Trial Outcomes & Findings for Safety and Efficacy Study of Dysport RU and Glabellar Lines (NCT NCT01333397)
NCT ID: NCT01333397
Last Updated: 2022-09-27
Results Overview
Investigator's live assessment (ILA), subject's self assessment (SSA), Next Generation (NG) 4-point photographic scale: Investigator's live assessment: None - 0; Mild - 1; Moderate - 2; Severe - 3; 4-point photographic scale: Subject's Self assessment: No wrinkles - 0; Mild wrinkles - 1; Moderate wrinkles - 2; Severe wrinkles - 3; A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on Day 29 and a severity grade of moderate or severe at maximum frown at Visit 2.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
176 participants
Primary outcome timeframe
Day 29
Results posted on
2022-09-27
Participant Flow
Study was performed as a multicentre study at eight investigational sites in France and Germany. Date of first enrolment: 30-Mar-2011 and Date of last completed: 27-Sep-2011.
A total of 178 patients were screened. 2 patient did not meet the entry criteria. 176 patients were randomized.Patients were randomized into 5 groups.
Participant milestones
| Measure |
Placebo
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 20 U
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
Ready to Use (RU)
|
Dysport NG 50 U
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 75 U
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport 50 U
Botulinum type A toxin (Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
36
|
35
|
35
|
35
|
|
Overall Study
COMPLETED
|
34
|
36
|
35
|
34
|
35
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 20 U
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
Ready to Use (RU)
|
Dysport NG 50 U
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 75 U
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport 50 U
Botulinum type A toxin (Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy Study of Dysport RU and Glabellar Lines
Baseline characteristics by cohort
| Measure |
Placebo
n=35 Participants
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 20 U
n=36 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 50 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 75 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport 50 U
n=35 Participants
Botulinum type A toxin (Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
46.7 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
48.1 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
47.9 years
STANDARD_DEVIATION 6.0 • n=4 Participants
|
47.0 years
STANDARD_DEVIATION 6.6 • n=21 Participants
|
47.3 years
STANDARD_DEVIATION 6.9 • n=10 Participants
|
|
Sex/Gender, Customized
Female
|
35 participants
n=5 Participants
|
36 participants
n=7 Participants
|
35 participants
n=5 Participants
|
35 participants
n=4 Participants
|
35 participants
n=21 Participants
|
176 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
1 participants
n=21 Participants
|
5 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
35 participants
n=5 Participants
|
34 participants
n=7 Participants
|
35 participants
n=5 Participants
|
33 participants
n=4 Participants
|
34 participants
n=21 Participants
|
171 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
35 participants
n=5 Participants
|
36 participants
n=7 Participants
|
35 participants
n=5 Participants
|
35 participants
n=4 Participants
|
35 participants
n=21 Participants
|
176 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: Intent-to-Treat Population: The intent-to-treat (ITT) population included all randomised subjects who received study treatment, regardless of the actual amount injected. N'=number of subjects with assessment
Investigator's live assessment (ILA), subject's self assessment (SSA), Next Generation (NG) 4-point photographic scale: Investigator's live assessment: None - 0; Mild - 1; Moderate - 2; Severe - 3; 4-point photographic scale: Subject's Self assessment: No wrinkles - 0; Mild wrinkles - 1; Moderate wrinkles - 2; Severe wrinkles - 3; A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on Day 29 and a severity grade of moderate or severe at maximum frown at Visit 2.
Outcome measures
| Measure |
Placebo
n=34 Participants
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 20 U
n=36 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 50 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 75 U
n=33 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport 50 U
|
|---|---|---|---|---|---|
|
Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown
ILA (N'=34,36,35,33)
|
0 percentage of subjects
|
88.9 percentage of subjects
|
91.4 percentage of subjects
|
87.9 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown
SSA (N'=34,36,35,33)
|
2.9 percentage of subjects
|
91.7 percentage of subjects
|
85.7 percentage of subjects
|
81.8 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: ITT Population; Day 29 (N'=34,36,35,33,35); N'= number of subjects with an Investigator's live assessment and a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit
A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2.
