Trial Outcomes & Findings for A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines (NCT NCT05100199)
NCT ID: NCT05100199
Last Updated: 2025-09-09
Results Overview
The Clinician Glabellar Lines Scale is a four point scale used to assess the severity of Glabellar Lines at maximum contraction ranging from 0 - None to 3 - Severe
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
328 participants
Primary outcome timeframe
Day 1 to Day 30
Results posted on
2025-09-09
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo will be injected into the Glabellar Complex on Day 1.
Placebo: Injection
|
OnabotulinumtoxinA X Dose A
OnabotulinumtoxinA X Dose A will be injected into the Glabellar Complex on Day 1.
OnabotulinumtoxinA X: Injection
|
OnabotulinumtoxinA X Dose B
OnabotulinumtoxinA X Dose B will be injected into the Glabellar Complex on Day 1.
OnabotulinumtoxinA X: Injection
|
OnabotulinumtoxinA X Dose C
OnabotulinumtoxinA X Dose C will be injected into the Glabellar Complex on Day 1.
OnabotulinumtoxinA X: Injection
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
45
|
90
|
92
|
101
|
|
Overall Study
COMPLETED
|
37
|
79
|
79
|
87
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
13
|
14
|
Reasons for withdrawal
| Measure |
Placebo
Placebo will be injected into the Glabellar Complex on Day 1.
Placebo: Injection
|
OnabotulinumtoxinA X Dose A
OnabotulinumtoxinA X Dose A will be injected into the Glabellar Complex on Day 1.
OnabotulinumtoxinA X: Injection
|
OnabotulinumtoxinA X Dose B
OnabotulinumtoxinA X Dose B will be injected into the Glabellar Complex on Day 1.
OnabotulinumtoxinA X: Injection
|
OnabotulinumtoxinA X Dose C
OnabotulinumtoxinA X Dose C will be injected into the Glabellar Complex on Day 1.
OnabotulinumtoxinA X: Injection
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
8
|
3
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
9
|
7
|
|
Overall Study
Other
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines
Baseline characteristics by cohort
| Measure |
Placebo
n=45 Participants
Placebo was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose A
n=90 Participants
OnabotulinumtoxinA X Dose A was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose B
n=92 Participants
OnabotulinumtoxinA X Dose B was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose C
n=101 Participants
OnabotulinumtoxinA X Dose C was injected into the Glabellar Complex on Day 1.
|
Total
n=328 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.1 years
STANDARD_DEVIATION 12.16 • n=5 Participants
|
49.3 years
STANDARD_DEVIATION 12.19 • n=7 Participants
|
46.9 years
STANDARD_DEVIATION 11.35 • n=5 Participants
|
50.4 years
STANDARD_DEVIATION 13.34 • n=4 Participants
|
48.8 years
STANDARD_DEVIATION 12.35 • n=21 Participants
|
|
Age, Customized
18-25 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Age, Customized
26-40 years
|
9 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
|
Age, Customized
41-55 years
|
25 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
153 Participants
n=21 Participants
|
|
Age, Customized
56-64 years
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Age, Customized
≥65 years
|
4 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
282 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
270 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
290 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 30Population: Multiple Imputation - Intent-to-Treat Population Estimated responder is the average number of responders across 5 imputed datasets. Confidence interval for responder rate is calculated using normal approximation.
The Clinician Glabellar Lines Scale is a four point scale used to assess the severity of Glabellar Lines at maximum contraction ranging from 0 - None to 3 - Severe
Outcome measures
| Measure |
Placebo
n=45 Participants
Placebo was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose A
n=90 Participants
OnabotulinumtoxinA X Dose A was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose B
n=92 Participants
OnabotulinumtoxinA X Dose B was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose C
n=101 Participants
OnabotulinumtoxinA X Dose C was injected into the Glabellar Complex on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline as Rated by Investigator Using the Clinician Glabellar Lines Scale.
|
17.8 percentage of participants
Interval 6.6 to 28.9
|
95.6 percentage of participants
Interval 91.3 to 99.8
|
98.9 percentage of participants
Interval 96.8 to 100.0
|
98.0 percentage of participants
Interval 95.3 to 100.0
|
PRIMARY outcome
Timeframe: Day 1 to Day 270Population: All participants who received at least 1 dose of study drug.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Outcome measures
| Measure |
Placebo
n=45 Participants
Placebo was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose A
n=90 Participants
OnabotulinumtoxinA X Dose A was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose B
n=91 Participants
OnabotulinumtoxinA X Dose B was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose C
n=99 Participants
OnabotulinumtoxinA X Dose C was injected into the Glabellar Complex on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
Treatment-Emergent Adverse Events (TEAE)
|
23 Participants
|
34 Participants
|
30 Participants
|
44 Participants
|
|
Percentage of Participants With Adverse Events (AEs)
TEAE Related to Study Treatment
|
7 Participants
|
13 Participants
|
10 Participants
|
15 Participants
|
|
Percentage of Participants With Adverse Events (AEs)
TEAE Related to Study Procedure
|
7 Participants
|
10 Participants
|
10 Participants
|
14 Participants
|
|
Percentage of Participants With Adverse Events (AEs)
TEAE Related to Study Drug
|
7 Participants
|
13 Participants
|
10 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 30Population: Multiple Imputation - Intent-to-Treat Population Estimated responder is the average number of responders across 5 imputed datasets. Confidence interval for responder rate is calculated using normal approximation.
