Trial Outcomes & Findings for MDs on Botox Utility (MOBILITY) (NCT NCT00535938)
NCT ID: NCT00535938
Last Updated: 2014-09-10
Results Overview
Cervical dystonia is a condition in which the neck muscles contract involuntarily, causing the head to turn to one side, forward or backward. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 505 days for patients with cervical dystonia.
COMPLETED
1372 participants
Baseline, SV1 (up to 505 days)
2014-09-10
Participant Flow
Participant milestones
| Measure |
Naïve to Botox® Treatment
Initiating treatment with BOTOX® upon entry to the project.
|
Non-naïve to Botox® Treatment
Receiving ongoing treatment with BOTOX® upon entry to the project.
|
|---|---|---|
|
Overall Study
STARTED
|
506
|
866
|
|
Overall Study
COMPLETED
|
115
|
404
|
|
Overall Study
NOT COMPLETED
|
391
|
462
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MDs on Botox Utility (MOBILITY)
Baseline characteristics by cohort
| Measure |
Naïve to Botox® Treatment
n=506 Participants
Initiating treatment with BOTOX® upon entry to the project.
|
Non-naïve to Botox® Treatment
n=866 Participants
Receiving ongoing treatment with BOTOX® upon entry to the project.
|
Total
n=1372 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
14 to 17 years
|
22 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Customized
18 to 65 years
|
374 Participants
n=5 Participants
|
641 Participants
n=7 Participants
|
1015 Participants
n=5 Participants
|
|
Age, Customized
>65 years
|
110 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
307 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
304 Participants
n=5 Participants
|
577 Participants
n=7 Participants
|
881 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
202 Participants
n=5 Participants
|
289 Participants
n=7 Participants
|
491 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, SV1 (up to 505 days)Population: Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point
Cervical dystonia is a condition in which the neck muscles contract involuntarily, causing the head to turn to one side, forward or backward. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 505 days for patients with cervical dystonia.
Outcome measures
| Measure |
Naïve to Botox® Treatment
n=44 Participants
Initiating treatment with BOTOX® upon entry to the project.
|
Non-naïve to Botox® Treatment
n=186 Participants
Receiving ongoing treatment with BOTOX® upon entry to the project.
|
|---|---|---|
|
Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia
Baseline
|
0.650 Scores on a Scale
Standard Deviation 0.154
|
0.676 Scores on a Scale
Standard Deviation 0.143
|
|
Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia
Change from Baseline at SV1 (N=33,174)
|
0.020 Scores on a Scale
Standard Deviation 0.084
|
-0.001 Scores on a Scale
Standard Deviation 0.104
|
PRIMARY outcome
Timeframe: Baseline, SV1 (up to 542 days)Population: Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point
Blepharospasm is a condition in which the eyelids blink/close involuntarily. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 542 days for patients with blepharospasm.
Outcome measures
| Measure |
Naïve to Botox® Treatment
n=23 Participants
Initiating treatment with BOTOX® upon entry to the project.
|
Non-naïve to Botox® Treatment
n=56 Participants
Receiving ongoing treatment with BOTOX® upon entry to the project.
|
|---|---|---|
|
Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm
Baseline
|
0.718 Scores on a Scale
Standard Deviation 0.122
|
0.754 Scores on a Scale
Standard Deviation 0.132
|
|
Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm
Change from Baseline at SV1 (N=21, 51)
|
0.053 Scores on a Scale
Standard Deviation 0.156
|
0.014 Scores on a Scale
Standard Deviation 0.120
|
PRIMARY outcome
Timeframe: Baseline, SV1 (up to 1,273 days)Population: Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point
Hyperhidrosis is a condition causing excessive sweating, regardless of temperature or exercise. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 1,273 days for patients with hyperhidrosis.
Outcome measures
| Measure |
Naïve to Botox® Treatment
n=101 Participants
Initiating treatment with BOTOX® upon entry to the project.
|
Non-naïve to Botox® Treatment
n=107 Participants
Receiving ongoing treatment with BOTOX® upon entry to the project.
|
|---|---|---|
|
Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis
Baseline
|
0.782 Scores on a Scale
Standard Deviation 0.129
|
0.799 Scores on a Scale
Standard Deviation 0.115
|
|
Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis
Change from Baseline at SV1 (N=58, 60)
|
0.010 Scores on a Scale
Standard Deviation 0.136
|
-0.000 Scores on a Scale
Standard Deviation 0.124
|
PRIMARY outcome
Timeframe: Baseline, SV1 (up to 925 days)Population: Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point
Cerebral Palsy is a disability resulting in muscular incoordination and speech disturbances. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 925 days for patients with cerebral palsy.
Outcome measures
| Measure |
Naïve to Botox® Treatment
n=3 Participants
Initiating treatment with BOTOX® upon entry to the project.
|
Non-naïve to Botox® Treatment
n=15 Participants
Receiving ongoing treatment with BOTOX® upon entry to the project.
|
|---|---|---|
|
Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cerebral Palsy
Baseline
|
0.712 Scores on a Scale
Standard Deviation 0.131
|
0.733 Scores on a Scale
Standard Deviation 0.117
|
|
Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cerebral Palsy
Change from Baseline at SV1 (N=0, 8)
|
NA Scores on a Scale
Standard Deviation NA
No patients had data at this time point.
|
0.018 Scores on a Scale
Standard Deviation 0.114
|
PRIMARY outcome
Timeframe: Baseline, SV1 (up to 1,562 days)Population: Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point
Adult Focal Spasticity is a condition in which muscles are continuously tight or stiff in a certain area. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 1,562 days for patients with adult focal spasticity.
Outcome measures
| Measure |
Naïve to Botox® Treatment
n=149 Participants
Initiating treatment with BOTOX® upon entry to the project.
|
Non-naïve to Botox® Treatment
n=241 Participants
Receiving ongoing treatment with BOTOX® upon entry to the project.
|
|---|---|---|
|
Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Adult Focal Spasticity
Baseline
|
0.621 Scores on a Scale
Standard Deviation 0.111
|
0.635 Scores on a Scale
Standard Deviation 0.124
|
|
Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Adult Focal Spasticity
Change from Baseline at Week 4 (N=114, 201)
|
0.002 Scores on a Scale
Standard Deviation 0.096
|
0.008 Scores on a Scale
Standard Deviation 0.096
|
PRIMARY outcome
Timeframe: Baseline, SV1 (up to 765 days)Population: Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point
Facial nerve disorder is a condition causing twitching, weakness or paralysis of the face. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person's preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 765 days for patients with facial nerve disorder.
Outcome measures
| Measure |
Naïve to Botox® Treatment
n=38 Participants
Initiating treatment with BOTOX® upon entry to the project.
|
Non-naïve to Botox® Treatment
n=77 Participants
Receiving ongoing treatment with BOTOX® upon entry to the project.
|
|---|---|---|
|
Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Facial Nerve Disorder
Baseline
|
0.770 Scores on a Scale
Standard Deviation 0.134
|
0.759 Scores on a Scale
Standard Deviation 0.134
|
|
Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Facial Nerve Disorder
Change from Baseline at SV1 (N=30, 63)
|
0.035 Scores on a Scale
Standard Deviation 0.158
|
0.002 Scores on a Scale
Standard Deviation 0.111
|
PRIMARY outcome
Timeframe: Baseline, SV1 (up to 568 days)Population: Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point
"Other" disorders include focal dystonia (involuntary muscular contractions/abnormal postures), headache, pain, tics (sudden, repetitive, nonrhythmic movements/vocalizations), tremors (unintentional, rhythmic muscle movements), and other nonspecified disorders. The SF-12 is 12 questions on various health questions. Health utility is a numerical indicator of a person's preference for a given health state or health outcome. Health utility is a sub-score ranging from 0(death) to 1(perfect health) calculated from the SF-12 total score based on: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and SV1 is scheduled at the physician's discretion and was a maximum of 568 days for patients with "other" disorders.
Outcome measures
| Measure |
Naïve to Botox® Treatment
n=47 Participants
Initiating treatment with BOTOX® upon entry to the project.
|
Non-naïve to Botox® Treatment
n=84 Participants
Receiving ongoing treatment with BOTOX® upon entry to the project.
|
|---|---|---|
|
Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With "Other" Disorders
Baseline
|
0.570 Scores on a Scale
Standard Deviation 0.137
|
0.610 Scores on a Scale
Standard Deviation 0.118
|
|
Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With "Other" Disorders
Change from Baseline at SV1 (N=33, 72)
|
0.060 Scores on a Scale
Standard Deviation 0.086
|
0.028 Scores on a Scale
Standard Deviation 0.113
|
SECONDARY outcome
Timeframe: Baseline, SV1 (up to 505 days)Population: Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point
Cervical dystonia is a condition in which the neck muscles contract involuntarily, causing the head to turn to one side, forward or backward. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 505 days for patients with cervical dystonia.
Outcome measures
| Measure |
Naïve to Botox® Treatment
n=48 Participants
Initiating treatment with BOTOX® upon entry to the project.
|
Non-naïve to Botox® Treatment
n=202 Participants
Receiving ongoing treatment with BOTOX® upon entry to the project.
|
|---|---|---|
|
BOTOX® Dose in Patients With Cervical Dystonia
Baseline
|
154.8 Units
Standard Deviation 61.1
|
242.7 Units
Standard Deviation 99.6
|
|
BOTOX® Dose in Patients With Cervical Dystonia
SV1 (N=37, 187)
|
169.9 Units
Standard Deviation 70.2
|
246.4 Units
Standard Deviation 101.7
|
SECONDARY outcome
Timeframe: Baseline, SV1 (up to 542 days)Population: Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point
Blepharospasm is a condition in which the eyelids blink/close involuntarily. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 542 days for patients with blepharospasm.
Outcome measures
| Measure |
Naïve to Botox® Treatment
n=24 Participants
Initiating treatment with BOTOX® upon entry to the project.
|
Non-naïve to Botox® Treatment
n=59 Participants
Receiving ongoing treatment with BOTOX® upon entry to the project.
|
|---|---|---|
|
BOTOX® Dose in Patients With Blepharospasm
Baseline
|
42.9 Units
Standard Deviation 13.8
|
67.3 Units
Standard Deviation 54.3
|
|
BOTOX® Dose in Patients With Blepharospasm
SV1 (N=23, 54)
|
47.8 Units
Standard Deviation 22.7
|
61.9 Units
Standard Deviation 39.5
|
SECONDARY outcome
Timeframe: Baseline, SV1 (up to 1,273 days)Population: Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point
Hyperhidrosis is a condition causing excessive sweating, regardless of temperature or exercise. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 1,273 days for patients with hyperhidrosis.
Outcome measures
| Measure |
Naïve to Botox® Treatment
n=151 Participants
Initiating treatment with BOTOX® upon entry to the project.
|
Non-naïve to Botox® Treatment
n=137 Participants
Receiving ongoing treatment with BOTOX® upon entry to the project.
|
|---|---|---|
|
BOTOX® Dose in Patients With Hyperhidrosis
Baseline
|
192.5 Units
Standard Deviation 60.4
|
203.6 Units
Standard Deviation 74.8
|
|
BOTOX® Dose in Patients With Hyperhidrosis
SV1 (N=80, 97)
|
186.9 Units
Standard Deviation 53.8
|
206.5 Units
Standard Deviation 81.6
|
SECONDARY outcome
Timeframe: Baseline, SV1 (up to 1,562 days)Population: Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point
Adult Focal Spasticity is a condition in which muscles are continuously tight or stiff in a certain area. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 1,562 days for patients with adult focal spasticity.
Outcome measures
| Measure |
Naïve to Botox® Treatment
n=178 Participants
Initiating treatment with BOTOX® upon entry to the project.
|
Non-naïve to Botox® Treatment
n=274 Participants
Receiving ongoing treatment with BOTOX® upon entry to the project.
|
|---|---|---|
|
BOTOX® Dose in Patients With Adult Focal Spasticity
Baseline
|
253.0 Units
Standard Deviation 132.6
|
346.4 Units
Standard Deviation 157.4
|
|
BOTOX® Dose in Patients With Adult Focal Spasticity
SV1 (N=127, 225)
|
295.4 Units
Standard Deviation 152.4
|
355.8 Units
Standard Deviation 150.2
|
SECONDARY outcome
Timeframe: Baseline, SV1 (up to 925 days)Population: Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point
Cerebral Palsy is a disability resulting in muscular incoordination and speech disturbances. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 925 days for patients with cerebral palsy.
Outcome measures
| Measure |
Naïve to Botox® Treatment
n=5 Participants
Initiating treatment with BOTOX® upon entry to the project.
|
Non-naïve to Botox® Treatment
n=22 Participants
Receiving ongoing treatment with BOTOX® upon entry to the project.
|
|---|---|---|
|
BOTOX® Dose in Patients With Cerebral Palsy
Baseline
|
260.0 Units
Standard Deviation 89.4
|
245.5 Units
Standard Deviation 101.1
|
|
BOTOX® Dose in Patients With Cerebral Palsy
SV1 (N=1, 12)
|
200.0 Units
Standard Deviation NA
Standard deviation is not available as only 1 patient had data at this time point.
|
252.5 Units
Standard Deviation 105.2
|
SECONDARY outcome
Timeframe: Baseline, SV1 (up to 765 days)Population: Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point
Facial nerve disorder is a condition causing twitching, weakness or paralysis of the face. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 765 days for patients with facial nerve disorder.
Outcome measures
| Measure |
Naïve to Botox® Treatment
n=42 Participants
Initiating treatment with BOTOX® upon entry to the project.
|
Non-naïve to Botox® Treatment
n=80 Participants
Receiving ongoing treatment with BOTOX® upon entry to the project.
|
|---|---|---|
|
BOTOX® Dose in Patients With Facial Nerve Disorder
Baseline
|
31.3 Units
Standard Deviation 13.7
|
40.6 Units
Standard Deviation 25.4
|
|
BOTOX® Dose in Patients With Facial Nerve Disorder
SV1 (N=31, 69)
|
30.9 Units
Standard Deviation 13.4
|
44.1 Units
Standard Deviation 31.2
|
SECONDARY outcome
Timeframe: Baseline, SV1 (up to 568 days)Population: Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point
"Other" disorders include focal dystonia (involuntary muscular contractions/abnormal postures), headache, pain, tics (sudden, repetitive, nonrhythmic movements/vocalizations), tremors (unintentional, rhythmic muscle movements), and other nonspecified disorders. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician's discretion and was a maximum of 568 days for patients with "other" disorders.
Outcome measures
| Measure |
Naïve to Botox® Treatment
n=58 Participants
Initiating treatment with BOTOX® upon entry to the project.
|
Non-naïve to Botox® Treatment
n=92 Participants
Receiving ongoing treatment with BOTOX® upon entry to the project.
|
|---|---|---|
|
BOTOX® Dose in Patients With "Other" Disorders
Baseline
|
157.2 Units
Standard Deviation 82.4
|
187.2 Units
Standard Deviation 106.8
|
|
BOTOX® Dose in Patients With "Other" Disorders
SV1 (N=40, 75)
|
173.4 Units
Standard Deviation 106.9
|
185.7 Units
Standard Deviation 110.1
|
SECONDARY outcome
Timeframe: Up to 1,785 daysPopulation: Enrolled Cohort: All patients enrolled in the study
Resource utilization patterns are assessed in terms of concurrent procedures utilized during the study (up to 1,785 days across all indications) and are grouped by highest level term. (Note: NEC=not elsewhere classified)
Outcome measures
| Measure |
Naïve to Botox® Treatment
n=506 Participants
Initiating treatment with BOTOX® upon entry to the project.
|
Non-naïve to Botox® Treatment
n=866 Participants
Receiving ongoing treatment with BOTOX® upon entry to the project.
|
|---|---|---|
|
Concurrent Procedure Resource Utilization Patterns
Bone and joint therapeutic procedures
|
0 Patients
|
3 Patients
|
|
Concurrent Procedure Resource Utilization Patterns
Economic and housing issues
|
2 Patients
|
1 Patients
|
|
Concurrent Procedure Resource Utilization Patterns
Eye therapeutic procedures
|
1 Patients
|
0 Patients
|
|
Concurrent Procedure Resource Utilization Patterns
Lifestyle issues
|
3 Patients
|
9 Patients
|
|
Concurrent Procedure Resource Utilization Patterns
Therapeutic procedures and supportive care NEC
|
41 Patients
|
69 Patients
|
SECONDARY outcome
Timeframe: Up to 1,785 daysPopulation: Enrolled Cohort: All patients enrolled in the study
Resource utilization patterns are assessed in terms of concurrent surgical procedures utilized during the study (up to 1,785 days across all indications) and are grouped by highest level term. (Note: NEC=not elsewhere classified)
Outcome measures
| Measure |
Naïve to Botox® Treatment
n=506 Participants
Initiating treatment with BOTOX® upon entry to the project.
|
Non-naïve to Botox® Treatment
n=866 Participants
Receiving ongoing treatment with BOTOX® upon entry to the project.
|
|---|---|---|
|
Concurrent Surgical Procedure Resource Utilization Patterns
Bone and joint therapeutic procedures
|
2 Patients
|
6 Patients
|
|
Concurrent Surgical Procedure Resource Utilization Patterns
Eye therapeutic procedures
|
1 Patients
|
2 Patients
|
|
Concurrent Surgical Procedure Resource Utilization Patterns
Gastrointestinal therapeutic procedures
|
0 Patients
|
1 Patients
|
|
Concurrent Surgical Procedure Resource Utilization Patterns
Head and neck therapeutic procedures
|
0 Patients
|
1 Patients
|
|
Concurrent Surgical Procedure Resource Utilization Patterns
Nervous system, skull&spine therapeutic procedures
|
2 Patients
|
6 Patients
|
|
Concurrent Surgical Procedure Resource Utilization Patterns
Renal/urinary tract investigations & urinalyses
|
1 Patients
|
0 Patients
|
|
Concurrent Surgical Procedure Resource Utilization Patterns
Renal and urinary tract therapeutic procedures
|
0 Patients
|
1 Patients
|
|
Concurrent Surgical Procedure Resource Utilization Patterns
Skin appendage conditions
|
0 Patients
|
1 Patients
|
|
Concurrent Surgical Procedure Resource Utilization Patterns
Soft tissue therapeutic procedures
|
2 Patients
|
6 Patients
|
|
Concurrent Surgical Procedure Resource Utilization Patterns
Therapeutic procedures and supportive care NEC
|
1 Patients
|
1 Patients
|
|
Concurrent Surgical Procedure Resource Utilization Patterns
Vascular therapeutic procedures
|
0 Patients
|
1 Patients
|
Adverse Events
Naïve to Botox® Treatment
Non-naïve to Botox® Treatment
Serious adverse events
| Measure |
Naïve to Botox® Treatment
n=506 participants at risk
Initiating treatment with BOTOX® upon entry to the project.
|
Non-naïve to Botox® Treatment
n=866 participants at risk
Receiving ongoing treatment with BOTOX® upon entry to the project.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.20%
1/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Gastrointestinal disorders
Dysphagia
|
0.20%
1/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.46%
4/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Nervous system disorders
Multiple Sclerosis
|
0.20%
1/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Malignant
|
0.20%
1/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
General disorders
Death
|
0.20%
1/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.69%
6/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Nervous system disorders
Lumbar Radiculopathy
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
General disorders
Pyrexia
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
General disorders
Asthenia
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.23%
2/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.20%
1/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.23%
2/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Hepatobiliary disorders
Bile Duct Obstruction
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Lung
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid Cancer
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Surgical and medical procedures
Haemorrhoid Operation
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Nervous system disorders
Dementia
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.23%
2/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.23%
2/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
General disorders
Chest Pain
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
General disorders
Local Swelling
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
General disorders
Sudden Cardiac Death
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Hepatobiliary disorders
Gallbladder Disorder
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Nervous system disorders
Head Titubation
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Nervous system disorders
Headache
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Surgical and medical procedures
Carpal Tunnel Decompression
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Surgical and medical procedures
Knee Operation
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Psychiatric disorders
Depression
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.23%
2/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Psychiatric disorders
Mental Disorder
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Nervous system disorders
Parkinson's Disease
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Investigations
Weight Decreased
|
0.00%
0/506
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.12%
1/866
The Safety Cohort included all subjects enrolled in the study who received at least one BOTOX® treatment. The Safety Cohort was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 4 weeks from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER