Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia (NCT NCT00447772)
NCT ID: NCT00447772
Last Updated: 2023-03-30
Results Overview
The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores: * Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0-9 points) * Subscore B: duration of movement (values 1 or 2) * Subscore C: severity and duration of shoulder elevation (range: 0-3 points) * Subscore D: severity and duration of tremor (range: 0-4 points). The total score was calculated as follows: total score = subscores (A x B) + C + D. The total score ranges between 0 and 25 points. A high total score represents severe CD. The mean change in the total score of the Tsui rating scale (patient in the sitting position) between baseline (Week 0 visit) and the first on-treatment visit (Week 4 or Week 12 visit) is presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
516 participants
Primary outcome timeframe
Baseline to Week 4 or Week 12 (up to 12 weeks)
Results posted on
2023-03-30
Participant Flow
First patient enrolled (signed informed consent) 28 Oct 2004, last patient completed 4 April 2008. 516 patients were recruited to this prospective, open, multicentre study at 77 study centres in Germany and 4 study centres in Austria.
To be eligible patients had to have 2 of the most frequent forms of cervical dystonia (CD): rotatory torticollis or laterocollis.
Participant milestones
| Measure |
Dysport® 500 U - Total Study Population
Patients with heterogeneous forms of CD were given a single intramuscular (i.m.) injection of 500 units (U) Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 millilitres (ml) 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.
The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.
|
|---|---|
|
Overall Study
STARTED
|
516
|
|
Overall Study
COMPLETED
|
489
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
Dysport® 500 U - Total Study Population
Patients with heterogeneous forms of CD were given a single intramuscular (i.m.) injection of 500 units (U) Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 millilitres (ml) 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.
The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Insufficient compliance
|
6
|
|
Overall Study
Discontinuation of drug therapy
|
1
|
|
Overall Study
Lost to Follow-up
|
9
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Unable to attend all study visits
|
2
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Patient relocated
|
1
|
|
Overall Study
Incomplete documentation at visit 1
|
1
|
|
Overall Study
Chemotherapy for lung cancer
|
1
|
|
Overall Study
Premature re-injection required
|
1
|
Baseline Characteristics
Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia
Baseline characteristics by cohort
| Measure |
Dysport® 500 U - Total Study Population
n=515 Participants
Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.
The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.
|
|---|---|
|
Age, Continuous
|
51.9 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
353 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
162 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4 or Week 12 (up to 12 weeks)Population: The Intention to Treat (ITT) Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale.
The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores: * Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0-9 points) * Subscore B: duration of movement (values 1 or 2) * Subscore C: severity and duration of shoulder elevation (range: 0-3 points) * Subscore D: severity and duration of tremor (range: 0-4 points). The total score was calculated as follows: total score = subscores (A x B) + C + D. The total score ranges between 0 and 25 points. A high total score represents severe CD. The mean change in the total score of the Tsui rating scale (patient in the sitting position) between baseline (Week 0 visit) and the first on-treatment visit (Week 4 or Week 12 visit) is presented.
Outcome measures
| Measure |
Rotatory Torticollis
n=396 Participants
Patients with rotatory torticollis type of CD who received a single i.m. injection of 500 U Dysport®.
|
Laterocollis
n=107 Participants
Patients with laterocollis type of CD who received a single i.m. injection of 500 U Dysport®.
|
Dysport® 500 U - Total Study Population
n=503 Participants
Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.
The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.
|
|---|---|---|---|
|
Change From Baseline in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) at the First On-treatment Visit (Week 4 or Week 12)
|
-3.8 units on a scale
Standard Deviation 3.3
|
-4.0 units on a scale
Standard Deviation 2.6
|
-3.8 units on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for the Week 12 visit are reported.
The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores: * Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0-9 points) * Subscore B: duration of movement (values 1 or 2) * Subscore C: severity and duration of shoulder elevation (range: 0-3 points) * Subscore D: severity and duration of tremor (range: 0-4 points). The total score was calculated as follows: total score = subscores (A x B) + C + D. The total score ranges between 0 and 25 points. A high total score represents severe CD. The mean change in the total score of the Tsui rating scale (patient in the sitting position) between baseline (Week 0 visit) and the Week 12 visit is presented.