Outcome measures
| Measure |
Placebo
n=34 Participants
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 20 U
n=36 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 50 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 75 U
n=33 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport 50 U
n=35 Participants
|
|---|---|---|---|---|---|
|
Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.
|
0 percentage of subjects
|
86.1 percentage of subjects
|
85.7 percentage of subjects
|
81.8 percentage of subjects
|
77.1 percentage of subjects
|
SECONDARY outcome
Timeframe: Days 8, 15, 57, 85 and 113Population: ITT Population; N'=number of subjects with an Investigator's live assessment of glabellar lines at maximum frown for the given post-Baseline visit
Outcome measures
| Measure |
Placebo
n=34 Participants
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 20 U
n=36 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 50 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 75 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport 50 U
|
|---|---|---|---|---|---|
|
Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment.
ILA: Day 8 (N'=34,36,35,35)
|
0 percentage of subjects
|
77.8 percentage of subjects
|
80.0 percentage of subjects
|
82.9 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment.
ILA: Day 15 (N'=33,36,35,35)
|
3.0 percentage of subjects
|
80.6 percentage of subjects
|
94.3 percentage of subjects
|
91.4 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment.
ILA: Day 57 (N'=33,35,34,34)
|
0 percentage of subjects
|
77.1 percentage of subjects
|
79.4 percentage of subjects
|
82.4 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment.
ILA: Day 85 (N'=34,33,34,32)
|
0 percentage of subjects
|
48.5 percentage of subjects
|
58.8 percentage of subjects
|
75.0 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment.
ILA: Day 113 (N'=34,36,35,34)
|
0 percentage of subjects
|
22.2 percentage of subjects
|
42.9 percentage of subjects
|
55.9 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: Days 8, 15, 57, 85 and 113Population: ITT Population; N'= number of subjects with a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit
Outcome measures
| Measure |
Placebo
n=34 Participants
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 20 U
n=36 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 50 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 75 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport 50 U
|
|---|---|---|---|---|---|
|
Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment.
SSA: Day 8 (N'=34,36,35,35)
|
2.9 percentage of subjects
|
66.7 percentage of subjects
|
65.7 percentage of subjects
|
74.3 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment.
SSA: Day 15 (N'=33,36,35,35)
|
3.0 percentage of subjects
|
80.6 percentage of subjects
|
82.9 percentage of subjects
|
80.0 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment.
SSA: Day 57 (N'=34,35,34,34)
|
0 percentage of subjects
|
80.0 percentage of subjects
|
67.6 percentage of subjects
|
82.4 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment.
SSA: Day 85 (N'=34,35,34,32)
|
0 percentage of subjects
|
57.1 percentage of subjects
|
47.1 percentage of subjects
|
62.5 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment.
SSA: Day 113 (N'=34,36,35,34)
|
0 percentage of subjects
|
36.1 percentage of subjects
|
34.3 percentage of subjects
|
52.9 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: Days 8, 15, 57, 85 and 113Population: ITT Population; N'= number of subjects with an Investigator's live assessment and a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit
Outcome measures
| Measure |
Placebo
n=34 Participants
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 20 U
n=36 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 50 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 75 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport 50 U
n=35 Participants
|
|---|---|---|---|---|---|
|
Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.
Day 8 (N'=34,36,35,35,35)
|
0 percentage of subjects
|
61.1 percentage of subjects
|
62.9 percentage of subjects
|
74.3 percentage of subjects
|
51.4 percentage of subjects
|
|
Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.
Day 15 (N'=34,36,35,35,34)
|
0 percentage of subjects
|
75.0 percentage of subjects
|
82.9 percentage of subjects
|
80.0 percentage of subjects
|
67.6 percentage of subjects
|
|
Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.
Day 57 (N'=34,35,34,34,34)
|
0 percentage of subjects
|
74.3 percentage of subjects
|
67.6 percentage of subjects
|
79.4 percentage of subjects
|
64.7 percentage of subjects
|
|
Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.
Day 85 (N'=34,33,34,32,34)
|
0 percentage of subjects
|
42.4 percentage of subjects
|
44.1 percentage of subjects
|
62.5 percentage of subjects
|
38.2 percentage of subjects
|
|
Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.
Day 113 (N'=34,36,35,34,35)
|
0 percentage of subjects
|
19.4 percentage of subjects
|
34.3 percentage of subjects
|
41.2 percentage of subjects
|
25.7 percentage of subjects
|
SECONDARY outcome
Timeframe: Days 8, 15, 29, 57, 85 and 113Population: ITT Population; N'= number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit;
A responder at rest was defined as a subject having a severity grade of none or mild at rest on the visit day and a severity grade of moderate or severe at rest at Visit 2.
Outcome measures
| Measure |
Placebo
n=18 Participants
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 20 U
n=17 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 50 U
n=13 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 75 U
n=14 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport 50 U
|
|---|---|---|---|---|---|
|
Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment.
ILA: Day 8 (N'=18,17,13,14)
|
11.1 percentage of subjects
|
70.6 percentage of subjects
|
76.9 percentage of subjects
|
71.4 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment.
ILA: Day 15 (N'=18,17,13,14)
|
11.1 percentage of subjects
|
70.6 percentage of subjects
|
92.3 percentage of subjects
|
78.6 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment.
ILA: Day 29 (N'=18,17,13,14)
|
5.6 percentage of subjects
|
82.4 percentage of subjects
|
76.9 percentage of subjects
|
85.7 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment.
ILA: Day 57 (N'=17,16,13,14)
|
11.8 percentage of subjects
|
81.3 percentage of subjects
|
76.9 percentage of subjects
|
78.6 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment.
ILA: Day 85 (N'=18,17,12,14)
|
5.6 percentage of subjects
|
82.4 percentage of subjects
|
75.0 percentage of subjects
|
64.3 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment.
ILA: Day 113 (N'=18,17,13,14)
|
11.1 percentage of subjects
|
52.9 percentage of subjects
|
53.8 percentage of subjects
|
57.1 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: Day 113Population: ITT Population; N'=number of responders at Day 29
A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2.
Outcome measures
| Measure |
Placebo
n=1 Participants
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 20 U
n=33 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 50 U
n=32 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 75 U
n=29 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport 50 U
n=29 Participants
|
|---|---|---|---|---|---|
|
Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders
ILA: Day 29 (N'=0,32,32,29,27)
|
0 percentage of subjects
|
25.0 percentage of subjects
|
46.9 percentage of subjects
|
65.5 percentage of subjects
|
40.7 percentage of subjects
|
|
Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders
SSA: Day 29 (N'=1,33,30,27,29)
|
0 percentage of subjects
|
36.4 percentage of subjects
|
40.0 percentage of subjects
|
63.0 percentage of subjects
|
34.5 percentage of subjects
|
SECONDARY outcome
Timeframe: Days 8, 15, 29, 57, 85 and 113Population: ITT Population; N'= number of subjects with an Investigator's live assessment of glabellar lines at maximum frown for the given post-Baseline visit
A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/none or from Visit 2 severity of moderate to none after treatment as measured by the Investigator's live assessment
Outcome measures
| Measure |
Placebo
n=34 Participants
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 20 U
n=36 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 50 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 75 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport 50 U
n=35 Participants
|
|---|---|---|---|---|---|
|
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Investigator's Live Assessment
ILA: Day 8 (N'=34,36,35,35,35)
|
0 percentage of subjects
|
30.6 percentage of subjects
|
45.7 percentage of subjects
|
45.7 percentage of subjects
|
31.4 percentage of subjects
|
|
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Investigator's Live Assessment
ILA: Day 15 (N'=33,36,35,35,34)
|
0 percentage of subjects
|
50.0 percentage of subjects
|
62.9 percentage of subjects
|
57.1 percentage of subjects
|
50.0 percentage of subjects
|
|
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Investigator's Live Assessment
ILA: Day 29 (N'=34,36,35,33,35)
|
0 percentage of subjects
|
55.6 percentage of subjects
|
68.6 percentage of subjects
|
63.6 percentage of subjects
|
57.1 percentage of subjects
|
|
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Investigator's Live Assessment
ILA: Day 57 (N'=33,35,34,34,34)
|
0 percentage of subjects
|
34.3 percentage of subjects
|
47.1 percentage of subjects
|
44.1 percentage of subjects
|
41.2 percentage of subjects
|
|
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Investigator's Live Assessment
ILA: Day 85 (N'=34,33,34,32,34)
|
0 percentage of subjects
|
24.2 percentage of subjects
|
29.4 percentage of subjects
|
31.3 percentage of subjects
|
26.5 percentage of subjects
|
|
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Investigator's Live Assessment
ILA: Day 113 (N'=34,36,35,34,35)
|
0 percentage of subjects
|
13.9 percentage of subjects
|
14.3 percentage of subjects
|
20.6 percentage of subjects
|
8.6 percentage of subjects
|
SECONDARY outcome
Timeframe: Days 8, 15, 29, 57, 85 and 113Population: ITT Population; N'= number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit
A reduction of two or more grades in the severity of glabellar lines at rest was a change from Visit 2 severity of glabellar lines from severe to mild or from Visit 2 severity of moderate to none after treatment as measured by the Investigator's live assessment.
Outcome measures
| Measure |
Placebo
n=18 Participants
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 20 U
n=17 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 50 U
n=13 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 75 U
n=14 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport 50 U
n=19 Participants
|
|---|---|---|---|---|---|
|
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Rest as Measured by the Investigator's Live Assessment
ILA: Day 8 (N'=18,17,13,14,19)
|
5.6 percentage of subjects
|
5.9 percentage of subjects
|
23.1 percentage of subjects
|
21.4 percentage of subjects
|
10.5 percentage of subjects
|
|
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Rest as Measured by the Investigator's Live Assessment
ILA: Day 15 (N'=18,17,13,14,18)
|
5.6 percentage of subjects
|
17.6 percentage of subjects
|
23.1 percentage of subjects
|
21.4 percentage of subjects
|
16.7 percentage of subjects
|
|
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Rest as Measured by the Investigator's Live Assessment
ILA: Day 29 (N'=18,17,13,14,19)
|
0 percentage of subjects
|
11.8 percentage of subjects
|
23.1 percentage of subjects
|
28.6 percentage of subjects
|
21.1 percentage of subjects
|
|
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Rest as Measured by the Investigator's Live Assessment
ILA: Day 57 (N'=17,16,13,14,19)
|
5.9 percentage of subjects
|
18.8 percentage of subjects
|
15.4 percentage of subjects
|
21.4 percentage of subjects
|
15.8 percentage of subjects
|
|
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Rest as Measured by the Investigator's Live Assessment
ILA: Day 85 (N'=18,17,12,14,19)
|
0 percentage of subjects
|
17.6 percentage of subjects
|
16.7 percentage of subjects
|
7.1 percentage of subjects
|
15.8 percentage of subjects
|
|
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Rest as Measured by the Investigator's Live Assessment
ILA: Day 113 (N'=18,17,13,14,19)
|
0 percentage of subjects
|
5.9 percentage of subjects
|
23.1 percentage of subjects
|
14.3 percentage of subjects
|
5.3 percentage of subjects
|
SECONDARY outcome
Timeframe: Days 8, 15, 29, 57, 85 and 113Population: ITT Population; N'= number of subjects with a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit
A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/no wrinkles or from Visit 2 severity of moderate to no wrinkles after treatment as measured by the subjects self assessment.
Outcome measures
| Measure |
Placebo
n=34 Participants
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 20 U
n=36 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 50 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 75 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport 50 U
n=35 Participants
|
|---|---|---|---|---|---|
|
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Subject's Self-assessment
SSA: Day 8 (N'=34,36,35,35,35)
|
0 percentage of subjects
|
25.0 percentage of subjects
|
42.9 percentage of subjects
|
40.0 percentage of subjects
|
34.3 percentage of subjects
|
|
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Subject's Self-assessment
SSA: Day 85 (N'=34,35,34,32,34)
|
0 percentage of subjects
|
28.6 percentage of subjects
|
29.4 percentage of subjects
|
31.3 percentage of subjects
|
29.4 percentage of subjects
|
|
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Subject's Self-assessment
SSA: Day 15 (N'=33,36,35,35,34)
|
0 percentage of subjects
|
52.8 percentage of subjects
|
57.1 percentage of subjects
|
54.3 percentage of subjects
|
47.1 percentage of subjects
|
|
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Subject's Self-assessment
SSA: Day 29 (N'=34,36,35,33,35)
|
0 percentage of subjects
|
52.8 percentage of subjects
|
60.0 percentage of subjects
|
57.6 percentage of subjects
|
57.1 percentage of subjects
|
|
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Subject's Self-assessment
SSA: Day 57 (N'=34,35,34,34,34)
|
0 percentage of subjects
|
40.0 percentage of subjects
|
52.9 percentage of subjects
|
44.1 percentage of subjects
|
47.1 percentage of subjects
|
|
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Subject's Self-assessment
SSA: Day 113 (N'=34,36,35,34,35)
|
0 percentage of subjects
|
8.3 percentage of subjects
|
22.9 percentage of subjects
|
11.8 percentage of subjects
|
17.1 percentage of subjects
|
SECONDARY outcome
Timeframe: Days 8, 15, 29, 57, 85 and 113Population: ITT Population; N'=number of subjects with assessment
Outcome measures
| Measure |
Placebo
n=36 Participants
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 20 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 50 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 75 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport 50 U
|
|---|---|---|---|---|---|
|
Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U)
ILA: Day 8 (N'=36,35,35,35)
|
77.8 percentage of subjects
|
80.0 percentage of subjects
|
82.9 percentage of subjects
|
57.1 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U)
ILA: Day 15 (N'=36,35,35,34)
|
80.6 percentage of subjects
|
94.3 percentage of subjects
|
91.4 percentage of subjects
|
73.5 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U)
ILA: Day 29 (N'=36,35,33,35)
|
88.9 percentage of subjects
|
91.4 percentage of subjects
|
87.9 percentage of subjects
|
77.1 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U)
ILA: Day 57 (N'=35,34,34,34)
|
77.1 percentage of subjects
|
79.4 percentage of subjects
|
82.4 percentage of subjects
|
70.6 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U)
ILA: Day 85 (N'=33,34,32,34)
|
48.5 percentage of subjects
|
58.8 percentage of subjects
|
75.0 percentage of subjects
|
52.9 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U)
ILA: Day 113 (N'=36,35,34,35)
|
22.2 percentage of subjects
|
42.9 percentage of subjects
|
55.9 percentage of subjects
|
31.4 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: Days 8, 15, 29, 57, 85 and 113Population: ITT Population; N'=number of subjects with assessment
Outcome measures
| Measure |
Placebo
n=36 Participants
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 20 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 50 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 75 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport 50 U
|
|---|---|---|---|---|---|
|
Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U)
SSA: Day 8 (N'=36,35,35,35)
|
66.7 percentage of subjects
|
65.7 percentage of subjects
|
74.3 percentage of subjects
|
57.1 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U)
SSA: Day 15 (N'=36,35,35,34)
|
80.6 percentage of subjects
|
82.9 percentage of subjects
|
80.0 percentage of subjects
|
73.5 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U)
SSA: Day 29 (N'=36,35,33,35)
|
91.7 percentage of subjects
|
85.7 percentage of subjects
|
81.8 percentage of subjects
|
82.9 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U)
SSA: Day 57 (N'=35,34,34,34)
|
80.0 percentage of subjects
|
67.6 percentage of subjects
|
82.4 percentage of subjects
|
73.5 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U)
SSA: Day 85 (N'=35,34,32,34)
|
57.1 percentage of subjects
|
47.1 percentage of subjects
|
62.5 percentage of subjects
|
41.2 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U)
SSA: Day 113 (N'=36,35,34,35)
|
36.1 percentage of subjects
|
34.3 percentage of subjects
|
52.9 percentage of subjects
|
28.6 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: Days 8, 15, 29, 57, 85 and 113Population: ITT Population; N'=number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit
Outcome measures
| Measure |
Placebo
n=17 Participants
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 20 U
n=13 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 50 U
n=14 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 75 U
n=19 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport 50 U
|
|---|---|---|---|---|---|
|
Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U)
ILA: Day 8 (N'=17,13,14,19)
|
70.6 percentage of subjects
|
76.9 percentage of subjects
|
71.4 percentage of subjects
|
63.2 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U)
ILA: Day 15 (N'=17,13,14,18)
|
70.6 percentage of subjects
|
92.3 percentage of subjects
|
78.6 percentage of subjects
|
72.2 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U)
ILA: Day 29 (N'=17,13,14,19)
|
82.4 percentage of subjects
|
76.9 percentage of subjects
|
85.7 percentage of subjects
|
84.2 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U)
ILA: Day 57 (N'=16,13,14,19)
|
81.3 percentage of subjects
|
76.9 percentage of subjects
|
78.6 percentage of subjects
|
84.2 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U)
ILA: Day 85 (N'=17,12,14,19)
|
82.4 percentage of subjects
|
75.0 percentage of subjects
|
64.3 percentage of subjects
|
68.4 percentage of subjects
|
—
|
|
Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U)
ILA: Day 113 (N'=17,13,14,19)
|
52.9 percentage of subjects
|
53.8 percentage of subjects
|
57.1 percentage of subjects
|
52.6 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: ITT Population; N'=number of subjects with an assessment at Day 29
Outcome measures
| Measure |
Placebo
n=34 Participants
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 20 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 50 U
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 75 U
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport 50 U
|
|---|---|---|---|---|---|
|
Percentage of Subjects as Responders at Day 29 by the Investigator's Live Assessment and by Subject's Self Assessment of Glabellar Lines at Maximum Frown (Assay Sensitivity)
ILA: (N'=34,35)
|
0 percentage of subjects
|
77.1 percentage of subjects
|
—
|
—
|
—
|
|
Percentage of Subjects as Responders at Day 29 by the Investigator's Live Assessment and by Subject's Self Assessment of Glabellar Lines at Maximum Frown (Assay Sensitivity)
SSA: (N'=34,35)
|
2.9 percentage of subjects
|
82.9 percentage of subjects
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Day 113 (±3 days)Population: Safety Population: The safety population included all randomised subjects who received study treatment, regardless of the actual amount injected
Treatment Emergent Adverse Event (TEAE)
Outcome measures
| Measure |
Placebo
n=35 Participants
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 20 U
n=36 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 50 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 75 U
n=35 Participants
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport 50 U
n=35 Participants
|
|---|---|---|---|---|---|
|
Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study
TEAE
|
12 participants
|
15 participants
|
10 participants
|
11 participants
|
10 participants
|
|
Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study
Severe TEAE
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study
Related TEAE
|
5 participants
|
6 participants
|
4 participants
|
4 participants
|
2 participants
|
|
Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study
Related and severe TEAE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study
TEAE leading to withdrawal
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study
TEAE leading to death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study
Serious Adverse Event (SAE)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Dysport NG 20 U
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Dysport NG 50 U
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Dysport NG 75 U
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Dysport 50 U
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=35 participants at risk
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 20 U
n=36 participants at risk
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 50 U
n=35 participants at risk
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 75 U
n=35 participants at risk
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport 50 U
n=35 participants at risk
Botulinum type A toxin ((Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.8%
1/36 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Nervous system disorders
Headache
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.8%
1/36 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
Other adverse events
| Measure |
Placebo
n=35 participants at risk
Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 20 U
n=36 participants at risk
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 50 U
n=35 participants at risk
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport NG 75 U
n=35 participants at risk
Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
Dysport 50 U
n=35 participants at risk
Botulinum type A toxin ((Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
11.4%
4/35 • Number of events 4 • Up to Day 113 (±3 days)
|
5.6%
2/36 • Number of events 2 • Up to Day 113 (±3 days)
|
8.6%
3/35 • Number of events 3 • Up to Day 113 (±3 days)
|
5.7%
2/35 • Number of events 3 • Up to Day 113 (±3 days)
|
8.6%
3/35 • Number of events 3 • Up to Day 113 (±3 days)
|
|
Nervous system disorders
Migraine
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.8%
1/36 • Number of events 1 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
|
Nervous system disorders
Syncope
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Infections and infestations
Nasopharyngitis
|
11.4%
4/35 • Number of events 4 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
5.7%
2/35 • Number of events 3 • Up to Day 113 (±3 days)
|
|
Infections and infestations
Influenza
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Infections and infestations
Cystitis
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
2.8%
1/36 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Infections and infestations
Oral herpes
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
2.8%
1/36 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Infections and infestations
Pharyngitis
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
2.8%
1/36 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Infections and infestations
Eczema infected
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.8%
1/36 • Number of events 2 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
5.7%
2/35 • Number of events 2 • Up to Day 113 (±3 days)
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Eye disorders
Eyelid oedema
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
|
Eye disorders
Dry eye
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.8%
1/36 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
5.7%
2/35 • Number of events 2 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Eye disorders
Keratitis
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.8%
1/36 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Eye disorders
Periorbital oedema
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Eye disorders
Visual acuity reduced
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
5.7%
2/35 • Number of events 2 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.8%
1/36 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Injury, poisoning and procedural complications
Face injury
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
General disorders
Injection site pain
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
5.6%
2/36 • Number of events 2 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
5.7%
2/35 • Number of events 2 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
|
General disorders
Injection site discomfort
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
|
General disorders
Asthenia
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
General disorders
Injection site reaction
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
2.8%
1/36 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
General disorders
Injection site swelling
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.8%
1/36 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.8%
1/36 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
General disorders
Injection site anaesthesia
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.8%
1/36 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.8%
1/36 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.8%
1/36 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.8%
1/36 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.8%
1/36 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Investigations
Laparoscopy
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
2.8%
1/36 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
|
Vascular disorders
Venous thrombosis
|
2.9%
1/35 • Number of events 1 • Up to Day 113 (±3 days)
|
0.00%
0/36 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
0.00%
0/35 • Up to Day 113 (±3 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place