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Clinical Trial Results:
A Multicenter, Long-term Follow-up Study of the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity

Summary
EudraCT number	2009-009216-53
Trial protocol	PT NL GB FR DE IT ES BE AT CZ SK
Global end of trial date	04 Sep 2013

Results information
Results version number	v1(current)
This version publication date	01 Jun 2016
First version publication date	01 Jun 2016
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

191622-094

ISRCTN number

US NCT number

NCT00876447

WHO universal trial number (UTN)

Sponsor organisation name

Allergan Limited

Sponsor organisation address

Allergan Limited Marlow International The Parkway, Marlow, United Kingdom, SL7 1YL

Public contact

Allergan Limited EU Regulatory Dept, Allergan Limited, 44 1628 494444, ml-eu_reg_affairs@allergan.com

Scientific contact

Allergan Limited EU Regulatory Dept, Allergan Limited, 44 1628 494444, ml-eu_reg_affairs@allergan.com

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

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

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

Analysis stage

Final

Date of interim/final analysis

14 Mar 2014

Is this the analysis of the primary completion data?

Yes

Primary completion date

12 Jun 2013

Global end of trial reached?

Yes

Global end of trial date

04 Sep 2013

Was the trial ended prematurely?

Main objective of the trial

To evaluate the long-term safety and maintenance of efficacy of BOTOX injected into the detrusor for the treatment of urinary incontinence caused by neurogenic detrusor overactivity in patients not been adequately managed with anticholinergic therapy

Protection of trial subjects

All study participants were required to read and sign an Informed Consent Form

Background therapy

Evidence for comparator

Actual start date of recruitment

04 Apr 2009

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 209

Country: Number of subjects enrolled

United Kingdom: 15

Country: Number of subjects enrolled

Australia: 16

Country: Number of subjects enrolled

Austria: 2

Country: Number of subjects enrolled

Belgium: 16

Country: Number of subjects enrolled

Brazil: 15

Country: Number of subjects enrolled

Canada: 20

Country: Number of subjects enrolled

Czech Republic: 15

Country: Number of subjects enrolled

Spain: 2

Country: Number of subjects enrolled

France: 7

Country: Number of subjects enrolled

Germany: 5

Country: Number of subjects enrolled

Italy: 1

Country: Number of subjects enrolled

Netherlands Antilles: 9

Country: Number of subjects enrolled

New Zealand: 1

Country: Number of subjects enrolled

Poland: 9

Country: Number of subjects enrolled

Portugal: 12

Country: Number of subjects enrolled

Taiwan: 3

Country: Number of subjects enrolled

South Africa: 3

Country: Number of subjects enrolled

Singapore: 2

Country: Number of subjects enrolled

Slovakia: 6

Country: Number of subjects enrolled

Russian Federation: 8

Country: Number of subjects enrolled

Ukraine: 12

Worldwide total number of subjects

388

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)

363

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

This was a long-term follow-up study that enrolled patients after participation in Study 191622-515 or 191622-516. A total of 397 patients were enrolled and 388 patients received at least 1 BOTOX treatment in study 191622-094 or in the preceding studies.

Screening details

The protocol was amended to remove the 300 U dose. Patients ongoing in the study who were treated with 300 U BOTOX prior to the amendment were assigned to 200 U BOTOX for all subsequent treatments. Participant Flow and Baseline Characteristics are based on the first BOTOX dose that patients received.

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, Monitor, Data analyst, Carer, Assessor

Are arms mutually exclusive

Yes

Botulinum Toxin Type A 300U

Arm description

Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.

Arm type

Experimental

Investigational medicinal product name

Botulinum Toxin Type A

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.

Botulinum Toxin Type A 200U

Arm description

Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

Arm type

Experimental

Investigational medicinal product name

Botulinum Toxin Type A

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.

Number of subjects in period 1	Botulinum Toxin Type A 300U	Botulinum Toxin Type A 200U
Started	185	203
Completed	105	122
Not completed	80	81
Personal reasons	30	28
Adverse event, non-fatal	4	8
Pregnancy	4	2
Other miscellaneous reasons	3	8
Lost to follow-up	6	15
Site closure	19	14
Lack of efficacy	5	3
Protocol deviation	9	3

Baseline characteristics

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Reporting group title

Botulinum Toxin Type A 300U

Reporting group description

Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.

Reporting group title

Botulinum Toxin Type A 200U

Reporting group description

Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

Reporting group values	Botulinum Toxin Type A 300U	Botulinum Toxin Type A 200U	Total
Number of subjects	185	203	388
Age categorical
Units: Subjects
Adults (18-64 years)	171	192	363
From 65-84 years	14	11	25
Age continuous
Units: years
arithmetic mean (standard deviation)	46.3 ± 12.96	46.5 ± 12.33	-
Gender, Male/Female
Units: Participants
Female	116	118	234
Male	69	85	154

End points

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Reporting group title

Botulinum Toxin Type A 300U

Reporting group description

Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.

Reporting group title

Botulinum Toxin Type A 200U

Reporting group description

Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

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End point title

Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes ^[1]

End point description

Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).

End point type

Primary

End point timeframe

Study Baseline, Week 6 Treatment Cycle 1

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No Statistical Analysis is reported for this outcome measure

End point values	Botulinum Toxin Type A 300U	Botulinum Toxin Type A 200U
Number of subjects analysed	183	201
Units: Incontinence Episodes
arithmetic mean (standard deviation)
Study Baseline (BL)	4.4 ± 2.54	4.5 ± 2.64
Chg from Study BL at Wk 6 Tmt Cycle1 (N=176, 195)	-3.4 ± 3.16	-3.2 ± 2.69

No statistical analyses for this end point

Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

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End point title

Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes ^[2]

End point description

End point type

Primary

End point timeframe

Study Baseline, Week 6 Treatment Cycle 2

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No Statistical Analysis is reported for this outcome measure

End point values	Botulinum Toxin Type A 300U	Botulinum Toxin Type A 200U
Number of subjects analysed	161	186
Units: Incontinence Episodes
arithmetic mean (standard deviation)
Study Baseline	4.5 ± 2.62	4.6 ± 2.71
Chg from Study BL at Wk 6 Tmt Cycle2 (N=153, 175)	-3.5 ± 3.13	-3.3 ± 2.85

No statistical analyses for this end point

Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

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End point title

Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes ^[3]

End point description

End point type

Primary

End point timeframe

Study Baseline, Week 6 Treatment Cycle 3

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No Statistical Analysis is reported for this outcome measure

End point values	Botulinum Toxin Type A 300U	Botulinum Toxin Type A 200U
Number of subjects analysed	118	173
Units: Incontinence Episodes
arithmetic mean (standard deviation)
Study Baseline	4.4 ± 2.33	4.6 ± 2.65
Chg from Study BL at Wk 6 Tmt Cycle3 (N=109, 164)	-3.3 ± 2.39	-3.5 ± 2.96

No statistical analyses for this end point

Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

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End point title

Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes ^[4]

End point description

End point type

Primary

End point timeframe

Study Baseline, Week 6 Treatment Cycle 4

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No Statistical Analysis is reported for this outcome measure

