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Secukinumab Dosage Optimisation in Partial Responders With Moderate to Severe Plaque-type Psoriasis (GAIN)

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ClinicalTrials.gov Identifier: NCT02474069
Recruitment Status : Completed
First Posted : June 17, 2015
Results First Posted : July 4, 2019
Last Update Posted : July 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 Moderate to Severe Plaque-type Psoriasis
Intervention Drug: Secukinumab
Enrollment 772
Recruitment Details 860 screened (not shown here). In selection phase (SP), 772 received 300 mg s.c. open-label secukinumab at baseline to wk 12. Those who did not achieve ≥Psoriasis Area and Severity Index (PASI) 75 at wk 16 discontinued. Those who had ≤ clear or almost clear skin (≥PASI75 but not PASI90) rolled over into double blind comparative dosing phase (CDP).
Pre-assignment Details and randomized 1:1 to: a.standard treatment: 300 mg s.c. secukinumab treatment every 4 weeks (weeks 16, 20, 24, & 28) and, to maintain the blind, placebo every 4 weeks b. OR dosage interval shortening: 300 mg s.c. secukinumab treatment every 2 weeks Those who achieved at least clear or almost clear skin (≥ PASI 90) at week 16 discontinued study
Arm/Group Title SP - Secukinumab 300 mg s.c. (4-weekly) CDP - Secukinumab 300 mg s.c. (4-weekly) CDP - Secukinumab 300 mg s.c. (2-weekly)
Hide Arm/Group Description In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12. In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30). In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Period Title: Selection Phase (SP)
Started 772 0 0
Completed 749 0 0
Not Completed 23 0 0
Reason Not Completed
Adverse Event             8             0             0
Lack of Efficacy             1             0             0
Lost to Follow-up             4             0             0
Physician Decision             1             0             0
Protocol Violation             1             0             0
No longer requires treatment             1             0             0
Technical Problem             1             0             0
Withdrawal by Subject             3             0             0
Withdrawal of Informed Consent             3             0             0
Period Title: Comparative Dosing Phase (CDP)
Started 0 162 163
Completed 0 153 157
Not Completed 0 9 6
Reason Not Completed
Adverse Event             0             3             2
Lost to Follow-up             0             4             1
Withdrawal by Subject             0             0             1
Withdrawal of informed Consent             0             2             2
Arm/Group Title SP - Secukinumab 300 mg s.c. (4-weekly
Hide Arm/Group Description In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12. At Week 16
Overall Number of Baseline Participants 772
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 772 participants
45.8  (13.72)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 772 participants
Female
222
  28.8%
Male
550
  71.2%
1.Primary Outcome
Title Number of Participants With PASI 90 Response at Week 32
Hide Description Number of participants with at least 90% improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Time Frame at 32 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) - Comparative Dosing Phase (CDP): consisted of all patients who were randomized and received at least one dose of study drug during the CDP and had at least one post-randomization assessment. Patients with missing PASI at week 32 were counted as non-responders, unless they were responders already at their last reported PASI.
Arm/Group Title CDP - Secukinumab 300 mg s.c. (4-weekly) CDP - Secukinumab 300 mg s.c. (2-weekly)
Hide Arm/Group Description:
In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).
In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Overall Number of Participants Analyzed 162 163
Measure Type: Number
Unit of Measure: participants
93 105
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CDP - Secukinumab 300 mg s.c. (4-weekly), CDP - Secukinumab 300 mg s.c. (2-weekly)
Comments Logistic regression model: Logit (proportion) = treatment + PASI Score at baseline + PASI score at randomization + error
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.087
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.39 to 1.07
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With PASI 90 Response at Week 32 for PPS
Hide Description Number of participants with at least 90% improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Time Frame at week 32
Hide Outcome Measure Data
Hide Analysis Population Description
PPS: consisted of all patients from the FAS-CDP who completed the study without any major protocol deviation.
Arm/Group Title CDP - Secukinumab 300 mg s.c. (4-weekly) CDP - Secukinumab 300 mg s.c. (2-weekly)
Hide Arm/Group Description:
In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).
In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Overall Number of Participants Analyzed 136 134
Measure Type: Number
Unit of Measure: participants
81 85
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CDP - Secukinumab 300 mg s.c. (4-weekly), CDP - Secukinumab 300 mg s.c. (2-weekly)
Comments Logistic regression model: Logit (proportion) = treatment + PASI Score at baseline + PASI score at randomization + error
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.281
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.43 to 1.28
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100
Hide Description Number of participants with at least 50, 75, 90 or 100% improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Time Frame at weeks 1, 2, 3, 4, 8, 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-SP: consists of all patients that received at least one dose of study drug during the selection phase and had at least one post-baseline assessment.
Arm/Group Title SP - Secukinumab 300 mg s.c. (4-weekly)
Hide Arm/Group Description:
In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12.
