring after rerandomization)
|
Any Secukinumab 300 mg
n=113 participants at risk
Includes Patients randomized to Secukinumab 300 mg at baseline + patients re-randomized to Secukinumab 300 mg at week 16 (for AEs occurring after rerandomization)
|
Any Secukinumab
n=223 participants at risk
Any Secukinumab 150 mg + Any Secukinumab 300 mg
|
Placebo
n=75 participants at risk
Includes Patients randomized to Placebo for AEs until time of re-randomization (Week 16) to Secukinumab.
|
|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Cardiac disorders
Sinus node dysfunction
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Cardiac disorders
Coronary artery disease
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Eye disorders
Cataract
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Eye disorders
Vogt-Koyanagi-Harada syndrome
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
General disorders
Fatigue
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Infections and infestations
Pyelonephritis acute
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Infections and infestations
Urinary tract infection
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.90%
2/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.3%
1/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Injury, poisoning and procedural complications
Fall
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Nervous system disorders
Migraine
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Nervous system disorders
Syncope
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Vascular disorders
Deep vein thrombosis
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.45%
1/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
Other adverse events
| Measure |
Any Secukinumab 150 mg
n=110 participants at risk
Includes Patients randomized to Secukinumab 150 mg at baseline + patients re-randomized to Secukinumab 150 mg at week 16 (for AEs occurring after rerandomization)
|
Any Secukinumab 300 mg
n=113 participants at risk
Includes Patients randomized to Secukinumab 300 mg at baseline + patients re-randomized to Secukinumab 300 mg at week 16 (for AEs occurring after rerandomization)
|
Any Secukinumab
n=223 participants at risk
Any Secukinumab 150 mg + Any Secukinumab 300 mg
|
Placebo
n=75 participants at risk
Includes Patients randomized to Placebo for AEs until time of re-randomization (Week 16) to Secukinumab.
|
|---|---|---|---|---|
|
Eye disorders
Iritis
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
3/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.3%
3/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Eye disorders
Uveitis
|
2.7%
3/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
4.4%
5/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
3.6%
8/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
3/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.8%
4/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
2/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
5/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
3/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
3.6%
8/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.3%
1/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
11/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
8.0%
9/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
9.0%
20/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Gastrointestinal disorders
Food poisoning
|
1.8%
2/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
3/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.2%
5/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Gastrointestinal disorders
Gastritis
|
2.7%
3/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.8%
4/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Gastrointestinal disorders
Nausea
|
2.7%
3/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
3.5%
4/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
3.1%
7/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.3%
1/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Gastrointestinal disorders
Toothache
|
2.7%
3/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.8%
2/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.2%
5/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.3%
1/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
3.5%
4/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.8%
4/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
General disorders
Fatigue
|
4.5%
5/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
3.5%
4/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
4.0%
9/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
General disorders
Influenza like illness
|
1.8%
2/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.3%
3/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
2/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Infections and infestations
Bronchitis
|
12.7%
14/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
8.0%
9/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
10.3%
23/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.3%
1/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Infections and infestations
Conjunctivitis
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
3/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.8%
4/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.3%
1/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Infections and infestations
Ear infection
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
3/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.3%
3/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Infections and infestations
Gastroenteritis viral
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
3/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.8%
4/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Infections and infestations
Influenza
|
2.7%
3/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
8.0%
9/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
5.4%
12/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Infections and infestations
Nasopharyngitis
|
24.5%
27/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
23.9%
27/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
24.2%
54/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
2/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Infections and infestations
Oral herpes
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
3/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.8%
4/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.3%
1/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Infections and infestations
Pharyngitis
|
2.7%
3/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
5.3%
6/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
4.0%
9/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.3%
1/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
3/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.3%
3/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Infections and infestations
Pneumonia
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
3/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.8%
4/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Infections and infestations
Pulpitis dental
|
3.6%
4/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.2%
5/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
2/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Infections and infestations
Respiratory tract infection
|
10.9%
12/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
8.8%
10/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
9.9%
22/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
5.3%
4/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Infections and infestations
Rhinitis
|
5.5%
6/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
3.5%
4/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
4.5%
10/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Infections and infestations
Sinusitis
|
7.3%
8/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
4.0%
9/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
2/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Infections and infestations
Tonsillitis
|
3.6%
4/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
3.5%
4/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
3.6%
8/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Infections and infestations
Upper respiratory tract infection
|
10.9%
12/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
14.2%
16/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
12.6%
28/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
2/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Infections and infestations
Urinary tract infection
|
3.6%
4/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
5.3%
6/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
4.5%
10/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
2/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
3/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.3%
3/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Investigations
Alanine aminotransferase increased
|
2.7%
3/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.8%
2/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.2%
5/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.6%
4/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
3/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
3.1%
7/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
4.5%
5/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
3/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
3.6%
8/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
2/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.7%
14/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
11.5%
13/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
12.1%
27/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
2/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.6%
4/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
3/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
3.1%
7/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.4%
7/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
10.6%
12/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
8.5%
19/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
2/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
3/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.8%
4/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.3%
1/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.7%
3/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
4.4%
5/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
3.6%
8/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.3%
1/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.7%
3/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.8%
4/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.8%
2/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
3.5%
4/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
6/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
4/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.8%
2/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
6/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.3%
1/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
3.6%
4/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
3.5%
4/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
3.6%
8/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
3/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.3%
3/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
2.7%
3/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.8%
4/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Nervous system disorders
Dizziness
|
1.8%
2/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
3.5%
4/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
6/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.3%
1/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Nervous system disorders
Headache
|
10.9%
12/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
12.4%
14/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
11.7%
26/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
6.7%
5/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Nervous system disorders
Hypoaesthesia
|
1.8%
2/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.90%
2/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
2/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Nervous system disorders
Migraine
|
4.5%
5/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
6/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Nervous system disorders
Paraesthesia
|
3.6%
4/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.8%
4/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Psychiatric disorders
Depression
|
2.7%
3/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
3/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
6/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.3%
1/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.5%
6/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
5.3%
6/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
5.4%
12/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
2/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.4%
7/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
6.2%
7/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
6.3%
14/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.7%
3/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.88%
1/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.8%
4/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.91%
1/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
2.7%
3/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
1.8%
4/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
|
Vascular disorders
Hypertension
|
6.4%
7/110 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
4.4%
5/113 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
5.4%
12/223 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
0.00%
0/75 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 3 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before re-randomization to Secukinumab (Week 16) and under the respective Secukinumab arm for AEs starting after re-randomization to Secukinumab (Week 16).
|
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