The Clinician Glabellar Lines Scale is a four point scale used to assess the severity of Glabellar Lines at maximum contraction ranging from 0 - None to 3 - Severe
Outcome measures
| Measure |
Placebo
n=45 Participants
Placebo was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose A
n=90 Participants
OnabotulinumtoxinA X Dose A was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose B
n=92 Participants
OnabotulinumtoxinA X Dose B was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose C
n=101 Participants
OnabotulinumtoxinA X Dose C was injected into the Glabellar Complex on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Achievement of None or Mild as Rated by Investigator Using the Clinician Glabellar Lines Scale.
|
6.7 percentage of participants
Interval 0.0 to 14.0
|
90.0 percentage of participants
Interval 83.8 to 96.2
|
93.5 percentage of participants
Interval 88.4 to 98.5
|
95.0 percentage of participants
Interval 90.8 to 99.3
|
SECONDARY outcome
Timeframe: Day 1 to Day 30Population: Multiple Imputation - Intent-to-Treat Population Estimated responder is the average number of responders across 5 imputed datasets. Confidence interval for responder rate is calculated using normal approximation.
The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective. Domain scores are calculated as the mean of transformed item scores on a 0 (low impact) to 100 (highest negative impact) scale.
Outcome measures
| Measure |
Placebo
n=45 Participants
Placebo was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose A
n=90 Participants
OnabotulinumtoxinA X Dose A was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose B
n=92 Participants
OnabotulinumtoxinA X Dose B was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose C
n=101 Participants
OnabotulinumtoxinA X Dose C was injected into the Glabellar Complex on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Achievement of Improvement Per the Facial Lines Satisfaction Questionnaire Impact Domain, Among Subjects With Baseline Scores of 14 Points or Greater.
|
42.2 percentage of participants
Interval 27.8 to 56.7
|
65.6 percentage of participants
Interval 55.7 to 75.4
|
71.7 percentage of participants
Interval 62.5 to 80.9
|
73.3 percentage of participants
Interval 64.6 to 81.9
|
SECONDARY outcome
Timeframe: Day 1 to Day 60Population: Multiple Imputation - Intent-to-Treat Population Estimated responder is the average number of responders across 5 imputed datasets. Confidence interval for responder rate is calculated using normal approximation.
The Facial Line Satisfaction Questionnaire assesses treatment expectations, treatment satisfaction, and psychosocial impact of GL from the subject perspective. A score of 100 represents the best score (very satisfied) and a score of 0 represent the worst score (very dissatisfied) on the satisfaction domain or satisfaction single items.
Outcome measures
| Measure |
Placebo
n=45 Participants
Placebo was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose A
n=90 Participants
OnabotulinumtoxinA X Dose A was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose B
n=92 Participants
OnabotulinumtoxinA X Dose B was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose C
n=101 Participants
OnabotulinumtoxinA X Dose C was injected into the Glabellar Complex on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Achievement of Satisfaction With Treatment Per the Facial Line Satisfaction Questionnaire Item 5.
|
4.4 percentage of participants
Interval 0.0 to 10.5
|
80.0 percentage of participants
Interval 71.7 to 88.3
|
78.3 percentage of participants
Interval 69.8 to 86.7
|
87.1 percentage of participants
Interval 80.6 to 93.7
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
OnabotulinumtoxinA X Dose A
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
OnabotulinumtoxinA X Dose B
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
OnabotulinumtoxinA X Dose C
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=45 participants at risk
Placebo was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose A
n=90 participants at risk
OnabotulinumtoxinA X Dose A was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose B
n=91 participants at risk
OnabotulinumtoxinA X Dose B was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose C
n=99 participants at risk
OnabotulinumtoxinA X Dose C was injected into the Glabellar Complex on Day 1.
|
|---|---|---|---|---|
|
Cardiac disorders
BUNDLE BRANCH BLOCK RIGHT
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
1.1%
1/90 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/99 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
|
Infections and infestations
AMNIOTIC CAVITY INFECTION
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
1.0%
1/99 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
1.0%
1/99 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE DUCTAL BREAST CARCINOMA
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/99 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
|
Nervous system disorders
INTRACRANIAL ANEURYSM
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
1.0%
1/99 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/90 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
0.00%
0/91 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
1.0%
1/99 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
Other adverse events
| Measure |
Placebo
n=45 participants at risk
Placebo was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose A
n=90 participants at risk
OnabotulinumtoxinA X Dose A was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose B
n=91 participants at risk
OnabotulinumtoxinA X Dose B was injected into the Glabellar Complex on Day 1.
|
OnabotulinumtoxinA X Dose C
n=99 participants at risk
OnabotulinumtoxinA X Dose C was injected into the Glabellar Complex on Day 1.
|
|---|---|---|---|---|
|
Eye disorders
EYELID PTOSIS
|
0.00%
0/45 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
2.2%
2/90 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
1.1%
1/91 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
8.1%
8/99 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
|
General disorders
INJECTION SITE OEDEMA
|
2.2%
1/45 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
5.6%
5/90 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
2.2%
2/91 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
4.0%
4/99 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
|
General disorders
INJECTION SITE PAIN
|
8.9%
4/45 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
4.4%
4/90 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
5.5%
5/91 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
5.1%
5/99 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
|
Infections and infestations
COVID-19
|
17.8%
8/45 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
10.0%
9/90 • Number of events 9 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
9.9%
9/91 • Number of events 9 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
8.1%
8/99 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 268, 267, 269, and 269 days for Placebo, OnabotulinumtoxinA X Dose A, Dose B and Dose C, respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place