Safety and Efficacy Study of AGN-214868 in Patients With... | NCT01157377 | Trialant
NCT01157377
Sponsor
Allergan
Status
Completed
Last Update Posted
Mar 19, 2014Estimated
Enrollment
160Actual
Phase
Phase 2
Conditions
Urinary Bladder, Overactive
Interventions
AGN-214868
AGN-214868 placebo
Countries
United States
France
Netherlands
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01157377
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
214868-004
Secondary IDs
Not provided
Brief Title
Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence
Official Title
Not provided
Acronym
Not provided
Organization
AllerganINDUSTRY
Status Module
Record Verification Date
Feb 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2010
Primary Completion Date
Feb 2013Actual
Completion Date
May 2013Actual
First Submitted Date
Jul 1, 2010
First Submission Date that Met QC Criteria
Jul 2, 2010
First Posted Date
Jul 7, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 4, 2014
Results First Submitted that Met QC Criteria
Feb 4, 2014
Results First Posted Date
Mar 19, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 4, 2014
Last Update Posted Date
Mar 19, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AllerganINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will evaluate the safety and efficacy of AGN-214868 in patients with idiopathic overactive bladder (IOAB) and urinary incontinence.
Detailed Description
Not provided
Conditions Module
Conditions
Urinary Bladder, Overactive
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
160Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
AGN-214868 total dose 500 ng
Experimental
AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
Drug: AGN-214868
AGN-214868 total dose 1000 ng
Experimental
AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
Drug: AGN-214868
AGN-214868 total dose 2000 ng
Experimental
AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
Drug: AGN-214868
AGN-214868 total dose 6000 ng
Experimental
AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
Drug: AGN-214868
AGN-214868 total dose 18000 ng
Experimental
AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
Drug: AGN-214868
AGN-214868 total dose 60000 ng
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AGN-214868
Drug
AGN-214868 injected into the bladder.
AGN-214868 total dose 1000 ng
AGN-214868 total dose 18000 ng
AGN-214868 total dose 2000 ng
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in the Daily Average Number of Micturition (Urination) 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).
Baseline, Week 12
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
If female, must be of nonreproductive potential
If male, must agree to use acceptable contraception
Symptoms of overactive bladder with urinary urgency incontinence
Inadequate response or limiting side effects with anticholinergics for the treatment of OAB
Treatment with botulinum toxin therapy of any serotype for any non-urological condition within the prior 12 weeks
Previous treatment with botulinum toxin therapy of any serotype for any urological condition
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Director
Allergan
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Richmond
Virginia
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
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.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
AGN-214868 Total Dose 500 ng
AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
FG001
AGN-214868 Total Dose 1000 ng
AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
FG002
AGN-214868 Total Dose 2000 ng
AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
FG003
AGN-214868 Total Dose 6000 ng
AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
FG004
AGN-214868 Total Dose 18000 ng
AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
FG005
AGN-214868 Total Dose 60000 ng
AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
FG006
Placebo to AGN-214868
Placebo to AGN-214868 injected into the bladder on Day 1.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00023 subjects
FG00123 subjects
FG00227 subjects
FG00315 subjects
FG00420 subjects
FG00519 subjects
FG00629 subjects
COMPLETED
FG00021 subjects
FG00120 subjects
FG00226 subjects
FG00314 subjects
FG004
NOT COMPLETED
FG0002 subjects
FG0013 subjects
FG0021 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Baseline characteristics are based on the Safety Population that included all participants who received study medication.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
AGN-214868 Total Dose 500 ng
AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
BG001
AGN-214868 Total Dose 1000 ng
AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in the Daily Average Number of Micturition (Urination) 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).
Modified Intent-to-treat population included all randomized participants who received study medication and had post-baseline data available for micturition episodes.
Posted
Mean
Standard Deviation
Episodes
Baseline, Week 12
ID
Title
Description
OG000
AGN-214868 Total Dose 500 ng
AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
OG001
AGN-214868 Total Dose 1000 ng
Adverse Events Module
Frequency Threshold
5
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
AGN-214868 Total Dose 500 ng
AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrioventricular block complete
Cardiac disorders
MedDRA 16.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Dysuria
Renal and urinary disorders
MedDRA 16.0
Non-systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Therapeutic Area Head,
Allergan, Inc
714-246-4500
clinicaltrials@allergan.com
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D053201
Urinary Bladder, Overactive
Ancestor Terms
ID
Term
D001745
Urinary Bladder Diseases
D014570
Urologic Diseases
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
Drug: AGN-214868
Placebo to AGN-214868
Placebo Comparator
Placebo to AGN-214868 injected into the bladder on Day 1.
Drug: AGN-214868 placebo
AGN-214868 total dose 500 ng
AGN-214868 total dose 6000 ng
AGN-214868 total dose 60000 ng
AGN-214868 placebo
Drug
AGN-214868 placebo injected into the bladder.
Placebo to AGN-214868
Lyon
France
Amsterdam
Netherlands
18 subjects
FG00516 subjects
FG00627 subjects
2 subjects
FG0053 subjects
FG0062 subjects
0 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
Personal Reasons
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Other Miscellaneous Reasons
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0061 subjects
BG002
AGN-214868 Total Dose 2000 ng
AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
BG003
AGN-214868 Total Dose 6000 ng
AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
BG004
AGN-214868 Total Dose 18000 ng
AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
BG005
AGN-214868 Total Dose 60000 ng
AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
BG006
Placebo to AGN-214868
Placebo to AGN-214868 injected into the bladder on Day 1.
BG007
Total
Total of all reporting groups
23
BG00123
BG00227
BG00315
BG00420
BG00519
BG00629
BG007156
Participants
Title
Denominators
Categories
< 40 years
Title
Measurements
BG0001
BG0011
BG0021
BG0030
BG0040
BG0050
BG0061
BG0074
40-64 years
Title
Measurements
BG00016
BG00115
BG00214
BG003
>=65 years
Title
Measurements
BG0006
BG0017
BG00212
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00023
BG00120
BG00223
BG00314
BG00419
BG00518
BG00627
BG007144
Male
BG0000
BG0013
BG0024
BG0031
BG004
AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
OG002
AGN-214868 Total Dose 2000 ng
AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
OG003
AGN-214868 Total Dose 6000 ng
AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
OG004
AGN-214868 Total Dose 18000 ng
AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
OG005
AGN-214868 Total Dose 60000 ng
AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
OG006
Placebo to AGN-214868
Placebo to AGN-214868 injected into the bladder on Day 1.
Units
Counts
Participants
OG00022
OG00123
OG00227
OG00315
OG00419
OG00519
OG00629
Title
Denominators
Categories
Baseline
Title
Measurements
OG00013.7± 4.98
OG00112.2± 4.08
OG00211.0± 3.44
OG00310.6± 2.27
OG00411.7± 3.90
OG00511.6± 3.23
OG00611.0± 2.48
Change from Baseline at Week 12
Title
Measurements
OG000-2.6± 6.38
OG001-2.1± 2.45
OG002-1.3± 4.26
OG003
2
23
23
23
EG001
AGN-214868 Total Dose 1000 ng
AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
1
23
22
23
EG002
AGN-214868 Total Dose 2000 ng
AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
3
27
27
27
EG003
AGN-214868 Total Dose 6000 ng
AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
1
15
15
15
EG004
AGN-214868 Total Dose 18000 ng
AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
3
20
20
20
EG005
AGN-214868 Total Dose 60000 ng
AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
0
19
19
19
EG006
Placebo to AGN-214868
Placebo to AGN-214868 injected into the bladder on Day 1.
1
29
29
29
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Cardiac failure congestive
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Device malfunction
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0061 affected29 at risk
Device related infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Uterine cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected20 at risk
EG0020 affected23 at risk
EG0031 affected14 at risk
EG0040 affected19 at risk
EG0050 affected18 at risk
EG0060 affected27 at risk
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0021 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Ureteric stenosis
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Breast mass
Reproductive system and breast disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
EG0006 affected23 at risk
EG0015 affected23 at risk
EG0024 affected27 at risk
EG0031 affected15 at risk
EG0043 affected20 at risk
EG0053 affected19 at risk
EG0062 affected29 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0003 affected23 at risk
EG0010 affected23 at risk
EG0022 affected27 at risk
EG0032 affected15 at risk
EG0040 affected20 at risk
EG0053 affected19 at risk
EG0061 affected29 at risk
Haematuria
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected23 at risk
EG0012 affected23 at risk
EG0025 affected27 at risk
EG0032 affected15 at risk
EG0044 affected20 at risk
EG0052 affected19 at risk
EG0065 affected29 at risk
Procedural pain
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0003 affected23 at risk
EG0011 affected23 at risk
EG0022 affected27 at risk
EG0031 affected15 at risk
EG0044 affected20 at risk
EG0052 affected19 at risk
EG0060 affected29 at risk
Urinary tract infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0002 affected23 at risk
EG0012 affected23 at risk
EG0023 affected27 at risk
EG0030 affected15 at risk
EG0044 affected20 at risk
EG0052 affected19 at risk
EG0063 affected29 at risk
Sinusitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0012 affected23 at risk
EG0021 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0052 affected19 at risk
EG0061 affected29 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0052 affected19 at risk
EG0061 affected29 at risk
Chills
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0052 affected19 at risk
EG0060 affected29 at risk
Nasopharyngitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0022 affected27 at risk
EG0031 affected15 at risk
EG0041 affected20 at risk
EG0051 affected19 at risk
EG0061 affected29 at risk
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected20 at risk
EG0020 affected23 at risk
EG0031 affected14 at risk
EG0041 affected19 at risk
EG0051 affected18 at risk
EG0061 affected27 at risk
Leukocyturia
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0051 affected19 at risk
EG0061 affected29 at risk
Pyrexia
General disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0051 affected19 at risk
EG0061 affected29 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Bronchitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0062 affected29 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0061 affected29 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Headache
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected23 at risk
EG0011 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Oral herpes
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Asthenia
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Urethritis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0061 affected29 at risk
Acute tonsillitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Breast abscess
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Escherichia urinary tract infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Eye infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Fungal skin infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Genital herpes
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Hypothyroidism
Endocrine disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Laryngitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Mental disorder
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Pharyngitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Pollakiuria
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Rhinitis
Infections and infestations
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Vitamin D decreased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0051 affected19 at risk
EG0060 affected29 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0042 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Cardiac failure congestive
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0042 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0022 affected27 at risk
EG0031 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Alanine aminotransferase increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0022 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0061 affected29 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0022 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Depression
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0021 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0021 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Blood creatinine increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Gamma-glutamyltransferase increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Hydronephrosis
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Blood creatine phosphokinase increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Conjunctivitis
Eye disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Muscle strain
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0061 affected29 at risk
Anaemia
Blood and lymphatic system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Anxiety
Psychiatric disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Atrioventricular block complete
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Blood urea increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Breast cyst
Reproductive system and breast disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Carotid artery disease
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Chest pain
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Device malfunction
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Device related infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Local swelling
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Lymphocyte count increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Neutrophil count increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Peripheral vascular disorder
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Rhinitis seasonal
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Seasonal allergy
Immune system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Syncope
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Ureteric stenosis
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Vocal cord polyp
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
White blood cell count increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0041 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Angina pectoris
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0032 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Nausea
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0021 affected27 at risk
EG0031 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Hot flush
Vascular disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected27 at risk
EG0031 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Bladder pain
Renal and urinary disorders
MedDRA 16.0
Non-systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0031 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0031 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0031 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Urethral pain
Renal and urinary disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0031 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Bacteriuria
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0031 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0061 affected29 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0031 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0031 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Bundle branch block left
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0031 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Device failure
General disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0031 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Gastroenteritis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0031 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Gingival disorder
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0031 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0031 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Herpes zoster
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0031 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Hydroureter
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0031 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Nerve compression
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0031 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0031 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Palpitations
Cardiac disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0031 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Uterine cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected20 at risk
EG0020 affected23 at risk
EG0031 affected14 at risk
EG0040 affected19 at risk
EG0050 affected18 at risk
EG0060 affected27 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0023 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Renal cyst
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0014 affected23 at risk
EG0022 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0061 affected29 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0022 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0061 affected29 at risk
Blood urine present
Investigations
MedDRA 16.0
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0062 affected29 at risk
Food poisoning
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0060 affected29 at risk
Nephrolithiasis
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected27 at risk
EG0030 affected15 at risk
EG0040 affected20 at risk
EG0050 affected19 at risk
EG0062 affected29 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.