Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 78 for:    psoriasis novartis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01358578
Recruitment Status : Completed
First Posted : May 23, 2011
Results First Posted : September 23, 2015
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Plaque Psoriasis
Interventions Drug: Placebo
Drug: secukinumab (AIN457)
Drug: etanercept
Enrollment 1306
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AIN457 150mg AIN457 300mg Placebo Etanercept AIN457 150mg From Placebo AIN457 300mg From Placebo
Hide 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 [1] 0 [1]
Completed 315 312 301 305 0 [1] 0 [1]
Not Completed 12 15 25 21 0 0
Reason Not Completed
Adverse Event             2             4             2             6             0             0
Lack of Efficacy             0             0             9             1             0             0
Lost to Follow-up             0             0             1             4             0             0
Physician Decision             2             1             2             0             0             0
Protocol Deviation             3             5             0             3             0             0
technical problems             0             0             1             1             0             0
Withdrawal by Subject             5             5             10             6             0             0
[1]
These groups are populated after the induction period
Period Title: Maintenance Period
Started 315 312 17 305 142 142
Completed 276 290 15 263 125 131
Not Completed 39 22 2 42 17 11
Reason Not Completed
Adverse Event             2             7             0             6             4             3
Lack of Efficacy             10             2             0             11             3             0
Lost to Follow-up             4             0             0             5             1             1
Non-compliance with study treatment             3             1             0             2             1             2
Physician Decision             0             1             0             1             0             0
Pregnancy             1             0             0             0             0             0
Protocol deviation             7             4             0             2             2             2
Withdrawal by Subject             12             7             2             15             6             3
Period Title: Follow-up Period
Started 148 [1] 125 [2] 26 [3] 279 [3] 0 [4] 0 [4]
Completed 138 119 21 [5] 260 [5] 0 [4] 0 [4]
Not Completed 10 6 5 19 0 0
Reason Not Completed
Adverse Event             1             1             0             0             0             0
Lack of Efficacy             3             0             4             1             0             0
Lost to Follow-up             0             1             0             4             0             0
non- compliance with study treatment             1             0             0             0             0             0
Pregnancy             1             0             0             0             0             0
Withdrawal by Subject             3             3             1             12             0             0
Physician Decision             1             1             0             2             0             0
[1]
Patients prior to follow up who did not enter the extension study but received the 150 mg dose
[2]
Patients prior to follow up who did not enter the extension study but received the 300 mg dose
[3]
contains patients who participated in follow up period from induction and maintenance
[4]
all placebo patients from induction were 1: 1 into either AIN457A 150 mg or 300 mg doses
[5]
contains patients who completed follow up period from induction and maintenance
Arm/Group Title AIN457 150mg AIN457 300mg Placebo Etanercept Total
Hide Arm/Group Description AIN457 150mg AIN457 300mg Placebo Etanercept Total of all reporting groups
Overall Number of Baseline Participants 327 327 326 326 1306
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 327 participants 327 participants 326 participants 326 participants 1306 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
304
  93.0%
305
  93.3%
311
  95.4%
308
  94.5%
1228
  94.0%
>=65 years
23
   7.0%
22
   6.7%
15
   4.6%
18
   5.5%
78
   6.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 327 participants 327 participants 326 participants 326 participants 1306 participants
45.4  (12.92) 44.5  (13.19) 44.1  (12.64) 43.8  (12.95) 44.4  (12.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 327 participants 327 participants 326 participants 326 participants 1306 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 327 participants 327 participants 326 participants 326 participants 1306 participants
American Indian or Alaska Native
28
   8.6%
22
   6.7%
25
   7.7%
27
   8.3%
102
   7.8%
Asian
72
  22.0%
73
  22.3%
72
  22.1%
74
  22.7%
291
  22.3%
Native Hawaiian or Other Pacific Islander
0
   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
   0.0%
8
   0.6%
White
219
  67.0%
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
   0.0%
2
   0.6%
1
   0.3%
3
   0.2%
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) .
