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FIXTURE: Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01358578
Collaborator
(none)
1,306
Enrollment
152
Locations
6
Arms
25
Duration (Months)
8.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1306 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: AIN457 150mg

AIN457 150mg

Drug: Placebo
Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept

Drug: secukinumab (AIN457)
secukinumab (AIN457) 150mg or 300mg subcutaneous
Experimental: AIN457 300mg

AIN457 300mg

Drug: Placebo
Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept

Drug: secukinumab (AIN457)
secukinumab (AIN457) 150mg or 300mg subcutaneous
Placebo Comparator: Placebo

Placebo

Drug: Placebo
Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept
Active Comparator: Etanercept

Etanercept

Drug: Placebo
Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept

Drug: etanercept
etanercept 50mg subcutaneous
Experimental: AIN457 150mg from Placebo

Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase

Drug: Placebo
Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept

Drug: secukinumab (AIN457)
secukinumab (AIN457) 150mg or 300mg subcutaneous
Experimental: AIN457 300mg from Placebo

Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase

Drug: Placebo
Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept

Drug: secukinumab (AIN457)
secukinumab (AIN457) 150mg or 300mg subcutaneous

Outcome Measures

Primary Outcome Measures

  1. Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . [12 wks]

    A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis

  2. Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 [12 wks]

    The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.

Secondary Outcome Measures

  1. Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12 [12 wks]

    A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above current benchmark of primary endpoints for most clinical trials of psoriasis

  2. Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12 [12 wks]

    A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis

  3. Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: :IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 [12 wks]

    The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.

  4. Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation) [52 wks]

  5. Maintenance of IGA Mod 2011 0 or 1 Response After 52 Weeks of Treatment for Subjects Who Were IGA Mod 2011 0 or 1 Responders After 12 Weeks of Treatment [52 wks]

  6. Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo [baseline to week 12]

    The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy

  7. Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept [baseline to week 12]

    The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy

  8. Number of Participants Developing Anti-secukinumab Antibodies [60 weeks]

    Describes the number of participants tested positive for anti-secukinumab antibodies. It refers to the number of patients who had no positive values at baseline but developed them only after start of active study treatment (AIN457 or etanercept)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Subjects with chronic, plaque-type psoriasis for at least 6 months

  • Must have moderate to severe psoriasis based on PASI greater than 12, IGA greater than 3, and greater than 10% body surface area

  • Must be inadequately controlled by prior treatments (topicals, phototherapy, and/or systemic therapies)

Exclusion Criteria:

  • Forms of psoriasis other than chronic, plaque-type (such as pustular, erythrodermic and guttate psoriasis)

  • Drug induced psoriasis

  • Use of other psoriasis treatments during the study

  • Prior use of etanercept

  • Prior use of secukinumab or any other drug that target IL-17 (interleukin 17) or the IL-17 receptor

  • Pregnant or lactating women; women who do not agree to use contraception during the study and for 16 weeks after stopping treatment

  • Significant medical problems such as uncontrolled high blood pressure, congestive heart failure, etc.

  • History of an ongoing, chronic or recurrent infection or evidence of tuberculosis

  • Allergy to rubber or latex

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novartis Investigative Site Birmingham Alabama United States 35205
2 Novartis Investigative Site Phoenix Arizona United States 85013
3 Novartis Investigative Site San Diego California United States 92103
4 Novartis Investigative Site San Diego California United States 92123
5 Novartis Investigative Site Indianapolis Indiana United States 46256
6 Novartis Investigative Site High Point North Carolina United States 27262
7 Novartis Investigative Site Warren Ohio United States 44483
8 Novartis Investigative Site Portland Oregon United States 97210
9 Novartis Investigative Site Johnston Rhode Island United States 02919
10 Novartis Investigative Site Charleston South Carolina United States 29407
11 Novartis Investigative Site Kingsport Tennessee United States 37660
12 Novartis Investigative Site San Antonio Texas United States 78229
13 Novartis Investigative Site Norfolk Virginia United States 23507
14 Novartis Investigative Site Caba Buenos Aires Argentina C1062ABK
15 Novartis Investigative Site Caba Buenos Aires Argentina C1114AAO
16 Novartis Investigative Site Caba Buenos Aires Argentina C1181ACH
17 Novartis Investigative Site Caba Buenos Aires Argentina C1425BEI
18 Novartis Investigative Site Caba Capital Federal Argentina
19 Novartis Investigative Site Buenos Aires Argentina C1425DKG
20 Novartis Investigative Site Mendoza Argentina M5502EZA
21 Novartis Investigative Site Kogarah New South Wales Australia 2217
22 Novartis Investigative Site Woolloongabba Queensland Australia 4102
23 Novartis Investigative Site Carlton Victoria Australia 3053
24 Novartis Investigative Site East Melbourne Victoria Australia 3002
25 Novartis Investigative Site Brussel Belgium 1090
26 Novartis Investigative Site Bruxelles Belgium 1200
27 Novartis Investigative Site Gent Belgium 9000
28 Novartis Investigative Site Liège Belgium 4000
29 Novartis Investigative Site Edmonton Alberta Canada T5K 1X3
30 Novartis Investigative Site Surrey British Columbia Canada V3V 0C6
31 Novartis Investigative Site Vancouver British Columbia Canada V5Z 4E8
32 Novartis Investigative Site Halifax Nova Scotia Canada B3H 1Z2
33 Novartis Investigative Site Markham Ontario Canada L3P 1A8
34 Novartis Investigative Site Richmond Hil Ontario Canada L4B 1A5
35 Novartis Investigative Site Waterloo Ontario Canada N2J 1C4
36 Novartis Investigative Site Sainte-Foy Quebec Canada G1V 4X7
37 Novartis Investigative Site Barranquilla Colombia
38 Novartis Investigative Site Bogotá Colombia
39 Novartis Investigative Site Bucaramanga Colombia
40 Novartis Investigative Site Alexandria Egypt 21131
41 Novartis Investigative Site Helsinki Finland 00250
42 Novartis Investigative Site Turku Finland FIN-20520
43 Novartis Investigative Site Marseille Cedex 9 France 13913
44 Novartis Investigative Site Martigues France 13500
45 Novartis Investigative Site Nice Cedex 3 France 06202
46 Novartis Investigative Site Paris France 75475
47 Novartis Investigative Site Pessac Cedex France 33604
48 Novartis Investigative Site Reims France 51092
49 Novartis Investigative Site Toulouse Cedex France 31059
50 Novartis Investigative Site Augsburg Germany 86179
51 Novartis Investigative Site Berlin Germany 10117
52 Novartis Investigative Site Berlin Germany 10827
53 Novartis Investigative Site Berlin Germany 13187
54 Novartis Investigative Site Bielefeld Germany 33647
55 Novartis Investigative Site Bochum Germany 44791
56 Novartis Investigative Site Bochum Germany 44803
57 Novartis Investigative Site Bonn Germany 53105
58 Novartis Investigative Site Darmstadt Germany 64283
59 Novartis Investigative Site Dresden Germany 01307
60 Novartis Investigative Site Erfurt Germany 99089
61 Novartis Investigative Site Erlangen Germany 91052
62 Novartis Investigative Site Essen Germany 45122
63 Novartis Investigative Site Frankfurt Germany 60590
64 Novartis Investigative Site Gera Germany 07548
65 Novartis Investigative Site Goettingen Germany 37075
66 Novartis Investigative Site Greifswald Germany 17475
67 Novartis Investigative Site Hamburg Germany 20354
68 Novartis Investigative Site Hamburg Germany 22143
69 Novartis Investigative Site Hamburg Germany 22391
70 Novartis Investigative Site Hanau Germany 63450
71 Novartis Investigative Site Heidelberg Germany 69115
72 Novartis Investigative Site Kiel Germany 24105
73 Novartis Investigative Site Krefeld Germany 47805
74 Novartis Investigative Site Köln Germany 50937
75 Novartis Investigative Site Muenster Germany 48149
76 Novartis Investigative Site München Germany 80802
77 Novartis Investigative Site Nuernberg Germany 90419
78 Novartis Investigative Site Osnabrück Germany 49074
79 Novartis Investigative Site Plauen Germany 08529
80 Novartis Investigative Site Recklinghausen Germany 45657
81 Novartis Investigative Site Regensburg Germany 93053
82 Novartis Investigative Site Schwerin Germany 19055
83 Novartis Investigative Site Tuebingen Germany 72076
84 Novartis Investigative Site Witten Germany 58452
85 Novartis Investigative Site Wuppertal Germany 42275
86 Novartis Investigative Site Guatemala City Guatemala 01010
87 Novartis Investigative Site Guatemala City Guatemala 01015
88 Novartis Investigative Site Budapest Hungary 1036
89 Novartis Investigative Site Budapest Hungary 1134
90 Novartis Investigative Site Debrecen Hungary 4032
91 Novartis Investigative Site Kaposvár Hungary 7400
92 Novartis Investigative Site Miskolc Hungary 3529
93 Novartis Investigative Site Szeged Hungary H-6720
94 Novartis Investigative Site Szombathely Hungary 9700
95 Novartis Investigative Site Kopavogur Iceland IS-201
96 Novartis Investigative Site Hyderabad Andhra Pradesh India 500008
97 Novartis Investigative Site Hyderabad Andhra Pradesh India 500012
98 Novartis Investigative Site Vishakhapatnam Andhra Pradesh India 532 002
99 Novartis Investigative Site Bangalore Karnataka India 400038
100 Novartis Investigative Site Bangalore Karnataka India 560002
101 Novartis Investigative Site Bangalore Karnataka India 560004
102 Novartis Investigative Site Mangalore Karnataka India 575002
103 Novartis Investigative Site Dadar (east) Mumbai Maharashtra India 400018
104 Novartis Investigative Site Mumbai Maharashtra India 400 022
105 Novartis Investigative Site Nagpur Maharashtra India 440019
106 Novartis Investigative Site Dehli New Delhi India 110 051
107 Novartis Investigative Site Hyderabad India 500044
108 Novartis Investigative Site L'Aquila AQ Italy 67100
109 Novartis Investigative Site Catania CT Italy 95123
110 Novartis Investigative Site Genova GE Italy 16132
111 Novartis Investigative Site Terracina LT Italy 04019
112 Novartis Investigative Site Modena MO Italy 41100
113 Novartis Investigative Site Roma RM Italy 00167
114 Novartis Investigative Site Napoli Italy 80131
115 Novartis Investigative Site Anyang Gyeonggi-do Korea, Republic of 431-070
116 Novartis Investigative Site Seoul Korea Korea, Republic of 135-710
117 Novartis Investigative Site Busan Korea, Republic of 602-739
118 Novartis Investigative Site Daejeon Korea, Republic of 301-747
119 Novartis Investigative Site Gwangju Korea, Republic of 501-575
120 Novartis Investigative Site Seoul Korea, Republic of 120-752
121 Novartis Investigative Site Seoul Korea, Republic of 137-701
122 Novartis Investigative Site Seoul Korea, Republic of 143-729
123 Novartis Investigative Site Seoul Korea, Republic of 156-755
124 Novartis Investigative Site Seoul Korea, Republic of 738-736
125 Novartis Investigative Site Las Pinas Philippines 1740
126 Novartis Investigative Site Manila Philippines 1000
127 Novartis Investigative Site Lodz Poland 90-265
128 Novartis Investigative Site Lodz Poland 90-436
129 Novartis Investigative Site Poznan Poland 60-529
130 Novartis Investigative Site Wroclaw Poland 50-368
131 Novartis Investigative Site Bucuresti Romania 011461
132 Novartis Investigative Site Bucuresti Romania 021105
133 Novartis Investigative Site Bucuresti Romania 041335
134 Novartis Investigative Site Bucuresti Romania 062272
135 Novartis Investigative Site Singapore Singapore 119074
136 Novartis Investigative Site Sabadell Barcelona Spain 08208
137 Novartis Investigative Site Santa Coloma De Gramanet Cataluña Spain 08923
138 Novartis Investigative Site Valencia Comunidad Valenciana Spain 46014
139 Novartis Investigative Site Barcelona Spain 08025
140 Novartis Investigative Site Madrid Spain 28031
141 Novartis Investigative Site Madrid Spain 28041
142 Novartis Investigative Site Göteborg Sweden 413 45
143 Novartis Investigative Site Luleå Sweden 972 33
144 Novartis Investigative Site Malmo Sweden SE-205 02
145 Novartis Investigative Site Uppsala Sweden 751 85
146 Novartis Investigative Site Plymouth Devon United Kingdom PL6 8DH
147 Novartis Investigative Site Salford Manchester United Kingdom M6 8HD
148 Novartis Investigative Site Yeovil Somerset United Kingdom BA21 4AT
149 Novartis Investigative Site Dudley United Kingdom DY1 2HQ
150 Novartis Investigative Site Harrogate United Kingdom HG2 7SX
151 Novartis Investigative Site London United Kingdom E11 1NR
152 Novartis Investigative Site Nuneaton United Kingdom CV10 7DJ

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01358578
Other Study ID Numbers:
  • CAIN457A2303
  • 2010-022228-66
First Posted:
May 23, 2011
Last Update Posted:
Jan 5, 2021
Last Verified:
Mar 1, 2019
Keywords provided by Novartis Pharmaceuticals
Psoriasis,
inflammatory skin disease,
scaly patches
Psoriasis
inflammatory skin disease
Additional relevant MeSH terms:
Psoriasis
Etanercept

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title AIN457 150mg AIN457 300mg Placebo Etanercept AIN457 150mg From Placebo AIN457 300mg From Placebo
Arm/Group Description s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12: Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab. Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 150 in maintenance Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 300 in maintenance
Period Title: Induction Period
STARTED 327 327 326 326 0 0
COMPLETED 315 312 301 305 0 0
NOT COMPLETED 12 15 25 21 0 0
Period Title: Induction Period
STARTED 315 312 17 305 142 142
COMPLETED 276 290 15 263 125 131
NOT COMPLETED 39 22 2 42 17 11
Period Title: Induction Period
STARTED 148 125 26 279 0 0
COMPLETED 138 119 21 260 0 0
NOT COMPLETED 10 6 5 19 0 0

Baseline Characteristics

Arm/Group Title AIN457 150mg AIN457 300mg Placebo Etanercept Total
Arm/Group Description AIN457 150mg AIN457 300mg Placebo Etanercept Total of all reporting groups
Overall Participants 327 327 326 326 1306
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
0
0%
0
0%
Between 18 and 65 years
304
93%
305
93.3%
311
95.4%
308
94.5%
1228
94%
>=65 years
23
7%
22
6.7%
15
4.6%
18
5.5%
78
6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
45.4
(12.92)
44.5
(13.19)
44.1
(12.64)
43.8
(12.95)
44.4
(12.93)
Sex: Female, Male (Count of Participants)
Female
91
27.8%
103
31.5%
89
27.3%
94
28.8%
377
28.9%
Male
236
72.2%
224
68.5%
237
72.7%
232
71.2%
929
71.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
28
8.6%
22
6.7%
25
7.7%
27
8.3%
102
7.8%
Asian
72
22%
73
22.3%
72
22.1%
74
22.7%
291
22.3%
Native Hawaiian or Other Pacific Islander
0
0%
1
0.3%
1
0.3%
1
0.3%
3
0.2%
Black or African American
3
0.9%
2
0.6%
3
0.9%
0
0%
8
0.6%
White
219
67%
224
68.5%
218
66.9%
219
67.2%
880
67.4%
More than one race
5
1.5%
5
1.5%
5
1.5%
4
1.2%
19
1.5%
Unknown or Not Reported
0
0%
0
0%
2
0.6%
1
0.3%
3
0.2%

Outcome Measures

1. Primary Outcome
Title Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) .
Description A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis
Time Frame 12 wks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title AIN457 150mg AIN457 300mg Placebo
Arm/Group Description s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
Measure Participants 327 323 324
Number [participants achieving goal]
219
67%
249
76.1%
16
4.9%
2. Primary Outcome
Title Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12
Description The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.
Time Frame 12 wks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title AIN457 150mg AIN457 300mg Placebo
Arm/Group Description s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
Measure Participants 327 323 324
Number [participants acheiving goal]
167
51.1%
202
61.8%
9
2.8%
3. Secondary Outcome
Title Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12
Description A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above current benchmark of primary endpoints for most clinical trials of psoriasis
Time Frame 12 wks

Outcome Measure Data

Analysis Population Description
FAS
Arm/Group Title AIN457 150mg AIN457 300mg Etanercept Placebo
Arm/Group Description s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab. s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
Measure Participants 327 323 323 324
Number [participant who acheived goal]
137
175
67
5
4. Secondary Outcome
Title Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12
Description A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis
Time Frame 12 wks

Outcome Measure Data

Analysis Population Description
FAS
Arm/Group Title AIN457 150mg AIN457 300mg Etanercept
Arm/Group Description s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
Measure Participants 327 323 323
Number [participant who acheived goal]
219
249
142
5. Secondary Outcome
Title Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: :IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12
Description The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.
Time Frame 12 wks

Outcome Measure Data

Analysis Population Description
FAS
Arm/Group Title AIN457 150mg AIN457 300mg Etanercept
Arm/Group Description s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
Measure Participants 327 323 323
Number [participant acheiving goal]
167
202
88
6. Secondary Outcome
Title Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation)
Description
Time Frame 52 wks

Outcome Measure Data

Analysis Population Description
Full analysis set
Arm/Group Title AIN457 150mg AIN457 300mg Etanercept
Arm/Group Description s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
Measure Participants 219 249 142
Number [participants who reached goal]
180
55%
210
64.2%
103
31.6%
7. Secondary Outcome
Title Maintenance of IGA Mod 2011 0 or 1 Response After 52 Weeks of Treatment for Subjects Who Were IGA Mod 2011 0 or 1 Responders After 12 Weeks of Treatment
Description
Time Frame 52 wks

