Trial Outcomes & Findings for Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine (NCT NCT05028569)
NCT ID: NCT05028569
Last Updated: 2025-12-09
Results Overview
The frequency of monthly migraine days across Months 5 and 6 is calculated by taking the 2-month average of monthly migraine days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
775 participants
Primary outcome timeframe
Baseline, Months 5-6
Results posted on
2025-12-09
Participant Flow
This study was conducted at 118 sites in 9 countries and was initiated in November 2021. Adults with episodic migraine (EM) were eligible.
Participants were randomized in a 1:1:1 ratio to receive 2 treatment cycles of BOTOX 195 U, BOTOX 155 U, or placebo. BOTOX (155 U or 195 U) or matching placebo was administered by a trained injector at Day 1 and Week 12 of the Double-Blind Phase. Those who continued to the Open-label Phase received BOTOX 195 U at 12-week intervals for up to 2 treatment cycles.
Participant milestones
| Measure |
Screening/Baseline Phase
Participants with 6 to 14 migraine days and \< 15 headache days per month in each of the 3 months prior to the screening visit (Visit 1) and during the 4-week Screening/Baseline Phase were randomized in this study.
|
Double-Blind Phase: Placebo
Participants randomized to receive placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
|
Double-Blind Phase: BOTOX 155 U
Participants randomized to receive intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
|
Double-Blind Phase: BOTOX 195 U
Participants randomized to receive intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
|
Double-Blind Phase: Placebo/Open-Label Phase: BOTOX 195 U
Participants randomized to receive placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 155 U/Open-Label Phase: BOTOX 195 U
Participants randomized to receive intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 195 U/Open-Label Phase: BOTOX 195 U
Participants randomized to receive intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
|---|---|---|---|---|---|---|---|
|
Screening/Baseline Phase
STARTED
|
775
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screening/Baseline Phase
COMPLETED
|
775
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screening/Baseline Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Phase
STARTED
|
0
|
257
|
257
|
261
|
0
|
0
|
0
|
|
Double-Blind Phase
Received at Least One Dose of Study Treatment
|
0
|
257
|
256
|
261
|
0
|
0
|
0
|
|
Double-Blind Phase
COMPLETED
|
0
|
217
|
230
|
223
|
0
|
0
|
0
|
|
Double-Blind Phase
NOT COMPLETED
|
0
|
40
|
27
|
38
|
0
|
0
|
0
|
|
Open-Label Phase
STARTED
|
0
|
0
|
0
|
0
|
217
|
230
|
223
|
|
Open-Label Phase
COMPLETED
|
0
|
0
|
0
|
0
|
186
|
199
|
192
|
|
Open-Label Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
31
|
31
|
31
|
Reasons for withdrawal
| Measure |
Screening/Baseline Phase
Participants with 6 to 14 migraine days and \< 15 headache days per month in each of the 3 months prior to the screening visit (Visit 1) and during the 4-week Screening/Baseline Phase were randomized in this study.
|
Double-Blind Phase: Placebo
Participants randomized to receive placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
|
Double-Blind Phase: BOTOX 155 U
Participants randomized to receive intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
|
Double-Blind Phase: BOTOX 195 U
Participants randomized to receive intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
|
Double-Blind Phase: Placebo/Open-Label Phase: BOTOX 195 U
Participants randomized to receive placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 155 U/Open-Label Phase: BOTOX 195 U
Participants randomized to receive intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 195 U/Open-Label Phase: BOTOX 195 U
Participants randomized to receive intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
|---|---|---|---|---|---|---|---|
|
Double-Blind Phase
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Double-Blind Phase
Lost to Follow-up
|
0
|
6
|
3
|
9
|
0
|
0
|
0
|
|
Double-Blind Phase
Protocol Deviation
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Phase
Withdrawal by Subject
|
0
|
27
|
20
|
22
|
0
|
0
|
0
|
|
Double-Blind Phase
Other, not specified
|
0
|
5
|
4
|
6
|
0
|
0
|
0
|
|
Open-Label Phase
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Open-Label Phase
Lost to Follow-up
|
0
|
0
|
0
|
0
|
5
|
5
|
4
|
|
Open-Label Phase
Protocol Deviation
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Open-Label Phase
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Open-Label Phase
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
15
|
8
|
13
|
|
Open-Label Phase
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
4
|
10
|
5
|
|
Open-Label Phase
Other, not specified
|
0
|
0
|
0
|
0
|
6
|
5
|
7
|
|
Open-Label Phase
Completed Double-Blind Phase and then withdrew from study
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Open-Label Phase
Completed Double-Blind Phase and then withdrew due to pregnancy
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine
Baseline characteristics by cohort
| Measure |
Double-Blind Phase: BOTOX 195 U
n=261 Participants
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
|
Double-Blind Phase: Placebo
n=257 Participants
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
|
Double-Blind Phase: BOTOX 155 U
n=257 Participants
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
|
Total
n=775 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 10.76 • n=518 Participants
|
40.3 years
STANDARD_DEVIATION 11.12 • n=4 Participants
|
41.1 years
STANDARD_DEVIATION 10.37 • n=50 Participants
|
40.8 years
STANDARD_DEVIATION 10.75 • n=175 Participants
|
|
Sex: Female, Male
Female
|
224 Participants
n=518 Participants
|
231 Participants
n=4 Participants
|
227 Participants
n=50 Participants
|
682 Participants
n=175 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=518 Participants
|
26 Participants
n=4 Participants
|
30 Participants
n=50 Participants
|
93 Participants
n=175 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=518 Participants
|
24 Participants
n=4 Participants
|
30 Participants
n=50 Participants
|
91 Participants
n=175 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
224 Participants
n=518 Participants
|
233 Participants
n=4 Participants
|
227 Participants
n=50 Participants
|
684 Participants
n=175 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=518 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=175 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=518 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=175 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=518 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=50 Participants
|
13 Participants
n=175 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=518 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=175 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=518 Participants
|
23 Participants
n=4 Participants
|
12 Participants
n=50 Participants
|
49 Participants
n=175 Participants
|
|
Race (NIH/OMB)
White
|
237 Participants
n=518 Participants
|
229 Participants
n=4 Participants
|
240 Participants
n=50 Participants
|
706 Participants
n=175 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=518 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
4 Participants
n=175 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=518 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=175 Participants
|
PRIMARY outcome
Timeframe: Baseline, Months 5-6Population: Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)
The frequency of monthly migraine days across Months 5 and 6 is calculated by taking the 2-month average of monthly migraine days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.
Outcome measures
| Measure |
Double-Blind Phase: BOTOX 195 U
n=227 Participants
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
|
Double-Blind Phase: Placebo
n=227 Participants
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
|
Double-Blind Phase: BOTOX 155 U
n=234 Participants
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
|
Double-Blind Phase: Placebo/Open-Label Phase: BOTOX 195 U
Participants who received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 155 U/Open-Label Phase: BOTOX 195 U
Participants who received intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 195 U/Open-Label Phase: BOTOX 195 U
Participants who received intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Frequency of Monthly Migraine Days Across Months 5 and 6
|
-3.0 monthly migraine days
Interval -3.51 to -2.43
|
-3.0 monthly migraine days
Interval -3.55 to -2.46
|
-3.1 monthly migraine days
Interval -3.65 to -2.57
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Double-Blind Phase (Week 0-24); Open-Label Phase (Week 24-48)Population: Safety Analysis Set: all participants who received any amount of study treatment; included in the analysis according to the study treatment that they actually received (as treated).
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 drug. 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 |
Double-Blind Phase: BOTOX 195 U
n=262 Participants
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
|
Double-Blind Phase: Placebo
n=257 Participants
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
|
Double-Blind Phase: BOTOX 155 U
n=255 Participants
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
|
Double-Blind Phase: Placebo/Open-Label Phase: BOTOX 195 U
n=217 Participants
Participants who received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 155 U/Open-Label Phase: BOTOX 195 U
n=225 Participants
Participants who received intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 195 U/Open-Label Phase: BOTOX 195 U
n=223 Participants
Participants who received intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Any TEAE
|
120 Participants
|
106 Participants
|
117 Participants
|
76 Participants
|
75 Participants
|
80 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs)
TESAE
|
6 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Months 5-6Population: Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)
The frequency of monthly headache days across Months 5 and 6 is calculated by taking the 2-month average of monthly headache days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.
Outcome measures
| Measure |
Double-Blind Phase: BOTOX 195 U
n=227 Participants
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
|
Double-Blind Phase: Placebo
n=227 Participants
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
|
Double-Blind Phase: BOTOX 155 U
n=234 Participants
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
|
Double-Blind Phase: Placebo/Open-Label Phase: BOTOX 195 U
Participants who received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 155 U/Open-Label Phase: BOTOX 195 U
Participants who received intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 195 U/Open-Label Phase: BOTOX 195 U
Participants who received intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Frequency of Monthly Headache Days Across Months 5 and 6
|
-2.9 monthly headache days
Interval -3.46 to -2.29
|
-3.2 monthly headache days
Interval -3.77 to -2.59
|
-3.1 monthly headache days
Interval -3.71 to -2.54
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 5-6Population: Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)
The frequency of monthly migraine days across Months 5 and 6 is calculated by taking the 2-month average of monthly migraine days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. The responder status of 50% reduction from Baseline is defined as a participant with at least a 50% reduction from Baseline in the 2-month average of monthly migraine days over Months 5 and 6.
Outcome measures
| Measure |
Double-Blind Phase: BOTOX 195 U
n=227 Participants
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
|
Double-Blind Phase: Placebo
n=227 Participants
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
|
Double-Blind Phase: BOTOX 155 U
n=234 Participants
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
|
Double-Blind Phase: Placebo/Open-Label Phase: BOTOX 195 U
Participants who received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 155 U/Open-Label Phase: BOTOX 195 U
Participants who received intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 195 U/Open-Label Phase: BOTOX 195 U
Participants who received intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With ≥ 50% Reduction From Baseline in the Frequency of Monthly Migraine Days Across Months 5 and 6
|
47.1 percentage of participants
Interval 40.5 to 53.85
|
44.9 percentage of participants
Interval 38.35 to 51.66
|
46.2 percentage of participants
Interval 39.64 to 52.77
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 5-6Population: Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)
Monthly acute headache medication days across Months 5 and 6 is calculated by taking the 2-month average of monthly acute headache medication days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.
Outcome measures
| Measure |
Double-Blind Phase: BOTOX 195 U
n=227 Participants
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
|
Double-Blind Phase: Placebo
n=227 Participants
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
|
Double-Blind Phase: BOTOX 155 U
n=234 Participants
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
|
Double-Blind Phase: Placebo/Open-Label Phase: BOTOX 195 U
Participants who received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 155 U/Open-Label Phase: BOTOX 195 U
Participants who received intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 195 U/Open-Label Phase: BOTOX 195 U
Participants who received intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Frequency of Monthly Acute Headache Medication Days Across Months 5 and 6
|
-1.8 Monthly Acute Headache Medication Days
Interval -2.34 to -1.35
|
-2.0 Monthly Acute Headache Medication Days
Interval -2.47 to -1.47
|
-1.9 Monthly Acute Headache Medication Days
Interval -2.44 to -1.44
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)
The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine over the past 4 weeks. It is divided into 3 domains, and the Role Function Restrictive (RFR) assesses how migraines limit one's daily social and work-related activities using a 6-point scale ranging from "none of the time" to "all of the time". Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. Positive changes from Baseline indicate improvement.
Outcome measures
| Measure |
Double-Blind Phase: BOTOX 195 U
n=218 Participants
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
|
Double-Blind Phase: Placebo
n=216 Participants
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
|
Double-Blind Phase: BOTOX 155 U
n=228 Participants
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
|
Double-Blind Phase: Placebo/Open-Label Phase: BOTOX 195 U
Participants who received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 155 U/Open-Label Phase: BOTOX 195 U
Participants who received intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 195 U/Open-Label Phase: BOTOX 195 U
Participants who received intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score At Month 6
|
19.0 units on a scale
Interval 16.15 to 21.87
|
18.6 units on a scale
Interval 15.77 to 21.51
|
19.4 units on a scale
Interval 16.58 to 22.27
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 5-6Population: Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)
AIM-D Physical Impairment Domain score is calculated based on the summation of AIM-D items 6-9. Participants answer each question based on the level of difficulty experienced in the 24 hours prior, with "during your headache" indicated for when they reported a headache, using a 6-point rating scale ranging from "not difficult at all" to "extremely difficult". The raw daily score is transformed to a 0-100 scale, and the monthly score is calculated using the average daily scores, where a higher score indicates worse physical impairment. AIM-D Physical Impairment domain score across Months 5 and 6 is calculated by taking the 2-month average of AIM-D Physical Impairment domain scores over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.
Outcome measures
| Measure |
Double-Blind Phase: BOTOX 195 U
n=222 Participants
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
|
Double-Blind Phase: Placebo
n=225 Participants
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
|
Double-Blind Phase: BOTOX 155 U
n=232 Participants
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
|
Double-Blind Phase: Placebo/Open-Label Phase: BOTOX 195 U
Participants who received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 155 U/Open-Label Phase: BOTOX 195 U
Participants who received intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 195 U/Open-Label Phase: BOTOX 195 U
Participants who received intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Activity Impairment in Migraine - Diary (AIM-D) Physical Impairment Domain Score Across Months 5 and 6
|
-4.9 units on a scale
Interval -6.07 to -3.66
|
-5.0 units on a scale
Interval -6.23 to -3.82
|
-4.6 units on a scale
Interval -5.82 to -3.39
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 5-6Population: Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)
The HIT-6 is a 6-item assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home and in social situations. It assesses the effect that headaches have on normal daily life and the subject's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses, each of which is assigned a score ranging from 6 points (never) to 13 points (always). The Total 6-item Headache Impact Test (HIT-6) score across Months 5 and 6 is calculated by taking the 2-month average of total 6-item Headache Impact Test (HIT-6) scores over Months 5 and 6. Negative changes from Baseline in the HIT-6 score indicate improvement.
Outcome measures
| Measure |
Double-Blind Phase: BOTOX 195 U
n=229 Participants
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
|
Double-Blind Phase: Placebo
n=228 Participants
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
|
Double-Blind Phase: BOTOX 155 U
n=238 Participants
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
|
Double-Blind Phase: Placebo/Open-Label Phase: BOTOX 195 U
Participants who received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 155 U/Open-Label Phase: BOTOX 195 U
Participants who received intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 195 U/Open-Label Phase: BOTOX 195 U
Participants who received intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in the Total 6-item Headache Impact Test (HIT-6) Score Across Months 5 and 6
|
-6.5 units on a scale
Interval -7.62 to -5.45
|
-6.2 units on a scale
Interval -7.26 to -5.08
|
-6.9 units on a scale
Interval -7.94 to -5.77
|
—
|
—
|
—
|
Adverse Events
Double-Blind Phase: BOTOX 155 U
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Double-Blind Phase: BOTOX 195 U
Serious events: 6 serious events
Other events: 22 other events
Deaths: 1 deaths
Screening/Baseline Phase
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Double-Blind Phase: Placebo
Serious events: 6 serious events
Other events: 21 other events
Deaths: 0 deaths
Double-Blind Phase: Placebo/Open-Label Phase: BOTOX 195 U
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Double-Blind Phase: BOTOX 155 U/Open-Label Phase: BOTOX 195 U
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Double-Blind Phase: BOTOX 195 U/Open-Label Phase: BOTOX 195 U
Serious events: 1 serious events
Other events: 14 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Double-Blind Phase: BOTOX 155 U
n=256 participants at risk
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
|
Double-Blind Phase: BOTOX 195 U
n=262 participants at risk
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
|
Screening/Baseline Phase
n=775 participants at risk
Participants with 6 to 14 migraine days and \< 15 headache days per month in each of the 3 months prior to the screening visit (Visit 1) and during the 4-week Screening/Baseline Phase were randomized in this study.
