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Botoxcharts
1. Plans are forward looking and are in preparation for FDA approval. No promotional activity will occur prior to FDA approval.
Significant Decrease in Urinary
Incontinence in Both Pivotal Studies
Study 515
-25
-20
-15
-10
-5
0
Week 2 Week 6 Week 12
Meanchangefrombaseline(episodes/week)
Placebo
N=149
200U
N=135
Study 516
-25
-20
-15
-10
-5
0
Week 2 Week 6 Week 12
Meanchangefrombaseline(episodes/week)
Placebo
N=92
200U
N=92
*
** **
* p= <0.05; ** p= <0.001 in pairwise comparison versus placebo
Mean baselines:
Placebo = 28.3/wk, 200U = 32.3/wk
**
*
*
Mean baselines:
Placebo = 36.7/wk, 200U = 32.5/wk
1. From NDO Clinical Program Overview - BOTOX® (onabotulinumtoxinA), NDO Clinical Trial
2. Plans are forward looking and are in preparation for FDA approval. No promotional activity will occur prior to FDA approval.
High Proportion of Treatment
Responders
% of patients with ≥50%
decrease in urinary
incontinence
0
10
20
30
40
50
60
70
80
90
100
Placebo 200U
%ofPatients
Week 6
% of patients with 100%
decrease in urinary
incontinence (‘DRY’)
0
10
20
30
40
50
60
70
80
90
100
Placebo 200U
%ofPatients
**
** p= <0.001 in among-group comparison,
**
Week 6
1. From NDO Clinical Program Overview - BOTOX® (onabotulinumtoxinA), NDO Clinical Trial
3. Plans are forward looking and are in preparation for FDA approval. No promotional activity will occur prior to FDA approval.
Significant Increase in MCC in
Both Pivotal Studies
Study 515
0
20
40
60
80
100
120
140
160
180
Meanchangefrombaseline(mL)
Placebo
N=129
200U
N=123
Study 516
0
20
40
60
80
100
120
140
160
180
Placebo
N=85
200U
N=88
**
**
** p= <0.001 in pairwise comparison versus placebo
1. From NDO Clinical Program Overview - BOTOX® (onabotulinumtoxinA), NDO Clinical Trial
4. Plans are forward looking and are in preparation for FDA approval. No promotional activity will occur prior to FDA approval.
-40
-35
-30
-25
-20
-15
-10
-5
0
5
10
Meanchangefrombaseline(cmH2O)
Placebo
N=68
200U
N=29
Significant Reduction in MDP During
First IDC in Both Pivotal Studies
Study 515
-40
-35
-30
-25
-20
-15
-10
-5
0
5
10
Meanchangefrombaseline(cmH2O)
Placebo
N=103
200U
N=41
Study 516
**
**
** p= <0.001 in pairwise comparison versus placebo
1. From NDO Clinical Program Overview - BOTOX® (onabotulinumtoxinA), NDO Clinical Trial
5. Plans are forward looking and are in preparation for FDA approval. No promotional activity will occur prior to FDA approval.
0
5
10
15
20
25
30
35
Week 6 Week 12
Meanchangefrombaseline(totalscore)
Placebo
N=149
200U
N=135
0
5
10
15
20
25
30
Week 6 Week 12
Meanchangefrombaseline(totalscore)
Placebo
N=92
200U
N=92
Significant Improvement in Quality
of Life in Both Pivotal Studies
** p= <0.001 in pairwise comparison versus placebo
Study 515 Study 516
Baseline Baseline
1. From NDO Clinical Program Overview - BOTOX® (onabotulinumtoxinA), NDO Clinical Trial
6. Plans are forward looking and are in preparation for FDA approval. No promotional activity will occur prior to FDA approval.
0 10 20 30 40 50
Placebo
200U
Weeks
Long Duration of Effect:
Patient Request for Re-Treatment
Patient could not request re-treatment until week 12
Median = 38.4 weeks
Median = 13.1 weeks
1. From NDO Clinical Program Overview - BOTOX® (onabotulinumtoxinA), NDO Clinical Trial