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Clinical Trial Results:
A randomized, double-blind, placebo-controlled, multicenter study of subcutaneous secukinumab in autoinjectors to demonstrate efficacy after twelve weeks of treatment, and to assess the safety, tolerability, usability and long-term efficacy in subjects with chronic plaque-type psoriasis: Judging the Efficacy of SecUkinumab in Patients with Psoriasis using AutoiNjector: a Clinical Trial Evaluating Treatment REsults (JUNCTURE) Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.novfor complete trial results.

Summary
EudraCT number	2012-002609-22
Trial protocol	DE EE
Global end of trial date	27 Oct 2016

Results information
Results version number	v1(current)
This version publication date	19 Jul 2018
First version publication date	19 Jul 2018
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CAIN457A2309

ISRCTN number

US NCT number

NCT01636687

WHO universal trial number (UTN)

Sponsor organisation name

Novartis Pharma AG

Sponsor organisation address

CH-4002, Basel, Switzerland,

Public contact

Clinical Disclosure Office, Novartis Pharma, AG, 41 613241111,

Scientific contact

Clinical Disclosure Office, Novartis Pharma, AG, 41 613241111,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

27 Oct 2016

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

27 Oct 2016

Was the trial ended prematurely?

Main objective of the trial

To demonstrate the efficacy of AI-administered secukinumab (150 mg and 300 mg) in patients with moderate to severe chronic plaque-type psoriasis with respect to both PASI 75 and IGA mod 2011 0 or 1 response (co-primary endpoints) at Week 12 compared to placebo.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.

Background therapy

Evidence for comparator

Actual start date of recruitment

17 Oct 2012

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 35

Country: Number of subjects enrolled

Estonia: 22

Country: Number of subjects enrolled

France: 24

Country: Number of subjects enrolled

Germany: 66

Country: Number of subjects enrolled

United States: 35

Worldwide total number of subjects

182

EEA total number of subjects

112

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

166

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

A total of 220 patients were screened at 39 study centers, and 182 patients were randomized at 38 study centers to 3 balanced groups.

Period 1 title

Induction Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

AIN457 150 mg

Arm description

Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.

Arm type

Experimental

Investigational medicinal product name

secukinumab 150 mg

Investigational medicinal product code

AIN457

Other name

secukinumab

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

150 mg

AIN457 300 mg

Arm description

Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.

Arm type

Experimental

Investigational medicinal product name

secukinumab 300 mg

Investigational medicinal product code

AIN457

Other name

secukinumab

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

300 mg

Placebo

Arm description

placebo secukinumab (2 s.c. injections) at each dosing

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Placebo

Other name

Placebo

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo

Number of subjects in period 1	AIN457 150 mg	AIN457 300 mg	Placebo
Started	61	60	61
Completed	58	60	59
Not completed	3	0	2
Physician decision	1	-	-
Consent withdrawn by subject	1	-	-
Adverse event, non-fatal	1	-	1
Lack of efficacy	-	-	1

Period 2 title

Maintenance Period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

AIN457 150 mg

Arm description

Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.

Arm type

Experimental

Investigational medicinal product name

secukinumab 150 mg

Investigational medicinal product code

AIN457

Other name

secukinumab

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

150 mg

AIN457 300 mg

Arm description

Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.

Arm type

Experimental

Investigational medicinal product name

secukinumab 300 mg

Investigational medicinal product code

AIN457

Other name

secukinumab

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

300 mg

Placebo - AIN457 150 mg

Arm description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Placebo

Other name

Placebo

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

150 mg

Placebo - AIN457 300mg

Arm description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Placebo

Other name

Placebo

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

300 mg

Placebo

Arm description

placebo secukinumab (2 s.c. injections) at each dosing

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Placebo

Other name

Placebo

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo

Number of subjects in period 2	AIN457 150 mg	AIN457 300 mg	Placebo - AIN457 150 mg	Placebo - AIN457 300mg	Placebo
Started	58	60	28	28	3
Completed	50	58	26	28	1
Not completed	8	2	2	0	2
Consent withdrawn by subject	2	-	2	-	-
Physician decision	-	-	-	-	1
Adverse event, non-fatal	1	-	-	-	-
Lost to follow-up	1	1	-	-	1
Lack of efficacy	4	1	-	-	-

Period 3 title

Extension Period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

AIN457 150 mg

Arm description

Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.

Arm type

Experimental

Investigational medicinal product name

secukinumab 150 mg

Investigational medicinal product code

AIN457

Other name

secukinumab

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

150 mg

AIN457 300 mg

Arm description

Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.

Arm type

Experimental

Investigational medicinal product name

secukinumab 300 mg

Investigational medicinal product code

AIN457

Other name

secukinumab

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

300 mg

Placebo - AIN457 150 mg

Arm description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Placebo

Other name

Placebo

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

150 mg

Placebo - AIN457 300mg

Arm description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Placebo

Other name

Placebo

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

300 mg

Number of subjects in period 3 ^[1]	AIN457 150 mg	AIN457 300 mg	Placebo - AIN457 150 mg	Placebo - AIN457 300mg
Started	47	54	25	28
Completed	0	0	0	0
Not completed	47	54	25	28
technical problems	-	1	2	1
Physician decision	1	-	-	1
Consent withdrawn by subject	1	-	1	1
Adverse event, non-fatal	4	3	2	1
study terminated by sponsor	33	50	17	23
Lost to follow-up	1	-	1	-
Lack of efficacy	7	-	2	1

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Not all patients were eligible or willing to enter the extension period after completing the preceding period (maintenance). This is the reason why the numbers are not equal.

Period 4 title

Follow-up Period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

AIN457 150 mg

Arm description

Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.

Arm type

Experimental

Investigational medicinal product name

secukinumab 150 mg

Investigational medicinal product code

AIN457

Other name

secukinumab

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

150 mg

AIN457 300 mg

Arm description

Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.

Arm type

Experimental

Investigational medicinal product name

secukinumab 300 mg

Investigational medicinal product code

AIN457

Other name

secukinumab

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

300 mg

Placebo - AIN457 150 mg

Arm description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Placebo

Other name

Placebo

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

150 mg

Placebo - AIN457 300mg

Arm description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Placebo

Other name

Placebo

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

300 mg

Placebo

Arm description

placebo secukinumab (2 s.c. injections) at each dosing

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Placebo

Other name

Placebo

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo

Number of subjects in period 4	AIN457 150 mg	AIN457 300 mg	Placebo - AIN457 150 mg	Placebo - AIN457 300mg	Placebo
Started	38	45	21	20	2
Completed	37	45	21	20	1
Not completed	1	0	0	0	1
Consent withdrawn by subject	1	-	-	-	1

Baseline characteristics

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Reporting group title

AIN457 150 mg

Reporting group description

Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.

Reporting group title

AIN457 300 mg

Reporting group description

Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.

Reporting group title

Placebo

Reporting group description

placebo secukinumab (2 s.c. injections) at each dosing

Reporting group values	AIN457 150 mg	AIN457 300 mg	Placebo	Total
Number of subjects	61	60	61	182
Age categorical
Units: Subjects
Age Continuous
Units: years
arithmetic mean (standard deviation)	43.9 ( 14.41 )	46.6 ( 14.23 )	43.7 ( 12.74 )	-
Gender, Male/Female
Units: Subjects
Female	20	14	23	57
Male	41	46	38	125

End points

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Reporting group title

AIN457 150 mg

Reporting group description

Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.

Reporting group title

AIN457 300 mg

Reporting group description

Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.

Reporting group title

Placebo

Reporting group description

placebo secukinumab (2 s.c. injections) at each dosing

Reporting group title

AIN457 150 mg

Reporting group description

Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.

Reporting group title

AIN457 300 mg

Reporting group description

Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.

Reporting group title

Placebo - AIN457 150 mg

Reporting group description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.

Reporting group title

Placebo - AIN457 300mg

Reporting group description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study.

Reporting group title

Placebo

Reporting group description

placebo secukinumab (2 s.c. injections) at each dosing

Reporting group title

AIN457 150 mg

Reporting group description

Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.

Reporting group title

AIN457 300 mg

Reporting group description

Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.

Reporting group title

Placebo - AIN457 150 mg

Reporting group description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.

Reporting group title

Placebo - AIN457 300mg

Reporting group description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study.

Reporting group title

AIN457 150 mg

Reporting group description

Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.

Reporting group title

AIN457 300 mg

Reporting group description

Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.

Reporting group title

Placebo - AIN457 150 mg

Reporting group description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.

Reporting group title

Placebo - AIN457 300mg

Reporting group description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study.

Reporting group title

Placebo

Reporting group description

placebo secukinumab (2 s.c. injections) at each dosing

Subject analysis set title

Placebo - AIN457 300 mg

Subject analysis set type

Full analysis

Subject analysis set description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.

Subject analysis set title

AIN 150 mg

Subject analysis set type

Full analysis

Subject analysis set description

Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.

Subject analysis set title

Placebo-AIN 150 mg

Subject analysis set type

Full analysis

Subject analysis set description

Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.

Primary: Psoriasis Area and Severity Index (PASI) 75 response and Investigators’ Global Assessment (IGA) mod 2011 0 or 1 response.

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End point title

Psoriasis Area and Severity Index (PASI) 75 response and Investigators’ Global Assessment (IGA) mod 2011 0 or 1 response.

End point description

Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis. PASI score was based on assessment of the head, trunk, upper limbs and lower limbs for erythema, thickening (plaque elevation, induration), and scaling (desquamation). PASI scores can range from 0, corresponding to no signs of psoriasis, up to a theoretical maximum of 72.0. PASI-based secondary variables included absolute PASI score, response rates for PASI 75. PASI 50 and PASI 90 were defined as ≥ 50% and ≥ 90% improvement from Baseline in PASI score, respectively, while PASI 100 response corresponded to complete clearing of psoriasis (PASI = 0). IGA mod 2011 was used to evaluate the overall severity of psoriatic disease, with scores ranging from 0 (clear) to 4 (severe). Treatment success was defined as achievement of IGA mod 2011 0 or 1 score.

End point type

Primary

End point timeframe

12 weeks

End point values	AIN457 150 mg	AIN457 300 mg	Placebo
Number of subjects analysed	60	60	61
Units: Percentages of participants
number (not applicable)
PASI 75	71.7	86.7	3.3
IGA 0/1	53.3	73.3	0.0

Efficacy of secukinumab compared to placebo

Statistical analysis description

Response criterion: IGA 0/1

Comparison groups

AIN457 150 mg v Placebo

Number of subjects included in analysis

121

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Fisher exact

Parameter type

Risk difference (RD)

Point estimate

53.3

Confidence interval

level

95%

sides

2-sided

lower limit

36.6

upper limit

67.7

Efficacy of secukinumab compared to placebo

Statistical analysis description

Response Criterion: IGA 0/1

Comparison groups

AIN457 300 mg v Placebo

Number of subjects included in analysis

121

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Fisher exact

Parameter type

Risk difference (RD)

Point estimate

73.3

Confidence interval

level

95%

sides

2-sided

lower limit

58.8

upper limit

83.9

Efficacy of secukinumab compared to placebo

Statistical analysis description

Response criterion: PASI 75

Comparison groups

AIN457 150 mg v Placebo

Number of subjects included in analysis

121

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Fisher exact

Parameter type

Risk difference (RD)

Point estimate

68.4

Confidence interval

level

95%

sides

2-sided

lower limit

53.1

upper limit

79.8

Efficacy of secukinumab compared to placebo

Statistical analysis description

Response criterion: PASI 75

Comparison groups

AIN457 300 mg v Placebo

Number of subjects included in analysis

121

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Fisher exact

Parameter type

Risk difference (RD)

Point estimate

83.4

Confidence interval

level

95%

sides

2-sided

lower limit

70.7

upper limit

91.7

Secondary: Percentages of subjects with successful self-administration of study drug at week 1

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End point title

Percentages of subjects with successful self-administration of study drug at week 1

End point description

To assess the subject’s ability to follow instructions for use with the secukinumab autoinjector

End point type

Secondary

End point timeframe

Week 1

End point values	AIN457 150 mg	AIN457 300 mg	Placebo
Number of subjects analysed	61	60	60
Units: Percentages of participants	100	100	100

No statistical analyses for this end point

Secondary: Percentage of subjects with possible use-related hazards

Top of page

End point title

Percentage of subjects with possible use-related hazards

End point description

To assess potential use-related hazards with the secukinumab autoinjector for the subject.

End point type

Secondary

End point timeframe

Week 1

End point values	AIN457 150 mg	AIN457 300 mg	Placebo
Number of subjects analysed	61	60	61
Units: Percentages of participants
number (not applicable)
Needle stick in a critical area	0	0	0
Needle stick in non-critical area	0	0	0
Any part of the device swallowed	0	0	0
Allergic reaction to devise material	0	0	0
Pain due to bent needle	0	0	0
Any breakage of the device	0	0	0
Swallowing of material debris observed	0	0	0
Any other problem	0	5.1	0
Less than full dose administered	0	1.7	0

No statistical analyses for this end point

Secondary: Absolute change from baseline in Self-Injection Assessment Questionnaire (SIAQ) domain scores at Week 12

Top of page

End point title

Absolute change from baseline in Self-Injection Assessment Questionnaire (SIAQ) domain scores at Week 12

End point description

The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.

End point type

Secondary

End point timeframe

Week 12

End point values	AIN457 150 mg	AIN457 300 mg	Placebo
Number of subjects analysed	61	60	61
Units: Score
arithmetic mean (standard deviation)
Feelings about injections (n=54, 59, 58)	0.94 ( 2.190 )	1.13 ( 1.796 )	0.93 ( 1.887 )
Self confidence (n=54, 60, 59)	1.76 ( 1.763 )	1.68 ( 1.901 )	1.00 ( 2.098 )
Satisfaction with self-injection (n=53, 58, 57)	2.74 ( 2.741 )	2.63 ( 2.361 )	1.71 ( 2.679 )

No statistical analyses for this end point

Secondary: Absolute change from baseline in Self-Injection Assessment Questionnaire (SIAQ) domain scores at Week 48

Top of page

End point title

Absolute change from baseline in Self-Injection Assessment Questionnaire (SIAQ) domain scores at Week 48

End point description

End point type

Secondary

End point timeframe

Absolute change from baseline at week 48

End point values	AIN457 150 mg	AIN457 300 mg	Placebo	Placebo - AIN457 150 mg	Placebo - AIN457 300 mg
Number of subjects analysed	58	60	3	28	28
Units: Score
arithmetic mean (standard deviation)
Feelings about injections	0.92 ( 1.853 )	1.34 ( 2.336 )	0.42 ( 1.768 )	1.43 ( 2.049 )	0.73 ( 1.450 )
Self confidence	1.88 ( 1.926 )	1.86 ( 2.052 )	0.00 ( 3.536 )	1.17 ( 3.033 )	1.70 ( 2.145 )
Satisfaction with self-injection	2.93 ( 2.853 )	2.50 ( 2.121 )	2.50 ( 0.000 )	2.29 ( 2.650 )	1.98 ( 2.853 )

No statistical analyses for this end point

Secondary: Percentages of participants with PASI 50, PASI 75, PASI 90, PASI 100 and IGA 0 or 1 response - induction period

Top of page

End point title

Percentages of participants with PASI 50, PASI 75, PASI 90, PASI 100 and IGA 0 or 1 response - induction period

End point description

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). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 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 and 4 = severe.

End point type

Secondary

End point timeframe

Week 12

End point values	AIN457 150 mg	AIN457 300 mg	Placebo
Number of subjects analysed	61	60	61
Units: Percentages of participants
number (not applicable)
PASI 50	78.3	96.7	8.2
PASI 90	40.0	55.0	0.0
PASI 100	16.7	26.7	0.0

No statistical analyses for this end point

Secondary: Percentages of participants with PASI 50, PASI 75, PASI 90, PASI 100 and IGA 0 or 1 response - maintenance period (observed data)

Top of page

End point title

Percentages of participants with PASI 50, PASI 75, PASI 90, PASI 100 and IGA 0 or 1 response - maintenance period (observed data) ^[1]

End point description

End point type

Secondary

End point timeframe

Week 12 up to Week 52

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Descriptive statistics were reported for this endpoint.

End point values	AIN457 150 mg	AIN457 300 mg	Placebo - AIN457 150 mg	Placebo - AIN457 300 mg
Number of subjects analysed	61	60	28	28
Units: Percentages of participants
number (not applicable)
Week 52 IGA 0/1	64.7	70.7	56.0	85.7
Week 52 PASI 75	82.4	82.8	76.0	96.4
Week 52 PASI 50	96.1	94.8	88.0	100.0
Week 52 PASI 90	62.7	65.5	52.0	89.3
Week 52 PASI 100	35.3	39.7	40.0	64.3

No statistical analyses for this end point

Secondary: Absolute change from baseline for PASI score - induction period

Top of page

End point title

Absolute change from baseline for PASI score - induction period

End point description

PASI: 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:01, arms:0.2 body:0.3 legs:0.4)

End point type

Secondary

End point timeframe

Week 12

End point values	AIN457 150 mg	AIN457 300 mg	Placebo
Number of subjects analysed	61	60	61
Units: Units on a scale
arithmetic mean (standard deviation)	-15.52 ( 7.841 )	-16.67 ( 6.552 )	-1.26 ( 6.621 )

No statistical analyses for this end point

Secondary: Absolute change from baseline for PASI score over time up to week 52 - Maintenance period (observed data)

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End point title

Absolute change from baseline for PASI score over time up to week 52 - Maintenance period (observed data) ^[2]

End point description

End point type

Secondary

End point timeframe

Week 52

Notes
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Descriptive statistics were reported for this endpoint.

End point values	AIN457 150 mg	AIN457 300 mg	Placebo - AIN457 150 mg	Placebo - AIN457 300mg
Number of subjects analysed	61	60	28	28
Units: Units on a scale
arithmetic mean (standard deviation)	-18.3 ( 6.75 )	-16.4 ( 5.99 )	-15.2 ( 5.85 )	-18.8 ( 5.59 )

No statistical analyses for this end point

Secondary: Percentage of participants in each IGA mod 2011 category - induction period

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End point title

Percentage of participants in each IGA mod 2011 category - induction period

End point description

The IGA mod 2011 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 and 4 = severe

End point type

Secondary

End point timeframe

Week 12

End point values	AIN457 150 mg	AIN457 300 mg	Placebo
Number of subjects analysed	61	60	61
Units: Percentages of participants
number (not applicable)
clear (n=60, 60, 61)	18.3	30.0	0.0
almost clear (n=60, 60, 61)	35.0	45.0	0.0
mild (n=60, 60, 61)	25.0	18.3	8.2
moderate (n=60, 60, 61)	15.0	6.7	60.7
severe (n=60, 60, 61)	6.7	0.0	31.1

No statistical analyses for this end point

Secondary: Percentages of participants in each IGA mod 2011 category over time up to week 52 - maintenance period (observed data)

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End point title

Percentages of participants in each IGA mod 2011 category over time up to week 52 - maintenance period (observed data) ^[3]

End point description

End point type

Secondary

End point timeframe

Week 52

Notes
[3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Descriptive statistics were reported for this endpoint.

End point values	AIN457 150 mg	AIN457 300 mg	Placebo - AIN457 150 mg	Placebo - AIN457 300mg
Number of subjects analysed	61	60	28	28
Units: Percentages of participants
number (not applicable)
Clear	35.3	39.7	40.0	64.3
Almost clear	29.4	31.0	16.0	21.4
Mild	19.6	19.0	24.0	10.7
Moderate	11.8	6.9	20.0	3.6
Severe	3.9	3.4	0.0	0.0

No statistical analyses for this end point

Secondary: Change from baseline in EQ-5D up to week 12 - induction period

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End point title

Change from baseline in EQ-5D up to week 12 - induction period

End point description

ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example “confined to bed”) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state).

End point type

Secondary

End point timeframe

Week 12

End point values	AIN457 150 mg	AIN457 300 mg	Placebo
Number of subjects analysed	61	60	61
Units: unit on a scale
arithmetic mean (standard deviation)	13.5 ( 19.63 )	15.3 ( 19.80 )	-0.5 ( 14.89 )

No statistical analyses for this end point

Secondary: Change from baseline in EQ-5D over time up to week 52 - maintenance period

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End point title

Change from baseline in EQ-5D over time up to week 52 - maintenance period

End point description

End point type

Secondary

End point timeframe

Week 52

End point values	AIN457 150 mg	AIN457 300 mg	Placebo	Placebo - AIN457 150 mg	Placebo - AIN457 300mg
Number of subjects analysed	61	60	3	28	28
Units: unit on a scale
arithmetic mean (standard deviation)	16.8 ( 20.34 )	17.4 ( 20.38 )	10.0 ( 9.00 )	12.9 ( 28.45 )	9.9 ( 10.94 )

No statistical analyses for this end point

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) score - induction period

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End point title

Change from Baseline in Dermatology Life Quality Index (DLQI) score - induction period

End point description

The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions

End point type

Secondary

End point timeframe

up to Week 12

End point values	AIN457 150 mg	AIN457 300 mg	Placebo
Number of subjects analysed	56	55	55
Units: Units on a scale
median (confidence interval 95%)	-83.3 (-88.9 to -75.0)	-86.8 (-95.0 to -82.5)	-17.9 (-32.7 to -1.1)

No statistical analyses for this end point

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) score over time up to Week 52 - maintenance period

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End point title

Change from Baseline in Dermatology Life Quality Index (DLQI) score over time up to Week 52 - maintenance period

End point description

End point type

Secondary

End point timeframe

Week 52

End point values	AIN457 150 mg	AIN457 300 mg	Placebo	Placebo - AIN457 150 mg	Placebo - AIN457 300mg
Number of subjects analysed	56	55	3	25	27
Units: Units on a scale
median (confidence interval 95%)	-90.9 (-95.0 to -85.0)	-91.2 (-94.7 to -84.2)	-53.7 (-72.7 to 9999)	-78.5 (-90.0 to -59.5)	-97.7 (-100 to -81.3)

No statistical analyses for this end point

Secondary: Percentage of participants achieving a DLQI score of 0 or 1 at week 12 - induction period

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End point title

Percentage of participants achieving a DLQI score of 0 or 1 at week 12 - induction period

End point description

End point type

Secondary

End point timeframe

Week 12

End point values	AIN457 150 mg	AIN457 300 mg	Placebo
Number of subjects analysed	59	59	59
Units: Percentage of participants
number (not applicable)	59.3	74.6	15.3

No statistical analyses for this end point

Secondary: Percentages of participants achieving a DLQI score of 0 or 1 over time up to week 52 - (maintenance)

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End point title

Percentages of participants achieving a DLQI score of 0 or 1 over time up to week 52 - (maintenance)

End point description

End point type

Secondary

End point timeframe

Week 52

End point values	AIN457 150 mg	AIN457 300 mg	Placebo	Placebo - AIN457 150 mg	Placebo - AIN457 300mg
Number of subjects analysed	59	60	3	28	28
Units: Percentage of participants
number (not applicable)	66.1	70.0	0.0	57.1	85.7

No statistical analyses for this end point

Secondary: Percentages of participants with PASI 50, PASI 75, PASI 90, PASI 100 and IGA 0 or 1 response after week 52 (observed data)

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End point title

Percentages of participants with PASI 50, PASI 75, PASI 90, PASI 100 and IGA 0 or 1 response after week 52 (observed data) ^[4]

End point description

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). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 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 and 4 = severe.

End point type

Secondary

End point timeframe

Week 160

Notes
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Descriptive statistics were reported for this endpoint.

End point values	AIN457 150 mg	AIN457 300 mg	Placebo - AIN457 150 mg	Placebo - AIN457 300mg
Number of subjects analysed	61	60	28	28
Units: Percentages of participants
number (not applicable)
IGA 0/1 (n=16, 24, 10, 15) Week 160	43.8	58.3	20.0	73.3
PASI 75 (n=16, 24, 10, 15) Week 160	93.8	87.5	70.0	86.7
PASI 50 (n=16, 24, 10, 15) Week 160	100.0	100.0	70.0	100.0
PASI 90 (n=16, 24, 10, 15) Week 160	62.5	70.8	40.0	73.3
PASI 100 (n=16, 24, 10, 15) Week 160	31.3	45.8	20.0	60.0

No statistical analyses for this end point

Secondary: Absolute change from baseline for PASI score after week 52 (observed data)

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End point title

Absolute change from baseline for PASI score after week 52 (observed data) ^[5]

End point description

End point type

Secondary

End point timeframe

Week 160

Notes
[5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Descriptive statistics were reported for this endpoint.

End point values	AIN457 150 mg	AIN457 300 mg	Placebo - AIN457 150 mg	Placebo - AIN457 300mg
Number of subjects analysed	61	60	28	28
Units: Units on a scale
arithmetic mean (standard deviation)	-18.7 ( 5.66 )	-15.9 ( 4.58 )	-12.7 ( 8.08 )	-18.1 ( 5.49 )

No statistical analyses for this end point

Secondary: Percentages of participants in each IGA Mod 2011 category after Week 52 (observed data)

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End point title

Percentages of participants in each IGA Mod 2011 category after Week 52 (observed data) ^[6]

End point description

End point type

Secondary

End point timeframe

Week 160

Notes
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Descriptive statistics were reported for this endpoint.

End point values	AIN457 150 mg	AIN457 300 mg	Placebo - AIN457 150 mg	Placebo - AIN457 300mg
Number of subjects analysed	61	60	28	28
Units: Percentages of participants
number (not applicable)
clear (n= 16, 24, 20, 10, 15) Week 160	25.0	45.8	20.0	60.0
almost clear (n= 16, 24, 20, 10, 15) Week 160	18.8	12.5	0.0	13.3
mild (n= 16, 24, 20, 10, 15) Week 160	31.3	20.8	50.0	6.7
moderate (n= 16, 24, 20, 10, 15) Week 160	25.0	16.7	20.0	13.3
severe (n= 16, 24, 20, 10, 15) Week 160	0.0	4.2	10.0	6.7

No statistical analyses for this end point

Secondary: Number of participants developing treatment-emergent anti-secukinumab antibodies

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End point title

Number of participants developing treatment-emergent anti-secukinumab antibodies

End point description

The development of anti-secunimubab anti-bodies decreases a participant’s ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to week 216.

End point type

Secondary

End point timeframe

Baseline and at Week 12, 24, 52, 100, 148, 196, 208, and 216

End point values	AIN457 150 mg	AIN457 300 mg	Placebo	Placebo - AIN457 150 mg	Placebo - AIN457 300mg
Number of subjects analysed	59	60	3	28	28
Units: Number of participants	1	2	0	0	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Timeframe for AE

Adverse event reporting additional description

AE additional description

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

19.1

Reporting group title

Induction AIN457 150 mg

Reporting group description

Induction AIN457 150 mg

Reporting group title

Induction AIN457 300 mg

Reporting group description

Induction AIN457 300 mg

Reporting group title

Induction Placebo

Reporting group description

Induction Placebo

Reporting group title

Entire Any AIN457 150 mg

Reporting group description

Entire Any AIN457 150 mg

Reporting group title

Entire Any AIN457 300 mg

Reporting group description

Entire Any AIN457 300 mg

Reporting group title

Entire Placebo

Reporting group description

Entire Placebo

Serious adverse events	Induction AIN457 150 mg	Induction AIN457 300 mg	Induction Placebo	Entire Any AIN457 150 mg	Entire Any AIN457 300 mg	Entire Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 61 (4.92%)	1 / 60 (1.67%)	1 / 61 (1.64%)	18 / 89 (20.22%)	16 / 88 (18.18%)	1 / 61 (1.64%)
number of deaths (all causes)	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANOGENITAL WARTS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
BASAL CELL CARCINOMA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
BOWEN'S DISEASE
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
LUNG CANCER METASTATIC
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
MALIGNANT MELANOMA IN SITU
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
PERIPHERAL ARTERY ANEURYSM
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PERIPHERAL ARTERY THROMBOSIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
UTERINE PROLAPSE
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
MAJOR DEPRESSION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	1 / 61 (1.64%)	0 / 89 (0.00%)	0 / 88 (0.00%)	1 / 61 (1.64%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
SUICIDE ATTEMPT
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
HEART RATE IRREGULAR
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
BONE CONTUSION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
DISLOCATION OF VERTEBRA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
FOOT FRACTURE
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
HUMERUS FRACTURE
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
POST PROCEDURAL HAEMORRHAGE
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
ULNA FRACTURE
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
ANGINA PECTORIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
ANGINA UNSTABLE
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
AORTIC VALVE STENOSIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
ATRIAL FIBRILLATION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
ATRIOVENTRICULAR BLOCK COMPLETE
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
CARDIAC FAILURE
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
CORONARY ARTERY DISEASE
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
LEFT VENTRICULAR DYSFUNCTION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
MYOCARDIAL INFARCTION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PALPITATIONS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
POSTINFARCTION ANGINA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
SINUS TACHYCARDIA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
CAROTID ARTERY ANEURYSM
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
CEREBROVASCULAR ACCIDENT
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
NEUROPATHY PERIPHERAL
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
AMAUROSIS FUGAX
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
CATARACT
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
ASCITES
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
COLITIS ULCERATIVE
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
GASTRITIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
INGUINAL HERNIA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
RECTAL PROLAPSE
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
CHOLELITHIASIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
PSORIASIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
TRANSIENT ACANTHOLYTIC DERMATOSIS
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
ACUTE KIDNEY INJURY
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
BLADDER PROLAPSE
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
LUMBAR SPINAL STENOSIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
OSTEOARTHRITIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
OSTEOLYSIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
ROTATOR CUFF SYNDROME
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
CHRONIC TONSILLITIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
ERYSIPELAS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
MYELITIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PNEUMONIA
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
URINARY TRACT INFECTION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
FLUID OVERLOAD
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	0 / 61 (0.00%)	0 / 89 (0.00%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 2%

Non-serious adverse events	Induction AIN457 150 mg	Induction AIN457 300 mg	Induction Placebo	Entire Any AIN457 150 mg	Entire Any AIN457 300 mg	Entire Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	35 / 61 (57.38%)	37 / 60 (61.67%)	30 / 61 (49.18%)	81 / 89 (91.01%)	81 / 88 (92.05%)	31 / 61 (50.82%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	0	2	0
MELANOCYTIC NAEVUS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	3 / 89 (3.37%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	0	0	3	0	0
SKIN PAPILLOMA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	1	0
Vascular disorders
HAEMATOMA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	1	3	0
HYPERTENSION
subjects affected / exposed	3 / 61 (4.92%)	1 / 60 (1.67%)	4 / 61 (6.56%)	4 / 89 (4.49%)	10 / 88 (11.36%)	4 / 61 (6.56%)
occurrences all number	3	1	4	4	11	4
General disorders and administration site conditions
CYST
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	0	0
FATIGUE
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	1 / 61 (1.64%)	4 / 89 (4.49%)	3 / 88 (3.41%)	1 / 61 (1.64%)
occurrences all number	1	0	1	5	4	1
INJECTION SITE BRUISING
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	0 / 61 (0.00%)	1 / 89 (1.12%)	4 / 88 (4.55%)	0 / 61 (0.00%)
occurrences all number	0	1	0	2	5	0
INJECTION SITE HAEMATOMA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	2 / 61 (3.28%)	1 / 89 (1.12%)	3 / 88 (3.41%)	2 / 61 (3.28%)
occurrences all number	0	0	2	1	3	2
INJECTION SITE PAIN
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	0 / 61 (0.00%)	1 / 89 (1.12%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	1	0	1	2	0
NON-CARDIAC CHEST PAIN
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	0 / 61 (0.00%)	3 / 89 (3.37%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	0	1	0	3	1	0
PYREXIA
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	0 / 61 (0.00%)	0 / 89 (0.00%)	5 / 88 (5.68%)	0 / 61 (0.00%)
occurrences all number	0	1	0	0	12	0
Immune system disorders
DRUG HYPERSENSITIVITY
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	1	0
Reproductive system and breast disorders
DYSMENORRHOEA
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences all number	1	0	0	2	0	0
Respiratory, thoracic and mediastinal disorders
ASTHMA
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	0 / 61 (0.00%)	0 / 89 (0.00%)	5 / 88 (5.68%)	0 / 61 (0.00%)
occurrences all number	0	1	0	0	6	0
COUGH
subjects affected / exposed	0 / 61 (0.00%)	3 / 60 (5.00%)	2 / 61 (3.28%)	5 / 89 (5.62%)	10 / 88 (11.36%)	2 / 61 (3.28%)
occurrences all number	0	3	2	5	13	2
DYSPHONIA
subjects affected / exposed	0 / 61 (0.00%)	2 / 60 (3.33%)	0 / 61 (0.00%)	0 / 89 (0.00%)	3 / 88 (3.41%)	0 / 61 (0.00%)
occurrences all number	0	4	0	0	5	0
DYSPNOEA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	0	0
EPISTAXIS
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences all number	1	0	0	2	0	0
NASAL CONGESTION
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	1 / 61 (1.64%)	0 / 89 (0.00%)	4 / 88 (4.55%)	1 / 61 (1.64%)
occurrences all number	0	1	1	0	4	1
OROPHARYNGEAL PAIN
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	2 / 61 (3.28%)	4 / 89 (4.49%)	8 / 88 (9.09%)	2 / 61 (3.28%)
occurrences all number	0	1	2	4	10	2
RHINORRHOEA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	0	2	0
Psychiatric disorders
ADJUSTMENT DISORDER WITH DEPRESSED MOOD
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	0	0
DEPRESSION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	1	0
INSOMNIA
subjects affected / exposed	1 / 61 (1.64%)	1 / 60 (1.67%)	0 / 61 (0.00%)	2 / 89 (2.25%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	1	1	0	2	2	0
Investigations
ALANINE AMINOTRANSFERASE INCREASED
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	0 / 61 (0.00%)	3 / 89 (3.37%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	1	0	0	3	2	0
ASPARTATE AMINOTRANSFERASE INCREASED
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	1	0	0	2	2	0
BLOOD URINE PRESENT
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	3 / 88 (3.41%)	0 / 61 (0.00%)
occurrences all number	0	0	0	0	3	0
GAMMA-GLUTAMYLTRANSFERASE INCREASED
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	0 / 61 (0.00%)	0 / 89 (0.00%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	1	0	0	2	0
LIVER FUNCTION TEST INCREASED
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	0	0
WEIGHT DECREASED
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	1 / 61 (1.64%)	2 / 89 (2.25%)	0 / 88 (0.00%)	1 / 61 (1.64%)
occurrences all number	0	0	1	2	0	1
WEIGHT INCREASED
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	1	0	0	2	1	0
Injury, poisoning and procedural complications
ANIMAL BITE
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	1	0
ARTHROPOD BITE
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	4 / 88 (4.55%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	4	0
ARTHROPOD STING
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	0	2	0
CONTUSION
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	1	0	0	3	1	0
FALL
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	2	0
JOINT DISLOCATION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	0	2	0
LACERATION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	4 / 88 (4.55%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	4	0
MUSCLE STRAIN
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	0 / 61 (0.00%)	0 / 89 (0.00%)	3 / 88 (3.41%)	0 / 61 (0.00%)
occurrences all number	0	1	0	0	3	0
POST PROCEDURAL COMPLICATION
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	0 / 61 (0.00%)	0 / 89 (0.00%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	6	0	0	30	0
PROCEDURAL PAIN
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	1	0
SUNBURN
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	3 / 88 (3.41%)	0 / 61 (0.00%)
occurrences all number	0	0	0	0	3	0
TENDON RUPTURE
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	0 / 61 (0.00%)	0 / 89 (0.00%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	1	0	0	2	0
TOOTH FRACTURE
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	1	0
Cardiac disorders
ANGINA PECTORIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	3 / 88 (3.41%)	0 / 61 (0.00%)
occurrences all number	0	0	0	1	3	0
AORTIC VALVE INCOMPETENCE
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	1	0
ATRIOVENTRICULAR BLOCK FIRST DEGREE
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	4 / 88 (4.55%)	0 / 61 (0.00%)
occurrences all number	0	0	0	0	5	0
BUNDLE BRANCH BLOCK LEFT
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	1 / 61 (1.64%)	1 / 89 (1.12%)	3 / 88 (3.41%)	1 / 61 (1.64%)
occurrences all number	0	0	1	1	3	1
SINUS BRADYCARDIA
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences all number	1	0	0	2	0	0
Nervous system disorders
HEADACHE
subjects affected / exposed	5 / 61 (8.20%)	3 / 60 (5.00%)	3 / 61 (4.92%)	13 / 89 (14.61%)	14 / 88 (15.91%)	3 / 61 (4.92%)
occurrences all number	5	3	6	16	28	6
HYPOAESTHESIA
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	0 / 61 (0.00%)	2 / 89 (2.25%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	0	1	0	2	1	0
PARAESTHESIA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	0	0
SCIATICA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	3 / 89 (3.37%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	0	0	3	0	0
Blood and lymphatic system disorders
EOSINOPHILIA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	1	2	0
LYMPHADENOPATHY
subjects affected / exposed	1 / 61 (1.64%)	1 / 60 (1.67%)	0 / 61 (0.00%)	1 / 89 (1.12%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	1	1	0	1	2	0
Eye disorders
BLEPHARITIS
subjects affected / exposed	0 / 61 (0.00%)	2 / 60 (3.33%)	0 / 61 (0.00%)	0 / 89 (0.00%)	4 / 88 (4.55%)	0 / 61 (0.00%)
occurrences all number	0	2	0	0	6	0
Gastrointestinal disorders
ABDOMINAL PAIN
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	1 / 61 (1.64%)	2 / 89 (2.25%)	1 / 88 (1.14%)	1 / 61 (1.64%)
occurrences all number	0	0	1	2	1	1
ABDOMINAL PAIN UPPER
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	0 / 61 (0.00%)	3 / 89 (3.37%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	0	1	0	3	1	0
CONSTIPATION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	1	0
DENTAL CARIES
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	1 / 61 (1.64%)	2 / 89 (2.25%)	0 / 88 (0.00%)	1 / 61 (1.64%)
occurrences all number	0	0	1	2	0	1
DIARRHOEA
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	0 / 61 (0.00%)	6 / 89 (6.74%)	7 / 88 (7.95%)	0 / 61 (0.00%)
occurrences all number	0	2	0	8	9	0
DYSPEPSIA
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	0 / 61 (0.00%)	3 / 89 (3.37%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	1	0	0	4	1	0
GASTRITIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	0	0	0	4	1	0
INGUINAL HERNIA
subjects affected / exposed	1 / 61 (1.64%)	1 / 60 (1.67%)	0 / 61 (0.00%)	2 / 89 (2.25%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	1	1	0	2	1	0
NAUSEA
subjects affected / exposed	0 / 61 (0.00%)	2 / 60 (3.33%)	0 / 61 (0.00%)	0 / 89 (0.00%)	3 / 88 (3.41%)	0 / 61 (0.00%)
occurrences all number	0	2	0	0	5	0
TOOTHACHE
subjects affected / exposed	1 / 61 (1.64%)	2 / 60 (3.33%)	2 / 61 (3.28%)	5 / 89 (5.62%)	5 / 88 (5.68%)	2 / 61 (3.28%)
occurrences all number	1	2	2	8	5	2
VOMITING
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	3 / 88 (3.41%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	3	0
Hepatobiliary disorders
HEPATIC STEATOSIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	3 / 88 (3.41%)	0 / 61 (0.00%)
occurrences all number	0	0	0	0	3	0
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	0	2	0
DERMATITIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	3 / 89 (3.37%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	0	0	3	0	0
DRUG ERUPTION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	3 / 89 (3.37%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	0	0	3	0	0
DRY SKIN
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	0 / 61 (0.00%)	0 / 89 (0.00%)	5 / 88 (5.68%)	0 / 61 (0.00%)
occurrences all number	0	1	0	0	5	0
ECZEMA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	5 / 89 (5.62%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	7	2	0
HYPERKERATOSIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	0	3	0
INTERTRIGO
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	0 / 61 (0.00%)	3 / 89 (3.37%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences all number	1	0	0	4	0	0
PAIN OF SKIN
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	1 / 61 (1.64%)	0 / 89 (0.00%)	2 / 88 (2.27%)	1 / 61 (1.64%)
occurrences all number	0	0	1	0	2	1
PITYRIASIS ROSEA
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	0 / 61 (0.00%)	0 / 89 (0.00%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	1	0	0	2	0
PRURITUS
subjects affected / exposed	1 / 61 (1.64%)	4 / 60 (6.67%)	2 / 61 (3.28%)	3 / 89 (3.37%)	7 / 88 (7.95%)	2 / 61 (3.28%)
occurrences all number	1	4	3	3	8	3
PRURITUS GENERALISED
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	3 / 88 (3.41%)	0 / 61 (0.00%)
occurrences all number	0	0	0	0	5	0
PSORIASIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	1 / 61 (1.64%)	6 / 89 (6.74%)	7 / 88 (7.95%)	1 / 61 (1.64%)
occurrences all number	0	0	1	7	7	1
SEBORRHOEA
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	0 / 61 (0.00%)	0 / 89 (0.00%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	1	0	0	6	0
SEBORRHOEIC DERMATITIS
subjects affected / exposed	0 / 61 (0.00%)	2 / 60 (3.33%)	0 / 61 (0.00%)	3 / 89 (3.37%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	2	0	3	6	0
STASIS DERMATITIS
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	0 / 61 (0.00%)	1 / 89 (1.12%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	1	0	1	2	0
Renal and urinary disorders
HAEMATURIA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	3 / 89 (3.37%)	6 / 88 (6.82%)	0 / 61 (0.00%)
occurrences all number	0	0	0	3	6	0
Musculoskeletal and connective tissue disorders
ARTHRALGIA
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	0 / 61 (0.00%)	11 / 89 (12.36%)	9 / 88 (10.23%)	0 / 61 (0.00%)
occurrences all number	0	1	0	11	12	0
BACK PAIN
subjects affected / exposed	1 / 61 (1.64%)	1 / 60 (1.67%)	0 / 61 (0.00%)	5 / 89 (5.62%)	9 / 88 (10.23%)	0 / 61 (0.00%)
occurrences all number	1	1	0	6	10	0
BURSITIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	3 / 88 (3.41%)	0 / 61 (0.00%)
occurrences all number	0	0	0	1	3	0
FIBROMYALGIA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	0	0
INTERVERTEBRAL DISC DEGENERATION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	0	0
MUSCLE SPASMS
subjects affected / exposed	1 / 61 (1.64%)	1 / 60 (1.67%)	0 / 61 (0.00%)	1 / 89 (1.12%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	1	1	0	1	3	0
MUSCULOSKELETAL PAIN
subjects affected / exposed	1 / 61 (1.64%)	1 / 60 (1.67%)	0 / 61 (0.00%)	3 / 89 (3.37%)	4 / 88 (4.55%)	0 / 61 (0.00%)
occurrences all number	1	1	0	3	4	0
MYALGIA
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	3 / 88 (3.41%)	1 / 61 (1.64%)
occurrences all number	1	0	0	2	3	1
NECK PAIN
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	0	2	0
OSTEOARTHRITIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	2 / 61 (3.28%)	1 / 89 (1.12%)	3 / 88 (3.41%)	2 / 61 (3.28%)
occurrences all number	0	0	2	1	3	2
PAIN IN EXTREMITY
subjects affected / exposed	1 / 61 (1.64%)	1 / 60 (1.67%)	1 / 61 (1.64%)	2 / 89 (2.25%)	3 / 88 (3.41%)	1 / 61 (1.64%)
occurrences all number	1	2	1	2	5	1
PSORIATIC ARTHROPATHY
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	3 / 88 (3.41%)	0 / 61 (0.00%)
occurrences all number	0	0	0	0	3	0
TENDONITIS
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	1 / 61 (1.64%)	0 / 89 (0.00%)	2 / 88 (2.27%)	1 / 61 (1.64%)
occurrences all number	0	1	1	0	2	1
Infections and infestations
BRONCHITIS
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	2 / 61 (3.28%)	6 / 89 (6.74%)	11 / 88 (12.50%)	2 / 61 (3.28%)
occurrences all number	1	0	2	8	14	2
CANDIDA INFECTION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	0	2	0
CONJUNCTIVITIS
subjects affected / exposed	1 / 61 (1.64%)	1 / 60 (1.67%)	0 / 61 (0.00%)	4 / 89 (4.49%)	6 / 88 (6.82%)	0 / 61 (0.00%)
occurrences all number	1	1	0	4	6	0
CYSTITIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	1	0
EAR INFECTION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	3 / 88 (3.41%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	3	0
FOLLICULITIS
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	1 / 61 (1.64%)	4 / 89 (4.49%)	0 / 88 (0.00%)	1 / 61 (1.64%)
occurrences all number	1	0	1	4	0	1
FUNGAL INFECTION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	3 / 88 (3.41%)	0 / 61 (0.00%)
occurrences all number	0	0	0	0	4	0
FUNGAL SKIN INFECTION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	0	2	0
GASTROENTERITIS
subjects affected / exposed	1 / 61 (1.64%)	1 / 60 (1.67%)	2 / 61 (3.28%)	6 / 89 (6.74%)	7 / 88 (7.95%)	2 / 61 (3.28%)
occurrences all number	1	1	2	6	8	2
GASTROENTERITIS VIRAL
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	3 / 89 (3.37%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	3	3	0
GASTROINTESTINAL VIRAL INFECTION
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	1	0	0	2	1	0
HORDEOLUM
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	1 / 61 (1.64%)	1 / 89 (1.12%)	2 / 88 (2.27%)	1 / 61 (1.64%)
occurrences all number	1	0	1	1	3	1
INFLUENZA
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	2 / 61 (3.28%)	8 / 89 (8.99%)	0 / 88 (0.00%)	2 / 61 (3.28%)
occurrences all number	1	0	2	10	0	2
NASOPHARYNGITIS
subjects affected / exposed	14 / 61 (22.95%)	19 / 60 (31.67%)	9 / 61 (14.75%)	37 / 89 (41.57%)	39 / 88 (44.32%)	9 / 61 (14.75%)
occurrences all number	15	22	10	66	96	10
ORAL CANDIDIASIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	1 / 61 (1.64%)	0 / 89 (0.00%)	4 / 88 (4.55%)	1 / 61 (1.64%)
occurrences all number	0	0	1	0	5	1
ORAL HERPES
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	0 / 61 (0.00%)	4 / 89 (4.49%)	4 / 88 (4.55%)	0 / 61 (0.00%)
occurrences all number	1	0	0	4	7	0
OTITIS EXTERNA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	3 / 88 (3.41%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	4	0
OTITIS MEDIA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	1	0
PERIODONTITIS
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	0 / 61 (0.00%)	1 / 89 (1.12%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	1	0	1	2	0
PHARYNGITIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	5 / 89 (5.62%)	5 / 88 (5.68%)	0 / 61 (0.00%)
occurrences all number	0	0	0	6	5	0
PHARYNGITIS STREPTOCOCCAL
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	0	2	0
PULPITIS DENTAL
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	0 / 61 (0.00%)	1 / 89 (1.12%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	1	0	1	2	0
PYURIA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	0	2	0
RHINITIS
subjects affected / exposed	2 / 61 (3.28%)	0 / 60 (0.00%)	0 / 61 (0.00%)	6 / 89 (6.74%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	2	0	0	6	1	0
SINUSITIS
subjects affected / exposed	1 / 61 (1.64%)	3 / 60 (5.00%)	0 / 61 (0.00%)	5 / 89 (5.62%)	7 / 88 (7.95%)	0 / 61 (0.00%)
occurrences all number	2	3	0	6	11	0
TINEA PEDIS
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	1 / 89 (1.12%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	1	2	0
TONSILLITIS
subjects affected / exposed	1 / 61 (1.64%)	1 / 60 (1.67%)	0 / 61 (0.00%)	2 / 89 (2.25%)	4 / 88 (4.55%)	0 / 61 (0.00%)
occurrences all number	1	1	0	6	4	0
TOOTH ABSCESS
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	1 / 61 (1.64%)	2 / 89 (2.25%)	1 / 88 (1.14%)	1 / 61 (1.64%)
occurrences all number	1	0	2	2	2	2
TOOTH INFECTION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	3 / 89 (3.37%)	3 / 88 (3.41%)	0 / 61 (0.00%)
occurrences all number	0	0	0	3	3	0
UPPER RESPIRATORY TRACT INFECTION
subjects affected / exposed	0 / 61 (0.00%)	1 / 60 (1.67%)	1 / 61 (1.64%)	17 / 89 (19.10%)	9 / 88 (10.23%)	1 / 61 (1.64%)
occurrences all number	0	1	1	27	13	1
URINARY TRACT INFECTION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	3 / 88 (3.41%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	3	0
VIRAL UPPER RESPIRATORY TRACT INFECTION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	3 / 89 (3.37%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	3	3	0
VULVOVAGINAL CANDIDIASIS
subjects affected / exposed	1 / 61 (1.64%)	0 / 60 (0.00%)	0 / 61 (0.00%)	4 / 89 (4.49%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	1	0	0	4	1	0
VULVOVAGINAL MYCOTIC INFECTION
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	3 / 89 (3.37%)	0 / 88 (0.00%)	0 / 61 (0.00%)
occurrences all number	0	0	0	4	0	0
Metabolism and nutrition disorders
GOUT
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	2	2	0
HYPERCHOLESTEROLAEMIA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	3 / 89 (3.37%)	1 / 88 (1.14%)	0 / 61 (0.00%)
occurrences all number	0	0	0	3	1	0
HYPERLIPIDAEMIA
subjects affected / exposed	1 / 61 (1.64%)	1 / 60 (1.67%)	0 / 61 (0.00%)	2 / 89 (2.25%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	1	1	0	2	2	0
HYPERTRIGLYCERIDAEMIA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	2 / 89 (2.25%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	3	2	0
HYPERURICAEMIA
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	0	2	0
VITAMIN B12 DEFICIENCY
subjects affected / exposed	0 / 61 (0.00%)	0 / 60 (0.00%)	0 / 61 (0.00%)	0 / 89 (0.00%)	2 / 88 (2.27%)	0 / 61 (0.00%)
occurrences all number	0	0	0	0	2	0

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Were there any global substantial amendments to the protocol? Yes

21 Aug 2013

Added an open-label Extension period with continued treatment for another 156 weeks or until the drug is available in the country of participation for eligible patients, who were on active therapy during the Maintenance period. Specified the rescreening procedures. Specified that at Week 52 the sites become aware which patients received placebo during the Maintenance period. After the Week 52 data base lock, the study will be open- label. Introduced home administration of study treatment for certain visits in the Extension period. Clarified concomitant medications and specified that topical corticosteroid use is allowed under certain restrictions, during the Extension period. Added instructions to report defects, malfunctions or product complaints for the AI and introduced Use of Device (AI) eCRF for the extension treatment period to record such information.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

Efficacy results after Wk 160 can't be interpreted meaningfully due to low # of evaluable patients. As per protocol, availability of AIN457 in participating countries led to discontinuation of most patients before they reached the later visits.

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Psoriasis Area and Severity Index (PASI) 75 response and Investigators’ Global Assessment (IGA) mod 2011 0 or 1 response.

Primary: Psoriasis Area and Severity Index (PASI) 75 response and Investigators’ Global Assessment (IGA) mod 2011 0 or 1 response.

Secondary: Percentages of subjects with successful self-administration of study drug at week 1

Secondary: Percentages of subjects with successful self-administration of study drug at week 1

Secondary: Percentage of subjects with possible use-related hazards

Secondary: Percentage of subjects with possible use-related hazards

Secondary: Absolute change from baseline in Self-Injection Assessment Questionnaire (SIAQ) domain scores at Week 12

Secondary: Absolute change from baseline in Self-Injection Assessment Questionnaire (SIAQ) domain scores at Week 12

Secondary: Absolute change from baseline in Self-Injection Assessment Questionnaire (SIAQ) domain scores at Week 48

Secondary: Absolute change from baseline in Self-Injection Assessment Questionnaire (SIAQ) domain scores at Week 48

Secondary: Percentages of participants with PASI 50, PASI 75, PASI 90, PASI 100 and IGA 0 or 1 response - induction period

Secondary: Percentages of participants with PASI 50, PASI 75, PASI 90, PASI 100 and IGA 0 or 1 response - induction period

Secondary: Percentages of participants with PASI 50, PASI 75, PASI 90, PASI 100 and IGA 0 or 1 response - maintenance period (observed data)

Secondary: Percentages of participants with PASI 50, PASI 75, PASI 90, PASI 100 and IGA 0 or 1 response - maintenance period (observed data)

Secondary: Absolute change from baseline for PASI score - induction period

Secondary: Absolute change from baseline for PASI score - induction period

Secondary: Absolute change from baseline for PASI score over time up to week 52 - Maintenance period (observed data)

Secondary: Absolute change from baseline for PASI score over time up to week 52 - Maintenance period (observed data)

Secondary: Percentage of participants in each IGA mod 2011 category - induction period

Secondary: Percentage of participants in each IGA mod 2011 category - induction period

Secondary: Percentages of participants in each IGA mod 2011 category over time up to week 52 - maintenance period (observed data)

Secondary: Percentages of participants in each IGA mod 2011 category over time up to week 52 - maintenance period (observed data)

Secondary: Change from baseline in EQ-5D up to week 12 - induction period

Secondary: Change from baseline in EQ-5D up to week 12 - induction period

Secondary: Change from baseline in EQ-5D over time up to week 52 - maintenance period

Secondary: Change from baseline in EQ-5D over time up to week 52 - maintenance period

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) score - induction period

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) score - induction period

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) score over time up to Week 52 - maintenance period

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) score over time up to Week 52 - maintenance period

Secondary: Percentage of participants achieving a DLQI score of 0 or 1 at week 12 - induction period

Secondary: Percentage of participants achieving a DLQI score of 0 or 1 at week 12 - induction period

Secondary: Percentages of participants achieving a DLQI score of 0 or 1 over time up to week 52 - (maintenance)

Secondary: Percentages of participants achieving a DLQI score of 0 or 1 over time up to week 52 - (maintenance)

Secondary: Percentages of participants with PASI 50, PASI 75, PASI 90, PASI 100 and IGA 0 or 1 response after week 52 (observed data)

Secondary: Percentages of participants with PASI 50, PASI 75, PASI 90, PASI 100 and IGA 0 or 1 response after week 52 (observed data)

Secondary: Absolute change from baseline for PASI score after week 52 (observed data)

Secondary: Absolute change from baseline for PASI score after week 52 (observed data)

Secondary: Percentages of participants in each IGA Mod 2011 category after Week 52 (observed data)

Secondary: Percentages of participants in each IGA Mod 2011 category after Week 52 (observed data)

Secondary: Number of participants developing treatment-emergent anti-secukinumab antibodies

Secondary: Number of participants developing treatment-emergent anti-secukinumab antibodies

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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