|
Double-Blind Phase: Placebo
n=257 participants at risk
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
|
Double-Blind Phase: Placebo/Open-Label Phase: BOTOX 195 U
n=217 participants at risk
Participants who received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 155 U/Open-Label Phase: BOTOX 195 U
n=227 participants at risk
Participants who received intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 195 U/Open-Label Phase: BOTOX 195 U
n=223 participants at risk
Participants who received intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
IMMUNE THROMBOCYTOPENIA
|
0.00%
0/256 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.38%
1/262 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/775 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/257 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/217 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/227 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/223 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
|
Ear and labyrinth disorders
VESTIBULAR DISORDER
|
0.00%
0/256 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/262 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.13%
1/775 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/257 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/217 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/227 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/223 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
|
Hepatobiliary disorders
PORTOSPLENOMESENTERIC VENOUS THROMBOSIS
|
0.00%
0/256 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.38%
1/262 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/775 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/257 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/217 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/227 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/223 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
|
Infections and infestations
STAPHYLOCOCCAL ABSCESS
|
0.00%
0/256 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.38%
1/262 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/775 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/257 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/217 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/227 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/223 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/256 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/262 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/775 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/257 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.46%
1/217 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/227 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/223 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/256 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/262 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/775 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.39%
1/257 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/217 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/227 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/223 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMATOMA
|
0.39%
1/256 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/262 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/775 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/257 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/217 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/227 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/223 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.39%
1/256 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/262 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/775 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.39%
1/257 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/217 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/227 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/223 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIPOSARCOMA
|
0.00%
0/256 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/262 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/775 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.39%
1/257 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/217 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/227 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/223 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/256 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/262 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/775 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/257 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.46%
1/217 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.44%
1/227 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/223 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
|
Nervous system disorders
MIGRAINE WITH AURA
|
0.00%
0/256 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.38%
1/262 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/775 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/257 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/217 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/227 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/223 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
|
Nervous system disorders
MYELOPATHY
|
0.00%
0/256 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/262 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/775 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.39%
1/257 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/217 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/227 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/223 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/256 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/262 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/775 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.39%
1/257 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/217 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/227 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/223 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.00%
0/256 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/262 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/775 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/257 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/217 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/227 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.45%
1/223 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.39%
1/256 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/262 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/775 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/257 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/217 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/227 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/223 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
|
Reproductive system and breast disorders
BREAST HYPERPLASIA
|
0.00%
0/256 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.38%
1/262 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/775 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/257 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/217 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/227 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/223 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/256 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.38%
1/262 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/775 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/257 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/217 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/227 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/223 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
|
Surgical and medical procedures
ABORTION INDUCED
|
0.00%
0/256 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/262 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/775 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.39%
1/257 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/217 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/227 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/223 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/256 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/262 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.13%
1/775 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/257 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/217 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/227 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/223 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
|
Vascular disorders
LABILE BLOOD PRESSURE
|
0.00%
0/256 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.38%
1/262 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/775 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/257 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/217 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/227 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.00%
0/223 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
Other adverse events
| Measure |
Double-Blind Phase: BOTOX 155 U
n=256 participants at risk
Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.
|
Double-Blind Phase: BOTOX 195 U
n=262 participants at risk
Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.
|
Screening/Baseline Phase
n=775 participants at risk
Participants with 6 to 14 migraine days and \< 15 headache days per month in each of the 3 months prior to the screening visit (Visit 1) and during the 4-week Screening/Baseline Phase were randomized in this study.
|
Double-Blind Phase: Placebo
n=257 participants at risk
Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.
|
Double-Blind Phase: Placebo/Open-Label Phase: BOTOX 195 U
n=217 participants at risk
Participants who received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 155 U/Open-Label Phase: BOTOX 195 U
n=227 participants at risk
Participants who received intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
Double-Blind Phase: BOTOX 195 U/Open-Label Phase: BOTOX 195 U
n=223 participants at risk
Participants who received intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
6.2%
16/256 • Number of events 16 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
3.1%
8/262 • Number of events 8 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
0.52%
4/775 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
3.5%
9/257 • Number of events 9 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
5.5%
12/217 • Number of events 12 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
4.0%
9/227 • Number of events 9 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
3.1%
7/223 • Number of events 7 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
|
Infections and infestations
NASOPHARYNGITIS
|
9.0%
23/256 • Number of events 26 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
5.7%
15/262 • Number of events 18 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
1.3%
10/775 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
5.4%
14/257 • Number of events 15 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
3.2%
7/217 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
4.4%
10/227 • Number of events 12 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
3.6%
8/223 • Number of events 8 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER