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Clinical Trial Results:
A Multicenter Study with a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Withdrawal Maintenance Dosing Period to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderate-to-Severe Plaque Psoriasis OASIS-1

Summary
EudraCT number	2017-003298-32
Trial protocol	DE PL
Global end of trial date	16 Jan 2020

Results information
Results version number	v1(current)
This version publication date	16 Sep 2020
First version publication date	16 Sep 2020
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

I6T-MC-AMAK

ISRCTN number

US NCT number

NCT03482011

WHO universal trial number (UTN)

Other trial identifiers

Trial Number: 16505

Sponsor organisation name

Eli Lilly and Company

Sponsor organisation address

Lilly Corporate Center, Indianapolis, IN, United States, 46285

Public contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,

Scientific contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,

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

16 Jan 2020

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

16 Jan 2020

Was the trial ended prematurely?

Main objective of the trial

The purpose of this study is to evaluate the efficacy and safety of mirikizumab in participants with moderate to severe plaque psoriasis.

Protection of trial subjects

This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.

Background therapy

Evidence for comparator

Actual start date of recruitment

24 Apr 2018

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

3 Months

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Korea, Republic of: 56

Country: Number of subjects enrolled

Puerto Rico: 20

Country: Number of subjects enrolled

United States: 85

Country: Number of subjects enrolled

Japan: 54

Country: Number of subjects enrolled

Taiwan: 61

Country: Number of subjects enrolled

Poland: 55

Country: Number of subjects enrolled

Mexico: 76

Country: Number of subjects enrolled

Germany: 74

Country: Number of subjects enrolled

Russian Federation: 49

Worldwide total number of subjects

530

EEA total number of subjects

129

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)

482

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

No Text Available

Screening details

No Text Available

Period 1 title

Induction Period (16 Weeks)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Placebo Q4W

Arm description

Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Administered SC.

250 mg Miri Q4W

Arm description

Induction Period: Participants received 250 milligrams (mg) mirikizumab (miri) administered SC Q4W.

Arm type

Experimental

Investigational medicinal product name

Mirikizumab

Investigational medicinal product code

Other name

LY3074828

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Administered SC.

Number of subjects in period 1	Placebo Q4W	250 mg Miri Q4W
Started	107	423
Received at least one dose of study drug	107	422
Completed	101	412
Not completed	6	11
Consent withdrawn by subject	2	5
Screen Failure	-	1
Adverse event, non-fatal	1	3
Lost to follow-up	-	1
Lack of efficacy	3	1

Period 2 title

Maintenance Period (36 Weeks)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Placebo Q4W to Placebo Q8W (Placebo Responder)

Arm description

Maintenance Period: Participants received placebo administered SC every 8 weeks (Q8W). Responders had ≥PASI 90. Participants had received placebo administered SC Q4W during induction period.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Administered SC.

Placebo Q4W to 250 mg Miri Q4W /Q8W (Placebo Non-Responders)

Arm description

Maintenance Period: Participants received 250 mg mirikizumab administered SC Q4W during week 16 to week 32 and Q8W during week 40 and 48. Non-responders had < PASI 90. Participants had received placebo administered SC Q4W during induction period.

Arm type

Experimental

Investigational medicinal product name

Mirikizumab

Investigational medicinal product code

Other name

LY3074828

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Administered SC.

250 mg Miri Q4W Responders to Placebo Q8W

Arm description

Maintenance Period: Participants received placebo administered SC Q8W. Responders had ≥PASI 90. Participants had received 250 mirikizumab administered SC Q4W during induction period.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Administered SC

250 mg Miri Q4W Responders to 125 mg Miri Q8W

Arm description

Maintenance Period: Participants received 125 mg mirikizumab administered SC Q8W. Responders had ≥PASI 90. Participants had received 250 mirikizumab administered SC Q4W during induction period.

Arm type

Experimental

Investigational medicinal product name

Mirikizumab

Investigational medicinal product code

Other name

LY3074828

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Administered SC.

250 mg Miri Q4W Responder to 250 mg Miri Q8W

Arm description

Maintenance Period: Participants received 250 mg mirikizumab administered SC Q8W. Responders had ≥PASI 90. Participants had received 250 mirikizumab administered SC Q4W during induction period.

Arm type

Experimental

Investigational medicinal product name

Mirikizumab

Investigational medicinal product code

Other name

LY3074828

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Administered SC.

250 mg Miri Q4W to 250 mg Miri Q8W (Miri Non-Responders)

Arm description

Maintenance Period: Participants received 250 mg mirikizumab administered SC Q8W. Non-responders had < PASI 90. Participants had received 250 mirikizumab administered SC Q4W during induction period.

Arm type

Experimental

Investigational medicinal product name

Mirikizumab

Investigational medicinal product code

Other name

LY3074828

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Administered SC.

Number of subjects in period 2	Placebo Q4W to Placebo Q8W (Placebo Responder)	Placebo Q4W to 250 mg Miri Q4W /Q8W (Placebo Non-Responders)	250 mg Miri Q4W Responders to Placebo Q8W	250 mg Miri Q4W Responders to 125 mg Miri Q8W	250 mg Miri Q4W Responder to 250 mg Miri Q8W	250 mg Miri Q4W to 250 mg Miri Q8W (Miri Non-Responders)
Started	7	94	91	90	91	140
Relapse	1 ^[1]	0 ^[2]	41 ^[3]	3 ^[4]	2 ^[5]	0 ^[6]
Roll Over to I6T-MC-AMAH(2017-003299-30)	6	88 ^[7]	86	85 ^[8]	87	121 ^[9]
Completed	6	90	86	86	87	123
Not completed	1	4	5	4	4	17
Physician decision	-	1	-	1	1	1
Consent withdrawn by subject	-	1	2	1	2	2
Adverse event, non-fatal	-	-	-	1	1	4
Lost to follow-up	-	-	2	-	-	1
Lack of efficacy	1	2	1	1	-	9

Notes
[1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: This represents the participants who relapsed.
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: This represents the participants who relapsed.
[3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: This represents the participants who relapsed.
[4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: This represents the participants who relapsed.
[5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: This represents the participants who relapsed.
[6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: This represents the participants who relapsed.
[7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: All participants that completed Week 52 had the opportunity to roll over into study I6T-MC-AMAH (2017-003299-30).
[8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: All participants that completed Week 52 had the opportunity to roll over into study I6T-MC-AMAH (2017-003299-30).
[9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: All participants that completed Week 52 had the opportunity to roll over into study I6T-MC-AMAH (2017-003299-30).

Period 3 title

Follow-up Period (12 Weeks)

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Placebo Q4W to Placebo Q8W (Placebo Responder) - Follow-up(FU)

Arm description

Follow-up Period: Participants did not receive drug during the follow-up period.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Placebo Q4W to 250mg Miri Q4W/Q8W (Placebo Non-Responder) - FU

Arm description

Follow-up Period: Participants did not receive drug during the follow-up period.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

250 mg Miri Q4W Responders to Placebo Q8W - Follow-up

Arm description

Follow-up Period: Participants did not receive drug during the follow-up period.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

250 mg Miri Q4W Responders to 125 mg Miri Q8W - Follow-up

Arm description

Follow-up Period: Participants did not receive drug during the follow-up period.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

250 mg Miri Q4W Responder to 250 mg Miri Q8W - Follow-up

Arm description

Follow-up Period: Participants did not receive drug during the follow-up period.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

250 mg Miri Q4W to 250 mg Miri Q8W (Miri Non-Responders) - FU

Arm description

Follow-up Period: Participants did not receive drug during the follow-up period.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Number of subjects in period 3 ^[10]	Placebo Q4W to Placebo Q8W (Placebo Responder) - Follow-up(FU)	Placebo Q4W to 250mg Miri Q4W/Q8W (Placebo Non-Responder) - FU	250 mg Miri Q4W Responders to Placebo Q8W - Follow-up	250 mg Miri Q4W Responders to 125 mg Miri Q8W - Follow-up	250 mg Miri Q4W Responder to 250 mg Miri Q8W - Follow-up	250 mg Miri Q4W to 250 mg Miri Q8W (Miri Non-Responders) - FU
Started	1	10	2	4	4	21
Completed	0	5	2	3	2	4
Not completed	1	5	0	1	2	17
Consent withdrawn by subject	-	2	-	1	1	5
Physician decision	-	-	-	-	-	1
Adverse event, non-fatal	-	-	-	-	1	4
Lost to follow-up	-	-	-	-	-	1
Lack of efficacy	1	3	-	-	-	6

Notes
[10] - 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 participants that completed maintenance period continued to follow-up period.

Baseline characteristics

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Reporting group title

Placebo Q4W

Reporting group description

Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).

Reporting group title

250 mg Miri Q4W

Reporting group description

Induction Period: Participants received 250 milligrams (mg) mirikizumab (miri) administered SC Q4W.

Reporting group values	Placebo Q4W	250 mg Miri Q4W	Total
Number of subjects	107	423	530
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	45.7 ± 13.70	46.4 ± 13.56	-
Gender categorical
Units: Subjects
Female	33	124	157
Male	74	299	373
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	4	13	17
Not Hispanic or Latino	11	53	64
Unknown or Not Reported	92	357	449
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	14	50	64
Asian	33	139	172
Native Hawaiian or Other Pacific Islander	0	1	1
Black or African American	4	2	6
White	56	231	287
More than one race	0	0	0
Unknown or Not Reported	0	0	0
Region of Enrollment
Units: Subjects
South Korea	11	45	56
Puerto Rico	5	15	20
United States	16	69	85
Japan	10	44	54
Taiwan	12	49	61
Poland	11	44	55
Mexico	15	61	76
Germany	16	58	74
Russia	11	38	49

End points

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Reporting group title

Placebo Q4W

Reporting group description

Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).

Reporting group title

250 mg Miri Q4W

Reporting group description

Induction Period: Participants received 250 milligrams (mg) mirikizumab (miri) administered SC Q4W.

Reporting group title

Placebo Q4W to Placebo Q8W (Placebo Responder)

Reporting group description

Maintenance Period: Participants received placebo administered SC every 8 weeks (Q8W). Responders had ≥PASI 90. Participants had received placebo administered SC Q4W during induction period.

Reporting group title

Placebo Q4W to 250 mg Miri Q4W /Q8W (Placebo Non-Responders)

Reporting group description

Reporting group title

250 mg Miri Q4W Responders to Placebo Q8W

Reporting group description

Maintenance Period: Participants received placebo administered SC Q8W. Responders had ≥PASI 90. Participants had received 250 mirikizumab administered SC Q4W during induction period.

Reporting group title

250 mg Miri Q4W Responders to 125 mg Miri Q8W

Reporting group description

Maintenance Period: Participants received 125 mg mirikizumab administered SC Q8W. Responders had ≥PASI 90. Participants had received 250 mirikizumab administered SC Q4W during induction period.

Reporting group title

250 mg Miri Q4W Responder to 250 mg Miri Q8W

Reporting group description

Maintenance Period: Participants received 250 mg mirikizumab administered SC Q8W. Responders had ≥PASI 90. Participants had received 250 mirikizumab administered SC Q4W during induction period.

Reporting group title

250 mg Miri Q4W to 250 mg Miri Q8W (Miri Non-Responders)

Reporting group description

Maintenance Period: Participants received 250 mg mirikizumab administered SC Q8W. Non-responders had < PASI 90. Participants had received 250 mirikizumab administered SC Q4W during induction period.

Reporting group title

Placebo Q4W to Placebo Q8W (Placebo Responder) - Follow-up(FU)

Reporting group description

Follow-up Period: Participants did not receive drug during the follow-up period.

Reporting group title

Placebo Q4W to 250mg Miri Q4W/Q8W (Placebo Non-Responder) - FU

Reporting group description

Follow-up Period: Participants did not receive drug during the follow-up period.

Reporting group title

250 mg Miri Q4W Responders to Placebo Q8W - Follow-up

Reporting group description

Follow-up Period: Participants did not receive drug during the follow-up period.

Reporting group title

250 mg Miri Q4W Responders to 125 mg Miri Q8W - Follow-up

Reporting group description

Follow-up Period: Participants did not receive drug during the follow-up period.

Reporting group title

250 mg Miri Q4W Responder to 250 mg Miri Q8W - Follow-up

Reporting group description

Follow-up Period: Participants did not receive drug during the follow-up period.

Reporting group title

250 mg Miri Q4W to 250 mg Miri Q8W (Miri Non-Responders) - FU

Reporting group description

Follow-up Period: Participants did not receive drug during the follow-up period.

Primary: Percentage of Participants with a Static Physician’s Global Assessment of (sPGA) (0,1) with at Least a 2-point Improvement from Baseline

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End point title

Percentage of Participants with a Static Physician’s Global Assessment of (sPGA) (0,1) with at Least a 2-point Improvement from Baseline

End point description

The sPGA is the physician's determination of the participant's psoriasis (PsO) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Analysis Population Description (APD): All randomized participants.

End point type

Primary

End point timeframe

Week 16

End point values	Placebo Q4W	250 mg Miri Q4W
Number of subjects analysed	107	423
Units: Percentage of participants
number (confidence interval 95%)	6.5 (1.9 to 11.2)	69.3 (64.9 to 73.7)

Statistical Analysis for sPGA (0,1)

Comparison groups

Placebo Q4W v 250 mg Miri Q4W

Number of subjects included in analysis

530

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

56.5

upper limit

69.4

Primary: Percentage of Participants Achieving a ≥90% Improvement from Baseline in Psoriasis Area and Severity Score (PASI 90)

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End point title

Percentage of Participants Achieving a ≥90% Improvement from Baseline in Psoriasis Area and Severity Score (PASI 90)

End point description

PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease). Analysis Population Description: All randomized participants.

End point type

Primary

End point timeframe

Week 16

End point values	Placebo Q4W	250 mg Miri Q4W
Number of subjects analysed	107	423
Units: Percentage of participants
number (confidence interval 95%)	6.5 (1.9 to 11.2)	64.3 (59.7 to 68.9)

Statistical Analysis for PASI 90

Comparison groups

Placebo Q4W v 250 mg Miri Q4W

Number of subjects included in analysis

530

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

57.8

Confidence interval

level

95%

sides

2-sided

lower limit

51.3

upper limit

64.4

Secondary: Percentage of Participants Achieving a ≥75% Improvement from Baseline in PASI (PASI 75)

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End point title

Percentage of Participants Achieving a ≥75% Improvement from Baseline in PASI (PASI 75)

End point description

End point type

Secondary

End point timeframe

Week 4

End point values	Placebo Q4W	250 mg Miri Q4W
Number of subjects analysed	107	423
Units: Percentage of participants
number (confidence interval 95%)	0.9 (0.0 to 2.8)	17.0 (13.4 to 20.6)

Statistical Analysis for PASI 75

Comparison groups

Placebo Q4W v 250 mg Miri Q4W

Number of subjects included in analysis

530

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

15.6

Confidence interval

level

95%

sides

2-sided

lower limit

11.6

upper limit

19.7

Secondary: Percentage of Participants Achieving a ≥75% Improvement from Baseline in PASI (PASI 75)

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End point title

Percentage of Participants Achieving a ≥75% Improvement from Baseline in PASI (PASI 75)

End point description

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo Q4W	250 mg Miri Q4W
Number of subjects analysed	107	423
Units: Percentage of participants
number (confidence interval 95%)	9.3 (3.8 to 14.9)	82.5 (78.9 to 86.1)

Statistical Analysis for PASI 75

Comparison groups

Placebo Q4W v 250 mg Miri Q4W

Number of subjects included in analysis

530

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

73.6

Confidence interval

level

95%

sides

2-sided

lower limit

67.1

upper limit

80.1

Secondary: Percentage of Participants Achieving a ≥100% Improvement from Baseline in Psoriasis Area and Severity Score (PASI 100)

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End point title

Percentage of Participants Achieving a ≥100% Improvement from Baseline in Psoriasis Area and Severity Score (PASI 100)

End point description

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo Q4W	250 mg Miri Q4W
Number of subjects analysed	107	423
Units: Percentage of participants
number (confidence interval 95%)	0.9 (0.0 to 2.8)	32.4 (27.9 to 36.8)

Statistical Analysis for PASI 100

Comparison groups

Placebo Q4W v 250 mg Miri Q4W

Number of subjects included in analysis

530

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

30.8

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

35.7

Secondary: Percentage of Participants with ≤1% of Body Surface Area (BSA) with Psoriasis Involvement

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End point title

Percentage of Participants with ≤1% of Body Surface Area (BSA) with Psoriasis Involvement

End point description

The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100. Analysis Population Description: All randomized participants.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo Q4W	250 mg Miri Q4W
Number of subjects analysed	107	423
Units: Percentage of participants
number (confidence interval 95%)	0.9 (0.0 to 2.8)	49.2 (44.4 to 53.9)

Statistical Analysis for BSA

Comparison groups

Placebo Q4W v 250 mg Miri Q4W

Number of subjects included in analysis

530

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

48.1

Confidence interval

level

95%

sides

2-sided

lower limit

42.9

upper limit

53.2

Secondary: Percentage of Participants with a Psoriasis Symptoms Scale (PSS) Symptoms Score of 0 in those with a PSS Symptoms Score ≥1 at Baseline

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End point title

Percentage of Participants with a Psoriasis Symptoms Scale (PSS) Symptoms Score of 0 in those with a PSS Symptoms Score ≥1 at Baseline

End point description

PSS is a patient-administered assessment of 4 symptoms (itch, pain, stinging, and burning); 3 signs (redness, scaling, and cracking); and 1 item on the discomfort related to symptoms/signs. The overall severity for each individual symptom/sign from the patient's psoriasis is indicated by selecting the number from a numeric rating scale (NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign. In addition, a symptoms score ranging from 0 (no symptoms) to 40 (worst imaginable symptoms), and a signs score of 0 (no signs) to 30 (worst imaginable signs) will be reported. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100. Analysis Population Description: All randomized participants who had PSS symptoms score ≥1 at baseline.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo Q4W	250 mg Miri Q4W
Number of subjects analysed	105	410
Units: Percentage of participants
number (confidence interval 95%)	0 (0.0 to 0.0)	19.0 (15.2 to 22.8)

Statistical Analysis for PSS

Comparison groups

Placebo Q4W v 250 mg Miri Q4W

Number of subjects included in analysis

515

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

18.3

Confidence interval

level

95%

sides

2-sided

lower limit

14.5

upper limit

22.1

Secondary: Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) with at Least a 5-Point Improvement (Reduction) from Baseline in Participants with a Baseline DLQI Total Score ≥5

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End point title

Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) with at Least a 5-Point Improvement (Reduction) from Baseline in Participants with a Baseline DLQI Total Score ≥5

End point description

The DLQI is a patient-reported, 10-question, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100. Analysis Population Description: All randomized participants who had a baseline DLQI Total Score ≥5.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo Q4W	250 mg Miri Q4W
Number of subjects analysed	92	384
Units: Percentage of participants
number (confidence interval 95%)	5.4 (0.8 to 10.1)	54.7 (49.7 to 59.7)

Statistical Analysis for DLQI

Comparison groups

Placebo Q4W v 250 mg Miri Q4W

Number of subjects included in analysis

476

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

49.6

Confidence interval

level

95%

sides

2-sided

lower limit

42.8

upper limit

56.4

Secondary: Percentage of Participants Maintaining Clinical Response (PASI 90) after Re-randomization at the Start of the Randomized Withdrawal Period

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End point title

Percentage of Participants Maintaining Clinical Response (PASI 90) after Re-randomization at the Start of the Randomized Withdrawal Period

End point description

End point type

Secondary

End point timeframe

Week 52

End point values	250 mg Miri Q4W Responders to Placebo Q8W	250 mg Miri Q4W Responders to 125 mg Miri Q8W	250 mg Miri Q4W Responder to 250 mg Miri Q8W
Number of subjects analysed	91	90	91
Units: Percentage of participants
number (confidence interval 95%)	18.7 (10.7 to 26.7)	85.6 (78.3 to 92.8)	84.6 (77.2 to 92.0)

Statistical Analysis for PASI 90

Comparison groups

250 mg Miri Q4W Responders to Placebo Q8W v 250 mg Miri Q4W Responders to 125 mg Miri Q8W

Number of subjects included in analysis

181

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

66.7

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

77.5

Statistical Analysis for PASI 90

Comparison groups

250 mg Miri Q4W Responders to Placebo Q8W v 250 mg Miri Q4W Responder to 250 mg Miri Q8W

Number of subjects included in analysis

182

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

65.9

Confidence interval

level

95%

sides

2-sided

lower limit

54.9

upper limit

Secondary: Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants with Palmoplantar Involvement at Baseline

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End point title

Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants with Palmoplantar Involvement at Baseline

End point description

The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. Least Squares Mean (LS Mean) was calculated using mixed model repeated measures (MMRM) model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as covariates. Analysis population Description: All randomized participants who had palmoplantar involvement at baseline.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo Q4W	250 mg Miri Q4W
Number of subjects analysed	24	111
Units: score on a scale
least squares mean (standard error)	-1.13 ± 1.29	-5.83 ± 0.72

Statistical Analysis for PPASI Total Score

Comparison groups

Placebo Q4W v 250 mg Miri Q4W

Number of subjects included in analysis

135

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Mean difference (net)

Point estimate

-4.7

Confidence interval

level

95%

sides

2-sided

lower limit

-7.31

upper limit

-2.1

Variability estimate

Standard error of the mean

Dispersion value

1.32

Secondary: Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants with Scalp Involvement at Baseline

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End point title

Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants with Scalp Involvement at Baseline

End point description

The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity). LS Mean was calculated using MMRM model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as covariates. Analysis Population Description: All randomized participants who had scalp involvement at baseline.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo Q4W	250 mg Miri Q4W
Number of subjects analysed	94	381
Units: score on a scale
least squares mean (standard error)	-2.70 ± 0.95	-20.03 ± 0.55

Statistical Analysis for PSSI Total Score

Comparison groups

Placebo Q4W v 250 mg Miri Q4W

Number of subjects included in analysis

475

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Mean difference (net)

Point estimate

-17.33

Confidence interval

level

95%

sides

2-sided

lower limit

-19.28

upper limit

-15.39

Variability estimate

Standard error of the mean

Dispersion value

0.99

Secondary: Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants with Fingernail Involvement at Baseline

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End point title

Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants with Fingernail Involvement at Baseline

End point description

The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix PsO by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed PsO 0 (none) to 4 (PsO in 4 quadrants of the fingernail) and fingernail matrix PsO 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix PsO in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis). LS Mean was calculated using MMRM model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as covariates. APD: All randomized participants who had Nail Psoriasis involvement at baseline.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo Q4W	250 mg Miri Q4W
Number of subjects analysed	64	248
Units: score on a scale
least squares mean (standard error)	-2.04 ± 1.60	-9.01 ± 0.89

Statistical Analysis for NAPSI Total Score

Comparison groups

Placebo Q4W v 250 mg Miri Q4W

Number of subjects included in analysis

312

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

Mean difference (net)

Point estimate

-6.98

Confidence interval

level

95%

sides

2-sided

lower limit

-10.37

upper limit

-3.58

Variability estimate

Standard error of the mean

Dispersion value

1.73

Secondary: Change from Baseline on the Short Form (SF)-36 Physical Component Summary (PCS)

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End point title

Change from Baseline on the Short Form (SF)-36 Physical Component Summary (PCS)

End point description

SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health. LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.

End point type

Secondary

End point timeframe

Baseline, Week 16 APD: All randomized participants who had a baseline and at least one post-baseline PCS value.

End point values	Placebo Q4W	250 mg Miri Q4W
Number of subjects analysed	106	418
Units: score on a scale
least squares mean (standard error)	0.35 ± 0.69	5.21 ± 0.43

Statistical Analysis for SF-36: PCS

Comparison groups

Placebo Q4W v 250 mg Miri Q4W

Number of subjects included in analysis

524

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Parameter type

Mean difference (net)

Point estimate

4.86

Confidence interval

level

95%

sides

2-sided

lower limit

3.5

upper limit

6.22

Variability estimate

Standard error of the mean

Dispersion value

0.69

Secondary: Change from Baseline on the SF-36 Mental Component Summary (MCS)

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End point title

Change from Baseline on the SF-36 Mental Component Summary (MCS)

End point description

End point type

Secondary

End point timeframe

Baseline, Week 16 APD: All randomized participants who had a baseline and at least one post-baseline MCS value.

End point values	Placebo Q4W	250 mg Miri Q4W
Number of subjects analysed	106	418
Units: score on a scale
least squares mean (standard error)	0.32 ± 0.73	5.10 ± 0.46

Statistical Analysis for SF-36: MCS

Comparison groups

Placebo Q4W v 250 mg Miri Q4W

Number of subjects included in analysis

524

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Parameter type

Mean difference (net)

Point estimate

4.78

Confidence interval

level

95%

sides

2-sided

lower limit

3.33

upper limit

6.23

Variability estimate

Standard error of the mean

Dispersion value

0.74

Secondary: Percentage of Participants with Patient’s Global Assessment of Psoriasis (PatGA (0,1)) and >=2 Improvement From Baseline

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End point title

Percentage of Participants with Patient’s Global Assessment of Psoriasis (PatGA (0,1)) and >=2 Improvement From Baseline

End point description

The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100. Analysis Population Description: All randomized participants who had a baseline >= 2.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo Q4W	250 mg Miri Q4W
Number of subjects analysed	104	419
Units: Percentage of participants
number (confidence interval 95%)	1.0 (0.0 to 2.8)	69.5 (65.0 to 73.9)

Statistical Analysis for PatGA(0,1)

Comparison groups

Placebo Q4W v 250 mg Miri Q4W

Number of subjects included in analysis

523

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

68.1

Confidence interval

level

95%

sides

2-sided

lower limit

63.2

upper limit

72.9

Secondary: Change from Baseline on the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO)

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End point title

Change from Baseline on the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO)

End point description

The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100) with higher numbers indicating greater impairment and less productivity, that is, worse outcomes. LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.

End point type

Secondary

End point timeframe

Baseline, Week 16 Analysis Population Description: All randomized participants who had a baseline and at least one post-baseline WPAI-PSO value.

End point values	Placebo Q4W	250 mg Miri Q4W
Number of subjects analysed	106	418
Units: score on a scale
least squares mean (standard error)
Absenteeism	0.10 ± 1.87	-3.57 ± 1.12
Presenteeism	-4.54 ± 2.39	-24.79 ± 1.42
Overall Absenteeism and Presenteeism	-3.45 ± 2.82	-24.54 ± 1.68
Impairment in Activities Performed Outside of Work	-6.83 ± 2.27	-29.73 ± 1.41

Statistical Analysis for WPAI-PSO: Absenteeism

Comparison groups

Placebo Q4W v 250 mg Miri Q4W

Number of subjects included in analysis

524

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002

Method

ANOVA

Parameter type

Mean difference (net)

Point estimate

-3.68

Confidence interval

level

95%

sides

2-sided

lower limit

-7.3

upper limit

-0.06

Variability estimate

Standard error of the mean

Dispersion value

1.84

Statistical Analysis for WPAI-PSO: Presenteeism

Comparison groups

Placebo Q4W v 250 mg Miri Q4W

Number of subjects included in analysis

524

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Parameter type

Mean difference (net)

Point estimate

-20.24

Confidence interval

level

95%

sides

2-sided

lower limit

-24.89

upper limit

-15.6

Variability estimate

Standard error of the mean

Dispersion value

2.37

Overall Absenteeism and Presenteeism

Comparison groups

Placebo Q4W v 250 mg Miri Q4W

Number of subjects included in analysis

524

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Parameter type

Mean difference (net)

Point estimate

-21.09

Confidence interval

level

95%

sides

2-sided

lower limit

-26.56

upper limit

-15.62

Variability estimate

Standard error of the mean

Dispersion value

2.78

Impairment in Activities Performed Outside of Work

Comparison groups

Placebo Q4W v 250 mg Miri Q4W

Number of subjects included in analysis

524

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Parameter type

Mean difference (net)

Point estimate

-22.91

Confidence interval

level

95%

sides

2-sided

lower limit

-27.39

upper limit

-18.43

Variability estimate

Standard error of the mean

Dispersion value

2.28

Secondary: Change from Baseline in Quick Inventory of Depressive Symptomology (QIDS-SR16) Total Score in those with a Baseline QIDS-SR16 Total Score ≥11

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End point title

Change from Baseline in Quick Inventory of Depressive Symptomology (QIDS-SR16) Total Score in those with a Baseline QIDS-SR16 Total Score ≥11

End point description

QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. Whereas 0-5 indicates no symptoms. LS Mean was calculated using ANCOVA model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.

End point type

Secondary

End point timeframe

Baseline, Week 16 Analysis Population Description: All participants who received at least one dose of study drug who had a baseline QIDS-SR16 total score >=11.

End point values	Placebo Q4W	250 mg Miri Q4W
Number of subjects analysed	10	35
Units: score on a scale
least squares mean (standard error)	-4.95 ± 1.94	-4.42 ± 1.43

Statistical Analysis for QIDS-SR16 Total Score

Comparison groups

Placebo Q4W v 250 mg Miri Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004

Method

ANCOVA

Parameter type

Mean difference (net)

Point estimate

0.53

Confidence interval

level

95%

sides

2-sided

lower limit

-3.08

upper limit

4.14

Variability estimate

Standard error of the mean

Dispersion value

1.79

Secondary: Induction Period: Pharmacokinetics (PK): Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab

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End point title

Induction Period: Pharmacokinetics (PK): Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab ^[1]

End point description

Minimum observed serum concentration at steady state (Ctrough,ss) of mirikizumab. Analysis Population Description: All participants who received at least one dose of study drug who had evaluable PK data.

End point type

Secondary

End point timeframe

Week 16 Day 113

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: Only induction data were planned to be reported due to nature of the design of randomized withdrawal in the maintenance period.

End point values	250 mg Miri Q4W
Number of subjects analysed	387
Units: micrograms per milliliter(micrograms/mL)
geometric mean (geometric coefficient of variation)	2.00 ± 139

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) (0,1)

Top of page

End point title

Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) (0,1)

End point description

The DLQI is a patient-reported, 10-question, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). A DLQI total score of 0 to 1 is considered as having no effect on a patient's health-related quality of life (HRQoL), and a 5-point change from baseline is considered as the minimal clinically important difference (MCID) threshold. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.

End point type

Secondary

End point timeframe

Week 16 Induction Period: All randomized participants who had a baseline and at least one post-baseline DLQI value.

End point values	Placebo Q4W	250 mg Miri Q4W
Number of subjects analysed	104	413
Units: Percentage of participants
number (confidence interval 95%)	8.7 (3.3 to 14.1)	57.1 (52.4 to 61.9)

Statistical Analysis For DLQI (0,1)

Comparison groups

Placebo Q4W v 250 mg Miri Q4W

Number of subjects included in analysis

517

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Risk difference (RD)

Point estimate

48.8

Confidence interval

level

95%

sides

2-sided

lower limit

41.6

upper limit

55.9

Adverse events

Top of page

Timeframe for reporting adverse events

Baseline Up To 64 Weeks

Adverse event reporting additional description

All participants who received at least one dose of study drug.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

22.1

Reporting group title

Placebo Q4W

Reporting group description

Induction Period: Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).

Reporting group title

250 mg Miri Q4W

Reporting group description

Induction Period: Participants received 250 mg mirikizumab (miri) administered SC Q4W.

Reporting group title

250 mg Miri Q4W Responders to Placebo Q8W

Reporting group description

Maintenance Period: Participants received placebo administered SC Q8W. Responders had ≥PASI 90. Participants had received 250 mirikizumab administered SC Q4W during induction period.

Reporting group title

250 mg Miri Q4W Responders to 125 mg Miri Q8W

Reporting group description

Maintenance Period: Participants received 125 mg mirikizumab administered SC Q8W. Responders had ≥PASI 90. Participants had received 250 mirikizumab administered SC Q4W during induction period.

Reporting group title

250 mg Miri Q4W Responder to 250 mg Miri Q8W

Reporting group description

Maintenance Period: Participants received 250 mg mirikizumab administered SC Q8W. Responders had ≥PASI 90. Participants had received 250 mirikizumab administered SC Q4W during induction period.

Reporting group title

250mg Miri Q4W to 250mg Miri Q8W(Miri Non-Responders)

Reporting group description

Maintenance Period: Participants received 250 mg mirikizumab administered SC Q8W. Non-responders had < PASI 90. Participants had received 250 mirikizumab administered SC Q4W during induction period.

Reporting group title

Placebo Q4W to Placebo Q8W (Placebo Responder)

Reporting group description

Maintenance Period: Participants received placebo administered SC Q8W. Responders had ≥PASI 90. Participants had received placebo administered SC Q4W during induction period.

Reporting group title

Placebo Q4W to 250 mg Miri Q4W /Q8W (Placebo Non-Responders)

Reporting group description

Maintenance Period: Participants received 250 mg mirikizumab administered SC Q4W during week 16 to week to week 32 and Q8W during week 40 and 48. Non-responders had < PASI 90. Participants had received placebo administered SC Q4W during induction period.

Reporting group title

Relapse

Reporting group description

Participants that relapsed were in the following arms: Placebo Q4W to Placebo Q8W (Placebo Responder). 250 mg Miri Q4W Responders to Placebo Q8W. 250 mg Miri Q4W Responders to 125 mg Miri Q8W. 250 mg Miri Q4W Responder to 250 mg Miri Q8W.

Reporting group title

Placebo Q4W Discontinued During Induction-Follow-up Period

Reporting group description

Follow-up Period: Participants did not receive drug during the follow-up period. Participants discontinued (DC) before induction week 16 and counted as placebo non-responders.

Reporting group title

250 Miri Q4W Discontinued During Induction-Follow-up

Reporting group description

Follow-up Period: Participants did not receive drug during the follow-up period. Participants discontinued (DC) before induction week 16 and counted as miri non-responders

Reporting group title

250 mg Miri Q4W to Placebo Q8W (Responders) Follow-up Period

Reporting group description

Follow-up Period: Participants did not receive drug during the follow-up period.

Reporting group title

250mg Miri Q4W to 125 mg Miri Q8W(Responders) Follow-up Period

Reporting group description

Follow-up Period: Participants did not receive drug during the follow-up period.

Reporting group title

250mg Miri Q4W to 250mg Miri Q8W(Responders) Follow-up Period

Reporting group description

Follow-up Period: Participants did not receive drug during the follow-up period.

Reporting group title

250 miri Q4W to Miri nonresponder-Follow-up Period

Reporting group description

Follow-up Period: Participants did not receive drug during the follow-up period.

Reporting group title

Placebo Q4W to Placebo Q8W (Placebo Responder) - Follow-up

Reporting group description

Follow-up Period: Participants did not receive drug during the follow-up period.

Reporting group title

Placebo Q4W to Placebo Non-Responder-Follow-up Period

Reporting group description

Follow-up Period: Participants did not receive drug during the follow-up period.

Placebo Q4W

250 mg Miri Q4W

250 mg Miri Q4W Responders to Placebo Q8W

250 mg Miri Q4W Responders to 125 mg Miri Q8W

250 mg Miri Q4W Responder to 250 mg Miri Q8W

250mg Miri Q4W to 250mg Miri Q8W(Miri Non-Responders)

Placebo Q4W to Placebo Q8W (Placebo Responder)

Placebo Q4W to 250 mg Miri Q4W /Q8W (Placebo Non-Responders)

Relapse

Placebo Q4W Discontinued During Induction-Follow-up Period

250 Miri Q4W Discontinued During Induction-Follow-up

250 mg Miri Q4W to Placebo Q8W (Responders) Follow-up Period

250mg Miri Q4W to 125 mg Miri Q8W(Responders) Follow-up Period

250mg Miri Q4W to 250mg Miri Q8W(Responders) Follow-up Period

250 miri Q4W to Miri nonresponder-Follow-up Period

Placebo Q4W to Placebo Q8W (Placebo Responder) - Follow-up

Placebo Q4W to Placebo Non-Responder-Follow-up Period

Total subjects affected by serious adverse events

subjects affected / exposed

2 / 107 (1.87%)

5 / 422 (1.18%)

3 / 91 (3.30%)

1 / 90 (1.11%)

3 / 91 (3.30%)

0 / 140 (0.00%)

0 / 7 (0.00%)

0 / 94 (0.00%)

0 / 47 (0.00%)

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

number of deaths (all causes)

number of deaths resulting from adverse events

Injury, poisoning and procedural complications

fall

alternative dictionary used: MedDRA 22.1

subjects affected / exposed

0 / 107 (0.00%)

1 / 422 (0.24%)

0 / 91 (0.00%)

0 / 90 (0.00%)

0 / 91 (0.00%)

0 / 140 (0.00%)

0 / 7 (0.00%)

0 / 94 (0.00%)

0 / 47 (0.00%)

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ligament rupture

alternative dictionary used: MedDRA 22.1

subjects affected / exposed

1 / 107 (0.93%)

0 / 422 (0.00%)

0 / 91 (0.00%)

0 / 90 (0.00%)

0 / 91 (0.00%)

0 / 140 (0.00%)

0 / 7 (0.00%)

0 / 94 (0.00%)

0 / 47 (0.00%)

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

skull fracture

alternative dictionary used: MedDRA 22.1

subjects affected / exposed

0 / 107 (0.00%)

1 / 422 (0.24%)

0 / 91 (0.00%)

0 / 90 (0.00%)

0 / 91 (0.00%)

0 / 140 (0.00%)

0 / 7 (0.00%)

0 / 94 (0.00%)

0 / 47 (0.00%)

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

acute myocardial infarction

alternative dictionary used: MedDRA 22.1

subjects affected / exposed

0 / 107 (0.00%)

0 / 422 (0.00%)

1 / 91 (1.10%)

0 / 90 (0.00%)

0 / 91 (0.00%)

0 / 140 (0.00%)

0 / 7 (0.00%)

0 / 94 (0.00%)

0 / 47 (0.00%)

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

atrial fibrillation

alternative dictionary used: MedDRA 22.1

subjects affected / exposed

0 / 107 (0.00%)

0 / 422 (0.00%)

0 / 91 (0.00%)

1 / 90 (1.11%)

0 / 91 (0.00%)

0 / 140 (0.00%)

0 / 7 (0.00%)

0 / 94 (0.00%)

0 / 47 (0.00%)

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Surgical and medical procedures

tonsillectomy

alternative dictionary used: MedDRA 22.1

subjects affected / exposed

0 / 107 (0.00%)

0 / 422 (0.00%)

1 / 91 (1.10%)

0 / 90 (0.00%)

0 / 91 (0.00%)

0 / 140 (0.00%)

0 / 7 (0.00%)

0 / 94 (0.00%)

0 / 47 (0.00%)

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Nervous system disorders

cerebral infarction

alternative dictionary used: MedDRA 22.1

subjects affected / exposed

0 / 107 (0.00%)

1 / 422 (0.24%)

0 / 91 (0.00%)

0 / 90 (0.00%)

0 / 91 (0.00%)

0 / 140 (0.00%)

0 / 7 (0.00%)

0 / 94 (0.00%)

0 / 47 (0.00%)

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

epilepsy

alternative dictionary used: MedDRA 22.1

subjects affected / exposed

0 / 107 (0.00%)

0 / 422 (0.00%)

0 / 91 (0.00%)

0 / 90 (0.00%)

1 / 91 (1.10%)

0 / 140 (0.00%)

0 / 7 (0.00%)

0 / 94 (0.00%)

0 / 47 (0.00%)

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

subarachnoid haemorrhage

alternative dictionary used: MedDRA 22.1

subjects affected / exposed

0 / 107 (0.00%)

1 / 422 (0.24%)

0 / 91 (0.00%)

0 / 90 (0.00%)

0 / 91 (0.00%)

0 / 140 (0.00%)

0 / 7 (0.00%)

0 / 94 (0.00%)

0 / 47 (0.00%)

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

syncope

alternative dictionary used: MedDRA 22.1

subjects affected / exposed

0 / 107 (0.00%)

1 / 422 (0.24%)

0 / 91 (0.00%)

0 / 90 (0.00%)

0 / 91 (0.00%)

0 / 140 (0.00%)

0 / 7 (0.00%)

0 / 94 (0.00%)

0 / 47 (0.00%)

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

bile duct stone

alternative dictionary used: MedDRA 22.1

subjects affected / exposed

1 / 107 (0.93%)

0 / 422 (0.00%)

0 / 91 (0.00%)

0 / 90 (0.00%)

0 / 91 (0.00%)

0 / 140 (0.00%)

0 / 7 (0.00%)

0 / 94 (0.00%)

0 / 47 (0.00%)

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

cholecystitis

alternative dictionary used: MedDRA 22.1

subjects affected / exposed

0 / 107 (0.00%)

0 / 422 (0.00%)

1 / 91 (1.10%)

0 / 90 (0.00%)

0 / 91 (0.00%)

0 / 140 (0.00%)

0 / 7 (0.00%)

0 / 94 (0.00%)

0 / 47 (0.00%)

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

glomerulonephritis membranous

alternative dictionary used: MedDRA 22.1

subjects affected / exposed

0 / 107 (0.00%)

0 / 422 (0.00%)

0 / 91 (0.00%)

0 / 90 (0.00%)

1 / 91 (1.10%)

0 / 140 (0.00%)

0 / 7 (0.00%)

0 / 94 (0.00%)

0 / 47 (0.00%)

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

appendicitis

alternative dictionary used: MedDRA 22.1

subjects affected / exposed

0 / 107 (0.00%)

0 / 422 (0.00%)

0 / 91 (0.00%)

0 / 90 (0.00%)

1 / 91 (1.10%)

0 / 140 (0.00%)

0 / 7 (0.00%)

0 / 94 (0.00%)

0 / 47 (0.00%)

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

arthritis bacterial

alternative dictionary used: MedDRA 22.1

subjects affected / exposed

0 / 107 (0.00%)

1 / 422 (0.24%)

0 / 91 (0.00%)

0 / 90 (0.00%)

0 / 91 (0.00%)

0 / 140 (0.00%)

0 / 7 (0.00%)

0 / 94 (0.00%)

0 / 47 (0.00%)

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

gastroenteritis

alternative dictionary used: MedDRA 22.1

subjects affected / exposed

0 / 107 (0.00%)

1 / 422 (0.24%)

0 / 91 (0.00%)

0 / 90 (0.00%)

0 / 91 (0.00%)

0 / 140 (0.00%)

0 / 7 (0.00%)

0 / 94 (0.00%)

0 / 47 (0.00%)

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

pharyngitis

alternative dictionary used: MedDRA 22.1

subjects affected / exposed

0 / 107 (0.00%)

1 / 422 (0.24%)

0 / 91 (0.00%)

0 / 90 (0.00%)

0 / 91 (0.00%)

0 / 140 (0.00%)

0 / 7 (0.00%)

0 / 94 (0.00%)

0 / 47 (0.00%)

0 / 4 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

0 / 4 (0.00%)

0 / 16 (0.00%)

0 / 1 (0.00%)

0 / 6 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Placebo Q4W	250 mg Miri Q4W	250 mg Miri Q4W Responders to Placebo Q8W	250 mg Miri Q4W Responders to 125 mg Miri Q8W	250 mg Miri Q4W Responder to 250 mg Miri Q8W	250mg Miri Q4W to 250mg Miri Q8W(Miri Non-Responders)	Placebo Q4W to Placebo Q8W (Placebo Responder)	Placebo Q4W to 250 mg Miri Q4W /Q8W (Placebo Non-Responders)	Relapse	Placebo Q4W Discontinued During Induction-Follow-up Period	250 Miri Q4W Discontinued During Induction-Follow-up	250 mg Miri Q4W to Placebo Q8W (Responders) Follow-up Period	250mg Miri Q4W to 125 mg Miri Q8W(Responders) Follow-up Period	250mg Miri Q4W to 250mg Miri Q8W(Responders) Follow-up Period	250 miri Q4W to Miri nonresponder-Follow-up Period	Placebo Q4W to Placebo Q8W (Placebo Responder) - Follow-up	Placebo Q4W to Placebo Non-Responder-Follow-up Period
Total subjects affected by non serious adverse events
subjects affected / exposed	51 / 107 (47.66%)	199 / 422 (47.16%)	49 / 91 (53.85%)	61 / 90 (67.78%)	55 / 91 (60.44%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	17 / 47 (36.17%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
anogenital warts
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
basal cell carcinoma
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
dysplastic naevus
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
fibroma
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
lipoma
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	1 / 47 (2.13%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
skin papilloma
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	1 / 91 (1.10%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	4	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Vascular disorders
blood pressure fluctuation
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
essential hypertension
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
haematoma
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
hypertension
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	9 / 422 (2.13%)	3 / 91 (3.30%)	3 / 90 (3.33%)	2 / 91 (2.20%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	10	6	4	2	0	0	0	0	0	0	0	0	0	0	0	0
varicose vein
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Surgical and medical procedures
cataract operation
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
duodenal sphincterotomy
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
tooth extraction
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
wisdom teeth removal
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
General disorders and administration site conditions
chest pain
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
fat necrosis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
fatigue
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	2 / 422 (0.47%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
hyperthermia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
influenza like illness
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
injection site erythema
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
injection site induration
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0
injection site pain
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	5 / 107 (4.67%)	22 / 422 (5.21%)	2 / 91 (2.20%)	5 / 90 (5.56%)	6 / 91 (6.59%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	20	109	48	49	65	0	0	0	0	0	0	0	0	0	0	0	0
injection site pruritus
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	2 / 422 (0.47%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	3	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
injection site reaction
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	5 / 422 (1.18%)	0 / 91 (0.00%)	2 / 90 (2.22%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	11	0	3	1	0	0	0	0	0	0	0	0	0	0	0	0
injection site swelling
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
malaise
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	2 / 91 (2.20%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	2	0	0	0	0	0	0	0	0	0	0	0	0
oedema peripheral
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	1 / 91 (1.10%)	2 / 90 (2.22%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	2	2	0	0	0	0	0	0	0	0	0	0	0	0	0
pain
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
pyrexia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
xerosis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	2 / 422 (0.47%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Immune system disorders
allergy to arthropod bite
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
drug hypersensitivity
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
hypersensitivity
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Reproductive system and breast disorders
amenorrhoea
alternative dictionary used: MedDRA 22.1
subjects affected / exposed ^[1]	0 / 33 (0.00%)	0 / 124 (0.00%)	1 / 30 (3.33%)	0 / 26 (0.00%)	0 / 32 (0.00%)	0 / 34 (0.00%)	0 / 4 (0.00%)	0 / 27 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 2 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
breast pain
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
dysmenorrhoea
alternative dictionary used: MedDRA 22.1
subjects affected / exposed ^[2]	0 / 33 (0.00%)	0 / 124 (0.00%)	0 / 30 (0.00%)	1 / 26 (3.85%)	1 / 32 (3.13%)	0 / 34 (0.00%)	0 / 4 (0.00%)	0 / 27 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 2 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	2	0	0	0	0	0	0	0	0	0	0	0	0
erectile dysfunction
alternative dictionary used: MedDRA 22.1
subjects affected / exposed ^[3]	0 / 74 (0.00%)	0 / 298 (0.00%)	0 / 61 (0.00%)	0 / 64 (0.00%)	1 / 59 (1.69%)	0 / 106 (0.00%)	0 / 3 (0.00%)	0 / 67 (0.00%)	0 / 31 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
menstruation irregular
alternative dictionary used: MedDRA 22.1
subjects affected / exposed ^[4]	0 / 33 (0.00%)	0 / 124 (0.00%)	1 / 30 (3.33%)	0 / 26 (0.00%)	0 / 32 (0.00%)	0 / 34 (0.00%)	0 / 4 (0.00%)	0 / 27 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 2 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
prostatitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed ^[5]	0 / 74 (0.00%)	1 / 298 (0.34%)	0 / 61 (0.00%)	0 / 64 (0.00%)	0 / 59 (0.00%)	0 / 106 (0.00%)	0 / 3 (0.00%)	0 / 67 (0.00%)	0 / 31 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
vaginal discharge
alternative dictionary used: MedDRA 22.1
subjects affected / exposed ^[6]	0 / 33 (0.00%)	1 / 124 (0.81%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 32 (0.00%)	0 / 34 (0.00%)	0 / 4 (0.00%)	0 / 27 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 2 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
asthma
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	4 / 422 (0.95%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	4	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
cough
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	9 / 422 (2.13%)	2 / 91 (2.20%)	2 / 90 (2.22%)	4 / 91 (4.40%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	10	4	2	4	0	0	0	0	0	0	0	0	0	0	0	0
dyspnoea
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
emphysema
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
nasal congestion
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	2 / 422 (0.47%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
oropharyngeal pain
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	3 / 422 (0.71%)	1 / 91 (1.10%)	1 / 90 (1.11%)	2 / 91 (2.20%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	4	2	1	2	0	0	0	0	0	0	0	0	0	0	0	0
pulmonary mass
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
rhinitis allergic
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	4 / 422 (0.95%)	1 / 91 (1.10%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	4	2	1	0	0	0	0	0	0	0	0	0	0	0	0	0
rhinorrhoea
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	1 / 422 (0.24%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
tonsillar hypertrophy
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
upper respiratory tract inflammation
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
upper-airway cough syndrome
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
vocal cord polyp
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Psychiatric disorders
anxiety
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	4 / 91 (4.40%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	8	0	0	0	0	0	0	0	0	0	0	0	0	0	0
depressed mood
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	1 / 47 (2.13%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
depression
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
insomnia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
irritability
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	2 / 422 (0.47%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
libido decreased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
sleep disorder
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
tobacco abuse
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Investigations
alanine aminotransferase increased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	2 / 107 (1.87%)	2 / 422 (0.47%)	1 / 91 (1.10%)	1 / 90 (1.11%)	2 / 91 (2.20%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	2	2	1	2	0	0	0	0	0	0	0	0	0	0	0	0
aspartate aminotransferase increased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	1 / 422 (0.24%)	0 / 91 (0.00%)	1 / 90 (1.11%)	2 / 91 (2.20%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	2	0	1	4	0	0	0	0	0	0	0	0	0	0	0	0
blood cholesterol increased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	4	0	0	0	0	0	0	0	0	0	0	0	0	0	0
blood creatine phosphokinase increased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	3 / 107 (2.80%)	3 / 422 (0.71%)	2 / 91 (2.20%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	3	3	4	0	0	0	0	0	0	0	0	0	0	0	0	0	0
blood glucose increased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	2 / 422 (0.47%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
blood pressure increased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	2 / 422 (0.47%)	0 / 91 (0.00%)	2 / 90 (2.22%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	0	3	0	0	0	0	0	0	0	0	0	0	0	0	0
blood triglycerides increased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	1 / 90 (1.11%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	1	2	0	0	0	0	0	0	0	0	0	0	0	0
blood urea increased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
blood uric acid increased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	2 / 422 (0.47%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
c-reactive protein increased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
electrocardiogram qt prolonged
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
fibrin d dimer increased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
gamma-glutamyltransferase increased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	2 / 422 (0.47%)	0 / 91 (0.00%)	1 / 90 (1.11%)	2 / 91 (2.20%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	2	0	1	2	0	0	0	0	0	0	0	0	0	0	0	0
heart rate increased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
hepatic enzyme increased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	1 / 90 (1.11%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	1	1	0	0	0	0	0	0	0	0	0	0	0	0
hepatitis b dna assay positive
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
liver function test abnormal
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
liver function test increased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	1 / 47 (2.13%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	2	0	0	0	0	0	1	0	0	0	0	0	0	0	0
lymphocyte count decreased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
thyroxine free decreased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
very low density lipoprotein increased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
weight decreased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	1	0	0	0	0	0	0	0	0	0	0	0	0
weight increased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	2 / 90 (2.22%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	2	2	0	0	0	0	0	0	0	0	0	0	0	0
white blood cell count increased
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	1 / 47 (2.13%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Injury, poisoning and procedural complications
animal bite
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	1	0	0	0	0	0	0	0	0	0	0	0	0	0
ankle fracture
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	2 / 422 (0.47%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
arthropod bite
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
arthropod sting
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
contusion
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	2 / 107 (1.87%)	1 / 422 (0.24%)	1 / 91 (1.10%)	2 / 90 (2.22%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	1	2	2	0	0	0	0	0	0	0	0	0	0	0	0	0
epicondylitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
fall
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	3 / 107 (2.80%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	3	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
foot fracture
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	1 / 47 (2.13%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
ligament sprain
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	2 / 91 (2.20%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0
limb injury
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	2 / 91 (2.20%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	1 / 47 (2.13%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	6	0	0	0	0	0	1	0	0	0	0	0	0	0	0
meniscus injury
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	2 / 90 (2.22%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	3	0	0	0	0	0	0	0	0	0	0	0	0	0
post concussion syndrome
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
procedural pain
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
rib fracture
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
skin abrasion
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
skin laceration
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0
thermal burn
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
wound
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
wound complication
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Cardiac disorders
acute myocardial infarction
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
bradycardia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
cardiac failure chronic
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
palpitations
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Nervous system disorders
cerebral infarction
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
cervical radiculopathy
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
dizziness
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
facial paralysis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
headache
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	5 / 107 (4.67%)	10 / 422 (2.37%)	2 / 91 (2.20%)	5 / 90 (5.56%)	4 / 91 (4.40%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	1 / 47 (2.13%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	6	10	6	9	5	0	0	0	1	0	0	0	0	0	0	0	0
hypoaesthesia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
migraine
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
sciatica
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
sinus headache
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
somnolence
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
syncope
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Blood and lymphatic system disorders
hilar lymphadenopathy
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
leukocytosis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
lymphadenopathy
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
thrombocytosis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Ear and labyrinth disorders
ear discomfort
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	1 / 47 (2.13%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
ear pain
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
tinnitus
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
vertigo
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	1 / 91 (1.10%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	2	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Eye disorders
blepharitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	2 / 422 (0.47%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
cataract
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
cataract subcapsular
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
conjunctival haemorrhage
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
ocular hyperaemia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	1 / 47 (2.13%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	1	0	0	0	0	0	0	0	0
visual impairment
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
vitreous floaters
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Gastrointestinal disorders
abdominal pain
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
abdominal pain lower
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
abdominal pain upper
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	2 / 422 (0.47%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
aphthous ulcer
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
chronic gastritis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
constipation
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
defaecation disorder
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
dental caries
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	2 / 422 (0.47%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
diarrhoea
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	8 / 422 (1.90%)	0 / 91 (0.00%)	0 / 90 (0.00%)	3 / 91 (3.30%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	9	0	0	3	0	0	0	0	0	0	0	0	0	0	0	0
dry mouth
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
dyspepsia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
enteritis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
faeces soft
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
food poisoning
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
gastritis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	2 / 422 (0.47%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
gastrointestinal disorder
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	1 / 422 (0.24%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
gastrooesophageal reflux disease
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
gingival atrophy
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
glossitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
haemorrhoids
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
nausea
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
periodontal disease
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
stomatitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
toothache
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	1 / 422 (0.24%)	1 / 91 (1.10%)	2 / 90 (2.22%)	2 / 91 (2.20%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	1	6	2	2	0	0	0	0	0	0	0	0	0	0	0	0
umbilical hernia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
vomiting
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hepatobiliary disorders
cholecystitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
cholelithiasis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
drug-induced liver injury
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
hepatic steatosis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	3 / 91 (3.30%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	3	0	0	0	0	0	0	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
acne
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
actinic keratosis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
alopecia areata
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
blister
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
dermal cyst
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0
dermatitis contact
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	2 / 107 (1.87%)	1 / 422 (0.24%)	1 / 91 (1.10%)	3 / 90 (3.33%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	3	1	2	3	0	0	0	0	0	0	0	0	0	0	0	0	0
dermatitis psoriasiform
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
diffuse alopecia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
dyshidrotic eczema
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	2 / 422 (0.47%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
eczema
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	3 / 422 (0.71%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
eczema asteatotic
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
erythema
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
ingrowing nail
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
intertrigo
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
perioral dermatitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
pruritus
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	3 / 107 (2.80%)	5 / 422 (1.18%)	4 / 91 (4.40%)	2 / 90 (2.22%)	2 / 91 (2.20%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	3	5	8	3	2	0	0	0	0	0	0	0	0	0	0	0	0
psoriasis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	2 / 422 (0.47%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	2	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
rash
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	1 / 90 (1.11%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0
rosacea
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
seborrhoeic dermatitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
skin fissures
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
urticaria
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	4 / 422 (0.95%)	2 / 91 (2.20%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	6	6	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Renal and urinary disorders
dysuria
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
hydronephrosis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
pollakiuria
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Endocrine disorders
goitre
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	1 / 47 (2.13%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
hypothyroidism
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	3 / 107 (2.80%)	10 / 422 (2.37%)	5 / 91 (5.49%)	3 / 90 (3.33%)	3 / 91 (3.30%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	3	11	12	3	3	0	0	0	0	0	0	0	0	0	0	0	0
arthritis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
arthropathy
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
back pain
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	2 / 107 (1.87%)	3 / 422 (0.71%)	3 / 91 (3.30%)	4 / 90 (4.44%)	2 / 91 (2.20%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	2 / 47 (4.26%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	3	6	4	2	0	0	0	2	0	0	0	0	0	0	0	0
bursitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
costochondritis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
enthesopathy
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
fasciitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
groin pain
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
intervertebral disc protrusion
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	2 / 422 (0.47%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
joint effusion
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
joint swelling
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
muscle spasms
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	2 / 422 (0.47%)	1 / 91 (1.10%)	1 / 90 (1.11%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	1 / 47 (2.13%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	2	1	1	0	0	0	1	0	0	0	0	0	0	0	0
muscle tightness
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
muscular weakness
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
musculoskeletal chest pain
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	2 / 90 (2.22%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0
musculoskeletal pain
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	1 / 47 (2.13%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	2	0	0	0	0	0	1	0	0	0	0	0	0	0	0
myalgia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	3 / 422 (0.71%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
osteoarthritis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	2 / 422 (0.47%)	1 / 91 (1.10%)	2 / 90 (2.22%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	2	2	1	0	0	0	0	0	0	0	0	0	0	0	0
pain in extremity
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	2 / 90 (2.22%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	1 / 47 (2.13%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	2	0	0	0	0	1	0	0	0	0	0	0	0	0
plantar fasciitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
psoriatic arthropathy
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	2 / 422 (0.47%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	2	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
rotator cuff syndrome
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
spinal osteoarthritis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
spinal pain
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	1 / 47 (2.13%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0
synovial cyst
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
tendonitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	4	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Infections and infestations
abdominal wall abscess
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
acne pustular
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
acute sinusitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
bacterial infection
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
bacteriuria
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
body tinea
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
borrelia infection
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
bronchitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	2 / 90 (2.22%)	3 / 91 (3.30%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	2	4	0	0	0	0	0	0	0	0	0	0	0	0
carbuncle
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
cellulitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
chronic sinusitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
conjunctivitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
conjunctivitis bacterial
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
cystitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
ear infection
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
enterocolitis bacterial
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
epididymitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed ^[7]	0 / 74 (0.00%)	1 / 298 (0.34%)	0 / 61 (0.00%)	0 / 64 (0.00%)	0 / 59 (0.00%)	0 / 106 (0.00%)	0 / 3 (0.00%)	0 / 67 (0.00%)	0 / 31 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 2 (0.00%)	0 / 9 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
erysipelas
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	1	0	0	0	0	0	0	0	0	0	0	0	0	0
erythema migrans
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
folliculitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	5 / 422 (1.18%)	0 / 91 (0.00%)	2 / 90 (2.22%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	5	0	2	2	0	0	0	0	0	0	0	0	0	0	0	0
gastroenteritis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	4 / 422 (0.95%)	0 / 91 (0.00%)	0 / 90 (0.00%)	3 / 91 (3.30%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	4	0	0	3	0	0	0	0	0	0	0	0	0	0	0	0
gastroenteritis viral
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	2 / 422 (0.47%)	0 / 91 (0.00%)	1 / 90 (1.11%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0
gastrointestinal infection
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0
helicobacter gastritis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
hepatitis a
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
hepatitis e
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
herpes zoster
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	1	0	0	0	0	0	0	0	0	0	0	0	0
hordeolum
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	3 / 422 (0.71%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
infected dermal cyst
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
influenza
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	2 / 422 (0.47%)	3 / 91 (3.30%)	0 / 90 (0.00%)	3 / 91 (3.30%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	6	0	3	0	0	0	0	0	0	0	0	0	0	0	0
laryngitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
molluscum contagiosum
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
nasopharyngitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	14 / 107 (13.08%)	55 / 422 (13.03%)	15 / 91 (16.48%)	13 / 90 (14.44%)	9 / 91 (9.89%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	2 / 47 (4.26%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	14	61	35	16	13	0	0	0	2	0	0	0	0	0	0	0	0
onychomycosis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
oral herpes
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	4 / 422 (0.95%)	0 / 91 (0.00%)	2 / 90 (2.22%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	4	0	5	1	0	0	0	0	0	0	0	0	0	0	0	0
otitis media
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
otitis media acute
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
paronychia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	2	0	0	0	0	0	0	0	0	0	0	0	0	0
parotitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
pelvic inflammatory disease
alternative dictionary used: MedDRA 22.1
subjects affected / exposed ^[8]	0 / 33 (0.00%)	0 / 124 (0.00%)	0 / 30 (0.00%)	1 / 26 (3.85%)	0 / 32 (0.00%)	0 / 34 (0.00%)	0 / 4 (0.00%)	0 / 27 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 2 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
periodontitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
pharyngitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	3 / 107 (2.80%)	7 / 422 (1.66%)	0 / 91 (0.00%)	3 / 90 (3.33%)	4 / 91 (4.40%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	3	7	0	3	4	0	0	0	0	0	0	0	0	0	0	0	0
pharyngitis streptococcal
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	1 / 47 (2.13%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
pharyngotonsillitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	3 / 422 (0.71%)	0 / 91 (0.00%)	1 / 90 (1.11%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	3	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0
pneumonia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
postoperative wound infection
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
pulpitis dental
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
respiratory tract infection
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	2 / 422 (0.47%)	0 / 91 (0.00%)	1 / 90 (1.11%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	2	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0
rhinitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
salpingo-oophoritis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed ^[9]	0 / 33 (0.00%)	0 / 124 (0.00%)	0 / 30 (0.00%)	0 / 26 (0.00%)	1 / 32 (3.13%)	0 / 34 (0.00%)	0 / 4 (0.00%)	0 / 27 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 2 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
sinusitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
subcutaneous abscess
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
tinea pedis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
tinea versicolour
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
tonsillitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	1 / 91 (1.10%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	2	1	0	0	0	0	0	0	0	0	0	0	0	0	0
tooth infection
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
tracheitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
typhoid fever
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	0 / 90 (0.00%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
upper respiratory tract infection
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	16 / 422 (3.79%)	7 / 91 (7.69%)	5 / 90 (5.56%)	10 / 91 (10.99%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	1 / 47 (2.13%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	20	17	5	11	0	0	0	1	0	0	0	0	0	0	0	0
urethritis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
urinary tract infection
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	8 / 422 (1.90%)	1 / 91 (1.10%)	3 / 90 (3.33%)	2 / 91 (2.20%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	1 / 47 (2.13%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	10	2	3	2	0	0	0	1	0	0	0	0	0	0	0	0
vaginal infection
alternative dictionary used: MedDRA 22.1
subjects affected / exposed ^[10]	0 / 33 (0.00%)	1 / 124 (0.81%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 32 (0.00%)	0 / 34 (0.00%)	0 / 4 (0.00%)	0 / 27 (0.00%)	1 / 16 (6.25%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 2 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
viral infection
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
vulvovaginal candidiasis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed ^[11]	0 / 33 (0.00%)	1 / 124 (0.81%)	0 / 30 (0.00%)	0 / 26 (0.00%)	0 / 32 (0.00%)	0 / 34 (0.00%)	0 / 4 (0.00%)	0 / 27 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 2 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Metabolism and nutrition disorders
cardiometabolic syndrome
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	1 / 91 (1.10%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
diabetes mellitus
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	3 / 422 (0.71%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
dyslipidaemia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	2 / 91 (2.20%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0
gout
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	3 / 422 (0.71%)	1 / 91 (1.10%)	0 / 90 (0.00%)	2 / 91 (2.20%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	3	2	0	2	0	0	0	0	0	0	0	0	0	0	0	0
hypercholesterolaemia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
hyperglycaemia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
hyperlipidaemia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	2 / 107 (1.87%)	3 / 422 (0.71%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	2	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
hypertriglyceridaemia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	5 / 422 (1.18%)	0 / 91 (0.00%)	2 / 90 (2.22%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	5	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0
hyperuricaemia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
increased appetite
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	1 / 422 (0.24%)	0 / 91 (0.00%)	0 / 90 (0.00%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
overweight
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 107 (0.00%)	0 / 422 (0.00%)	0 / 91 (0.00%)	1 / 90 (1.11%)	0 / 91 (0.00%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
type 2 diabetes mellitus
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 107 (0.93%)	5 / 422 (1.18%)	0 / 91 (0.00%)	1 / 90 (1.11%)	1 / 91 (1.10%)	0 / 140 (0.00%)	0 / 7 (0.00%)	0 / 94 (0.00%)	0 / 47 (0.00%)	0 / 4 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 16 (0.00%)	0 / 1 (0.00%)	0 / 6 (0.00%)
occurrences all number	1	5	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.

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Were there any global substantial amendments to the protocol? No

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.

None reported

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Clinical trials

Clinical Trial Results: A Multicenter Study with a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Withdrawal Maintenance Dosing Period to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderate-to-Severe Plaque Psoriasis OASIS-1

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants with a Static Physician’s Global Assessment of (sPGA) (0,1) with at Least a 2-point Improvement from Baseline

Primary: Percentage of Participants with a Static Physician’s Global Assessment of (sPGA) (0,1) with at Least a 2-point Improvement from Baseline

Primary: Percentage of Participants Achieving a ≥90% Improvement from Baseline in Psoriasis Area and Severity Score (PASI 90)

Primary: Percentage of Participants Achieving a ≥90% Improvement from Baseline in Psoriasis Area and Severity Score (PASI 90)

Secondary: Percentage of Participants Achieving a ≥75% Improvement from Baseline in PASI (PASI 75)

Secondary: Percentage of Participants Achieving a ≥75% Improvement from Baseline in PASI (PASI 75)

Secondary: Percentage of Participants Achieving a ≥75% Improvement from Baseline in PASI (PASI 75)

Secondary: Percentage of Participants Achieving a ≥75% Improvement from Baseline in PASI (PASI 75)

Secondary: Percentage of Participants Achieving a ≥100% Improvement from Baseline in Psoriasis Area and Severity Score (PASI 100)

Secondary: Percentage of Participants Achieving a ≥100% Improvement from Baseline in Psoriasis Area and Severity Score (PASI 100)

Secondary: Percentage of Participants with ≤1% of Body Surface Area (BSA) with Psoriasis Involvement

Secondary: Percentage of Participants with ≤1% of Body Surface Area (BSA) with Psoriasis Involvement

Secondary: Percentage of Participants with a Psoriasis Symptoms Scale (PSS) Symptoms Score of 0 in those with a PSS Symptoms Score ≥1 at Baseline

Secondary: Percentage of Participants with a Psoriasis Symptoms Scale (PSS) Symptoms Score of 0 in those with a PSS Symptoms Score ≥1 at Baseline

Secondary: Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) with at Least a 5-Point Improvement (Reduction) from Baseline in Participants with a Baseline DLQI Total Score ≥5

Secondary: Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) with at Least a 5-Point Improvement (Reduction) from Baseline in Participants with a Baseline DLQI Total Score ≥5

Secondary: Percentage of Participants Maintaining Clinical Response (PASI 90) after Re-randomization at the Start of the Randomized Withdrawal Period

Secondary: Percentage of Participants Maintaining Clinical Response (PASI 90) after Re-randomization at the Start of the Randomized Withdrawal Period

Secondary: Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants with Palmoplantar Involvement at Baseline

Secondary: Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants with Palmoplantar Involvement at Baseline

Secondary: Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants with Scalp Involvement at Baseline

Secondary: Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants with Scalp Involvement at Baseline

Secondary: Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants with Fingernail Involvement at Baseline

Secondary: Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants with Fingernail Involvement at Baseline

Secondary: Change from Baseline on the Short Form (SF)-36 Physical Component Summary (PCS)

Secondary: Change from Baseline on the Short Form (SF)-36 Physical Component Summary (PCS)

Secondary: Change from Baseline on the SF-36 Mental Component Summary (MCS)

Secondary: Change from Baseline on the SF-36 Mental Component Summary (MCS)

Secondary: Percentage of Participants with Patient’s Global Assessment of Psoriasis (PatGA (0,1)) and >=2 Improvement From Baseline

Secondary: Percentage of Participants with Patient’s Global Assessment of Psoriasis (PatGA (0,1)) and >=2 Improvement From Baseline

Secondary: Change from Baseline on the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO)

Secondary: Change from Baseline on the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO)

Secondary: Change from Baseline in Quick Inventory of Depressive Symptomology (QIDS-SR16) Total Score in those with a Baseline QIDS-SR16 Total Score ≥11

Secondary: Change from Baseline in Quick Inventory of Depressive Symptomology (QIDS-SR16) Total Score in those with a Baseline QIDS-SR16 Total Score ≥11

Secondary: Induction Period: Pharmacokinetics (PK): Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab

Secondary: Induction Period: Pharmacokinetics (PK): Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab

Secondary: Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) (0,1)

Secondary: Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) (0,1)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Multicenter Study with a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Withdrawal Maintenance Dosing Period to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderate-to-Severe Plaque Psoriasis OASIS-1