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16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis (MEASURE 1)

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ClinicalTrials.gov Identifier: NCT01358175
Recruitment Status : Completed
First Posted : May 23, 2011
Results First Posted : January 27, 2017
Last Update Posted : March 9, 2017
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 Ankylosing Spondylitis
Interventions Drug: Secukinumab (75 mg)
Drug: Secukinumab (150 mg)
Drug: Placebo
Enrollment 371
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Secukinumab 10 mg/kg i.v. / 75 mg s.c. Secukinumab 10 mg/kg i.v. / 150 mg s.c. Placebo
Hide Arm/Group Description Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study. Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study. Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Period Title: Overall Study
Started 124 125 122
Completed 103 97 90
Not Completed 21 28 32
Reason Not Completed
Death             1             0             1
Withdrawal by Subject             9             5             10
Technical issues             0             1             0
Pregnancy             0             1             0
Physician Decision             1             0             0
Non Compliance with Study Treatment             0             1             1
Lost to Follow-up             1             1             3
Lack of Efficacy             3             8             6
Adverse Event             6             11             11
Arm/Group Title Secukinumab 10 mg/kg i.v. / 75 mg s.c. Secukinumab 10 mg/kg i.v. / 150 mg s.c. Placebo Total
Hide Arm/Group Description Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study. Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study. Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 Total of all reporting groups
Overall Number of Baseline Participants 124 125 122 371
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 125 participants 122 participants 371 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
117
  94.4%
122
  97.6%
115
  94.3%
354
  95.4%
>=65 years
7
   5.6%
3
   2.4%
7
   5.7%
17
   4.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 125 participants 122 participants 371 participants
Female
36
  29.0%
41
  32.8%
37
  30.3%
114
  30.7%
Male
88
  71.0%
84
  67.2%
85
  69.7%
257
  69.3%
1.Primary Outcome
Title Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response
Hide Description ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS comprised all patients who were randomized and to whom study treatment had been assigned. The efficacy analyses are based on the FAS.
Arm/Group Title Secukinumab 10 mg/kg i.v. / 75 mg s.c. Secukinumab 10 mg/kg i.v. / 150 mg s.c. Placebo
Hide Arm/Group Description:
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Overall Number of Participants Analyzed 124 125 122
Measure Type: Number
Unit of Measure: % responders
59.7 60.8 28.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab 10 mg/kg i.v. / 75 mg s.c., Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.76
Confidence Interval (2-Sided) 95%
2.20 to 6.42
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Secukinumab 10 mg/kg i.v. / 150 mg s.c., Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.89
Confidence Interval (2-Sided) 95%
2.28 to 6.65
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Assessment of Responders for the SpondyloArthritis International Society ASAS 40 Response
Hide Description ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 40 is used to assess the efficacy of at least one dose of secukinumab against placebo.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS comprised all patients who were randomized and to whom study treatment had been assigned. The efficacy analyses are based on the FAS.
Arm/Group Title Secukinumab 10 mg/kg i.v. / 75 mg s.c. Secukinumab 10 mg/kg i.v. / 150 mg s.c. Placebo
Hide Arm/Group Description:
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Overall Number of Participants Analyzed 124 125 122
Measure Type: Number
Unit of Measure: % responders
33.1 41.6 13.1
3.Secondary Outcome
Title Change From Baseline in Serum hsCRP
Hide Description The change from baseline in hsCRP is expressed as a ratio of post-baseline to baseline values. With the ratio normalized to 1.0 at baseline, ratios less than 1.0 represent decreased postbaseline values, whereas ratios greater than 1.0 represent increased post-baseline values.
Time Frame Base line and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Analysis was done on the log(e) ratio of the treatment value vs. baseline value to normalize the distribution of the hsCRP at each visit. LS Mean, SE, 95% CI and p-value are from mixed-effect model repeated measures (MMRM) with treatment, visit, TNF-alpha inhibitor status as factors, log(e) baseline and weight as covariates.
Arm/Group Title Secukinumab 10 mg/kg i.v. / 75 mg s.c. Secukinumab 10 mg/kg i.v. / 150 mg s.c. Placebo
Hide Arm/Group Description:
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Overall Number of Participants Analyzed 124 125 122
Least Squares Mean (Standard Error)
Unit of Measure: ratio
0.45  (1.092) 0.4  (1.090) 0.97  (1.095)
4.Secondary Outcome
Title Assessment of Responders for the SpondyloArthritis International Society ASAS 5/6 Response
Hide Description ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevent to AS and no worsening in the remaining domain. In this study, ASAS 5/6 is used to assess the efficacy of at least one dose of secukinumab against placebo.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Secukinumab 10 mg/kg i.v. / 75 mg s.c. Secukinumab 10 mg/kg i.v. / 150 mg s.c. Placebo
Hide Arm/Group Description:
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Overall Number of Participants Analyzed 124 125 122
Measure Type: Number
Unit of Measure: % responders
45.2 48.8 13.1
5.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index / BASDAI
Hide Description BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating "no problem" and 10 indicating " worst problem"), to characterize six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI is used to assess the efficacy of at least one dose of secukinumab verus placebo. To give each symptom equal weighting, the mean (average) of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 – 10 BASDAI score. Scores of 4 or greater suggest suboptimal control of disease, and patients with scores of 4 or greater are usually good candidates for either a change in their medical therapy or for enrollment in clinical trials evaluating new drug therapies directed at Ankylosing Spondylitis.
Time Frame Baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Secukinumab 10 mg/kg i.v. / 75 mg s.c. Secukinumab 10 mg/kg i.v. / 150 mg s.c. Placebo
Hide Arm/Group Description:
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Overall Number of Participants Analyzed 124 125 122
Least Squares Mean (Standard Error)
Unit of Measure: units on scale
-2.34  (0.175) -2.32  (0.172) -0.59  (0.180)
6.Secondary Outcome
Title Change From Baseline in Physical Function Component of the Short-form Health Survey / SF-36 PCS
Hide Description SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both phyically and emotionally based. Two overall summary scores, the Phyical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
Time Frame baseline, 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Secukinumab 10 mg/kg i.v. / 75 mg s.c. Secukinumab 10 mg/kg i.v. / 150 mg s.c. Placebo
Hide Arm/Group Description:
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Overall Number of Participants Analyzed 124 125 122
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
5.64  (0.595) 5.57  (0.586) 0.96  (0.612)
7.Secondary Outcome
Title Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire / ASQoL
Hide Description ASQoL is an 18 item questionnaire that assesses disease-specific quality of life (QoL), consisting of statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). In this study, ASQoL is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.
Time Frame baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Secukinumab 10 mg/kg i.v. / 75 mg s.c. Secukinumab 10 mg/kg i.v. / 150 mg s.c. Placebo
Hide Arm/Group Description:
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Overall Number of Participants Analyzed 124 125 122
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.61  (0.424) -3.58  (0.420) -1.04  (0.437)
8.Secondary Outcome
Title Assessment of Responders for ASAS Partial Remission
Hide Description ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale of 10. In this study ASAS partial remission is used to assess the efficacy of at least one dose of secukinumab versus placebo.ASAS partial remission was defined as a VAS score of less than 2 units in each of the 4 domains of ASAS 20: participant global assessment, pain (total back pain), function and inflammation. The percentages of participants who achieved ASAS partial remission were calculated.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Secukinumab 10 mg/kg i.v. / 75 mg s.c. Secukinumab 10 mg/kg i.v. / 150 mg s.c. Placebo
Hide Arm/Group Description:
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Overall Number of Participants Analyzed 124 125 122
Measure Type: Number
Unit of Measure: % responders
16.1 15.2 3.3
Time Frame Baseline to week 104
Adverse Event Reporting Description Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
 
Arm/Group Title Secukinumab 10mg/kg -75 mg Secukinumab 10mg/kg -150 mg Placebo Secukinumab Placebo Non-Resp Secukinumab 75 mg Placebo Non-Resp Secukinumab 150 mg Placebo Resp Secukinumab 75 mg Placebo Resp Secukinumab 150 mg
Hide Arm/Group Description Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study. Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study. Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 up to end of Study Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 16 to Secukinumab 75 mg Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 16 to Secukinumab 150 mg Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 24 to Secukinumab 75 mg Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 24 to Secukinumab 150 mg
All-Cause Mortality
Secukinumab 10mg/kg -75 mg Secukinumab 10mg/kg -150 mg Placebo Secukinumab Placebo Non-Resp Secukinumab 75 mg Placebo Non-Resp Secukinumab 150 mg Placebo Resp Secukinumab 75 mg Placebo Resp Secukinumab 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Secukinumab 10mg/kg -75 mg Secukinumab 10mg/kg -150 mg Placebo Secukinumab Placebo Non-Resp Secukinumab 75 mg Placebo Non-Resp Secukinumab 150 mg Placebo Resp Secukinumab 75 mg Placebo Resp Secukinumab 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   16/124 (12.90%)   13/125 (10.40%)   5/122 (4.10%)   5/39 (12.82%)   8/38 (21.05%)   3/17 (17.65%)   1/18 (5.56%) 
Blood and lymphatic system disorders               
Abdominal lymphadenopathy  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Anaemia  1  0/124 (0.00%)  0/125 (0.00%)  1/122 (0.82%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Pancytopenia  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Cardiac disorders               
Cardiac failure  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Coronary artery stenosis  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Myocardial infarction  1  2/124 (1.61%)  2/125 (1.60%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Ear and labyrinth disorders               
Sudden hearing loss  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Vertigo  1  0/124 (0.00%)  0/125 (0.00%)  1/122 (0.82%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Endocrine disorders               
Hyperparathyroidism  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Eye disorders               
Cataract  1  1/124 (0.81%)  1/125 (0.80%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Uveitis  1  0/124 (0.00%)  1/125 (0.80%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Gastrointestinal disorders               
Colitis  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Diarrhoea  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Epigastric discomfort  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Gastritis  1  0/124 (0.00%)  1/125 (0.80%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Gastrooesophageal reflux disease  1  0/124 (0.00%)  1/125 (0.80%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Hiatus hernia  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Lumbar hernia  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Pancreatitis  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  1/38 (2.63%)  0/17 (0.00%)  0/18 (0.00%) 
Pancreatitis acute  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  1/38 (2.63%)  0/17 (0.00%)  0/18 (0.00%) 
Small intestinal obstruction  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  1/38 (2.63%)  0/17 (0.00%)  0/18 (0.00%) 
General disorders               
Adverse drug reaction  1  0/124 (0.00%)  0/125 (0.00%)  1/122 (0.82%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Application site pain  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Chest discomfort  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Pyrexia  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Hepatobiliary disorders               
Cholelithiasis  1  2/124 (1.61%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Hepatitis toxic  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  1/38 (2.63%)  0/17 (0.00%)  0/18 (0.00%) 
Hepatosplenomegaly  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Infections and infestations               
Appendicitis  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Helicobacter gastritis  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Pneumonia  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Pyelonephritis acute  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  1/38 (2.63%)  0/17 (0.00%)  0/18 (0.00%) 
Tonsillitis  1  0/124 (0.00%)  2/125 (1.60%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Injury, poisoning and procedural complications               
Cartilage injury  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Cervical vertebral fracture  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Craniocerebral injury  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Dislocation of vertebra  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Injury  1  0/124 (0.00%)  1/125 (0.80%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Laceration  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Lower limb fracture  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  1/38 (2.63%)  0/17 (0.00%)  0/18 (0.00%) 
Postoperative thrombosis  1  0/124 (0.00%)  1/125 (0.80%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Rib fracture  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  2/38 (5.26%)  0/17 (0.00%)  0/18 (0.00%) 
Spinal fracture  1  0/124 (0.00%)  1/125 (0.80%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Thoracic vertebral fracture  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Tibia fracture  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  1/38 (2.63%)  0/17 (0.00%)  0/18 (0.00%) 
Upper limb fracture  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders               
Ankylosing spondylitis  1  0/124 (0.00%)  2/125 (1.60%)  0/122 (0.00%)  0/39 (0.00%)  1/38 (2.63%)  0/17 (0.00%)  0/18 (0.00%) 
Back pain  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  1/38 (2.63%)  0/17 (0.00%)  0/18 (0.00%) 
Rotator cuff syndrome  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
B-cell lymphoma  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Bladder transitional cell carcinoma  1  0/124 (0.00%)  1/125 (0.80%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Breast cancer  1  0/124 (0.00%)  1/125 (0.80%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Lymphoma  1  0/124 (0.00%)  0/125 (0.00%)  1/122 (0.82%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Nervous system disorders               
Brain oedema  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Cerebrovascular accident  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Generalised tonic-clonic seizure  1  0/124 (0.00%)  1/125 (0.80%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Hemiparesis  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Peripheral sensory neuropathy  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  1/38 (2.63%)  0/17 (0.00%)  0/18 (0.00%) 
Subarachnoid haemorrhage  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Trigeminal neuralgia  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Vocal cord paresis  1  0/124 (0.00%)  0/125 (0.00%)  1/122 (0.82%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Pregnancy, puerperium and perinatal conditions               
Abortion incomplete  1  0/124 (0.00%)  1/125 (0.80%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Psychiatric disorders               
Completed suicide  1  0/124 (0.00%)  0/125 (0.00%)  1/122 (0.82%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Depression  1  0/124 (0.00%)  0/125 (0.00%)  1/122 (0.82%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Renal and urinary disorders               
Renal colic  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  1/38 (2.63%)  0/17 (0.00%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Acute respiratory failure  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Asthma  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Chronic obstructive pulmonary disease  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Dyspnoea  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Nasal septum deviation  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Pulmonary fibrosis  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Respiratory failure  1  1/124 (0.81%)  1/125 (0.80%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Vascular disorders               
Peripheral venous disease  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Varicose vein  1  0/124 (0.00%)  1/125 (0.80%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Secukinumab 10mg/kg -75 mg Secukinumab 10mg/kg -150 mg Placebo Secukinumab Placebo Non-Resp Secukinumab 75 mg Placebo Non-Resp Secukinumab 150 mg Placebo Resp Secukinumab 75 mg Placebo Resp Secukinumab 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   88/124 (70.97%)   100/125 (80.00%)   52/122 (42.62%)   24/39 (61.54%)   27/38 (71.05%)   12/17 (70.59%)   13/18 (72.22%) 
Blood and lymphatic system disorders               
Leukopenia  1  10/124 (8.06%)  8/125 (6.40%)  1/122 (0.82%)  1/39 (2.56%)  0/38 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Lymphadenopathy  1  4/124 (3.23%)  3/125 (2.40%)  0/122 (0.00%)  2/39 (5.13%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Lymphopenia  1  0/124 (0.00%)  2/125 (1.60%)  1/122 (0.82%)  0/39 (0.00%)  0/38 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Cardiac disorders               
Bradycardia  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Bundle branch block right  1  0/124 (0.00%)  2/125 (1.60%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Ear and labyrinth disorders               
Sudden hearing loss  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Vertigo  1  1/124 (0.81%)  2/125 (1.60%)  0/122 (0.00%)  2/39 (5.13%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Eye disorders               
Iritis  1  1/124 (0.81%)  1/125 (0.80%)  1/122 (0.82%)  0/39 (0.00%)  1/38 (2.63%)  1/17 (5.88%)  0/18 (0.00%) 
Uveitis  1  4/124 (3.23%)  4/125 (3.20%)  2/122 (1.64%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  3/18 (16.67%) 
Gastrointestinal disorders               
Abdominal pain  1  3/124 (2.42%)  8/125 (6.40%)  0/122 (0.00%)  0/39 (0.00%)  1/38 (2.63%)  0/17 (0.00%)  0/18 (0.00%) 
Abdominal pain upper  1  9/124 (7.26%)  7/125 (5.60%)  0/122 (0.00%)  0/39 (0.00%)  1/38 (2.63%)  0/17 (0.00%)  0/18 (0.00%) 
Aphthous stomatitis  1  1/124 (0.81%)  3/125 (2.40%)  1/122 (0.82%)  0/39 (0.00%)  0/38 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Crohn's disease  1  3/124 (2.42%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  1/38 (2.63%)  1/17 (5.88%)  0/18 (0.00%) 
Dental caries  1  1/124 (0.81%)  2/125 (1.60%)  1/122 (0.82%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Diarrhoea  1  16/124 (12.90%)  21/125 (16.80%)  7/122 (5.74%)  4/39 (10.26%)  3/38 (7.89%)  2/17 (11.76%)  1/18 (5.56%) 
Diverticulum intestinal  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Gastric ulcer  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Gastritis  1  1/124 (0.81%)  1/125 (0.80%)  1/122 (0.82%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Gastrooesophageal reflux disease  1  1/124 (0.81%)  1/125 (0.80%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Irritable bowel syndrome  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  1/38 (2.63%)  1/17 (5.88%)  0/18 (0.00%) 
Mouth ulceration  1  8/124 (6.45%)  5/125 (4.00%)  3/122 (2.46%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  2/18 (11.11%) 
Nausea  1  7/124 (5.65%)  8/125 (6.40%)  2/122 (1.64%)  2/39 (5.13%)  1/38 (2.63%)  0/17 (0.00%)  1/18 (5.56%) 
Tongue ulceration  1  1/124 (0.81%)  3/125 (2.40%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
General disorders               
Fatigue  1  5/124 (4.03%)  3/125 (2.40%)  2/122 (1.64%)  1/39 (2.56%)  1/38 (2.63%)  0/17 (0.00%)  1/18 (5.56%) 
Pyrexia  1  0/124 (0.00%)  1/125 (0.80%)  2/122 (1.64%)  0/39 (0.00%)  4/38 (10.53%)  0/17 (0.00%)  0/18 (0.00%) 
Infections and infestations               
VARICELLA ZOSTER VIRUS INFECTION  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Acute tonsillitis  1  3/124 (2.42%)  2/125 (1.60%)  0/122 (0.00%)  1/39 (2.56%)  1/38 (2.63%)  1/17 (5.88%)  0/18 (0.00%) 
Bronchitis  1  1/124 (0.81%)  6/125 (4.80%)  2/122 (1.64%)  0/39 (0.00%)  2/38 (5.26%)  1/17 (5.88%)  2/18 (11.11%) 
Infection parasitic  1  3/124 (2.42%)  1/125 (0.80%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Influenza  1  7/124 (5.65%)  12/125 (9.60%)  2/122 (1.64%)  4/39 (10.26%)  4/38 (10.53%)  2/17 (11.76%)  1/18 (5.56%) 
Nasopharyngitis  1  25/124 (20.16%)  34/125 (27.20%)  9/122 (7.38%)  7/39 (17.95%)  6/38 (15.79%)  3/17 (17.65%)  4/18 (22.22%) 
Oral herpes  1  2/124 (1.61%)  6/125 (4.80%)  0/122 (0.00%)  0/39 (0.00%)  2/38 (5.26%)  0/17 (0.00%)  0/18 (0.00%) 
Paronychia  1  1/124 (0.81%)  1/125 (0.80%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Pharyngitis  1  10/124 (8.06%)  18/125 (14.40%)  1/122 (0.82%)  2/39 (5.13%)  1/38 (2.63%)  0/17 (0.00%)  2/18 (11.11%) 
Rhinitis  1  4/124 (3.23%)  8/125 (6.40%)  0/122 (0.00%)  1/39 (2.56%)  3/38 (7.89%)  0/17 (0.00%)  1/18 (5.56%) 
Sinusitis  1  4/124 (3.23%)  5/125 (4.00%)  3/122 (2.46%)  0/39 (0.00%)  2/38 (5.26%)  0/17 (0.00%)  0/18 (0.00%) 
Tooth abscess  1  1/124 (0.81%)  1/125 (0.80%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Tooth infection  1  1/124 (0.81%)  1/125 (0.80%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Upper respiratory tract infection  1  17/124 (13.71%)  9/125 (7.20%)  2/122 (1.64%)  2/39 (5.13%)  6/38 (15.79%)  2/17 (11.76%)  2/18 (11.11%) 
Urinary tract infection  1  2/124 (1.61%)  7/125 (5.60%)  0/122 (0.00%)  1/39 (2.56%)  1/38 (2.63%)  0/17 (0.00%)  1/18 (5.56%) 
Viral upper respiratory tract infection  1  1/124 (0.81%)  1/125 (0.80%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Injury, poisoning and procedural complications               
Arthropod bite  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  2/39 (5.13%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Fall  1  4/124 (3.23%)  3/125 (2.40%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Wound  1  3/124 (2.42%)  5/125 (4.00%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Investigations               
Blood cholesterol increased  1  1/124 (0.81%)  1/125 (0.80%)  1/122 (0.82%)  0/39 (0.00%)  2/38 (5.26%)  0/17 (0.00%)  0/18 (0.00%) 
Gamma-glutamyltransferase increased  1  2/124 (1.61%)  1/125 (0.80%)  1/122 (0.82%)  0/39 (0.00%)  1/38 (2.63%)  0/17 (0.00%)  1/18 (5.56%) 
Low density lipoprotein increased  1  1/124 (0.81%)  3/125 (2.40%)  1/122 (0.82%)  0/39 (0.00%)  2/38 (5.26%)  0/17 (0.00%)  0/18 (0.00%) 
Osteoprotegerin decreased  1  2/124 (1.61%)  4/125 (3.20%)  2/122 (1.64%)  0/39 (0.00%)  2/38 (5.26%)  0/17 (0.00%)  0/18 (0.00%) 
Metabolism and nutrition disorders               
Dyslipidaemia  1  15/124 (12.10%)  13/125 (10.40%)  6/122 (4.92%)  1/39 (2.56%)  1/38 (2.63%)  0/17 (0.00%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders               
Ankylosing spondylitis  1  2/124 (1.61%)  6/125 (4.80%)  4/122 (3.28%)  0/39 (0.00%)  0/38 (0.00%)  2/17 (11.76%)  1/18 (5.56%) 
Arthralgia  1  8/124 (6.45%)  11/125 (8.80%)  4/122 (3.28%)  3/39 (7.69%)  2/38 (5.26%)  0/17 (0.00%)  0/18 (0.00%) 
Back pain  1  6/124 (4.84%)  11/125 (8.80%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Bone pain  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Bursitis  1  1/124 (0.81%)  2/125 (1.60%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Intervertebral disc protrusion  1  0/124 (0.00%)  0/125 (0.00%)  1/122 (0.82%)  1/39 (2.56%)  2/38 (5.26%)  0/17 (0.00%)  0/18 (0.00%) 
Musculoskeletal pain  1  2/124 (1.61%)  2/125 (1.60%)  0/122 (0.00%)  2/39 (5.13%)  1/38 (2.63%)  0/17 (0.00%)  0/18 (0.00%) 
Myalgia  1  0/124 (0.00%)  0/125 (0.00%)  1/122 (0.82%)  1/39 (2.56%)  0/38 (0.00%)  1/17 (5.88%)  1/18 (5.56%) 
Neck pain  1  3/124 (2.42%)  2/125 (1.60%)  0/122 (0.00%)  2/39 (5.13%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Osteoarthritis  1  2/124 (1.61%)  0/125 (0.00%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Osteoporosis  1  0/124 (0.00%)  3/125 (2.40%)  1/122 (0.82%)  1/39 (2.56%)  3/38 (7.89%)  1/17 (5.88%)  0/18 (0.00%) 
Pain in extremity  1  3/124 (2.42%)  4/125 (3.20%)  2/122 (1.64%)  2/39 (5.13%)  1/38 (2.63%)  1/17 (5.88%)  0/18 (0.00%) 
Plantar fasciitis  1  0/124 (0.00%)  0/125 (0.00%)  1/122 (0.82%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Spinal pain  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  1/38 (2.63%)  0/17 (0.00%)  1/18 (5.56%) 
Tendonitis  1  4/124 (3.23%)  1/125 (0.80%)  2/122 (1.64%)  1/39 (2.56%)  1/38 (2.63%)  0/17 (0.00%)  1/18 (5.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Benign breast neoplasm  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Nervous system disorders               
Dizziness  1  5/124 (4.03%)  6/125 (4.80%)  4/122 (3.28%)  1/39 (2.56%)  1/38 (2.63%)  0/17 (0.00%)  1/18 (5.56%) 
Headache  1  18/124 (14.52%)  18/125 (14.40%)  7/122 (5.74%)  2/39 (5.13%)  2/38 (5.26%)  0/17 (0.00%)  2/18 (11.11%) 
Paraesthesia  1  2/124 (1.61%)  5/125 (4.00%)  0/122 (0.00%)  1/39 (2.56%)  1/38 (2.63%)  0/17 (0.00%)  1/18 (5.56%) 
Tremor  1  0/124 (0.00%)  1/125 (0.80%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Psychiatric disorders               
Anxiety  1  3/124 (2.42%)  0/125 (0.00%)  0/122 (0.00%)  2/39 (5.13%)  0/38 (0.00%)  0/17 (0.00%)  0/18 (0.00%) 
Insomnia  1  3/124 (2.42%)  4/125 (3.20%)  2/122 (1.64%)  1/39 (2.56%)  1/38 (2.63%)  0/17 (0.00%)  1/18 (5.56%) 
Renal and urinary disorders               
Cystitis haemorrhagic  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Reproductive system and breast disorders               
Benign prostatic hyperplasia  1  1/124 (0.81%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Ovarian cyst  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Asthma  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Cough  1  7/124 (5.65%)  7/125 (5.60%)  2/122 (1.64%)  2/39 (5.13%)  2/38 (5.26%)  0/17 (0.00%)  1/18 (5.56%) 
Oropharyngeal pain  1  10/124 (8.06%)  11/125 (8.80%)  6/122 (4.92%)  3/39 (7.69%)  4/38 (10.53%)  0/17 (0.00%)  1/18 (5.56%) 
Rhinitis allergic  1  0/124 (0.00%)  1/125 (0.80%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  1/17 (5.88%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders               
Dermatitis  1  0/124 (0.00%)  5/125 (4.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Eczema  1  1/124 (0.81%)  1/125 (0.80%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Erythema  1  0/124 (0.00%)  0/125 (0.00%)  1/122 (0.82%)  0/39 (0.00%)  2/38 (5.26%)  0/17 (0.00%)  0/18 (0.00%) 
Nail dystrophy  1  0/124 (0.00%)  0/125 (0.00%)  0/122 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Pruritus  1  2/124 (1.61%)  6/125 (4.80%)  1/122 (0.82%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  1/18 (5.56%) 
Rash  1  1/124 (0.81%)  5/125 (4.00%)  0/122 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/17 (0.00%)  2/18 (11.11%) 
Urticaria  1  1/124 (0.81%)  2/125 (1.60%)  0/122 (0.00%)  0/39 (0.00%)  2/38 (5.26%)  0/17 (0.00%)  0/18 (0.00%) 
Vascular disorders               
Hypertension  1  6/124 (4.84%)  4/125 (3.20%)  0/122 (0.00%)  1/39 (2.56%)  1/38 (2.63%)  1/17 (5.88%)  1/18 (5.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
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 (ie, data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Clinical Disclosure Office
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01358175     History of Changes
Other Study ID Numbers: CAIN457F2305
2010-024529-18 ( EudraCT Number )
First Submitted: May 19, 2011
First Posted: May 23, 2011
Results First Submitted: December 14, 2015
Results First Posted: January 27, 2017
Last Update Posted: March 9, 2017