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Clinical Trial Results:
A Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures

Summary
EudraCT number	2020-002109-24
Trial protocol	Outside EU/EEA
Global end of trial date	28 May 2020

Results information
Results version number	v1(current)
This version publication date	13 Dec 2020
First version publication date	13 Dec 2020
Other versions

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

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Trial information

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Sponsor protocol code

E2007-J000-335

ISRCTN number

US NCT number

NCT01618695

WHO universal trial number (UTN)

Other trial identifiers

China: CTR20131839, Japan: JapicCTI-121906

Sponsor organisation name

Eisai Co., Ltd.

Sponsor organisation address

4-6-10 Koishikawa, Bunkyo-Ku, Tokyo, Japan, 112-8088

Public contact

Inquiry Service., Eisai Co., Ltd., eisai-chiken_hotline@hhc.eisai.co.jp

Scientific contact

Inquiry Service., Eisai Co., Ltd., eisai-chiken_hotline@hhc.eisai.co.jp

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

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

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

Yes

Analysis stage

Final

Date of interim/final analysis

28 May 2020

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

28 May 2020

Was the trial ended prematurely?

Main objective of the trial

The primary purpose of this trial was to confirm the efficacy of perampanel (4 milligram [mg], 8 mg and 12 mg) compared to placebo given as an adjunctive therapy in subjects with refractory partial-onset seizures.

Protection of trial subjects

This study was conducted in accordance with standard operating procedures of the sponsor (or designee), which are designed to ensure adherence to Good Clinical Practice (GCP) guidelines as required by the following: - Principles of the World Medical Association Declaration of Helsinki (World Medical Association, 2008). - International Council on Harmonisation (ICH) E6 Guideline for GCP (CPMP/ICH/135/95) of the European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products, International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. - Title 21 of the United States (US) Code of Federal Regulations (US 21 CFR) regarding clinical studies, including Part 50 and Part 56 concerning informed subject consent and Institutional Review Board regulations and applicable sections of US 21 CFR Part 312. - European Good Clinical Practice Directive 2005/28/EC and Clinical Trial Directive 2001/20/EC for studies conducted within any European Union (EU) country. All suspected unexpected serious adverse reactions were reported, as required, to the Competent Authorities of all involved EU member states. - Article 14, Paragraph 3, and Article 80-2 of the Pharmaceutical Affairs Law (Law No. 145, 1960) for studies conducted in Japan, in addition to Japan’s GCP Subject Information and Informed Consent.

Background therapy

Evidence for comparator

Actual start date of recruitment

15 May 2012

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Korea, Republic of: 171

Country: Number of subjects enrolled

Thailand: 36

Country: Number of subjects enrolled

Malaysia: 14

Country: Number of subjects enrolled

Japan: 245

Country: Number of subjects enrolled

China: 185

Country: Number of subjects enrolled

Australia: 44

Country: Number of subjects enrolled

Taiwan: 12

Worldwide total number of subjects

707

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

623

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Subjects took part in the study at 119 investigative sites in Australia, China, Korea, Japan, Malaysia, Taiwan, and Thailand from 15th May 2012 to 28th May 2020.

Screening details

A total of 940 subjects were enrolled and screened, of which 230 subjects were screen failures, 710 subjects were randomized and 707 subjects were treated in this study. This study included Core Phase and an Extension Phase.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Core Phase: Placebo

Arm description

Subjects received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime.

Core Phase: Perampanel 4 mg

Arm description

Subjects received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period was 19 weeks.

Arm type

Experimental

Investigational medicinal product name

Perampanel

Investigational medicinal product code

Other name

E2007

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received perampanel 2 mg (administered as a single tablet) orally, once daily before bedtime and then titrated up to maximum dose of 4 mg (administered as two 2 mg tablets) orally, once daily (titration period), followed by perampanel 4 mg orally, once daily (maintenance period). Each perampanel tablet contained 2 mg, subjects also received either 5 or 4 placebo tablets to ensure all subjects received 6 tablets regardless of the perampanel dose.

Core Phase: Perampanel 8 mg

Arm description

Subjects received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period was 19 weeks.

Arm type

Experimental

Investigational medicinal product name

Perampanel

Investigational medicinal product code

Other name

E2007

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received perampanel 2 mg (administered as a single tablet) orally, once daily before bedtime and then titrated up to maximum dose of 8 mg (administered as four 2 mg tablets with weekly increments of 2 mg) orally, once daily (titration period), followed by perampanel 8 mg orally, once daily (maintenance period). Each perampanel tablet contained 2 mg, subjects also received 5, 4, 3 or 2 placebo tablets to ensure all subjects received 6 tablets regardless of the perampanel dose.

Core Phase: Perampanel 12 mg

Arm description

Subjects received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period was 19 weeks.

Arm type

Experimental

Investigational medicinal product name

Perampanel

Investigational medicinal product code

Other name

E2007

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received perampanel 2 mg (administered as a single tablet) orally, once daily before bedtime and then titrated up to maximum dose of 12 mg (administered as six 2 mg tablets with weekly increments of 2 mg from Week 1 up to Week 5) orally, once daily (titration period), followed by perampanel 12 mg orally, once daily (maintenance period). Each perampanel tablet contained 2 mg, subjects also received 5, 4, 3, 2, 1 or 0 placebo tablets to ensure all subjects received 6 tablets regardless of the perampanel dose.

Extension Phase: Perampanel 12 mg

Arm description

Subjects received the same dose of perampanel in Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). This dose was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally once daily up to Week 28 (conversion period). Subjects who received perampanel matched-placebo in Core Phase were given perampanel 2 mg weekly increments up to a maximum dose of 12 mg, orally once daily up to Week 28 (conversion period). A maintenance period was followed by conversion period in which subjects received perampanel 12 mg, orally once daily before bedtime up to Week 75 or longer depending on the requirements of each country.

Arm type

Experimental

Investigational medicinal product name

Perampanel

Investigational medicinal product code

Other name

E2007

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received the same dose of perampanel in Extension Phase as they received in Core Phase, orally once daily before bedtime from Week 19 to Week 22 (preconversion period) and then dose was up titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally once daily up to Week 28 (conversion period). Subjects who received perampanel matched-placebo in Core Phase were given perampanel 2 mg weekly increments up to a maximum dose of 12 mg, orally once daily up to Week 28 (conversion period). A maintenance period was followed by conversion period in which subjects received perampanel 12 mg, orally once daily before bedtime up to Week 75 or longer depending on the requirements of each country. Each perampanel tablet contained 2 mg, subjects also received 5, 4, 3, 2, 1 or 0 placebo tablets to ensure all subjects received 6 tablets regardless of the perampanel dose.

Number of subjects in period 1	Core Phase: Placebo	Core Phase: Perampanel 4 mg	Core Phase: Perampanel 8 mg	Core Phase: Perampanel 12 mg	Extension Phase: Perampanel 12 mg
Started	176	176	175	180	596
Completed	152	156	147	144	196
Not completed	24	20	28	36	400
Consent withdrawn by subject	16	11	9	13	166
Pregnancy	2	-	-	-	4
Other than specified	1	2	2	2	62
Adverse Events	4	5	15	20	63
Lost to follow-up	-	-	1	-	5
Lack of efficacy	1	2	1	1	100

Baseline characteristics

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Reporting group title

Overall Study

Reporting group description

Reporting group values	Overall Study	Total
Number of subjects	707	707
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	33.4 ( 13.21 )	-
Gender categorical
Units: Subjects
Female	361	361
Male	346	346
Ethnicity
Units: Subjects
Hispanic or Latino	2	2
Not Hispanic or Latino	705	705
Unknown or Not Reported	0	0
Race
Units: Subjects
American Indian or Alaska Native	0	0
Asian	667	667
Native Hawaiian or Other Pacific Islander	1	1
Black or African American	0	0
White	35	35
More than one race	0	0
Unknown or Not Reported	4	4

End points

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Reporting group title

Core Phase: Placebo

Reporting group description

Subjects received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).

Reporting group title

Core Phase: Perampanel 4 mg

Reporting group description

Reporting group title

Core Phase: Perampanel 8 mg

Reporting group description

Reporting group title

Core Phase: Perampanel 12 mg

Reporting group description

Reporting group title

Extension Phase: Perampanel 12 mg

Reporting group description

Primary: Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline)

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End point title

Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline) ^[1]

End point description

Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. All partial seizure included simple partial seizures without motor signs, simple partial with motor signs, complex partial, and complex partial with secondary generalized seizures. A simple partial seizure takes place on one side of the brain. Usually, people experiencing a simple partial seizure do not lose consciousness or awareness. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain. The seizure affects people's awareness and may cause them to lose consciousness. Intent-to-treat (ITT) Analysis Set included all subjects who signed informed consent, were randomized, received at least one dose of study medication, and have at least one postdose seizure frequency data.

End point type

Primary

End point timeframe

Baseline, Week 19

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was only planned to be analyzed for the reporting groups of Core Phase.

End point values	Core Phase: Placebo	Core Phase: Perampanel 4 mg	Core Phase: Perampanel 8 mg	Core Phase: Perampanel 12 mg
Number of subjects analysed	175	174	175	180
Units: percent change
median (full range (min-max))	-10.76 (-90.4 to 400.0)	-17.32 (-97.1 to 473.4)	-28.95 (-100.0 to 809.4)	-38.03 (-100.0 to 456.8)

Placebo, Perampanel 4 mg

Statistical analysis description

Median Difference to placebo and the 95 percent (%) confidence interval are based on the Hodges-Lehmann method.

Comparison groups

Core Phase: Placebo v Core Phase: Perampanel 4 mg

Number of subjects included in analysis

349

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.233

Method

ANCOVA

Parameter type

Median difference (final values)

Point estimate

-5.09

Confidence interval

level

95%

sides

2-sided

lower limit

-14.112

upper limit

4.519

Placebo, Perampanel 8 mg

Statistical analysis description

Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.

Comparison groups

Core Phase: Placebo v Core Phase: Perampanel 8 mg

Number of subjects included in analysis

350

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0003

Method

ANCOVA

Parameter type

Median difference (final values)

Point estimate

-16.45

Confidence interval

level

95%

sides

2-sided

lower limit

-25.683

upper limit

-7.251

Placebo, Perampanel 12 mg

Statistical analysis description

Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.

Comparison groups

Core Phase: Placebo v Core Phase: Perampanel 12 mg

Number of subjects included in analysis

355

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

ANCOVA

Parameter type

Median difference (final values)

Point estimate

-24.95

Confidence interval

level

95%

sides

2-sided

lower limit

-33.878

upper limit

-16.235

Secondary: Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF)

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End point title

Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF) ^[2]

End point description

Responder rate was percentage of subjects with greater than or equal to (>=) 50% reduction in seizure frequency during maintenance period of the randomization phase relative to prerandomization phase (baseline). If the reduction in seizure frequency is less than (<) 50%, then the subjects are considered as non-responders. ITT Analysis Set included all subjects who signed informed consent, were randomized, received at least one dose of study medication, and have at least one postdose seizure frequency data.

End point type

Secondary

End point timeframe

Baseline, Week 19

Notes
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was only planned to be analyzed for the reporting groups of Core Phase.

End point values	Core Phase: Placebo	Core Phase: Perampanel 4 mg	Core Phase: Perampanel 8 mg	Core Phase: Perampanel 12 mg
Number of subjects analysed	175	174	175	180
Units: percentage of subjects
number (not applicable)	19.4	23.0	36.0	43.3

Placebo, Perampanel 4 mg

Comparison groups

Core Phase: Placebo v Core Phase: Perampanel 4 mg

Number of subjects included in analysis

349

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3954

Method

Cochran-Mantel-Haenszel

Confidence interval

Placebo, Perampanel 8 mg

Comparison groups

Core Phase: Placebo v Core Phase: Perampanel 8 mg

Number of subjects included in analysis

350

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0005

Method

Cochran-Mantel-Haenszel

Confidence interval

Placebo, Perampanel 12 mg

Comparison groups

Core Phase: Placebo v Core Phase: Perampanel 12 mg

Number of subjects included in analysis

355

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Cochran-Mantel-Haenszel

Confidence interval

Secondary: Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline)

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End point title

Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline) ^[3]

End point description

Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain and it affects awareness and may cause in loss of consciousness. Secondary generalized seizures begin in one part of the brain, but then spread to both sides of the brain. ITT Analysis Set included all subjects who signed informed consent, were randomized, received at least one dose of study medication, and have at least one postdose seizure frequency data. Here "subjects analyzed" signifies subjects who were evaluable for this outcome measure.

End point type

Secondary

End point timeframe

Baseline, Week 19

Notes
[3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was only planned to be analyzed for the reporting groups of Core Phase.

End point values	Core Phase: Placebo	Core Phase: Perampanel 4 mg	Core Phase: Perampanel 8 mg	Core Phase: Perampanel 12 mg
Number of subjects analysed	158	151	157	167
Units: percent change
median (full range (min-max))	-11.70 (-88.6 to 400.0)	-19.08 (-100.0 to 410.0)	-33.68 (-100.0 to 1103.4)	-41.80 (-100.0 to 456.8)

Placebo, Perampanel 4 mg

Comparison groups

Core Phase: Placebo v Core Phase: Perampanel 4 mg

Number of subjects included in analysis

309

Analysis specification

Pre-specified

Analysis type

superiority ^[4]

P-value

= 0.0552

Method

ANCOVA

Parameter type

Median difference (final values)

Point estimate

-8.27

Confidence interval

level

95%

sides

2-sided

lower limit

-18.067

upper limit

1.671

Notes
[4] - Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.

Placebo, Perampanel 8 mg

Statistical analysis description

Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.

Comparison groups

Core Phase: Placebo v Core Phase: Perampanel 8 mg

Number of subjects included in analysis

315

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

ANCOVA

Parameter type

Median difference (final values)

Point estimate

-21.21

Confidence interval

level

95%

sides

2-sided

lower limit

-30.941

upper limit

-11.368

Placebo, Perampanel 12 mg

Statistical analysis description

Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.

Comparison groups

Core Phase: Placebo v Core Phase: Perampanel 12 mg

Number of subjects included in analysis

325

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

ANCOVA

Parameter type

Median difference (final values)

Point estimate

-28.65

Confidence interval

level

95%

sides

2-sided

lower limit

-37.698

upper limit

-19.794

Secondary: Core Phase: Number of Subjects With Clinical Global Impression of Change (CGIC) Scores

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End point title

Core Phase: Number of Subjects With Clinical Global Impression of Change (CGIC) Scores ^[5]

End point description

The investigator evaluated each subject for CGIC questionnaire to assess change in subject's disease clinical status from baseline. Assessment evaluated frequency of seizures, severity of seizures, occurrence of adverse events, and overall functional status of the subject using the 7-point scale. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Lower score indicated improvement. Higher score indicated worsening. ITT Analysis Set included all subjects who signed informed consent, were randomized, received at least one dose of study medication, and have at least one postdose seizure frequency data.

End point type

Secondary

End point timeframe

Baseline, Week 19

Notes
[5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was only planned to be analyzed for the reporting groups of Core Phase. Only descriptive data was planned to be analyzed for this endpoint.

End point values	Core Phase: Placebo	Core Phase: Perampanel 4 mg	Core Phase: Perampanel 8 mg	Core Phase: Perampanel 12 mg
Number of subjects analysed	175	174	175	180
Units: subjects
Very much improved	3	5	11	9
Much improved	31	39	41	54
Minimally improved	54	45	53	40
No change	67	56	37	37
Minimally worse	3	10	5	4
Much worse	1	0	0	1
Very much worse	0	0	0	1

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)

Adverse event reporting additional description

Safety Analysis Set included all subjects who signed informed consent, were randomized, received at least one dose of study medication, and have at least one post-dose safety assessment.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.1

Reporting group title

Core Phase: Placebo

Reporting group description

Subjects received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).

Reporting group title

Core Phase: Perampanel 4 mg

Reporting group description

Reporting group title

Core Phase: Perampanel 8 mg

Reporting group description

Reporting group title

Core Phase: Perampanel 12 mg

Reporting group description

Reporting group title

Extension Phase: Perampanel 12 mg

Reporting group description

Serious adverse events	Core Phase: Placebo	Core Phase: Perampanel 4 mg	Core Phase: Perampanel 8 mg	Core Phase: Perampanel 12 mg	Extension Phase: Perampanel 12 mg
Total subjects affected by serious adverse events
subjects affected / exposed	10 / 176 (5.68%)	6 / 176 (3.41%)	7 / 175 (4.00%)	12 / 180 (6.67%)	113 / 679 (16.64%)
number of deaths (all causes)	1	0	1	0	7
number of deaths resulting from adverse events	1	0	1	0	7
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute promyelocytic leukaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Benign hydatidiform mole
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Brain neoplasm
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Breast cancer
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Colon cancer
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Fibroadenoma of breast
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Aneurysm
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Thrombophlebitis superficial
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Abortion induced
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	2 / 176 (1.14%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	4 / 679 (0.59%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Pregnancy
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Death
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
Sudden cardiac death
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Sudden unexplained death in epilepsy
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
Reproductive system and breast disorders
Adenomyosis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Asphyxia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
Pneumonia aspiration
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumothorax
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory failure
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Aggression
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	2 / 180 (1.11%)	3 / 679 (0.44%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	2 / 2	3 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Suicide attempt
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	1 / 175 (0.57%)	1 / 180 (0.56%)	3 / 679 (0.44%)
occurrences causally related to treatment / all	1 / 1	0 / 0	1 / 1	0 / 1	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Acute psychosis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Conversion disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	0 / 679 (0.00%)
occurrences causally related to treatment / all	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
Self-injurious ideation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anxiety
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anxiety disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bipolar disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Delusion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Emotional disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hallucination, auditory
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Irritability
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mental disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Postictal psychosis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychogenic seizure
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychotic disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychotic disorder due to a general medical condition
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Suicidal behaviour
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Brain contusion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	3 / 679 (0.44%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Burns second degree
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Facial bones fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Road traffic accident
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	2 / 679 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
Contusion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	4 / 679 (0.59%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ankle fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Clavicle fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Fibula fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Foot fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Head injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
Intentional overdose
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ligament injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Limb injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lumbar vertebral fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Meniscus injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Patella fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pelvic fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin laceration
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	4 / 679 (0.59%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Spinal compression fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Thermal burn
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Myocardial infarction
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sinus node dysfunction
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Epilepsy
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	1 / 180 (0.56%)	5 / 679 (0.74%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	1 / 1	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Status epilepticus
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	2 / 180 (1.11%)	6 / 679 (0.88%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	1 / 2	1 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Complex partial seizures
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences causally related to treatment / all	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
Convulsion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences causally related to treatment / all	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
Haemorrhage intracranial
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	2 / 679 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
Partial seizures with secondary generalisation
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Grand mal convulsion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences causally related to treatment / all	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
Altered state of consciousness
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ataxia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cerebral infarction
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cerebrovascular accident
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dizziness
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dysarthria
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Focal dyscognitive seizures
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Generalised tonic-clonic seizure
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Idiopathic partial epilepsy
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lacunar infarction
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Limbic encephalitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Normal pressure hydrocephalus
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Seizure
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	5 / 679 (0.74%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Seizure cluster
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Somnolence
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Subarachnoid haemorrhage
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
Eye disorders
Cataract
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	4 / 679 (0.59%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lens dislocation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Haemorrhoids
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal haemorrhage
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Diarrhoea
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Enterocolitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gingival hypertrophy
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Haematemesis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholelithiasis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Excessive granulation tissue
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rash
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Ureterolithiasis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary retention
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	2 / 176 (1.14%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Osteoarthritis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rotator cuff syndrome
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Anal abscess
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	2 / 176 (1.14%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	5 / 679 (0.74%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis acute
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal abscess
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Appendicitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Herpes zoster
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lung infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nasopharyngitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Periodontitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pharyngitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Post procedural infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sepsis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
Urinary tract infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Diabetes mellitus
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hyperkalaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hyponatraemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Core Phase: Placebo	Core Phase: Perampanel 4 mg	Core Phase: Perampanel 8 mg	Core Phase: Perampanel 12 mg	Extension Phase: Perampanel 12 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	114 / 176 (64.77%)	119 / 176 (67.61%)	127 / 175 (72.57%)	155 / 180 (86.11%)	618 / 679 (91.02%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	1	0	0	0	1
Acrochordon
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Benign breast neoplasm
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Benign hepatobiliary neoplasm
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Leiomyoma
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Skin papilloma
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Uterine leiomyoma
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	3
Vascular disorders
Hypertension
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	5 / 679 (0.74%)
occurrences all number	1	1	0	0	5
Hypotension
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	2 / 679 (0.29%)
occurrences all number	0	0	0	1	2
Angiodysplasia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	1	0	0	0	0
Hyperaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Orthostatic hypotension
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Peripheral coldness
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Phlebitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Surgical and medical procedures
Tooth extraction
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	2
Wisdom teeth removal
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Pregnancy, puerperium and perinatal conditions
Pregnancy
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	1	0	0	0	2
General disorders and administration site conditions
Irritability
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	8 / 176 (4.55%)	10 / 175 (5.71%)	9 / 180 (5.00%)	0 / 679 (0.00%)
occurrences all number	1	9	10	9	0
Fatigue
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	5 / 176 (2.84%)	4 / 176 (2.27%)	6 / 175 (3.43%)	9 / 180 (5.00%)	34 / 679 (5.01%)
occurrences all number	5	4	6	9	36
Gait disturbance
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	3 / 176 (1.70%)	2 / 176 (1.14%)	4 / 175 (2.29%)	9 / 180 (5.00%)	28 / 679 (4.12%)
occurrences all number	3	2	4	9	34
Pyrexia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	3 / 176 (1.70%)	2 / 176 (1.14%)	4 / 175 (2.29%)	4 / 180 (2.22%)	39 / 679 (5.74%)
occurrences all number	6	2	4	6	90
Asthenia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	2 / 175 (1.14%)	2 / 180 (1.11%)	17 / 679 (2.50%)
occurrences all number	1	0	2	3	20
Malaise
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	2 / 175 (1.14%)	0 / 180 (0.00%)	5 / 679 (0.74%)
occurrences all number	0	1	2	0	5
Feeling abnormal
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	1 / 175 (0.57%)	0 / 180 (0.00%)	6 / 679 (0.88%)
occurrences all number	0	1	1	0	7
Face oedema
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	1	0	1
Foreign body reaction
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Influenza like illness
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	5 / 679 (0.74%)
occurrences all number	0	0	1	0	6
Oedema
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Chest discomfort
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	8 / 679 (1.18%)
occurrences all number	1	0	0	0	9
Pain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	1	0	0	0	1
Chest pain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Chills
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	2
Decreased activity
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Feeling hot
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Generalised oedema
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Oedema peripheral
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	3
Peripheral swelling
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	3
Thirst
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Immune system disorders
Allergy to arthropod sting
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	4 / 679 (0.59%)
occurrences all number	0	1	0	0	4
Seasonal allergy
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	1	0	0	0	4
Social circumstances
Hearing aid user
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Reproductive system and breast disorders
Prostatitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	1 / 180 (0.56%)	2 / 679 (0.29%)
occurrences all number	0	1	0	1	2
Cervical cyst
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	1	0	1
Cervical polyp
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Hypomenorrhoea
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Menorrhagia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	3
Menstrual disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Menstruation irregular
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	4 / 679 (0.59%)
occurrences all number	0	0	0	1	6
Pelvic fluid collection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	1	0	1
Scrotal swelling
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	0 / 679 (0.00%)
occurrences all number	0	0	0	1	0
Dysmenorrhoea
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	4	0	0	0	5
Amenorrhoea
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	2
Benign prostatic hyperplasia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Breast tenderness
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Genital haemorrhage
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	3
Menopausal symptoms
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Menstruation delayed
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Oligomenorrhoea
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Ovarian cyst
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Pelvic pain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Scrotal inflammation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Sexual dysfunction
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Vaginal discharge
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Laryngeal discomfort
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	2 / 176 (1.14%)	0 / 175 (0.00%)	2 / 180 (1.11%)	13 / 679 (1.91%)
occurrences all number	0	2	0	2	15
Epistaxis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	1 / 176 (0.57%)	1 / 175 (0.57%)	0 / 180 (0.00%)	8 / 679 (1.18%)
occurrences all number	1	1	1	0	10
Rhinitis allergic
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	1 / 180 (0.56%)	5 / 679 (0.74%)
occurrences all number	0	0	1	4	10
Upper respiratory tract inflammation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	1 / 180 (0.56%)	4 / 679 (0.59%)
occurrences all number	0	1	0	1	4
Cough
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	2 / 176 (1.14%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	9 / 679 (1.33%)
occurrences all number	3	0	1	0	9
Dyspnoea
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	4 / 679 (0.59%)
occurrences all number	0	0	1	0	6
Hiccups
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Productive cough
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	2 / 679 (0.29%)
occurrences all number	1	0	0	1	2
Rhinorrhoea
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	3 / 176 (1.70%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	9 / 679 (1.33%)
occurrences all number	4	1	0	0	11
Sneezing
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Wheezing
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	1	0	0	0	0
Asthma
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Atelectasis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Dysphonia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Hyperventilation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	3
Laryngeal inflammation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Nasal congestion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Oropharyngeal discomfort
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	3
Pharyngeal inflammation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Pneumonia aspiration
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Respiratory tract congestion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Sputum increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Tonsillar inflammation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	2
Vasomotor rhinitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Psychiatric disorders
Aggression
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	4 / 176 (2.27%)	5 / 175 (2.86%)	4 / 180 (2.22%)	22 / 679 (3.24%)
occurrences all number	0	4	5	4	24
Suicidal ideation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	3 / 176 (1.70%)	7 / 175 (4.00%)	2 / 180 (1.11%)	21 / 679 (3.09%)
occurrences all number	1	3	7	2	28
Anxiety
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	6 / 175 (3.43%)	1 / 180 (0.56%)	22 / 679 (3.24%)
occurrences all number	0	1	6	1	22
Insomnia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	7 / 176 (3.98%)	3 / 176 (1.70%)	2 / 175 (1.14%)	3 / 180 (1.67%)	25 / 679 (3.68%)
occurrences all number	7	4	2	3	27
Mood swings
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	3 / 176 (1.70%)	2 / 175 (1.14%)	0 / 180 (0.00%)	12 / 679 (1.77%)
occurrences all number	1	3	2	0	13
Anger
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	1 / 175 (0.57%)	3 / 180 (1.67%)	9 / 679 (1.33%)
occurrences all number	1	0	1	3	9
Depression
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	2 / 175 (1.14%)	2 / 180 (1.11%)	16 / 679 (2.36%)
occurrences all number	0	0	2	2	19
Affect lability
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	2 / 180 (1.11%)	6 / 679 (0.88%)
occurrences all number	0	0	1	2	6
Depressed mood
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	1 / 176 (0.57%)	2 / 175 (1.14%)	0 / 180 (0.00%)	4 / 679 (0.59%)
occurrences all number	1	1	2	0	4
Abnormal behaviour
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	1 / 180 (0.56%)	4 / 679 (0.59%)
occurrences all number	0	0	1	1	4
Hallucination, auditory
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	2 / 176 (1.14%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	2	0	0	3
Mood altered
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	1 / 180 (0.56%)	3 / 679 (0.44%)
occurrences all number	0	0	1	1	4
Sleep disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	2 / 176 (1.14%)	0 / 175 (0.00%)	0 / 180 (0.00%)	7 / 679 (1.03%)
occurrences all number	1	2	0	0	8
Affective disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	2 / 679 (0.29%)
occurrences all number	0	0	0	1	2
Agitation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	5 / 679 (0.74%)
occurrences all number	1	0	0	1	6
Anxiety disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	3 / 679 (0.44%)
occurrences all number	1	0	0	1	3
Confusional arousal
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	2 / 679 (0.29%)
occurrences all number	0	0	0	1	2
Emotional disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Expressive language disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	0	1	0	0	0
Fear
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Impatience
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Nervousness
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	1	0	4
Obsessive-compulsive disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	3 / 679 (0.44%)
occurrences all number	0	0	0	1	3
Personality change
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Personality disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	1	0	0	1	1
Regressive behaviour
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Restlessness
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	1	0	0	3
Self-injurious ideation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Sleep talking
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	1	0	1
Soliloquy
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	1	0	1
Stubbornness
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	1	0	1
Suicide attempt
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	7 / 679 (1.03%)
occurrences all number	0	0	0	1	7
Thinking abnormal
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Tic
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	1	0	1
Abnormal dreams
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	1	0	0	0	0
Acute stress disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	1	0	0	0	0
Intentional self-injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	2	0	0	0	2
Panic attack
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	1	0	0	0	0
Bipolar disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Bruxism
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Confusional state
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Conversion disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Delusion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Depressive symptom
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Dissociative disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Enuresis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Hallucination
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Impulsive behaviour
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Major depression
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Mania
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Mental disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Middle insomnia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Mixed anxiety and depressive disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Neurosis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Nightmare
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Panic disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Paranoia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Persecutory delusion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Persistent depressive disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Psychogenic seizure
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	4 / 679 (0.59%)
occurrences all number	0	0	0	0	4
Somatic symptom disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Stress
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Suicidal behaviour
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Product issues
Device breakage
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Product blister packaging issue
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Hepatobiliary disorders
Hepatic function abnormal
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	2 / 180 (1.11%)	6 / 679 (0.88%)
occurrences all number	0	0	1	2	6
Cholecystitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	1	0	0	0	0
Cholelithiasis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Hepatic mass
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	2
Hepatic steatosis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Investigations
Weight increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	7 / 176 (3.98%)	6 / 175 (3.43%)	6 / 180 (3.33%)	40 / 679 (5.89%)
occurrences all number	1	8	6	6	44
Blood creatine phosphokinase increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	2 / 175 (1.14%)	5 / 180 (2.78%)	24 / 679 (3.53%)
occurrences all number	0	2	2	5	32
Electrocardiogram QT prolonged
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	2 / 176 (1.14%)	0 / 175 (0.00%)	4 / 180 (2.22%)	9 / 679 (1.33%)
occurrences all number	1	2	0	4	13
Blood phosphorus decreased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	2 / 180 (1.11%)	9 / 679 (1.33%)
occurrences all number	0	0	1	2	10
Protein urine present
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	2 / 176 (1.14%)	0 / 176 (0.00%)	2 / 175 (1.14%)	1 / 180 (0.56%)	12 / 679 (1.77%)
occurrences all number	2	0	2	1	14
Weight decreased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	2 / 175 (1.14%)	1 / 180 (0.56%)	13 / 679 (1.91%)
occurrences all number	1	0	2	1	14
Blood cholesterol increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	1 / 180 (0.56%)	4 / 679 (0.59%)
occurrences all number	0	1	0	1	4
Blood uric acid increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	2 / 176 (1.14%)	0 / 175 (0.00%)	0 / 180 (0.00%)	7 / 679 (1.03%)
occurrences all number	0	2	0	0	7
Gamma-glutamyltransferase increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	2 / 180 (1.11%)	5 / 679 (0.74%)
occurrences all number	1	0	0	2	5
White blood cell count decreased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	1 / 176 (0.57%)	0 / 175 (0.00%)	1 / 180 (0.56%)	4 / 679 (0.59%)
occurrences all number	1	1	0	1	4
Alanine aminotransferase increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	2 / 679 (0.29%)
occurrences all number	0	0	0	1	2
Aspartate aminotransferase increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	2 / 679 (0.29%)
occurrences all number	0	0	0	1	2
Blood parathyroid hormone abnormal
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	1	0	1
Blood sodium decreased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	4 / 679 (0.59%)
occurrences all number	0	0	0	1	6
Blood triglycerides abnormal
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Eosinophil count increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	1	0	1	0	1
Monocyte count increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	1	0	1
Neutrophil count decreased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	3 / 679 (0.44%)
occurrences all number	0	0	0	1	3
Platelet count decreased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	1	0	1	0	3
Red blood cells urine
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	0 / 679 (0.00%)
occurrences all number	0	0	0	1	0
Urine ketone body present
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	2 / 679 (0.29%)
occurrences all number	0	0	0	1	2
Vitamin D decreased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	1	0	2
Blood glucose increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	1	0	0	0	0
Blood triglycerides increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	1	0	0	0	2
Blood urine present
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	2	0	0	0	4
Anticonvulsant drug level increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Blood bicarbonate decreased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Blood bilirubin increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Blood creatinine decreased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Blood lactate dehydrogenase increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Blood magnesium abnormal
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Blood phosphorus increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Blood pressure increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Blood sodium increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Gamma-glutamyltransferase abnormal
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Liver function test abnormal
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Liver function test increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Lymphocyte count decreased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	3
Neutrophil count increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Red blood cell count decreased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Red blood cells urine positive
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Thyroxine free decreased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Urine uric acid increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
White blood cell count increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
pH urine increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Injury, poisoning and procedural complications
Contusion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	4 / 176 (2.27%)	5 / 176 (2.84%)	6 / 175 (3.43%)	5 / 180 (2.78%)	49 / 679 (7.22%)
occurrences all number	5	19	6	5	81
Joint sprain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	3 / 176 (1.70%)	2 / 175 (1.14%)	3 / 180 (1.67%)	0 / 679 (0.00%)
occurrences all number	0	3	2	3	0
Excoriation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	3 / 176 (1.70%)	1 / 176 (0.57%)	1 / 175 (0.57%)	2 / 180 (1.11%)	0 / 679 (0.00%)
occurrences all number	3	1	1	4	0
Foot fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	1 / 176 (0.57%)	1 / 175 (0.57%)	1 / 180 (0.56%)	12 / 679 (1.77%)
occurrences all number	1	1	1	2	13
Skin laceration
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	3 / 176 (1.70%)	0 / 176 (0.00%)	1 / 175 (0.57%)	2 / 180 (1.11%)	21 / 679 (3.09%)
occurrences all number	3	0	1	2	21
Thermal burn
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	2 / 180 (1.11%)	14 / 679 (2.06%)
occurrences all number	0	0	1	2	15
Wound
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	2 / 180 (1.11%)	8 / 679 (1.18%)
occurrences all number	0	1	0	2	9
Animal bite
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	2 / 180 (1.11%)	4 / 679 (0.59%)
occurrences all number	0	0	0	2	4
Fall
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	2 / 176 (1.14%)	0 / 176 (0.00%)	2 / 175 (1.14%)	0 / 180 (0.00%)	14 / 679 (2.06%)
occurrences all number	2	0	2	0	20
Head injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	2 / 176 (1.14%)	0 / 175 (0.00%)	0 / 180 (0.00%)	11 / 679 (1.62%)
occurrences all number	0	2	0	0	13
Limb injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	1 / 175 (0.57%)	0 / 180 (0.00%)	8 / 679 (1.18%)
occurrences all number	0	1	1	0	8
Lip injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	1 / 176 (0.57%)	0 / 175 (0.00%)	1 / 180 (0.56%)	4 / 679 (0.59%)
occurrences all number	1	1	0	1	4
Rib fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	1 / 176 (0.57%)	1 / 175 (0.57%)	0 / 180 (0.00%)	5 / 679 (0.74%)
occurrences all number	1	1	1	0	5
Ankle fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	1	0	3
Arthropod sting
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	2	0	3
Burns second degree
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	1	0	2
Heat stroke
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Joint dislocation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	1	0	0	4
Ligament rupture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	1	0	0	2
Multiple injuries
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Periorbital haematoma
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	0	1	0	0	0
Radius fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	1	0	3
Road traffic accident
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Stab wound
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Sunburn
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Tibia fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	1	0	1
Tooth fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	1	0	0	3
Tooth injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	0 / 679 (0.00%)
occurrences all number	1	0	0	1	0
Wrist fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Forearm fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	1	0	0	0	0
Scratch
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	4 / 679 (0.59%)
occurrences all number	1	0	0	0	4
Arthropod bite
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Bone contusion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Bone fissure
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Burns first degree
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Chemical poisoning
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Chest injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Chillblains
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	2
Clavicle fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Closed globe injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Concussion
alternative dictionary used: MedDRA 21.11
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Compression fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Conjunctival abrasion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Ear canal abrasion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Eye contusion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Eye injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Eyelid contusion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Eyelid injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Face injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	4
Fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Hand fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Heat illness
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Joint injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	3
Ligament injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	3
Ligament sprain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	23 / 679 (3.39%)
occurrences all number	0	0	0	0	24
Mouth injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Neck injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Patella fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Post-traumatic neck syndrome
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Procedural pain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Scar
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Skin abrasion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	16 / 679 (2.36%)
occurrences all number	0	0	0	0	18
Skin injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Skin wound
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Soft tissue injury
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Subcutaneous haematoma
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Subdural haematoma
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Tooth dislocation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Toxicity to various agents
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Upper limb fracture
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Congenital, familial and genetic disorders
Hypophosphatasia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Cardiac disorders
Angina pectoris
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	1	0	0	2
Atrial fibrillation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Arteriosclerosis coronary artery
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Palpitations
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	4
Tachycardia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Nervous system disorders
Dizziness
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	10 / 176 (5.68%)	40 / 176 (22.73%)	50 / 175 (28.57%)	76 / 180 (42.22%)	317 / 679 (46.69%)
occurrences all number	11	48	60	85	435
Somnolence
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	23 / 176 (13.07%)	28 / 176 (15.91%)	31 / 175 (17.71%)	32 / 180 (17.78%)	165 / 679 (24.30%)
occurrences all number	24	28	36	33	199
Headache
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	13 / 176 (7.39%)	12 / 176 (6.82%)	13 / 175 (7.43%)	10 / 180 (5.56%)	94 / 679 (13.84%)
occurrences all number	18	22	14	11	164
Ataxia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	2 / 176 (1.14%)	1 / 175 (0.57%)	7 / 180 (3.89%)	22 / 679 (3.24%)
occurrences all number	0	2	1	8	26
Balance disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	4 / 176 (2.27%)	1 / 175 (0.57%)	4 / 180 (2.22%)	17 / 679 (2.50%)
occurrences all number	0	4	1	4	18
Dysarthria
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	3 / 175 (1.71%)	4 / 180 (2.22%)	22 / 679 (3.24%)
occurrences all number	1	0	3	4	24
Hypoaesthesia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	3 / 176 (1.70%)	1 / 175 (0.57%)	2 / 180 (1.11%)	12 / 679 (1.77%)
occurrences all number	1	4	1	2	17
Tremor
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	2 / 176 (1.14%)	0 / 175 (0.00%)	3 / 180 (1.67%)	19 / 679 (2.80%)
occurrences all number	1	2	0	3	23
Convulsion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	2 / 176 (1.14%)	0 / 175 (0.00%)	2 / 180 (1.11%)	0 / 679 (0.00%)
occurrences all number	1	2	0	2	0
Memory impairment
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	1 / 175 (0.57%)	2 / 180 (1.11%)	14 / 679 (2.06%)
occurrences all number	0	1	1	3	16
Nystagmus
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	2 / 176 (1.14%)	1 / 175 (0.57%)	1 / 180 (0.56%)	4 / 679 (0.59%)
occurrences all number	0	2	1	1	4
Amnesia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	2 / 176 (1.14%)	1 / 175 (0.57%)	0 / 180 (0.00%)	9 / 679 (1.33%)
occurrences all number	0	2	1	0	9
Complex partial seizures
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	2 / 175 (1.14%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	0	0	2	0	0
Dementia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	1 / 180 (0.56%)	2 / 679 (0.29%)
occurrences all number	0	0	1	1	2
Lethargy
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	2 / 175 (1.14%)	0 / 180 (0.00%)	6 / 679 (0.88%)
occurrences all number	0	0	2	0	6
Paraesthesia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	1 / 175 (0.57%)	1 / 180 (0.56%)	3 / 679 (0.44%)
occurrences all number	1	0	2	1	5
Aphasia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	1	0	2
Clumsiness
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	1	0	2
Cranial nerve disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Dizziness postural
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	1	0	0	2
Dysaesthesia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	1	0	0	2
Dyskinesia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	1	0	1
Dystonia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Head discomfort
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	1	0	1
Hypersomnia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	5 / 679 (0.74%)
occurrences all number	0	0	2	0	7
Migraine
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	4 / 679 (0.59%)
occurrences all number	0	0	0	1	4
Myoclonus
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Nerve root compression
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	1	0	1
Psychomotor hyperactivity
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	2 / 679 (0.29%)
occurrences all number	0	0	0	1	2
Sensory disturbance
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Anaesthesia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	1	0	0	0	0
Dyslalia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	1	0	0	0	4
Grand mal convulsion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	1	0	0	0	0
Partial seizures with secondary generalisation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	3 / 176 (1.70%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	4 / 679 (0.59%)
occurrences all number	3	0	0	0	4
Syncope
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	2 / 176 (1.14%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	4 / 679 (0.59%)
occurrences all number	2	0	0	0	6
Tongue biting
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	1	0	0	0	2
Burning sensation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Carpal tunnel syndrome
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Cerebral disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Change in seizure presentation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Drooling
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Dysgeusia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Dysstasia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Epilepsy
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Focal dyscognitive seizures
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Hemiplegia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Hyposmia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Language disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Loss of consciousness
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Neuralgia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Neuropathy peripheral
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Postictal headache
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Postural tremor
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Radial nerve palsy
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Seizure
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	16 / 679 (2.36%)
occurrences all number	0	0	0	0	19
Seizure cluster
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	4
Sleep deficit
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Slow response to stimuli
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Speech disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	3
Status epilepticus
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Tonic convulsion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Visual field defect
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Vocal cord paralysis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Blood and lymphatic system disorders
Anaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	2 / 180 (1.11%)	12 / 679 (1.77%)
occurrences all number	1	0	0	2	13
Lymphadenitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	2 / 175 (1.14%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	2	0	2
Eosinophilia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	3 / 679 (0.44%)
occurrences all number	0	0	0	1	3
Iron deficiency anaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	1	0	3
Leukopenia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	3 / 679 (0.44%)
occurrences all number	0	0	0	1	3
Neutropenia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	5 / 679 (0.74%)
occurrences all number	0	1	0	0	5
Lymphopenia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	3
Neutrophilia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	2
Thrombocytopenia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Ear and labyrinth disorders
Vertigo
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	3 / 176 (1.70%)	5 / 175 (2.86%)	4 / 180 (2.22%)	23 / 679 (3.39%)
occurrences all number	1	3	6	4	25
Cerumen impaction
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Tinnitus
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	5 / 679 (0.74%)
occurrences all number	0	0	0	1	6
Deafness neurosensory
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Ear pain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	2
Ear pruritus
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	2
Hypoacusis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Motion sickness
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Sudden hearing loss
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Vertigo positional
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Eye disorders
Vision blurred
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	2 / 176 (1.14%)	2 / 175 (1.14%)	3 / 180 (1.67%)	12 / 679 (1.77%)
occurrences all number	0	2	2	3	13
Asthenopia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	2 / 180 (1.11%)	3 / 679 (0.44%)
occurrences all number	0	0	1	2	3
Conjunctivitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	2 / 180 (1.11%)	0 / 679 (0.00%)
occurrences all number	0	1	0	2	0
Diplopia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	2 / 175 (1.14%)	1 / 180 (0.56%)	11 / 679 (1.62%)
occurrences all number	1	0	2	1	12
Eyelid oedema
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	1	0	1	1
Visual impairment
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	2 / 180 (1.11%)	2 / 679 (0.29%)
occurrences all number	1	0	0	2	2
Cataract
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	1	0	0	3
Chalazion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	4 / 679 (0.59%)
occurrences all number	0	0	1	0	5
Conjunctival haemorrhage
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	2 / 679 (0.29%)
occurrences all number	0	0	0	1	2
Dry eye
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	5 / 679 (0.74%)
occurrences all number	1	1	0	0	6
Dysmetropsia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	1	0	1
Glaucoma
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	1	0	2
Keratoconjunctivitis sicca
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	0 / 679 (0.00%)
occurrences all number	0	0	0	1	0
Normal tension glaucoma
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Retinal disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	2 / 679 (0.29%)
occurrences all number	0	0	0	1	2
Vitreous floaters
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	3 / 679 (0.44%)
occurrences all number	0	0	0	1	3
Eye pain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	1	0	0	0	2
Lacrimation increased
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	1	0	0	0	1
Blepharitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Borderline glaucoma
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Conjunctival hyperaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Conjunctivitis allergic
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	5 / 679 (0.74%)
occurrences all number	0	0	0	0	5
Corneal erosion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	2
Diabetic retinopathy
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Episcleritis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Excessive eye blinking
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Eye discharge
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Eye pruritus
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Eyelid myoclonus
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Foreign body sensation in eyes
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Keratitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	4
Ocular hyperaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Psychogenic visual disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Punctate keratitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Swelling of eyelid
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Visual acuity reduced
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Xerophthalmia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Gastrointestinal disorders
Nausea
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	6 / 176 (3.41%)	4 / 176 (2.27%)	4 / 175 (2.29%)	10 / 180 (5.56%)	35 / 679 (5.15%)
occurrences all number	6	4	4	10	37
Diarrhoea
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	6 / 176 (3.41%)	3 / 176 (1.70%)	4 / 175 (2.29%)	6 / 180 (3.33%)	33 / 679 (4.86%)
occurrences all number	7	3	4	6	42
Stomatitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	2 / 176 (1.14%)	5 / 175 (2.86%)	3 / 180 (1.67%)	25 / 679 (3.68%)
occurrences all number	2	2	6	3	35
Constipation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	2 / 176 (1.14%)	5 / 175 (2.86%)	1 / 180 (0.56%)	27 / 679 (3.98%)
occurrences all number	2	2	5	1	36
Vomiting
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	7 / 176 (3.98%)	1 / 176 (0.57%)	1 / 175 (0.57%)	3 / 180 (1.67%)	24 / 679 (3.53%)
occurrences all number	8	1	1	3	25
Abdominal discomfort
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	3 / 176 (1.70%)	1 / 176 (0.57%)	1 / 175 (0.57%)	2 / 180 (1.11%)	11 / 679 (1.62%)
occurrences all number	3	1	1	2	13
Abdominal pain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	2 / 176 (1.14%)	0 / 175 (0.00%)	2 / 180 (1.11%)	13 / 679 (1.91%)
occurrences all number	1	2	0	2	15
Dyspepsia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	3 / 175 (1.71%)	0 / 180 (0.00%)	11 / 679 (1.62%)
occurrences all number	0	1	3	0	11
Gastritis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	2 / 180 (1.11%)	7 / 679 (1.03%)
occurrences all number	0	0	1	2	7
Toothache
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	1 / 176 (0.57%)	2 / 175 (1.14%)	0 / 180 (0.00%)	10 / 679 (1.47%)
occurrences all number	1	1	2	0	10
Abdominal pain lower
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	1 / 180 (0.56%)	3 / 679 (0.44%)
occurrences all number	0	0	2	1	4
Cheilitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	1 / 180 (0.56%)	2 / 679 (0.29%)
occurrences all number	0	0	1	1	2
Dental caries
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	2 / 175 (1.14%)	0 / 180 (0.00%)	23 / 679 (3.39%)
occurrences all number	1	0	2	0	25
Gingivitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	2 / 176 (1.14%)	0 / 175 (0.00%)	0 / 180 (0.00%)	6 / 679 (0.88%)
occurrences all number	0	2	0	0	6
Abdominal pain upper
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	8 / 679 (1.18%)
occurrences all number	1	0	0	1	8
Aphthous stomatitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	0	1	0	0	0
Colonic polyp
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	0	1	0	0	0
Crohn's disease
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Gingival bleeding
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Gingival hyperplasia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	0	1	0	0	0
Gingival pain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	1	0	0	1	1
Gingival ulceration
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	2 / 679 (0.29%)
occurrences all number	0	0	0	1	3
Haemorrhoids
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	4 / 679 (0.59%)
occurrences all number	0	1	0	0	4
Oral disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Oral pain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	1	0	0	2
Periodontal disease
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	1	0	0	3
Reflux oesophagitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	1	1	0	0	0
Salivary hypersecretion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Dry mouth
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	1	0	0	0	2
Enteritis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	1	0	0	0	0
Epigastric discomfort
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	1	0	0	0	0
Gastritis atrophic
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	1	0	0	0	0
Lip dry
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	1	0	0	0	0
Aphthous ulcer
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	7
Breath odour
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Chronic gastritis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Dysphagia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Enterocolitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Faecaloma
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Faeces soft
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Food poisoning
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Gastric ulcer
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Gastrooesophageal reflux disease
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	4 / 679 (0.59%)
occurrences all number	0	0	0	0	4
Gingival hypertrophy
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	3
Glossitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Haemorrhoidal haemorrhage
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Ileus paralytic
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Irritable bowel syndrome
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Large intestine polyp
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Lip ulceration
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Lumbar hernia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Noninfective gingivitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Oesophagitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Oral contusion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Peptic ulcer
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Salivary gland mucocoele
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Skin and subcutaneous tissue disorders
Rash
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	2 / 176 (1.14%)	2 / 176 (1.14%)	2 / 175 (1.14%)	9 / 180 (5.00%)	31 / 679 (4.57%)
occurrences all number	2	2	2	9	37
Pruritus
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	1 / 176 (0.57%)	4 / 175 (2.29%)	2 / 180 (1.11%)	13 / 679 (1.91%)
occurrences all number	1	1	4	2	16
Eczema
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	2 / 176 (1.14%)	1 / 176 (0.57%)	1 / 175 (0.57%)	2 / 180 (1.11%)	18 / 679 (2.65%)
occurrences all number	2	1	1	2	20
Dermatitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	1 / 176 (0.57%)	1 / 175 (0.57%)	1 / 180 (0.56%)	13 / 679 (1.91%)
occurrences all number	1	1	1	1	13
Urticaria
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	4 / 176 (2.27%)	0 / 176 (0.00%)	1 / 175 (0.57%)	2 / 180 (1.11%)	8 / 679 (1.18%)
occurrences all number	5	0	1	2	9
Heat rash
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	1 / 180 (0.56%)	0 / 679 (0.00%)
occurrences all number	0	1	0	1	0
Acne
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	7 / 679 (1.03%)
occurrences all number	0	0	0	1	7
Blister
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	0	0	1	0	0
Dermatitis allergic
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	3 / 679 (0.44%)
occurrences all number	0	0	0	1	3
Dermatitis atopic
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	5 / 679 (0.74%)
occurrences all number	0	0	0	1	9
Dermatitis contact
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	6 / 679 (0.88%)
occurrences all number	1	0	0	1	7
Dry skin
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	6 / 679 (0.88%)
occurrences all number	0	1	0	0	6
Eczema asteatotic
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	1	1	0	0	2
Erythema
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	1	0	0	1	1
Pityriasis alba
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	1	0	1
Rash erythematous
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Rash papular
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	1	0	0	2
Rash pruritic
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Skin burning sensation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Skin erosion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Skin ulcer
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	1	0	1
Alopecia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	3 / 176 (1.70%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	3	0	0	0	1
Night sweats
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	1	0	0	0	0
Androgenetic alopecia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Anhidrosis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Dermal cyst
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	3
Drug eruption
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Fracture blisters
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Hyperkeratosis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Ingrowing nail
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Miliaria
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	4 / 679 (0.59%)
occurrences all number	0	0	0	0	4
Onychalgia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Palmoplantar keratoderma
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Pigmentation disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Pruritus generalised
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Purpura
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Seborrhoeic dermatitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	3
Skin discolouration
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Skin fissures
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Skin lesion
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Swelling face
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Renal and urinary disorders
Dysuria
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	1 / 180 (0.56%)	4 / 679 (0.59%)
occurrences all number	0	0	1	1	4
Bladder irritation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	1	0	1
Calculus ureteric
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	0 / 679 (0.00%)
occurrences all number	0	0	0	1	0
Hypertonic bladder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Nephrolithiasis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	2 / 679 (0.29%)
occurrences all number	0	0	0	1	2
Neurogenic bladder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	2 / 679 (0.29%)
occurrences all number	0	0	0	1	2
Nocturia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	1	1	0	0	3
Polyuria
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Proteinuria
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	6 / 679 (0.88%)
occurrences all number	0	0	0	1	6
Urinary incontinence
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	1	0	0	1	1
Haematuria
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	1	0	0	0	1
Pollakiuria
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	2 / 176 (1.14%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	5 / 679 (0.74%)
occurrences all number	2	0	0	0	5
Calculus urinary
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Ketonuria
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Renal cyst
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Ureterolithiasis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Urinary retention
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Endocrine disorders
Autoimmune thyroiditis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Hypothyroidism
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Musculoskeletal and connective tissue disorders
Muscular weakness
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	4 / 175 (2.29%)	2 / 180 (1.11%)	6 / 679 (0.88%)
occurrences all number	0	0	5	2	7
Back pain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	1 / 176 (0.57%)	2 / 175 (1.14%)	2 / 180 (1.11%)	20 / 679 (2.95%)
occurrences all number	1	1	3	2	22
Myalgia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	2 / 176 (1.14%)	2 / 176 (1.14%)	0 / 175 (0.00%)	1 / 180 (0.56%)	7 / 679 (1.03%)
occurrences all number	2	2	0	1	7
Arthralgia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	1 / 180 (0.56%)	10 / 679 (1.47%)
occurrences all number	0	0	1	1	13
Musculoskeletal pain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	1 / 175 (0.57%)	1 / 180 (0.56%)	9 / 679 (1.33%)
occurrences all number	1	0	1	1	9
Musculoskeletal stiffness
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	2 / 180 (1.11%)	5 / 679 (0.74%)
occurrences all number	0	0	0	2	6
Pain in extremity
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	2 / 176 (1.14%)	0 / 176 (0.00%)	2 / 175 (1.14%)	0 / 180 (0.00%)	14 / 679 (2.06%)
occurrences all number	2	0	2	0	15
Monarthritis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	0 / 679 (0.00%)
occurrences all number	0	0	0	1	0
Muscle spasms
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Muscle twitching
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	1	0	0	2
Musculoskeletal chest pain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	4 / 679 (0.59%)
occurrences all number	0	0	0	1	4
Myokymia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Tenosynovitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	3 / 679 (0.44%)
occurrences all number	0	0	0	1	3
Flank pain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	2 / 176 (1.14%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	2	0	0	0	3
Neck pain
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	1	0	0	0	2
Osteoarthritis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	2 / 176 (1.14%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	2	0	0	0	2
Arthritis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	3
Joint swelling
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Muscle tightness
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Osteoporosis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	3
Periarthritis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Posture abnormal
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Spinal osteoarthritis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Spondylolisthesis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Systemic lupus erythematosus
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Tendonitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Infections and infestations
Periodontitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	5 / 679 (0.74%)
occurrences all number	1	0	0	0	5
Nasopharyngitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	26 / 176 (14.77%)	23 / 176 (13.07%)	24 / 175 (13.71%)	23 / 180 (12.78%)	170 / 679 (25.04%)
occurrences all number	26	23	30	28	325
Upper respiratory tract infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	8 / 176 (4.55%)	8 / 176 (4.55%)	14 / 175 (8.00%)	11 / 180 (6.11%)	70 / 679 (10.31%)
occurrences all number	9	12	17	19	147
Pharyngitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	3 / 176 (1.70%)	1 / 176 (0.57%)	4 / 175 (2.29%)	2 / 180 (1.11%)	24 / 679 (3.53%)
occurrences all number	3	2	5	2	36
Influenza
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	2 / 176 (1.14%)	3 / 176 (1.70%)	1 / 175 (0.57%)	2 / 180 (1.11%)	31 / 679 (4.57%)
occurrences all number	2	3	1	2	36
Gastroenteritis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	2 / 176 (1.14%)	2 / 175 (1.14%)	1 / 180 (0.56%)	18 / 679 (2.65%)
occurrences all number	1	3	2	1	20
Tinea pedis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	1 / 175 (0.57%)	1 / 180 (0.56%)	8 / 679 (1.18%)
occurrences all number	0	1	1	1	9
Bronchitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	1 / 175 (0.57%)	1 / 180 (0.56%)	7 / 679 (1.03%)
occurrences all number	1	0	1	1	7
Gastroenteritis viral
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	1 / 175 (0.57%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	1	1	0	3
Oral herpes
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	1 / 176 (0.57%)	0 / 175 (0.00%)	1 / 180 (0.56%)	4 / 679 (0.59%)
occurrences all number	1	1	0	1	5
Rhinitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	1 / 180 (0.56%)	12 / 679 (1.77%)
occurrences all number	0	1	0	1	13
Bacterial infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	0	0	0	1	1
Gastroenteritis bacterial
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Herpes zoster
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	3 / 679 (0.44%)
occurrences all number	1	0	0	1	3
Impetigo
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	1	0	1	0	2
Otitis externa
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	8 / 679 (1.18%)
occurrences all number	0	1	0	0	10
Otitis media
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	4 / 679 (0.59%)
occurrences all number	0	1	0	0	5
Pneumonia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	7 / 679 (1.03%)
occurrences all number	0	0	0	1	7
Purulence
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	1	0	2
Respiratory tract infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	1	1	0	0	1
Sinusitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	3 / 679 (0.44%)
occurrences all number	0	0	0	1	3
Syphilis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Tonsillitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	6 / 679 (0.88%)
occurrences all number	0	0	0	1	8
Urinary tract infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	8 / 679 (1.18%)
occurrences all number	0	0	1	0	10
Viral infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	1	0	3
Wound infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	1 / 180 (0.56%)	1 / 679 (0.15%)
occurrences all number	1	0	0	1	1
Eczema infected
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	1	0	0	0	0
Onychomycosis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	1	0	0	0	0
Angular cheilitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Bartholin's abscess
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Candida infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Carbuncle
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Cellulitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Chronic sinusitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Conjunctivitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	11 / 679 (1.62%)
occurrences all number	0	0	0	0	12
Cystitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	3
Dermatophytosis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Dermatophytosis of nail
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Ear infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Eczema impetiginous
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Enteritis infectious
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Eye infection bacterial
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Folliculitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	3
Fungal infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Fungal skin infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	3
Gingival abscess
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Helicobacter infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Herpes dermatitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Hordeolum
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Infected dermal cyst
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Kidney infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Lung infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Mumps
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Oral candidiasis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Paronychia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	3
Pericoronitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Peritonsillar abscess
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Pyoderma
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Tinea manuum
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Vaginal infection
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	3
Varicella
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Vulvovaginitis
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Metabolism and nutrition disorders
Decreased appetite
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	3 / 176 (1.70%)	1 / 176 (0.57%)	5 / 175 (2.86%)	3 / 180 (1.67%)	21 / 679 (3.09%)
occurrences all number	3	1	5	3	21
Hyponatraemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	2 / 175 (1.14%)	2 / 180 (1.11%)	10 / 679 (1.47%)
occurrences all number	0	1	2	2	12
Increased appetite
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	2 / 175 (1.14%)	3 / 180 (1.67%)	6 / 679 (0.88%)
occurrences all number	0	0	2	3	6
Dyslipidaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	2 / 180 (1.11%)	6 / 679 (0.88%)
occurrences all number	0	0	1	2	6
Hyperlipidaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	3 / 175 (1.71%)	0 / 180 (0.00%)	7 / 679 (1.03%)
occurrences all number	0	0	3	0	8
Diabetes mellitus
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	2 / 175 (1.14%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	2	0	3
Hypochloraemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	2 / 175 (1.14%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	2	0	4
Dehydration
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	1	0	0	1
Hypertriglyceridaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	5 / 679 (0.74%)
occurrences all number	0	1	0	0	7
Hypokalaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	1 / 176 (0.57%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	1	0	0	3
Weight fluctuation
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	1 / 175 (0.57%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	1	0	1
Appetite disorder
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	0 / 679 (0.00%)
occurrences all number	1	0	0	0	0
Hyperglycaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	1 / 176 (0.57%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	4 / 679 (0.59%)
occurrences all number	1	0	0	0	5
Hyperammonaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Hypercholesterolaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	3 / 679 (0.44%)
occurrences all number	0	0	0	0	4
Hypermagnesaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	2
Hyperuricaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	5 / 679 (0.74%)
occurrences all number	0	0	0	0	6
Hypoglycaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	2 / 679 (0.29%)
occurrences all number	0	0	0	0	6
Hypoproteinaemia
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1
Obesity
alternative dictionary used: MedDRA 21.1
subjects affected / exposed	0 / 176 (0.00%)	0 / 176 (0.00%)	0 / 175 (0.00%)	0 / 180 (0.00%)	1 / 679 (0.15%)
occurrences all number	0	0	0	0	1

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Were there any global substantial amendments to the protocol? Yes

19 Mar 2012

Amendment 01: Inclusion/Exclusion criteria was updated as per amendment 01 dated 19 March 2012.

09 Nov 2012

Amendment 02: - Increased the number of sites and added Oceania as a region for conducting the study. - Specified that it was not required to obtain a written or verbal assent from subjects with severe mental retardation. - Modified the mode of administration of study drug to allow for study drug to be taken without food before bedtime. - Specified that subjects should not increase or decrease their dose more than once unless there was a significant medical reason.

16 Apr 2013

Amendment 03: No major changes were made to the protocol Version 4.0 (Amendment 03) dated 16 April 2013.

05 Nov 2014

Amendment 04: - Clarified that, depending on the requirements in each country, the Maintenance Period of the Extension Phase was terminated within 3 months from the market launch date of perampanel in that country or at Week 75, whichever is later. - Clarified that the Follow-up Visit was not required if the study drug was switched to the commercial product for perampanel.

28 May 2015

Amendment 05: Specified the schedule of procedures/assessments separately for subjects whose visit exceeded Week 75 in the Extension Phase because some assessments were deemed unnecessary for evaluation, per sponsor’s decision.

Were there any global interruptions to the trial? No

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

None reported

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Clinical trials

Clinical Trial Results:
A Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline)

Primary: Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline)

Secondary: Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF)

Secondary: Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF)

Secondary: Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline)

Secondary: Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline)

Secondary: Core Phase: Number of Subjects With Clinical Global Impression of Change (CGIC) Scores

Secondary: Core Phase: Number of Subjects With Clinical Global Impression of Change (CGIC) Scores

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline)

Primary: Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline)

Secondary: Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF)

Secondary: Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF)

Secondary: Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline)

Secondary: Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline)

Secondary: Core Phase: Number of Subjects With Clinical Global Impression of Change (CGIC) Scores

Secondary: Core Phase: Number of Subjects With Clinical Global Impression of Change (CGIC) Scores

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures