Trial Outcomes & Findings for Study Comparing Short Term Efficacy of Dysport and Dysport NG to Placebo, and to Assess Efficacy and Safety of Dysport NG of Subjects With Cervical Dystonia (NCT NCT01261611)
NCT ID: NCT01261611
Last Updated: 2022-09-28
Results Overview
TWSTRS measures the degree of CD and is comprised of three different components, namely Severity, Disability and Pain subscales. There is an ordinal scale score and range for each component. Severity scores range from 0 (absence of severity) to 35 (maximum severity), Disability scores range from 0 (no disability) to 30 (maximum disability) and Pain scores range from 0 (no pain) to 20 (maximum pain). TWSTRS Total score is the sum of the 3 component scores ranging from 0 to a maximum of 85, with higher scores denoting worse outcome. If the change from baseline is negative, this represents an improvement in symptoms.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
382 participants
Primary outcome timeframe
Baseline and Week 4
Results posted on
2022-09-28
Participant Flow
Subjects recruited at 61 centres in Australia (2 subjects), Austria (9 subjects), Belgium (9 subjects), Czech Republic (58 subjects), France (31 subjects), Germany (38 subjects), Hungary (44 subjects), Poland (68 subjects), Portugal (12 subjects), Russia (36 subjects) and Ukraine (62 subjects).
382 subjects screened, 369 randomised due to 13 screen failures.
Participant milestones
| Measure |
Dysport NG
Up to 5 treatment cycles of Dysport NG
|
Dysport
1 treatment cycle of Dysport
|
Placebo
1 treatment cycle of placebo
|
|---|---|---|---|
|
Treatment Cycle 1
STARTED
|
156
|
159
|
54
|
|
Treatment Cycle 1
COMPLETED
|
152
|
156
|
52
|
|
Treatment Cycle 1
NOT COMPLETED
|
4
|
3
|
2
|
|
Treatment Cycle 2
STARTED
|
359
|
0
|
0
|
|
Treatment Cycle 2
COMPLETED
|
346
|
0
|
0
|
|
Treatment Cycle 2
NOT COMPLETED
|
13
|
0
|
0
|
|
Treatment Cycle 3
STARTED
|
346
|
0
|
0
|
|
Treatment Cycle 3
COMPLETED
|
316
|
0
|
0
|
|
Treatment Cycle 3
NOT COMPLETED
|
30
|
0
|
0
|
|
Treatment Cycle 4
STARTED
|
316
|
0
|
0
|
|
Treatment Cycle 4
COMPLETED
|
220
|
0
|
0
|
|
Treatment Cycle 4
NOT COMPLETED
|
96
|
0
|
0
|
|
Treatment Cycle 5
STARTED
|
220
|
0
|
0
|
|
Treatment Cycle 5
COMPLETED
|
217
|
0
|
0
|
|
Treatment Cycle 5
NOT COMPLETED
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Dysport NG
Up to 5 treatment cycles of Dysport NG
|
Dysport
1 treatment cycle of Dysport
|
Placebo
1 treatment cycle of placebo
|
|---|---|---|---|
|
Treatment Cycle 1
Withdrawal by Subject
|
3
|
2
|
0
|
|
Treatment Cycle 1
Lost to Follow-up
|
1
|
0
|
0
|
|
Treatment Cycle 1
Adverse Event
|
0
|
1
|
0
|
|
Treatment Cycle 1
Protocol Violation
|
0
|
0
|
2
|
|
Treatment Cycle 2
Completed study
|
4
|
0
|
0
|
|
Treatment Cycle 2
Withdrawal by Subject
|
4
|
0
|
0
|
|
Treatment Cycle 2
Adverse Event
|
1
|
0
|
0
|
|
Treatment Cycle 2
Protocol Violation
|
2
|
0
|
0
|
|
Treatment Cycle 2
Not otherwise specified
|
2
|
0
|
0
|
|
Treatment Cycle 3
Completed study
|
24
|
0
|
0
|
|
Treatment Cycle 3
Withdrawal by Subject
|
4
|
0
|
0
|
|
Treatment Cycle 3
Adverse Event
|
1
|
0
|
0
|
|
Treatment Cycle 3
Lost to Follow-up
|
1
|
0
|
0
|
|
Treatment Cycle 4
Completed study
|
87
|
0
|
0
|
|
Treatment Cycle 4
Withdrawal by Subject
|
3
|
0
|
0
|
|
Treatment Cycle 4
Adverse Event
|
1
|
0
|
0
|
|
Treatment Cycle 4
Lost to Follow-up
|
2
|
0
|
0
|
|
Treatment Cycle 4
Not otherwise specified
|
3
|
0
|
0
|
|
Treatment Cycle 5
Withdrawal by Subject
|
1
|
0
|
0
|
|
Treatment Cycle 5
Adverse Event
|
1
|
0
|
0
|
|
Treatment Cycle 5
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
Study Comparing Short Term Efficacy of Dysport and Dysport NG to Placebo, and to Assess Efficacy and Safety of Dysport NG of Subjects With Cervical Dystonia
Baseline characteristics by cohort
| Measure |
Dysport NG
n=156 Participants
500U (1mL) administered as intramuscular injection on day 1 of treatment cycle 1 and 2.
250U (0.5mL), 500U (1mL) or 750U (1.5mL) administered as intramuscular injection on day 1 of treatment cycle 3.
250U (0.5mL), 500U (1mL), 750U (1.5mL) or 1000U (2mL) administered as intramuscular injection on day 1 of treatment cycle 4 and 5.
Botulinum type A toxin (Dysport NG): I.M. (in the muscle) injection on day 1 of up to 5 treatment cycles.
|
Dysport
n=159 Participants
500U (1mL) injected as intramuscular injection on day 1 of treatment cycle 1.
Botulinum type A toxin (Dysport®): I.M. injection on day 1 of treatment cycle 1.
|
Placebo
n=54 Participants
1mL administered as, intramuscular injection on day 1 of treatment cycle 1.
Placebo: I.M. injection on day 1 of treatment cycle 1.
|
Total
n=369 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
49.1 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
49.7 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
50.3 years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
235 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
154 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
357 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Time since diagnosis of CD, years
|
7.13 years
STANDARD_DEVIATION 7.95 • n=5 Participants
|
6.88 years
STANDARD_DEVIATION 7.49 • n=7 Participants
|
6.25 years
STANDARD_DEVIATION 7.31 • n=5 Participants
|
6.84 years
STANDARD_DEVIATION 7.63 • n=4 Participants
|
|
Baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total score
|
44.56 Units on a scale
STANDARD_DEVIATION 9.20 • n=5 Participants
|
46.23 Units on a scale
STANDARD_DEVIATION 8.82 • n=7 Participants
|
47.02 Units on a scale
STANDARD_DEVIATION 9.19 • n=5 Participants
|
45.64 Units on a scale
STANDARD_DEVIATION 9.06 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: Analysis based on number (n) of subjects in the Intent to Treat (ITT) population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed.
TWSTRS measures the degree of CD and is comprised of three different components, namely Severity, Disability and Pain subscales. There is an ordinal scale score and range for each component. Severity scores range from 0 (absence of severity) to 35 (maximum severity), Disability scores range from 0 (no disability) to 30 (maximum disability) and Pain scores range from 0 (no pain) to 20 (maximum pain). TWSTRS Total score is the sum of the 3 component scores ranging from 0 to a maximum of 85, with higher scores denoting worse outcome. If the change from baseline is negative, this represents an improvement in symptoms.
Outcome measures
| Measure |
Dysport NG
n=153 Participants
500U
|
Dysport
n=156 Participants
500U
|
Placebo
n=53 Participants
|
|---|---|---|---|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score Following First Treatment Cycle
|
-12.46 Units on a scale
Interval -14.3 to -10.62
|
-13.99 Units on a scale
Interval -15.78 to -12.21
|
-3.93 Units on a scale
Interval -6.74 to -1.12
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed.
TWSTRS measures the degree of CD and comprises three different components, one of which is the Severity subscale. TWSTRS Severity subscale scores range from 0 (absence of severity) to 35 (maximum severity). If the change from baseline is negative, this represents an improvement in symptoms.
Outcome measures
| Measure |
Dysport NG
n=153 Participants
500U
|
Dysport
n=156 Participants
500U
|
Placebo
n=53 Participants
|
|---|---|---|---|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Subscale Score Following First Treatment Cycle
|
-6.2 Units on a scale
Interval -7.0 to -5.4
|
-6.6 Units on a scale
Interval -7.3 to -5.8
|
-1.9 Units on a scale
Interval -3.1 to -0.6
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed.
TWSTRS measures the degree of CD and comprises three different components, one of which is the Disability subscale. TWSTRS Disability subscale scores range from 0 (no disability) to 30 (maximum disability). If the change from baseline is negative, this represents an improvement in symptoms.
Outcome measures
| Measure |
Dysport NG
n=153 Participants
500U
|
Dysport
n=156 Participants
500U
|
Placebo
n=53 Participants
|
|---|---|---|---|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Subscale Score Following First Treatment Cycle
|
-3.3 Units on a scale
Interval -4.1 to -2.6
|
-3.9 Units on a scale
Interval -4.7 to -3.2
|
-0.8 Units on a scale
Interval -1.9 to 0.4
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed.
TWSTRS measures the degree of CD and comprises three different components, one of which is the Pain subscale. TWSTRS Pain subscale scores range from 0 (no pain) to 20 (maximum pain). If the change from baseline is negative, this represents an improvement in symptoms.
Outcome measures
| Measure |
Dysport NG
n=153 Participants
500U
|
Dysport
n=156 Participants
500U
|
Placebo
n=53 Participants
|
|---|---|---|---|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Pain Subscale Score Following First Treatment Cycle
|
-3.10 Units on a scale
Interval -3.7 to -2.51
|
-3.44 Units on a scale
Interval -4.03 to -2.86
|
-1.21 Units on a scale
Interval -2.12 to -0.29
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed.
The assessment was made on a continuous 100-mm horizontal line with a scale range of 0 mm (no pain) to 100 mm (worst possible pain).
Outcome measures
| Measure |
Dysport NG
n=153 Participants
500U
|
Dysport
n=156 Participants
500U
|
Placebo
n=53 Participants
|
|---|---|---|---|
|
Change From Baseline in Subject Visual Analogue Score (VAS) for Pain From Cervical Dystonia Following First Treatment Cycle
|
-14.8 Units on a scale
Interval -19.0 to -10.7
|
-19.2 Units on a scale
Interval -23.3 to -15.2
|
-3.4 Units on a scale
Interval -9.8 to 3.0
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed.
The assessment was made on a continuous 100-mm horizontal line with a scale range of 0 mm (no symptoms) to 100 mm (worst possible symptoms).
Outcome measures
| Measure |
Dysport NG
n=152 Participants
500U
|
Dysport
n=156 Participants
500U
|
Placebo
n=53 Participants
|
|---|---|---|---|
|
Change From Baseline in Subject Visual Analogue Score (VAS) for Symptoms of Cervical Dystonia Following First Treatment Cycle
|
-18.7 Units on a scale
Interval -22.7 to -14.7
|
-23.6 Units on a scale
Interval -27.5 to -19.7
|
-3.3 Units on a scale
Interval -9.4 to 2.8
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered). The ITT population was analysed using subjects as randomised. Missing data were not imputed.
A treatment responder was defined as a patient with \>30% improvement in TWSTRS Total score compared to baseline. TWSTRS measures the degree of CD and is comprised of three different components, namely Severity, Disability and Pain subscales. There is an ordinal scale score and range for each component. Severity scores range from 0 (absence of severity) to 35 (maximum severity), Disability scores range from 0 (no disability) to 30 (maximum disability) and Pain scores range from 0 (no pain) to 20 (maximum pain). TWSTRS Total score is the sum of the 3 component scores ranging from 0 to a maximum of 85, with higher scores denoting worse outcome. If the change from baseline is negative, this represents an improvement in symptoms.
Outcome measures
| Measure |
Dysport NG
n=153 Participants
500U
|
Dysport
n=156 Participants
500U
|
Placebo
n=53 Participants
|
|---|---|---|---|
|
Percentage of Treatment Responders Following First Treatment Cycle
|
45.8 Percentage of participants
|
55.8 Percentage of participants
|
20.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Treatment cycle Baseline and Week 4Population: Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered) in each cycle. The ITT population was analysed using subjects as randomised. Missing data were not imputed.
TWSTRS measures the degree of CD and is comprised of three different components, namely Severity, Disability and Pain subscales. There is an ordinal scale score and range for each component. Severity scores range from 0 (absence of severity) to 35 (maximum severity), Disability scores range from 0 (no disability) to 30 (maximum disability) and Pain scores range from 0 (no pain) to 20 (maximum pain). TWSTRS Total score is the sum of the 3 component scores ranging from 0 to a maximum of 85, with higher scores denoting worse outcome. If the change from baseline is negative, this represents an improvement in symptoms.
Outcome measures
| Measure |
Dysport NG
n=359 Participants
500U
|
Dysport
500U
|
Placebo
|
|---|---|---|---|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score for Treatment Cycles 2 to 5
Cycle 2
|
-15.35 Units on a scale
Interval -16.36 to -14.34
|
—
|
—
|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score for Treatment Cycles 2 to 5
Cycle 3
|
-14.85 Units on a scale
Interval -15.86 to -13.84
|
—
|
—
|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score for Treatment Cycles 2 to 5
Cycle 4
|
-15.58 Units on a scale
Interval -16.61 to -14.55
|
—
|
—
|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score for Treatment Cycles 2 to 5
Cycle 5
|
-15.28 Units on a scale
Interval -16.42 to -14.14
|
—
|
—
|
SECONDARY outcome
Timeframe: Treatment cycle Baseline and Week 4Population: Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered) in each cycle. The ITT population was analysed using subjects as randomised. Missing data were not imputed.
TWSTRS measures the degree of CD and comprises three different components, one of which is the Severity subscale. TWSTRS Severity subscale scores range from 0 (absence of severity) to 35 (maximum severity). If the change from baseline is negative, this represents an improvement in symptoms.
Outcome measures
| Measure |
Dysport NG
n=359 Participants
500U
|
Dysport
500U
|
Placebo
|
|---|---|---|---|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Score for Treatment Cycles 2 to 5
Cycle 2
|
-7.2 Units on a scale
Interval -7.6 to -6.7
|
—
|
—
|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Score for Treatment Cycles 2 to 5
Cycle 3
|
-7.1 Units on a scale
Interval -7.5 to -6.6
|
—
|
—
|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Score for Treatment Cycles 2 to 5
Cycle 4
|
-7.3 Units on a scale
Interval -7.7 to -6.8
|
—
|
—
|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Score for Treatment Cycles 2 to 5
Cycle 5
|
-7.0 Units on a scale
Interval -7.5 to -6.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Treatment cycle Baseline and Week 4Population: Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered) in each cycle. The ITT population was analysed using subjects as randomised. Missing data were not imputed.
TWSTRS measures the degree of CD and comprises three different components, one of which is the Disability subscale. TWSTRS Disability subscale scores range from 0 (no disability) to 30 (maximum disability). If the change from baseline is negative, this represents an improvement in symptoms.
Outcome measures
| Measure |
Dysport NG
n=359 Participants
500U
|
Dysport
500U
|
Placebo
|
|---|---|---|---|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Score for Treatment Cycles 2 to 5
Cycle 2
|
-4.7 Units on a scale
Interval -5.2 to -4.3
|
—
|
—
|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Score for Treatment Cycles 2 to 5
Cycle 3
|
-4.6 Units on a scale
Interval -5.0 to -4.1
|
—
|
—
|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Score for Treatment Cycles 2 to 5
Cycle 4
|
-5.0 Units on a scale
Interval -5.5 to -4.5
|
—
|
—
|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Score for Treatment Cycles 2 to 5
Cycle 5
|
-4.9 Units on a scale
Interval -5.5 to -4.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Treatment cycle Baseline and Week 4Population: Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered) in each cycle. The ITT population was analysed using subjects as randomised. Missing data were not imputed.
TWSTRS measures the degree of CD and comprises three different components, one of which is the Pain subscale. TWSTRS Pain subscale scores range from 0 (no pain) to 20 (maximum pain). If the change from baseline is negative, this represents an improvement in symptoms.
Outcome measures
| Measure |
Dysport NG
n=359 Participants
500U
|
Dysport
500U
|
Placebo
|
|---|---|---|---|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Pain Subscale Score for Treatment Cycles 2 to 5
Cycle 2
|
-3.45 Units on a scale
Interval -3.8 to -3.1
|
—
|
—
|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Pain Subscale Score for Treatment Cycles 2 to 5
Cycle 3
|
-3.21 Units on a scale
Interval -3.57 to -2.85
|
—
|
—
|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Pain Subscale Score for Treatment Cycles 2 to 5
Cycle 4
|
-3.34 Units on a scale
Interval -3.69 to -2.98
|
—
|
—
|
|
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Pain Subscale Score for Treatment Cycles 2 to 5
Cycle 5
|
-3.41 Units on a scale
Interval -3.79 to -3.04
|
—
|
—
|
SECONDARY outcome
Timeframe: Treatment cycle Baseline and Week 4Population: Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered) in each cycle. The ITT population was analysed using subjects as randomised. Missing data were not imputed.
The assessment was made on a continuous 100-mm horizontal line with a scale range of 0 mm (no pain) to 100 mm (worst possible pain).
Outcome measures
| Measure |
Dysport NG
n=359 Participants
500U
|
Dysport
500U
|
Placebo
|
|---|---|---|---|
|
Change From Baseline in Subject Visual Analogue Score (VAS) for Pain From Cervical Dystonia for Treatment Cycles 2 to 5
Cycle 5
|
-16.1 Units on a scale
Interval -19.3 to -12.8
|
—
|
—
|
|
Change From Baseline in Subject Visual Analogue Score (VAS) for Pain From Cervical Dystonia for Treatment Cycles 2 to 5
Cycle 2
|
-20.1 Units on a scale
Interval -22.5 to -17.6
|
—
|
—
|
|
Change From Baseline in Subject Visual Analogue Score (VAS) for Pain From Cervical Dystonia for Treatment Cycles 2 to 5
Cycle 3
|
-17.8 Units on a scale
Interval -20.4 to -15.2
|
—
|
—
|
|
Change From Baseline in Subject Visual Analogue Score (VAS) for Pain From Cervical Dystonia for Treatment Cycles 2 to 5
Cycle 4
|
-18.0 Units on a scale
Interval -20.5 to -15.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Treatment cycle Baseline and Week 4Population: Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered) in each cycle. The ITT population was analysed using subjects as randomised. Missing data were not imputed.
The assessment was made on a continuous 100-mm horizontal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).
Outcome measures
| Measure |
Dysport NG
n=359 Participants
500U
|
Dysport
500U
|
Placebo
|
|---|---|---|---|
|
Change From Baseline in Subject Visual Analogue Score (VAS) for Symptoms of Cervical Dystonia for Treatment Cycles 2 to 5
Cycle 2
|
-24.0 Units on a scale
Interval -26.4 to -21.7
|
—
|
—
|
|
Change From Baseline in Subject Visual Analogue Score (VAS) for Symptoms of Cervical Dystonia for Treatment Cycles 2 to 5
Cycle 3
|
-18.9 Units on a scale
Interval -21.4 to -16.4
|
—
|
—
|
|
Change From Baseline in Subject Visual Analogue Score (VAS) for Symptoms of Cervical Dystonia for Treatment Cycles 2 to 5
Cycle 4
|
-21.0 Units on a scale
Interval -23.5 to -18.5
|
—
|
—
|
|
Change From Baseline in Subject Visual Analogue Score (VAS) for Symptoms of Cervical Dystonia for Treatment Cycles 2 to 5
Cycle 5
|
-18.2 Units on a scale
Interval -21.2 to -15.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Treatment cycle Baseline and Week 4Population: Analysis based on number (n) of subjects in the ITT population (all randomised subjects who received at least one injection of study treatment regardless of the amount of study treatment administered) in each cycle. The ITT population was analysed using subjects as randomised. Missing data were not imputed.
A treatment responder was defined as a patient with \>30% improvement in TWSTRS Total score compared to baseline. TWSTRS measures the degree of CD and is comprised of three different components, namely Severity, Disability and Pain subscales. There is an ordinal scale score and range for each component. Severity scores range from 0 (absence of severity) to 35 (maximum severity), Disability scores range from 0 (no disability) to 30 (maximum disability) and Pain scores range from 0 (no pain) to 20 (maximum pain). TWSTRS Total score is the sum of the 3 component scores ranging from 0 to a maximum of 85, with higher scores denoting worse outcome. If the change from baseline is negative, this represents an improvement in symptoms.
Outcome measures
| Measure |
Dysport NG
n=359 Participants
500U
|
Dysport
500U
|
Placebo
|
|---|---|---|---|
|
Percentage of Treatment Responders for Treatment Cycles 2 to 5
Cycle 2
|
58.5 Percentage of participants
|
—
|
—
|
|
Percentage of Treatment Responders for Treatment Cycles 2 to 5
Cycle 3
|
56.8 Percentage of participants
|
—
|
—
|
|
Percentage of Treatment Responders for Treatment Cycles 2 to 5
Cycle 4
|
63.5 Percentage of participants
|
—
|
—
|
|
Percentage of Treatment Responders for Treatment Cycles 2 to 5
Cycle 5
|
57.5 Percentage of participants
|
—
|
—
|
Adverse Events
Dysport NG, 250U
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dysport NG, 500U
Serious events: 16 serious events
Other events: 59 other events
Deaths: 0 deaths
Dysport NG, 750U
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Dysport NG, 1000U
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Dysport, 500U
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dysport NG, 250U
n=4 participants at risk
Subjects in the safety population were analysed as treated.
|
Dysport NG, 500U
n=363 participants at risk
Subjects in the safety population were analysed as treated.
|
Dysport NG, 750U
n=210 participants at risk
Subjects in the safety population were analysed as treated.
|
Dysport NG, 1000U
n=57 participants at risk
Subjects in the safety population were analysed as treated.
|
Dysport, 500U
n=156 participants at risk
The safety population was analysed using subjects as treated. One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population, and the Dysport group for the ITT population.
|
Placebo
n=55 participants at risk
The safety population was analysed using subjects as treated. One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population, and the Dysport group for the ITT population.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.28%
1/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.28%
1/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.28%
1/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.28%
1/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.28%
1/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.28%
1/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.28%
1/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.28%
1/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.28%
1/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.64%
1/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.64%
1/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.28%
1/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Vascular disorders
Paget-Schroetter syndrome
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.28%
1/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial effusion malignant
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.64%
1/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.64%
1/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Infections and infestations
Proctitis infectious
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.28%
1/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.28%
1/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Endocrine disorders
Thyroid cyst
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.28%
1/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.28%
1/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.64%
1/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Infections and infestations
Vaginal abscess
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.28%
1/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.48%
1/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
1.8%
1/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Gastrointestinal disorders
Gastrooesphageal reflux disease
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
1.8%
1/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Gastrointestinal disorders
Rectal perforation
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.48%
1/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/363 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.48%
1/210 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/57 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
Other adverse events
| Measure |
Dysport NG, 250U
n=4 participants at risk
Subjects in the safety population were analysed as treated.
|
Dysport NG, 500U
n=363 participants at risk
Subjects in the safety population were analysed as treated.
|
Dysport NG, 750U
n=210 participants at risk
Subjects in the safety population were analysed as treated.
|
Dysport NG, 1000U
n=57 participants at risk
Subjects in the safety population were analysed as treated.
|
Dysport, 500U
n=156 participants at risk
The safety population was analysed using subjects as treated. One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population, and the Dysport group for the ITT population.
|
Placebo
n=55 participants at risk
The safety population was analysed using subjects as treated. One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population, and the Dysport group for the ITT population.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
10.5%
38/363 • Number of events 54 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
9.5%
20/210 • Number of events 25 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
8.8%
5/57 • Number of events 5 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
7.1%
11/156 • Number of events 11 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
5.8%
21/363 • Number of events 26 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
4.3%
9/210 • Number of events 9 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
3.5%
2/57 • Number of events 2 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
2.6%
4/156 • Number of events 4 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
1.8%
1/55 • Number of events 1 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
25.0%
1/4 • Number of events 1 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
3.0%
11/363 • Number of events 15 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
6.2%
13/210 • Number of events 14 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
10.5%
6/57 • Number of events 6 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/156 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
0.00%
0/55 • 2 years
Analysis based on number of subjects in the safety population (all randomised subjects who received at least one injection of study treatment). One subject was randomised to Dysport 500 U but actually received placebo; therefore, this subject was counted in the placebo group for the safety population analysis (n=55 not n=54). Data are broken down by dose across all treatment cycles and the denominator (total number of patients at risk) for each group could not be reported in participant flow.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place