End point values	Botulinum Toxin Type A 300U	Botulinum Toxin Type A 200U
Number of subjects analysed	67	149
Units: Incontinence Episodes
arithmetic mean (standard deviation)
Study Baseline	4.4 ± 2.13	4.4 ± 2.57
Chg from Study BL at Wk 6 Tmt Cycle4 (N=62, 141)	-3.4 ± 2.57	-3.5 ± 2.61

No statistical analyses for this end point

Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

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End point title

Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes ^[5]

End point description

End point type

Primary

End point timeframe

Study Baseline, Week 6 Treatment Cycle 5

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No Statistical Analysis is reported for this outcome measure

End point values	Botulinum Toxin Type A 300U	Botulinum Toxin Type A 200U
Number of subjects analysed	33	108
Units: Incontinence Episodes
arithmetic mean (standard deviation)
Study Baseline	4.1 ± 2.34	4.6 ± 2.57
Chg from Study BL at Wk 6 Tmt Cycle5 (N=29, 99)	-3.7 ± 2.82	-3.6 ± 2.27

No statistical analyses for this end point

Secondary: Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

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End point title

Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

End point description

The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.

End point type

Secondary

End point timeframe

Study Baseline, Week 6 Treatment Cycle 1

End point values	Botulinum Toxin Type A 300U	Botulinum Toxin Type A 200U
Number of subjects analysed	185	202
Units: Scores on a Scale
arithmetic mean (standard deviation)
Study Baseline	33.9 ± 18.19	34.4 ± 18.18
Chg from Study BL at Wk 6 Tmt Cycle1 (N=180, 199)	32.3 ± 26.07	30.3 ± 26.37

No statistical analyses for this end point

Secondary: Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

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End point title

Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

End point description

End point type

Secondary

End point timeframe

Study Baseline, Week 6 Treatment Cycle 2

End point values	Botulinum Toxin Type A 300U	Botulinum Toxin Type A 200U
Number of subjects analysed	162	185
Units: Scores on a Scale
arithmetic mean (standard deviation)
Study Baseline	33.3 ± 18.17	33.8 ± 18.17
Chg from Study BL at Wk 6 Tmt Cycle2 (N=157, 178)	31.4 ± 27.73	33.5 ± 26.23

No statistical analyses for this end point

Secondary: Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

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End point title

Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

End point description

End point type

Secondary

End point timeframe

Study Baseline, Week 6 Treatment Cycle 3

End point values	Botulinum Toxin Type A 300U	Botulinum Toxin Type A 200U
Number of subjects analysed	118	173
Units: Scores on a Scale
arithmetic mean (standard deviation)
Study Baseline	32.5 ± 17.83	34.8 ± 18.95
Chg from Study BL at Wk 6 Tmt Cycle3 (N=114, 164)	28.8 ± 28.96	30.4 ± 29.25

No statistical analyses for this end point

Secondary: Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

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End point title

Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

End point description

End point type

Secondary

End point timeframe

Study Baseline, Week 6 Treatment Cycle 4

End point values	Botulinum Toxin Type A 300U	Botulinum Toxin Type A 200U
Number of subjects analysed	66	151
Units: Scores on a Scale
arithmetic mean (standard deviation)
Study Baseline	27.9 ± 16.66	35.5 ± 17.7
Chg from Study BL at Wk 6 Tmt Cycle4 (N=63, 147)	30.4 ± 31.77	30.1 ± 26.07

No statistical analyses for this end point

Secondary: Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

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End point title

Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

End point description

End point type

Secondary

End point timeframe

Study Baseline, Week 6 Treatment Cycle 5

End point values	Botulinum Toxin Type A 300U	Botulinum Toxin Type A 200U
Number of subjects analysed	31	109
Units: Scores on a Scale
arithmetic mean (standard deviation)
Study Baseline	32 ± 16.13	33 ± 19.61
Chg from Study BL at Wk 6 Tmt Cycle5 (N=28, 100)	36.6 ± 28.28	27.1 ± 24.54

No statistical analyses for this end point

Secondary: Change from Study Baseline in Volume Per Void

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End point title

Change from Study Baseline in Volume Per Void

End point description

The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.

End point type

Secondary

End point timeframe

Study Baseline, Week 6 Treatment Cycle 1

End point values	Botulinum Toxin Type A 300U	Botulinum Toxin Type A 200U
Number of subjects analysed	178	196
Units: Milliliters (mL)
arithmetic mean (standard deviation)
Study Baseline	147.3 ± 90.15	154.2 ± 96.54
Chg from Study BL at Wk 6 Tmt Cycle1 (N=168, 186)	133.8 ± 137.23	133.2 ± 128.19

No statistical analyses for this end point

Secondary: Change from Study Baseline in Volume Per Void

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End point title

Change from Study Baseline in Volume Per Void

End point description

End point type

Secondary

End point timeframe

Study Baseline, Week 6 Treatment Cycle 2

End point values	Botulinum Toxin Type A 300U	Botulinum Toxin Type A 200U
Number of subjects analysed	157	181
Units: Milliliters (mL)
arithmetic mean (standard deviation)
Study Baseline	149.8 ± 91.03	151.9 ± 95.22
Chg from Study BL at Wk 6 Tmt Cycle2 (N=146, 168)	148 ± 134.45	135.1 ± 127.62

No statistical analyses for this end point

Secondary: Change from Study Baseline in Volume Per Void

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End point title

Change from Study Baseline in Volume Per Void

End point description

End point type

Secondary

End point timeframe

Study Baseline, Week 6 Treatment Cycle 3

End point values	Botulinum Toxin Type A 300U	Botulinum Toxin Type A 200U
Number of subjects analysed	114	168
Units: Milliliters (mL)
arithmetic mean (standard deviation)
Study Baseline	155 ± 90.7	149.6 ± 91.12
Chg from Study BL at Wk 6 Tmt Cycle3 (N=105, 158)	166.9 ± 133.59	157.5 ± 129.81

No statistical analyses for this end point

Secondary: Change from Study Baseline in Volume Per Void

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End point title

Change from Study Baseline in Volume Per Void

End point description

End point type

Secondary

End point timeframe

Study Baseline, Week 6 Treatment Cycle 4

End point values	Botulinum Toxin Type A 300U	Botulinum Toxin Type A 200U
Number of subjects analysed	65	143
Units: Milliliters (mL)
arithmetic mean (standard deviation)
Study Baseline	159.7 ± 89.37	151.7 ± 93.65
Chg from Study BL at Wk 6 Tmt Cycle4 (N=61, 135)	170.8 ± 128.26	147.3 ± 122.09

No statistical analyses for this end point

Secondary: Change from Study Baseline in Volume Per Void

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End point title

Change from Study Baseline in Volume Per Void

End point description

End point type

Secondary

End point timeframe

Study Baseline, Week 6 Treatment Cycle 5

End point values	Botulinum Toxin Type A 300U	Botulinum Toxin Type A 200U
Number of subjects analysed	32	104
Units: Milliliters (mL)
arithmetic mean (standard deviation)
Study Baseline	182.7 ± 85.03	140.8 ± 91.32
Chg from Study BL at Wk 6 Tmt Cycle5 (N=28, 95)	163.5 ± 106.44	160.2 ± 119.4

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse events were recorded from signing the informed consent to the end of study (Week 156).