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AIN457 150mg AIN457 300mg Placebo
Hide 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:
Overall Number of Participants Analyzed 327 323 324
Measure Type: Number
Unit of Measure: participants achieving goal
219 249 16
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AIN457 150mg AIN457 300mg Placebo
Hide 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:
Overall Number of Participants Analyzed 327 323 324
Measure Type: Number
Unit of Measure: participants acheiving goal
167 202 9
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150mg AIN457 300mg Etanercept Placebo
Hide 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:
Overall Number of Participants Analyzed 327 323 323 324
Measure Type: Number
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150mg AIN457 300mg Etanercept
Hide 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.
Overall Number of Participants Analyzed 327 323 323
Measure Type: Number
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150mg AIN457 300mg Etanercept
Hide 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.
Overall Number of Participants Analyzed 327 323 323
Measure Type: Number
Unit of Measure: 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)
Hide Description [Not Specified]
Time Frame 52 wks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title AIN457 150mg AIN457 300mg Etanercept
Hide 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.
Overall Number of Participants Analyzed 219 249 142
Measure Type: Number
Unit of Measure: participants who reached goal
180 210 103
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
Hide Description [Not Specified]
Time Frame 52 wks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title AIN457 150mg AIN457 300mg Etanercept
Hide 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.
Overall Number of Participants Analyzed 167 202 88
Measure Type: Number
Unit of Measure: participants who reached goal
113 161 50
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title AIN457 150mg AIN457 300mg Placebo
Hide 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
Overall Number of Participants Analyzed 117 117 109
Mean (Standard Error)
Unit of Measure: units on scale
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title AIN457 150mg AIN457 300mg Etanercept
Hide 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
Overall Number of Participants Analyzed 117 117 116
Mean (Standard Error)
Unit of Measure: Units on a scale
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title AIN457 150mg AIN457 300mg PLACEBO-150 mg AIN457 PLACEBO-300 mg AIN457 Placebo Etanercept
Hide 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
Overall Number of Participants Analyzed 327 327 142 142 17 326
Measure Type: Number
Unit of Measure: # participants tested positive
2 3 0 0 0 6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/327 (2.14%)   4/326 (1.23%)   6/327 (1.83%)   3/323 (0.93%)   18/327 (5.50%)   21/326 (6.44%)   24/469 (5.12%)   27/467 (5.78%)   7/327 (2.14%)   20/323 (6.19%)   2/148 (1.35%)   2/125 (1.60%)   0/27 (0.00%)   2/278 (0.72%) 
Blood and lymphatic system disorders                             
ANAEMIA  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  1/278 (0.36%) 
Cardiac disorders                             
ANGINA PECTORIS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
ANGINA UNSTABLE  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
ARTERIOSCLEROSIS CORONARY ARTERY  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
CARDIAC ARREST  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
MITRAL VALVE INCOMPETENCE  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
MYOCARDIAL INFARCTION  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
PALPITATIONS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Endocrine disorders                             
BASEDOW'S DISEASE  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/148 (0.68%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
HYPERTHYROIDISM  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
PARATHYROID GLAND ENLARGEMENT  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
THYROTOXIC CRISIS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Gastrointestinal disorders                             
ANAL FISTULA  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
COLITIS ULCERATIVE  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
CROHN'S DISEASE  1  1/327 (0.31%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
DYSPHAGIA  1  1/327 (0.31%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
INGUINAL HERNIA  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
OESOPHAGEAL FOOD IMPACTION  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
General disorders                             
NON-CARDIAC CHEST PAIN  1  1/327 (0.31%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  1/278 (0.36%) 
POLYSEROSITIS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  1/125 (0.80%)  0/27 (0.00%)  0/278 (0.00%) 
Hepatobiliary disorders                             
CHOLECYSTITIS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
CHOLECYSTITIS ACUTE  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  1/323 (0.31%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Infections and infestations                             
ACUTE TONSILLITIS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
ANAL ABSCESS  1  0/327 (0.00%)  1/326 (0.31%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
APPENDICITIS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
CELLULITIS  1  0/327 (0.00%)  0/326 (0.00%)  1/327 (0.31%)  0/323 (0.00%)  1/327 (0.31%)  1/326 (0.31%)  1/469 (0.21%)  1/467 (0.21%)  1/327 (0.31%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
DIVERTICULITIS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
HEPATITIS B  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/148 (0.68%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
PERIRECTAL ABSCESS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
PHARYNGOTONSILLITIS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
PYELONEPHRITIS ACUTE  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
SUBCUTANEOUS ABSCESS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
TONSILLITIS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  1/125 (0.80%)  0/27 (0.00%)  0/278 (0.00%) 
URINARY TRACT INFECTION  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Injury, poisoning and procedural complications                             
ALCOHOL POISONING  1  0/327 (0.00%)  0/326 (0.00%)  1/327 (0.31%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  1/327 (0.31%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
CARTILAGE INJURY  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
CLAVICLE FRACTURE  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
HEAD INJURY  1  1/327 (0.31%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
JOINT DISLOCATION  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
LACERATION  1  1/327 (0.31%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
LIGAMENT RUPTURE  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
OVERDOSE  1  1/327 (0.31%)  1/326 (0.31%)  1/327 (0.31%)  0/323 (0.00%)  1/327 (0.31%)  1/326 (0.31%)  1/469 (0.21%)  1/467 (0.21%)  1/327 (0.31%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
POST PROCEDURAL HYPOTHYROIDISM  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/148 (0.68%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
POSTOPERATIVE RESPIRATORY DISTRESS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/148 (0.68%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
RADIUS FRACTURE  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
RIB FRACTURE  1  0/327 (0.00%)  1/326 (0.31%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
TENDON INJURY  1  0/327 (0.00%)  0/326 (0.00%)  1/327 (0.31%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  1/327 (0.31%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
UPPER LIMB FRACTURE  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Metabolism and nutrition disorders                             
HYPERGLYCAEMIA  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
HYPOKALAEMIA  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Musculoskeletal and connective tissue disorders                             
ARTHRALGIA  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
BACK PAIN  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  1/326 (0.31%)  1/469 (0.21%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
BURSITIS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
CHONDROPATHY  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
INTERVERTEBRAL DISC PROTRUSION  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
JOINT INSTABILITY  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
MUSCULAR WEAKNESS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
NECK PAIN  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
OSTEONECROSIS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
PSORIATIC ARTHROPATHY  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
ROTATOR CUFF SYNDROME  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                             
RENAL CANCER  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Nervous system disorders                             
CEREBROVASCULAR ACCIDENT  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
FACIAL PARESIS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
HEADACHE  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
HYPOAESTHESIA  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
SCIATICA  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
SYNCOPE  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
TRANSIENT ISCHAEMIC ATTACK  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  1/323 (0.31%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  1/327 (0.31%)  2/323 (0.62%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
VIITH NERVE PARALYSIS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
VITH NERVE PARALYSIS  1  1/327 (0.31%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Psychiatric disorders                             
DEPRESSION SUICIDAL  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
DRUG ABUSE  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
INSOMNIA  1  1/327 (0.31%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Renal and urinary disorders                             
CALCULUS URETHRAL  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  1/323 (0.31%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
HAEMATURIA  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  1/326 (0.31%)  1/469 (0.21%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
RENAL COLIC  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Reproductive system and breast disorders                             
PROSTATOMEGALY  1  0/327 (0.00%)  1/326 (0.31%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Respiratory, thoracic and mediastinal disorders                             
EPISTAXIS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  1/278 (0.36%) 
INTERSTITIAL LUNG DISEASE  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
OROPHARYNGEAL PAIN  1  1/327 (0.31%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Skin and subcutaneous tissue disorders                             
DERMATITIS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
DYSHIDROTIC ECZEMA  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
LICHEN SCLEROSUS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
PAIN OF SKIN  1  1/327 (0.31%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  0/326 (0.00%)  1/469 (0.21%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
PSORIASIS  1  0/327 (0.00%)  0/326 (0.00%)  2/327 (0.61%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  2/327 (0.61%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Social circumstances                             
ABSTAINS FROM ALCOHOL  1  0/327 (0.00%)  0/326 (0.00%)  1/327 (0.31%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  1/327 (0.31%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Vascular disorders                             
ARTERIAL OCCLUSIVE DISEASE  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
BEHCET'S SYNDROME  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  1/125 (0.80%)  0/27 (0.00%)  0/278 (0.00%) 
HYPERTENSIVE CRISIS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  1/469 (0.21%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  1/326 (0.31%)  0/469 (0.00%)  1/467 (0.21%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   157/327 (48.01%)   145/326 (44.48%)   121/327 (37.00%)   130/323 (40.25%)   225/327 (68.81%)   230/326 (70.55%)   297/469 (63.33%)   316/467 (67.67%)   122/327 (37.31%)   213/323 (65.94%)   25/148 (16.89%)   11/125 (8.80%)   7/27 (25.93%)   59/278 (21.22%) 
Eye disorders                             
CONJUNCTIVITIS  1  0/327 (0.00%)  3/326 (0.92%)  1/327 (0.31%)  0/323 (0.00%)  3/327 (0.92%)  9/326 (2.76%)  3/469 (0.64%)  10/467 (2.14%)  1/327 (0.31%)  3/323 (0.93%)  0/148 (0.00%)  1/125 (0.80%)  0/27 (0.00%)  0/278 (0.00%) 
Gastrointestinal disorders                             
ABDOMINAL PAIN  1  2/327 (0.61%)  3/326 (0.92%)  4/327 (1.22%)  3/323 (0.93%)  7/327 (2.14%)  5/326 (1.53%)  11/469 (2.35%)  6/467 (1.28%)  4/327 (1.22%)  8/323 (2.48%)  1/148 (0.68%)  0/125 (0.00%)  0/27 (0.00%)  2/278 (0.72%) 
ABDOMINAL PAIN UPPER  1  4/327 (1.22%)  2/326 (0.61%)  4/327 (1.22%)  1/323 (0.31%)  10/327 (3.06%)  10/326 (3.07%)  12/469 (2.56%)  14/467 (3.00%)  4/327 (1.22%)  3/323 (0.93%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
DIARRHOEA  1  12/327 (3.67%)  17/326 (5.21%)  6/327 (1.83%)  11/323 (3.41%)  30/327 (9.17%)  34/326 (10.43%)  36/469 (7.68%)  38/467 (8.14%)  7/327 (2.14%)  22/323 (6.81%)  2/148 (1.35%)  1/125 (0.80%)  0/27 (0.00%)  3/278 (1.08%) 
NAUSEA  1  6/327 (1.83%)  8/326 (2.45%)  7/327 (2.14%)  4/323 (1.24%)  10/327 (3.06%)  9/326 (2.76%)  10/469 (2.13%)  11/467 (2.36%)  7/327 (2.14%)  7/323 (2.17%)  1/148 (0.68%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
TOOTHACHE  1  3/327 (0.92%)  6/326 (1.84%)  5/327 (1.53%)  3/323 (0.93%)  10/327 (3.06%)  10/326 (3.07%)  12/469 (2.56%)  13/467 (2.78%)  6/327 (1.83%)  7/323 (2.17%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  1/278 (0.36%) 
VOMITING  1  1/327 (0.31%)  4/326 (1.23%)  1/327 (0.31%)  5/323 (1.55%)  2/327 (0.61%)  10/326 (3.07%)  4/469 (0.85%)  10/467 (2.14%)  1/327 (0.31%)  9/323 (2.79%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  1/278 (0.36%) 
General disorders                             
ADVERSE DRUG REACTION  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  1/27 (3.70%)  0/278 (0.00%) 
FATIGUE  1  5/327 (1.53%)  7/326 (2.15%)  3/327 (0.92%)  5/323 (1.55%)  9/327 (2.75%)  14/326 (4.29%)  12/469 (2.56%)  16/467 (3.43%)  3/327 (0.92%)  6/323 (1.86%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  1/278 (0.36%) 
INFLUENZA LIKE ILLNESS  1  2/327 (0.61%)  2/326 (0.61%)  1/327 (0.31%)  3/323 (0.93%)  7/327 (2.14%)  5/326 (1.53%)  7/469 (1.49%)  8/467 (1.71%)  1/327 (0.31%)  9/323 (2.79%)  1/148 (0.68%)  1/125 (0.80%)  0/27 (0.00%)  1/278 (0.36%) 
INJECTION SITE ERYTHEMA  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  16/323 (4.95%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  17/323 (5.26%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
OEDEMA PERIPHERAL  1  5/327 (1.53%)  1/326 (0.31%)  4/327 (1.22%)  1/323 (0.31%)  9/327 (2.75%)  3/326 (0.92%)  10/469 (2.13%)  4/467 (0.86%)  4/327 (1.22%)  5/323 (1.55%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  1/278 (0.36%) 
PYREXIA  1  2/327 (0.61%)  5/326 (1.53%)  3/327 (0.92%)  7/323 (2.17%)  10/327 (3.06%)  12/326 (3.68%)  14/469 (2.99%)  19/467 (4.07%)  3/327 (0.92%)  15/323 (4.64%)  1/148 (0.68%)  0/125 (0.00%)  0/27 (0.00%)  1/278 (0.36%) 
Infections and infestations                             
BRONCHITIS  1  4/327 (1.22%)  4/326 (1.23%)  2/327 (0.61%)  4/323 (1.24%)  12/327 (3.67%)  15/326 (4.60%)  14/469 (2.99%)  17/467 (3.64%)  2/327 (0.61%)  9/323 (2.79%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  2/278 (0.72%) 
EAR INFECTION  1  0/327 (0.00%)  1/326 (0.31%)  1/327 (0.31%)  0/323 (0.00%)  4/327 (1.22%)  8/326 (2.45%)  4/469 (0.85%)  8/467 (1.71%)  1/327 (0.31%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  1/278 (0.36%) 
FOLLICULITIS  1  4/327 (1.22%)  0/326 (0.00%)  1/327 (0.31%)  3/323 (0.93%)  9/327 (2.75%)  9/326 (2.76%)  14/469 (2.99%)  13/467 (2.78%)  1/327 (0.31%)  8/323 (2.48%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
GASTROENTERITIS  1  3/327 (0.92%)  5/326 (1.53%)  2/327 (0.61%)  3/323 (0.93%)  10/327 (3.06%)  15/326 (4.60%)  12/469 (2.56%)  18/467 (3.85%)  3/327 (0.92%)  8/323 (2.48%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
IMPETIGO  1  0/327 (0.00%)  4/326 (1.23%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  7/326 (2.15%)  1/469 (0.21%)  9/467 (1.93%)  0/327 (0.00%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
INFLUENZA  1  5/327 (1.53%)  5/326 (1.53%)  3/327 (0.92%)  2/323 (0.62%)  9/327 (2.75%)  18/326 (5.52%)  12/469 (2.56%)  22/467 (4.71%)  3/327 (0.92%)  11/323 (3.41%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  2/278 (0.72%) 
NASOPHARYNGITIS  1  44/327 (13.46%)  35/326 (10.74%)  26/327 (7.95%)  37/323 (11.46%)  82/327 (25.08%)  91/326 (27.91%)  107/469 (22.81%)  122/467 (26.12%)  26/327 (7.95%)  87/323 (26.93%)  6/148 (4.05%)  1/125 (0.80%)  3/27 (11.11%)  14/278 (5.04%) 
ORAL CANDIDIASIS  1  1/327 (0.31%)  2/326 (0.61%)  0/327 (0.00%)  0/323 (0.00%)  4/327 (1.22%)  10/326 (3.07%)  6/469 (1.28%)  12/467 (2.57%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
ORAL HERPES  1  1/327 (0.31%)  5/326 (1.53%)  0/327 (0.00%)  0/323 (0.00%)  1/327 (0.31%)  8/326 (2.45%)  4/469 (0.85%)  10/467 (2.14%)  0/327 (0.00%)  9/323 (2.79%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  1/278 (0.36%) 
PHARYNGITIS  1  5/327 (1.53%)  4/326 (1.23%)  0/327 (0.00%)  0/323 (0.00%)  7/327 (2.14%)  9/326 (2.76%)  10/469 (2.13%)  13/467 (2.78%)  0/327 (0.00%)  6/323 (1.86%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
RHINITIS  1  4/327 (1.22%)  7/326 (2.15%)  4/327 (1.22%)  3/323 (0.93%)  7/327 (2.14%)  10/326 (3.07%)  8/469 (1.71%)  14/467 (3.00%)  4/327 (1.22%)  6/323 (1.86%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
SINUSITIS  1  5/327 (1.53%)  0/326 (0.00%)  1/327 (0.31%)  0/323 (0.00%)  9/327 (2.75%)  8/326 (2.45%)  11/469 (2.35%)  9/467 (1.93%)  1/327 (0.31%)  5/323 (1.55%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  1/278 (0.36%) 
TINEA PEDIS  1  3/327 (0.92%)  3/326 (0.92%)  0/327 (0.00%)  0/323 (0.00%)  6/327 (1.83%)  8/326 (2.45%)  7/469 (1.49%)  10/467 (2.14%)  0/327 (0.00%)  4/323 (1.24%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
TONSILLITIS  1  3/327 (0.92%)  2/326 (0.61%)  2/327 (0.61%)  0/323 (0.00%)  7/327 (2.14%)  9/326 (2.76%)  10/469 (2.13%)  12/467 (2.57%)  2/327 (0.61%)  3/323 (0.93%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
TOOTH ABSCESS  1  0/327 (0.00%)  0/326 (0.00%)  1/327 (0.31%)  0/323 (0.00%)  3/327 (0.92%)  1/326 (0.31%)  4/469 (0.85%)  2/467 (0.43%)  1/327 (0.31%)  3/323 (0.93%)  0/148 (0.00%)  0/125 (0.00%)  1/27 (3.70%)  0/278 (0.00%) 
TRICHOMONIASIS  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  1/27 (3.70%)  0/278 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  10/327 (3.06%)  7/326 (2.15%)  3/327 (0.92%)  7/323 (2.17%)  21/327 (6.42%)  19/326 (5.83%)  26/469 (5.54%)  26/467 (5.57%)  3/327 (0.92%)  18/323 (5.57%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  2/278 (0.72%) 
URINARY TRACT INFECTION  1  2/327 (0.61%)  2/326 (0.61%)  3/327 (0.92%)  6/323 (1.86%)  6/327 (1.83%)  8/326 (2.45%)  8/469 (1.71%)  13/467 (2.78%)  3/327 (0.92%)  9/323 (2.79%)  1/148 (0.68%)  0/125 (0.00%)  0/27 (0.00%)  2/278 (0.72%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  1/327 (0.31%)  1/326 (0.31%)  1/327 (0.31%)  0/323 (0.00%)  7/327 (2.14%)  7/326 (2.15%)  8/469 (1.71%)  11/467 (2.36%)  1/327 (0.31%)  1/323 (0.31%)  2/148 (1.35%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Injury, poisoning and procedural complications                             
MUSCLE RUPTURE  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  1/27 (3.70%)  0/278 (0.00%) 
MUSCLE STRAIN  1  2/327 (0.61%)  2/326 (0.61%)  3/327 (0.92%)  0/323 (0.00%)  9/327 (2.75%)  3/326 (0.92%)  9/469 (1.92%)  3/467 (0.64%)  3/327 (0.92%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
TENDON RUPTURE  1  1/327 (0.31%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  2/327 (0.61%)  0/326 (0.00%)  2/469 (0.43%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  1/27 (3.70%)  0/278 (0.00%) 
Metabolism and nutrition disorders                             
HYPERCHOLESTEROLAEMIA  1  6/327 (1.83%)  1/326 (0.31%)  5/327 (1.53%)  4/323 (1.24%)  10/327 (3.06%)  5/326 (1.53%)  10/469 (2.13%)  6/467 (1.28%)  5/327 (1.53%)  7/323 (2.17%)  2/148 (1.35%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
HYPERTRIGLYCERIDAEMIA  1  2/327 (0.61%)  3/326 (0.92%)  2/327 (0.61%)  0/323 (0.00%)  8/327 (2.45%)  3/326 (0.92%)  8/469 (1.71%)  5/467 (1.07%)  2/327 (0.61%)  4/323 (1.24%)  1/148 (0.68%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
HYPERURICAEMIA  1  6/327 (1.83%)  1/326 (0.31%)  3/327 (0.92%)  2/323 (0.62%)  8/327 (2.45%)  3/326 (0.92%)  8/469 (1.71%)  3/467 (0.64%)  3/327 (0.92%)  3/323 (0.93%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Musculoskeletal and connective tissue disorders                             
ARTHRALGIA  1  14/327 (4.28%)  5/326 (1.53%)  10/327 (3.06%)  12/323 (3.72%)  25/327 (7.65%)  18/326 (5.52%)  32/469 (6.82%)  23/467 (4.93%)  10/327 (3.06%)  22/323 (6.81%)  3/148 (2.03%)  0/125 (0.00%)  0/27 (0.00%)  6/278 (2.16%) 
BACK PAIN  1  8/327 (2.45%)  8/326 (2.45%)  6/327 (1.83%)  10/323 (3.10%)  17/327 (5.20%)  22/326 (6.75%)  20/469 (4.26%)  30/467 (6.42%)  6/327 (1.83%)  27/323 (8.36%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  2/278 (0.72%) 
MUSCULOSKELETAL PAIN  1  3/327 (0.92%)  2/326 (0.61%)  1/327 (0.31%)  0/323 (0.00%)  10/327 (3.06%)  3/326 (0.92%)  10/469 (2.13%)  4/467 (0.86%)  1/327 (0.31%)  1/323 (0.31%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  1/278 (0.36%) 
MYALGIA  1  3/327 (0.92%)  3/326 (0.92%)  4/327 (1.22%)  3/323 (0.93%)  5/327 (1.53%)  7/326 (2.15%)  9/469 (1.92%)  10/467 (2.14%)  4/327 (1.22%)  9/323 (2.79%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
OSTEOARTHRITIS  1  2/327 (0.61%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  8/327 (2.45%)  3/326 (0.92%)  8/469 (1.71%)  4/467 (0.86%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
PAIN IN EXTREMITY  1  2/327 (0.61%)  5/326 (1.53%)  4/327 (1.22%)  1/323 (0.31%)  5/327 (1.53%)  12/326 (3.68%)  8/469 (1.71%)  13/467 (2.78%)  4/327 (1.22%)  4/323 (1.24%)  2/148 (1.35%)  1/125 (0.80%)  0/27 (0.00%)  1/278 (0.36%) 
Nervous system disorders                             
HEADACHE  1  16/327 (4.89%)  30/326 (9.20%)  23/327 (7.03%)  23/323 (7.12%)  34/327 (10.40%)  47/326 (14.42%)  46/469 (9.81%)  59/467 (12.63%)  24/327 (7.34%)  40/323 (12.38%)  3/148 (2.03%)  2/125 (1.60%)  0/27 (0.00%)  2/278 (0.72%) 
PARAESTHESIA  1  2/327 (0.61%)  1/326 (0.31%)  2/327 (0.61%)  1/323 (0.31%)  7/327 (2.14%)  4/326 (1.23%)  7/469 (1.49%)  5/467 (1.07%)  2/327 (0.61%)  3/323 (0.93%)  2/148 (1.35%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Renal and urinary disorders                             
URETHRAL HAEMORRHAGE  1  0/327 (0.00%)  0/326 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/327 (0.00%)  0/326 (0.00%)  0/469 (0.00%)  0/467 (0.00%)  0/327 (0.00%)  0/323 (0.00%)  0/148 (0.00%)  0/125 (0.00%)  1/27 (3.70%)  0/278 (0.00%) 
Respiratory, thoracic and mediastinal disorders                             
COUGH  1  6/327 (1.83%)  11/326 (3.37%)  4/327 (1.22%)  4/323 (1.24%)  13/327 (3.98%)  24/326 (7.36%)  16/469 (3.41%)  30/467 (6.42%)  4/327 (1.22%)  12/323 (3.72%)  1/148 (0.68%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
OROPHARYNGEAL PAIN  1  4/327 (1.22%)  9/326 (2.76%)  7/327 (2.14%)  4/323 (1.24%)  15/327 (4.59%)  21/326 (6.44%)  19/469 (4.05%)  26/467 (5.57%)  7/327 (2.14%)  10/323 (3.10%)  0/148 (0.00%)  1/125 (0.80%)  0/27 (0.00%)  1/278 (0.36%) 
RHINORRHOEA  1  1/327 (0.31%)  7/326 (2.15%)  1/327 (0.31%)  2/323 (0.62%)  3/327 (0.92%)  9/326 (2.76%)  3/469 (0.64%)  10/467 (2.14%)  1/327 (0.31%)  2/323 (0.62%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Skin and subcutaneous tissue disorders                             
ECZEMA  1  2/327 (0.61%)  3/326 (0.92%)  0/327 (0.00%)  1/323 (0.31%)  8/327 (2.45%)  9/326 (2.76%)  10/469 (2.13%)  11/467 (2.36%)  0/327 (0.00%)  2/323 (0.62%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  3/278 (1.08%) 
ERYTHRODERMIC PSORIASIS  1  1/327 (0.31%)  1/326 (0.31%)  0/327 (0.00%)  0/323 (0.00%)  4/327 (1.22%)  1/326 (0.31%)  4/469 (0.85%)  1/467 (0.21%)  0/327 (0.00%)  2/323 (0.62%)  3/148 (2.03%)  5/125 (4.00%)  0/27 (0.00%)  12/278 (4.32%) 
PRURITUS  1  12/327 (3.67%)  8/326 (2.45%)  11/327 (3.36%)  9/323 (2.79%)  18/327 (5.50%)  14/326 (4.29%)  21/469 (4.48%)  17/467 (3.64%)  11/327 (3.36%)  16/323 (4.95%)  2/148 (1.35%)  1/125 (0.80%)  0/27 (0.00%)  1/278 (0.36%) 
PSORIASIS  1  5/327 (1.53%)  1/326 (0.31%)  7/327 (2.14%)  2/323 (0.62%)  9/327 (2.75%)  5/326 (1.53%)  11/469 (2.35%)  7/467 (1.50%)  7/327 (2.14%)  6/323 (1.86%)  2/148 (1.35%)  0/125 (0.00%)  0/27 (0.00%)  5/278 (1.80%) 
SEBORRHOEIC DERMATITIS  1  1/327 (0.31%)  2/326 (0.61%)  0/327 (0.00%)  0/323 (0.00%)  7/327 (2.14%)  5/326 (1.53%)  8/469 (1.71%)  5/467 (1.07%)  0/327 (0.00%)  2/323 (0.62%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  1/278 (0.36%) 
URTICARIA  1  5/327 (1.53%)  1/326 (0.31%)  0/327 (0.00%)  2/323 (0.62%)  7/327 (2.14%)  3/326 (0.92%)  9/469 (1.92%)  4/467 (0.86%)  0/327 (0.00%)  3/323 (0.93%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  0/278 (0.00%) 
Vascular disorders                             
HYPERTENSION  1  10/327 (3.06%)  5/326 (1.53%)  4/327 (1.22%)  5/323 (1.55%)  18/327 (5.50%)  16/326 (4.91%)  22/469 (4.69%)  20/467 (4.28%)  4/327 (1.22%)  14/323 (4.33%)  0/148 (0.00%)  0/125 (0.00%)  0/27 (0.00%)  2/278 (0.72%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis
Phone: 862-778-8300
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01358578    
Other Study ID Numbers: CAIN457A2303
2010-022228-66
First Submitted: May 20, 2011
First Posted: May 23, 2011
Results First Submitted: February 16, 2015
Results First Posted: September 23, 2015
Last Update Posted: April 9, 2019