A Study of LY3076226 in Participants With Advanced or Met... | NCT02529553 | Trialant
NCT02529553
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Apr 17, 2020Actual
Enrollment
25Actual
Phase
Phase 1
Conditions
Advanced Cancer
Metastatic Cancer
Interventions
LY3076226
Countries
United States
Canada
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
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT02529553
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
15383
Secondary IDs
ID
Type
Description
Link
I7O-MC-JOBA
Other Identifier
Eli Lilly and Company
Brief Title
A Study of LY3076226 in Participants With Advanced or Metastatic Cancer
Official Title
A Phase 1 Study of LY3076226, a Fibroblast Growth Factor Receptor 3 (FGFR3) Antibody-Drug Conjugate, in Patients With Advanced or Metastatic Cancer
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Apr 2020
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
Sep 2015
Primary Completion Date
Mar 28, 2018Actual
Completion Date
Mar 28, 2018Actual
First Submitted Date
Aug 19, 2015
First Submission Date that Met QC Criteria
Aug 19, 2015
First Posted Date
Aug 20, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 8, 2020
Results First Submitted that Met QC Criteria
Apr 9, 2020
Results First Posted Date
Apr 17, 2020Actual
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
Apr 9, 2020
Last Update Posted Date
Apr 17, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
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
The main purpose of this study is to evaluate the safety of the study drug known as LY3076226 in participants with advanced or metastatic cancer.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Cancer
Metastatic Cancer
Keywords
bladder cancer
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
25Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LY3076226
Experimental
Part A (dose escalation in advanced cancer): LY3076226 administered intravenously (IV) on day 1 of each 21 day cycle.
Part B (dose expansion in advanced urothelial carcinoma): LY3076226 administered IV on day 1 of each 21 day cycle.
Drug: LY3076226
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY3076226
Drug
Administered IV
LY3076226
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Maximum Tolerated Dose (MTD) of LY3076226
The MTD was defined as the highest dose tested that had less than 33% probability of causing a dose limiting toxicity (DLT).
Cycle 1 (21 Days)
Secondary Outcomes
Measure
Description
Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3076226
Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hours
PK: Area Under the Concentration-Time Curve (AUC) of LY3076226
Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hours
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have advanced or metastatic cancer and be an appropriate candidate for experimental therapy.
Part B: Have a diagnosis of bladder cancer.
Part B: Have alterations of FGFR3.
Have adequate organ function.
Have discontinued previous treatments for cancer and have resolution, except where otherwise stated in the inclusion criteria, of all clinically significant toxic effects of prior chemotherapy, surgery, or radiotherapy to Grade ≤1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 (v 4.0).
If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug. If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 7 days of the first dose of study drug and must not be breastfeeding.
Exclusion Criteria:
Have received treatment within 28 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device (other than the study drug/device used in this study) or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Have preexisting corneal disease that may interfere with assessment for potential eye toxicity during the study.
Have preexisting Grade ≥2 skin disorder (for example, erythema, dermatitis).
Have serious preexisting medical conditions (left to the discretion of the investigator).
Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required). Participants with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least 28 days.
Have current acute or chronic leukemia.
Have an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
Have a second primary malignancy that, in the judgment of the investigator and sponsor, may affect the interpretation of results. Curatively treated nonmelanoma skin cancer or in situ carcinoma of any origin is allowed.
Have Fridericia-corrected QT interval (QTcF) >480 milliseconds on screening electrocardiogram (ECG).
Have a serious cardiac condition, such as congestive heart failure; New York Heart Association Class III/IV heart disease; unstable angina pectoris; myocardial infarction within the last 3 months; valvulopathy that is severe, moderate, or deemed clinically significant; or arrhythmias that are symptomatic or require treatment (not including participants with rate-controlled atrial fibrillation).
Accepts Healthy Volunteers
No
Sex
All
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
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Tumor response was assessed using confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST version 1.1). Complete response (CR) was the disappearance of all target and non-target lesions and normalization of tumor marker levels of non-target lesions; partial response (PR) was at least a 30% decrease in the sum of the longest diameter of target lesions.
Baseline through Study Completion (Cycle 3, day 21)
Charleston
South Carolina
29425
United States
The START Center for Cancer Care
San Antonio
Texas
78229
United States
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Vancouver
British Columbia
V5Z 4E6
Canada
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
3 subjects
FG0054 subjects
FG0063 subjects
FG0076 subjects
FG0083 subjects
3 subjects
FG0042 subjects
FG0053 subjects
FG0063 subjects
FG0075 subjects
FG0083 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
BG002
LY3076226-0.8mg/kg
Part A cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
BG003
LY3076226-1.6mg/kg
Part A cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
BG004
LY3076226-2.4mg/kg
Part A cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
BG005
LY3076226-3.2mg/kg
Part A cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
BG006
LY3076226-4.0mg/kg
Part A cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
BG007
LY3076226-5.0mg/kg
Part A cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
BG008
LY3076226-5.0mg/kg Dose Expansion
Part B dose expansion of LY3076226 at 5.0mg/kg.
BG009
Total
Total of all reporting groups
1
BG0011
BG0021
BG0033
BG0043
BG0054
BG0063
BG0076
BG0083
BG00925
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00041.0
BG00173.0
BG00256.0
BG00368.3± 1.5
BG00455.0± 6.2
BG00563.0± 5.5
BG00672.7± 9.8
BG00765.8± 8.7
BG00856.3± 5.9
BG00963.0± 9.5
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG0020
BG0032
BG0042
BG0054
BG0062
BG0072
BG0081
BG00913
Male
BG0001
BG0011
BG0021
BG0031
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG0020
BG0031
BG0041
BG0051
BG0061
BG0071
BG0080
BG0096
Not Hispanic or Latino
BG0000
BG0011
BG0021
BG0032
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
White
BG0001
BG0011
BG0021
BG0033
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Canada
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0042
BG0051
BG0061
BG0071
BG0082
BG0097
United States
Title
Measurements
BG0001
BG0011
BG0021
BG003
OG00022
Title
Denominators
Categories
Title
Measurements
OG0005.0
Secondary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3076226
All participants with adequate measurable PK concentrations.
Posted
Geometric Mean
Geometric Coefficient of Variation
Micrograms per milliliter(μg/mL)
Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hours
ID
Title
Description
OG000
LY3076226-0.2mg/kg
Cohort 1 of dose escalation of LY3076226 at 0.2 mg/kg.
OG001
LY3076226-0.4mg/kg
Cohort 2 of dose escalation of LY3076226 at 0.4mg/kg.
OG002
LY3076226-0.8mg/kg
Cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
OG003
LY3076226-1.6mg/kg
Cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
OG004
LY3076226-2.4mg/kg
Cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
OG005
LY3076226-3.2mg/kg
Cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
OG006
LY3076226-4.0mg/kg
Cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
OG007
LY3076226-5.0mg/kg
Cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
OG008
LY3076226-5.0mg/kg Dose Expansion
Dose expansion of LY3076226 at 5.0mg/kg.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG003
Secondary
PK: Area Under the Concentration-Time Curve (AUC) of LY3076226
All participants with adequate measurable PK concentrations.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg per day per mL(μg/day/mL)
Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hours
ID
Title
Description
OG000
LY3076226-0.2mg/kg
Cohort 1 of dose escalation of LY3076226 at 0.2 mg/kg.
OG001
LY3076226-0.4mg/kg
Cohort 2 of dose escalation of LY3076226 at 0.4mg/kg.
OG002
LY3076226-0.8mg/kg
Cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
OG003
LY3076226-1.6mg/kg
Cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
OG004
LY3076226-2.4mg/kg
Cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
OG005
LY3076226-3.2mg/kg
Cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
OG006
LY3076226-4.0mg/kg
Cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
OG007
LY3076226-5.0mg/kg
Cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
OG008
LY3076226-5.0mg/kg Dose Expansion
Dose expansion of LY3076226 at 5.0mg/kg.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
Cycle 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG003
Secondary
Number of Participants With Tumor Response
Tumor response was assessed using confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST version 1.1). Complete response (CR) was the disappearance of all target and non-target lesions and normalization of tumor marker levels of non-target lesions; partial response (PR) was at least a 30% decrease in the sum of the longest diameter of target lesions.
All enrolled participants.
Posted
Number
participants
Baseline through Study Completion (Cycle 3, day 21)
ID
Title
Description
OG000
LY3076226-0.2mg/kg
Cohort 1 of dose escalation of LY3076226 at 0.2 mg/kg.
OG001
LY3076226-0.4mg/kg
Cohort 2 of dose escalation of LY3076226 at 0.4mg/kg.
OG002
LY3076226-0.8mg/kg
Cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
OG003
LY3076226-1.6mg/kg
Cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
OG004
LY3076226-2.4mg/kg
Cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
OG005
LY3076226-3.2mg/kg
Cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
OG006
LY3076226-4.0mg/kg
Cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
OG007
LY3076226-5.0mg/kg
Cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
OG008
LY3076226-5.0mg/kg Dose Expansion
Dose expansion of LY3076226 at 5.0mg/kg.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
0
1
0
1
1
1
EG001
LY3076226-0.4mg/kg
Part A cohort 2 of dose escalation of LY3076226 at 0.4mg/kg.
0
1
1
1
1
1
EG002
LY3076226-0.8mg/kg
Part A cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
0
1
0
1
1
1
EG003
LY3076226-1.6mg/kg
Part A cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
0
3
1
3
3
3
EG004
LY3076226-2.4mg/kg
Part A cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
0
3
1
3
3
3
EG005
LY3076226-3.2mg/kg
Cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
0
4
0
4
4
4
EG006
LY3076226-4.0mg/kg
Cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
0
3
0
3
3
3
EG007
LY3076226-5.0mg/kg
Cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
0
6
1
6
6
6
EG008
LY3076226-5.0mg/kg Dose Expansion
Part B dose expansion of LY3076226 at 5.0mg/kg.
0
3
0
3
3
3
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Kidney infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Acute kidney injury
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0072 events1 affected6 at risk
EG0080 events0 affected3 at risk
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0071 events1 affected6 at risk
EG0081 events1 affected3 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Sinus bradycardia
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Sinus tachycardia
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Corneal epithelial microcysts
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected3 at risk
Dry eye
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Keratitis
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Photopsia
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0062 events1 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Retinal pigment epitheliopathy
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Vision blurred
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0042 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0062 events1 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0021 events1 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0062 events1 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Ascites
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Constipation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0072 events2 affected6 at risk
EG0080 events0 affected3 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0043 events1 affected3 at risk
EG0051 events1 affected4 at risk
EG0066 events3 affected3 at risk
EG0074 events4 affected6 at risk
EG0080 events0 affected3 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Dysphagia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Eructation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Gastritis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Nausea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0033 events2 affected3 at risk
EG0043 events3 affected3 at risk
EG0052 events2 affected4 at risk
EG0060 events0 affected3 at risk
EG0072 events2 affected6 at risk
EG0088 events2 affected3 at risk
Oesophageal pain
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Rectal discharge
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Vomiting
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0082 events1 affected3 at risk
Chest discomfort
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Chills
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0062 events1 affected3 at risk
EG0072 events1 affected6 at risk
EG0080 events0 affected3 at risk
Early satiety
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Fatigue
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0032 events2 affected3 at risk
EG0041 events1 affected3 at risk
EG0052 events2 affected4 at risk
EG0064 events3 affected3 at risk
EG0070 events0 affected6 at risk
EG0083 events2 affected3 at risk
Non-cardiac chest pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Oedema peripheral
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Pyrexia
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Cystitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected3 at risk
EG0071 events1 affected6 at risk
EG0081 events1 affected3 at risk
Nasal vestibulitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Oral candidiasis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Pharyngitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Sepsis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Skin infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Urinary tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0072 events2 affected6 at risk
EG0080 events0 affected3 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Thermal burn
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Alanine aminotransferase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0073 events3 affected6 at risk
EG0081 events1 affected3 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0032 events2 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0082 events1 affected3 at risk
Blood bilirubin increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Blood creatinine increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Platelet count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0072 events2 affected6 at risk
EG0083 events2 affected3 at risk
Weight decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0062 events1 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected4 at risk
EG0062 events2 affected3 at risk
EG0072 events1 affected6 at risk
EG0082 events1 affected3 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0032 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0081 events1 affected3 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0072 events1 affected6 at risk
EG0080 events0 affected3 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0072 events2 affected6 at risk
EG0080 events0 affected3 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0021 events1 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected3 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected3 at risk
Dysaesthesia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Dysgeusia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Headache
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0042 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0063 events2 affected3 at risk
EG0072 events1 affected6 at risk
EG0080 events0 affected3 at risk
Neuralgia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Paraesthesia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected3 at risk
Peripheral motor neuropathy
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected3 at risk
EG0072 events1 affected6 at risk
EG0081 events1 affected3 at risk
Spinal cord compression
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Syncope
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Tremor
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Anxiety
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Confusional state
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Depression
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Acute kidney injury
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Chromaturia
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Haematuria
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Urinary retention
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0081 events1 affected3 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0071 events1 affected6 at risk
EG0081 events1 affected3 at risk
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0062 events2 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected3 at risk
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0052 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected3 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0062 events1 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0062 events2 affected3 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected3 at risk
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0052 events1 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Embolism
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Hot flush
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected3 at risk
Hypertension
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected3 at risk
EG0073 events2 affected6 at risk
EG0080 events0 affected3 at risk
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
D014571
Urologic Neoplasms
D014565
Urogenital Neoplasms
D009371
Neoplasms by Site
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications