Trial Outcomes & Findings for Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions (NCT NCT02091739)
NCT ID: NCT02091739
Last Updated: 2018-03-27
Results Overview
uSFR was assessed by weighing of dental rolls soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes and the average of the 2 results for flow rate was calculated.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
184 participants
Primary outcome timeframe
Baseline and Week 4
Results posted on
2018-03-27
Participant Flow
The study was conducted at 12 sites in Poland and Germany.
A total of 216 participants were screened for the study, of which 184 participants were randomized and treated in the Main Period (MP) of the study. A total of 173 participants who completed the MP, entered the 2 treatment arms of the Extension Period (EP) of the study.
Participant milestones
| Measure |
Placebo
Participants received one injection session of overall 2.0 milliliter (mL) placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
MP: IncobotulinumtoxinA (Xeomin) (75 Units)
Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
MP: IncobotulinumtoxinA (Xeomin) (100 Units)
Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
EP: IncobotulinumtoxinA (Xeomin) (75 Units)
Participants received overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands at each of the three injection sessions in the EP.
|
EP: IncobotulinumtoxinA (Xeomin) (100 Units)
Participants received overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands at each of the three injection sessions in the EP.
|
|---|---|---|---|---|---|
|
MP: 16 Weeks
STARTED
|
36
|
74
|
74
|
0
|
0
|
|
MP: 16 Weeks
COMPLETED
|
32
|
69
|
72
|
0
|
0
|
|
MP: 16 Weeks
NOT COMPLETED
|
4
|
5
|
2
|
0
|
0
|
|
EP: 48 Weeks
STARTED
|
0
|
0
|
0
|
84
|
89
|
|
EP: 48 Weeks
COMPLETED
|
0
|
0
|
0
|
76
|
75
|
|
EP: 48 Weeks
NOT COMPLETED
|
0
|
0
|
0
|
8
|
14
|
Reasons for withdrawal
| Measure |
Placebo
Participants received one injection session of overall 2.0 milliliter (mL) placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
MP: IncobotulinumtoxinA (Xeomin) (75 Units)
Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
MP: IncobotulinumtoxinA (Xeomin) (100 Units)
Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
EP: IncobotulinumtoxinA (Xeomin) (75 Units)
Participants received overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands at each of the three injection sessions in the EP.
|
EP: IncobotulinumtoxinA (Xeomin) (100 Units)
Participants received overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands at each of the three injection sessions in the EP.
|
|---|---|---|---|---|---|
|
MP: 16 Weeks
Adverse Event
|
1
|
1
|
1
|
0
|
0
|
|
MP: 16 Weeks
Withdrawal by Subject
|
3
|
4
|
0
|
0
|
0
|
|
MP: 16 Weeks
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
|
EP: 48 Weeks
Other
|
0
|
0
|
0
|
1
|
0
|
|
EP: 48 Weeks
Death
|
0
|
0
|
0
|
3
|
2
|
|
EP: 48 Weeks
Adverse Event
|
0
|
0
|
0
|
2
|
6
|
|
EP: 48 Weeks
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
6
|
Baseline Characteristics
Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions
Baseline characteristics by cohort
| Measure |
MP: Placebo
n=36 Participants
Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
MP: IncobotulinumtoxinA (Xeomin) (75 Units)
n=74 Participants
Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
MP: IncobotulinumtoxinA (Xeomin) (100 Units)
n=74 Participants
Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
183 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
183 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Weight
|
80.6 kilogram (kg)
STANDARD_DEVIATION 16.4 • n=5 Participants
|
78.4 kilogram (kg)
STANDARD_DEVIATION 17.1 • n=7 Participants
|
79.8 kilogram (kg)
STANDARD_DEVIATION 14 • n=5 Participants
|
79.4 kilogram (kg)
STANDARD_DEVIATION 15.7 • n=4 Participants
|
|
Body Mass Index (BMI)
|
28.5 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 6 • n=5 Participants
|
26.7 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 5.2 • n=7 Participants
|
27.7 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.8 • n=5 Participants
|
27.5 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: Analysis covers all participants from FAS who have at least one post-baseline uSFR assessment. The FAS is the subset of participants who were treated and had at least the baseline value of uSFR.
uSFR was assessed by weighing of dental rolls soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes and the average of the 2 results for flow rate was calculated.
Outcome measures
| Measure |
MP: Placebo
n=36 Participants
Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
MP: IncobotulinumtoxinA (Xeomin) (75 Units)
n=73 Participants
Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
MP: IncobotulinumtoxinA (Xeomin) (100 Units)
n=73 Participants
Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
|---|---|---|---|
|
MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 4
|
-0.04 gram per minute (g/min)
Standard Error 0.033
|
-0.06 gram per minute (g/min)
Standard Error 0.027
|
-0.13 gram per minute (g/min)
Standard Error 0.026
|
PRIMARY outcome
Timeframe: Week 4Population: The FAS is the subset of participants who were treated and had at least the baseline value of uSFR.
The GICS was used to measure the impression of change due to treatment. The response option was a common 7-point Likert scale that ranged from -3 = very much worse to +3 = very much improved and was applicable for participant and caregiver. If the participant was not able to answer then carer's rating was to be recorded instead of participant's rating and the participant's rating was left blank.
Outcome measures
| Measure |
MP: Placebo
n=36 Participants
Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
MP: IncobotulinumtoxinA (Xeomin) (75 Units)
n=74 Participants
Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
MP: IncobotulinumtoxinA (Xeomin) (100 Units)
n=74 Participants
Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
|---|---|---|---|
|
MP: Participant's Global Impression of Change Scale (GICS) at Week 4
|
0.67 units on a scale
Standard Error 0.186
|
1.02 units on a scale
Standard Error 0.148
|
1.25 units on a scale
Standard Error 0.144
|
SECONDARY outcome
Timeframe: Baseline, Week 8 and 12Population: Analysis covers all participants from FAS who have at least one post-baseline uSFR assessment. The FAS is the subset of participants who were treated and had at least the baseline value of uSFR.
uSFR was assessed by weighing of dental rolls soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes and the average of the 2 results for flow rate was calculated.
Outcome measures
| Measure |
MP: Placebo
n=36 Participants
Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
MP: IncobotulinumtoxinA (Xeomin) (75 Units)
n=73 Participants
Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
MP: IncobotulinumtoxinA (Xeomin) (100 Units)
n=73 Participants
Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
|---|---|---|---|
|
MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 8 and 12
Week 8
|
-0.02 g/min
Standard Error 0.033
|
-0.08 g/min
Standard Error 0.027
|
-0.13 g/min
Standard Error 0.026
|
|
MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 8 and 12
Week 12
|
-0.03 g/min
Standard Error 0.033
|
-0.1 g/min
Standard Error 0.027
|
-0.12 g/min
Standard Error 0.026
|
SECONDARY outcome
Timeframe: Week 1, 2, 8, and 12Population: The FAS is the subset of participants who were treated and had at least the baseline value of uSFR.
The GICS was used to measure the investigator's impression of change due to treatment. The response option was a common 7-point Likert scale that ranged from -3 = very much worse to +3 = very much improved and was applicable for participant and caregiver. If the participant was not able to answer then carer's rating was to be recorded instead of participant's rating and the participant's rating was left blank.
Outcome measures
| Measure |
MP: Placebo
n=36 Participants
Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
MP: IncobotulinumtoxinA (Xeomin) (75 Units)
n=74 Participants
Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
MP: IncobotulinumtoxinA (Xeomin) (100 Units)
n=74 Participants
Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
|---|---|---|---|
|
MP: Global Impression of Change Scale (GICS) at Week 1, 2, 8 and 12
Week 1
|
0.67 units on a scale
Standard Error 0.17
|
0.73 units on a scale
Standard Error 0.138
|
0.96 units on a scale
Standard Error 0.133
|
|
MP: Global Impression of Change Scale (GICS) at Week 1, 2, 8 and 12
Week 8
|
0.47 units on a scale
Standard Error 0.192
|
1.07 units on a scale
Standard Error 0.151
|
1.3 units on a scale
Standard Error 0.148
|
|
MP: Global Impression of Change Scale (GICS) at Week 1, 2, 8 and 12
Week 2
|
0.83 units on a scale
Standard Error 0.178
|
0.91 units on a scale
Standard Error 0.143
|
1.11 units on a scale
Standard Error 0.139
|
|
MP: Global Impression of Change Scale (GICS) at Week 1, 2, 8 and 12
Week 12
|
0.56 units on a scale
Standard Error 0.197
|
0.98 units on a scale
Standard Error 0.156
|
1.21 units on a scale
Standard Error 0.152
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
MP: IncobotulinumtoxinA (Xeomin) (75 Units)
Serious events: 6 serious events
Other events: 14 other events
Deaths: 0 deaths
MP: IncobotulinumtoxinA (Xeomin) (100 Units)
Serious events: 9 serious events
Other events: 10 other events
Deaths: 0 deaths
EP: IncobotulinumtoxinA (Xeomin) (75 Units)
Serious events: 15 serious events
Other events: 22 other events
Deaths: 3 deaths
EP: IncobotulinumtoxinA (Xeomin) (100 Units)
Serious events: 14 serious events
Other events: 22 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Placebo
n=36 participants at risk
Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
MP: IncobotulinumtoxinA (Xeomin) (75 Units)
n=74 participants at risk
Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
MP: IncobotulinumtoxinA (Xeomin) (100 Units)
n=74 participants at risk
Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
EP: IncobotulinumtoxinA (Xeomin) (75 Units)
n=82 participants at risk
Participants received overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands at each of the three injection sessions in the EP.
|
EP: IncobotulinumtoxinA (Xeomin) (100 Units)
n=89 participants at risk
Participants received overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands at each of the three injection sessions in the EP.
|
|---|---|---|---|---|---|
|
Vascular disorders
Orthostatic hypotension
|
2.8%
1/36 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 2 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Surgical and medical procedures
Medical device battery replacement
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Surgical and medical procedures
Medical device change
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Surgical and medical procedures
Rehabilitation therapy
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Surgical and medical procedures
Angioplasty
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Surgical and medical procedures
Appendicectomy
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Surgical and medical procedures
Enterostomy
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Surgical and medical procedures
Explorative laparotomy
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Surgical and medical procedures
Laparotomy
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Surgical and medical procedures
Nephrectomy
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Surgical and medical procedures
Renal stone removal
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Surgical and medical procedures
Ureter dilation procedure
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Surgical and medical procedures
Ureteral stent insertion
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
General disorders
Chest pain
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
General disorders
General physical health deterioration
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
General disorders
Pain
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
General disorders
Pyrexia
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Psychiatric disorders
Delusion
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 2 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Psychiatric disorders
Depression
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Psychiatric disorders
Dopamine dysregulation syndrome
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 2 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 2 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Investigations
Angiogram
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Cardiac disorders
Cardiac failure
|
2.8%
1/36 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract inflammation
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
7.3%
6/82 • Number of events 8 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
2.2%
2/89 • Number of events 2 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Nervous system disorders
Drop attacks
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Nervous system disorders
Freezing phenomenon
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Nervous system disorders
Akinesia
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Nervous system disorders
Dementia
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 2 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Nervous system disorders
Movement disorder
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Nervous system disorders
Orthostatic intolerance
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Nervous system disorders
Cardiac pacemaker insertion
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Ear and labyrinth disorders
Vertigo
|
2.8%
1/36 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
2.4%
2/82 • Number of events 2 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 2 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Gastrointestinal disorders
Faecal vomiting
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Gastrointestinal disorders
Giant cell epulis
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Gastrointestinal disorders
Megacolon
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Renal and urinary disorders
Hydronephrosis
|
2.8%
1/36 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
2.2%
2/89 • Number of events 2 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Renal and urinary disorders
Extravasation of urine
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Product Issues
Device occlusion
|
2.8%
1/36 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.4%
1/74 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Infections and infestations
Pyuria
|
2.8%
1/36 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
2.4%
2/82 • Number of events 2 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/82 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
Other adverse events
| Measure |
Placebo
n=36 participants at risk
Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
MP: IncobotulinumtoxinA (Xeomin) (75 Units)
n=74 participants at risk
Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
MP: IncobotulinumtoxinA (Xeomin) (100 Units)
n=74 participants at risk
Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
|
EP: IncobotulinumtoxinA (Xeomin) (75 Units)
n=82 participants at risk
Participants received overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands at each of the three injection sessions in the EP.
|
EP: IncobotulinumtoxinA (Xeomin) (100 Units)
n=89 participants at risk
Participants received overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands at each of the three injection sessions in the EP.
|
|---|---|---|---|---|---|
|
Vascular disorders
Hypertension
|
2.8%
1/36 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
2.7%
2/74 • Number of events 2 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
4.1%
3/74 • Number of events 3 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
6.1%
5/82 • Number of events 5 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
2.2%
2/89 • Number of events 2 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
8.1%
6/74 • Number of events 8 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
2.7%
2/74 • Number of events 5 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
6.1%
5/82 • Number of events 9 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
4.5%
4/89 • Number of events 5 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
5.4%
4/74 • Number of events 5 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
3.7%
3/82 • Number of events 3 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.1%
1/89 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
5.4%
4/74 • Number of events 4 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
3.7%
3/82 • Number of events 4 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
4.5%
4/89 • Number of events 5 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
5.4%
4/74 • Number of events 5 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
4.1%
3/74 • Number of events 3 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
3.7%
3/82 • Number of events 4 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
11.2%
10/89 • Number of events 13 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
1/36 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
2.7%
2/74 • Number of events 2 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
2.7%
2/74 • Number of events 2 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
1.2%
1/82 • Number of events 1 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
6.7%
6/89 • Number of events 6 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/36 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
2.7%
2/74 • Number of events 2 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/74 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
6.1%
5/82 • Number of events 6 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
0.00%
0/89 • MP: From first injection up to first injection in EP (Week 16). EP: From first injection in EP (Week 16) up to end of study (Week 64).
The investigator asked the participant for adverse events systematically at each visit. Two participants received the wrong or no dose in single EP cycles due to procedural reasons and hence were not included in the safety analyses that cover the complete EP: IncobotulinumtoxinA (Xeomin) (75 Units) arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
- Publication restrictions are in place
Restriction type: OTHER