Outcome Measure Data

Analysis Population Description
Full analysis set
Arm/Group Title AIN457 150mg AIN457 300mg Etanercept
Arm/Group Description s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
Measure Participants 167 202 88
Number [participants who reached goal]
113
34.6%
161
49.2%
50
15.3%
8. Secondary Outcome
Title Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo
Description The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy
Time Frame baseline to week 12

Outcome Measure Data

Analysis Population Description
Full analysis set
Arm/Group Title AIN457 150mg AIN457 300mg Placebo
Arm/Group Description s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 AIN457A exact match Placebo
Measure Participants 117 117 109
Itching
-4.92
(0.249)
-4.93
(0.247)
-0.54
(0.201)
Pain
-4.10
(0.277)
-4.48
(0.278)
-0.33
(0.216)
Scaling
-4.89
(0.241)
-4.93
(0.258)
-0.42
(0.217)
9. Secondary Outcome
Title Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept
Description The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy
Time Frame baseline to week 12

Outcome Measure Data

Analysis Population Description
Full analysis set
Arm/Group Title AIN457 150mg AIN457 300mg Etanercept
Arm/Group Description s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 etanercept 50 mg twice per week until Week 12
Measure Participants 117 117 116
Itching
-4.92
(0.277)
-4.93
(0.278)
-3.80
(0.257)
Pain
-4.10
(0.268)
-4.48
(0.269)
-3.48
(0.251)
Scaling
-4.89
(0.241)
-4.93
(0.258)
-3.74
(0.260)
10. Secondary Outcome
Title Number of Participants Developing Anti-secukinumab Antibodies
Description Describes the number of participants tested positive for anti-secukinumab antibodies. It refers to the number of patients who had no positive values at baseline but developed them only after start of active study treatment (AIN457 or etanercept)
Time Frame 60 weeks

Outcome Measure Data

Analysis Population Description
Full Analysis Set
Arm/Group Title AIN457 150mg AIN457 300mg PLACEBO-150 mg AIN457 PLACEBO-300 mg AIN457 Placebo Etanercept
Arm/Group Description s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48 Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 150 in maintenance Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 300 in maintenance s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to treatment groups based on their PASI 75 response status at Week 12: Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab
Measure Participants 327 327 142 142 17 326
Number [# participants tested positive]
2
0.6%
3
0.9%
0
0%
0
0%
0
0%
6
NaN

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title INDUCTION-AIN457 150mg INDUCTION-AIN457 300mg INDUCTION-Placebo INDUCTION-Etanercept ENTIRE-AIN457 150mg ENTIRE-AIN457 300mg ENTIRE-Any AIN457 150mg ENTIRE-Any AIN457 300mg ENTIRE-Placebo ENTIRE-Etanercept FOLLOW UP-Any AIN457 150mg FOLLOW UP-Any AIN457 300mg FOLLOW UP-Placebo FOLLOW UP-Etanercept
Arm/Group Description INDUCTION-AIN457 150mg INDUCTION-AIN457 300mg INDUCTION-Placebo INDUCTION-Etanercept ENTIRE-AIN457 150mg ENTIRE-AIN457 300mg ENTIRE-Any AIN457 150mg ENTIRE-Any AIN457 300mg ENTIRE-Placebo ENTIRE-Etanercept FOLLOW UP-Any AIN457 150mg FOLLOW UP-Any AIN457 300mg FOLLOW UP-Placebo FOLLOW UP-Etanercept
All Cause Mortality
INDUCTION-AIN457 150mg INDUCTION-AIN457 300mg INDUCTION-Placebo INDUCTION-Etanercept ENTIRE-AIN457 150mg ENTIRE-AIN457 300mg ENTIRE-Any AIN457 150mg ENTIRE-Any AIN457 300mg ENTIRE-Placebo ENTIRE-Etanercept FOLLOW UP-Any AIN457 150mg FOLLOW UP-Any AIN457 300mg FOLLOW UP-Placebo FOLLOW UP-Etanercept
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
INDUCTION-AIN457 150mg INDUCTION-AIN457 300mg INDUCTION-Placebo INDUCTION-Etanercept ENTIRE-AIN457 150mg ENTIRE-AIN457 300mg ENTIRE-Any AIN457 150mg ENTIRE-Any AIN457 300mg ENTIRE-Placebo ENTIRE-Etanercept FOLLOW UP-Any AIN457 150mg FOLLOW UP-Any AIN457 300mg FOLLOW UP-Placebo FOLLOW UP-Etanercept
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 7/327 (2.1%) 4/326 (1.2%) 6/327 (1.8%) 3/323 (0.9%) 18/327 (5.5%) 21/326 (6.4%) 24/469 (5.1%) 27/467 (5.8%) 7/327 (2.1%) 20/323 (6.2%) 2/148 (1.4%) 2/125 (1.6%) 0/27 (0%) 2/278 (0.7%)
Blood and lymphatic system disorders
ANAEMIA 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 1/278 (0.4%)
Cardiac disorders
ANGINA PECTORIS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
ANGINA UNSTABLE 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
ARTERIOSCLEROSIS CORONARY ARTERY 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
CARDIAC ARREST 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
MITRAL VALVE INCOMPETENCE 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
MYOCARDIAL INFARCTION 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
PALPITATIONS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Endocrine disorders
BASEDOW'S DISEASE 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 1/148 (0.7%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
HYPERTHYROIDISM 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
PARATHYROID GLAND ENLARGEMENT 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
THYROTOXIC CRISIS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Gastrointestinal disorders
ANAL FISTULA 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
COLITIS ULCERATIVE 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
CROHN'S DISEASE 1/327 (0.3%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
DYSPHAGIA 1/327 (0.3%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
INGUINAL HERNIA 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
OESOPHAGEAL FOOD IMPACTION 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
General disorders
NON-CARDIAC CHEST PAIN 1/327 (0.3%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 1/278 (0.4%)
POLYSEROSITIS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 1/125 (0.8%) 0/27 (0%) 0/278 (0%)
Hepatobiliary disorders
CHOLECYSTITIS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
CHOLECYSTITIS ACUTE 0/327 (0%) 0/326 (0%) 0/327 (0%) 1/323 (0.3%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Infections and infestations
ACUTE TONSILLITIS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
ANAL ABSCESS 0/327 (0%) 1/326 (0.3%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
APPENDICITIS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
CELLULITIS 0/327 (0%) 0/326 (0%) 1/327 (0.3%) 0/323 (0%) 1/327 (0.3%) 1/326 (0.3%) 1/469 (0.2%) 1/467 (0.2%) 1/327 (0.3%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
DIVERTICULITIS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
HEPATITIS B 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 1/148 (0.7%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
PERIRECTAL ABSCESS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
PHARYNGOTONSILLITIS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
PYELONEPHRITIS ACUTE 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
SUBCUTANEOUS ABSCESS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
TONSILLITIS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 1/125 (0.8%) 0/27 (0%) 0/278 (0%)
URINARY TRACT INFECTION 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Injury, poisoning and procedural complications
ALCOHOL POISONING 0/327 (0%) 0/326 (0%) 1/327 (0.3%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 1/327 (0.3%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
CARTILAGE INJURY 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
CLAVICLE FRACTURE 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
HEAD INJURY 1/327 (0.3%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
JOINT DISLOCATION 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
LACERATION 1/327 (0.3%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
LIGAMENT RUPTURE 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
OVERDOSE 1/327 (0.3%) 1/326 (0.3%) 1/327 (0.3%) 0/323 (0%) 1/327 (0.3%) 1/326 (0.3%) 1/469 (0.2%) 1/467 (0.2%) 1/327 (0.3%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
POST PROCEDURAL HYPOTHYROIDISM 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 1/148 (0.7%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
POSTOPERATIVE RESPIRATORY DISTRESS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 1/148 (0.7%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
RADIUS FRACTURE 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
RIB FRACTURE 0/327 (0%) 1/326 (0.3%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
TENDON INJURY 0/327 (0%) 0/326 (0%) 1/327 (0.3%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 1/327 (0.3%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
UPPER LIMB FRACTURE 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Metabolism and nutrition disorders
HYPERGLYCAEMIA 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
HYPOKALAEMIA 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
BACK PAIN 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 1/326 (0.3%) 1/469 (0.2%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
BURSITIS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
CHONDROPATHY 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
INTERVERTEBRAL DISC PROTRUSION 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
JOINT INSTABILITY 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
MUSCULAR WEAKNESS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
NECK PAIN 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
OSTEONECROSIS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
PSORIATIC ARTHROPATHY 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
ROTATOR CUFF SYNDROME 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Nervous system disorders
CEREBROVASCULAR ACCIDENT 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
FACIAL PARESIS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
HEADACHE 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
HYPOAESTHESIA 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
SCIATICA 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
SYNCOPE 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
TRANSIENT ISCHAEMIC ATTACK 0/327 (0%) 0/326 (0%) 0/327 (0%) 1/323 (0.3%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 1/327 (0.3%) 2/323 (0.6%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
VIITH NERVE PARALYSIS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
VITH NERVE PARALYSIS 1/327 (0.3%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Psychiatric disorders
DEPRESSION SUICIDAL 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
DRUG ABUSE 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
INSOMNIA 1/327 (0.3%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Renal and urinary disorders
CALCULUS URETHRAL 0/327 (0%) 0/326 (0%) 0/327 (0%) 1/323 (0.3%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
HAEMATURIA 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 1/326 (0.3%) 1/469 (0.2%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
RENAL COLIC 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Reproductive system and breast disorders
PROSTATOMEGALY 0/327 (0%) 1/326 (0.3%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Respiratory, thoracic and mediastinal disorders
EPISTAXIS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 1/278 (0.4%)
INTERSTITIAL LUNG DISEASE 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
OROPHARYNGEAL PAIN 1/327 (0.3%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Skin and subcutaneous tissue disorders
DERMATITIS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
DYSHIDROTIC ECZEMA 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
LICHEN SCLEROSUS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
PAIN OF SKIN 1/327 (0.3%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 0/326 (0%) 1/469 (0.2%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
PSORIASIS 0/327 (0%) 0/326 (0%) 2/327 (0.6%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 2/327 (0.6%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Social circumstances
ABSTAINS FROM ALCOHOL 0/327 (0%) 0/326 (0%) 1/327 (0.3%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 1/327 (0.3%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Vascular disorders
ARTERIAL OCCLUSIVE DISEASE 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
BEHCET'S SYNDROME 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 1/125 (0.8%) 0/27 (0%) 0/278 (0%)
HYPERTENSIVE CRISIS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 1/469 (0.2%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 1/326 (0.3%) 0/469 (0%) 1/467 (0.2%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Other (Not Including Serious) Adverse Events
INDUCTION-AIN457 150mg INDUCTION-AIN457 300mg INDUCTION-Placebo INDUCTION-Etanercept ENTIRE-AIN457 150mg ENTIRE-AIN457 300mg ENTIRE-Any AIN457 150mg ENTIRE-Any AIN457 300mg ENTIRE-Placebo ENTIRE-Etanercept FOLLOW UP-Any AIN457 150mg FOLLOW UP-Any AIN457 300mg FOLLOW UP-Placebo FOLLOW UP-Etanercept
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 157/327 (48%) 145/326 (44.5%) 121/327 (37%) 130/323 (40.2%) 225/327 (68.8%) 230/326 (70.6%) 297/469 (63.3%) 316/467 (67.7%) 122/327 (37.3%) 213/323 (65.9%) 25/148 (16.9%) 11/125 (8.8%) 7/27 (25.9%) 59/278 (21.2%)
Eye disorders
CONJUNCTIVITIS 0/327 (0%) 3/326 (0.9%) 1/327 (0.3%) 0/323 (0%) 3/327 (0.9%) 9/326 (2.8%) 3/469 (0.6%) 10/467 (2.1%) 1/327 (0.3%) 3/323 (0.9%) 0/148 (0%) 1/125 (0.8%) 0/27 (0%) 0/278 (0%)
Gastrointestinal disorders
ABDOMINAL PAIN 2/327 (0.6%) 3/326 (0.9%) 4/327 (1.2%) 3/323 (0.9%) 7/327 (2.1%) 5/326 (1.5%) 11/469 (2.3%) 6/467 (1.3%) 4/327 (1.2%) 8/323 (2.5%) 1/148 (0.7%) 0/125 (0%) 0/27 (0%) 2/278 (0.7%)
ABDOMINAL PAIN UPPER 4/327 (1.2%) 2/326 (0.6%) 4/327 (1.2%) 1/323 (0.3%) 10/327 (3.1%) 10/326 (3.1%) 12/469 (2.6%) 14/467 (3%) 4/327 (1.2%) 3/323 (0.9%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
DIARRHOEA 12/327 (3.7%) 17/326 (5.2%) 6/327 (1.8%) 11/323 (3.4%) 30/327 (9.2%) 34/326 (10.4%) 36/469 (7.7%) 38/467 (8.1%) 7/327 (2.1%) 22/323 (6.8%) 2/148 (1.4%) 1/125 (0.8%) 0/27 (0%) 3/278 (1.1%)
NAUSEA 6/327 (1.8%) 8/326 (2.5%) 7/327 (2.1%) 4/323 (1.2%) 10/327 (3.1%) 9/326 (2.8%) 10/469 (2.1%) 11/467 (2.4%) 7/327 (2.1%) 7/323 (2.2%) 1/148 (0.7%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
TOOTHACHE 3/327 (0.9%) 6/326 (1.8%) 5/327 (1.5%) 3/323 (0.9%) 10/327 (3.1%) 10/326 (3.1%) 12/469 (2.6%) 13/467 (2.8%) 6/327 (1.8%) 7/323 (2.2%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 1/278 (0.4%)
VOMITING 1/327 (0.3%) 4/326 (1.2%) 1/327 (0.3%) 5/323 (1.5%) 2/327 (0.6%) 10/326 (3.1%) 4/469 (0.9%) 10/467 (2.1%) 1/327 (0.3%) 9/323 (2.8%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 1/278 (0.4%)
General disorders
ADVERSE DRUG REACTION 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 1/27 (3.7%) 0/278 (0%)
FATIGUE 5/327 (1.5%) 7/326 (2.1%) 3/327 (0.9%) 5/323 (1.5%) 9/327 (2.8%) 14/326 (4.3%) 12/469 (2.6%) 16/467 (3.4%) 3/327 (0.9%) 6/323 (1.9%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 1/278 (0.4%)
INFLUENZA LIKE ILLNESS 2/327 (0.6%) 2/326 (0.6%) 1/327 (0.3%) 3/323 (0.9%) 7/327 (2.1%) 5/326 (1.5%) 7/469 (1.5%) 8/467 (1.7%) 1/327 (0.3%) 9/323 (2.8%) 1/148 (0.7%) 1/125 (0.8%) 0/27 (0%) 1/278 (0.4%)
INJECTION SITE ERYTHEMA 0/327 (0%) 0/326 (0%) 0/327 (0%) 16/323 (5%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 17/323 (5.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
OEDEMA PERIPHERAL 5/327 (1.5%) 1/326 (0.3%) 4/327 (1.2%) 1/323 (0.3%) 9/327 (2.8%) 3/326 (0.9%) 10/469 (2.1%) 4/467 (0.9%) 4/327 (1.2%) 5/323 (1.5%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 1/278 (0.4%)
PYREXIA 2/327 (0.6%) 5/326 (1.5%) 3/327 (0.9%) 7/323 (2.2%) 10/327 (3.1%) 12/326 (3.7%) 14/469 (3%) 19/467 (4.1%) 3/327 (0.9%) 15/323 (4.6%) 1/148 (0.7%) 0/125 (0%) 0/27 (0%) 1/278 (0.4%)
Infections and infestations
BRONCHITIS 4/327 (1.2%) 4/326 (1.2%) 2/327 (0.6%) 4/323 (1.2%) 12/327 (3.7%) 15/326 (4.6%) 14/469 (3%) 17/467 (3.6%) 2/327 (0.6%) 9/323 (2.8%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 2/278 (0.7%)
EAR INFECTION 0/327 (0%) 1/326 (0.3%) 1/327 (0.3%) 0/323 (0%) 4/327 (1.2%) 8/326 (2.5%) 4/469 (0.9%) 8/467 (1.7%) 1/327 (0.3%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 1/278 (0.4%)
FOLLICULITIS 4/327 (1.2%) 0/326 (0%) 1/327 (0.3%) 3/323 (0.9%) 9/327 (2.8%) 9/326 (2.8%) 14/469 (3%) 13/467 (2.8%) 1/327 (0.3%) 8/323 (2.5%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
GASTROENTERITIS 3/327 (0.9%) 5/326 (1.5%) 2/327 (0.6%) 3/323 (0.9%) 10/327 (3.1%) 15/326 (4.6%) 12/469 (2.6%) 18/467 (3.9%) 3/327 (0.9%) 8/323 (2.5%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
IMPETIGO 0/327 (0%) 4/326 (1.2%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 7/326 (2.1%) 1/469 (0.2%) 9/467 (1.9%) 0/327 (0%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
INFLUENZA 5/327 (1.5%) 5/326 (1.5%) 3/327 (0.9%) 2/323 (0.6%) 9/327 (2.8%) 18/326 (5.5%) 12/469 (2.6%) 22/467 (4.7%) 3/327 (0.9%) 11/323 (3.4%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 2/278 (0.7%)
NASOPHARYNGITIS 44/327 (13.5%) 35/326 (10.7%) 26/327 (8%) 37/323 (11.5%) 82/327 (25.1%) 91/326 (27.9%) 107/469 (22.8%) 122/467 (26.1%) 26/327 (8%) 87/323 (26.9%) 6/148 (4.1%) 1/125 (0.8%) 3/27 (11.1%) 14/278 (5%)
ORAL CANDIDIASIS 1/327 (0.3%) 2/326 (0.6%) 0/327 (0%) 0/323 (0%) 4/327 (1.2%) 10/326 (3.1%) 6/469 (1.3%) 12/467 (2.6%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
ORAL HERPES 1/327 (0.3%) 5/326 (1.5%) 0/327 (0%) 0/323 (0%) 1/327 (0.3%) 8/326 (2.5%) 4/469 (0.9%) 10/467 (2.1%) 0/327 (0%) 9/323 (2.8%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 1/278 (0.4%)
PHARYNGITIS 5/327 (1.5%) 4/326 (1.2%) 0/327 (0%) 0/323 (0%) 7/327 (2.1%) 9/326 (2.8%) 10/469 (2.1%) 13/467 (2.8%) 0/327 (0%) 6/323 (1.9%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
RHINITIS 4/327 (1.2%) 7/326 (2.1%) 4/327 (1.2%) 3/323 (0.9%) 7/327 (2.1%) 10/326 (3.1%) 8/469 (1.7%) 14/467 (3%) 4/327 (1.2%) 6/323 (1.9%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
SINUSITIS 5/327 (1.5%) 0/326 (0%) 1/327 (0.3%) 0/323 (0%) 9/327 (2.8%) 8/326 (2.5%) 11/469 (2.3%) 9/467 (1.9%) 1/327 (0.3%) 5/323 (1.5%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 1/278 (0.4%)
TINEA PEDIS 3/327 (0.9%) 3/326 (0.9%) 0/327 (0%) 0/323 (0%) 6/327 (1.8%) 8/326 (2.5%) 7/469 (1.5%) 10/467 (2.1%) 0/327 (0%) 4/323 (1.2%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
TONSILLITIS 3/327 (0.9%) 2/326 (0.6%) 2/327 (0.6%) 0/323 (0%) 7/327 (2.1%) 9/326 (2.8%) 10/469 (2.1%) 12/467 (2.6%) 2/327 (0.6%) 3/323 (0.9%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
TOOTH ABSCESS 0/327 (0%) 0/326 (0%) 1/327 (0.3%) 0/323 (0%) 3/327 (0.9%) 1/326 (0.3%) 4/469 (0.9%) 2/467 (0.4%) 1/327 (0.3%) 3/323 (0.9%) 0/148 (0%) 0/125 (0%) 1/27 (3.7%) 0/278 (0%)
TRICHOMONIASIS 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 1/27 (3.7%) 0/278 (0%)
UPPER RESPIRATORY TRACT INFECTION 10/327 (3.1%) 7/326 (2.1%) 3/327 (0.9%) 7/323 (2.2%) 21/327 (6.4%) 19/326 (5.8%) 26/469 (5.5%) 26/467 (5.6%) 3/327 (0.9%) 18/323 (5.6%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 2/278 (0.7%)
URINARY TRACT INFECTION 2/327 (0.6%) 2/326 (0.6%) 3/327 (0.9%) 6/323 (1.9%) 6/327 (1.8%) 8/326 (2.5%) 8/469 (1.7%) 13/467 (2.8%) 3/327 (0.9%) 9/323 (2.8%) 1/148 (0.7%) 0/125 (0%) 0/27 (0%) 2/278 (0.7%)
VIRAL UPPER RESPIRATORY TRACT INFECTION 1/327 (0.3%) 1/326 (0.3%) 1/327 (0.3%) 0/323 (0%) 7/327 (2.1%) 7/326 (2.1%) 8/469 (1.7%) 11/467 (2.4%) 1/327 (0.3%) 1/323 (0.3%) 2/148 (1.4%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Injury, poisoning and procedural complications
MUSCLE RUPTURE 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 1/27 (3.7%) 0/278 (0%)
MUSCLE STRAIN 2/327 (0.6%) 2/326 (0.6%) 3/327 (0.9%) 0/323 (0%) 9/327 (2.8%) 3/326 (0.9%) 9/469 (1.9%) 3/467 (0.6%) 3/327 (0.9%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
TENDON RUPTURE 1/327 (0.3%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 2/327 (0.6%) 0/326 (0%) 2/469 (0.4%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 1/27 (3.7%) 0/278 (0%)
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA 6/327 (1.8%) 1/326 (0.3%) 5/327 (1.5%) 4/323 (1.2%) 10/327 (3.1%) 5/326 (1.5%) 10/469 (2.1%) 6/467 (1.3%) 5/327 (1.5%) 7/323 (2.2%) 2/148 (1.4%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
HYPERTRIGLYCERIDAEMIA 2/327 (0.6%) 3/326 (0.9%) 2/327 (0.6%) 0/323 (0%) 8/327 (2.4%) 3/326 (0.9%) 8/469 (1.7%) 5/467 (1.1%) 2/327 (0.6%) 4/323 (1.2%) 1/148 (0.7%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
HYPERURICAEMIA 6/327 (1.8%) 1/326 (0.3%) 3/327 (0.9%) 2/323 (0.6%) 8/327 (2.4%) 3/326 (0.9%) 8/469 (1.7%) 3/467 (0.6%) 3/327 (0.9%) 3/323 (0.9%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA 14/327 (4.3%) 5/326 (1.5%) 10/327 (3.1%) 12/323 (3.7%) 25/327 (7.6%) 18/326 (5.5%) 32/469 (6.8%) 23/467 (4.9%) 10/327 (3.1%) 22/323 (6.8%) 3/148 (2%) 0/125 (0%) 0/27 (0%) 6/278 (2.2%)
BACK PAIN 8/327 (2.4%) 8/326 (2.5%) 6/327 (1.8%) 10/323 (3.1%) 17/327 (5.2%) 22/326 (6.7%) 20/469 (4.3%) 30/467 (6.4%) 6/327 (1.8%) 27/323 (8.4%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 2/278 (0.7%)
MUSCULOSKELETAL PAIN 3/327 (0.9%) 2/326 (0.6%) 1/327 (0.3%) 0/323 (0%) 10/327 (3.1%) 3/326 (0.9%) 10/469 (2.1%) 4/467 (0.9%) 1/327 (0.3%) 1/323 (0.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 1/278 (0.4%)
MYALGIA 3/327 (0.9%) 3/326 (0.9%) 4/327 (1.2%) 3/323 (0.9%) 5/327 (1.5%) 7/326 (2.1%) 9/469 (1.9%) 10/467 (2.1%) 4/327 (1.2%) 9/323 (2.8%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
OSTEOARTHRITIS 2/327 (0.6%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 8/327 (2.4%) 3/326 (0.9%) 8/469 (1.7%) 4/467 (0.9%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
PAIN IN EXTREMITY 2/327 (0.6%) 5/326 (1.5%) 4/327 (1.2%) 1/323 (0.3%) 5/327 (1.5%) 12/326 (3.7%) 8/469 (1.7%) 13/467 (2.8%) 4/327 (1.2%) 4/323 (1.2%) 2/148 (1.4%) 1/125 (0.8%) 0/27 (0%) 1/278 (0.4%)
Nervous system disorders
HEADACHE 16/327 (4.9%) 30/326 (9.2%) 23/327 (7%) 23/323 (7.1%) 34/327 (10.4%) 47/326 (14.4%) 46/469 (9.8%) 59/467 (12.6%) 24/327 (7.3%) 40/323 (12.4%) 3/148 (2%) 2/125 (1.6%) 0/27 (0%) 2/278 (0.7%)
PARAESTHESIA 2/327 (0.6%) 1/326 (0.3%) 2/327 (0.6%) 1/323 (0.3%) 7/327 (2.1%) 4/326 (1.2%) 7/469 (1.5%) 5/467 (1.1%) 2/327 (0.6%) 3/323 (0.9%) 2/148 (1.4%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Renal and urinary disorders
URETHRAL HAEMORRHAGE 0/327 (0%) 0/326 (0%) 0/327 (0%) 0/323 (0%) 0/327 (0%) 0/326 (0%) 0/469 (0%) 0/467 (0%) 0/327 (0%) 0/323 (0%) 0/148 (0%) 0/125 (0%) 1/27 (3.7%) 0/278 (0%)
Respiratory, thoracic and mediastinal disorders
COUGH 6/327 (1.8%) 11/326 (3.4%) 4/327 (1.2%) 4/323 (1.2%) 13/327 (4%) 24/326 (7.4%) 16/469 (3.4%) 30/467 (6.4%) 4/327 (1.2%) 12/323 (3.7%) 1/148 (0.7%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
OROPHARYNGEAL PAIN 4/327 (1.2%) 9/326 (2.8%) 7/327 (2.1%) 4/323 (1.2%) 15/327 (4.6%) 21/326 (6.4%) 19/469 (4.1%) 26/467 (5.6%) 7/327 (2.1%) 10/323 (3.1%) 0/148 (0%) 1/125 (0.8%) 0/27 (0%) 1/278 (0.4%)
RHINORRHOEA 1/327 (0.3%) 7/326 (2.1%) 1/327 (0.3%) 2/323 (0.6%) 3/327 (0.9%) 9/326 (2.8%) 3/469 (0.6%) 10/467 (2.1%) 1/327 (0.3%) 2/323 (0.6%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Skin and subcutaneous tissue disorders
ECZEMA 2/327 (0.6%) 3/326 (0.9%) 0/327 (0%) 1/323 (0.3%) 8/327 (2.4%) 9/326 (2.8%) 10/469 (2.1%) 11/467 (2.4%) 0/327 (0%) 2/323 (0.6%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 3/278 (1.1%)
ERYTHRODERMIC PSORIASIS 1/327 (0.3%) 1/326 (0.3%) 0/327 (0%) 0/323 (0%) 4/327 (1.2%) 1/326 (0.3%) 4/469 (0.9%) 1/467 (0.2%) 0/327 (0%) 2/323 (0.6%) 3/148 (2%) 5/125 (4%) 0/27 (0%) 12/278 (4.3%)
PRURITUS 12/327 (3.7%) 8/326 (2.5%) 11/327 (3.4%) 9/323 (2.8%) 18/327 (5.5%) 14/326 (4.3%) 21/469 (4.5%) 17/467 (3.6%) 11/327 (3.4%) 16/323 (5%) 2/148 (1.4%) 1/125 (0.8%) 0/27 (0%) 1/278 (0.4%)
PSORIASIS 5/327 (1.5%) 1/326 (0.3%) 7/327 (2.1%) 2/323 (0.6%) 9/327 (2.8%) 5/326 (1.5%) 11/469 (2.3%) 7/467 (1.5%) 7/327 (2.1%) 6/323 (1.9%) 2/148 (1.4%) 0/125 (0%) 0/27 (0%) 5/278 (1.8%)
SEBORRHOEIC DERMATITIS 1/327 (0.3%) 2/326 (0.6%) 0/327 (0%) 0/323 (0%) 7/327 (2.1%) 5/326 (1.5%) 8/469 (1.7%) 5/467 (1.1%) 0/327 (0%) 2/323 (0.6%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 1/278 (0.4%)
URTICARIA 5/327 (1.5%) 1/326 (0.3%) 0/327 (0%) 2/323 (0.6%) 7/327 (2.1%) 3/326 (0.9%) 9/469 (1.9%) 4/467 (0.9%) 0/327 (0%) 3/323 (0.9%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 0/278 (0%)
Vascular disorders
HYPERTENSION 10/327 (3.1%) 5/326 (1.5%) 4/327 (1.2%) 5/323 (1.5%) 18/327 (5.5%) 16/326 (4.9%) 22/469 (4.7%) 20/467 (4.3%) 4/327 (1.2%) 14/323 (4.3%) 0/148 (0%) 0/125 (0%) 0/27 (0%) 2/278 (0.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.

Results Point of Contact

Name/Title Study Director
Organization Novartis
Phone 862-778-8300
Email
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01358578
Other Study ID Numbers:
  • CAIN457A2303
  • 2010-022228-66
First Posted:
May 23, 2011
Last Update Posted:
Jan 5, 2021
Last Verified:
Mar 1, 2019