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Clinical Trial Results:
A Multicenter, Long-Term Extension to Evaluate the Long Term Safety and Maintenance of Treatment Effect of Mirikizumab in Patients with Moderate to Severe Plaque Psoriasis

Summary
EudraCT number	2017-003299-30
Trial protocol	DE CZ HU PL FR GB ES IT
Global end of trial date	07 Feb 2022

Results information
Results version number	v1(current)
This version publication date	22 Feb 2023
First version publication date	22 Feb 2023
Other versions

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

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

I6T-MC-AMAH

ISRCTN number

-

US NCT number

NCT03556202

WHO universal trial number (UTN)

-

Other trial identifiers

Trial Number: 16491

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)

No

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

No

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

No

Analysis stage

Final

Date of interim/final analysis

07 Feb 2022

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

07 Feb 2022

Was the trial ended prematurely?

No

Main objective of the trial

The purpose of this study is to evaluate the long-term safety and maintenance of efficacy 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

03 Sep 2018

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 85

Country: Number of subjects enrolled

Australia: 56

Country: Number of subjects enrolled

Canada: 94

Country: Number of subjects enrolled

Czechia: 88

Country: Number of subjects enrolled

France: 53

Country: Number of subjects enrolled

Germany: 243

Country: Number of subjects enrolled

Hungary: 70

Country: Number of subjects enrolled

Israel: 42

Country: Number of subjects enrolled

Italy: 17

Country: Number of subjects enrolled

Japan: 162

Country: Number of subjects enrolled

Mexico: 71

Country: Number of subjects enrolled

Poland: 279

Country: Number of subjects enrolled

Russian Federation: 46

Country: Number of subjects enrolled

Korea, Republic of: 105

Country: Number of subjects enrolled

Spain: 70

Country: Number of subjects enrolled

Taiwan: 53

Country: Number of subjects enrolled

United Kingdom: 5

Country: Number of subjects enrolled

United States: 397

Worldwide total number of subjects

1936

EEA total number of subjects

820

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

1730

From 65 to 84 years

205

85 years and over

1

Subject disposition

Top of page

Recruitment details

-

Screening details

Participants who completed an originating study: I6T-MC-AMAF (NCT02899988), I6T-MC-AMAK (NCT03482011) and I6T-MC-AMAJ (NCT03535194) were eligible for enrollment into study AMAH.

Period 1 title

Extension Treatment Period

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Blinding implementation details

Initially double-blind (until original, pivotal studies AMAK [NCT03482011] and AMAJ [NCT03535194] are locked and unblinded), then open-label.

Are arms mutually exclusive

Yes

125 milligram (mg) Mirikizumab Q8W

Arm description

Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).

Arm type

Experimental

Investigational medicinal product name

Mirikizumab

Investigational medicinal product code

LY3074828

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received 125 mg mirikizumab administered SC Q8W.

250 mg Mirikizumab Q8W Excluding Secukinumab

Arm description

Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).

Arm type

Experimental

Investigational medicinal product name

Mirikizumab

Investigational medicinal product code

LY3074828

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).

Secukinumab/250 mg Mirikizumab Q8W

Arm description

Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.

Arm type

Experimental

Investigational medicinal product name

Mirikizumab

Investigational medicinal product code

LY3074828

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.

Number of subjects in period 1	125 milligram (mg) Mirikizumab Q8W	250 mg Mirikizumab Q8W Excluding Secukinumab	Secukinumab/250 mg Mirikizumab Q8W
Started	527	1020	389
Received at Least One Dose of Study Drug	527	1020	389
From AMAF	35	132	0
From AMAK	83	390	0
From AMAJ	409	498	389
Completed	0	0	0
Not completed	527	1020	389
Adverse event, serious fatal	2	6	-
Consent withdrawn by subject	22	47	22
Physician decision	-	8	2
Adverse event, non-fatal	18	14	9
Due to Exclusion Criteria of AMAJ study	-	-	1
Pregnancy	2	4	3
Sponsor Decision	-	1	-
Study Terminated by Sponsor	469	907	331
Lost to follow-up	9	20	2
Lack of efficacy	5	12	18
Protocol deviation	-	1	1

Period 2 title

Follow-Up Period (12 weeks)

Is this the baseline period?

No

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

No

125 milligram (mg) Mirikizumab Q8W Follow-up Period

Arm description

Participants did not receive any intervention in post- treatment follow-up period.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

250 mg Mirikizumab Q8W Excluding Secukinumab Follow-up Period

Arm description

Participants did not receive any intervention in post- treatment follow-up period.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Secukinumab/250 mg Mirikizumab Q8W Follow-up Period

Arm description

Participants did not receive any intervention in post- treatment follow-up period.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Number of subjects in period 2	125 milligram (mg) Mirikizumab Q8W Follow-up Period	250 mg Mirikizumab Q8W Excluding Secukinumab Follow-up Period	Secukinumab/250 mg Mirikizumab Q8W Follow-up Period
Started	453	861	333
Completed	0	0	0
Not completed	453	861	333
Adverse event, serious fatal	1	-	-
Physician decision	-	3	1
To meet exclusion criteria of the AMAJ study	-	-	1
Site Terminated by Sponsor	-	1	-
Study Terminated by Sponsor	396	750	273
Second follow-up not done, unable to reach patient	-	-	1
Study discontinued by sponsor	-	2	1
Study terminated & subject missed follow-up visit	-	1	-
Second follow-up visit: Patient refused	-	1	-
Consent withdrawn by subject	36	65	31
Adverse event, non-fatal	11	11	8
Pregnancy	1	4	1
Lost to follow-up	4	14	3
Lack of efficacy	4	9	13

Baseline characteristics

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Reporting group title

125 milligram (mg) Mirikizumab Q8W

Reporting group description

Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).

Reporting group title

250 mg Mirikizumab Q8W Excluding Secukinumab

Reporting group description

Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).

Reporting group title

Secukinumab/250 mg Mirikizumab Q8W

Reporting group description

Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.

Reporting group values	125 milligram (mg) Mirikizumab Q8W	250 mg Mirikizumab Q8W Excluding Secukinumab	Secukinumab/250 mg Mirikizumab Q8W	Total
Number of subjects	527	1020	389	1936
Age categorical
Units: Subjects
Age continuous
All randomized participants.
Units: years
arithmetic mean (standard deviation)	47.90 ± 13.81	47.00 ± 12.87	46.50 ± 14.41	-
Gender categorical
All randomized participants.
Units: Subjects
Female	159	309	110	578
Male	368	711	279	1358
Ethnicity (NIH/OMB)
All randomized participants.
Units: Subjects
Hispanic or Latino	29	63	20	112
Not Hispanic or Latino	79	150	53	282
Unknown or Not Reported	419	807	316	1542
Race (NIH/OMB)
All randomized participants.
Units: Subjects
American Indian or Alaska Native	15	48	2	65
Asian	89	217	63	369
Native Hawaiian or Other Pacific Islander	1	1	1	3
Black or African American	5	18	6	29
White	415	734	315	1464
More than one race	2	2	2	6
Unknown or Not Reported	0	0	0	0
Region of Enrollment
All randomized participants.
Units: Subjects
Argentina	32	30	23	85
Australia	16	21	19	56
Canada	26	44	24	94
Czechia	25	35	28	88
France	20	15	18	53
Germany	65	136	42	243
Hungary	23	27	20	70
Israel	12	15	15	42
Italy	7	5	5	17
Japan	39	86	37	162
Mexico	15	56	0	71
Poland	75	157	47	279
Russia	3	43	0	46
South Korea	24	68	13	105
Spain	24	22	24	70
Taiwan	9	44	0	53
United Kingdom	2	2	1	5
United States	110	214	73	397

End points

Top of page

Reporting group title

125 milligram (mg) Mirikizumab Q8W

Reporting group description

Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).

Reporting group title

250 mg Mirikizumab Q8W Excluding Secukinumab

Reporting group description

Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).

Reporting group title

Secukinumab/250 mg Mirikizumab Q8W

Reporting group description

Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.

Reporting group title

125 milligram (mg) Mirikizumab Q8W Follow-up Period

Reporting group description

Participants did not receive any intervention in post- treatment follow-up period.

Reporting group title

250 mg Mirikizumab Q8W Excluding Secukinumab Follow-up Period

Reporting group description

Participants did not receive any intervention in post- treatment follow-up period.

Reporting group title

Secukinumab/250 mg Mirikizumab Q8W Follow-up Period

Reporting group description

Participants did not receive any intervention in post- treatment follow-up period.

Primary: Percentage of Participants with a Static Physician’s Global Assessment Among Those who Entered the Study with a sPGA of 0,1

Top of page

End point title

Percentage of Participants with a Static Physician’s Global Assessment Among Those who Entered the Study with a sPGA of 0,1 ^[1]

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. Participants who did not meet the clinical response criteria or had missing data at Week 104 were considered non-responders for non-responder Imputation (NRI) analysis. Analysis population description (APD): All randomized participants who received at least one dose of drug and who entered Study AMAH with sPGA (0,1).

End point type

Primary

End point timeframe

Week 104

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No inferential statistics was planned/conducted for this endpoint.

End point values	125 milligram (mg) Mirikizumab Q8W	250 mg Mirikizumab Q8W Excluding Secukinumab	Secukinumab/250 mg Mirikizumab Q8W
Number of subjects analysed	467	820	296
Units: percentage of participants
number (confidence interval 95%)	46.7 (42.2 to 51.2)	55.7 (52.3 to 59.1)	38.9 (33.3 to 44.4)

No statistical analyses for this end point

Primary: Percentage of Participants who Maintained a ≥90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those who Entered the Study with a PASI 90

Top of page

End point title

Percentage of Participants who Maintained a ≥90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those who Entered the Study with a PASI 90 ^[2]

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. 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). APD: All randomized participants who received at least one dose of drug and who entered AMAH with PASI 90 Response.

End point type

Primary

End point timeframe

Week 104

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No inferential statistics was planned/conducted for this endpoint.

End point values	125 milligram (mg) Mirikizumab Q8W	250 mg Mirikizumab Q8W Excluding Secukinumab	Secukinumab/250 mg Mirikizumab Q8W
Number of subjects analysed	460	813	302
Units: percentage of participants
number (confidence interval 95%)	49.3 (44.8 to 53.9)	56.8 (53.4 to 60.2)	39.4 (33.9 to 44.9)

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)

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End point title

Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)

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. 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). APD: All randomized participants who received at least one dose of drug.

End point type

Secondary

End point timeframe

Week 104

End point values	125 milligram (mg) Mirikizumab Q8W	250 mg Mirikizumab Q8W Excluding Secukinumab	Secukinumab/250 mg Mirikizumab Q8W
Number of subjects analysed	527	1020	389
Units: percentage of participants
number (confidence interval 95%)	30.4 (26.4 to 34.3)	36.4 (33.4 to 39.3)	22.6 (18.5 to 26.8)

No statistical analyses for this end point

Secondary: Percentage of Participants with a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 (free of itch, pain, stinging, and burning) 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) Symptom Score of 0 (free of itch, pain, stinging, and burning) 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 sign score of 0 (no signs) to 30 (worst imaginable signs) will be reported. APD: All randomized participants with PSS symptom score of ≥1 at baseline.

End point type

Secondary

End point timeframe

Week 104

End point values	125 milligram (mg) Mirikizumab Q8W	250 mg Mirikizumab Q8W Excluding Secukinumab	Secukinumab/250 mg Mirikizumab Q8W
Number of subjects analysed	518	1008	376
Units: percentage of participants
number (confidence interval 95%)	31.1 (27.1 to 35.1)	33.6 (30.7 to 36.5)	23.4 (19.1 to 27.7)

No statistical analyses for this end point

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). 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. APD: All randomized participants who had a baseline DLQI Total Score ≥5.

End point type

Secondary

End point timeframe

Week 104

End point values	125 milligram (mg) Mirikizumab Q8W	250 mg Mirikizumab Q8W Excluding Secukinumab	Secukinumab/250 mg Mirikizumab Q8W
Number of subjects analysed	477	922	345
Units: percentage of participants
number (confidence interval 95%)	41.5 (37.1 to 45.9)	47.3 (44.1 to 50.5)	34.5 (29.5 to 39.5)

No statistical analyses for this end point

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). APD: All randomized participants who had Scalp Involvement at baseline.

End point type

Secondary

End point timeframe

Baseline, Week 104

End point values	125 milligram (mg) Mirikizumab Q8W	250 mg Mirikizumab Q8W Excluding Secukinumab	Secukinumab/250 mg Mirikizumab Q8W
Number of subjects analysed	204	454	136
Units: score on a scale
arithmetic mean (standard deviation)	-20.9 ± 15.79	-19.5 ± 13.48	-19.6 ± 13.44

No statistical analyses for this end point

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). APD: All randomized participants who had Nail Psoriasis involvement at baseline.

End point type

Secondary

End point timeframe

Baseline, Week 104

End point values	125 milligram (mg) Mirikizumab Q8W	250 mg Mirikizumab Q8W Excluding Secukinumab	Secukinumab/250 mg Mirikizumab Q8W
Number of subjects analysed	136	304	89
Units: score on a scale
arithmetic mean (standard deviation)	-19.4 ± 17.75	-21.0 ± 17.69	-22.2 ± 18.75

No statistical analyses for this end point

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 PPASI 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. APD: All randomized participants who had palmoplantar involvement at baseline.

End point type

Secondary

End point timeframe

Baseline, Week 104

End point values	125 milligram (mg) Mirikizumab Q8W	250 mg Mirikizumab Q8W Excluding Secukinumab	Secukinumab/250 mg Mirikizumab Q8W
Number of subjects analysed	51	114	31
Units: score on a scale
arithmetic mean (standard deviation)	-6.55 ± 7.058	-6.80 ± 8.391	-7.38 ± 6.632

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Treatment Period: Baseline Up To 208 Weeks, Follow-up Period: 0-12 Weeks

Adverse event reporting additional description

All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.1

Reporting group title

125 Milligram (mg) Mirikizumab Q8W

Reporting group description

Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).

Reporting group title

250 mg Mirikizumab Q8W Excluding Secukinumab

Reporting group description

Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).

Reporting group title

Secukinumab/250 mg Mirikizumab Q8W

Reporting group description

Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.

Reporting group title

125 Milligram (mg) Mirikizumab Q8W Follow-up Period

Reporting group description

Participants did not receive any intervention in post- treatment follow-up period.

Reporting group title

250 mg Mirikizumab Q8W Excluding Secukinumab Follow-up Period

Reporting group description

Participants did not receive any intervention in post- treatment follow-up period.

Reporting group title

Secukinumab/250 mg Mirikizumab Q8W Follow-up Period

Reporting group description

Participants did not receive any intervention in post- treatment follow-up period.

Serious adverse events	125 Milligram (mg) Mirikizumab Q8W	250 mg Mirikizumab Q8W Excluding Secukinumab	Secukinumab/250 mg Mirikizumab Q8W	125 Milligram (mg) Mirikizumab Q8W Follow-up Period	250 mg Mirikizumab Q8W Excluding Secukinumab Follow-up Period	Secukinumab/250 mg Mirikizumab Q8W Follow-up Period
Total subjects affected by serious adverse events
subjects affected / exposed	55 / 527 (10.44%)	88 / 1020 (8.63%)	35 / 389 (9.00%)	7 / 453 (1.55%)	6 / 861 (0.70%)	0 / 333 (0.00%)
number of deaths (all causes)	2	6	0	1	0	0
number of deaths resulting from adverse events	1	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
acute myeloid leukaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
adenocarcinoma of colon
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
b-cell lymphoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
breast cancer
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
colon cancer metastatic
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
gastric cancer
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
glioblastoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
growth hormone-producing pituitary tumour
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
haemangioma of bone
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
invasive lobular breast carcinoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
lipoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
lung adenocarcinoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
marginal zone lymphoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
myelodysplastic syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
non-small cell lung cancer stage iii
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
prostate cancer recurrent
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[1]	0 / 368 (0.00%)	0 / 711 (0.00%)	1 / 279 (0.36%)	0 / 323 (0.00%)	0 / 602 (0.00%)	0 / 244 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
sinonasal papilloma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
squamous cell carcinoma of the oral cavity
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
superficial spreading melanoma stage unspecified
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
thyroid cancer
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
aortic aneurysm rupture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deep vein thrombosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
embolism
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
haematoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
hypertension
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
peripheral arterial occlusive disease
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
varicose vein
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
vasculitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
blepharoplasty
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
cholecystectomy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
coronary revascularisation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
gastric polypectomy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
hysterectomy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[2]	0 / 159 (0.00%)	1 / 309 (0.32%)	0 / 110 (0.00%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
percutaneous coronary intervention
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
peripheral revascularisation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
stent placement
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
stent removal
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
asthenia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
death
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
gait disturbance
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
oedema peripheral
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
corneal graft rejection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
acquired phimosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[3]	0 / 368 (0.00%)	1 / 711 (0.14%)	0 / 279 (0.00%)	0 / 323 (0.00%)	0 / 602 (0.00%)	0 / 244 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
endometriosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[4]	0 / 159 (0.00%)	0 / 309 (0.00%)	1 / 110 (0.91%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
genital haemorrhage
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
haemorrhagic ovarian cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[5]	0 / 159 (0.00%)	0 / 309 (0.00%)	1 / 110 (0.91%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
uterine polyp
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[6]	0 / 159 (0.00%)	0 / 309 (0.00%)	1 / 110 (0.91%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
asthma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
asthmatic crisis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
chronic obstructive pulmonary disease
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
dyspnoea exertional
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
hypercapnia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
pulmonary embolism
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
respiratory failure
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
sleep apnoea syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
alcohol withdrawal syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
depression
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
mental status changes
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Product issues
device dislocation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
aspartate aminotransferase increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
animal bite
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
ankle fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
cervical vertebral fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
clavicle fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
closed globe injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
concussion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
face injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
facial bones fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
femoral neck fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
foot fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
graft complication
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
hand fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
hip fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
joint dislocation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
ligament sprain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
limb injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
limb traumatic amputation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
lower limb fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
lumbar vertebral fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
meniscus injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
muscle injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
neovaginal complication
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[7]	0 / 159 (0.00%)	0 / 309 (0.00%)	1 / 110 (0.91%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
post procedural complication
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
pulmonary contusion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
radius fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
rib fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
road traffic accident
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
scapula fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
skull fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
spinal compression fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
tendon injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
tendon rupture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Congenital, familial and genetic disorders
odontogenic cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
acute coronary syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
acute myocardial infarction
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	2 / 1020 (0.20%)	3 / 389 (0.77%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 2	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
angina unstable
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
atrial fibrillation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	4 / 1020 (0.39%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
cardiac failure
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
cardiac failure congestive
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
cardiogenic shock
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
coronary artery disease
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
coronary artery stenosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
myocardial infarction
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
myocardial ischaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
pericarditis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
ventricular tachycardia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
carotid artery stenosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
cerebral arteriosclerosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
cerebral venous sinus thrombosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
cerebrovascular accident
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
chronic inflammatory demyelinating polyradiculoneuropathy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
essential tremor
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
haemorrhage intracranial
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
headache
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
ischaemic stroke
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
sedation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
transient ischaemic attack
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
sudden hearing loss
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
vertigo
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
cataract
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
keratitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
ocular hypertension
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
optic neuropathy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
colitis ulcerative
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
diverticulum
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
gastric haemorrhage
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
gastric ulcer
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
gastritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
large intestine polyp
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
pancreatitis acute
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
cholecystitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
cholecystitis acute
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
cholecystitis chronic
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
cholelithiasis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	1 / 1	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
gallbladder fistula
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
dermatitis contact
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
drug eruption
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
urticaria
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
nephrolithiasis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
ureterolithiasis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Endocrine disorders
primary hyperaldosteronism
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
flank pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
intervertebral disc disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
intervertebral disc protrusion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
osteoarthritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
rotator cuff syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
abscess limb
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
acute sinusitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
appendicitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
appendicitis perforated
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
bacteraemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
bronchitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
covid-19
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	3 / 1020 (0.29%)	1 / 389 (0.26%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
covid-19 pneumonia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	5 / 527 (0.95%)	8 / 1020 (0.78%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	1 / 5	0 / 8	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
campylobacter colitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
campylobacter gastroenteritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
cellulitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	1 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
chronic tonsillitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
diverticulitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
enterocolitis viral
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
erysipelas
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
escherichia pyelonephritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
localised infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
neutropenic sepsis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
osteomyelitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
pneumonia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 2	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
pneumonia bacterial
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
post procedural infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
postoperative wound infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
scrotal abscess
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[8]	0 / 368 (0.00%)	1 / 711 (0.14%)	0 / 279 (0.00%)	0 / 323 (0.00%)	0 / 602 (0.00%)	0 / 244 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
sinusitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
soft tissue infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
diabetes mellitus
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
shock hypoglycaemic
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	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 to this adverse event. These numbers are expected to be equal.
Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

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

Non-serious adverse events	125 Milligram (mg) Mirikizumab Q8W	250 mg Mirikizumab Q8W Excluding Secukinumab	Secukinumab/250 mg Mirikizumab Q8W	125 Milligram (mg) Mirikizumab Q8W Follow-up Period	250 mg Mirikizumab Q8W Excluding Secukinumab Follow-up Period	Secukinumab/250 mg Mirikizumab Q8W Follow-up Period
Total subjects affected by non serious adverse events
subjects affected / exposed	388 / 527 (73.62%)	756 / 1020 (74.12%)	288 / 389 (74.04%)	70 / 453 (15.45%)	120 / 861 (13.94%)	47 / 333 (14.11%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
acrochordon
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	2	1	0	0	0
adenoma benign
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
anogenital warts
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
basal cell carcinoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	1	0	0	0
benign breast neoplasm
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
benign hepatobiliary neoplasm
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
benign neoplasm of thyroid gland
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
benign vascular neoplasm
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
bowen's disease
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
colon adenoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	1	0
dysplastic naevus
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	3	0	0	0
fibroma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
fibrous histiocytoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
focal nodular hyperplasia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	0	1	0	0
haemangioma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
lentigo maligna
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
lipoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	1 / 333 (0.30%)
occurrences all number	2	0	0	0	0	1
malignant ascites
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	0	1	0	0
melanocytic naevus
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	4 / 1020 (0.39%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	4	1	0	0	0
meningioma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
neoplasm malignant
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
pituitary tumour benign
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
prostate cancer
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[9]	0 / 368 (0.00%)	1 / 711 (0.14%)	0 / 279 (0.00%)	0 / 323 (0.00%)	0 / 602 (0.00%)	0 / 244 (0.00%)
occurrences all number	0	1	0	0	0	0
pyogenic granuloma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
seborrhoeic keratosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	4 / 1020 (0.39%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	4	0	0	0	0
skin papilloma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	6 / 1020 (0.59%)	4 / 389 (1.03%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	7	4	1	0	0
squamous cell carcinoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
uterine leiomyoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[10]	3 / 159 (1.89%)	4 / 309 (1.29%)	0 / 110 (0.00%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	3	4	0	0	0	0
Vascular disorders
aortic thrombosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
arteriosclerosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	3	0	0	0	0
deep vein thrombosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	1	0	0	0
essential hypertension
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
flushing
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
haematoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	3	0	0	0	0
hot flush
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
hypertension
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	22 / 527 (4.17%)	52 / 1020 (5.10%)	14 / 389 (3.60%)	0 / 453 (0.00%)	3 / 861 (0.35%)	0 / 333 (0.00%)
occurrences all number	22	54	15	0	3	0
hypertensive crisis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	2	1	0	0	0
hypotension
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
jugular vein thrombosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
lymphoedema
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
lymphorrhoea
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
orthostatic hypotension
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
peripheral artery occlusion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
peripheral venous disease
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	3	0	0	0	0
phlebitis superficial
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
post thrombotic syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
thrombosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
varicose vein
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	5	0	0	0	0	0
white coat hypertension
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
Surgical and medical procedures
abscess drainage
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
acrochordon excision
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
ankle operation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
appendicectomy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
cardiac ablation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
cardioversion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
carpal tunnel decompression
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	4	1	0	0	0
cataract operation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	1	2	2	0	0
cholecystectomy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
circumcision
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[11]	0 / 368 (0.00%)	1 / 711 (0.14%)	0 / 279 (0.00%)	0 / 323 (0.00%)	0 / 602 (0.00%)	0 / 244 (0.00%)
occurrences all number	0	1	0	0	0	0
corneal transplant
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
coronary revascularisation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
dental care
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	1	0	0
dental implantation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	2	3	0	0	1	0
endodontic procedure
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
endoscopic sleeve gastroplasty
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
eyelid cyst removal
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
finger amputation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
gastric bypass
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
hernia hiatus repair
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
hernia repair
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
hysterectomy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[12]	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 130 (0.00%)	1 / 259 (0.39%)	0 / 89 (0.00%)
occurrences all number	0	0	0	0	1	0
internal fixation of fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
intra-uterine contraceptive device insertion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[13]	0 / 159 (0.00%)	1 / 309 (0.32%)	0 / 110 (0.00%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	0	1	0	0	0	0
intraocular lens implant
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
knee arthroplasty
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	1	0	0	0	0
knee operation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
laparoscopic surgery
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
large intestinal polypectomy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	2	0	1	0	0
lens extraction
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
lipolysis procedure
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
lipoma excision
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
lithotripsy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	0	0	0	0	0
nasal operation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
open reduction of fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
papilloma excision
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
percutaneous coronary intervention
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	5 / 1020 (0.49%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	6	1	0	0	0
peripheral nerve neurostimulation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
phlebectomy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
polypectomy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	2	0	0	0	0
pterygium operation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
rhinoplasty
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
sinus operation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	0	1	0	0
skin neoplasm excision
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
splint application
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
suture insertion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
tenoplasty
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
tonsillectomy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	1 / 333 (0.30%)
occurrences all number	0	1	0	0	0	1
tooth extraction
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	7 / 527 (1.33%)	22 / 1020 (2.16%)	2 / 389 (0.51%)	1 / 453 (0.22%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	9	23	2	1	1	0
tooth restoration
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
tumour excision
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	3	0	0	0	0
uterine dilation and curettage
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[14]	0 / 159 (0.00%)	1 / 309 (0.32%)	0 / 110 (0.00%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	0	1	0	0	0	0
vasectomy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[15]	0 / 368 (0.00%)	1 / 711 (0.14%)	0 / 279 (0.00%)	0 / 323 (0.00%)	0 / 602 (0.00%)	0 / 244 (0.00%)
occurrences all number	0	1	0	0	0	0
vitrectomy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
wisdom teeth removal
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	1	2	1	0	1	0
wound drainage
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
General disorders and administration site conditions
adverse drug reaction
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	3	0	0	0
asthenia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	1 / 1020 (0.10%)	4 / 389 (1.03%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	1	4	0	0	0
chest discomfort
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
chest pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	3	0	0	0	0
chills
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	1	1	0	0
cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
effusion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
fatigue
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	5 / 527 (0.95%)	10 / 1020 (0.98%)	3 / 389 (0.77%)	0 / 453 (0.00%)	0 / 861 (0.00%)	2 / 333 (0.60%)
occurrences all number	6	10	3	0	0	2
granuloma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
hyperthermia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
implant site irritation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
influenza like illness
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	4 / 1020 (0.39%)	4 / 389 (1.03%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	3	5	6	0	1	0
injection site discolouration
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
injection site bruising
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
injection site erythema
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	8 / 1020 (0.78%)	3 / 389 (0.77%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	26	6	0	0	0
injection site haematoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	3	0	0	0
injection site induration
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
injection site inflammation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	3	0	0	0
injection site oedema
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	5	2	0	0	0
injection site pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	8 / 527 (1.52%)	22 / 1020 (2.16%)	6 / 389 (1.54%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	79	283	36	0	0	0
injection site rash
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
injection site pruritus
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	12	3	0	0	0
injection site swelling
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	3	1	0	1	0
injection site reaction
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	6 / 527 (1.14%)	19 / 1020 (1.86%)	19 / 389 (4.88%)	1 / 453 (0.22%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	15	108	44	1	1	0
lithiasis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
malaise
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	1	1	1	0	1	0
mucosal inflammation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
nodule
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
non-cardiac chest pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
oedema peripheral
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	4	2	1	0	0	0
pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	3 / 389 (0.77%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	3	0	0	0
peripheral swelling
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	3 / 1020 (0.29%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	3	2	0	0	0
puncture site pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
pyrexia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	11 / 527 (2.09%)	17 / 1020 (1.67%)	11 / 389 (2.83%)	5 / 453 (1.10%)	2 / 861 (0.23%)	1 / 333 (0.30%)
occurrences all number	12	17	13	5	2	1
swelling face
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
temperature regulation disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
tenderness
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
ulcer
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
vaccination site joint pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
vaccination site oedema
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
vaccination site swelling
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	0	0	0	1	0
vaccination site pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	12 / 1020 (1.18%)	2 / 389 (0.51%)	0 / 453 (0.00%)	2 / 861 (0.23%)	0 / 333 (0.00%)
occurrences all number	1	16	2	0	2	0
xerosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
Immune system disorders
allergy to animal
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
allergy to arthropod bite
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
allergy to arthropod sting
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
anaphylactic reaction
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
drug hypersensitivity
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	2	1	0	0	1	0
food allergy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
hypersensitivity
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	2	1	0	0	0
seasonal allergy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	5 / 527 (0.95%)	9 / 1020 (0.88%)	3 / 389 (0.77%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	6	10	3	0	0	0
Reproductive system and breast disorders
adenomyosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[16]	2 / 159 (1.26%)	0 / 309 (0.00%)	0 / 110 (0.00%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	2	0	0	0	0	0
balanoposthitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[17]	1 / 368 (0.27%)	1 / 711 (0.14%)	0 / 279 (0.00%)	0 / 323 (0.00%)	0 / 602 (0.00%)	0 / 244 (0.00%)
occurrences all number	1	1	0	0	0	0
benign prostatic hyperplasia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[18]	3 / 368 (0.82%)	6 / 711 (0.84%)	2 / 279 (0.72%)	0 / 323 (0.00%)	0 / 602 (0.00%)	0 / 244 (0.00%)
occurrences all number	3	6	2	0	0	0
breast calcifications
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
breast cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
breast disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
breast mass
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
breast pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
cervical cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[19]	0 / 159 (0.00%)	1 / 309 (0.32%)	0 / 110 (0.00%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	0	1	0	0	0	0
dysmenorrhoea
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[20]	0 / 159 (0.00%)	3 / 309 (0.97%)	1 / 110 (0.91%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	0	12	1	0	0	0
endometrial thickening
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[21]	0 / 159 (0.00%)	1 / 309 (0.32%)	0 / 110 (0.00%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	0	1	0	0	0	0
endometriosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[22]	0 / 159 (0.00%)	1 / 309 (0.32%)	1 / 110 (0.91%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
erectile dysfunction
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[23]	0 / 368 (0.00%)	1 / 711 (0.14%)	0 / 279 (0.00%)	0 / 323 (0.00%)	0 / 602 (0.00%)	0 / 244 (0.00%)
occurrences all number	0	1	0	0	0	0
genital erythema
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
genital lesion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
heavy menstrual bleeding
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[24]	0 / 159 (0.00%)	0 / 309 (0.00%)	1 / 110 (0.91%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	0	0	1	0	0	0
intermenstrual bleeding
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[25]	0 / 159 (0.00%)	1 / 309 (0.32%)	0 / 110 (0.00%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	0	1	0	0	0	0
menopausal symptoms
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[26]	0 / 159 (0.00%)	1 / 309 (0.32%)	0 / 110 (0.00%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	0	1	0	0	0	0
menstruation irregular
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[27]	1 / 159 (0.63%)	0 / 309 (0.00%)	0 / 110 (0.00%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	1	0	0	0	0	0
ovarian cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[28]	1 / 159 (0.63%)	2 / 309 (0.65%)	2 / 110 (1.82%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	1	2	2	0	0	0
perineal cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
perineal pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
polycystic ovaries
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[29]	1 / 159 (0.63%)	0 / 309 (0.00%)	0 / 110 (0.00%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	1	0	0	0	0	0
premenstrual pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[30]	0 / 159 (0.00%)	1 / 309 (0.32%)	0 / 110 (0.00%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	0	1	0	0	0	0
prostatitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[31]	1 / 368 (0.27%)	0 / 711 (0.00%)	0 / 279 (0.00%)	0 / 323 (0.00%)	0 / 602 (0.00%)	0 / 244 (0.00%)
occurrences all number	1	0	0	0	0	0
pruritus genital
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
uterine cervical metaplasia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[32]	0 / 159 (0.00%)	1 / 309 (0.32%)	0 / 110 (0.00%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	0	1	0	0	0	0
vulval eczema
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[33]	0 / 159 (0.00%)	1 / 309 (0.32%)	0 / 110 (0.00%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	0	1	0	0	0	0
vulvovaginal inflammation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[34]	1 / 159 (0.63%)	0 / 309 (0.00%)	0 / 110 (0.00%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	1	0	0	0	0	0
vulvovaginal pruritus
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[35]	1 / 159 (0.63%)	0 / 309 (0.00%)	0 / 110 (0.00%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	1	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
allergic cough
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
allergic pharyngitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
asthma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	5 / 527 (0.95%)	5 / 1020 (0.49%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	6	5	0	0	0	0
atelectasis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
bronchitis chronic
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
catarrh
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	2	1	0	1	0
chronic obstructive pulmonary disease
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	4 / 1020 (0.39%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	4	0	0	0	0
cough
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	16 / 527 (3.04%)	28 / 1020 (2.75%)	8 / 389 (2.06%)	1 / 453 (0.22%)	2 / 861 (0.23%)	0 / 333 (0.00%)
occurrences all number	16	30	8	1	2	0
cough variant asthma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
dysphonia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
dyspnoea exertional
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
dyspnoea
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	7 / 1020 (0.69%)	2 / 389 (0.51%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	4	8	3	0	1	0
epistaxis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	3 / 389 (0.77%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	0	3	0	0	0
hiccups
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	0	1	0	0
hyperventilation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
laryngeal disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
lower respiratory tract congestion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	0	0	0	1	0
nasal congestion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	5	4	0	0	0	0
nasal oedema
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
nasal septum deviation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	1	0	0	0
nasal polyps
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
nasal turbinate abnormality
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
nasal turbinate hypertrophy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
nasal ulcer
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	0	0	0	1	0
oropharyngeal pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	11 / 1020 (1.08%)	6 / 389 (1.54%)	0 / 453 (0.00%)	2 / 861 (0.23%)	1 / 333 (0.30%)
occurrences all number	5	12	6	0	2	1
paranasal cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
paranasal sinus discomfort
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
pleural effusion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
productive cough
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	1	0	0	0	0
pulmonary hypertension
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
pulmonary mass
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
pulmonary oedema
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
rhinitis allergic
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	15 / 1020 (1.47%)	2 / 389 (0.51%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	3	17	2	0	1	0
rhinorrhoea
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	6 / 1020 (0.59%)	1 / 389 (0.26%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	4	8	1	0	1	0
sinonasal obstruction
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
sinus congestion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	4 / 1020 (0.39%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	6	1	0	0	0
sleep apnoea syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	6 / 1020 (0.59%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	6	2	0	0	0
sneezing
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	2	0
throat irritation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	1	0
upper respiratory tract inflammation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	2	0	0	0	0
vocal cord leukoplakia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
vocal cord polyp
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
wheezing
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
Psychiatric disorders
adjustment disorder with depressed mood
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
affective disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
alcohol abuse
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
anxiety
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	6 / 527 (1.14%)	11 / 1020 (1.08%)	7 / 389 (1.80%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	7	12	7	0	1	0
attention deficit hyperactivity disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
confusional state
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
depression
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	7 / 527 (1.33%)	6 / 1020 (0.59%)	4 / 389 (1.03%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	7	6	4	0	0	0
depressed mood
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
distractibility
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
dysphoria
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
initial insomnia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	3	0	0	0
insomnia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	11 / 1020 (1.08%)	1 / 389 (0.26%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	4	11	1	0	1	0
major depression
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
mental fatigue
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
mental status changes
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
mood swings
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	2	0	0	0
panic attack
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	1	0	0	0
sleep disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	6 / 1020 (0.59%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	7	0	0	0	0
stress
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	1	0
suicidal ideation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	1	0
suicidal behaviour
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	0	0	0	1	0
suicide attempt
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
Investigations
alanine aminotransferase increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	9 / 527 (1.71%)	23 / 1020 (2.25%)	3 / 389 (0.77%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	10	28	3	0	1	0
arthroscopy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
aspartate aminotransferase increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	9 / 527 (1.71%)	15 / 1020 (1.47%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	11	22	0	0	0	0
aspiration joint
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
basophil count increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
bilirubin conjugated increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
biopsy lymph gland
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
biopsy skin
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
blood alkaline phosphatase increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	4 / 1020 (0.39%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	5	0	1	0	0
blood bilirubin increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	3	0	0	0	0
blood cholesterol increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	1	0	0	0
blood creatine phosphokinase increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	10 / 527 (1.90%)	20 / 1020 (1.96%)	7 / 389 (1.80%)	1 / 453 (0.22%)	0 / 861 (0.00%)	2 / 333 (0.60%)
occurrences all number	11	25	8	1	0	2
blood creatinine increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	3	0	0	0	0
blood gastrin increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
blood glucose increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	2 / 861 (0.23%)	0 / 333 (0.00%)
occurrences all number	0	2	1	0	2	0
blood iron decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	0	0	0	0	0
blood parathyroid hormone increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
blood potassium increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	1	0	0	0
blood pressure abnormal
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
blood pressure increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	4 / 1020 (0.39%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	4	6	2	0	0	0
blood testosterone decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
blood thyroid stimulating hormone increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
blood triglycerides increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	9 / 1020 (0.88%)	2 / 389 (0.51%)	1 / 453 (0.22%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	1	11	2	1	1	0
blood urea increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
blood uric acid increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	4 / 1020 (0.39%)	1 / 389 (0.26%)	0 / 453 (0.00%)	2 / 861 (0.23%)	0 / 333 (0.00%)
occurrences all number	3	5	1	0	2	0
body height decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
body temperature increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
bone scan
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
cardiac murmur
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	2	1	0	0	0
cardiac stress test
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
catheterisation cardiac
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
chest x-ray
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
colonoscopy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
colonoscopy normal
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
computerised tomogram coronary artery
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
coronavirus test positive
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	2	1	0	0	0
culture urine positive
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
echocardiogram
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
ejection fraction decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
electrocardiogram qt prolonged
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
endoscopy upper gastrointestinal tract
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	1	0
gamma-glutamyltransferase increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	9 / 527 (1.71%)	21 / 1020 (2.06%)	2 / 389 (0.51%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	11	28	2	0	1	0
glomerular filtration rate decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
haematocrit increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	0	0	0	0	0
haemoglobin decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
haemoglobin increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
heart rate decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
heart rate increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
heart rate irregular
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
hepatic enzyme increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	5 / 527 (0.95%)	10 / 1020 (0.98%)	3 / 389 (0.77%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	6	11	3	0	0	0
high density lipoprotein increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
hormone level abnormal
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
influenza a virus test positive
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
intraocular pressure increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
kl-6 increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
liver function test abnormal
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
liver function test increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	4 / 1020 (0.39%)	1 / 389 (0.26%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	3	4	1	0	1	0
lymphocyte count decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
lymphocyte morphology abnormal
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
lymphocyte count increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
mammogram
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
neutrophil count increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	0	0	0	0	0
neutrophil count decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	1	0
platelet count decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
platelet count increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
podiatric examination normal
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
prostatic specific antigen increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[36]	0 / 368 (0.00%)	1 / 711 (0.14%)	0 / 279 (0.00%)	0 / 323 (0.00%)	0 / 602 (0.00%)	0 / 244 (0.00%)
occurrences all number	0	1	0	0	0	0
protein urine
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	0	0	0	1	0
red blood cell count decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
renal function test abnormal
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	1 / 333 (0.30%)
occurrences all number	0	0	0	0	0	1
sars-cov-2 test positive
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	3 / 1020 (0.29%)	5 / 389 (1.29%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	3	5	0	0	0
serum ferritin decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
smear cervix
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[37]	0 / 159 (0.00%)	1 / 309 (0.32%)	0 / 110 (0.00%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	0	1	0	0	0	0
spermatozoa progressive motility abnormal
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[38]	0 / 368 (0.00%)	0 / 711 (0.00%)	1 / 279 (0.36%)	0 / 323 (0.00%)	0 / 602 (0.00%)	0 / 244 (0.00%)
occurrences all number	0	0	1	0	0	0
transaminases increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	3	0	0	0	0
ultrasound kidney
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
ultrasound scan
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
urine leukocyte esterase
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	0	1	0	0
urine output decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
vitamin d decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
weight decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	2 / 1020 (0.20%)	3 / 389 (0.77%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	2	3	0	0	0
weight increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	11 / 1020 (1.08%)	1 / 389 (0.26%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	2	11	1	0	1	0
white blood cell count decreased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	1	0
white blood cell count increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	0	0	0	0	0
Injury, poisoning and procedural complications
abdominal injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
accidental overdose
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
animal bite
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	2	0	0	0
animal scratch
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
ankle fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
arthropod bite
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	6 / 1020 (0.59%)	3 / 389 (0.77%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	4	8	3	0	1	0
arthropod sting
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	1	2	0	0	0
avulsion fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	1	0	0	0
back injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
bite
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
bone contusion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	2	0	0	0	0
burns second degree
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
cartilage injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	1	0	0	0	0
chest injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
chillblains
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
clavicle fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
concussion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	0	1	0	0	0
contusion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	7 / 1020 (0.69%)	5 / 389 (1.29%)	1 / 453 (0.22%)	1 / 861 (0.12%)	1 / 333 (0.30%)
occurrences all number	4	7	6	1	1	1
corneal abrasion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
epicondylitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	1	0	0	0
eye injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
fall
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	10 / 1020 (0.98%)	1 / 389 (0.26%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	11	1	1	0	0
fibula fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
foot fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	4 / 1020 (0.39%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	4	1	0	0	0
foreign body in eye
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
forearm fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
foreign body in throat
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
hand fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	1 / 333 (0.30%)
occurrences all number	0	3	1	0	0	1
heat stroke
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
humerus fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	2	0	0	0
injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	2	0	0	0	0
joint dislocation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
joint injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	3	1	0	0	0
ligament rupture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	1	0	0	0
limb injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	8 / 1020 (0.78%)	5 / 389 (1.29%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	8	5	0	2	0
ligament sprain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	6 / 527 (1.14%)	15 / 1020 (1.47%)	3 / 389 (0.77%)	1 / 453 (0.22%)	0 / 861 (0.00%)	1 / 333 (0.30%)
occurrences all number	6	15	3	1	0	2
lower limb fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
lumbar vertebral fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
meniscus injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	2	2	0	0	0
muscle injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
muscle rupture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	2	0	0	0
muscle strain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	4 / 1020 (0.39%)	2 / 389 (0.51%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	3	4	2	0	1	0
post procedural haematoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	0	1	0	0
post vaccination syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
post-traumatic neck syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
procedural nausea
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
procedural pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	6 / 527 (1.14%)	9 / 1020 (0.88%)	2 / 389 (0.51%)	2 / 453 (0.44%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	7	9	2	2	0	0
radius fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
retinal injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
rib fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	2	1	0	0	0
road traffic accident
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
scar
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
skin abrasion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	3 / 1020 (0.29%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	3	1	0	0	0
skin laceration
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	8 / 527 (1.52%)	5 / 1020 (0.49%)	4 / 389 (1.03%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	8	5	5	0	0	0
soft tissue injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
spinal column injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
synovial rupture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
tendon injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
tendon rupture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	4 / 1020 (0.39%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	4	1	0	0	0
thermal burn
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
tooth fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	5 / 1020 (0.49%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	5	1	0	0	0
upper limb fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
vaccination complication
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	13 / 1020 (1.27%)	4 / 389 (1.03%)	1 / 453 (0.22%)	1 / 861 (0.12%)	2 / 333 (0.60%)
occurrences all number	3	13	5	1	1	3
vascular pseudoaneurysm
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
wound complication
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
wound
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	4 / 1020 (0.39%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	4	0	0	0	0
wrist fracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	1	1	0	0
Congenital, familial and genetic disorders
atrial septal defect
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
block vertebra
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
dermoid cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	2	0	0	0
hydrocele
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[39]	0 / 368 (0.00%)	1 / 711 (0.14%)	0 / 279 (0.00%)	0 / 323 (0.00%)	0 / 602 (0.00%)	0 / 244 (0.00%)
occurrences all number	0	1	0	0	0	0
Cardiac disorders
angina pectoris
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	2	0	1	0	0
angina unstable
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
aortic valve incompetence
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
aortic valve sclerosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
arrhythmia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
atrial fibrillation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	5 / 527 (0.95%)	3 / 1020 (0.29%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	1 / 333 (0.30%)
occurrences all number	5	3	2	0	0	1
atrioventricular block first degree
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
bradycardia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
bundle branch block left
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
cardiac failure
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	2	1	0	0	0
cardiac failure congestive
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
cardiomegaly
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
cardiomyopathy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
cardiovascular disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
coronary artery disease
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	3	0	0	0	0
coronary artery stenosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	1 / 333 (0.30%)
occurrences all number	0	1	1	0	0	1
coronary artery thrombosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
coronary ostial stenosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
extrasystoles
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
left atrial enlargement
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
left ventricular failure
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
left ventricular hypertrophy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
mitral valve incompetence
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	3	0	0	0	0
myocardial ischaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	3	0	0	0	0
palpitations
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	3	0	0	0	0
pericarditis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
right atrial enlargement
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
right ventricular hypertrophy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
sinus bradycardia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	1	0	0	0	0
sinus tachycardia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
tachycardia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	3	2	0	0	0
tricuspid valve incompetence
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
ventricular extrasystoles
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
Nervous system disorders
amnesia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
anosmia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
aphasia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
arachnoid cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
ataxia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
bell's palsy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
burning sensation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
carotid arteriosclerosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	0	0	0	0	0
carpal tunnel syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	4 / 1020 (0.39%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	6	0	0	0	0
cerebrovascular accident
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
cervical radiculopathy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
cervicobrachial syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
cognitive disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
complex regional pain syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	0	0	0	1	0
cubital tunnel syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
diabetic neuropathy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	3	0	0	0	0
dizziness
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	9 / 1020 (0.88%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	4	9	0	0	1	0
facial paralysis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	1	0	0
generalised tonic-clonic seizure
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
headache
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	18 / 527 (3.42%)	55 / 1020 (5.39%)	21 / 389 (5.40%)	2 / 453 (0.44%)	7 / 861 (0.81%)	2 / 333 (0.60%)
occurrences all number	21	93	32	2	7	2
hemianopia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
hemiparesis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
hyperaesthesia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
hypoaesthesia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	4 / 1020 (0.39%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	4	0	0	0	0
lethargy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
loss of consciousness
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
lumbar radiculopathy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
memory impairment
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	0	0	0	0	0
migraine
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	6 / 1020 (0.59%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	6	1	0	0	0
myelopathy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
nerve compression
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
neuralgia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	3	1	0	0	0
neuropathy peripheral
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
paraesthesia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	4 / 1020 (0.39%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	5	0	0	0	0
peripheral nerve lesion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	0	0	0	1	0
peroneal nerve palsy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
pineal gland cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
post herpetic neuralgia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
psychomotor hyperactivity
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
sciatica
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	9 / 1020 (0.88%)	3 / 389 (0.77%)	1 / 453 (0.22%)	0 / 861 (0.00%)	1 / 333 (0.30%)
occurrences all number	2	11	3	1	0	1
seizure
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
somnolence
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	1	0
syncope
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	1	0	0	0
transient aphasia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
tremor
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
Blood and lymphatic system disorders
anaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	14 / 1020 (1.37%)	2 / 389 (0.51%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	4	16	2	0	1	0
anaemia macrocytic
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
anaemia of chronic disease
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
bone marrow oedema
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
eosinophilia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
febrile neutropenia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
hypercoagulation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
iron deficiency anaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	0	1	0	0	0
leukocytosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	2	0	0	0
leukopenia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	3 / 389 (0.77%)	0 / 453 (0.00%)	1 / 861 (0.12%)	1 / 333 (0.30%)
occurrences all number	0	2	3	0	1	1
lymphadenitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	0	0	0	0	0
lymphadenopathy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	2	0	0	0
lymphopenia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	2 / 389 (0.51%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	0	2	0	1	0
macrocytosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
neutropenia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	3 / 389 (0.77%)	0 / 453 (0.00%)	0 / 861 (0.00%)	1 / 333 (0.30%)
occurrences all number	0	1	3	0	0	1
neutrophilia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
pancytopenia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	0	1	0	0
splenomegaly
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
thrombocytopenia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	5 / 1020 (0.49%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	5	0	0	0	0
thrombocytosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
Ear and labyrinth disorders
cerumen impaction
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
deafness
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
deafness neurosensory
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
deafness unilateral
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	1	0	0	0
ear discomfort
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
ear inflammation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	0	1	0	0
ear pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	2	0	0	0
eustachian tube dysfunction
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
eustachian tube obstruction
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
external ear inflammation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
hypoacusis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	2	0	0	0
inner ear inflammation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
middle ear effusion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
tinnitus
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	4 / 1020 (0.39%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	4	0	0	0	0
tympanic membrane perforation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
vertigo
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	6 / 1020 (0.59%)	3 / 389 (0.77%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	7	3	0	0	0
vertigo positional
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
Eye disorders
arteriosclerotic retinopathy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
blepharitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
blepharospasm
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	0	0	0	1	0
cataract
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	3 / 1020 (0.29%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	4	2	0	0	0
chalazion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	3	0	0	0	0
chorioretinopathy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
conjunctival haemorrhage
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	2	1	0	0	0
conjunctival hyperaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
conjunctivitis allergic
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	2 / 1020 (0.20%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	2	2	0	0	0
diabetic retinopathy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
dry eye
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	3	0	0	0	0
eye allergy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
eye disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
eye irritation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
eye pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	1	0	0	0
eyelid thickening
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
glaucoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	0	0	0	0	0
iridocyclitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
lacrimation increased
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
macular degeneration
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
ocular hyperaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
ocular surface disease
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
open angle glaucoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
optic disc drusen
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
optic neuropathy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	2	0	0	0
trichiasis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
ulcerative keratitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
vision blurred
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	2	0	0	0	0
vitreous detachment
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	1	0	0	0
vitreous haemorrhage
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
vitreous prolapse
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	0	0	0	0	0
Gastrointestinal disorders
abdominal discomfort
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	3	1	0	0	0
abdominal distension
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	2	0	0	0
abdominal hernia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
abdominal pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	13 / 1020 (1.27%)	5 / 389 (1.29%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	15	17	0	0	0
abdominal pain lower
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	1	0	0	0
abdominal pain upper
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	9 / 1020 (0.88%)	6 / 389 (1.54%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	4	10	6	0	0	0
angular cheilitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
anorectal discomfort
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
cheilitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
chronic gastritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	1	0	0	0
colitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	1	0	0	0
constipation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	9 / 1020 (0.88%)	4 / 389 (1.03%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	9	5	1	0	0
dental caries
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	12 / 1020 (1.18%)	2 / 389 (0.51%)	0 / 453 (0.00%)	1 / 861 (0.12%)	1 / 333 (0.30%)
occurrences all number	3	13	2	0	1	1
diarrhoea
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	15 / 527 (2.85%)	20 / 1020 (1.96%)	9 / 389 (2.31%)	1 / 453 (0.22%)	3 / 861 (0.35%)	2 / 333 (0.60%)
occurrences all number	15	21	33	1	3	2
dry mouth
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
duodenitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
dyspepsia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	6 / 1020 (0.59%)	5 / 389 (1.29%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	9	16	0	0	0
dysphagia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	1	0	0	0
enteritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
enterocolitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
epiploic appendagitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
flatulence
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
food poisoning
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	3 / 1020 (0.29%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	3	1	0	0	0
gastric polyps
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	2	0	0	0	0
gastric ulcer
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	1	0	0	0	0
gastritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	8 / 1020 (0.78%)	2 / 389 (0.51%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	4	10	2	0	1	0
gastritis erosive
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	1	0
gastrointestinal disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
gastrointestinal pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	0	1	0	0
gastrooesophageal reflux disease
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	5 / 527 (0.95%)	8 / 1020 (0.78%)	3 / 389 (0.77%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	5	9	3	0	0	0
gingival pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
glossitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
haematochezia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	2	0	0	0	0
haemorrhagic erosive gastritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
haemorrhoids
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	3 / 1020 (0.29%)	3 / 389 (0.77%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	1	3	3	0	1	0
hiatus hernia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
hyperaesthesia teeth
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
ileus
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
inguinal hernia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	1 / 1020 (0.10%)	3 / 389 (0.77%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	1	3	0	0	0
intra-abdominal haematoma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
irritable bowel syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	1	0	0	0
large intestine polyp
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	1 / 453 (0.22%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	2	2	1	1	1	0
lip swelling
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
lip erosion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
lumbar hernia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
melaena
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
mouth ulceration
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
nausea
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	12 / 1020 (1.18%)	1 / 389 (0.26%)	2 / 453 (0.44%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	4	19	1	2	1	0
noninfective sialoadenitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
odynophagia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	1 / 453 (0.22%)	0 / 861 (0.00%)	1 / 333 (0.30%)
occurrences all number	1	2	1	1	0	1
oesophageal obstruction
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
oesophagitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
oral hyperkeratosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
oral lichen planus
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
oral papule
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	0	1	0	0
pancreatic disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
periodontal disease
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	6 / 1020 (0.59%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	6	1	0	0	0
proctitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
rectal polyp
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
stomatitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	1	0	0	0
terminal ileitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	0	0	0	1	0
tooth disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
tooth impacted
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
toothache
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	5 / 527 (0.95%)	16 / 1020 (1.57%)	9 / 389 (2.31%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	5	19	9	0	1	0
umbilical hernia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
vomiting
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	5 / 527 (0.95%)	5 / 1020 (0.49%)	1 / 389 (0.26%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	5	5	1	1	0	0
Hepatobiliary disorders
biliary colic
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	2	1	0	0	1	0
cholangitis acute
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
cholecystitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
cholelithiasis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	8 / 1020 (0.78%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	8	2	0	0	0
fatty liver alcoholic
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
gallbladder polyp
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	3 / 389 (0.77%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	3	0	0	0
hepatic cirrhosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
hepatic cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	3	0	0	0	0
hepatic function abnormal
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	4 / 1020 (0.39%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	4	0	0	0	0
hepatic steatosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	5 / 527 (0.95%)	12 / 1020 (1.18%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	5	12	2	0	0	0
hepatitis alcoholic
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
hepatomegaly
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
liver disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
non-alcoholic steatohepatitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
nonalcoholic fatty liver disease
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
primary biliary cholangitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
Skin and subcutaneous tissue disorders
acanthosis nigricans
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
acne
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	6 / 1020 (0.59%)	4 / 389 (1.03%)	1 / 453 (0.22%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	4	6	4	1	1	0
acne varioliformis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
actinic keratosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	5 / 1020 (0.49%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	5	2	0	0	0
alopecia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	2	0	0	0	0
alopecia areata
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	2	0	0	0	0
angioedema
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	2	0	0	0
asteatosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
dermal cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	4 / 1020 (0.39%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	4	0	0	0	0
dermatitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	3 / 1020 (0.29%)	1 / 389 (0.26%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	1	3	1	0	1	0
dermatitis contact
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	10 / 1020 (0.98%)	5 / 389 (1.29%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	4	12	8	0	0	0
dermatitis papillaris capillitii
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
diabetic foot
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
drug eruption
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	2	0	0	0
dry skin
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	3 / 1020 (0.29%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	3	3	0	0	0
dyshidrotic eczema
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	3 / 1020 (0.29%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	4	1	0	0	0
eczema
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	10 / 1020 (0.98%)	3 / 389 (0.77%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	4	10	3	0	1	0
eczema asteatotic
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	1 / 1020 (0.10%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	1 / 333 (0.30%)
occurrences all number	2	1	2	0	0	1
eczema nummular
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	0	0	0	0	0
erythema
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	3	0	0	0	0
hand dermatitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
hyperhidrosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
hyperkeratosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	4 / 1020 (0.39%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	4	0	0	0	0
ingrowing nail
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	0	1	0	0	0
intertrigo
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	4 / 1020 (0.39%)	1 / 389 (0.26%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	3	5	1	0	1	0
itching scar
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	0	1	0	0
lichen planus
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
lichen sclerosus
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
lichenification
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
lichenoid keratosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
mechanical urticaria
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
milia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
miliaria
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	3	0	0	0
nail discolouration
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
nail dystrophy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
neurodermatitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	2	0	0	0	0
night sweats
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	1	0	0	0
onycholysis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	3	0	0	0	0
palmar erythema
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	2	0	0	0
papule
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
photosensitivity reaction
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	2	0	0	0
post inflammatory pigmentation change
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
prurigo
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
pruritus
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	12 / 527 (2.28%)	17 / 1020 (1.67%)	6 / 389 (1.54%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	12	20	7	0	1	0
psoriasis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	0	0	0	0	0
rash
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	5 / 1020 (0.49%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	5	2	0	0	0
rosacea
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
seborrhoeic dermatitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	4 / 1020 (0.39%)	0 / 389 (0.00%)	1 / 453 (0.22%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	1	4	0	1	1	0
skin burning sensation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
skin erosion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
skin exfoliation
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
skin fissures
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	2	0	0	0
skin lesion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
skin tightness
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
skin plaque
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
skin ulcer
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
stasis dermatitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
urticaria physical
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
urticaria
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	5 / 527 (0.95%)	12 / 1020 (1.18%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	5	12	1	0	0	0
vitiligo
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
Renal and urinary disorders
acute kidney injury
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	2	0	0	0	0
chronic kidney disease
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
cystitis noninfective
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	1	0	0	0	0
dysuria
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	2 / 861 (0.23%)	0 / 333 (0.00%)
occurrences all number	0	2	1	0	2	0
glycosuria
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	1 / 453 (0.22%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	1	0	0	1	1	0
haematuria
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	3 / 1020 (0.29%)	1 / 389 (0.26%)	1 / 453 (0.22%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	2	3	1	1	1	0
haemorrhage urinary tract
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
hydronephrosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
ketonuria
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	0	1	0	0
kidney congestion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
leukocyturia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
nephritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
nephrolithiasis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	5 / 1020 (0.49%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	8	0	0	0	0
nocturia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
pollakiuria
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
proteinuria
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	0	1	0	0
renal colic
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	4	0	0	0	0
renal cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	3 / 1020 (0.29%)	3 / 389 (0.77%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	3	3	0	0	0
renal failure
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
renal impairment
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	1 / 333 (0.30%)
occurrences all number	0	0	0	0	0	1
ureterolithiasis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	2	0	0	0	0
Endocrine disorders
acromegaly
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
autoimmune thyroiditis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
goitre
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	1	0
hyperparathyroidism
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
hyperprolactinaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
hyperthyroidism
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	2	0	0	0
hypogonadism
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
hypothyroidism
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	6 / 1020 (0.59%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	4	6	1	0	0	0
thyroid mass
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	30 / 527 (5.69%)	87 / 1020 (8.53%)	19 / 389 (4.88%)	0 / 453 (0.00%)	1 / 861 (0.12%)	2 / 333 (0.60%)
occurrences all number	36	95	23	0	1	2
arthritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	10 / 1020 (0.98%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	10	2	0	0	0
arthropathy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
axillary mass
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
back pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	25 / 527 (4.74%)	48 / 1020 (4.71%)	20 / 389 (5.14%)	0 / 453 (0.00%)	4 / 861 (0.46%)	0 / 333 (0.00%)
occurrences all number	27	61	22	0	4	0
bursitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	6 / 1020 (0.59%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	4	6	0	0	0	0
cervical spinal stenosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
chondrocalcinosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
chondropathy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
costochondritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	0	0	0	0	0
dactylitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	5	1	2	0	0	0
enthesopathy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	4	0	0	0	0
exostosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
fibromyalgia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	2	0	0	0	0
flank pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	0	1	0	0	0
groin pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
haemarthrosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
intervertebral disc degeneration
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	3	0	0	0	0
intervertebral disc disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	1	0	0	0
intervertebral disc protrusion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	7 / 1020 (0.69%)	2 / 389 (0.51%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	3	7	2	0	1	0
intervertebral disc space narrowing
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
joint effusion
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
joint stiffness
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
joint swelling
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
ligament disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
ligament pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
lumbar spinal stenosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
muscle contracture
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
muscle spasms
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	9 / 1020 (0.88%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	10	0	0	0	0
muscle tightness
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
musculoskeletal chest pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	2	0	0	0	1	0
musculoskeletal pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	4	1	0	0	0
myalgia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	5 / 527 (0.95%)	12 / 1020 (1.18%)	3 / 389 (0.77%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	7	16	3	0	1	0
musculoskeletal stiffness
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	3	0	0	0	0
myositis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
neck pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	9 / 1020 (0.88%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	9	3	0	0	0
osteoarthritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	6 / 527 (1.14%)	8 / 1020 (0.78%)	4 / 389 (1.03%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	7	8	4	0	0	0
osteopenia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
osteoporosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
pain in extremity
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	6 / 527 (1.14%)	22 / 1020 (2.16%)	7 / 389 (1.80%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	7	28	8	1	0	0
pain in jaw
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
patellofemoral pain syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
periarthritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	4 / 1020 (0.39%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	4	0	0	0	0
plantar fasciitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	2	0	0	0	0
psoriatic arthropathy
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	9 / 527 (1.71%)	12 / 1020 (1.18%)	10 / 389 (2.57%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	9	12	12	0	0	0
rheumatic disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
rotator cuff syndrome
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	4 / 1020 (0.39%)	2 / 389 (0.51%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	4	2	1	0	0
sacroiliitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
scoliosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
spinal osteoarthritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	7 / 1020 (0.69%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	7	2	0	0	0
spinal pain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	6 / 527 (1.14%)	7 / 1020 (0.69%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	6	11	1	0	0	0
spinal retrolisthesis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
spondylolisthesis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
synovial cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	2	0	0	0	0
synovitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	3 / 1020 (0.29%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	5	3	1	0	0	0
tendon disorder
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
tendonitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	10 / 1020 (0.98%)	4 / 389 (1.03%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	10	4	0	0	0
tenosynovitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	2	3	0	0	1	0
tenosynovitis stenosans
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
trigger finger
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
vertebral foraminal stenosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
Infections and infestations
abdominal infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
abscess
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	2	0	0	0	0
abscess jaw
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
abscess limb
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
acarodermatitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	3	0	0	0	0
acute sinusitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	4 / 1020 (0.39%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	6	0	0	0	0
adenoviral conjunctivitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
appendicitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
appendicitis perforated
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	0	0	0	1	0
asymptomatic covid-19
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	0	0	0	0	0
bacterial vaginosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[40]	0 / 159 (0.00%)	0 / 309 (0.00%)	1 / 110 (0.91%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	0	0	1	0	0	0
body tinea
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	1	0	0	0
bronchitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	10 / 527 (1.90%)	24 / 1020 (2.35%)	4 / 389 (1.03%)	1 / 453 (0.22%)	2 / 861 (0.23%)	0 / 333 (0.00%)
occurrences all number	11	25	4	1	2	0
bronchitis bacterial
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
covid-19
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	33 / 527 (6.26%)	66 / 1020 (6.47%)	26 / 389 (6.68%)	16 / 453 (3.53%)	11 / 861 (1.28%)	6 / 333 (1.80%)
occurrences all number	33	67	28	16	11	6
covid-19 pneumonia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	0	0	0	0	0
candida infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	0	0	0	0	0
cellulitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	6 / 1020 (0.59%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	1 / 333 (0.30%)
occurrences all number	1	6	2	0	0	1
chronic sinusitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
conjunctivitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	8 / 1020 (0.78%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	4	8	2	0	0	0
conjunctivitis bacterial
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
conjunctivitis viral
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
coronavirus infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
coronavirus pneumonia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
cystitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	7 / 1020 (0.69%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	4	8	2	0	0	0
cystitis bacterial
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
dermatophytosis of nail
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
diverticulitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	3 / 389 (0.77%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	2	4	0	1	0
ear infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	2	1	0	0	0
endocarditis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
enterococcal infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
epididymitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[41]	0 / 368 (0.00%)	3 / 711 (0.42%)	0 / 279 (0.00%)	0 / 323 (0.00%)	0 / 602 (0.00%)	0 / 244 (0.00%)
occurrences all number	0	3	0	0	0	0
erysipelas
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	2	1	0	0	0
erythema migrans
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
erythrasma
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
folliculitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	7 / 527 (1.33%)	6 / 1020 (0.59%)	3 / 389 (0.77%)	0 / 453 (0.00%)	1 / 861 (0.12%)	1 / 333 (0.30%)
occurrences all number	7	6	3	0	1	1
fungal infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	1	0	0	0
fungal skin infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	1 / 333 (0.30%)
occurrences all number	1	0	0	0	0	1
furuncle
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	6 / 1020 (0.59%)	4 / 389 (1.03%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	8	6	0	0	0
gastroenteritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	6 / 527 (1.14%)	15 / 1020 (1.47%)	3 / 389 (0.77%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	6	17	3	1	0	0
gastroenteritis norovirus
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	1	0	0	0
gastroenteritis bacterial
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
gastroenteritis viral
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	6 / 1020 (0.59%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	6	1	0	0	0
gastrointestinal infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	5 / 1020 (0.49%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	5	0	0	0	0
gastrointestinal viral infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
genital candidiasis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	0	0	0	1	0
genital herpes
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	3	0	0	0
genital herpes simplex
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
genital infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
gingivitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	5 / 1020 (0.49%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	5	1	0	0	0
helicobacter infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	2	0	0	0	0
hepatitis a
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
herpangina
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
herpes simplex
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	4	0	0	0	0
herpes zoster
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	6 / 527 (1.14%)	7 / 1020 (0.69%)	4 / 389 (1.03%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	6	8	4	0	1	0
herpes zoster infection neurological
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
histoplasmosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
hordeolum
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	3 / 1020 (0.29%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	3	1	0	0	0
impetigo
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	1	0	0	0
infected cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
influenza
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	18 / 1020 (1.76%)	2 / 389 (0.51%)	1 / 453 (0.22%)	0 / 861 (0.00%)	1 / 333 (0.30%)
occurrences all number	4	18	2	1	0	1
injection site infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
intervertebral discitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
laryngitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	2 / 389 (0.51%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	2	2	0	1	0
latent tuberculosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	4 / 1020 (0.39%)	4 / 389 (1.03%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	4	4	4	0	0	0
localised infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	1	0
lower respiratory tract infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	2	0	0	0
lyme disease
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
lymphogranuloma venereum
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
molluscum contagiosum
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
mucocutaneous candidiasis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
mycobacterial infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
myringitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
nasopharyngitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	55 / 527 (10.44%)	157 / 1020 (15.39%)	43 / 389 (11.05%)	5 / 453 (1.10%)	11 / 861 (1.28%)	5 / 333 (1.50%)
occurrences all number	69	226	57	5	11	5
onychomycosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	1 / 1020 (0.10%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	1	2	0	0	0
ophthalmic herpes simplex
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
oral candidiasis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	4 / 1020 (0.39%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	4	0	0	0	0
oral fungal infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
oral herpes
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	7 / 527 (1.33%)	11 / 1020 (1.08%)	2 / 389 (0.51%)	1 / 453 (0.22%)	2 / 861 (0.23%)	0 / 333 (0.00%)
occurrences all number	9	12	2	1	2	0
oral infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
oropharyngeal candidiasis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
otitis media
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	5 / 1020 (0.49%)	2 / 389 (0.51%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	5	2	1	0	0
otitis externa
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	4	0	0	0	0
papilloma viral infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
paronychia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	1	3	0	0	1	0
parotitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
pericoronitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
perineal abscess
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
periodontitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	4 / 1020 (0.39%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	4	2	0	0	0
pharyngitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	9 / 527 (1.71%)	17 / 1020 (1.67%)	10 / 389 (2.57%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	11	19	10	0	1	0
pharyngitis streptococcal
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	4 / 1020 (0.39%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	4	1	0	0	0
pharyngotonsillitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	5 / 1020 (0.49%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	0	5	0	0	1	0
pilonidal cyst
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
pneumonia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	3 / 1020 (0.29%)	1 / 389 (0.26%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	1	3	1	0	1	0
post procedural infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
postoperative wound infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	1	0	0	0
pulpitis dental
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	3 / 1020 (0.29%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	5	2	0	0	0
rash pustular
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
respiratory tract infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	8 / 1020 (0.78%)	4 / 389 (1.03%)	1 / 453 (0.22%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	4	9	4	1	1	0
respiratory tract infection viral
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
rhinitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	5 / 527 (0.95%)	11 / 1020 (1.08%)	3 / 389 (0.77%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	5	12	3	0	1	0
rhinovirus infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	2	0	0	0
root canal infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
salmonellosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	1	0	0	0
sinusitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	7 / 527 (1.33%)	21 / 1020 (2.06%)	7 / 389 (1.80%)	1 / 453 (0.22%)	0 / 861 (0.00%)	2 / 333 (0.60%)
occurrences all number	8	23	8	1	0	2
skin candida
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	1	3	0	0	1	0
skin infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	2	1	0	0	0
soft tissue infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
subcutaneous abscess
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	1	0	0
superinfection mycobacterial
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
superinfection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
suspected covid-19
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	3	0	0	0	0
testicular abscess
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[42]	1 / 368 (0.27%)	0 / 711 (0.00%)	0 / 279 (0.00%)	0 / 323 (0.00%)	0 / 602 (0.00%)	0 / 244 (0.00%)
occurrences all number	1	0	0	0	0	0
tinea cruris
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	1	0	0	0	0
tinea infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	1	0	0	0	0
tinea pedis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	5 / 527 (0.95%)	12 / 1020 (1.18%)	4 / 389 (1.03%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	8	13	4	0	1	0
tinea versicolour
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	7 / 1020 (0.69%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	6	9	1	0	0	0
tonsillitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	10 / 1020 (0.98%)	5 / 389 (1.29%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	5	10	5	0	0	0
tooth abscess
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	4 / 1020 (0.39%)	1 / 389 (0.26%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	4	1	1	0	0
tooth infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	10 / 1020 (0.98%)	4 / 389 (1.03%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	5	11	4	0	0	0
trichophytosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
tuberculosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
upper respiratory tract infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	22 / 527 (4.17%)	54 / 1020 (5.29%)	29 / 389 (7.46%)	5 / 453 (1.10%)	5 / 861 (0.58%)	4 / 333 (1.20%)
occurrences all number	29	64	42	5	5	4
urethritis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	1 / 333 (0.30%)
occurrences all number	0	1	0	0	0	1
urinary tract infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	11 / 527 (2.09%)	30 / 1020 (2.94%)	9 / 389 (2.31%)	0 / 453 (0.00%)	5 / 861 (0.58%)	1 / 333 (0.30%)
occurrences all number	14	38	9	0	6	1
urinary tract infection enterococcal
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
vaginal infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[43]	1 / 159 (0.63%)	3 / 309 (0.97%)	0 / 110 (0.00%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	1	8	0	0	0	0
viral infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	0	0	0
viral sinusitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
viral upper respiratory tract infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	4 / 1020 (0.39%)	2 / 389 (0.51%)	0 / 453 (0.00%)	2 / 861 (0.23%)	0 / 333 (0.00%)
occurrences all number	2	4	2	0	2	0
vulvovaginal candidiasis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[44]	1 / 159 (0.63%)	2 / 309 (0.65%)	1 / 110 (0.91%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	1	4	1	0	0	0
vulvovaginal mycotic infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[45]	3 / 159 (1.89%)	1 / 309 (0.32%)	2 / 110 (1.82%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	3	1	2	0	0	0
vulvovaginitis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed ^[46]	0 / 159 (0.00%)	0 / 309 (0.00%)	1 / 110 (0.91%)	0 / 130 (0.00%)	0 / 259 (0.00%)	0 / 89 (0.00%)
occurrences all number	0	0	1	0	0	0
wound infection
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	2	0	0	0
Metabolism and nutrition disorders
abnormal weight gain
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
decreased appetite
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	4 / 1020 (0.39%)	1 / 389 (0.26%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	4	1	1	0	0
diabetes mellitus
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	5 / 527 (0.95%)	12 / 1020 (1.18%)	2 / 389 (0.51%)	1 / 453 (0.22%)	0 / 861 (0.00%)	2 / 333 (0.60%)
occurrences all number	5	13	2	1	0	2
dyslipidaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	5 / 1020 (0.49%)	3 / 389 (0.77%)	1 / 453 (0.22%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	4	5	3	1	1	0
glucose tolerance impaired
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	1	0	0	0	0
gout
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	9 / 1020 (0.88%)	3 / 389 (0.77%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	3	13	4	0	1	0
hypercalcaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	1 / 333 (0.30%)
occurrences all number	0	1	0	0	0	1
hypercholesterolaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	4 / 527 (0.76%)	12 / 1020 (1.18%)	3 / 389 (0.77%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	4	14	3	0	0	0
hyperglycaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	2 / 527 (0.38%)	10 / 1020 (0.98%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	2	10	2	0	0	0
hyperkalaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	1 / 389 (0.26%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	1	2	1	0	1	0
hyperlipidaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	11 / 1020 (1.08%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	11	0	0	0	0
hypernatraemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	1 / 333 (0.30%)
occurrences all number	0	0	0	0	0	1
hypertriglyceridaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	17 / 1020 (1.67%)	0 / 389 (0.00%)	1 / 453 (0.22%)	2 / 861 (0.23%)	0 / 333 (0.00%)
occurrences all number	0	28	0	1	2	0
hyperuricaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	5 / 527 (0.95%)	5 / 1020 (0.49%)	1 / 389 (0.26%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	5	6	1	0	1	0
hypokalaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	2	0	1	0	0
hypomagnesaemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	2 / 1020 (0.20%)	0 / 389 (0.00%)	1 / 453 (0.22%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	2	0	1	0	0
hyponatraemia
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	3 / 1020 (0.29%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	3	0	0	0	0
hypovitaminosis
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
impaired fasting glucose
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
insulin resistance
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	1 / 527 (0.19%)	0 / 1020 (0.00%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	1	0	0	0	0	0
iron deficiency
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	0 / 1020 (0.00%)	1 / 389 (0.26%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	0	1	0	0	0
overweight
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
type 2 diabetes mellitus
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	5 / 527 (0.95%)	8 / 1020 (0.78%)	5 / 389 (1.29%)	0 / 453 (0.00%)	1 / 861 (0.12%)	0 / 333 (0.00%)
occurrences all number	5	8	5	0	1	0
underweight
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	1 / 1020 (0.10%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	1	0	0	0	0
vitamin b12 deficiency
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	0 / 527 (0.00%)	4 / 1020 (0.39%)	0 / 389 (0.00%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	0	4	0	0	0	0
vitamin d deficiency
alternative dictionary used: MedDRA 24.1
subjects affected / exposed	3 / 527 (0.57%)	5 / 1020 (0.49%)	2 / 389 (0.51%)	0 / 453 (0.00%)	0 / 861 (0.00%)	0 / 333 (0.00%)
occurrences all number	3	5	2	0	0	0

Notes
[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: Gender specific events only occurring in male or female participants have had the number of participants at risk 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: Gender specific events only occurring in male or female participants have had the number of participants at risk 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[12] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[13] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[14] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[15] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[16] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[17] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[18] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[19] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[20] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[21] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[22] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[23] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[24] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[25] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[26] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[27] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[28] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[29] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[30] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[31] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[32] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[33] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[34] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[35] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[36] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[37] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[38] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[39] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[40] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[41] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[42] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[43] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[44] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[45] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
[46] - 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: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

More information

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Were there any global substantial amendments to the protocol? Yes

15 Nov 2018

- Modified schedule of activities, clinical laboratory tests, inclusion criteria and immunogenicity assessments sections; -Added ability for participants to receive psoriasis therapy with another agent(s) in post-treatment follow-up period; - Text clarified in blinding details; - Stricter discontinuation language for clinically significant systemic hypersensitivity events has been applied throughout the protocol; - Added expectation on timing of clinical assessments of tuberculosis (TB) risk.

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.

This study was terminated before completion of the long-term extension trial, due to strategic business decision made by the company.

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