Adverse event reporting additional description

The Botox-Treated Population includes all patients who received at least 1 BOTOX treatment (in Study 191622-094, 191622-515 or 191622-516) and is used to assess adverse events (AEs) and serious adverse events (SAEs). AEs and SAEs are reported by treatment cycle.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

16.0

Reporting group title

Botulinum Toxin Type A 300U Treatment Cycle 1

Reporting group description

Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.

Reporting group title

Botulinum Toxin Type A 200U Treatment Cycle 1

Reporting group description

Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

Reporting group title

Botulinum Toxin Type A 300U Treatment Cycle 2

Reporting group description

Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.

Reporting group title

Botulinum Toxin Type A 200U Treatment Cycle 2

Reporting group description

Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

Reporting group title

Botulinum Toxin Type A 300U Treatment Cycle 3

Reporting group description

Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.

Reporting group title

Botulinum Toxin Type A 200U Treatment Cycle 3

Reporting group description

Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

Reporting group title

Botulinum Toxin Type A 300U Treatment Cycle 4

Reporting group description

Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.

Reporting group title

Botulinum Toxin Type A 200U Treatment Cycle 4

Reporting group description

Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

Reporting group title

Botulinum Toxin Type A 300U Treatment Cycle 5

Reporting group description

Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.

Reporting group title

Botulinum Toxin Type A 200U Treatment Cycle 5

Reporting group description

Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

Reporting group title

Botulinum Toxin Type A 300U Treatment Cycle 6

Reporting group description

Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.

Reporting group title

Botulinum Toxin Type A 200U Treatment Cycle 6

Reporting group description

Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

Reporting group title

Botulinum Toxin Type A 300U Treatment Cycle 7

Reporting group description

Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.

Reporting group title

Botulinum Toxin Type A 200U Treatment Cycle 7

Reporting group description

Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

Reporting group title

Botulinum Toxin Type A 200U Treatment Cycle 8

Reporting group description

Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

Reporting group title

Botulinum Toxin Type A 200U Treatment Cycle 9

Reporting group description

Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

Reporting group title

Botulinum Toxin Type A 200U Treatment Cycle 10

Reporting group description

Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

Reporting group title

Botulinum Toxin Type A 200U Treatment Cycle 11

Reporting group description

Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

Reporting group title

Botulinum Toxin Type A 200U Treatment Cycle 12

Reporting group description

Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

Botulinum Toxin Type A 300U Treatment Cycle 1

Botulinum Toxin Type A 200U Treatment Cycle 1

Botulinum Toxin Type A 300U Treatment Cycle 2

Botulinum Toxin Type A 200U Treatment Cycle 2

Botulinum Toxin Type A 300U Treatment Cycle 3

Botulinum Toxin Type A 200U Treatment Cycle 3

Botulinum Toxin Type A 300U Treatment Cycle 4

Botulinum Toxin Type A 200U Treatment Cycle 4

Botulinum Toxin Type A 300U Treatment Cycle 5

Botulinum Toxin Type A 200U Treatment Cycle 5

Botulinum Toxin Type A 300U Treatment Cycle 6

Botulinum Toxin Type A 200U Treatment Cycle 6

Botulinum Toxin Type A 300U Treatment Cycle 7

Botulinum Toxin Type A 200U Treatment Cycle 7

Botulinum Toxin Type A 200U Treatment Cycle 8

Botulinum Toxin Type A 200U Treatment Cycle 9

Botulinum Toxin Type A 200U Treatment Cycle 10

Botulinum Toxin Type A 200U Treatment Cycle 11

Botulinum Toxin Type A 200U Treatment Cycle 12

Total subjects affected by serious adverse events

subjects affected / exposed

28 / 185 (15.14%)

35 / 203 (17.24%)

26 / 163 (15.95%)

21 / 187 (11.23%)

20 / 119 (16.81%)

19 / 175 (10.86%)

11 / 69 (15.94%)

20 / 153 (13.07%)

5 / 34 (14.71%)

11 / 110 (10.00%)

0 / 16 (0.00%)

9 / 70 (12.86%)

0 / 8 (0.00%)

6 / 48 (12.50%)

0 / 36 (0.00%)

2 / 22 (9.09%)

1 / 11 (9.09%)

0 / 5 (0.00%)

0 / 2 (0.00%)

number of deaths (all causes)

number of deaths resulting from adverse events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Basal Cell Carcinoma

subjects affected / exposed

1 / 185 (0.54%)

0 / 203 (0.00%)

0 / 163 (0.00%)

1 / 187 (0.53%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

2 / 34 (5.88%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Prostate cancer

Additional description: Males Only

subjects affected / exposed

1 / 185 (0.54%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Breast Cancer

subjects affected / exposed

0 / 185 (0.00%)

2 / 203 (0.99%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Squamous Cell Carcinoma

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Thyroid Neoplasm

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Squamous Cell Carcinoma of Skin

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

1 / 119 (0.84%)

0 / 175 (0.00%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Invasive Ductal Breast Carcinoma

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Glioblastoma

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

1 / 110 (0.91%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Uterine Leiomyoma

Additional description: Females Only

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

1 / 48 (2.08%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular disorders

Hypertension

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

2 / 175 (1.14%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Peripheral Ischaemia

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

1 / 187 (0.53%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Deep Vein Thrombosis

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

1 / 119 (0.84%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Peripheral Vascular Disorder

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

1 / 119 (0.84%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Surgical and medical procedures

Abortion Induced

Additional description: Females Only

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

1 / 110 (0.91%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

Adverse Drug Reaction

subjects affected / exposed

1 / 185 (0.54%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Non-Cardiac Chest Pain

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

2 / 203 (0.99%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

1 / 70 (1.43%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

1 / 11 (9.09%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pyrexia

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Device Dislocation

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Oedema Peripheral

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Device Deployment Issue

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Impaired Healing

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Device Malfunction

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Immune system disorders

Anaphylactic Reaction

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Reproductive system and breast disorders

Epididymitis

Additional description: Males Only

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

1 / 175 (0.57%)

1 / 69 (1.45%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pelvic Prolapse

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Erectile Dysfunction

Additional description: Males Only

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

1 / 119 (0.84%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

Asthma

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

1 / 69 (1.45%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory Failure

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia Aspiration

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

1 / 187 (0.53%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumothorax

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

1 / 187 (0.53%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pulmonary Embolism

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Psychiatric disorders

Mental Status Changes

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

1 / 70 (1.43%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Acute Psychosis

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Depression

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

1 / 119 (0.84%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Confusional State

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Investigations

Urine Cytology Abnormal

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Medical observation

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

1 / 110 (0.91%)

0 / 16 (0.00%)

1 / 70 (1.43%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Craniocerebral Injury

alternative assessment type: Non-systematic

subjects affected / exposed

1 / 185 (0.54%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tendon Rupture

alternative assessment type: Non-systematic

subjects affected / exposed

1 / 185 (0.54%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Concussion

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Fall

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Forearm Fracture

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Incisional Hernia

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lower Limb Fracture

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

1 / 187 (0.53%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Overdose

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Femur fracture

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

1 / 187 (0.53%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hip Fracture

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

1 / 187 (0.53%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tibia Fracture

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

1 / 187 (0.53%)

0 / 119 (0.00%)

0 / 175 (0.00%)

1 / 69 (1.45%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Joint Dislocation

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

1 / 119 (0.84%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Spinal Compression Fracture

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Scar

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

1 / 69 (1.45%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Scrotal Haematoma

Additional description: Males Only

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

1 / 69 (1.45%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Post Procedural Haemorrhage

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

1 / 110 (0.91%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Foot Fracture

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

1 / 48 (2.08%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ankle Fracture

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

1 / 22 (4.55%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Myocardial Infarction

subjects affected / exposed

1 / 185 (0.54%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Acute myocardial infarction

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Atrioventricular Block

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Angina Pectoris

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

1 / 187 (0.53%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

1 / 70 (1.43%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Atrial Fibrillation

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Arrhythmia

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nervous system disorders

Multiple Sclerosis Relapse

alternative assessment type: Non-systematic

subjects affected / exposed

4 / 185 (2.16%)

4 / 203 (1.97%)

4 / 163 (2.45%)

0 / 187 (0.00%)

3 / 119 (2.52%)

3 / 175 (1.71%)

4 / 69 (5.80%)

2 / 153 (1.31%)

1 / 34 (2.94%)

1 / 110 (0.91%)

0 / 16 (0.00%)

3 / 70 (4.29%)

0 / 8 (0.00%)

2 / 48 (4.17%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 4

0 / 0

0 / 3

0 / 4

0 / 2

0 / 1

0 / 0

0 / 3

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Muscle Spasticity

alternative assessment type: Non-systematic

subjects affected / exposed

1 / 185 (0.54%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cerebrovascular Accident

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ischaemic Stroke

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Myasthenia Gravis

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Multiple Sclerosis

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

2 / 163 (1.23%)

0 / 187 (0.00%)

1 / 119 (0.84%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Paraparesis

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Convulsion

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

1 / 187 (0.53%)

1 / 119 (0.84%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Epilepsy

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

1 / 187 (0.53%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cervical myelopathy

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Spinal Cord Compression

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

1 / 110 (0.91%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Syncope

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

1 / 48 (2.08%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Blood and lymphatic system disorders

Neutropenia

subjects affected / exposed

1 / 185 (0.54%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Eye disorders

Vision Blurred

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

1 / 187 (0.53%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Intestinal Obstruction

subjects affected / exposed

2 / 185 (1.08%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

1 / 119 (0.84%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Enterocolitis

subjects affected / exposed

1 / 185 (0.54%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Umbilical Hernia

subjects affected / exposed

1 / 185 (0.54%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Enterocutaneous Fistula

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Faecaloma

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Abdominal pain

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

1 / 70 (1.43%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Colitis Ischaemic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Diarrhoea

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

1 / 70 (1.43%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haemorrhoidal Haemorrhage

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Large Intestine Perforation

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lower Gastrointestinal Haemorrhage

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Melaena

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Small Intestinal Obstruction

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Volvulus

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Constipation

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

1 / 187 (0.53%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

1 / 110 (0.91%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

Cholecystitis Acute

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cholecystitis

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Skin and subcutaneous tissue disorders

Decubitus Ulcer

alternative assessment type: Non-systematic

subjects affected / exposed

2 / 185 (1.08%)

4 / 203 (1.97%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

2 / 175 (1.14%)

0 / 69 (0.00%)

0 / 153 (0.00%)

1 / 34 (2.94%)

1 / 110 (0.91%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

1 / 48 (2.08%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 4

0 / 1

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

Urinary Retention

alternative assessment type: Non-systematic

subjects affected / exposed

1 / 185 (0.54%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urethral Haemorrhage

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Stress Urinary Incontinence

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

1 / 187 (0.53%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Bladder Neck Obstruction

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haematuria

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urethral Stenosis

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nephrolithiasis

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

1 / 187 (0.53%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Neurogenic Bladder

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urinary Incontinence

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

1 / 69 (1.45%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hydronephrosis

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hydroureter

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Endocrine disorders

Hyperthyroidism

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

1 / 69 (1.45%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

Lumbar Spinal Stenosis

subjects affected / exposed

2 / 185 (1.08%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Spondylolisthesis

subjects affected / exposed

1 / 185 (0.54%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Foot Deformity

alternative assessment type: Non-systematic

subjects affected / exposed

1 / 185 (0.54%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Intervertebral Disc Protrusion

subjects affected / exposed

1 / 185 (0.54%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Muscular Weakness

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

2 / 203 (0.99%)

0 / 163 (0.00%)

1 / 187 (0.53%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Back Pain

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vertebral Foraminal Stenosis

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Bone Pain

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lupus-Like Syndrome

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Costochondritis

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

1 / 187 (0.53%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Exostosis

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

1 / 187 (0.53%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Osteoarthritis

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

1 / 187 (0.53%)

1 / 119 (0.84%)

0 / 175 (0.00%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Arthralgia

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cervical Spinal Stenosis

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rotator Cuff Syndrome

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Mobility Decreased

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

1 / 48 (2.08%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Urinary Tract Infection

alternative assessment type: Non-systematic

subjects affected / exposed

7 / 185 (3.78%)

5 / 203 (2.46%)

3 / 163 (1.84%)

1 / 187 (0.53%)

3 / 119 (2.52%)

2 / 175 (1.14%)

0 / 69 (0.00%)

1 / 153 (0.65%)

1 / 34 (2.94%)

1 / 110 (0.91%)

0 / 16 (0.00%)

1 / 70 (1.43%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

2 / 7

3 / 5

1 / 3

0 / 1

0 / 3

1 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia

subjects affected / exposed

1 / 185 (0.54%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

1 / 110 (0.91%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Clostridium Difficile Colitis

subjects affected / exposed

1 / 185 (0.54%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pyelonephritis

subjects affected / exposed

1 / 185 (0.54%)

0 / 203 (0.00%)

0 / 163 (0.00%)

3 / 187 (1.60%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

Upper Respiratory Tract Infection

alternative assessment type: Non-systematic

subjects affected / exposed

1 / 185 (0.54%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

1 / 70 (1.43%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urinary Tract Infection Bacterial

subjects affected / exposed

1 / 185 (0.54%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urosepsis

subjects affected / exposed

1 / 185 (0.54%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

1 / 110 (0.91%)

0 / 16 (0.00%)

1 / 70 (1.43%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Wound Infection

alternative assessment type: Non-systematic

subjects affected / exposed

1 / 185 (0.54%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Appendicitis

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cellulitis

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

1 / 110 (0.91%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Escherichia Sepsis

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Meningitis

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Necrotising Fasciitis

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

2 / 119 (1.68%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Paronychia

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Sepsis

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

1 / 187 (0.53%)

2 / 119 (1.68%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Osteomyelitis

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

1 / 119 (0.84%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pyelonephritis Acute

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

1 / 119 (0.84%)

0 / 175 (0.00%)

0 / 69 (0.00%)

3 / 153 (1.96%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

Systemic Candida

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

1 / 163 (0.61%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Localised Infection

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

1 / 187 (0.53%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Abscess of Salivary Gland

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

1 / 119 (0.84%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Skin Infection

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

1 / 119 (0.84%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Device Related Infection

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

1 / 175 (0.57%)

1 / 69 (1.45%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Bacteraemia

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Erysipelas

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Parotitis

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Viral Infection

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

1 / 153 (0.65%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Post Procedural Infection

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

1 / 110 (0.91%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Subcutaneous Abscess

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

1 / 22 (4.55%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

Obesity

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

1 / 203 (0.49%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

0 / 175 (0.00%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Dehydration

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hyperkalaemia

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypoglycaemia

subjects affected / exposed

0 / 185 (0.00%)

0 / 203 (0.00%)

0 / 163 (0.00%)

0 / 187 (0.00%)

0 / 119 (0.00%)

1 / 175 (0.57%)

0 / 69 (0.00%)

0 / 153 (0.00%)

0 / 34 (0.00%)

0 / 110 (0.00%)

0 / 16 (0.00%)

0 / 70 (0.00%)

0 / 8 (0.00%)

0 / 48 (0.00%)

0 / 36 (0.00%)

0 / 22 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Botulinum Toxin Type A 300U Treatment Cycle 1	Botulinum Toxin Type A 200U Treatment Cycle 1	Botulinum Toxin Type A 300U Treatment Cycle 2	Botulinum Toxin Type A 200U Treatment Cycle 2	Botulinum Toxin Type A 300U Treatment Cycle 3	Botulinum Toxin Type A 200U Treatment Cycle 3	Botulinum Toxin Type A 300U Treatment Cycle 4	Botulinum Toxin Type A 200U Treatment Cycle 4	Botulinum Toxin Type A 300U Treatment Cycle 5	Botulinum Toxin Type A 200U Treatment Cycle 5	Botulinum Toxin Type A 300U Treatment Cycle 6	Botulinum Toxin Type A 200U Treatment Cycle 6	Botulinum Toxin Type A 300U Treatment Cycle 7	Botulinum Toxin Type A 200U Treatment Cycle 7	Botulinum Toxin Type A 200U Treatment Cycle 8	Botulinum Toxin Type A 200U Treatment Cycle 9	Botulinum Toxin Type A 200U Treatment Cycle 10	Botulinum Toxin Type A 200U Treatment Cycle 11	Botulinum Toxin Type A 200U Treatment Cycle 12
Total subjects affected by non serious adverse events
subjects affected / exposed	154 / 185 (83.24%)	170 / 203 (83.74%)	126 / 163 (77.30%)	147 / 187 (78.61%)	89 / 119 (74.79%)	123 / 175 (70.29%)	51 / 69 (73.91%)	109 / 153 (71.24%)	19 / 34 (55.88%)	72 / 110 (65.45%)	8 / 16 (50.00%)	46 / 70 (65.71%)	3 / 8 (37.50%)	28 / 48 (58.33%)	23 / 36 (63.89%)	13 / 22 (59.09%)	5 / 11 (45.45%)	3 / 5 (60.00%)	1 / 2 (50.00%)
General disorders and administration site conditions
Oedema Peripheral
alternative assessment type: Non-systematic
subjects affected / exposed	6 / 185 (3.24%)	8 / 203 (3.94%)	3 / 163 (1.84%)	3 / 187 (1.60%)	4 / 119 (3.36%)	6 / 175 (3.43%)	3 / 69 (4.35%)	2 / 153 (1.31%)	2 / 34 (5.88%)	1 / 110 (0.91%)	0 / 16 (0.00%)	2 / 70 (2.86%)	0 / 8 (0.00%)	2 / 48 (4.17%)	2 / 36 (5.56%)	1 / 22 (4.55%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	6	10	5	3	4	6	3	3	2	1	0	2	0	2	2	1	0	0	0
Fatigue
alternative assessment type: Non-systematic
subjects affected / exposed	6 / 185 (3.24%)	13 / 203 (6.40%)	4 / 163 (2.45%)	6 / 187 (3.21%)	3 / 119 (2.52%)	4 / 175 (2.29%)	1 / 69 (1.45%)	0 / 153 (0.00%)	0 / 34 (0.00%)	2 / 110 (1.82%)	0 / 16 (0.00%)	1 / 70 (1.43%)	0 / 8 (0.00%)	0 / 48 (0.00%)	1 / 36 (2.78%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	8	14	4	7	3	5	1	0	0	2	0	1	0	0	1	0	0	0	0
Pyrexia
alternative assessment type: Non-systematic
subjects affected / exposed	4 / 185 (2.16%)	17 / 203 (8.37%)	5 / 163 (3.07%)	4 / 187 (2.14%)	2 / 119 (1.68%)	4 / 175 (2.29%)	0 / 69 (0.00%)	3 / 153 (1.96%)	0 / 34 (0.00%)	1 / 110 (0.91%)	0 / 16 (0.00%)	0 / 70 (0.00%)	0 / 8 (0.00%)	2 / 48 (4.17%)	1 / 36 (2.78%)	1 / 22 (4.55%)	1 / 11 (9.09%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	4	19	6	7	2	5	0	3	0	1	0	0	0	2	2	1	1	0	0
Reproductive system and breast disorders
Ovarian Cyst
Additional description: Females Only
subjects affected / exposed	0 / 185 (0.00%)	0 / 203 (0.00%)	0 / 163 (0.00%)	0 / 187 (0.00%)	0 / 119 (0.00%)	0 / 175 (0.00%)	0 / 69 (0.00%)	0 / 153 (0.00%)	1 / 34 (2.94%)	0 / 110 (0.00%)	0 / 16 (0.00%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Vulvovaginal Pruritus
Additional description: Females Only
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 185 (0.00%)	1 / 203 (0.49%)	0 / 163 (0.00%)	0 / 187 (0.00%)	0 / 119 (0.00%)	0 / 175 (0.00%)	0 / 69 (0.00%)	1 / 153 (0.65%)	0 / 34 (0.00%)	1 / 110 (0.91%)	0 / 16 (0.00%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 48 (0.00%)	1 / 36 (2.78%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	3	0	0	0	0	0	1	0	1	0	0	0	0	1	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Rhinitis Seasonal
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 185 (0.00%)	0 / 203 (0.00%)	0 / 163 (0.00%)	1 / 187 (0.53%)	0 / 119 (0.00%)	0 / 175 (0.00%)	0 / 69 (0.00%)	0 / 153 (0.00%)	0 / 34 (0.00%)	0 / 110 (0.00%)	0 / 16 (0.00%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Psychiatric disorders
Depression
alternative assessment type: Non-systematic
subjects affected / exposed	5 / 185 (2.70%)	6 / 203 (2.96%)	3 / 163 (1.84%)	5 / 187 (2.67%)	3 / 119 (2.52%)	0 / 175 (0.00%)	1 / 69 (1.45%)	1 / 153 (0.65%)	3 / 34 (8.82%)	1 / 110 (0.91%)	0 / 16 (0.00%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	1 / 22 (4.55%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	6	6	4	5	4	0	1	1	3	1	0	0	0	0	0	1	0	0	0
Investigations
Expanded Disability Status Scale Score Increased
subjects affected / exposed	7 / 185 (3.78%)	10 / 203 (4.93%)	13 / 163 (7.98%)	12 / 187 (6.42%)	4 / 119 (3.36%)	8 / 175 (4.57%)	2 / 69 (2.90%)	5 / 153 (3.27%)	0 / 34 (0.00%)	3 / 110 (2.73%)	0 / 16 (0.00%)	1 / 70 (1.43%)	0 / 8 (0.00%)	1 / 48 (2.08%)	2 / 36 (5.56%)	1 / 22 (4.55%)	1 / 11 (9.09%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	9	10	14	18	4	9	2	7	0	3	0	1	0	2	2	1	1	0	0
Haemoglobin Decreased
subjects affected / exposed	0 / 185 (0.00%)	0 / 203 (0.00%)	0 / 163 (0.00%)	0 / 187 (0.00%)	0 / 119 (0.00%)	0 / 175 (0.00%)	0 / 69 (0.00%)	0 / 153 (0.00%)	0 / 34 (0.00%)	0 / 110 (0.00%)	0 / 16 (0.00%)	0 / 70 (0.00%)	1 / 8 (12.50%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Central Nervous System Function Test Abnormal
subjects affected / exposed	0 / 185 (0.00%)	0 / 203 (0.00%)	0 / 163 (0.00%)	0 / 187 (0.00%)	0 / 119 (0.00%)	0 / 175 (0.00%)	0 / 69 (0.00%)	0 / 153 (0.00%)	0 / 34 (0.00%)	0 / 110 (0.00%)	0 / 16 (0.00%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Injury, poisoning and procedural complications
Fall
alternative assessment type: Non-systematic
subjects affected / exposed	5 / 185 (2.70%)	6 / 203 (2.96%)	7 / 163 (4.29%)	6 / 187 (3.21%)	1 / 119 (0.84%)	9 / 175 (5.14%)	2 / 69 (2.90%)	5 / 153 (3.27%)	0 / 34 (0.00%)	4 / 110 (3.64%)	0 / 16 (0.00%)	3 / 70 (4.29%)	0 / 8 (0.00%)	3 / 48 (6.25%)	3 / 36 (8.33%)	1 / 22 (4.55%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	6	13	9	7	2	9	2	7	0	4	0	3	0	7	6	1	0	0	0
Muscle Strain
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 185 (0.00%)	3 / 203 (1.48%)	1 / 163 (0.61%)	0 / 187 (0.00%)	2 / 119 (1.68%)	1 / 175 (0.57%)	1 / 69 (1.45%)	1 / 153 (0.65%)	0 / 34 (0.00%)	0 / 110 (0.00%)	1 / 16 (6.25%)	1 / 70 (1.43%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	3	1	0	2	1	1	1	0	0	1	1	0	0	0	0	0	0	0
Hand Fracture
subjects affected / exposed	0 / 185 (0.00%)	0 / 203 (0.00%)	0 / 163 (0.00%)	0 / 187 (0.00%)	0 / 119 (0.00%)	0 / 175 (0.00%)	0 / 69 (0.00%)	0 / 153 (0.00%)	0 / 34 (0.00%)	0 / 110 (0.00%)	1 / 16 (6.25%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Contusion
subjects affected / exposed	0 / 185 (0.00%)	2 / 203 (0.99%)	2 / 163 (1.23%)	1 / 187 (0.53%)	0 / 119 (0.00%)	1 / 175 (0.57%)	0 / 69 (0.00%)	2 / 153 (1.31%)	0 / 34 (0.00%)	0 / 110 (0.00%)	0 / 16 (0.00%)	0 / 70 (0.00%)	0 / 8 (0.00%)	3 / 48 (6.25%)	0 / 36 (0.00%)	1 / 22 (4.55%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	5	3	1	0	1	0	2	0	0	0	0	0	3	0	1	0	0	0
Thermal Burn
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 185 (0.00%)	2 / 203 (0.99%)	0 / 163 (0.00%)	0 / 187 (0.00%)	2 / 119 (1.68%)	1 / 175 (0.57%)	0 / 69 (0.00%)	1 / 153 (0.65%)	1 / 34 (2.94%)	0 / 110 (0.00%)	0 / 16 (0.00%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	1 / 5 (20.00%)	0 / 2 (0.00%)
occurrences all number	0	2	0	0	2	1	0	1	1	0	0	0	0	0	0	0	0	1	0
Cardiac disorders
Bundle Branch Block Right
subjects affected / exposed	0 / 185 (0.00%)	0 / 203 (0.00%)	0 / 163 (0.00%)	0 / 187 (0.00%)	0 / 119 (0.00%)	0 / 175 (0.00%)	0 / 69 (0.00%)	0 / 153 (0.00%)	0 / 34 (0.00%)	0 / 110 (0.00%)	0 / 16 (0.00%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Nervous system disorders
Muscle Spasticity
alternative assessment type: Non-systematic
subjects affected / exposed	4 / 185 (2.16%)	1 / 203 (0.49%)	2 / 163 (1.23%)	3 / 187 (1.60%)	1 / 119 (0.84%)	0 / 175 (0.00%)	1 / 69 (1.45%)	1 / 153 (0.65%)	2 / 34 (5.88%)	0 / 110 (0.00%)	1 / 16 (6.25%)	1 / 70 (1.43%)	0 / 8 (0.00%)	1 / 48 (2.08%)	1 / 36 (2.78%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	5	1	2	3	1	0	1	1	3	0	1	1	0	1	1	0	0	0	0
Headache
alternative assessment type: Non-systematic
subjects affected / exposed	8 / 185 (4.32%)	9 / 203 (4.43%)	3 / 163 (1.84%)	4 / 187 (2.14%)	3 / 119 (2.52%)	4 / 175 (2.29%)	1 / 69 (1.45%)	1 / 153 (0.65%)	1 / 34 (2.94%)	3 / 110 (2.73%)	0 / 16 (0.00%)	2 / 70 (2.86%)	0 / 8 (0.00%)	1 / 48 (2.08%)	2 / 36 (5.56%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	8	9	3	4	3	4	1	1	1	3	0	2	0	1	2	0	0	0	0
Blood and lymphatic system disorders
Leukocytosis
subjects affected / exposed	0 / 185 (0.00%)	0 / 203 (0.00%)	0 / 163 (0.00%)	1 / 187 (0.53%)	0 / 119 (0.00%)	1 / 175 (0.57%)	0 / 69 (0.00%)	0 / 153 (0.00%)	1 / 34 (2.94%)	0 / 110 (0.00%)	0 / 16 (0.00%)	1 / 70 (1.43%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	1	0	0	1	0	0	0	0	1	0	0
Gastrointestinal disorders
Diarrhoea
alternative assessment type: Non-systematic
subjects affected / exposed	7 / 185 (3.78%)	10 / 203 (4.93%)	7 / 163 (4.29%)	6 / 187 (3.21%)	3 / 119 (2.52%)	1 / 175 (0.57%)	3 / 69 (4.35%)	4 / 153 (2.61%)	2 / 34 (5.88%)	4 / 110 (3.64%)	0 / 16 (0.00%)	4 / 70 (5.71%)	0 / 8 (0.00%)	3 / 48 (6.25%)	0 / 36 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	7	13	9	6	3	1	3	5	2	4	0	5	0	4	0	0	0	0	0
Vomiting
alternative assessment type: Non-systematic
subjects affected / exposed	2 / 185 (1.08%)	1 / 203 (0.49%)	5 / 163 (3.07%)	2 / 187 (1.07%)	1 / 119 (0.84%)	4 / 175 (2.29%)	1 / 69 (1.45%)	2 / 153 (1.31%)	1 / 34 (2.94%)	3 / 110 (2.73%)	1 / 16 (6.25%)	2 / 70 (2.86%)	0 / 8 (0.00%)	0 / 48 (0.00%)	1 / 36 (2.78%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	2	1	5	2	1	5	1	2	1	4	1	2	0	0	2	0	0	0	0
Nausea
alternative assessment type: Non-systematic
subjects affected / exposed	4 / 185 (2.16%)	8 / 203 (3.94%)	7 / 163 (4.29%)	2 / 187 (1.07%)	3 / 119 (2.52%)	1 / 175 (0.57%)	1 / 69 (1.45%)	1 / 153 (0.65%)	0 / 34 (0.00%)	3 / 110 (2.73%)	1 / 16 (6.25%)	1 / 70 (1.43%)	0 / 8 (0.00%)	1 / 48 (2.08%)	1 / 36 (2.78%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	5	12	7	2	3	1	2	1	0	3	1	1	0	1	2	0	0	0	0
Constipation
alternative assessment type: Non-systematic
subjects affected / exposed	5 / 185 (2.70%)	10 / 203 (4.93%)	3 / 163 (1.84%)	5 / 187 (2.67%)	5 / 119 (4.20%)	4 / 175 (2.29%)	1 / 69 (1.45%)	7 / 153 (4.58%)	0 / 34 (0.00%)	4 / 110 (3.64%)	0 / 16 (0.00%)	1 / 70 (1.43%)	0 / 8 (0.00%)	3 / 48 (6.25%)	1 / 36 (2.78%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	5	11	4	6	5	4	1	8	0	5	0	1	0	3	1	0	0	0	0
Skin and subcutaneous tissue disorders
Dermatitis Atopic
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 185 (0.00%)	0 / 203 (0.00%)	0 / 163 (0.00%)	0 / 187 (0.00%)	0 / 119 (0.00%)	0 / 175 (0.00%)	0 / 69 (0.00%)	0 / 153 (0.00%)	0 / 34 (0.00%)	0 / 110 (0.00%)	0 / 16 (0.00%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Rash
alternative assessment type: Non-systematic
subjects affected / exposed	3 / 185 (1.62%)	0 / 203 (0.00%)	0 / 163 (0.00%)	2 / 187 (1.07%)	0 / 119 (0.00%)	1 / 175 (0.57%)	1 / 69 (1.45%)	0 / 153 (0.00%)	0 / 34 (0.00%)	1 / 110 (0.91%)	0 / 16 (0.00%)	1 / 70 (1.43%)	0 / 8 (0.00%)	1 / 48 (2.08%)	1 / 36 (2.78%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 5 (0.00%)	1 / 2 (50.00%)
occurrences all number	4	0	0	2	0	1	1	0	0	1	0	1	0	1	1	0	1	0	1
Renal and urinary disorders
Urinary Retention
alternative assessment type: Non-systematic
subjects affected / exposed	42 / 185 (22.70%)	41 / 203 (20.20%)	13 / 163 (7.98%)	15 / 187 (8.02%)	8 / 119 (6.72%)	11 / 175 (6.29%)	0 / 69 (0.00%)	4 / 153 (2.61%)	0 / 34 (0.00%)	2 / 110 (1.82%)	0 / 16 (0.00%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	50	44	13	15	9	11	0	4	0	3	0	0	0	0	0	0	0	0	0
Pollakiuria
subjects affected / exposed	4 / 185 (2.16%)	5 / 203 (2.46%)	2 / 163 (1.23%)	0 / 187 (0.00%)	0 / 119 (0.00%)	2 / 175 (1.14%)	0 / 69 (0.00%)	3 / 153 (1.96%)	1 / 34 (2.94%)	0 / 110 (0.00%)	0 / 16 (0.00%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	1 / 5 (20.00%)	1 / 2 (50.00%)
occurrences all number	4	5	2	0	0	2	0	3	1	0	0	0	0	0	0	0	0	1	1
Urine abnormality
subjects affected / exposed	1 / 185 (0.54%)	1 / 203 (0.49%)	0 / 163 (0.00%)	1 / 187 (0.53%)	0 / 119 (0.00%)	0 / 175 (0.00%)	0 / 69 (0.00%)	0 / 153 (0.00%)	0 / 34 (0.00%)	0 / 110 (0.00%)	0 / 16 (0.00%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	1 / 5 (20.00%)	1 / 2 (50.00%)
occurrences all number	2	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1
Endocrine disorders
Hypothyroidism
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 185 (0.54%)	2 / 203 (0.99%)	1 / 163 (0.61%)	1 / 187 (0.53%)	1 / 119 (0.84%)	1 / 175 (0.57%)	1 / 69 (1.45%)	0 / 153 (0.00%)	0 / 34 (0.00%)	1 / 110 (0.91%)	0 / 16 (0.00%)	0 / 70 (0.00%)	1 / 8 (12.50%)	1 / 48 (2.08%)	0 / 36 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	2	1	1	1	1	1	0	0	1	0	0	1	1	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Muscular Weakness
alternative assessment type: Non-systematic
subjects affected / exposed	5 / 185 (2.70%)	8 / 203 (3.94%)	10 / 163 (6.13%)	8 / 187 (4.28%)	2 / 119 (1.68%)	6 / 175 (3.43%)	2 / 69 (2.90%)	0 / 153 (0.00%)	0 / 34 (0.00%)	2 / 110 (1.82%)	0 / 16 (0.00%)	2 / 70 (2.86%)	0 / 8 (0.00%)	1 / 48 (2.08%)	1 / 36 (2.78%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	6	10	10	10	2	8	3	0	0	2	0	2	0	1	1	0	0	0	0
Fracture Pain
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 185 (0.00%)	0 / 203 (0.00%)	0 / 163 (0.00%)	0 / 187 (0.00%)	0 / 119 (0.00%)	0 / 175 (0.00%)	0 / 69 (0.00%)	0 / 153 (0.00%)	0 / 34 (0.00%)	0 / 110 (0.00%)	1 / 16 (6.25%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Tendonitis
subjects affected / exposed	0 / 185 (0.00%)	0 / 203 (0.00%)	0 / 163 (0.00%)	0 / 187 (0.00%)	0 / 119 (0.00%)	0 / 175 (0.00%)	0 / 69 (0.00%)	0 / 153 (0.00%)	0 / 34 (0.00%)	1 / 110 (0.91%)	1 / 16 (6.25%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0
Infections and infestations
Urinary Tract Infection
subjects affected / exposed	100 / 185 (54.05%)	118 / 203 (58.13%)	86 / 163 (52.76%)	92 / 187 (49.20%)	61 / 119 (51.26%)	84 / 175 (48.00%)	28 / 69 (40.58%)	60 / 153 (39.22%)	11 / 34 (32.35%)	35 / 110 (31.82%)	4 / 16 (25.00%)	21 / 70 (30.00%)	3 / 8 (37.50%)	15 / 48 (31.25%)	12 / 36 (33.33%)	7 / 22 (31.82%)	1 / 11 (9.09%)	1 / 5 (20.00%)	1 / 2 (50.00%)
occurrences all number	226	263	177	161	111	144	46	89	16	58	5	32	6	19	20	11	2	1	1
Nasopharyngitis
alternative assessment type: Non-systematic
subjects affected / exposed	10 / 185 (5.41%)	9 / 203 (4.43%)	7 / 163 (4.29%)	5 / 187 (2.67%)	6 / 119 (5.04%)	1 / 175 (0.57%)	1 / 69 (1.45%)	3 / 153 (1.96%)	0 / 34 (0.00%)	2 / 110 (1.82%)	0 / 16 (0.00%)	0 / 70 (0.00%)	0 / 8 (0.00%)	1 / 48 (2.08%)	1 / 36 (2.78%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	12	12	7	5	6	1	1	4	0	2	0	0	0	1	1	0	0	0	0
Vulvovaginal Mycotic Infection
Additional description: Females Only
alternative assessment type: Non-systematic
subjects affected / exposed	4 / 185 (2.16%)	7 / 203 (3.45%)	4 / 163 (2.45%)	5 / 187 (2.67%)	2 / 119 (1.68%)	3 / 175 (1.71%)	1 / 69 (1.45%)	1 / 153 (0.65%)	0 / 34 (0.00%)	0 / 110 (0.00%)	0 / 16 (0.00%)	1 / 70 (1.43%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	4	7	4	6	2	4	1	2	0	0	0	1	0	0	0	0	0	0	0
Upper Respiratory Tract Infection
alternative assessment type: Non-systematic
subjects affected / exposed	7 / 185 (3.78%)	6 / 203 (2.96%)	3 / 163 (1.84%)	2 / 187 (1.07%)	0 / 119 (0.00%)	10 / 175 (5.71%)	1 / 69 (1.45%)	2 / 153 (1.31%)	0 / 34 (0.00%)	2 / 110 (1.82%)	1 / 16 (6.25%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	10	7	3	2	0	10	1	2	0	2	1	1	0	0	0	0	0	0	0
Herpes Zoster
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 185 (0.54%)	1 / 203 (0.49%)	0 / 163 (0.00%)	1 / 187 (0.53%)	3 / 119 (2.52%)	1 / 175 (0.57%)	1 / 69 (1.45%)	2 / 153 (1.31%)	0 / 34 (0.00%)	2 / 110 (1.82%)	0 / 16 (0.00%)	2 / 70 (2.86%)	1 / 8 (12.50%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	1	0	1	3	1	1	2	0	2	0	2	1	0	0	0	0	0	0
Fungal Skin Infection
subjects affected / exposed	1 / 185 (0.54%)	2 / 203 (0.99%)	0 / 163 (0.00%)	0 / 187 (0.00%)	0 / 119 (0.00%)	1 / 175 (0.57%)	0 / 69 (0.00%)	0 / 153 (0.00%)	0 / 34 (0.00%)	0 / 110 (0.00%)	0 / 16 (0.00%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	2	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0
Gastroenteritis Norovirus
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 185 (0.00%)	0 / 203 (0.00%)	0 / 163 (0.00%)	0 / 187 (0.00%)	0 / 119 (0.00%)	0 / 175 (0.00%)	0 / 69 (0.00%)	0 / 153 (0.00%)	0 / 34 (0.00%)	0 / 110 (0.00%)	0 / 16 (0.00%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Osteomyelitis Acute
subjects affected / exposed	0 / 185 (0.00%)	0 / 203 (0.00%)	0 / 163 (0.00%)	0 / 187 (0.00%)	0 / 119 (0.00%)	0 / 175 (0.00%)	0 / 69 (0.00%)	0 / 153 (0.00%)	0 / 34 (0.00%)	0 / 110 (0.00%)	0 / 16 (0.00%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Staphylococcal Infection
subjects affected / exposed	0 / 185 (0.00%)	1 / 203 (0.49%)	0 / 163 (0.00%)	0 / 187 (0.00%)	0 / 119 (0.00%)	0 / 175 (0.00%)	0 / 69 (0.00%)	0 / 153 (0.00%)	0 / 34 (0.00%)	0 / 110 (0.00%)	0 / 16 (0.00%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	1 / 11 (9.09%)	0 / 5 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Folliculitis
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 185 (0.00%)	2 / 203 (0.99%)	0 / 163 (0.00%)	0 / 187 (0.00%)	0 / 119 (0.00%)	0 / 175 (0.00%)	0 / 69 (0.00%)	0 / 153 (0.00%)	1 / 34 (2.94%)	0 / 110 (0.00%)	0 / 16 (0.00%)	0 / 70 (0.00%)	0 / 8 (0.00%)	0 / 48 (0.00%)	0 / 36 (0.00%)	0 / 22 (0.00%)	0 / 11 (0.00%)	1 / 5 (20.00%)	0 / 2 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0

More information

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Were there any global substantial amendments to the protocol? Yes

01 Nov 2009

Collection of hematology and blood chemistry samples was added at week-12.

01 Mar 2011

1) The 300 U BOTOX dose group was removed from the protocol; 2) It was clarified that the latest time study treatment could be administered was week 144; and 3) It was clarified that the responder analysis included a cut-off of 100% and references to analysis of these data were removed, as the information from the responder analysis would be summarized only.

01 Jul 2012

Optional urodynamic assessments were to be done at sites that agreed to perform them and for those patients who agreed to undergo the procedure.

Were there any global interruptions to the trial? No

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

None reported

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Clinical trials

Clinical Trial Results: A Multicenter, Long-term Follow-up Study of the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

Secondary: Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

Secondary: Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

Secondary: Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

Secondary: Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

Secondary: Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

Secondary: Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

Secondary: Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

Secondary: Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

Secondary: Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

Secondary: Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score

Secondary: Change from Study Baseline in Volume Per Void

Secondary: Change from Study Baseline in Volume Per Void

Secondary: Change from Study Baseline in Volume Per Void

Secondary: Change from Study Baseline in Volume Per Void

Secondary: Change from Study Baseline in Volume Per Void

Secondary: Change from Study Baseline in Volume Per Void

Secondary: Change from Study Baseline in Volume Per Void

Secondary: Change from Study Baseline in Volume Per Void

Secondary: Change from Study Baseline in Volume Per Void

Secondary: Change from Study Baseline in Volume Per Void

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Multicenter, Long-term Follow-up Study of the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity