Trial Outcomes & Findings for A Research Study for Patients With Overactive Bladder (NCT NCT00168454)
NCT ID: NCT00168454
Last Updated: 2013-11-06
Results Overview
Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
313 participants
Primary outcome timeframe
Baseline, Week 2, Week 6, Week 12
Results posted on
2013-11-06
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo (normal saline)injection on Day 1 into detrusor
|
BOTOX 50 U
botulinum toxin Type A 50 U injection on Day 1 into detrusor
|
BOTOX 100 U
botulinum toxin Type A 100 U injection on Day 1 into detrusor
|
BOTOX 150 U
botulinum toxin Type A 150 U injection on Day 1 into detrusor
|
BOTOX 200 U
botulinum toxin Type A 200 U injection on Day 1 into detrusor
|
BOTOX 300 U
botulinum toxin Type A 300 U injection on Day 1 into detrusor
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
44
|
57
|
54
|
49
|
53
|
56
|
|
Overall Study
COMPLETED
|
37
|
50
|
48
|
40
|
47
|
50
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
6
|
9
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Research Study for Patients With Overactive Bladder
Baseline characteristics by cohort
| Measure |
Placebo
n=44 Participants
Placebo (normal saline)injection on Day 1 into detrusor
|
BOTOX 50 U
n=57 Participants
botulinum toxin Type A 50 U injection on Day 1 into detrusor
|
BOTOX 100 U
n=54 Participants
botulinum toxin Type A 100 U injection on Day 1 into detrusor
|
BOTOX 150 U
n=49 Participants
botulinum toxin Type A 150 U injection on Day 1 into detrusor
|
BOTOX 200 U
n=53 Participants
botulinum toxin Type A 200 U injection on Day 1 into detrusor
|
BOTOX 300 U
n=56 Participants
botulinum toxin Type A 300 U injection on Day 1 into detrusor
|
Total
n=313 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
<45 years
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
6 participants
n=5 Participants
|
8 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=8 Participants
|
42 participants
n=8 Participants
|
|
Age, Customized
45-64 years
|
24 participants
n=5 Participants
|
27 participants
n=7 Participants
|
25 participants
n=5 Participants
|
27 participants
n=4 Participants
|
21 participants
n=21 Participants
|
29 participants
n=8 Participants
|
153 participants
n=8 Participants
|
|
Age, Customized
65-74 years
|
6 participants
n=5 Participants
|
13 participants
n=7 Participants
|
16 participants
n=5 Participants
|
12 participants
n=4 Participants
|
20 participants
n=21 Participants
|
15 participants
n=8 Participants
|
82 participants
n=8 Participants
|
|
Age, Customized
>=75 years
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
2 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=8 Participants
|
36 participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
52 Participants
n=8 Participants
|
288 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
25 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 12Population: Intent to Treat
Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.
Outcome measures
| Measure |
Placebo
n=44 Participants
Placebo (normal saline)injection on Day 1 into detrusor
|
BOTOX 50 U
n=57 Participants
botulinum toxin Type A 50 U injection on Day 1 into detrusor
|
BOTOX 100 U
n=54 Participants
botulinum toxin Type A 100 U injection on Day 1 into detrusor
|
BOTOX 150 U
n=49 Participants
botulinum toxin Type A 150 U injection on Day 1 into detrusor
|
BOTOX 200 U
n=53 Participants
botulinum toxin Type A 200 U injection on Day 1 into detrusor
|
BOTOX 300 U
n=56 Participants
botulinum toxin Type A 300 U injection on Day 1 into detrusor
|
|---|---|---|---|---|---|---|
|
Change in Number of Urinary Urge Incontinence Episodes
Baseline
|
32.5 episodes
|
30.3 episodes
|
27.8 episodes
|
28.3 episodes
|
24.1 episodes
|
26.8 episodes
|
|
Change in Number of Urinary Urge Incontinence Episodes
Week 2
|
-17.3 episodes
|
-20.0 episodes
|
-18.6 episodes
|
-20.8 episodes
|
-16.8 episodes
|
-18.6 episodes
|
|
Change in Number of Urinary Urge Incontinence Episodes
Week 6
|
-18.2 episodes
|
-21.2 episodes
|
-19.9 episodes
|
-23.4 episodes
|
-20.0 episodes
|
-18.8 episodes
|
|
Change in Number of Urinary Urge Incontinence Episodes
Week 12
|
-17.4 episodes
|
-20.7 episodes
|
-18.4 episodes
|
-23.0 episodes
|
-19.6 episodes
|
-19.4 episodes
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 12Population: Intent to Treat
Mean number of micturitions measured over a 7 day diary prior to each visit. Micturation is defined as urinating into the toilet.
Outcome measures
| Measure |
Placebo
n=44 Participants
Placebo (normal saline)injection on Day 1 into detrusor
|
BOTOX 50 U
n=57 Participants
botulinum toxin Type A 50 U injection on Day 1 into detrusor
|
BOTOX 100 U
n=54 Participants
botulinum toxin Type A 100 U injection on Day 1 into detrusor
|
BOTOX 150 U
n=49 Participants
botulinum toxin Type A 150 U injection on Day 1 into detrusor
|
BOTOX 200 U
n=53 Participants
botulinum toxin Type A 200 U injection on Day 1 into detrusor
|
BOTOX 300 U
n=56 Participants
botulinum toxin Type A 300 U injection on Day 1 into detrusor
|
|---|---|---|---|---|---|---|
|
Change in Number of Micturitions
Baseline
|
73.3 micturitions
|
76.3 micturitions
|
80.3 micturitions
|
76.5 micturitions
|
76.7 micturitions
|
75.6 micturitions
|
|
Change in Number of Micturitions
Week 2
|
-6.5 micturitions
|
-10.0 micturitions
|
-12.5 micturitions
|
-9.8 micturitions
|
-7.2 micturitions
|
-9.2 micturitions
|
|
Change in Number of Micturitions
Week 6
|
-9.4 micturitions
|
-15.2 micturitions
|
-22.9 micturitions
|
-17.0 micturitions
|
-18.9 micturitions
|
-19.9 micturitions
|
|
Change in Number of Micturitions
Week 12
|
-8.3 micturitions
|
-15.3 micturitions
|
-21.7 micturitions
|
-18.8 micturitions
|
-19.7 micturitions
|
-21.2 micturitions
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent to Treat
Mean number of nocturia episodes measured over a 7 day diary prior to each visit. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep.
Outcome measures
| Measure |
Placebo
n=44 Participants
Placebo (normal saline)injection on Day 1 into detrusor
|
BOTOX 50 U
n=57 Participants
botulinum toxin Type A 50 U injection on Day 1 into detrusor
|
BOTOX 100 U
n=54 Participants
botulinum toxin Type A 100 U injection on Day 1 into detrusor
|
BOTOX 150 U
n=49 Participants
botulinum toxin Type A 150 U injection on Day 1 into detrusor
|
BOTOX 200 U
n=53 Participants
botulinum toxin Type A 200 U injection on Day 1 into detrusor
|
BOTOX 300 U
n=56 Participants
botulinum toxin Type A 300 U injection on Day 1 into detrusor
|
|---|---|---|---|---|---|---|
|
Change in Number of Nocturia Episodes
Baseline
|
12.3 episodes
|
12.2 episodes
|
13.9 episodes
|
17.9 episodes
|
12.2 episodes
|
14.9 episodes
|
|
Change in Number of Nocturia Episodes
Week 12
|
-0.3 episodes
|
-2.5 episodes
|
-4.1 episodes
|
-6.5 episodes
|
-3.8 episodes
|
-7.0 episodes
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent to Treat
Maximum Cystometric Capacity (maximum volume that the bladder can hold) measured in mean milliliters
Outcome measures
| Measure |
Placebo
n=44 Participants
Placebo (normal saline)injection on Day 1 into detrusor
|
BOTOX 50 U
n=57 Participants
botulinum toxin Type A 50 U injection on Day 1 into detrusor
|
BOTOX 100 U
n=54 Participants
botulinum toxin Type A 100 U injection on Day 1 into detrusor
|
BOTOX 150 U
n=49 Participants
botulinum toxin Type A 150 U injection on Day 1 into detrusor
|
BOTOX 200 U
n=53 Participants
botulinum toxin Type A 200 U injection on Day 1 into detrusor
|
BOTOX 300 U
n=56 Participants
botulinum toxin Type A 300 U injection on Day 1 into detrusor
|
|---|---|---|---|---|---|---|
|
Maximum Cystometric Capacity (MCC) by Urodynamic Measurements
Baseline
|
267.1 milliliters
|
262.9 milliliters
|
255.0 milliliters
|
258.4 milliliters
|
280.1 milliliters
|
271.7 milliliters
|
|
Maximum Cystometric Capacity (MCC) by Urodynamic Measurements
Week 12
|
49.5 milliliters
|
50.0 milliliters
|
71.0 milliliters
|
101.7 milliliters
|
91.5 milliliters
|
130.8 milliliters
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 12Population: Intent to Treat
Measured on 3 domains; a 5-point scale (1-5) for each domain. Sum of the domain scores is normalized to a scale of 0-100 (100 = no impact of incontinence on daily activities, 0 = maximum impact of incontinence on daily activities). Mean scores presented.
Outcome measures
| Measure |
Placebo
n=44 Participants
Placebo (normal saline)injection on Day 1 into detrusor
|
BOTOX 50 U
n=57 Participants
botulinum toxin Type A 50 U injection on Day 1 into detrusor
|
BOTOX 100 U
n=54 Participants
botulinum toxin Type A 100 U injection on Day 1 into detrusor
|
BOTOX 150 U
n=49 Participants
botulinum toxin Type A 150 U injection on Day 1 into detrusor
|
BOTOX 200 U
n=53 Participants
botulinum toxin Type A 200 U injection on Day 1 into detrusor
|
BOTOX 300 U
n=56 Participants
botulinum toxin Type A 300 U injection on Day 1 into detrusor
|
|---|---|---|---|---|---|---|
|
Incontinence Quality of Life Instrument (I-QOL)
Baseline
|
35.9 Units on a scale
|
32.3 Units on a scale
|
34.3 Units on a scale
|
30.5 Units on a scale
|
32.0 Units on a scale
|
34.5 Units on a scale
|
|
Incontinence Quality of Life Instrument (I-QOL)
Week 2
|
14.8 Units on a scale
|
21.1 Units on a scale
|
28.1 Units on a scale
|
29.5 Units on a scale
|
26.7 Units on a scale
|
31.6 Units on a scale
|
|
Incontinence Quality of Life Instrument (I-QOL)
Week 6
|
16.3 Units on a scale
|
30.6 Units on a scale
|
32.1 Units on a scale
|
37.2 Units on a scale
|
34.5 Units on a scale
|
41.6 Units on a scale
|
|
Incontinence Quality of Life Instrument (I-QOL)
Week 12
|
17.9 Units on a scale
|
29.8 Units on a scale
|
32.9 Units on a scale
|
35.2 Units on a scale
|
37.1 Units on a scale
|
39.7 Units on a scale
|
POST_HOC outcome
Timeframe: Baseline, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36Population: Intent to Treat
Measured by the 7 day diary preceding each visit. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.
Outcome measures
| Measure |
Placebo
n=44 Participants
Placebo (normal saline)injection on Day 1 into detrusor
|
BOTOX 50 U
n=57 Participants
botulinum toxin Type A 50 U injection on Day 1 into detrusor
|
BOTOX 100 U
n=54 Participants
botulinum toxin Type A 100 U injection on Day 1 into detrusor
|
BOTOX 150 U
n=49 Participants
botulinum toxin Type A 150 U injection on Day 1 into detrusor
|
BOTOX 200 U
n=53 Participants
botulinum toxin Type A 200 U injection on Day 1 into detrusor
|
BOTOX 300 U
n=56 Participants
botulinum toxin Type A 300 U injection on Day 1 into detrusor
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes
Week 2
|
11.4 Percentage of patients
|
12.3 Percentage of patients
|
27.8 Percentage of patients
|
26.5 Percentage of patients
|
28.3 Percentage of patients
|
44.6 Percentage of patients
|
|
Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes
Week 6
|
18.2 Percentage of patients
|
24.6 Percentage of patients
|
44.4 Percentage of patients
|
49.0 Percentage of patients
|
49.1 Percentage of patients
|
55.4 Percentage of patients
|
|
Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes
Week 12
|
15.9 Percentage of patients
|
29.8 Percentage of patients
|
37.0 Percentage of patients
|
40.8 Percentage of patients
|
50.9 Percentage of patients
|
57.1 Percentage of patients
|
|
Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes
Week 18
|
13.6 Percentage of patients
|
26.3 Percentage of patients
|
38.9 Percentage of patients
|
44.9 Percentage of patients
|
39.6 Percentage of patients
|
46.4 Percentage of patients
|
|
Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes
Week 24
|
13.6 Percentage of patients
|
28.1 Percentage of patients
|
27.8 Percentage of patients
|
42.9 Percentage of patients
|
54.7 Percentage of patients
|
53.6 Percentage of patients
|
|
Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes
Week 30
|
18.2 Percentage of patients
|
21.1 Percentage of patients
|
35.2 Percentage of patients
|
28.6 Percentage of patients
|
41.5 Percentage of patients
|
46.4 Percentage of patients
|
|
Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes
Week 36
|
11.4 Percentage of patients
|
15.8 Percentage of patients
|
33.3 Percentage of patients
|
36.7 Percentage of patients
|
32.1 Percentage of patients
|
42.9 Percentage of patients
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 33 other events
Deaths: 0 deaths
BOTOX 50 U
Serious events: 9 serious events
Other events: 44 other events
Deaths: 0 deaths
BOTOX 100 U
Serious events: 5 serious events
Other events: 44 other events
Deaths: 0 deaths
BOTOX 150 U
Serious events: 7 serious events
Other events: 39 other events
Deaths: 0 deaths
BOTOX 200 U
Serious events: 4 serious events
Other events: 44 other events
Deaths: 0 deaths
BOTOX 300 U
Serious events: 4 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
Placebo (normal saline)injection on Day 1 into detrusor
|
BOTOX 50 U
botulinum toxin Type A 50 U injection on Day 1 into detrusor
|
BOTOX 100 U
botulinum toxin Type A 100 U injection on Day 1 into detrusor
|
BOTOX 150 U
botulinum toxin Type A 150 U injection on Day 1 into detrusor
|
BOTOX 200 U
botulinum toxin Type A 200 U injection on Day 1 into detrusor
|
BOTOX 300 U
botulinum toxin Type A 300 U injection on Day 1 into detrusor
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.9%
1/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
2.0%
1/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
2.0%
1/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.9%
1/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.9%
1/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Herpes ophthalmic
|
2.3%
1/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.9%
1/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Injury, poisoning and procedural complications
Concussion
|
2.3%
1/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
2.3%
1/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
2.0%
1/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
3.6%
2/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
2.0%
1/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
2.3%
1/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
4.0%
2/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
3.6%
2/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
2.0%
1/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.3%
1/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamos cell carcinoma
|
2.3%
1/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Headache
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
2.0%
1/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Syncope
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
2.0%
1/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
2.3%
1/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Psychiatric disorders
Schizophrenia, undifferentiated type
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.9%
1/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Vascular disorders
Hypertension
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.9%
1/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Vascular disorders
Hypotension
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
2.0%
1/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
Other adverse events
| Measure |
Placebo
Placebo (normal saline)injection on Day 1 into detrusor
|
BOTOX 50 U
botulinum toxin Type A 50 U injection on Day 1 into detrusor
|
BOTOX 100 U
botulinum toxin Type A 100 U injection on Day 1 into detrusor
|
BOTOX 150 U
botulinum toxin Type A 150 U injection on Day 1 into detrusor
|
BOTOX 200 U
botulinum toxin Type A 200 U injection on Day 1 into detrusor
|
BOTOX 300 U
botulinum toxin Type A 300 U injection on Day 1 into detrusor
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
16.3%
7/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
33.9%
19/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
36.4%
20/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
44.0%
22/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
48.1%
25/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
34.5%
19/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.7%
2/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.4%
3/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.5%
3/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
8.0%
4/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
3.8%
2/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
9.1%
5/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
3.6%
2/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.5%
3/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
3.8%
2/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.5%
3/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
1/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
10.9%
6/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
2.0%
1/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
3.8%
2/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
3.6%
2/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Influenza
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.5%
3/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
6.0%
3/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
9.6%
5/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.5%
3/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
4.0%
2/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Sinusitis
|
4.7%
2/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
8.9%
5/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
3.6%
2/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
2.0%
1/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Renal and urinary disorders
Urinary retention
|
2.3%
1/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
8.9%
5/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
18.2%
10/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
28.0%
14/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
23.1%
12/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
25.5%
14/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Renal and urinary disorders
Bladder pain
|
2.3%
1/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
8.0%
4/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.9%
1/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
3.6%
2/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
7.1%
4/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
2.0%
1/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
3.6%
2/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Renal and urinary disorders
Dysuria
|
11.6%
5/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
12.5%
7/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
8.0%
4/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
11.5%
6/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Renal and urinary disorders
Renal cyst
|
4.7%
2/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
3.6%
2/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
2.0%
1/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.8%
3/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Renal and urinary disorders
Haematuria
|
14.0%
6/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
8.9%
5/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
4.0%
2/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.9%
1/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
1/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
8.9%
5/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
3.6%
2/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
2.0%
1/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.8%
3/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
3.6%
2/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Gastrointestinal disorders
Nausea
|
9.3%
4/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
7.3%
4/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
3.8%
2/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.3%
4/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.4%
3/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Investigations
White blood cells urine positive
|
4.7%
2/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
7.3%
4/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
2.0%
1/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.8%
3/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
3.6%
2/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Investigations
Residual urine volume
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.4%
3/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
6.0%
3/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
7.7%
4/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Investigations
Blood urine present
|
7.0%
3/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.6%
5/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.5%
3/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
2.0%
1/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.5%
3/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.7%
2/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.5%
3/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
2.0%
1/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.5%
3/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
3.6%
2/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
4.0%
2/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
7.7%
4/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Dizziness
|
2.3%
1/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.4%
3/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
9.1%
5/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.5%
3/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Headache
|
4.7%
2/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
4.0%
2/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.8%
3/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Sciatica
|
7.0%
3/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
2.0%
1/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
1/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
3.6%
2/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
2.0%
1/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.5%
3/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.4%
3/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
3.6%
2/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
0.00%
0/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.5%
3/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
2.0%
1/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.9%
1/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Vascular disorders
Hypertension
|
4.7%
2/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
4.0%
2/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.8%
3/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
|
Psychiatric disorders
Depression
|
2.3%
1/43
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/56
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
5.5%
3/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
2.0%
1/50
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.9%
1/52
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
1.8%
1/55
The Safety Population is defined as all randomized patients who received treatment and was used to analyze Serious Adverse Events and Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60