Trial Outcomes & Findings for Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence (NCT NCT01157377)
NCT ID: NCT01157377
Last Updated: 2014-03-19
Results Overview
The average number of urinary episodes (urination into the toilet) was recorded by a patient bladder diary during 3 consecutive days in the week prior to Baseline and Week 12. A negative change from Baseline indicated improvement (fewer urinary episodes).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
160 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2014-03-19
Participant Flow
160 patients were enrolled, 3 patients did not receive treatment and 1 patient received an incorrect dose. 156 patients were included in the Safety Population.
Participant milestones
| Measure |
AGN-214868 Total Dose 500 ng
AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
|
AGN-214868 Total Dose 1000 ng
AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
|
AGN-214868 Total Dose 2000 ng
AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
|
AGN-214868 Total Dose 6000 ng
AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
|
AGN-214868 Total Dose 18000 ng
AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
|
AGN-214868 Total Dose 60000 ng
AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
|
Placebo to AGN-214868
Placebo to AGN-214868 injected into the bladder on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
27
|
15
|
20
|
19
|
29
|
|
Overall Study
COMPLETED
|
21
|
20
|
26
|
14
|
18
|
16
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
1
|
1
|
2
|
3
|
2
|
Reasons for withdrawal
| Measure |
AGN-214868 Total Dose 500 ng
AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
|
AGN-214868 Total Dose 1000 ng
AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
|
AGN-214868 Total Dose 2000 ng
AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
|
AGN-214868 Total Dose 6000 ng
AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
|
AGN-214868 Total Dose 18000 ng
AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
|
AGN-214868 Total Dose 60000 ng
AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
|
Placebo to AGN-214868
Placebo to AGN-214868 injected into the bladder on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
|
Overall Study
Personal Reasons
|
2
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Other Miscellaneous Reasons
|
0
|
2
|
0
|
0
|
1
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence
Baseline characteristics by cohort
| Measure |
AGN-214868 Total Dose 500 ng
n=23 Participants
AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
|
AGN-214868 Total Dose 1000 ng
n=23 Participants
AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
|
AGN-214868 Total Dose 2000 ng
n=27 Participants
AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
|
AGN-214868 Total Dose 6000 ng
n=15 Participants
AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
|
AGN-214868 Total Dose 18000 ng
n=20 Participants
AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
|
AGN-214868 Total Dose 60000 ng
n=19 Participants
AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
|
Placebo to AGN-214868
n=29 Participants
Placebo to AGN-214868 injected into the bladder on Day 1.
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
< 40 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
|
Age, Customized
40-64 years
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
93 Participants
n=24 Participants
|
|
Age, Customized
>=65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
59 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
144 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Modified Intent-to-treat population included all randomized participants who received study medication and had post-baseline data available for micturition episodes.
The average number of urinary episodes (urination into the toilet) was recorded by a patient bladder diary during 3 consecutive days in the week prior to Baseline and Week 12. A negative change from Baseline indicated improvement (fewer urinary episodes).
Outcome measures
| Measure |
AGN-214868 Total Dose 500 ng
n=22 Participants
AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
|
AGN-214868 Total Dose 1000 ng
n=23 Participants
AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
|
AGN-214868 Total Dose 2000 ng
n=27 Participants
AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
|
AGN-214868 Total Dose 6000 ng
n=15 Participants
AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
|
AGN-214868 Total Dose 18000 ng
n=19 Participants
AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
|
AGN-214868 Total Dose 60000 ng
n=19 Participants
AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
|
Placebo to AGN-214868
n=29 Participants
Placebo to AGN-214868 injected into the bladder on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes
Baseline
|
13.7 Episodes
Standard Deviation 4.98
|
12.2 Episodes
Standard Deviation 4.08
|
11.0 Episodes
Standard Deviation 3.44
|
10.6 Episodes
Standard Deviation 2.27
|
11.7 Episodes
Standard Deviation 3.90
|
11.6 Episodes
Standard Deviation 3.23
|
11.0 Episodes
Standard Deviation 2.48
|
|
Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes
Change from Baseline at Week 12
|
-2.6 Episodes
Standard Deviation 6.38
|
-2.1 Episodes
Standard Deviation 2.45
|
-1.3 Episodes
Standard Deviation 4.26
|
-0.9 Episodes
Standard Deviation 2.40
|
-1.7 Episodes
Standard Deviation 3.90
|
-2.7 Episodes
Standard Deviation 2.62
|
-1.9 Episodes
Standard Deviation 2.18
|
Adverse Events
AGN-214868 Total Dose 500 ng
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
AGN-214868 Total Dose 1000 ng
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
AGN-214868 Total Dose 2000 ng
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
AGN-214868 Total Dose 6000 ng
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
AGN-214868 Total Dose 18000 ng
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
AGN-214868 Total Dose 60000 ng
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo to AGN-214868
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AGN-214868 Total Dose 500 ng
n=23 participants at risk
AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
|
AGN-214868 Total Dose 1000 ng
n=23 participants at risk
AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
|
AGN-214868 Total Dose 2000 ng
n=27 participants at risk
AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
|
AGN-214868 Total Dose 6000 ng
n=15 participants at risk
AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
|
AGN-214868 Total Dose 18000 ng
n=20 participants at risk
AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
|
AGN-214868 Total Dose 60000 ng
n=19 participants at risk
AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
|
Placebo to AGN-214868
n=29 participants at risk
Placebo to AGN-214868 injected into the bladder on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
General disorders
Device malfunction
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/23
|
0.00%
0/23
|
3.7%
1/27
|
0.00%
0/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/23
|
0.00%
0/23
|
3.7%
1/27
|
0.00%
0/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
4.3%
1/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
0.00%
0/19
|
3.4%
1/29
|
|
Infections and infestations
Device related infection
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/23
|
0.00%
0/20
|
0.00%
0/23
|
7.1%
1/14
|
0.00%
0/19
|
0.00%
0/18
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/23
|
4.3%
1/23
|
3.7%
1/27
|
0.00%
0/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Reproductive system and breast disorders
Breast mass
|
4.3%
1/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
Other adverse events
| Measure |
AGN-214868 Total Dose 500 ng
n=23 participants at risk
AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
|
AGN-214868 Total Dose 1000 ng
n=23 participants at risk
AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
|
AGN-214868 Total Dose 2000 ng
n=27 participants at risk
AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
|
AGN-214868 Total Dose 6000 ng
n=15 participants at risk
AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
|
AGN-214868 Total Dose 18000 ng
n=20 participants at risk
AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
|
AGN-214868 Total Dose 60000 ng
n=19 participants at risk
AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
|
Placebo to AGN-214868
n=29 participants at risk
Placebo to AGN-214868 injected into the bladder on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Dysuria
|
26.1%
6/23
|
21.7%
5/23
|
14.8%
4/27
|
6.7%
1/15
|
15.0%
3/20
|
15.8%
3/19
|
6.9%
2/29
|
|
Infections and infestations
Upper respiratory tract infection
|
13.0%
3/23
|
0.00%
0/23
|
7.4%
2/27
|
13.3%
2/15
|
0.00%
0/20
|
15.8%
3/19
|
3.4%
1/29
|
|
Renal and urinary disorders
Haematuria
|
4.3%
1/23
|
8.7%
2/23
|
18.5%
5/27
|
13.3%
2/15
|
20.0%
4/20
|
10.5%
2/19
|
17.2%
5/29
|
|
Injury, poisoning and procedural complications
Procedural pain
|
13.0%
3/23
|
4.3%
1/23
|
7.4%
2/27
|
6.7%
1/15
|
20.0%
4/20
|
10.5%
2/19
|
0.00%
0/29
|
|
Infections and infestations
Urinary tract infection
|
8.7%
2/23
|
8.7%
2/23
|
11.1%
3/27
|
0.00%
0/15
|
20.0%
4/20
|
10.5%
2/19
|
10.3%
3/29
|
|
Infections and infestations
Sinusitis
|
0.00%
0/23
|
8.7%
2/23
|
3.7%
1/27
|
0.00%
0/15
|
0.00%
0/20
|
10.5%
2/19
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
10.5%
2/19
|
3.4%
1/29
|
|
General disorders
Chills
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
10.5%
2/19
|
0.00%
0/29
|
|
Infections and infestations
Nasopharyngitis
|
8.7%
2/23
|
0.00%
0/23
|
7.4%
2/27
|
6.7%
1/15
|
5.0%
1/20
|
5.3%
1/19
|
3.4%
1/29
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/23
|
5.0%
1/20
|
0.00%
0/23
|
7.1%
1/14
|
5.3%
1/19
|
5.6%
1/18
|
3.7%
1/27
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
5.3%
1/19
|
3.4%
1/29
|
|
General disorders
Pyrexia
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
5.3%
1/19
|
3.4%
1/29
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Infections and infestations
Bronchitis
|
0.00%
0/23
|
0.00%
0/23
|
3.7%
1/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
6.9%
2/29
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/23
|
0.00%
0/23
|
3.7%
1/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
3.4%
1/29
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/23
|
0.00%
0/23
|
3.7%
1/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/23
|
0.00%
0/23
|
3.7%
1/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Nervous system disorders
Headache
|
4.3%
1/23
|
4.3%
1/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Infections and infestations
Oral herpes
|
0.00%
0/23
|
4.3%
1/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
General disorders
Asthenia
|
4.3%
1/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Infections and infestations
Urethritis
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
3.4%
1/29
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Infections and infestations
Breast abscess
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Infections and infestations
Eye infection
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Infections and infestations
Genital herpes
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Infections and infestations
Laryngitis
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Infections and infestations
Rhinitis
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Investigations
Vitamin D decreased
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
5.3%
1/19
|
0.00%
0/29
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
10.0%
2/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
10.0%
2/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/23
|
0.00%
0/23
|
7.4%
2/27
|
6.7%
1/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Investigations
Alanine aminotransferase increased
|
8.7%
2/23
|
0.00%
0/23
|
7.4%
2/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
3.4%
1/29
|
|
Injury, poisoning and procedural complications
Fall
|
4.3%
1/23
|
0.00%
0/23
|
7.4%
2/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Psychiatric disorders
Depression
|
0.00%
0/23
|
4.3%
1/23
|
3.7%
1/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Injury, poisoning and procedural complications
Contusion
|
4.3%
1/23
|
0.00%
0/23
|
3.7%
1/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Investigations
Blood creatinine increased
|
0.00%
0/23
|
0.00%
0/23
|
3.7%
1/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/23
|
0.00%
0/23
|
3.7%
1/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/23
|
0.00%
0/23
|
3.7%
1/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Investigations
Blood creatine phosphokinase increased
|
4.3%
1/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Eye disorders
Conjunctivitis
|
4.3%
1/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Injury, poisoning and procedural complications
Muscle strain
|
4.3%
1/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
3.4%
1/29
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Investigations
Blood urea increased
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
General disorders
Chest pain
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
General disorders
Device malfunction
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Infections and infestations
Device related infection
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
General disorders
Local swelling
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Investigations
Neutrophil count increased
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis seasonal
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Nervous system disorders
Syncope
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Investigations
White blood cell count increased
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
5.0%
1/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
13.3%
2/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/23
|
4.3%
1/23
|
3.7%
1/27
|
6.7%
1/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Vascular disorders
Hot flush
|
0.00%
0/23
|
4.3%
1/23
|
0.00%
0/27
|
6.7%
1/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Renal and urinary disorders
Bladder pain
|
8.7%
2/23
|
0.00%
0/23
|
0.00%
0/27
|
6.7%
1/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
1/23
|
0.00%
0/23
|
0.00%
0/27
|
6.7%
1/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
4.3%
1/23
|
0.00%
0/23
|
0.00%
0/27
|
6.7%
1/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Renal and urinary disorders
Urethral pain
|
4.3%
1/23
|
0.00%
0/23
|
0.00%
0/27
|
6.7%
1/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
6.7%
1/15
|
0.00%
0/20
|
0.00%
0/19
|
3.4%
1/29
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
6.7%
1/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
6.7%
1/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
6.7%
1/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
General disorders
Device failure
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
6.7%
1/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
6.7%
1/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Gastrointestinal disorders
Gingival disorder
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
6.7%
1/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
6.7%
1/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
6.7%
1/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Renal and urinary disorders
Hydroureter
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
6.7%
1/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
6.7%
1/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
6.7%
1/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Cardiac disorders
Palpitations
|
0.00%
0/23
|
0.00%
0/23
|
0.00%
0/27
|
6.7%
1/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/23
|
0.00%
0/20
|
0.00%
0/23
|
7.1%
1/14
|
0.00%
0/19
|
0.00%
0/18
|
0.00%
0/27
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
1/23
|
0.00%
0/23
|
11.1%
3/27
|
0.00%
0/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/23
|
17.4%
4/23
|
7.4%
2/27
|
0.00%
0/15
|
0.00%
0/20
|
0.00%
0/19
|
3.4%
1/29
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/23
|
0.00%
0/23
|
7.4%
2/27
|
0.00%
0/15
|
0.00%
0/20
|
0.00%
0/19
|
3.4%
1/29
|
|
Investigations
Blood urine present
|
0.00%
0/23
|
0.00%
0/23
|
3.7%
1/27
|
0.00%
0/15
|
0.00%
0/20
|
0.00%
0/19
|
6.9%
2/29
|
|
Gastrointestinal disorders
Food poisoning
|
8.7%
2/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/29
|
|
Renal and urinary disorders
Nephrolithiasis
|
4.3%
1/23
|
0.00%
0/23
|
0.00%
0/27
|
0.00%
0/15
|
0.00%
0/20
|
0.00%
0/19
|
6.9%
2/29
|
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 less than or equal to 90 days 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