Overall Number of Participants Analyzed 772
Measure Type: Number
Unit of Measure: Number of participants
Week 1, PASI 50 Number Analyzed 768 participants
43
Week 1, PASI 75 Number Analyzed 768 participants
3
Week 1, PASI 90 Number Analyzed 768 participants
0
Week 1, PASI 100 Number Analyzed 768 participants
0
Week 2, PASI 50 Number Analyzed 766 participants
232
week 2, PASI 75 Number Analyzed 766 participants
25
Week 2, PASI 90 Number Analyzed 766 participants
5
Week 2, PASI 100 Number Analyzed 766 participants
1
Week 3, PASI 50 Number Analyzed 766 participants
468
Week 3, PASI 75 Number Analyzed 766 participants
128
Week 3, PASI 90 Number Analyzed 766 participants
22
Week 3, PASI 100 Number Analyzed 766 participants
3
Week 4, PASI 50 Number Analyzed 768 participants
591
Week 4, PASI 75 Number Analyzed 768 participants
281
Week 4, PASI 90 Number Analyzed 768 participants
71
Week 4, PASI 100 Number Analyzed 768 participants
12
Week 8, PASI 50 Number Analyzed 762 participants
718
Week 8, PASI 75 Number Analyzed 762 participants
538
Week 8, PASI 90 Number Analyzed 762 participants
266
Week 8, PASI 100 Number Analyzed 762 participants
70
Week 12, PASI 50 Number Analyzed 761 participants
733
Week 12, PASI 75 Number Analyzed 761 participants
611
Week 12, PASI 90 Number Analyzed 761 participants
370
Week 12, PASI 100 Number Analyzed 761 participants
110
Week 16, PASI 50 Number Analyzed 753 participants
732
Week 16, PASI 75 Number Analyzed 753 participants
698
Week 16, PASI 90 Number Analyzed 753 participants
363
Week 16, PASI 100 Number Analyzed 753 participants
124
4.Secondary Outcome
Title Comparative Dose Phase: Number of Participants Achieving Psoriasis Area and Severity Index Score (PASI) 90 and 100
Hide Description Number of participants with at least 90 or 100% improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Time Frame at weeks 18, 22, 30, 32
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-CDP: consists of all patients that were randomized and received at least one dose of study drug during the comparative dosing phase and had at least one post-randomization assessment.
Arm/Group Title CDP - Secukinumab 300 mg s.c. (4-weekly) CDP - Secukinumab 300 mg s.c. (2-weekly)
Hide Arm/Group Description:
In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).
In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Overall Number of Participants Analyzed 162 163
Measure Type: Number
Unit of Measure: Number of participants
Week 18, PASI 90 42 36
Week 18, PASI 100 1 1
Week 22, PASI 90 70 67
Week 22, PASI 100 9 9
Week 26, PASI 90 85 94
Week 26, PASI 100 9 14
Week 30, PASI 90 93 104
Week 30, PASI 100 17 19
Week 32, PASI 90 93 105
Week 32, PASI 100 22 26
5.Secondary Outcome
Title Selection Phase:Summary of PASI Total Score
Hide Description PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Time Frame at weeks 1,2,3,4,8, 12, 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-SP: consists of all patients that received at least one dose of study drug during the selection phase and had at least one post-baseline assessment.
Arm/Group Title SP - Secukinumab 300 mg s.c. (4-weekly)
Hide Arm/Group Description:
In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12.
Overall Number of Participants Analyzed 772
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
week 1 Number Analyzed 768 participants
18.78  (9.629)
week 2 Number Analyzed 766 participants
14.32  (8.435)
week 3 Number Analyzed 766 participants
10.69  (7.372)
week 4 Number Analyzed 768 participants
8.12  (6.494)
week 8 Number Analyzed 762 participants
4.41  (4.544)
Week 12 Number Analyzed 761 participants
3.34  (3.833)
Week 16 Number Analyzed 753 participants
2.90  (3.816)
6.Secondary Outcome
Title Comparative Dose Phase: Summary of PASI Total Score
Hide Description PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Time Frame Weeks 18, 22, 26, 30 and 32
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-CDP: consists of all patients that were randomized and received at least one dose of study drug during the comparative dosing phase and had at least one post-randomization assessment.
Arm/Group Title CDP - Secukinumab 300 mg s.c. (4-weekly) CDP - Secukinumab 300 mg s.c. (2-weekly)
Hide Arm/Group Description:
In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).
In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Overall Number of Participants Analyzed 162 163
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Week 18 Number Analyzed 162 participants 163 participants
3.71  (2.532) 3.59  (2.595)
Week 22 Number Analyzed 161 participants 161 participants
3.24  (2.947) 3.07  (2.726)
Week 26 Number Analyzed 156 participants 160 participants
2.85  (2.852) 2.68  (3.393)
Week 30 Number Analyzed 154 participants 158 participants
2.83  (3.339) 2.34  (2.812)
Week 32 Number Analyzed 153 participants 152 participants
2.84  (3.552) 2.11  (2.701)
7.Secondary Outcome
Title Number of Patients Achieving Dermatology Life Quality Index (DLQI) Scores of 0 or 1 by Visits in the CDP
Hide Description

The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.

The DLQI was designed to assess health-related quality of life (HRQoL) in adult patients with skin diseases including psoriasis.

Time Frame Weeks 4, 16, 18, 22, 26, 30, 32
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-CDP: consists of all patients that were randomized and received at least one dose of study drug during the comparative dosing phase and had at least one post-randomization assessment.
Arm/Group Title Secukinumab 300 mg s.c. (4-weekly) CDP - Secukinumab 300 mg s.c. (2-weekly)
Hide Arm/Group Description:
Patients received 300 mg s.c. secukinumab treatment every 4 weeks and placebo every 4 weeks
In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Overall Number of Participants Analyzed 162 163
Measure Type: Number
Unit of Measure: participants with DLQI score 0/1
Week 18 65 58
Week 22 70 73
Week 26 69 83
Week 30 75 89
Week 32 82 96
8.Secondary Outcome
Title Number of Patients Achieving DLQI Total Score <= 5 in the CDP
Hide Description The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.
Time Frame Weeks 4, 16, 18, 22, 26, 30, 32
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-CDP: consists of all patients that were randomized and received at least one dose of study drug during the comparative dosing phase and had at least one post-randomization assessment.
Arm/Group Title Secukinumab 300 mg s.c. (4-weekly) CDP - Secukinumab 300 mg s.c. (2-weekly)
Hide Arm/Group Description:
Patients received 300 mg s.c. secukinumab treatment every 4 weeks and placebo every 4 weeks.
