Extension Study Investigating the Long-Term Safety and To... | NCT00215657 | Trialant
NCT00215657
Sponsor
Ferring Pharmaceuticals
Status
Terminated
Last Update Posted
May 20, 2011Estimated
Enrollment
131Actual
Phase
Phase 2
Conditions
Prostate Cancer
Interventions
Degarelix
Degarelix
Degarelix
Degarelix
Degarelix
Degarelix
Degarelix
Degarelix
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT00215657
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
FE200486 CS07A
Secondary IDs
Not provided
Brief Title
Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Official Title
An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Acronym
Not provided
Organization
Ferring PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
May 2011
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The doses were not effective in maintaining testosterone suppression
Expanded Access Info
No
Start Date
Mar 2003
Primary Completion Date
Mar 2006Actual
Completion Date
Mar 2006Actual
First Submitted Date
Sep 20, 2005
First Submission Date that Met QC Criteria
Sep 20, 2005
First Posted Date
Sep 22, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 22, 2009
Results First Submitted that Met QC Criteria
Apr 24, 2009
Results First Posted Date
Jun 12, 2009Estimated
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
May 18, 2011
Last Update Posted Date
May 20, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Ferring PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Detailed Description
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention (FDA regulated intervention is therefore ticked "YES").
The data include participants from both the main study (FE200486 CS07; NCT00818623) and the extension study FE200486 CS07A.
Conditions Module
Conditions
Prostate Cancer
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
131Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Degarelix 120 mg (20 mg/mL)
Experimental
Degarelix 120 mg (20 mg/mL)
Drug: Degarelix
Degarelix 120 mg (40 mg/mL)
Experimental
Degarelix 120 mg (40 mg/mL)
Drug: Degarelix
Degarelix 160 mg (40 mg/mL)
Experimental
Degarelix 160 mg (40 mg/mL)
Drug: Degarelix
Degarelix 200 mg (40 mg/mL)
Experimental
Degarelix 200 mg (40 mg/mL)
Drug: Degarelix
Degarelix 200 mg (60 mg/mL)
Experimental
Degarelix 200 mg (60 mg/mL)
Drug: Degarelix
Degarelix 240 mg (40 mg/mL)
Experimental
Degarelix 240 mg (40 mg/mL)
Drug: Degarelix
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Degarelix
Drug
Degarelix 120 mg (20 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Liver Function Tests
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.
3 years
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.
3 years
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Males aged 18 or over
Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy)
Has completed Study FE200486 CS07
Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07
Accepts Healthy Volunteers
No
Sex
Male
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Development Support
Ferring Pharmaceuticals
Study Director
Locations
Not provided
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.
Results Section
Participant Flow Module
Pre-assignment Details
180 participants started the main study CS07 and 172 participants received degarelix treatment (intention-to-treat population). Of these, 131 participants were recruited into the extension study CS07A
Recruitment Details
Participants who responded to degarelix in FE200486 CS07 (NCT00818623) were eligible to enroll into this extension study with the intention of continuing treatment until degarelix became commercially available or until the study was discontinued. Participants received the same dose of degarelix as they received in FE200486 CS07.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
FG001
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
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
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Degarelix 240 mg (60 mg/mL)
Experimental
Degarelix 240 mg (60 mg/mL)
Drug: Degarelix
Degarelix 320 mg (60 mg/mL)
Experimental
Degarelix 320 mg (60 mg/mL)
Drug: Degarelix
Degarelix 120 mg (20 mg/mL)
FE200486
Degarelix
Drug
Degarelix 120 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix 120 mg (40 mg/mL)
FE200486
Degarelix
Drug
Degarelix 160 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix 160 mg (40 mg/mL)
FE200486
Degarelix
Drug
Degarelix 200 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix 200 mg (40 mg/mL)
FE200486
Degarelix
Drug
Degarelix 200 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix 200 mg (60 mg/mL)
FE200486
Degarelix
Drug
Degarelix 240 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix 240 mg (40 mg/mL)
FE200486
Degarelix
Drug
Degarelix 240 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix 240 mg (60 mg/mL)
FE200486
Degarelix
Drug
Degarelix 320 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Degarelix 320 mg (60 mg/mL)
FE200486
FG002
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
FG003
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
FG004
Degarelix 200mg (60mg/mL)
Degarelix 200 mg (60 mg/mL)
FG005
Degarelix 240mg (40mg/mL)
Degarelix 240 mg (40 mg/mL)
FG006
Degarelix 240mg (60mg/mL)
Degarelix 240 mg (60 mg/mL)
FG007
Degarelix 320mg (60mg/mL)
Degarelix 320 mg (60 mg/mL)
FG00026 subjects
FG00112 subjects
FG00213 subjects
FG00324 subjects
FG00427 subjects
FG00524 subjects
FG00627 subjects
FG00727 subjects
Intention-to-treat Population
FG00025 subjects
FG00112 subjects
FG00212 subjects
FG00324 subjects
FG00424 subjects
FG00524 subjects
FG00624 subjects
FG00727 subjects
Started FE200486 CS07A
FG00020 subjects
FG0016 subjects
FG0027 subjects
FG00324 subjects
FG00417 subjects
FG00520 subjects
FG00614 subjects
FG00723 subjects
COMPLETED
FG0004 subjectsParticipants ongoing at the time of study closure were considered to have completed the study.
FG0011 subjects
FG0022 subjects
FG0036 subjects
FG0044 subjects
FG0054 subjects
FG0064 subjects
FG00711 subjects
NOT COMPLETED
FG00022 subjects
FG00111 subjects
FG00211 subjects
FG00318 subjects
FG00423 subjects
FG00520 subjects
FG00623 subjects
FG00716 subjects
Type
Comment
Reasons
Adverse Event
FG0005 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
FG0043 subjects
FG0051 subjects
FG0060 subjects
FG0073 subjects
Withdrawal by Subject
FG0006 subjects
FG0013 subjects
FG0023 subjects
FG0031 subjects
FG004
Insuff prostate specific antigen resp
FG0003 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
Insufficient testosterone response
FG0005 subjects
FG0014 subjects
FG0021 subjects
FG00312 subjects
FG004
Other
FG0003 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
BG001
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
BG002
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
BG003
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
BG004
Degarelix 200mg (60mg/mL)
Degarelix 200 mg (60 mg/mL)
BG005
Degarelix 240mg (40mg/mL)
Degarelix 240 mg (40 mg/mL)
BG006
Degarelix 240mg (60mg/mL)
Degarelix 240 mg (60 mg/mL)
BG007
Degarelix 320mg (60mg/mL)
Degarelix 320 mg (60 mg/mL)
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00025
BG00112
BG00212
BG00324
BG00424
BG00524
BG00624
BG00727
BG008172
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Intention-to-treat (ITT) population.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age Continuous
ITT population.
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00070.0± 10.3
BG00173.8± 3.97
BG002
Sex: Female, Male
ITT population.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Race/Ethnicity, Customized
ITT population.
Number
participants
Title
Denominators
Categories
Caucasian
Title
Measurements
BG00025
BG00112
BG002
Curative intent
ITT population. A curative intent of Yes refers to participants who have been castrated via radical prostatectomy or radiotherapy.
Number
participants
Title
Denominators
Categories
Yes
Title
Measurements
BG0000
BG0010
BG002
Gleason score
ITT population. The Gleason score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10, with low numbers being the least aggressive and 10 being the most aggressive.
Number
participants
Title
Denominators
Categories
2-4
Title
Measurements
BG0004
BG001
Stage of prostate cancer
ITT population. Prostate cancer stage was classified to describe the extent of cancer. Localized refers to tumors without involvement of lymph nodes or metastasis. Advanced localized can be larger tumors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor.
Number
participants
Title
Denominators
Categories
Localized
Title
Measurements
BG00010
BG001
Body mass index
ITT population.
Mean
Standard Deviation
kilogram per square meter
Title
Denominators
Categories
Title
Measurements
BG00026.2± 2.97
BG00126.6± 4.58
BG002
Time since prostate cancer diagnosis
ITT population.
Mean
Standard Deviation
days
Title
Denominators
Categories
Title
Measurements
BG00083± 157
BG00166± 53
BG002
Weight
ITT population.
Mean
Standard Deviation
kilogram
Title
Denominators
Categories
Title
Measurements
BG00077.8± 12.4
BG00182.2± 12.1
BG002
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
Liver Function Tests
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.
The data include patients from both the main study (FE200486 CS07) and the extension study FE200486 CS07A
Posted
Number
participants
3 years
ID
Title
Description
OG000
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
OG001
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
OG002
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
OG003
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
OG004
Degarelix 200mg (60mg/mL)
Degarelix 200 mg (60 mg/mL)
OG005
Degarelix 240mg (40mg/mL)
Degarelix 240 mg (40 mg/mL)
OG006
Degarelix 240mg (60mg/mL)
Degarelix 240 mg (60 mg/mL)
OG007
Degarelix 320mg (60mg/mL)
Degarelix 320 mg (60 mg/mL)
Units
Counts
Participants
OG00025
OG00112
OG00212
OG003
Title
Denominators
Categories
Abnormal alanine aminotransferase (ALAT)
Title
Measurements
OG00011
OG0014
OG0023
OG003
Primary
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.
These data include patients from the main study (FE200486 CS07) and the extension study (FE200486 CS07A).
Posted
Number
participants
3 years
ID
Title
Description
OG000
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
OG001
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
OG002
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
OG003
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
OG004
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
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
8
18
EG001
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
4
10
EG002
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
3
9
EG003
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
7
24
EG004
Degarelix 200mg (60mg/mL)
Degarelix 200 mg (60 mg/mL)
8
17
EG005
Degarelix 240mg (40mg/mL)
Degarelix 240 mg (40 mg/mL)
5
22
EG006
Degarelix 240mg (60mg/mL)
Degarelix 240 mg (60 mg/mL)
3
12
EG007
Degarelix 320mg (60mg/mL)
Degarelix 320 mg (60 mg/mL)
9
19
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hypochromic anaemia
Blood and lymphatic system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected24 at risk
EG0041 events1 affected24 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected27 at risk
Cardiac failure
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0002 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Myocardial ischemia
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Mallory-weiss syndrome
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Mechanical ileus
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Disease progression
General disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pyrexia
General disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Asthenia
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Chest pain
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Sepsis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Caustic injury
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Metastases to lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Bladder transitional cell carcinoma stage iii
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Bronchial carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Laryngeal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Metastases to liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Metastasis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Metastatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0002 events2 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Metastatic pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Prostate cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Parkinson's disease
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Condition aggravated
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Oedema
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hepatitis toxic
Hepatobiliary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gangrene
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Areflexia
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Paraplegia
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Depression
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Amputation revision
Surgical and medical procedures
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hypertension
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG0032 events2 affected24 at risk
EG0040 events0 affected24 at risk
EG0050 events0 affected24 at risk
EG0061 events1 affected24 at risk
EG0070 events0 affected27 at risk
Angina pectoris
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Arrhytmia
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Phimosis
Congenital, familial and genetic disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cataract
Eye disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Glaucoma
Eye disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0002 events2 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0012 events2 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pyrexia
General disorders
MedDRA 9.0
Systematic Assessment
EG0002 events2 affected25 at risk
EG0010 events0 affected12 at risk
EG0022 events1 affected12 at risk
EG003
Fatigue
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Injection site erythema
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0022 events1 affected12 at risk
EG003
Injection site induration
General disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Injection site swelling
General disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0022 events1 affected12 at risk
EG003
Injection site pain
General disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0012 events2 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Oedema peripheral
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Chills
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Feeling of body temperature change
General disorders
MedDRA 9.0
Systematic Assessment
EG0003 events2 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Injection site pruritus
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Injection site reaction
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0004 events3 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0013 events3 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Influenza
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Injection site abscess
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Localised infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Nail infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Oral fungal infection
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0014 events1 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 9.0
Systematic Assessment
EG0005 events4 affected25 at risk
EG0012 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Alanine aminotranseferases increased
Investigations
MedDRA 9.0
Systematic Assessment
EG0005 events4 affected25 at risk
EG0013 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 9.0
Systematic Assessment
EG0004 events3 affected25 at risk
EG0013 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Weight decreased
Investigations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 9.0
Systematic Assessment
EG0003 events3 affected25 at risk
EG0013 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
White blood cells urine positive
Investigations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Blood pressure increased
Investigations
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Prostatic specific antigen increased
Investigations
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0012 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0002 events2 affected25 at risk
EG0010 events0 affected12 at risk
EG0022 events2 affected12 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0003 events2 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Arthritis reactive
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Metastatic pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 9.0
Systematic Assessment
EG0002 events2 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Headache
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Anosmia
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0003 events3 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0023 events2 affected12 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cystitis noninfective
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0002 events2 affected25 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0002 events2 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 9.0
Systematic Assessment
EG0006 events6 affected25 at risk
EG0012 events2 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0022 events1 affected12 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Skin reaction
Skin and subcutaneous tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hot flush
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0004 events4 affected25 at risk
EG0011 events1 affected12 at risk
EG0024 events3 affected12 at risk
EG003
Hypertension
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Stomach discomfort
Gastrointestinal disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Chest pain
General disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cystitis
Infections and infestations
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 9.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0012 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Flushing
Vascular disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 9.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript.