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Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab

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ClinicalTrials.gov Identifier: NCT02008890
Recruitment Status : Completed
First Posted : December 11, 2013
Results First Posted : January 4, 2019
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Palmoplantar Pustular Psoriasis
Interventions Biological: Secukinumab 300mg
Biological: Secukinumab 150mg
Biological: Placebo
Enrollment 237
Recruitment Details A total of 337 patients were screened, and 237 of these patients completed the screening phase and were randomized to treatment.
Pre-assignment Details At baseline patients were randomized at 61 study centers to one of the three treatment groups in a 1:1:1 ratio.
Arm/Group Title AIN457 150mg AIN457 300mg Placebo Placebo - AIN457 150 mg Placebo - AIN457 300 mg
Hide Arm/Group Description Secukinumab 150mg at each dosing. Secukinumab 300mg at each dosing. Placebo at each dosing. Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study. Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
Period Title: Period 1
Started 80 79 78 0 0
Completed 65 64 66 0 0
Not Completed 15 15 12 0 0
Reason Not Completed
Withdrawal by Subject             7             7             5             0             0
Pregnancy             1             0             0             0             0
Physician Decision             1             0             1             0             0
Adverse Event             6             8             6             0             0
Period Title: Period 2
Started 65 64 10 27 28
Completed 38 49 9 13 20
Not Completed 27 15 1 14 8
Reason Not Completed
Adverse Event             12             7             0             5             5
Withdrawal by Subject             11             8             0             7             2
Physician Decision             4             0             0             2             1
Lost to Follow-up             0             0             1             0             0
Period Title: Extension Period
Started 31 36 0 10 17
Completed 26 31 0 6 13
Not Completed 5 5 0 4 4
Reason Not Completed
Withdrawal by Subject             3             2             0             4             2
Lost to Follow-up             1             0             0             0             0
Adverse Event             1             3             0             0             2
Arm/Group Title AIN457 150mg AIN457 300mg Placebo Total
Hide Arm/Group Description Secukinumab 150mg at each dosing in period 1. Secukinumab 300mg at each dosing in period 1. Placebo at each dosing in period 1. Total of all reporting groups
Overall Number of Baseline Participants 80 79 78 237
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 79 participants 78 participants 237 participants
50.7  (13.68) 50.6  (14.77) 52.9  (11.33) 51.4  (13.33)
[1]
Measure Analysis Population Description: Randomized (Started)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 79 participants 78 participants 237 participants
Female
63
  78.8%
64
  81.0%
59
  75.6%
186
  78.5%
Male
17
  21.3%
15
  19.0%
19
  24.4%
51
  21.5%
[1]
Measure Analysis Population Description: Randomized (Started)
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 80 participants 79 participants 78 participants 237 participants
Black 1 0 1 2
Caucasian 78 78 76 232
Missing 1 0 1 2
Other 0 1 0 1
1.Primary Outcome
Title Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1)
Hide Description The primary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS = Started). A patient with a missing ppPASI assessment at Week 16 was considered as a responder if he/she has met the response criterion already at the time of drop-out. Otherwise he/she was considered as a non-responder.
Arm/Group Title AIN457 150mg AIN457 300mg Placebo
Hide Arm/Group Description:
Secukinumab 150mg at each dosing.
Secukinumab 300mg at each dosing
Placebo at each dosing.
Overall Number of Participants Analyzed 80 79 78
Measure Type: Number
Unit of Measure: percentage of participants
17.5 26.6 14.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AIN457 150mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5722
Comments [Not Specified]
Method Regression, Logistic
Comments with factors treatment, country, body weight at baseline visit (> 90 kg or >= 90kg) and presence of plaque-type psoriasis
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
0.50 to 3.53
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AIN457 300mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0411
Comments [Not Specified]
Method Regression, Logistic
Comments with factors treatment, country, body weight at baseline visit (> 90 kg or >= 90kg) and presence of plaque-type psoriasis
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.62
Confidence Interval (2-Sided) 95%
1.04 to 6.60
Estimation Comments [Not Specified]
2.Secondary Outcome
Title ppPASI: Absolute Change From Baseline to Week 16
Hide Description A secondary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI). The mean change of ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS - Including only Patients with ppPASI Scores at Baseline and Week 16
Arm/Group Title AIN457 150mg AIN457 300mg Placebo
Hide Arm/Group Description:
Secukinumab 150mg at each dosing.
Secukinumab 300mg at each dosing
Placebo at each dosing.
Overall Number of Participants Analyzed 68 69 70
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 21.79  (8.211) 23.01  (10.787) 23.10  (10.198)
Change from Baseline to Week 16 -6.99  (10.904) -9.74  (12.130) -6.73  (9.868)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AIN457 150mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9431
Comments [Not Specified]
Method Regression, Linear
Comments with factors treatment, country, body weight at baseline visit (> 90 kg or >= 90kg) and presence of plaque-type psoriasis
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.56
Confidence Interval (2-Sided) 95%
-4.59 to 3.47
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AIN457 300mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1576
Comments [Not Specified]
Method Regression, Linear
Comments with factors treatment, country, body weight at baseline visit (> 90 kg or >= 90kg) and presence of plaque-type psoriasis
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.13
Confidence Interval (2-Sided) 95%
-7.14 to 0.88
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With ppPASI 75 Response Over Time (Period 1)
Hide Description A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150mg AIN457 300mg Placebo
Hide Arm/Group Description:
Secukinumab 150mg at each dosing.
Secukinumab 300mg at each dosing
Placebo at each dosing.
Overall Number of Participants Analyzed 80 79 78
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 Number Analyzed 79 participants 79 participants 75 participants
0 1.3 1.3
Week 2 Number Analyzed 79 participants 78 participants 77 participants
1.3 1.3 0
Week 3 Number Analyzed 78 participants 74 participants 71 participants
2.6 5.4 0
Week 4 Number Analyzed 77 participants 77 participants 74 participants
6.5 9.1 1.4
Week 8 Number Analyzed 77 participants 75 participants 73 participants
13.0 13.3 9.6
Week 12 Number Analyzed 75 participants 71 participants 69 participants
14.7 23.9 10.1
Week 16 Number Analyzed 80 participants 79 participants 78 participants
17.5 26.6 14.1
4.Secondary Outcome
Title Percentage of Participants With ppPASI 75 Response Over Time (Period 2)
Hide Description A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Time Frame Week 16 to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS - Including only patients entering period 2
Arm/Group Title AIN457 150mg AIN457 300mg Placebo Placebo - AIN457 150 mg Placebo - AIN457 300 mg
Hide Arm/Group Description:
Secukinumab 150mg at each dosing.
Secukinumab 300mg at each dosing
Placebo at each dosing.
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
Overall Number of Participants Analyzed 64 64 10 27 28
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 Number Analyzed 64 participants 64 participants 10 participants 27 participants 28 participants
18.8 31.3 90.0 0 0
Week 20 Number Analyzed 64 participants 64 participants 10 participants 26 participants 28 participants
20.3 31.3 80.0 7.7 17.9
Week 24 Number Analyzed 63 participants 64 participants 10 participants 26 participants 26 participants
30.2 37.5 80.0 19.2 38.5
Week 32 Number Analyzed 55 participants 58 participants 10 participants 20 participants 25 participants
36.4 48.3 80.0 25.0 44.0
Week 40 Number Analyzed 45 participants 55 participants 10 participants 16 participants 24 participants
44.4 56.4 70.0 37.5 50.0
Week 48 Number Analyzed 42 participants 50 participants 10 participants 15 participants 19 participants
52.4 58.0 60.0 40.0 47.4
Week 52 Number Analyzed 38 participants 51 participants 9 participants 14 participants 20 participants
57.9 58.8 66.7 50.0 60.0
5.Secondary Outcome
Title Percentage of Participants With ppPASI 75 Response Over Time (Extension Period)
Hide Description A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to each post-baseline visit was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
Time Frame Week 52 to Week 148
Hide Outcome Measure Data
Hide Analysis Population Description
FAS - Including only patients entering extension period (Placebo Week 16 responders not eligible)
Arm/Group Title AIN457 150mg AIN457 300mg Placebo - AIN457 150 mg Placebo - AIN457 300 mg
Hide Arm/Group Description:
Secukinumab 150mg at each dosing.
Secukinumab 300mg at each dosing
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
Overall Number of Participants Analyzed 31 36 10 17
Measure Type: Number
Unit of Measure: percentage of participants
Week 52 Number Analyzed 31 participants 36 participants 10 participants 17 participants
64.5 63.9 50.0 64.7
Week 64 Number Analyzed 30 participants 36 participants 10 participants 17 participants
56.7 66.7 40.0 82.4
Week 76 Number Analyzed 22 participants 31 participants 8 participants 15 participants
68.2 67.7 62.5 60.0
Week 88 Number Analyzed 17 participants 25 participants 7 participants 12 participants
88.2 80.0 42.9 75.0
Week 100 Number Analyzed 16 participants 24 participants 6 participants 11 participants
100.0 75.0 33.3 54.5
Week 112 Number Analyzed 15 participants 24 participants 5 participants 9 participants
100.0 75.0 60.0 66.7
Week 124 Number Analyzed 15 participants 23 participants 5 participants 10 participants
93.3 78.3 40.0 70.0
Week 136 Number Analyzed 15 participants 22 participants 5 participants 9 participants
93.3 77.3 40.0 66.7
Week 148 Number Analyzed 15 participants 23 participants 4 participants 9 participants
100.0 78.3 75.0 77.8
6.Secondary Outcome
Title Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)
Hide Description Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Time Frame Baseline to Week 16 (Period 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title AIN457 150mg AIN457 300mg Placebo
Hide Arm/Group Description:
Secukinumab 150mg at each dosing.
Secukinumab 300mg at each dosing
Placebo at each dosing.
Overall Number of Participants Analyzed 80 79 78
Measure Type: Number
Unit of Measure: percentage of participants
Nasopharyngitis 10.0 20.3 14.1
Pustular psoriasis 12.5 16.5 5.1
Headache 5.0 12.7 14.1
Pruritus 6.3 8.9 5.1
Psoriasis 6.3 5.1 3.8
Urinary tract infection 2.5 5.1 3.8
Cough 6.3 3.8 0
Folliculitis 3.8 5.1 1.3
Nausea 3.8 5.1 0
Oral herpes 5.0 1.3 0
Rash pustular 5.0 1.3 0
7.Secondary Outcome
Title Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)
Hide Description Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Time Frame Week 16 to Week 52 (Period 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set - Including only patients entering period 2
Arm/Group Title AIN457 150mg AIN457 300mg Placebo Placebo - AIN457 150 mg Placebo - AIN457 300 mg
Hide Arm/Group Description:
Secukinumab 150mg at each dosing.
Secukinumab 300mg at each dosing
Placebo at each dosing.
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 150mg from Week 16 until the end of the study.
Placebo until Week 12. ppPASI 75 non-responder at Week 16. Secukinumab 300mg from Week 16 until the end of the study.
Overall Number of Participants Analyzed 64 64 10 27 28
Measure Type: Number
Unit of Measure: percentage of participants
Nasopharyngitis 12.5 21.9 10.0 11.1 21.4
Pustular psoriasis 18.8 10.9 10.0 14.8 21.4
Bronchitis 4.7 9.4 0.0 3.7 10.7
Headache 4.7 6.3 0.0 3.7 7.1
Eczema 1.6 9.4 0.0 7.4 0.0
Psoriasis 3.1 4.7 20.0 7.4 0.0
Pruritus 3.1 4.7 10.0 0.0 7.1
Folliculitis 3.1 6.3 0.0 0.0 3.6
Pain in extremity 0.0 7.8 0.0 7.4 0.0
Cough 0.0 6.3 0.0 0.0 3.6
Sinusitis 0.0 1.6 10.0 7.4 3.6
Skin infection 1.6 3.1 0.0 7.4 0.0
Urinary tract infection 0.0 4.7 0.0 7.4 0.0
Pruritus generalised 1.6 1.6 0.0 7.4 0.0
Rash 0.0 6.3 0.0 0.0 0.0
8.Secondary Outcome
Title Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety)
Hide Description Most frequent (at least 5% in any of the AIN457 groups) Adverse Events
Time Frame Week 52 to Week 148 (extension period)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set - including only patients entering the extension period
Arm/Group Title AIN457 150mg AIN457 300mg
Hide Arm/Group Description:
Secukinumab 150mg at each dosing.
Secukinumab 300mg at each dosing
Overall Number of Participants Analyzed 41 53
Measure Type: Number
Unit of Measure: percentage of participants
Viral upper respiratory tract infection 12.2 18.9
Headache 7.3 5.7
Upper respiratory tract infection 2.4 9.4
Urinary tract infection 9.8 3.8
Diarrhoea 4.9 5.7
Tonsillitis 2.4 5.7
Ear infection 7.3 0.0
Oropharyngeal pain 0.0 5.7
Time Frame Baseline to Week 148
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Initial AIN457 150 mg Initial AIN457 300 mg Placebo AIN457 150 mg in Any Period AIN457 300 mg in Any Period Any AIN457
Hide Arm/Group Description AEs for patients randomized to Secukinumab 150 mg at start of study. AEs for patients randomized to Secukinumab 300 mg at start of study. AEs for patients randomized to Placebo at start of study while treated with Placebo (AEs that occurred after re-randomization to Secukinumab are not counted in this group). AEs for patients initially randomized to AIN457 150mg and placebo non-responder re-randomized to AIN457 150 mg at Week 16 AEs for patients initially randomized to AIN457 300mg and placebo non-responder re-randomized to AIN457 300 mg at Week 16 Any Secukinumab
All-Cause Mortality
Initial AIN457 150 mg Initial AIN457 300 mg Placebo AIN457 150 mg in Any Period AIN457 300 mg in Any Period Any AIN457
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   0/79 (0.00%)   0/78 (0.00%)   0/107 (0.00%)   0/107 (0.00%)   0/214 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Initial AIN457 150 mg Initial AIN457 300 mg Placebo AIN457 150 mg in Any Period AIN457 300 mg in Any Period Any AIN457
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/80 (11.25%)   13/79 (16.46%)   5/78 (6.41%)   11/107 (10.28%)   17/107 (15.89%)   28/214 (13.08%) 
Cardiac disorders             
Arrhythmia  1  0/80 (0.00%)  1/79 (1.27%)  0/78 (0.00%)  0/107 (0.00%)  1/107 (0.93%)  1/214 (0.47%) 
Atrial thrombosis  1  0/80 (0.00%)  1/79 (1.27%)  0/78 (0.00%)  0/107 (0.00%)  1/107 (0.93%)  1/214 (0.47%) 
Cardiac arrest  1  0/80 (0.00%)  1/79 (1.27%)  1/78 (1.28%)  0/107 (0.00%)  2/107 (1.87%)  2/214 (0.93%) 
Cardiogenic shock  1  0/80 (0.00%)  1/79 (1.27%)  0/78 (0.00%)  0/107 (0.00%)  1/107 (0.93%)  1/214 (0.47%) 
Cardiomyopathy  1  1/80 (1.25%)  1/79 (1.27%)  0/78 (0.00%)  1/107 (0.93%)  1/107 (0.93%)  2/214 (0.93%) 
Coronary artery disease  1  0/80 (0.00%)  1/79 (1.27%)  0/78 (0.00%)  0/107 (0.00%)  1/107 (0.93%)  1/214 (0.47%) 
Coronary artery stenosis  1  1/80 (1.25%)  0/79 (0.00%)  0/78 (0.00%)  1/107 (0.93%)  0/107 (0.00%)  1/214 (0.47%) 
Myocardial infarction  1  0/80 (0.00%)  0/79 (0.00%)  0/78 (0.00%)  0/107 (0.00%)  1/107 (0.93%)  1/214 (0.47%) 
Tachycardia  1  1/80 (1.25%)  0/79 (0.00%)  0/78 (0.00%)  1/107 (0.93%)  0/107 (0.00%)  1/214 (0.47%) 
Gastrointestinal disorders             
Abdominal mass  1  1/80 (1.25%)  0/79 (0.00%)  0/78 (0.00%)  1/107 (0.93%)  0/107 (0.00%)  1/214 (0.47%) 
General disorders             
Drug ineffective  1  0/80 (0.00%)  0/79 (0.00%)  0/78 (0.00%)  0/107 (0.00%)  1/107 (0.93%)  1/214 (0.47%) 
Multiple organ dysfunction syndrome  1  0/80 (0.00%)  1/79 (1.27%)  0/78 (0.00%)  0/107 (0.00%)  1/107 (0.93%)  1/214 (0.47%) 
Hepatobiliary disorders             
Drug-induced liver injury  1  0/80 (0.00%)  0/79 (0.00%)  1/78 (1.28%)  0/107 (0.00%)  0/107 (0.00%)  0/214 (0.00%) 
Infections and infestations             
Cellulitis  1  0/80 (0.00%)  1/79 (1.27%)  0/78 (0.00%)  0/107 (0.00%)  1/107 (0.93%)  1/214 (0.47%) 
Erysipelas  1  0/80 (0.00%)  0/79 (0.00%)  1/78 (1.28%)  0/107 (0.00%)  0/107 (0.00%)  0/214 (0.00%) 
Lower respiratory tract infection  1  0/80 (0.00%)  0/79 (0.00%)  0/78 (0.00%)  1/107 (0.93%)  0/107 (0.00%)  1/214 (0.47%) 
Peritonsillar abscess  1  0/80 (0.00%)  1/79 (1.27%)  0/78 (0.00%)  0/107 (0.00%)  1/107 (0.93%)  1/214 (0.47%) 
Rash pustular  1  1/80 (1.25%)  0/79 (0.00%)  0/78 (0.00%)  1/107 (0.93%)  0/107 (0.00%)  1/214 (0.47%) 
Superinfection bacterial  1  0/80 (0.00%)  1/79 (1.27%)  0/78 (0.00%)  0/107 (0.00%)  1/107 (0.93%)  1/214 (0.47%) 
Upper respiratory tract infection  1  0/80 (0.00%)  0/79 (0.00%)  0/78 (0.00%)  1/107 (0.93%)  0/107 (0.00%)  1/214 (0.47%) 
Urinary tract infection  1  0/80 (0.00%)  1/79 (1.27%)  0/78 (0.00%)  0/107 (0.00%)  1/107 (0.93%)  1/214 (0.47%) 
Injury, poisoning and procedural complications             
Subarachnoid haemorrhage  1  0/80 (0.00%)  0/79 (0.00%)  1/78 (1.28%)  0/107 (0.00%)  0/107 (0.00%)  0/214 (0.00%) 
Investigations             
Aspartate aminotransferase increased  1  1/80 (1.25%)  0/79 (0.00%)  0/78 (0.00%)  1/107 (0.93%)  0/107 (0.00%)  1/214 (0.47%) 
Transaminases increased  1  0/80 (0.00%)  1/79 (1.27%)  1/78 (1.28%)  0/107 (0.00%)  1/107 (0.93%)  1/214 (0.47%) 
Metabolism and nutrition disorders             
Diabetes mellitus  1  0/80 (0.00%)  1/79 (1.27%)  0/78 (0.00%)  0/107 (0.00%)  1/107 (0.93%)  1/214 (0.47%) 
Musculoskeletal and connective tissue disorders             
Cervical spinal stenosis  1  0/80 (0.00%)  1/79 (1.27%)  0/78 (0.00%)  0/107 (0.00%)  1/107 (0.93%)  1/214 (0.47%) 
Osteoarthritis  1  0/80 (0.00%)  0/79 (0.00%)  0/78 (0.00%)  0/107 (0.00%)  1/107 (0.93%)  1/214 (0.47%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Tonsil cancer  1  0/80 (0.00%)  0/79 (0.00%)  0/78 (0.00%)  0/107 (0.00%)  1/107 (0.93%)  1/214 (0.47%) 
Uterine leiomyoma  1  1/80 (1.25%)  0/79 (0.00%)  0/78 (0.00%)  1/107 (0.93%)  0/107 (0.00%)  1/214 (0.47%) 
Nervous system disorders             
Cerebrovascular accident  1  0/80 (0.00%)  0/79 (0.00%)  1/78 (1.28%)  0/107 (0.00%)  0/107 (0.00%)  0/214 (0.00%) 
Reproductive system and breast disorders             
Endometrial hyperplasia  1  1/80 (1.25%)  0/79 (0.00%)  0/78 (0.00%)  1/107 (0.93%)  0/107 (0.00%)  1/214 (0.47%) 
Respiratory, thoracic and mediastinal disorders             
Chronic obstructive pulmonary disease  1  0/80 (0.00%)  1/79 (1.27%)  0/78 (0.00%)  0/107 (0.00%)  1/107 (0.93%)  1/214 (0.47%) 
Skin and subcutaneous tissue disorders             
Erythema multiforme  1  1/80 (1.25%)  0/79 (0.00%)  0/78 (0.00%)  1/107 (0.93%)  0/107 (0.00%)  1/214 (0.47%) 
Psoriasis  1  1/80 (1.25%)  0/79 (0.00%)  0/78 (0.00%)  1/107 (0.93%)  0/107 (0.00%)  1/214 (0.47%) 
Pustular psoriasis  1  1/80 (1.25%)  4/79 (5.06%)  0/78 (0.00%)  1/107 (0.93%)  4/107 (3.74%)  5/214 (2.34%) 
Surgical and medical procedures             
Hip arthroplasty  1  0/80 (0.00%)  1/79 (1.27%)  0/78 (0.00%)  0/107 (0.00%)  1/107 (0.93%)  1/214 (0.47%) 
Vascular disorders             
Hypotension  1  0/80 (0.00%)  0/79 (0.00%)  0/78 (0.00%)  1/107 (0.93%)  0/107 (0.00%)  1/214 (0.47%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Initial AIN457 150 mg Initial AIN457 300 mg Placebo AIN457 150 mg in Any Period AIN457 300 mg in Any Period Any AIN457
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   73/80 (91.25%)   73/79 (92.41%)   53/78 (67.95%)   92/107 (85.98%)   94/107 (87.85%)   186/214 (86.92%) 
Cardiac disorders             
Bradycardia  1  1/80 (1.25%)  2/79 (2.53%)  0/78 (0.00%)  1/107 (0.93%)  3/107 (2.80%)  4/214 (1.87%) 
Tachycardia  1  2/80 (2.50%)  2/79 (2.53%)  1/78 (1.28%)  2/107 (1.87%)  2/107 (1.87%)  4/214 (1.87%) 
Ear and labyrinth disorders             
Vertigo  1  2/80 (2.50%)  0/79 (0.00%)  1/78 (1.28%)  2/107 (1.87%)  0/107 (0.00%)  2/214 (0.93%) 
Gastrointestinal disorders             
Abdominal pain  1  2/80 (2.50%)  2/79 (2.53%)  0/78 (0.00%)  3/107 (2.80%)  3/107 (2.80%)  6/214 (2.80%) 
Aphthous ulcer  1  1/80 (1.25%)  2/79 (2.53%)  0/78 (0.00%)  1/107 (0.93%)  2/107 (1.87%)  3/214 (1.40%) 
Constipation  1  3/80 (3.75%)  0/79 (0.00%)  0/78 (0.00%)  3/107 (2.80%)  0/107 (0.00%)  3/214 (1.40%) 
Dental caries  1  0/80 (0.00%)  2/79 (2.53%)  0/78 (0.00%)  0/107 (0.00%)  2/107 (1.87%)  2/214 (0.93%) 
Diarrhoea  1  5/80 (6.25%)  8/79 (10.13%)  4/78 (5.13%)  5/107 (4.67%)  9/107 (8.41%)  14/214 (6.54%) 
Nausea  1  3/80 (3.75%)  6/79 (7.59%)  0/78 (0.00%)  4/107 (3.74%)  7/107 (6.54%)  11/214 (5.14%) 
Vomiting  1  2/80 (2.50%)  2/79 (2.53%)  0/78 (0.00%)  2/107 (1.87%)  2/107 (1.87%)  4/214 (1.87%) 
General disorders             
Asthenia  1  0/80 (0.00%)  2/79 (2.53%)  1/78 (1.28%)  0/107 (0.00%)  2/107 (1.87%)  2/214 (0.93%) 
Chest pain  1  2/80 (2.50%)  1/79 (1.27%)  1/78 (1.28%)  2/107 (1.87%)  1/107 (0.93%)  3/214 (1.40%) 
Fatigue  1  1/80 (1.25%)  3/79 (3.80%)  3/78 (3.85%)  1/107 (0.93%)  3/107 (2.80%)  4/214 (1.87%) 
Feeling hot  1  0/80 (0.00%)  0/79 (0.00%)  2/78 (2.56%)  0/107 (0.00%)  0/107 (0.00%)  0/214 (0.00%) 
Injection site urticaria  1  0/80 (0.00%)  2/79 (2.53%)  0/78 (0.00%)  0/107 (0.00%)  2/107 (1.87%)  2/214 (0.93%) 
Pyrexia  1  4/80 (5.00%)  1/79 (1.27%)  0/78 (0.00%)  4/107 (3.74%)  1/107 (0.93%)  5/214 (2.34%) 
Immune system disorders             
Drug hypersensitivity  1  0/80 (0.00%)  2/79 (2.53%)  0/78 (0.00%)  0/107 (0.00%)  2/107 (1.87%)  2/214 (0.93%) 
Infections and infestations             
Bacterial vaginosis  1  2/80 (2.50%)  0/79 (0.00%)  0/78 (0.00%)  2/107 (1.87%)  0/107 (0.00%)  2/214 (0.93%) 
Bronchitis  1  5/80 (6.25%)  6/79 (7.59%)  1/78 (1.28%)  6/107 (5.61%)  11/107 (10.28%)  17/214 (7.94%) 
Cellulitis  1  1/80 (1.25%)  2/79 (2.53%)  0/78 (0.00%)  1/107 (0.93%)  2/107 (1.87%)  3/214 (1.40%) 
Conjunctivitis  1  4/80 (5.00%)  3/79 (3.80%)  0/78 (0.00%)  4/107 (3.74%)  4/107 (3.74%)  8/214 (3.74%) 
Cystitis  1  3/80 (3.75%)  1/79 (1.27%)  1/78 (1.28%)  4/107 (3.74%)  2/107 (1.87%)  6/214 (2.80%) 
Ear infection  1  1/80 (1.25%)  0/79 (0.00%)  0/78 (0.00%)  4/107 (3.74%)  0/107 (0.00%)  4/214 (1.87%) 
Eczema impetiginous  1  2/80 (2.50%)  0/79 (0.00%)  0/78 (0.00%)  2/107 (1.87%)  0/107 (0.00%)  2/214 (0.93%) 
Erysipelas  1  1/80 (1.25%)  2/79 (2.53%)  0/78 (0.00%)  1/107 (0.93%)  2/107 (1.87%)  3/214 (1.40%) 
Folliculitis  1  5/80 (6.25%)  8/79 (10.13%)  1/78 (1.28%)  5/107 (4.67%)  9/107 (8.41%)  14/214 (6.54%) 
Fungal skin infection  1  2/80 (2.50%)  2/79 (2.53%)  1/78 (1.28%)  2/107 (1.87%)  2/107 (1.87%)  4/214 (1.87%) 
Furuncle  1  2/80 (2.50%)  2/79 (2.53%)  1/78 (1.28%)  2/107 (1.87%)  2/107 (1.87%)  4/214 (1.87%) 
Gastroenteritis  1  2/80 (2.50%)  3/79 (3.80%)  0/78 (0.00%)  2/107 (1.87%)  3/107 (2.80%)  5/214 (2.34%) 
Impetigo  1  0/80 (0.00%)  2/79 (2.53%)  0/78 (0.00%)  0/107 (0.00%)  2/107 (1.87%)  2/214 (0.93%) 
Influenza  1  5/80 (6.25%)  3/79 (3.80%)  2/78 (2.56%)  5/107 (4.67%)  3/107 (2.80%)  8/214 (3.74%) 
Laryngitis  1  0/80 (0.00%)  0/79 (0.00%)  2/78 (2.56%)  0/107 (0.00%)  0/107 (0.00%)  0/214 (0.00%) 
Localised infection  1  1/80 (1.25%)  3/79 (3.80%)  0/78 (0.00%)  1/107 (0.93%)  3/107 (2.80%)  4/214 (1.87%) 
Lower respiratory tract infection  1  0/80 (0.00%)  2/79 (2.53%)  0/78 (0.00%)  1/107 (0.93%)  2/107 (1.87%)  3/214 (1.40%) 
Oral candidiasis  1  0/80 (0.00%)  5/79 (6.33%)  2/78 (2.56%)  0/107 (0.00%)  5/107 (4.67%)  5/214 (2.34%) 
Oral herpes  1  4/80 (5.00%)  3/79 (3.80%)  0/78 (0.00%)  4/107 (3.74%)  3/107 (2.80%)  7/214 (3.27%) 
Otitis externa  1  2/80 (2.50%)  0/79 (0.00%)  0/78 (0.00%)  2/107 (1.87%)  0/107 (0.00%)  2/214 (0.93%) 
Paronychia  1  2/80 (2.50%)  1/79 (1.27%)  0/78 (0.00%)  2/107 (1.87%)  1/107 (0.93%)  3/214 (1.40%) 
Pharyngitis  1  3/80 (3.75%)  1/79 (1.27%)  0/78 (0.00%)  4/107 (3.74%)  1/107 (0.93%)  5/214 (2.34%) 
Pharyngotonsillitis  1  1/80 (1.25%)  2/79 (2.53%)  0/78 (0.00%)  1/107 (0.93%)  3/107 (2.80%)  4/214 (1.87%) 
Rash pustular  1  3/80 (3.75%)  1/79 (1.27%)  0/78 (0.00%)  3/107 (2.80%)  1/107 (0.93%)  4/214 (1.87%) 
Sinusitis  1  1/80 (1.25%)  3/79 (3.80%)  1/78 (1.28%)  3/107 (2.80%)  4/107 (3.74%)  7/214 (3.27%) 
Skin bacterial infection  1  3/80 (3.75%)  3/79 (3.80%)  1/78 (1.28%)  3/107 (2.80%)  4/107 (3.74%)  7/214 (3.27%) 
Skin infection  1  1/80 (1.25%)  2/79 (2.53%)  1/78 (1.28%)  3/107 (2.80%)  2/107 (1.87%)  5/214 (2.34%) 
Staphylococcal skin infection  1  3/80 (3.75%)  1/79 (1.27%)  0/78 (0.00%)  3/107 (2.80%)  1/107 (0.93%)  4/214 (1.87%) 
Subcutaneous abscess  1  2/80 (2.50%)  0/79 (0.00%)  0/78 (0.00%)  2/107 (1.87%)  0/107 (0.00%)  2/214 (0.93%) 
Tinea pedis  1  1/80 (1.25%)  3/79 (3.80%)  0/78 (0.00%)  1/107 (0.93%)  4/107 (3.74%)  5/214 (2.34%) 
Tonsillitis  1  3/80 (3.75%)  3/79 (3.80%)  0/78 (0.00%)  3/107 (2.80%)  5/107 (4.67%)  8/214 (3.74%) 
Tooth abscess  1  1/80 (1.25%)  2/79 (2.53%)  0/78 (0.00%)  1/107 (0.93%)  3/107 (2.80%)  4/214 (1.87%) 
Upper respiratory tract infection  1  4/80 (5.00%)  7/79 (8.86%)  4/78 (5.13%)  4/107 (3.74%)  8/107 (7.48%)  12/214 (5.61%) 
Urinary tract infection  1  5/80 (6.25%)  5/79 (6.33%)  3/78 (3.85%)  7/107 (6.54%)  6/107 (5.61%)  13/214 (6.07%) 
Viral upper respiratory tract infection  1  17/80 (21.25%)  31/79 (39.24%)  12/78 (15.38%)  20/107 (18.69%)  40/107 (37.38%)  60/214 (28.04%) 
Vulvovaginal candidiasis  1  1/80 (1.25%)  3/79 (3.80%)  1/78 (1.28%)  1/107 (0.93%)  3/107 (2.80%)  4/214 (1.87%) 
Injury, poisoning and procedural complications             
Arthropod bite  1  1/80 (1.25%)  2/79 (2.53%)  0/78 (0.00%)  1/107 (0.93%)  2/107 (1.87%)  3/214 (1.40%) 
Investigations             
Alanine aminotransferase increased  1  2/80 (2.50%)  2/79 (2.53%)  1/78 (1.28%)  2/107 (1.87%)  2/107 (1.87%)  4/214 (1.87%) 
Blood pressure increased  1  1/80 (1.25%)  2/79 (2.53%)  0/78 (0.00%)  1/107 (0.93%)  2/107 (1.87%)  3/214 (1.40%) 
Gamma-glutamyltransferase increased  1  0/80 (0.00%)  2/79 (2.53%)  2/78 (2.56%)  0/107 (0.00%)  2/107 (1.87%)  2/214 (0.93%) 
Metabolism and nutrition disorders             
Dyslipidaemia  1  2/80 (2.50%)  0/79 (0.00%)  0/78 (0.00%)  3/107 (2.80%)  0/107 (0.00%)  3/214 (1.40%) 
Hypercholesterolaemia  1  4/80 (5.00%)  1/79 (1.27%)  3/78 (3.85%)  4/107 (3.74%)  1/107 (0.93%)  5/214 (2.34%) 
Hyperlipidaemia  1  0/80 (0.00%)  2/79 (2.53%)  0/78 (0.00%)  0/107 (0.00%)  2/107 (1.87%)  2/214 (0.93%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  5/80 (6.25%)  4/79 (5.06%)  5/78 (6.41%)  6/107 (5.61%)  4/107 (3.74%)  10/214 (4.67%) 
Back pain  1  4/80 (5.00%)  7/79 (8.86%)  4/78 (5.13%)  5/107 (4.67%)  8/107 (7.48%)  13/214 (6.07%) 
Musculoskeletal pain  1  3/80 (3.75%)  1/79 (1.27%)  1/78 (1.28%)  4/107 (3.74%)  1/107 (0.93%)  5/214 (2.34%) 
Pain in extremity  1  2/80 (2.50%)  7/79 (8.86%)  6/78 (7.69%)  4/107 (3.74%)  7/107 (6.54%)  11/214 (5.14%) 
Psoriatic arthropathy  1  1/80 (1.25%)  0/79 (0.00%)  2/78 (2.56%)  1/107 (0.93%)  0/107 (0.00%)  1/214 (0.47%) 
Spinal pain  1  0/80 (0.00%)  2/79 (2.53%)  0/78 (0.00%)  0/107 (0.00%)  2/107 (1.87%)  2/214 (0.93%) 
Tendonitis  1  0/80 (0.00%)  2/79 (2.53%)  0/78 (0.00%)  0/107 (0.00%)  2/107 (1.87%)  2/214 (0.93%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Skin papilloma  1  2/80 (2.50%)  0/79 (0.00%)  0/78 (0.00%)  2/107 (1.87%)  0/107 (0.00%)  2/214 (0.93%) 
Nervous system disorders             
Burning sensation  1  0/80 (0.00%)  1/79 (1.27%)  2/78 (2.56%)  0/107 (0.00%)  2/107 (1.87%)  2/214 (0.93%) 
Dizziness  1  1/80 (1.25%)  1/79 (1.27%)  2/78 (2.56%)  2/107 (1.87%)  2/107 (1.87%)  4/214 (1.87%) 
Headache  1  7/80 (8.75%)  12/79 (15.19%)  10/78 (12.82%)  9/107 (8.41%)  15/107 (14.02%)  24/214 (11.21%) 
Migraine  1  2/80 (2.50%)  1/79 (1.27%)  0/78 (0.00%)  2/107 (1.87%)  1/107 (0.93%)  3/214 (1.40%) 
Sciatica  1  2/80 (2.50%)  3/79 (3.80%)  2/78 (2.56%)  2/107 (1.87%)  4/107 (3.74%)  6/214 (2.80%) 
Psychiatric disorders             
Anxiety  1  0/80 (0.00%)  1/79 (1.27%)  0/78 (0.00%)  0/107 (0.00%)  3/107 (2.80%)  3/214 (1.40%) 
Depression  1  3/80 (3.75%)  1/79 (1.27%)  2/78 (2.56%)  3/107 (2.80%)  1/107 (0.93%)  4/214 (1.87%) 
Insomnia  1  1/80 (1.25%)  2/79 (2.53%)  2/78 (2.56%)  1/107 (0.93%)  2/107 (1.87%)  3/214 (1.40%) 
Renal and urinary disorders             
Dysuria  1  0/80 (0.00%)  2/79 (2.53%)  1/78 (1.28%)  0/107 (0.00%)  2/107 (1.87%)  2/214 (0.93%) 
Proteinuria  1  2/80 (2.50%)  0/79 (0.00%)  0/78 (0.00%)  3/107 (2.80%)  0/107 (0.00%)  3/214 (1.40%) 
Respiratory, thoracic and mediastinal disorders             
Cough  1  5/80 (6.25%)  8/79 (10.13%)  0/78 (0.00%)  5/107 (4.67%)  9/107 (8.41%)  14/214 (6.54%) 
Oropharyngeal pain  1  1/80 (1.25%)  4/79 (5.06%)  2/78 (2.56%)  2/107 (1.87%)  6/107 (5.61%)  8/214 (3.74%) 
Skin and subcutaneous tissue disorders             
Dermatitis  1  1/80 (1.25%)  4/79 (5.06%)  1/78 (1.28%)  1/107 (0.93%)  4/107 (3.74%)  5/214 (2.34%) 
Dermatitis contact  1  3/80 (3.75%)  0/79 (0.00%)  0/78 (0.00%)  3/107 (2.80%)  0/107 (0.00%)  3/214 (1.40%) 
Dermatitis psoriasiform  1  2/80 (2.50%)  1/79 (1.27%)  0/78 (0.00%)  2/107 (1.87%)  1/107 (0.93%)  3/214 (1.40%) 
Drug eruption  1  2/80 (2.50%)  0/79 (0.00%)  0/78 (0.00%)  2/107 (1.87%)  0/107 (0.00%)  2/214 (0.93%) 
Dyshidrotic eczema  1  3/80 (3.75%)  0/79 (0.00%)  0/78 (0.00%)  3/107 (2.80%)  0/107 (0.00%)  3/214 (1.40%) 
Eczema  1  3/80 (3.75%)  7/79 (8.86%)  3/78 (3.85%)  5/107 (4.67%)  7/107 (6.54%)  12/214 (5.61%) 
Hyperkeratosis  1  0/80 (0.00%)  2/79 (2.53%)  0/78 (0.00%)  0/107 (0.00%)  2/107 (1.87%)  2/214 (0.93%) 
Intertrigo  1  3/80 (3.75%)  2/79 (2.53%)  0/78 (0.00%)  3/107 (2.80%)  2/107 (1.87%)  5/214 (2.34%) 
Lichen planus  1  2/80 (2.50%)  1/79 (1.27%)  0/78 (0.00%)  2/107 (1.87%)  1/107 (0.93%)  3/214 (1.40%) 
Pruritus  1  6/80 (7.50%)  11/79 (13.92%)  4/78 (5.13%)  6/107 (5.61%)  13/107 (12.15%)  19/214 (8.88%) 
Pruritus generalised  1  2/80 (2.50%)  2/79 (2.53%)  1/78 (1.28%)  4/107 (3.74%)  2/107 (1.87%)  6/214 (2.80%) 
Psoriasis  1  5/80 (6.25%)  7/79 (8.86%)  5/78 (6.41%)  7/107 (6.54%)  7/107 (6.54%)  14/214 (6.54%) 
Pustular psoriasis  1  19/80 (23.75%)  16/79 (20.25%)  4/78 (5.13%)  24/107 (22.43%)  23/107 (21.50%)  47/214 (21.96%) 
Rash  1  1/80 (1.25%)  5/79 (6.33%)  0/78 (0.00%)  1/107 (0.93%)  6/107 (5.61%)  7/214 (3.27%) 
Seborrhoeic dermatitis  1  3/80 (3.75%)  0/79 (0.00%)  1/78 (1.28%)  3/107 (2.80%)  0/107 (0.00%)  3/214 (1.40%) 
Skin exfoliation  1  2/80 (2.50%)  0/79 (0.00%)  0/78 (0.00%)  2/107 (1.87%)  1/107 (0.93%)  3/214 (1.40%) 
Skin fissures  1  0/80 (0.00%)  3/79 (3.80%)  0/78 (0.00%)  0/107 (0.00%)  3/107 (2.80%)  3/214 (1.40%) 
Urticaria  1  0/80 (0.00%)  4/79 (5.06%)  0/78 (0.00%)  1/107 (0.93%)  5/107 (4.67%)  6/214 (2.80%) 
Vascular disorders             
Hypertension  1  2/80 (2.50%)  5/79 (6.33%)  3/78 (3.85%)  3/107 (2.80%)  6/107 (5.61%)  9/214 (4.21%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: Novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02008890     History of Changes
Other Study ID Numbers: CAIN457A3301
2013-003086-34 ( EudraCT Number )
First Submitted: December 8, 2013
First Posted: December 11, 2013
Results First Submitted: May 31, 2018
Results First Posted: January 4, 2019
Last Update Posted: January 4, 2019