In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Overall Number of Participants Analyzed 162 163
Measure Type: Number
Unit of Measure: participants
Week 18 109 108
Week 22 112 117
Week 26 116 121
Week 30 114 127
Week 32 117 126
9.Secondary Outcome
Title Selection Phase: Number of Patients Achieving Investigator Global Assessment (IGA) 0 or 1
Hide Description The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.
Time Frame Weeks 4, 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-SP: consists of all patients that received at least one dose of study drug during the selection phase and had at least one post-baseline assessment.
Arm/Group Title SP - Secukinumab 300 mg s.c. (4-weekly)
Hide Arm/Group Description:
In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12.
Overall Number of Participants Analyzed 772
Measure Type: Number
Unit of Measure: Participants
week 4 Number Analyzed 768 participants
150
week 16 Number Analyzed 759 participants
446
10.Secondary Outcome
Title Comparative Dose Phase: Number of Patients Achieving Investigator Global Assessment (IGA) 0 or 1
Hide Description The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.
Time Frame Weeks 18, 22, 26, 30, 32
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-CDP: consists of all patients that were randomized and received at least one dose of study drug during the comparative dosing phase and had at least one post-randomization assessment.
Arm/Group Title CDP - Secukinumab 300 mg s.c. (4-weekly) CDP - Secukinumab 300 mg s.c. (2-weekly)
Hide Arm/Group Description:
In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).
In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Overall Number of Participants Analyzed 162 163
Measure Type: Number
Unit of Measure: Participants
week 18 Number Analyzed 162 participants 163 participants
67 68
week 22 Number Analyzed 161 participants 161 participants
88 90
week 26 Number Analyzed 156 participants 160 participants
87 111
week 30 Number Analyzed 154 participants 158 participants
97 106
week 32 Number Analyzed 153 participants 152 participants
98 111
11.Secondary Outcome
Title Selection Phase: Summary of IGA Score
Hide Description The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.
Time Frame Weeks 4, 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-CDPFAS-SP: consists of all patients that received at least one dose of study drug during the selection phase and had at least one post-baseline assessment.
Arm/Group Title SP - Secukinumab 300 mg s.c. (4-weekly)
Hide Arm/Group Description:
In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12.
Overall Number of Participants Analyzed 772
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Week 4 Number Analyzed 768 participants
2.10  (0.790)
Week 16 Number Analyzed 759 participants
1.26  (0.875)
12.Secondary Outcome
Title Comparative Dose Phase:Summary of IGA Score
Hide Description The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.
Time Frame Weeks 18, 22, 26, 30, 32
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-CDP: consists of all patients that were randomized and received at least one dose of study drug during the comparative dosing phase and had at least one post-randomization assessment.
Arm/Group Title CDP - Secukinumab 300 mg s.c. (4-weekly) CDP - Secukinumab 300 mg s.c. (2-weekly)
Hide Arm/Group Description:
In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).
In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Overall Number of Participants Analyzed 162 163
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Week 18 Number Analyzed 162 participants 163 participants
1.63  (0.619) 1.64  (0.656)
Week 22 Number Analyzed 161 participants 161 participants
1.46  (0.733) 1.42  (0.704)
Week 26 Number Analyzed 156 participants 160 participants
1.48  (0.758) 1.30  (0.759)
Week 30 Number Analyzed 154 participants 158 participants
1.33  (0.848) 1.27  (0.803)
Week 32 Number Analyzed 153 participants 152 participants
1.30  (0.925) 1.13  (0.819)
Time Frame Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year and 4 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SP-Secukinumab: AIN457 300 mg s.c. (4-weekly) CDP-Secukinumab: AIN457 300 mg s.c. (4-weekly) CDP-Secukinumab: AIN457 300 mg s.c. (2-weekly)
Hide Arm/Group Description In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12. In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30). In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
All-Cause Mortality
SP-Secukinumab: AIN457 300 mg s.c. (4-weekly) CDP-Secukinumab: AIN457 300 mg s.c. (4-weekly) CDP-Secukinumab: AIN457 300 mg s.c. (2-weekly)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SP-Secukinumab: AIN457 300 mg s.c. (4-weekly) CDP-Secukinumab: AIN457 300 mg s.c. (4-weekly) CDP-Secukinumab: AIN457 300 mg s.c. (2-weekly)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   32/772 (4.15%)   8/162 (4.94%)   4/163 (2.45%) 
Cardiac disorders       
ATRIAL FIBRILLATION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
CARDIAC FAILURE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
MYOCARDITIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
VENTRICULAR EXTRASYSTOLES  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
Gastrointestinal disorders       
COLITIS ULCERATIVE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
DIARRHOEA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
GASTRITIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
UMBILICAL HERNIA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
General disorders       
CHEST PAIN  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
CHILLS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
GENERAL PHYSICAL HEALTH DETERIORATION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
IMPAIRED HEALING  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
Hepatobiliary disorders       
BILIARY COLIC  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
CHOLECYSTITIS CHRONIC  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
Infections and infestations       
ERYSIPELAS  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
MASTOIDITIS  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
PYODERMA  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
SINUSITIS  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
TONSILLITIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
VARICELLA  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
Injury, poisoning and procedural complications       
CHEST INJURY  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
CONCUSSION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
CONTUSION  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
FALL  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
FEMUR FRACTURE  1  1/772 (0.13%)  0/162 (0.00%)  1/163 (0.61%) 
HUMERUS FRACTURE  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
LIGAMENT RUPTURE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
RADIAL HEAD DISLOCATION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
RADIUS FRACTURE  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
STERNAL FRACTURE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
TENDON RUPTURE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
UPPER LIMB FRACTURE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
WOUND  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
Investigations       
ALANINE AMINOTRANSFERASE INCREASED  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
HEPATIC ENZYME INCREASED  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
Metabolism and nutrition disorders       
HYPERGLYCAEMIA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
Musculoskeletal and connective tissue disorders       
INTERVERTEBRAL DISC PROTRUSION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
PAIN IN EXTREMITY  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
SPINAL OSTEOARTHRITIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
B-CELL LYMPHOMA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
BASAL CELL CARCINOMA  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
MYCOSIS FUNGOIDES  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
PANCREATIC CARCINOMA  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
Nervous system disorders       
CEREBRAL ISCHAEMIA  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
CEREBROVASCULAR ACCIDENT  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
INTERCOSTAL NEURALGIA  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
Psychiatric disorders       
MANIA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
PANIC ATTACK  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
Renal and urinary disorders       
FIBRILLARY GLOMERULONEPHRITIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
RENAL CYST HAEMORRHAGE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
URETEROLITHIASIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
ASTHMA EXERCISE INDUCED  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
DYSPNOEA EXERTIONAL  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
HYPERVENTILATION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
PULMONARY EMBOLISM  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
Skin and subcutaneous tissue disorders       
ACROKERATOSIS PARANEOPLASTICA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
DERMATITIS EXFOLIATIVE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
SKIN ULCER  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
Vascular disorders       
HAEMORRHAGE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
HYPERTENSIVE CRISIS  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.0001%
SP-Secukinumab: AIN457 300 mg s.c. (4-weekly) CDP-Secukinumab: AIN457 300 mg s.c. (4-weekly) CDP-Secukinumab: AIN457 300 mg s.c. (2-weekly)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   510/772 (66.06%)   85/162 (52.47%)   87/163 (53.37%) 
Blood and lymphatic system disorders       
LEUKOCYTOSIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
LYMPHADENOPATHY  1  2/772 (0.26%)  2/162 (1.23%)  0/163 (0.00%) 
LYMPHOPENIA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
NEUTROPENIA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
THROMBOCYTOPENIA  1  1/772 (0.13%)  0/162 (0.00%)  1/163 (0.61%) 
Cardiac disorders       
ATRIAL FIBRILLATION  1  0/772 (0.00%)  1/162 (0.62%)  1/163 (0.61%) 
ATRIOVENTRICULAR BLOCK  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
BUNDLE BRANCH BLOCK LEFT  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
SINUS ARRHYTHMIA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
TACHYCARDIA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
Congenital, familial and genetic disorders       
CONGENITAL NAEVUS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
Ear and labyrinth disorders       
EAR PAIN  1  1/772 (0.13%)  2/162 (1.23%)  0/163 (0.00%) 
EAR PRURITUS  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
HYPOACUSIS  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
SUDDEN HEARING LOSS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
TINNITUS  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
TYMPANIC MEMBRANE PERFORATION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
VERTIGO  1  3/772 (0.39%)  0/162 (0.00%)  0/163 (0.00%) 
Endocrine disorders       
HYPERTHYROIDISM  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
HYPOTHYROIDISM  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
THYROID CYST  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
Eye disorders       
BLEPHARITIS  1  3/772 (0.39%)  1/162 (0.62%)  0/163 (0.00%) 
CATARACT  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
CHALAZION  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
CONJUNCTIVAL HYPERAEMIA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
CONJUNCTIVITIS ALLERGIC  1  4/772 (0.52%)  1/162 (0.62%)  1/163 (0.61%) 
DRY EYE  1  3/772 (0.39%)  0/162 (0.00%)  1/163 (0.61%) 
ECZEMA EYELIDS  1  2/772 (0.26%)  0/162 (0.00%)  1/163 (0.61%) 
EYE IRRITATION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
EYE PAIN  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
EYE SWELLING  1  2/772 (0.26%)  1/162 (0.62%)  0/163 (0.00%) 
EYELID OEDEMA  1  1/772 (0.13%)  0/162 (0.00%)  1/163 (0.61%) 
EYELIDS PRURITUS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
INTRAOCULAR HAEMATOMA  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
KERATITIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
LACRIMATION INCREASED  1  4/772 (0.52%)  0/162 (0.00%)  0/163 (0.00%) 
VISUAL IMPAIRMENT  1  3/772 (0.39%)  0/162 (0.00%)  0/163 (0.00%) 
Gastrointestinal disorders       
ABDOMINAL DISTENSION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
ABDOMINAL PAIN  1  2/772 (0.26%)  1/162 (0.62%)  0/163 (0.00%) 
ABDOMINAL PAIN LOWER  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
ABDOMINAL PAIN UPPER  1  17/772 (2.20%)  1/162 (0.62%)  1/163 (0.61%) 
ANAL SKIN TAGS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
ANORECTAL DISCOMFORT  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
APHTHOUS ULCER  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
COLITIS  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
COLITIS MICROSCOPIC  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
CONSTIPATION  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
DENTAL CARIES  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
DIARRHOEA  1  34/772 (4.40%)  3/162 (1.85%)  1/163 (0.61%) 
DRY MOUTH  1  4/772 (0.52%)  0/162 (0.00%)  0/163 (0.00%) 
DYSPEPSIA  1  2/772 (0.26%)  1/162 (0.62%)  0/163 (0.00%) 
DYSPHAGIA  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
EPULIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
FAECES SOFT  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
FLATULENCE  1  3/772 (0.39%)  0/162 (0.00%)  0/163 (0.00%) 
FREQUENT BOWEL MOVEMENTS  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
GASTRITIS  1  5/772 (0.65%)  0/162 (0.00%)  1/163 (0.61%) 
GASTRITIS EROSIVE  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
GASTROINTESTINAL PAIN  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  6/772 (0.78%)  0/162 (0.00%)  1/163 (0.61%) 
GINGIVAL DISORDER  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
GINGIVAL EROSION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
HAEMORRHOIDS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
HYPOAESTHESIA ORAL  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
INTRA-ABDOMINAL HAEMATOMA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
LARGE INTESTINE POLYP  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
LIP BLISTER  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
LIP DRY  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
MALLORY-WEISS SYNDROME  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
MOUTH SWELLING  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
MOUTH ULCERATION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
NAUSEA  1  9/772 (1.17%)  1/162 (0.62%)  0/163 (0.00%) 
PARAESTHESIA ORAL  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
POUCHITIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
TONGUE COATED  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
TONGUE DISCOLOURATION  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
TOOTHACHE  1  9/772 (1.17%)  0/162 (0.00%)  0/163 (0.00%) 
VASCULITIS GASTROINTESTINAL  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
VOMITING  1  3/772 (0.39%)  1/162 (0.62%)  1/163 (0.61%) 
General disorders       
APPLICATION SITE HAEMATOMA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
ASTHENIA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
CHILLS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
DRUG THERAPEUTIC INCOMPATIBILITY  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
FATIGUE  1  28/772 (3.63%)  4/162 (2.47%)  3/163 (1.84%) 
FEELING HOT  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
IMPAIRED HEALING  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
INFLUENZA LIKE ILLNESS  1  10/772 (1.30%)  2/162 (1.23%)  1/163 (0.61%) 
INJECTION SITE BRUISING  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
INJECTION SITE ERYTHEMA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
INJECTION SITE HAEMATOMA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
INJECTION SITE HAEMORRHAGE  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
INJECTION SITE PAIN  1  3/772 (0.39%)  0/162 (0.00%)  1/163 (0.61%) 
INJECTION SITE PRURITUS  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
INJURY ASSOCIATED WITH DEVICE  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
NON-CARDIAC CHEST PAIN  1  3/772 (0.39%)  0/162 (0.00%)  0/163 (0.00%) 
OEDEMA PERIPHERAL  1  4/772 (0.52%)  0/162 (0.00%)  0/163 (0.00%) 
PERIPHERAL SWELLING  1  1/772 (0.13%)  0/162 (0.00%)  1/163 (0.61%) 
PUNCTURE SITE REACTION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
PYREXIA  1  9/772 (1.17%)  0/162 (0.00%)  0/163 (0.00%) 
SENSATION OF FOREIGN BODY  1  1/772 (0.13%)  1/162 (0.62%)  0/163 (0.00%) 
THIRST  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
Hepatobiliary disorders       
BILIARY COLIC  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
CHOLECYSTITIS  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
CHOLELITHIASIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
HEPATIC STEATOSIS  1  3/772 (0.39%)  0/162 (0.00%)  0/163 (0.00%) 
HYPERBILIRUBINAEMIA  1  1/772 (0.13%)  1/162 (0.62%)  0/163 (0.00%) 
Immune system disorders       
SEASONAL ALLERGY  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
Infections and infestations       
ABDOMINAL ABSCESS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
ABSCESS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
ANGULAR CHEILITIS  1  5/772 (0.65%)  0/162 (0.00%)  1/163 (0.61%) 
BACTERIAL INFECTION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
BACTERIAL RHINITIS  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
BACTERIAL VAGINOSIS  1  0/772 (0.00%)  2/162 (1.23%)  0/163 (0.00%) 
BALANITIS CANDIDA  1  2/772 (0.26%)  0/162 (0.00%)  1/163 (0.61%) 
BODY TINEA  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
BRONCHITIS  1  10/772 (1.30%)  2/162 (1.23%)  2/163 (1.23%) 
BRONCHITIS BACTERIAL  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
BRONCHITIS VIRAL  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
CANDIDA INFECTION  1  5/772 (0.65%)  0/162 (0.00%)  0/163 (0.00%) 
CONJUNCTIVITIS  1  8/772 (1.04%)  1/162 (0.62%)  2/163 (1.23%) 
CONJUNCTIVITIS BACTERIAL  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
CYSTITIS  1  4/772 (0.52%)  2/162 (1.23%)  1/163 (0.61%) 
CYSTITIS BACTERIAL  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
ECZEMA IMPETIGINOUS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
EPIDIDYMITIS  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
EPIGLOTTITIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
ERYSIPELAS  1  2/772 (0.26%)  1/162 (0.62%)  0/163 (0.00%) 
FOLLICULITIS  1  13/772 (1.68%)  4/162 (2.47%)  2/163 (1.23%) 
FUNGAL INFECTION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
FUNGAL SKIN INFECTION  1  5/772 (0.65%)  0/162 (0.00%)  0/163 (0.00%) 
FURUNCLE  1  3/772 (0.39%)  0/162 (0.00%)  0/163 (0.00%) 
GASTROENTERITIS  1  7/772 (0.91%)  1/162 (0.62%)  0/163 (0.00%) 
GASTROENTERITIS VIRAL  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
GASTROINTESTINAL INFECTION  1  8/772 (1.04%)  1/162 (0.62%)  1/163 (0.61%) 
GASTROINTESTINAL VIRAL INFECTION  1  2/772 (0.26%)  0/162 (0.00%)  1/163 (0.61%) 
GENITAL CANDIDIASIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
GENITAL INFECTION FUNGAL  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
GINGIVITIS  1  4/772 (0.52%)  1/162 (0.62%)  0/163 (0.00%) 
HELICOBACTER INFECTION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
HERPES SIMPLEX  1  3/772 (0.39%)  0/162 (0.00%)  0/163 (0.00%) 
HERPES VIRUS INFECTION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
HERPES ZOSTER  1  2/772 (0.26%)  2/162 (1.23%)  0/163 (0.00%) 
HERPES ZOSTER INFECTION NEUROLOGICAL  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
HORDEOLUM  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
IMPETIGO  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
INFLUENZA  1  9/772 (1.17%)  2/162 (1.23%)  2/163 (1.23%) 
LABYRINTHITIS  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
LARYNGITIS  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
LOCALISED INFECTION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
LOWER RESPIRATORY TRACT INFECTION  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
LYME DISEASE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
MUCOSAL INFECTION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
NAIL BED INFECTION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
NASOPHARYNGITIS  1  168/772 (21.76%)  23/162 (14.20%)  27/163 (16.56%) 
OESOPHAGEAL CANDIDIASIS  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
ORAL CANDIDIASIS  1  14/772 (1.81%)  2/162 (1.23%)  3/163 (1.84%) 
ORAL FUNGAL INFECTION  1  1/772 (0.13%)  1/162 (0.62%)  0/163 (0.00%) 
ORAL HERPES  1  15/772 (1.94%)  1/162 (0.62%)  1/163 (0.61%) 
ORCHITIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
OTITIS EXTERNA  1  4/772 (0.52%)  1/162 (0.62%)  1/163 (0.61%) 
OTITIS MEDIA  1  4/772 (0.52%)  0/162 (0.00%)  1/163 (0.61%) 
OTITIS MEDIA ACUTE  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
PARONYCHIA  1  2/772 (0.26%)  0/162 (0.00%)  1/163 (0.61%) 
PERICHONDRITIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
PERIODONTITIS  1  1/772 (0.13%)  0/162 (0.00%)  1/163 (0.61%) 
PHARYNGITIS  1  6/772 (0.78%)  2/162 (1.23%)  1/163 (0.61%) 
PHARYNGITIS BACTERIAL  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
PHARYNGITIS STREPTOCOCCAL  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
POSTOPERATIVE WOUND INFECTION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
PULPITIS DENTAL  1  5/772 (0.65%)  0/162 (0.00%)  1/163 (0.61%) 
RESPIRATORY TRACT INFECTION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
RHINITIS  1  16/772 (2.07%)  1/162 (0.62%)  0/163 (0.00%) 
SINUSITIS  1  8/772 (1.04%)  2/162 (1.23%)  1/163 (0.61%) 
SKIN CANDIDA  1  1/772 (0.13%)  0/162 (0.00%)  1/163 (0.61%) 
SKIN INFECTION  1  2/772 (0.26%)  0/162 (0.00%)  1/163 (0.61%) 
STAPHYLOCOCCAL SKIN INFECTION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
SUBCUTANEOUS ABSCESS  1  2/772 (0.26%)  1/162 (0.62%)  0/163 (0.00%) 
TINEA INFECTION  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
TINEA PEDIS  1  8/772 (1.04%)  3/162 (1.85%)  1/163 (0.61%) 
TONSILLITIS  1  6/772 (0.78%)  1/162 (0.62%)  2/163 (1.23%) 
TONSILLITIS BACTERIAL  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
TOOTH INFECTION  1  2/772 (0.26%)  2/162 (1.23%)  0/163 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  3/772 (0.39%)  1/162 (0.62%)  0/163 (0.00%) 
URETHRITIS  1  1/772 (0.13%)  1/162 (0.62%)  0/163 (0.00%) 
URINARY TRACT INFECTION  1  3/772 (0.39%)  0/162 (0.00%)  1/163 (0.61%) 
VIRAL INFECTION  1  1/772 (0.13%)  1/162 (0.62%)  1/163 (0.61%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  3/772 (0.39%)  0/162 (0.00%)  1/163 (0.61%) 
VULVOVAGINAL CANDIDIASIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
VULVOVAGINAL MYCOTIC INFECTION  1  2/772 (0.26%)  1/162 (0.62%)  0/163 (0.00%) 
Injury, poisoning and procedural complications       
ACCIDENT AT WORK  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
ANIMAL BITE  1  1/772 (0.13%)  0/162 (0.00%)  1/163 (0.61%) 
ANKLE FRACTURE  1  1/772 (0.13%)  1/162 (0.62%)  0/163 (0.00%) 
ARTHROPOD BITE  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
ARTHROPOD STING  1  3/772 (0.39%)  0/162 (0.00%)  0/163 (0.00%) 
BURN ORAL CAVITY  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
CERVICAL VERTEBRAL FRACTURE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
CONTUSION  1  5/772 (0.65%)  0/162 (0.00%)  0/163 (0.00%) 
CRANIOCEREBRAL INJURY  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
FALL  1  1/772 (0.13%)  1/162 (0.62%)  0/163 (0.00%) 
FOREIGN BODY IN EYE  1  1/772 (0.13%)  0/162 (0.00%)  1/163 (0.61%) 
HAND FRACTURE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
JOINT DISLOCATION  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
JOINT INJURY  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
LACERATION  1  2/772 (0.26%)  1/162 (0.62%)  0/163 (0.00%) 
LIGAMENT RUPTURE  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
LIGAMENT SPRAIN  1  6/772 (0.78%)  0/162 (0.00%)  0/163 (0.00%) 
LIMB INJURY  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
MENISCUS INJURY  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
MUSCLE STRAIN  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
PLAQUE SHIFT  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
PROCEDURAL DIZZINESS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
PROCEDURAL PAIN  1  2/772 (0.26%)  1/162 (0.62%)  1/163 (0.61%) 
RIB FRACTURE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
ROAD TRAFFIC ACCIDENT  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
SKIN ABRASION  1  3/772 (0.39%)  0/162 (0.00%)  0/163 (0.00%) 
SUBCUTANEOUS HAEMATOMA  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
SUNBURN  1  2/772 (0.26%)  1/162 (0.62%)  0/163 (0.00%) 
TENDON RUPTURE  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
THERMAL BURN  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
TOOTH FRACTURE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
UPPER LIMB FRACTURE  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
WOUND  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
Investigations       
ALANINE AMINOTRANSFERASE INCREASED  1  3/772 (0.39%)  1/162 (0.62%)  1/163 (0.61%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
BILIRUBIN URINE PRESENT  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
BLOOD CHOLESTEROL INCREASED  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
BLOOD CREATININE INCREASED  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
BLOOD TRIGLYCERIDES INCREASED  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
BLOOD URINE PRESENT  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
BODY TEMPERATURE INCREASED  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
ELECTROCARDIOGRAM ABNORMAL  1  1/772 (0.13%)  0/162 (0.00%)  1/163 (0.61%) 
ELECTROCARDIOGRAM Q WAVE ABNORMAL  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  3/772 (0.39%)  0/162 (0.00%)  0/163 (0.00%) 
HEPATIC ENZYME INCREASED  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
HIGH DENSITY LIPOPROTEIN DECREASED  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
HUMAN CHORIONIC GONADOTROPIN INCREASED  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
LIVER FUNCTION TEST INCREASED  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
MONOCYTE COUNT INCREASED  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
NEUTROPHIL COUNT DECREASED  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
PLATELET COUNT DECREASED  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
TRANSAMINASES INCREASED  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
WEIGHT INCREASED  1  1/772 (0.13%)  1/162 (0.62%)  0/163 (0.00%) 
Metabolism and nutrition disorders       
DECREASED APPETITE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
DIABETES MELLITUS  1  2/772 (0.26%)  1/162 (0.62%)  1/163 (0.61%) 
FLUID RETENTION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
GOUT  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
HAEMOSIDEROSIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
HYPERCHOLESTEROLAEMIA  1  2/772 (0.26%)  1/162 (0.62%)  0/163 (0.00%) 
HYPERKALAEMIA  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
HYPERLIPIDAEMIA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
HYPERTRIGLYCERIDAEMIA  1  3/772 (0.39%)  0/162 (0.00%)  0/163 (0.00%) 
HYPONATRAEMIA  1  1/772 (0.13%)  1/162 (0.62%)  0/163 (0.00%) 
IRON DEFICIENCY  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
TYPE 2 DIABETES MELLITUS  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
VITAMIN D DEFICIENCY  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
ZINC DEFICIENCY  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  21/772 (2.72%)  4/162 (2.47%)  3/163 (1.84%) 
ARTHRITIS  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
BACK PAIN  1  9/772 (1.17%)  3/162 (1.85%)  3/163 (1.84%) 
BURSITIS  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
FIBROMYALGIA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
FLANK PAIN  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
INTERVERTEBRAL DISC PROTRUSION  1  1/772 (0.13%)  1/162 (0.62%)  0/163 (0.00%) 
JOINT CREPITATION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
JOINT EFFUSION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
JOINT SWELLING  1  4/772 (0.52%)  0/162 (0.00%)  0/163 (0.00%) 
METATARSALGIA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
MUSCLE SPASMS  1  3/772 (0.39%)  0/162 (0.00%)  0/163 (0.00%) 
MUSCLE TIGHTNESS  1  3/772 (0.39%)  0/162 (0.00%)  1/163 (0.61%) 
MUSCULOSKELETAL PAIN  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
MUSCULOSKELETAL STIFFNESS  1  1/772 (0.13%)  0/162 (0.00%)  1/163 (0.61%) 
MYALGIA  1  4/772 (0.52%)  1/162 (0.62%)  0/163 (0.00%) 
NECK PAIN  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
OSTEOARTHRITIS  1  1/772 (0.13%)  1/162 (0.62%)  2/163 (1.23%) 
PAIN IN EXTREMITY  1  12/772 (1.55%)  0/162 (0.00%)  0/163 (0.00%) 
PATELLOFEMORAL PAIN SYNDROME  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
PSORIATIC ARTHROPATHY  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
RHEUMATIC DISORDER  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
SCOLIOSIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
SPINAL OSTEOARTHRITIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
SPINAL PAIN  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
SYNOVIAL CYST  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
TENDONITIS  1  1/772 (0.13%)  1/162 (0.62%)  0/163 (0.00%) 
TENOSYNOVITIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
BASAL CELL CARCINOMA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
DYSPLASTIC NAEVUS  1  1/772 (0.13%)  1/162 (0.62%)  0/163 (0.00%) 
FIBROMA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
FIBROUS HISTIOCYTOMA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
MELANOCYTIC NAEVUS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
MONOCLONAL GAMMOPATHY  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
SEBORRHOEIC KERATOSIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
SKIN PAPILLOMA  1  9/772 (1.17%)  3/162 (1.85%)  1/163 (0.61%) 
Nervous system disorders       
BURNING SENSATION  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
CARPAL TUNNEL SYNDROME  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
CERVICOGENIC VERTIGO  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
DIZZINESS  1  3/772 (0.39%)  1/162 (0.62%)  0/163 (0.00%) 
DYSAESTHESIA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
DYSGEUSIA  1  2/772 (0.26%)  0/162 (0.00%)  1/163 (0.61%) 
HEADACHE  1  60/772 (7.77%)  5/162 (3.09%)  5/163 (3.07%) 
HYPERAESTHESIA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
MIGRAINE  1  2/772 (0.26%)  0/162 (0.00%)  1/163 (0.61%) 
NERVE COMPRESSION  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
NEURALGIA  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
NEURITIS  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
NEUROPATHY PERIPHERAL  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
ORTHOSTATIC INTOLERANCE  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
SCIATICA  1  4/772 (0.52%)  1/162 (0.62%)  4/163 (2.45%) 
SOMNOLENCE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
Psychiatric disorders       
ALCOHOL ABUSE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
DEPRESSION  1  3/772 (0.39%)  0/162 (0.00%)  0/163 (0.00%) 
INITIAL INSOMNIA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
INSOMNIA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
MOOD SWINGS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
NERVOUSNESS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
SLEEP DISORDER  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
Renal and urinary disorders       
DYSURIA  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
HAEMATURIA  1  5/772 (0.65%)  1/162 (0.62%)  0/163 (0.00%) 
LEUKOCYTURIA  1  4/772 (0.52%)  0/162 (0.00%)  0/163 (0.00%) 
NEPHROLITHIASIS  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
POLLAKIURIA  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
PROTEINURIA  1  3/772 (0.39%)  0/162 (0.00%)  0/163 (0.00%) 
Reproductive system and breast disorders       
BALANOPOSTHITIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
BENIGN PROSTATIC HYPERPLASIA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
BREAST CYST  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
DYSMENORRHOEA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
MENOPAUSAL SYMPTOMS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
MENSTRUATION IRREGULAR  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
METRORRHAGIA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
PROSTATITIS  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
PRURITUS GENITAL  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
COUGH  1  12/772 (1.55%)  0/162 (0.00%)  2/163 (1.23%) 
DYSPHONIA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
DYSPNOEA  1  3/772 (0.39%)  0/162 (0.00%)  0/163 (0.00%) 
EPISTAXIS  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
NASAL CONGESTION  1  3/772 (0.39%)  1/162 (0.62%)  0/163 (0.00%) 
NASAL INFLAMMATION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
NASAL MUCOSAL EROSION  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
OROPHARYNGEAL DISCOMFORT  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
OROPHARYNGEAL PAIN  1  12/772 (1.55%)  1/162 (0.62%)  2/163 (1.23%) 
PHARYNGEAL INFLAMMATION  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
PRODUCTIVE COUGH  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
RHINITIS ALLERGIC  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
RHINORRHOEA  1  10/772 (1.30%)  1/162 (0.62%)  0/163 (0.00%) 
SLEEP APNOEA SYNDROME  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
THROAT IRRITATION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
Skin and subcutaneous tissue disorders       
ACNE  1  1/772 (0.13%)  1/162 (0.62%)  0/163 (0.00%) 
ACTINIC KERATOSIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
ALOPECIA  1  5/772 (0.65%)  0/162 (0.00%)  0/163 (0.00%) 
ALOPECIA AREATA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
BLISTER  1  1/772 (0.13%)  1/162 (0.62%)  0/163 (0.00%) 
BLOOD BLISTER  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
DERMAL CYST  1  3/772 (0.39%)  0/162 (0.00%)  0/163 (0.00%) 
DERMATITIS ALLERGIC  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
DERMATITIS CONTACT  1  5/772 (0.65%)  2/162 (1.23%)  0/163 (0.00%) 
DRUG ERUPTION  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
DRY SKIN  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
DYSHIDROTIC ECZEMA  1  3/772 (0.39%)  2/162 (1.23%)  2/163 (1.23%) 
ECZEMA  1  10/772 (1.30%)  4/162 (2.47%)  1/163 (0.61%) 
ECZEMA WEEPING  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
ERYTHEMA  1  2/772 (0.26%)  1/162 (0.62%)  0/163 (0.00%) 
ERYTHEMA NODOSUM  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
HYPERHIDROSIS  1  3/772 (0.39%)  0/162 (0.00%)  0/163 (0.00%) 
INGROWING NAIL  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
INTERTRIGO  1  8/772 (1.04%)  0/162 (0.00%)  1/163 (0.61%) 
MILIARIA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
MYXOID CYST  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
PAIN OF SKIN  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
PAPULE  1  1/772 (0.13%)  1/162 (0.62%)  0/163 (0.00%) 
PETECHIAE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
PHOTODERMATOSIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
PHOTOSENSITIVITY REACTION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
PRURIGO  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
PRURITUS  1  32/772 (4.15%)  2/162 (1.23%)  0/163 (0.00%) 
PRURITUS ALLERGIC  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
PRURITUS GENERALISED  1  8/772 (1.04%)  1/162 (0.62%)  1/163 (0.61%) 
PSORIASIS  1  3/772 (0.39%)  2/162 (1.23%)  2/163 (1.23%) 
PUSTULAR PSORIASIS  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
RASH  1  2/772 (0.26%)  0/162 (0.00%)  1/163 (0.61%) 
RASH MACULAR  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
RASH PAPULAR  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
ROSACEA  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
SEBORRHOEA  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
SEBORRHOEIC DERMATITIS  1  13/772 (1.68%)  0/162 (0.00%)  1/163 (0.61%) 
SKIN ATROPHY  1  0/772 (0.00%)  0/162 (0.00%)  1/163 (0.61%) 
SKIN EXFOLIATION  1  2/772 (0.26%)  0/162 (0.00%)  0/163 (0.00%) 
SKIN FISSURES  1  1/772 (0.13%)  0/162 (0.00%)  1/163 (0.61%) 
SKIN IRRITATION  1  1/772 (0.13%)  0/162 (0.00%)  1/163 (0.61%) 
SKIN PLAQUE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
SKIN ULCER  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
SKIN ULCER HAEMORRHAGE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
SOLAR DERMATITIS  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
URTICARIA  1  7/772 (0.91%)  1/162 (0.62%)  1/163 (0.61%) 
Vascular disorders       
DIASTOLIC HYPERTENSION  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
FLUSHING  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
HAEMATOMA  1  1/772 (0.13%)  1/162 (0.62%)  1/163 (0.61%) 
HAEMORRHAGE  1  1/772 (0.13%)  0/162 (0.00%)  0/163 (0.00%) 
HYPERTENSION  1  8/772 (1.04%)  3/162 (1.85%)  4/163 (2.45%) 
LYMPHOEDEMA  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
PERIPHERAL VENOUS DISEASE  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
VARICOSE VEIN  1  0/772 (0.00%)  1/162 (0.62%)  0/163 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.1)
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: Clinical Disclosure Office
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: NCT02474069     History of Changes
Other Study ID Numbers: CAIN457ADE04
2014-001974-32 ( EudraCT Number )
First Submitted: February 26, 2015
First Posted: June 17, 2015
Results First Submitted: September 15, 2017
Results First Posted: July 4, 2019
Last Update Posted: July 4, 2019