Trial Outcomes & Findings for Efficacy and Safety of Clostridium Botulinum Toxin Type A to Improve Appearance of Moderate to Severe Glabellar Lines (NCT NCT02353871)
NCT ID: NCT02353871
Last Updated: 2022-09-28
Results Overview
ILA 4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3. A responder at maximum frown was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at maximum frown on Day 29 and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1). The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
185 participants
Primary outcome timeframe
Day 29
Results posted on
2022-09-28
Participant Flow
Subjects were recruited from nine active sites in France and Germany from January 2015. The study was completed in August 2015.
Overall, 190 subjects were screened, five of whom were screening failures. A total of 185 subjects were randomised to receive treatment. One of the subjects who was randomised to placebo did not receive study treatment due to violation of inclusion criterion 3.
Participant milestones
| Measure |
BTX-A-HAC NG Solution (50 U)
Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
|
Placebo
Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
60
|
|
Overall Study
COMPLETED
|
122
|
51
|
|
Overall Study
NOT COMPLETED
|
3
|
9
|
Reasons for withdrawal
| Measure |
BTX-A-HAC NG Solution (50 U)
Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
|
Placebo
Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
|
|---|---|---|
|
Overall Study
Protocol deviation
|
0
|
1
|
|
Overall Study
Consent withdrawn
|
1
|
8
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Efficacy and Safety of Clostridium Botulinum Toxin Type A to Improve Appearance of Moderate to Severe Glabellar Lines
Baseline characteristics by cohort
| Measure |
BTX-A-HAC NG Solution (50 U)
n=125 Participants
Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
|
Placebo
n=60 Participants
Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.7 Years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
48.0 Years
STANDARD_DEVIATION 9.09 • n=7 Participants
|
47.8 Years
STANDARD_DEVIATION 9.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
125 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian/White
|
124 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: Modified intent-to-treat (mITT) population included all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. Subjects who did not have available data at Day 29 were excluded from the analysis.
ILA 4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3. A responder at maximum frown was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at maximum frown on Day 29 and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1). The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model.
Outcome measures
| Measure |
BTX-A-HAC NG Solution (50 U)
n=124 Participants
Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
|
Placebo
n=58 Participants
Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
|
|---|---|---|
|
The Proportion of Responders at Day 29 in the ILA of Glabellar Lines at Maximum Frown.
|
88.3 Adjusted percentage of responders
Interval 76.1 to 94.7
|
1.4 Adjusted percentage of responders
Interval 0.3 to 6.5
|
SECONDARY outcome
Timeframe: Day 8, 15, 57, 85, 113, 148 and 183Population: mITT: all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo.
ILA 4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3. A responder at maximum frown was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at maximum frown at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1). The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model.
Outcome measures
| Measure |
BTX-A-HAC NG Solution (50 U)
n=125 Participants
Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
|
Placebo
n=59 Participants
Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
|
|---|---|---|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre (Except Day 29) as Measured by the ILA at Maximum Frown.
Day 8
|
80.5 Adjusted percentage of responders
Interval 65.3 to 90.0
|
1.3 Adjusted percentage of responders
Interval 0.3 to 6.2
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre (Except Day 29) as Measured by the ILA at Maximum Frown.
Day 15
|
87.0 Adjusted percentage of responders
Interval 74.5 to 93.9
|
1.5 Adjusted percentage of responders
Interval 0.3 to 7.0
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre (Except Day 29) as Measured by the ILA at Maximum Frown.
Day 57
|
77.4 Adjusted percentage of responders
Interval 63.0 to 87.3
|
1.0 Adjusted percentage of responders
Interval 0.2 to 5.4
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre (Except Day 29) as Measured by the ILA at Maximum Frown.
Day 85
|
51.3 Adjusted percentage of responders
Interval 35.1 to 67.3
|
1.0 Adjusted percentage of responders
Interval 0.2 to 5.6
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre (Except Day 29) as Measured by the ILA at Maximum Frown.
Day 113
|
34.0 Adjusted percentage of responders
Interval 20.5 to 50.7
|
0.8 Adjusted percentage of responders
Interval 0.1 to 5.1
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre (Except Day 29) as Measured by the ILA at Maximum Frown.
Day 148
|
17.1 Adjusted percentage of responders
Interval 7.9 to 33.1
|
1.8 Adjusted percentage of responders
Interval 0.3 to 9.8
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre (Except Day 29) as Measured by the ILA at Maximum Frown.
Day 183
|
4.9 Adjusted percentage of responders
Interval 0.9 to 23.2
|
0.9 Adjusted percentage of responders
Interval 0.1 to 8.9
|
SECONDARY outcome
Timeframe: Day 57, 85, 113, 148 and 183Population: mITT: All randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo.
ILA 4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3. A responder at maximum frown was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at maximum frown at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1). Subjects who were not responders at Day 29 were excluded from the analysis. The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model.
Outcome measures
| Measure |
BTX-A-HAC NG Solution (50 U)
n=125 Participants
Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
|
Placebo
n=59 Participants
Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
|
|---|---|---|
|
The Proportion of Responders on Day 29 Who Remained Responders on Days 57, 85, 113, 148 and 183 as Measured by the ILA at Maximum Frown.
Day 57
|
87.3 Adjusted percentage of responders
Interval 72.4 to 94.8
|
47.0 Adjusted percentage of responders
Interval 2.8 to 96.5
|
|
The Proportion of Responders on Day 29 Who Remained Responders on Days 57, 85, 113, 148 and 183 as Measured by the ILA at Maximum Frown.
Day 85
|
61.1 Adjusted percentage of responders
Interval 42.5 to 77.0
|
4.9 Adjusted percentage of responders
Interval 0.1 to 73.4
|
|
The Proportion of Responders on Day 29 Who Remained Responders on Days 57, 85, 113, 148 and 183 as Measured by the ILA at Maximum Frown.
Day 113
|
39.6 Adjusted percentage of responders
Interval 23.9 to 57.9
|
24.0 Adjusted percentage of responders
Interval 0.7 to 93.5
|
|
The Proportion of Responders on Day 29 Who Remained Responders on Days 57, 85, 113, 148 and 183 as Measured by the ILA at Maximum Frown.
Day 148
|
20.1 Adjusted percentage of responders
Interval 9.0 to 39.0
|
32.1 Adjusted percentage of responders
Interval 1.8 to 92.6
|
|
The Proportion of Responders on Day 29 Who Remained Responders on Days 57, 85, 113, 148 and 183 as Measured by the ILA at Maximum Frown.
Day 183
|
5.3 Adjusted percentage of responders
Interval 0.9 to 26.6
|
8.0 Adjusted percentage of responders
Interval 0.2 to 76.9
|
SECONDARY outcome
Timeframe: Day 8, 15, 29, 57, 85, 113, 148 and 183Population: mITT: all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit.; P=placebo.
ILA 4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3. A responder at rest was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at rest at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1). The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model.
Outcome measures
| Measure |
BTX-A-HAC NG Solution (50 U)
n=125 Participants
Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
|
Placebo
n=59 Participants
Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
|
|---|---|---|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Rest.
Day 8
|
73.2 Adjusted percentage of responders
Interval 38.4 to 92.3
|
2.0 Adjusted percentage of responders
Interval 0.2 to 15.8
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Rest.
Day 15
|
74.5 Adjusted percentage of responders
Interval 37.7 to 93.3
|
1.3 Adjusted percentage of responders
Interval 0.1 to 12.7
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Rest.
Day 29
|
81.1 Adjusted percentage of responders
Interval 46.5 to 95.5
|
1.5 Adjusted percentage of responders
Interval 0.1 to 14.4
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Rest.
Day 57
|
77.2 Adjusted percentage of responders
Interval 41.7 to 94.1
|
0.5 Adjusted percentage of responders
Interval 0.0 to 10.6
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Rest.
Day 85
|
58.5 Adjusted percentage of responders
Interval 24.0 to 86.2
|
0.5 Adjusted percentage of responders
Interval 0.0 to 8.0
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Rest.
Day 113
|
74.7 Adjusted percentage of responders
Interval 43.5 to 91.8
|
4.8 Adjusted percentage of responders
Interval 0.8 to 24.6
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Rest.
Day 148
|
NA Adjusted percentage of responders
Not calculable due to quasi-complete separation of data point. Therefore statistical analysis was not possible.
|
NA Adjusted percentage of responders
Not calculable due to quasi-complete separation of data point. Therefore statistical analysis was not possible.
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Rest.
Day 183
|
56.0 Adjusted percentage of responders
Interval 26.4 to 81.9
|
10.4 Adjusted percentage of responders
Interval 2.2 to 37.9
|
SECONDARY outcome
Timeframe: Day 8, 15, 29, 57, 85, 113, 148 and 183Population: mITT: all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo.
ILA 4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3. Adjusted proportion of subjects with a reduction of two or more grades in the severity of glabellar lines at each post-treatment visit compared with Baseline. The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model.
Outcome measures
| Measure |
BTX-A-HAC NG Solution (50 U)
n=125 Participants
Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
|
Placebo
n=59 Participants
Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
|
|---|---|---|
|
The Proportion of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Maximum Frown.
Day 8
|
56.2 Adjusted percentage of responders
Interval 37.1 to 73.6
|
0.2 Adjusted percentage of responders
Interval 0.0 to 3.0
|
|
The Proportion of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Maximum Frown.
Day 15
|
69.7 Adjusted percentage of responders
Interval 52.0 to 83.0
|
0.2 Adjusted percentage of responders
Interval 0.0 to 3.1
|
|
The Proportion of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Maximum Frown.
Day 29
|
63.6 Adjusted percentage of responders
Interval 46.4 to 77.9
|
0.1 Adjusted percentage of responders
Interval 0.0 to 1.8
|
|
The Proportion of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Maximum Frown.
Day 57
|
48.0 Adjusted percentage of responders
Interval 31.6 to 64.9
|
0.1 Adjusted percentage of responders
Interval 0.0 to 2.6
|
|
The Proportion of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Maximum Frown.
Day 85
|
24.3 Adjusted percentage of responders
Interval 13.4 to 39.9
|
0.3 Adjusted percentage of responders
Interval 0.0 to 4.8
|
|
The Proportion of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Maximum Frown.
Day 113
|
10.1 Adjusted percentage of responders
Interval 4.3 to 21.7
|
0.3 Adjusted percentage of responders
Interval 0.0 to 4.4
|
|
The Proportion of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Maximum Frown.
Day 148
|
3.5 Adjusted percentage of responders
Interval 0.8 to 13.5
|
0.3 Adjusted percentage of responders
Interval 0.0 to 5.4
|
|
The Proportion of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Maximum Frown.
Day 183
|
3.4 Adjusted percentage of responders
Interval 0.8 to 12.6
|
1.3 Adjusted percentage of responders
Interval 0.1 to 12.0
|
SECONDARY outcome
Timeframe: Day 8, 15, 29, 57, 85, 113, 148 and 183Population: mITT: all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo.
SSA 4-point photographic scale: No wrinkles - 0; Mild wrinkles - 1; Moderate wrinkles - 2; Severe wrinkles - 3. A responder at maximum frown was defined as having a severity grade of no wrinkles (Grade 0) or mild wrinkles (Grade 1) at maximum frown at a given visit and a severity grade of moderate wrinkles (Grade 2) or severe wrinkles (Grade 3) at Baseline (Day 1). The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model.
Outcome measures
| Measure |
BTX-A-HAC NG Solution (50 U)
n=125 Participants
Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
|
Placebo
n=59 Participants
Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
|
|---|---|---|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Self-assessment (SSA) at Maximum Frown.
Day 8
|
62.0 Adjusted percentage of responders
Interval 47.2 to 74.9
|
5.1 Adjusted percentage of responders
Interval 1.6 to 14.8
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Self-assessment (SSA) at Maximum Frown.
Day 15
|
75.6 Adjusted percentage of responders
Interval 61.8 to 85.6
|
4.4 Adjusted percentage of responders
Interval 1.3 to 13.7
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Self-assessment (SSA) at Maximum Frown.
Day 29
|
76.0 Adjusted percentage of responders
Interval 62.2 to 85.9
|
5.2 Adjusted percentage of responders
Interval 1.7 to 15.0
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Self-assessment (SSA) at Maximum Frown.
Day 57
|
67.5 Adjusted percentage of responders
Interval 52.4 to 79.6
|
2.2 Adjusted percentage of responders
Interval 0.6 to 8.3
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Self-assessment (SSA) at Maximum Frown.
Day 85
|
61.8 Adjusted percentage of responders
Interval 46.1 to 75.3
|
3.9 Adjusted percentage of responders
Interval 1.1 to 12.6
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Self-assessment (SSA) at Maximum Frown.
Day 113
|
46.2 Adjusted percentage of responders
Interval 32.8 to 60.2
|
9.8 Adjusted percentage of responders
Interval 3.9 to 22.5
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Self-assessment (SSA) at Maximum Frown.
Day 148
|
44.1 Adjusted percentage of responders
Interval 31.2 to 57.7
|
13.1 Adjusted percentage of responders
Interval 5.3 to 28.9
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Self-assessment (SSA) at Maximum Frown.
Day 183
|
27.0 Adjusted percentage of responders
Interval 16.4 to 41.1
|
6.0 Adjusted percentage of responders
Interval 1.8 to 17.8
|
SECONDARY outcome
Timeframe: Day 8, 15, 29, 57, 85, 113, 148 and 183Population: mITT: All randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo.
Adjusted proportion of responders at each post-treatment visit (measured by the subject's level of satisfaction with the appearance of their glabellar lines). 4-point categorical scale: Grade 0 - very satisfied; Grade 1 - satisfied; Grade 2 - dissatisfied; Grade 3 - very dissatisfied. A responder was defined as having a satisfaction rating of very satisfied (Grade 0) or satisfied (Grade 1) at a given visit and a satisfaction rating of dissatisfied (Grade 2) or very dissatisfied (Grade 3) at Baseline (Day 1). The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model.
Outcome measures
| Measure |
BTX-A-HAC NG Solution (50 U)
n=125 Participants
Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
|
Placebo
n=59 Participants
Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
|
|---|---|---|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Level of Satisfaction With the Appearance of Their Glabellar Lines.
Day 8
|
72.7 Adjusted percentage of responders
Interval 58.9 to 83.2
|
4.9 Adjusted percentage of responders
Interval 1.6 to 14.5
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Level of Satisfaction With the Appearance of Their Glabellar Lines.
Day 15
|
80.6 Adjusted percentage of responders
Interval 68.4 to 88.9
|
7.9 Adjusted percentage of responders
Interval 3.1 to 19.1
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Level of Satisfaction With the Appearance of Their Glabellar Lines.
Day 29
|
80.9 Adjusted percentage of responders
Interval 68.7 to 89.1
|
8.3 Adjusted percentage of responders
Interval 3.1 to 20.2
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Level of Satisfaction With the Appearance of Their Glabellar Lines.
Day 57
|
74.7 Adjusted percentage of responders
Interval 61.2 to 84.6
|
5.9 Adjusted percentage of responders
Interval 2.1 to 15.3
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Level of Satisfaction With the Appearance of Their Glabellar Lines.
Day 85
|
70.9 Adjusted percentage of responders
Interval 56.1 to 82.3
|
7.3 Adjusted percentage of responders
Interval 2.7 to 18.7
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Level of Satisfaction With the Appearance of Their Glabellar Lines.
Day 113
|
61.9 Adjusted percentage of responders
Interval 48.3 to 73.8
|
9.8 Adjusted percentage of responders
Interval 4.0 to 22.2
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Level of Satisfaction With the Appearance of Their Glabellar Lines.
Day 148
|
58.9 Adjusted percentage of responders
Interval 45.4 to 71.3
|
12.3 Adjusted percentage of responders
Interval 5.0 to 27.3
|
|
The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Level of Satisfaction With the Appearance of Their Glabellar Lines.
Day 183
|
49.8 Adjusted percentage of responders
Interval 36.3 to 63.3
|
11.3 Adjusted percentage of responders
Interval 4.5 to 25.6
|
SECONDARY outcome
Timeframe: Day 1 to 7Population: mITT: All randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. One subject from the placebo group was excluded from the analysis due to missing data.
Median time to onset of treatment response: subjects asked to record their assessment of study treatment response in a diary card on Days 1 to 7. They responded 'yes' or 'no' to the following question: 'since being injected have you noticed an improvement in the appearance of your glabellar lines (lines between your eyebrows)?'
Outcome measures
| Measure |
BTX-A-HAC NG Solution (50 U)
n=125 Participants
Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
|
Placebo
n=58 Participants
Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
|
|---|---|---|
|
The Time to Onset of Treatment Response Based on the Subject's Diary Card.
|
3.0 Days
Interval 2.0 to 3.0
|
NA Days
Median could not be calculated because insufficient number of participants with events in the placebo group (11 events).
|
Adverse Events
BTX-A-HAC NG Solution (50 U)
Serious events: 2 serious events
Other events: 49 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BTX-A-HAC NG Solution (50 U)
n=125 participants at risk
Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
|
Placebo
n=59 participants at risk
Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
|
|---|---|---|
|
Eye disorders
Mydriasis
|
0.80%
1/125 • Number of events 1 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
0.00%
0/59 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/125 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
1.7%
1/59 • Number of events 1 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.80%
1/125 • Number of events 1 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
0.00%
0/59 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
Other adverse events
| Measure |
BTX-A-HAC NG Solution (50 U)
n=125 participants at risk
Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected.
|
Placebo
n=59 participants at risk
Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.0%
10/125 • Number of events 10 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
8.5%
5/59 • Number of events 6 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Infections and infestations
Influenza
|
2.4%
3/125 • Number of events 4 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
5.1%
3/59 • Number of events 3 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Nervous system disorders
Headache
|
14.4%
18/125 • Number of events 27 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
3.4%
2/59 • Number of events 2 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
General disorders
Injection site pain
|
8.0%
10/125 • Number of events 10 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
5.1%
3/59 • Number of events 3 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Infections and infestations
Tonsillitis
|
2.4%
3/125 • Number of events 3 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
0.00%
0/59 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Skin and subcutaneous tissue disorders
Brow ptosis
|
2.4%
3/125 • Number of events 3 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
0.00%
0/59 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Infections and infestations
Cystitis
|
1.6%
2/125 • Number of events 2 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
0.00%
0/59 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Infections and infestations
Gastroenteritis
|
1.6%
2/125 • Number of events 2 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
0.00%
0/59 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Infections and infestations
Oral herpes
|
1.6%
2/125 • Number of events 2 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
0.00%
0/59 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Eye disorders
Eyelid oedema
|
1.6%
2/125 • Number of events 2 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
0.00%
0/59 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Eye disorders
Blepharochalasis
|
1.6%
2/125 • Number of events 2 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
0.00%
0/59 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Infections and infestations
Bronchitis
|
0.80%
1/125 • Number of events 1 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
1.7%
1/59 • Number of events 1 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Infections and infestations
Pharyngitis
|
0.80%
1/125 • Number of events 1 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
1.7%
1/59 • Number of events 1 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Infections and infestations
Sinusitis
|
0.80%
1/125 • Number of events 1 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
1.7%
1/59 • Number of events 1 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/125 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
1.7%
1/59 • Number of events 1 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/125 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
1.7%
1/59 • Number of events 1 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/125 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
1.7%
1/59 • Number of events 1 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Skin and subcutaneous tissue disorders
Pruritis generalised
|
0.00%
0/125 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
1.7%
1/59 • Number of events 1 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/125 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
1.7%
1/59 • Number of events 1 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/125 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
1.7%
1/59 • Number of events 1 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/125 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
1.7%
1/59 • Number of events 1 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Musculoskeletal and connective tissue disorders
Tendon calcification
|
0.00%
0/125 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
1.7%
1/59 • Number of events 1 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/125 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
1.7%
1/59 • Number of events 1 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/125 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
1.7%
1/59 • Number of events 1 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/125 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
1.7%
1/59 • Number of events 1 • Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A plan for scientific publication and presentation of the results could be agreed and implemented by the study investigators or a steering committee. The sponsor required that reasonable opportunity be given to review the content and conclusions of any abstract, presentation, or paper before the material was submitted for publication or communicated. This condition also applied to any amendments that were subsequently requested by referees or journal editors.
- Publication restrictions are in place
Restriction type: OTHER