Outcome measures
| Measure |
Rotatory Torticollis
n=386 Participants
Patients with rotatory torticollis type of CD who received a single i.m. injection of 500 U Dysport®.
|
Laterocollis
n=104 Participants
Patients with laterocollis type of CD who received a single i.m. injection of 500 U Dysport®.
|
Dysport® 500 U - Total Study Population
n=490 Participants
Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.
The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.
|
|---|---|---|---|
|
Change in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) Between Visit 1 (Week 0) and Visit 3 (Week 12)
|
-2.3 units on a scale
Standard Deviation 3.4
|
-2.4 units on a scale
Standard Deviation 2.5
|
-2.3 units on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline to Week 4 and Week 12Population: The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.
The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores: * Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0-9 points) * Subscore B: duration of movement (values 1 or 2) * Subscore C: severity and duration of shoulder elevation (range: 0-3 points) * Subscore D: severity and duration of tremor (range: 0-4 points). The total score was calculated as follows: total score = subscores (A x B) + C + D. The total score ranges between 0 and 25 points. A high total score represents severe CD. The mean changes in the total score of the Tsui rating scale (patient walking) between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented.
Outcome measures
| Measure |
Rotatory Torticollis
n=396 Participants
Patients with rotatory torticollis type of CD who received a single i.m. injection of 500 U Dysport®.
|
Laterocollis
n=107 Participants
Patients with laterocollis type of CD who received a single i.m. injection of 500 U Dysport®.
|
Dysport® 500 U - Total Study Population
n=503 Participants
Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.
The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.
|
|---|---|---|---|
|
Change in the Total Score of the Tsui Rating Scale (Patient Walking) Between Baseline (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 4 in total Tsui score
|
-3.8 units on a scale
Standard Deviation 3.2
|
-4.3 units on a scale
Standard Deviation 2.9
|
-3.9 units on a scale
Standard Deviation 3.2
|
|
Change in the Total Score of the Tsui Rating Scale (Patient Walking) Between Baseline (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 12 in total Tsui score
|
-2.3 units on a scale
Standard Deviation 3.6
|
-2.3 units on a scale
Standard Deviation 3.1
|
-2.3 units on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline to Week 4 and Week 12Population: The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.
The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores: * Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0-9 points) * Subscore B: duration of movement (values 1 or 2) * Subscore C: severity and duration of shoulder elevation (range: 0-3 points) * Subscore D: severity and duration of tremor (range: 0-4 points). A higher score for each subscale represents severe CD symptoms. The total score was calculated as follows: total score = subscores (A x B) + C + D. The total score ranges between 0 and 25 points. A high total score represents severe CD. The mean changes in the subscores A to D of the Tsui rating scale (patient in the sitting position) between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented.
Outcome measures
| Measure |
Rotatory Torticollis
n=396 Participants
Patients with rotatory torticollis type of CD who received a single i.m. injection of 500 U Dysport®.
|
Laterocollis
n=107 Participants
Patients with laterocollis type of CD who received a single i.m. injection of 500 U Dysport®.
|
Dysport® 500 U - Total Study Population
n=503 Participants
Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.
The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.
|
|---|---|---|---|
|
Change in the 4 Subscores of the Tsui Rating Scale (Patient in the Sitting Position) Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Chang to Week 4 in Tsui rating scale subscore C
|
-0.4 units on a scale
Standard Deviation 0.8
|
-0.6 units on a scale
Standard Deviation 0.8
|
-0.4 units on a scale
Standard Deviation 0.8
|
|
Change in the 4 Subscores of the Tsui Rating Scale (Patient in the Sitting Position) Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 4 in Tsui rating scale subscore D
|
-0.6 units on a scale
Standard Deviation 1.0
|
-0.5 units on a scale
Standard Deviation 1.0
|
-0.6 units on a scale
Standard Deviation 1.0
|
|
Change in the 4 Subscores of the Tsui Rating Scale (Patient in the Sitting Position) Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 12 in Tsui rating scale subscore A
|
-0.8 units on a scale
Standard Deviation 1.3
|
-0.9 units on a scale
Standard Deviation 1.2
|
-0.8 units on a scale
Standard Deviation 1.3
|
|
Change in the 4 Subscores of the Tsui Rating Scale (Patient in the Sitting Position) Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 12 in Tsui rating scale subscore B
|
-0.2 units on a scale
Standard Deviation 0.5
|
-0.1 units on a scale
Standard Deviation 0.4
|
-0.2 units on a scale
Standard Deviation 0.5
|
|
Change in the 4 Subscores of the Tsui Rating Scale (Patient in the Sitting Position) Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 12 in Tsui rating scale subscore C
|
-0.2 units on a scale
Standard Deviation 0.8
|
-0.3 units on a scale
Standard Deviation 0.7
|
-0.2 units on a scale
Standard Deviation 0.8
|
|
Change in the 4 Subscores of the Tsui Rating Scale (Patient in the Sitting Position) Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 12 in Tsui rating scale subscore D
|
-0.4 units on a scale
Standard Deviation 0.9
|
-0.3 units on a scale
Standard Deviation 0.9
|
-0.4 units on a scale
Standard Deviation 0.9
|
|
Change in the 4 Subscores of the Tsui Rating Scale (Patient in the Sitting Position) Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 4 in Tsui rating scale subscore A
|
-1.3 units on a scale
Standard Deviation 1.3
|
-1.5 units on a scale
Standard Deviation 1.2
|
-1.4 units on a scale
Standard Deviation 1.3
|
|
Change in the 4 Subscores of the Tsui Rating Scale (Patient in the Sitting Position) Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 4 in Tsui rating scale subscore B
|
-0.4 units on a scale
Standard Deviation 0.6
|
-0.3 units on a scale
Standard Deviation 0.5
|
-0.3 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline to Week 4 and Week 12Population: The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.
The CDQ-24 is a disease-specific quality of life (QoL) instrument and was assessed at Visits 1 to 3. It consists of 24 items investigating problems in daily living skills related to CD. This instrument is based on 5 subscales: Stigma, Emotional well-being, Pain, Activities of daily living (ADL), Social/family life to which a number of the 24 items are assigned. There are five possible answers to each item representing increasing severity of impairment (scores 0 to 4). The total scores ranged from 0 to 96 (best to worst QoL). In order to obtain scores of the individual subscales, the total score of each subscale (sum of the individual item scores) was transformed linearly to a 0 to 100 scale (best to worst QoL). The mean changes in the CDQ-24 total score between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented.
Outcome measures
| Measure |
Rotatory Torticollis
n=503 Participants
Patients with rotatory torticollis type of CD who received a single i.m. injection of 500 U Dysport®.
|
Laterocollis
Patients with laterocollis type of CD who received a single i.m. injection of 500 U Dysport®.
|
Dysport® 500 U - Total Study Population
Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.
The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.
|
|---|---|---|---|
|
Change in the Craniocervical Dystonia Questionnaire (CDQ-24) Total Score and Subscores Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 4 in CDQ-24 Stigma subscale
|
-16.8 units on a scale
Standard Deviation 24.0
|
—
|
—
|
|
Change in the Craniocervical Dystonia Questionnaire (CDQ-24) Total Score and Subscores Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 4 in CDQ-24 Emotional subscale
|
-10.3 units on a scale
Standard Deviation 19.9
|
—
|
—
|
|
Change in the Craniocervical Dystonia Questionnaire (CDQ-24) Total Score and Subscores Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 4 in CDQ-24 Pain subscale
|
-11.5 units on a scale
Standard Deviation 27.8
|
—
|
—
|
|
Change in the Craniocervical Dystonia Questionnaire (CDQ-24) Total Score and Subscores Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 4 in CDQ-24 ADL subscale
|
-11.1 units on a scale
Standard Deviation 19.6
|
—
|
—
|
|
Change in the Craniocervical Dystonia Questionnaire (CDQ-24) Total Score and Subscores Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 12 in CDQ-24 total score
|
-11.8 units on a scale
Standard Deviation 14.6
|
—
|
—
|
|
Change in the Craniocervical Dystonia Questionnaire (CDQ-24) Total Score and Subscores Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 12 in CDQ-24 Stigma subscale
|
-16.4 units on a scale
Standard Deviation 22.5
|
—
|
—
|
|
Change in the Craniocervical Dystonia Questionnaire (CDQ-24) Total Score and Subscores Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 12 in CDQ-24 Emotional subscale
|
-11.1 units on a scale
Standard Deviation 18.7
|
—
|
—
|
|
Change in the Craniocervical Dystonia Questionnaire (CDQ-24) Total Score and Subscores Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 12 in CDQ-24 Pain subscale
|
-13.2 units on a scale
Standard Deviation 25.5
|
—
|
—
|
|
Change in the Craniocervical Dystonia Questionnaire (CDQ-24) Total Score and Subscores Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 12 in CDQ-24 ADL subscale
|
-12.5 units on a scale
Standard Deviation 18.6
|
—
|
—
|
|
Change in the Craniocervical Dystonia Questionnaire (CDQ-24) Total Score and Subscores Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 12 in CDQ-24 Social life subscale
|
-6.7 units on a scale
Standard Deviation 17.8
|
—
|
—
|
|
Change in the Craniocervical Dystonia Questionnaire (CDQ-24) Total Score and Subscores Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 4 in CDQ-24 total score
|
-11.1 units on a scale
Standard Deviation 16.1
|
—
|
—
|
|
Change in the Craniocervical Dystonia Questionnaire (CDQ-24) Total Score and Subscores Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 4 in CDQ-24 Social subscale
|
-5.6 units on a scale
Standard Deviation 17.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 4 and Week 12Population: The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.
The weekly recorded patient diary consists of the three items: Day-to-Day Capacities and Activities, Pain and Duration of Pain. Each item was rated by the patient on an 11-point scale ranging from 0 = no problems at all to 10 = most severe problems (the actual wording is adapted to each item in question). The mean changes between the baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented.
Outcome measures
| Measure |
Rotatory Torticollis
n=503 Participants
Patients with rotatory torticollis type of CD who received a single i.m. injection of 500 U Dysport®.
|
Laterocollis
Patients with laterocollis type of CD who received a single i.m. injection of 500 U Dysport®.
|
Dysport® 500 U - Total Study Population
Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.
The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.
|
|---|---|---|---|
|
Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 4 in Day-to-day functions
|
-1.1 units on a scale
Standard Deviation 3.0
|
—
|
—
|
|
Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 4 in Pain
|
-0.8 units on a scale
Standard Deviation 2.7
|
—
|
—
|
|
Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 4 in Duration of pain
|
-1.2 units on a scale
Standard Deviation 2.9
|
—
|
—
|
|
Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 12 in Day-to-day functions
|
-1.1 units on a scale
Standard Deviation 2.6
|
—
|
—
|
|
Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 12 in Pain
|
-0.9 units on a scale
Standard Deviation 2.5
|
—
|
—
|
|
Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Change to Week 12 in Duration of pain
|
-1.3 units on a scale
Standard Deviation 2.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 4 and Week 12Population: The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.
The weekly recorded patient diary consists of the three items: Day-to-Day Capacities and Activities, Pain and Duration of Pain. Each item was rated by the patient on an 11-point scale ranging from 0 = no problems at all to 10 = most severe problems (the actual wording is adapted to each item in question). The following categorical changes between the baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented: Improvement, No change and Deterioration.
Outcome measures
| Measure |
Rotatory Torticollis
n=503 Participants
Patients with rotatory torticollis type of CD who received a single i.m. injection of 500 U Dysport®.
|
Laterocollis
Patients with laterocollis type of CD who received a single i.m. injection of 500 U Dysport®.
|
Dysport® 500 U - Total Study Population
Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.
The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.
|
|---|---|---|---|
|
Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Improvement in Day-to-day functions to Week 4
|
59.9 percentage of patients
|
—
|
—
|
|
Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
No change in Day-to-day functions to Week 4
|
19.6 percentage of patients
|
—
|
—
|
|
Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Deterioration in Day-to-day functions to Week 4
|
20.5 percentage of patients
|
—
|
—
|
|
Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Improvement in Pain to Week 4
|
50.2 percentage of patients
|
—
|
—
|
|
Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
No change in Pain to Week 4
|
23.0 percentage of patients
|
—
|
—
|
|
Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Deterioration in Pain to Week 4
|
26.8 percentage of patients
|
—
|
—
|
|
Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Improvement in Duration in pain to Week 4
|
52.3 percentage of patients
|
—
|
—
|
|
Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
No change in Duration of pain to Week 4
|
24.6 percentage of patients
|
—
|
—
|
|
Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Deterioration in Duration of pain to Week 4
|
23.1 percentage of patients
|
—
|
—
|
|
Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Improvement in Day-to-day functions to Week 12
|
55.2 percentage of patients
|
—
|
—
|
|
Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
No change in Day-to-day functions to Week 12
|
22.9 percentage of patients
|
—
|
—
|
|
Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Deterioration in Day-to-day functions to Week 12
|
21.9 percentage of patients
|
—
|
—
|
|
Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Improvement in Pain to Week 12
|
48.3 percentage of patients
|
—
|
—
|
|
Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
No change in Pain to Week 12
|
25.1 percentage of patients
|
—
|
—
|
|
Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Deterioration in Pain to Week 12
|
26.6 percentage of patients
|
—
|
—
|
|
Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Improvement in Duration of pain to Week 12
|
55.2 percentage of patients
|
—
|
—
|
|
Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
No change in Duration of pain to Week 12
|
24.3 percentage of patients
|
—
|
—
|
|
Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12)
Deterioration in Duration of pain to Week 12
|
20.4 percentage of patients
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 visit and Week 12 visitPopulation: The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.
Global pain was assessed at Visit 2 (Week 4) and Visit 3 (Week 12); investigators and patients assessed change in global pain according to the following response categories: 1. = no pain (anymore) 2. = less pain 3. = no change 4. = more pain The numbers of patients falling under each of these categories as assessed by the investigator and patient at Weeks 4 and 12 are presented.
Outcome measures
| Measure |
Rotatory Torticollis
n=503 Participants
Patients with rotatory torticollis type of CD who received a single i.m. injection of 500 U Dysport®.
|
Laterocollis
Patients with laterocollis type of CD who received a single i.m. injection of 500 U Dysport®.
|
Dysport® 500 U - Total Study Population
Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.
The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.
|
|---|---|---|---|
|
Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
No pain at Week 4 (Investigator assessment)
|
131 Participants
|
—
|
—
|
|
Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Less pain at Week 4 (Investigator assessment)
|
205 Participants
|
—
|
—
|
|
Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
No change at Week 4 (Investigator assessment)
|
94 Participants
|
—
|
—
|
|
Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
No pain at Week 12 (Investigator assessment)
|
142 Participants
|
—
|
—
|
|
Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Less pain at Week 12 (Investigator assessment)
|
227 Participants
|
—
|
—
|
|
Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
No change at Week 12 (Investigator assessment)
|
87 Participants
|
—
|
—
|
|
Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
More pain at Week 12 (Investigator assessment)
|
33 Participants
|
—
|
—
|
|
Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
No pain at Week 4 (Patient assessment)
|
128 Participants
|
—
|
—
|
|
Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Less pain at Week 4 (Patient assessment)
|
202 Participants
|
—
|
—
|
|
Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
No change at Week 4 (Patient assessment)
|
82 Participants
|
—
|
—
|
|
Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
No pain at Week 12 (Patient assessment)
|
132 Participants
|
—
|
—
|
|
Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Less pain at Week 12 (Patient assessment)
|
231 Participants
|
—
|
—
|
|
Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
No change at Week 12 (Patient assessment)
|
83 Participants
|
—
|
—
|
|
Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
More pain at Week 12 (Patient assessment)
|
44 Participants
|
—
|
—
|
|
Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
More pain at Week 4 (Investigator assessment)
|
70 Participants
|
—
|
—
|
|
Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
More pain at Week 4 (Patient assessment)
|
88 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 and Week 12Population: The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported.
At Visit 2 (Week 4) and Visit 3 (Week 12) investigators and patients assessed global efficacy of injection of 500 U Dysport® according to the following response categories: 1. = very good 2. = good 3. = moderate 4. = insufficient The numbers of patients falling under each of these categories as assessed by the investigator and patient at Weeks 4 and 12 are presented.
Outcome measures
| Measure |
Rotatory Torticollis
n=503 Participants
Patients with rotatory torticollis type of CD who received a single i.m. injection of 500 U Dysport®.
|
Laterocollis
Patients with laterocollis type of CD who received a single i.m. injection of 500 U Dysport®.
|
Dysport® 500 U - Total Study Population
Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.
The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.
|
|---|---|---|---|
|
Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Week 4 (Investigator assessment): Very good
|
129 Participants
|
—
|
—
|
|
Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Week 4 (Investigator assessment): Good
|
221 Participants
|
—
|
—
|
|
Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Week 4 (Investigator assessment): Moderate
|
109 Participants
|
—
|
—
|
|
Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Week 12 (Investigator assessment): Good
|
218 Participants
|
—
|
—
|
|
Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Week 12 (Investigator assessment): Moderate
|
102 Participants
|
—
|
—
|
|
Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Week 4 (Patient assessment): Moderate
|
113 Participants
|
—
|
—
|
|
Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Week 4 (Patient assessment): Insufficient
|
83 Participants
|
—
|
—
|
|
Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Week 12 (Patient assessment): Very good
|
113 Participants
|
—
|
—
|
|
Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Week 12 (Patient assessment): Good
|
205 Participants
|
—
|
—
|
|
Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Week 12 (Patient assessment): Moderate
|
100 Participants
|
—
|
—
|
|
Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Week 12 (Patient assessment): Insufficient
|
72 Participants
|
—
|
—
|
|
Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Week 4 (Investigator assessment): Insufficient
|
41 Participants
|
—
|
—
|
|
Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Week 12 (Investigator assessment): Very good
|
134 Participants
|
—
|
—
|
|
Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Week 12 (Investigator assessment): Insufficient
|
35 Participants
|
—
|
—
|
|
Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Week 4 (Patient assessment): Very good
|
97 Participants
|
—
|
—
|
|
Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
Week 4 (Patient assessment): Good
|
207 Participants
|
—
|
—
|
Adverse Events
Dysport® 500 U - Total Study Population
Serious events: 11 serious events
Other events: 206 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dysport® 500 U - Total Study Population
n=515 participants at risk
Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.
The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Nervous system disorders
Syncope
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Cardiac disorders
Bradycardia
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Infections and infestations
Appendicitis
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Gastrointestinal disorders
Peritonitis
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Injury, poisoning and procedural complications
Fall
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Cardiac disorders
Myocardial infarction
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Infections and infestations
Pneumonia
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Cardiac disorders
Cardiac failure
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Psychiatric disorders
Depression
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Cardiac disorders
Coronary artery disease
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Eye disorders
Blindness
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Psychiatric disorders
Apathy
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
Other adverse events
| Measure |
Dysport® 500 U - Total Study Population
n=515 participants at risk
Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments.
The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments.
|
|---|---|
|
Vascular disorders
Circulatory collapse
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Vascular disorders
Hypertension
|
0.78%
4/515 • Number of events 4 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Vascular disorders
Orthostatic hypotension
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Vascular disorders
Thrombophlebitis
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Surgical and medical procedures
Limb operation
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
General disorders
Asthenia
|
0.58%
3/515 • Number of events 3 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
General disorders
Facial pain
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
General disorders
Fatigue
|
1.2%
6/515 • Number of events 6 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
General disorders
Gait disturbance
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
General disorders
General physical health deterioration
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
General disorders
Influenza like illness
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
General disorders
Injection site pain
|
1.4%
7/515 • Number of events 7 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
General disorders
Injection site paraesthesia
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
General disorders
Local swelling
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
General disorders
Malaise
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
General disorders
Oedema peripheral
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
General disorders
Sensation of foreign body
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
General disorders
Thirst
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Psychiatric disorders
Anxiety
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Psychiatric disorders
Anxiety disorder
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Psychiatric disorders
Conversion disorder
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Psychiatric disorders
Depression
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Psychiatric disorders
Initial insomnia
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Psychiatric disorders
Middle insomnia
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Psychiatric disorders
Panic attack
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Psychiatric disorders
Psychotic disorder
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Psychiatric disorders
Restlessness
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Investigations
Blood pressure diastolic increased
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Investigations
Blood pressure increased
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Investigations
Blood pressure orthostatic abnormal
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Cardiac disorders
Angina pectoris
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Cardiac disorders
Coronary artery disease
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Cardiac disorders
Tachycardia
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Nervous system disorders
Burning sensation
|
0.78%
4/515 • Number of events 4 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Nervous system disorders
Cervical root pain
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Nervous system disorders
Disturbance in attention
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Nervous system disorders
Dizziness
|
2.3%
12/515 • Number of events 13 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Nervous system disorders
Dysarthria
|
0.78%
4/515 • Number of events 4 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Nervous system disorders
Head discomfort
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Nervous system disorders
Head titubation
|
0.19%
1/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Nervous system disorders
Headache
|
3.3%
17/515 • Number of events 21 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Nervous system disorders
Hypoaesthesia
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Nervous system disorders
Mastication disorder
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Nervous system disorders
Migraine
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Nervous system disorders
Neuritis
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Nervous system disorders
Paraesthesia
|
0.78%
4/515 • Number of events 4 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Nervous system disorders
Paralysis
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Nervous system disorders
Paresis
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Nervous system disorders
Restless legs syndrome
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Nervous system disorders
Speech disorder
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Nervous system disorders
Tongue paralysis
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Nervous system disorders
Tremor
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Eye disorders
Blepharitis
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Eye disorders
Dry eye
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Eye disorders
Eyelid ptosis
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Eye disorders
Glaucoma
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Eye disorders
Keratoconjunctivitis sicca
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Eye disorders
Vision blurred
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.58%
3/515 • Number of events 3 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Ear and labyrinth disorders
Vertigo
|
0.78%
4/515 • Number of events 5 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.58%
3/515 • Number of events 3 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Gastrointestinal disorders
Constipation
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Gastrointestinal disorders
Dental caries
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.78%
4/515 • Number of events 4 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Gastrointestinal disorders
Dry mouth
|
1.2%
6/515 • Number of events 6 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Gastrointestinal disorders
Dysphagia
|
9.9%
51/515 • Number of events 51 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Gastrointestinal disorders
Gastritis
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Gastrointestinal disorders
Nausea
|
0.58%
3/515 • Number of events 3 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Gastrointestinal disorders
Toothache
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Gastrointestinal disorders
Vomiting
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Renal and urinary disorders
Dysuria
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Renal and urinary disorders
Haematuria
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Renal and urinary disorders
Nephritis
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.19%
1/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.58%
3/515 • Number of events 3 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.39%
2/515 • Number of events 3 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.97%
5/515 • Number of events 5 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
8/515 • Number of events 8 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
13.6%
70/515 • Number of events 70 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.7%
9/515 • Number of events 12 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.97%
5/515 • Number of events 5 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.6%
8/515 • Number of events 9 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.6%
34/515 • Number of events 35 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.19%
1/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.58%
3/515 • Number of events 4 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Endocrine disorders
Goitre
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Infections and infestations
Acute tonsillitis
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Infections and infestations
Bronchitis
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Infections and infestations
Cystitis
|
0.58%
3/515 • Number of events 3 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Infections and infestations
Device related infection
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Infections and infestations
Eye infection viral
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Infections and infestations
Herpes simplex
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Infections and infestations
Herpes zoster
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Infections and infestations
Hordeolum
|
0.39%
2/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Infections and infestations
Laryngitis
|
0.58%
3/515 • Number of events 4 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
19/515 • Number of events 20 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Infections and infestations
Otitis media
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Infections and infestations
Pneumonia bacterial
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Infections and infestations
Respiratory tract infection
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Infections and infestations
Rhinitis
|
0.19%
1/515 • Number of events 2 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Infections and infestations
Sinusitis
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.19%
1/515 • Number of events 1 • From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60