PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses o... | NCT03149549 | Trialant
NCT03149549
Sponsor
CytomX Therapeutics
Status
Terminated
Last Update Posted
Jan 5, 2024Actual
Enrollment
99Actual
Phase
Phase 1Phase 2
Conditions
Solid Tumor, Adult
Breast Cancer
Non Small Cell Lung Cancer
Head and Neck Cancer
Ovarian Cancer
Interventions
CX-2009
Countries
United States
Netherlands
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03149549
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CTMX-M-2009-001
Secondary IDs
Not provided
Brief Title
PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors
Official Title
A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009)
Acronym
Not provided
Organization
CytomX TherapeuticsINDUSTRY
Status Module
Record Verification Date
Jan 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Covid Pandemic; Business Decision to separate Phase 2 to new study
Expanded Access Info
No
Start Date
Jun 1, 2017Actual
Primary Completion Date
Sep 10, 2020Actual
Completion Date
Sep 10, 2020Actual
First Submitted Date
May 4, 2017
First Submission Date that Met QC Criteria
May 9, 2017
First Posted Date
May 11, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Oct 1, 2021
Results First Submitted that Met QC Criteria
Jan 3, 2024
Results First Posted Date
Jan 5, 2024Actual
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
Jan 3, 2024
Last Update Posted Date
Jan 5, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
CytomX TherapeuticsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
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 purpose of this first-in-human study of CX-2009 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009 in adult subjects with metastatic or locally advanced unresectable solid tumors. PROCLAIM: PRObody CLinical Assessment In Man CX-2009 clinical trial 001
PROBODY is a trademark of CytomX Therapeutics, Inc
The Number of Subjects Experiencing a Dose Limiting Toxicity at Various Dose Levels When Given CX-2009 as a Monotherapy
All AEs will be captured according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 and considered for assessment of DLTs as outlined by the criteria in Protocol Table 5.
21 days for the Q3W schedule, 28 days for the Q2W schedule
Secondary Outcomes
Measure
Description
Time Frame
Subjects Experiencing Anti-cancer Activity (ORR) at Various Dose Levels When Given CX-2009 as a Monotherapy
Efficacy will be assessed via objective response rate (ORR) by RECIST version 1.1. ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) on two consecutive tumor assessments with scan dates at least 4 weeks apart according to RECIST (version 1.1, refer to SAP section 13.1.1). Complete criteria for RECIST 1.1 are provided as an appendix to the protocol.
>
> For as long as a subject continues follow-up for response in the study, CT/MRI/Tumor assessment are to be conducted every 8 (+/- 1) weeks from the first dose of CX 2009 with assessment for response per
> RECIST Version 1.1
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of metastatic or locally advanced unresectable tumors
Patients demonstrating disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment,
Agreement to provide mandatory archival tissue or fresh biopsy.
At least 18 years of age.
Exclusion Criteria:
Active or chronic corneal disorder, history of corneal transplantation, active herpetic keratitis, and active ocular conditions requiring ongoing treatment/monitoring
Serious concurrent illness, including clinically relevant active infection
History of or current active autoimmune diseases
Significant cardiac disease such as recent myocardial infarction
History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;
Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;
Currently receiving anticoagulation therapy with warfarin;
Major surgery (requiring general anesthesia) within 3 months prior to dosing.
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
Monika Vainorius, MD
CytomX Therapeutics
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
USC Norris Comprehensive Cancer Center
Los Angeles
California
90033
United States
Yale University School of Medicine - Yale Cancer Center
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
The study was conducted in 4 parts (Part A, Part A2, Part B, and Part C1). Doses used were as follows: Parts A, A2, and B dosed 0.25, 0.5, 1, 2, 4, 5, 6, 7, 8, 9, and 10 mg/kg every 21 days, and Part C1: 4 and 6 mg/kg dosed every 14 days. A2 biomarker cohorts and Cohort B are pooled with A cohorts receiving the identical dose and schedule. Study periods are reported as defined in the protocol.
Columbia University College of Physicians & Surgeons, Columbia University
New York
New York
10032
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Providence Portland Medical Center
Portland
Oregon
97213
United States
The Sarah Cannon Research Institute
Nashville
Tennessee
37203
United States
MD Anderson Cancer Center
Houston
Texas
77030
United States
Huntsman Cancer Institute
Salt Lake City
Utah
84112
United States
Viriginia Cancer Specialists
Fairfax
Virginia
22031
United States
Swedish Cancer Institute (SCI)
Seattle
Washington
98104
United States
University of Wisconsin-Carbone Cancer Center
Madison
Wisconsin
53579
United States
Amsterdam UMC - Locatie VUmc
Amsterdam
1007
Netherlands
Universitair Medisch Centrum Groningen
Groningen
9713 GZ
Netherlands
Clinica Universidad de Navarra
Pamplona
Navarre
31008
Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynals
Barcelona
08908
Spain
Hospital Clinic Barcelona
Barcelona
8036
Spain
Centro Integral Oncologico Clara Campal
Madrid
28050
Spain
Instituto Valenciano de Oncologia
Valencia
46009
Spain
Beatson, West of Scotland Cancer Centre
Glasgow
G12 0YN
United Kingdom
Sarah Cannon Research Institute UK Limited
London
W1G 6AD
United Kingdom
Northern Centre for Cancer Care
Newcastle upon Tyne
NE7 7DN
United Kingdom
FG002
A 1 mg/kg Q3W
Part A 1mg/kg Q3W
FG003
A 2 mg/kg Q3W
Part A 2 mg/kg Q3W
FG004
A, A2 4 mg/kg Q3W
Parts A & A2 4 mg/kg Q3W
FG005
A, A2 5 mg/kg Q3W
Parts A & A2 5 mg/kg Q3W
FG006
A, A2 6 mg/kg Q3W
Parts A & A2 6 mg/kg Q3W
FG007
A, A2, B 7 mg/kg Q3W
Parts A, A2 & B 7 mg/kg Q3W
FG008
A, A2 8 mg/kg Q3W
Parts A & A2 8 mg/kg Q3W
FG009
A, A2 9 mg/kg Q3W
Parts A & A2 9 mg/kg Q3W
FG010
A, A2 10 mg/kg Q3W
Parts A & A2 10 mg/kg Q3W
FG011
C1 4 mg/kg Q2W
Part C1 4 mg/kg Q2W
FG012
C1 6 mg/kg Q2W
Part C1 6 mg/kg Q2W
FG0001 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG00410 subjects
FG0059 subjects
FG0069 subjects
FG00712 subjects
FG00822 subjects
FG0099 subjects
FG0108 subjects
FG0114 subjects
FG0126 subjects
COMPLETED
FG0001 subjects
FG0013 subjects
FG0023 subjects
FG0031 subjects
FG0046 subjects
FG0057 subjects
FG0066 subjects
FG0078 subjects
FG00816 subjects
FG0097 subjects
FG0108 subjects
FG0114 subjects
FG0124 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0044 subjects
FG0052 subjects
FG0063 subjects
FG0074 subjects
FG0086 subjects
FG0092 subjects
FG0100 subjects
FG0110 subjects
FG0122 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0042 subjects
FG0051 subjects
FG0061 subjects
FG0072 subjects
FG0084 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
Termination by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study Discontinuation--Follow-Up Period
Type
Comment
Milestone Data
STARTED
FG0001 subjects
FG0013 subjects
FG0023 subjects
FG0031 subjects
FG0046 subjects
FG0057 subjects
FG0066 subjects
FG0078 subjects
FG00816 subjects
FG0097 subjects
FG0108 subjects
FG0114 subjects
FG0124 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0013 subjects
FG0023 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Summaries are presented by dose and schedule. Specifically, all available data from Parts A, A2, and B is pooled by dose group; Part C1 dosing 4 mg/kg Q2W and 6 mg/kg Q2W are also presented by dose and schedule.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
A 0.25 mg/kg Q3W
Part A 0.25 mg/kg Q3W
BG001
A 0.5 mg/kg Q3W
Part A 0.5 mg/kg Q3W
BG002
A 1 mg/kg Q3W
Part A 1 mg/kg Q3W
BG003
A 2 mg/kg Q3W
Part A 2 mg/kg Q3W
BG004
A, A2 4 mg/kg Q3W
Parts A & A2 4 mg/kg Q3W
BG005
A, A2 5 mg/kg Q3W
Parts A & A2 5 mg/kg Q3W
BG006
A, A2 6 mg/kg Q3W
Parts A & A2 6 mg/kg Q3W
BG007
A, A2 7 mg/kg Q3W
Parts A & A2 7 mg/kg Q3W
BG008
A, A2 8 mg/kg Q3W
Parts A & A2 8 mg/kg Q3W
BG009
A, A2 9 mg/kg Q3W
Parts A & A2 9 mg/kg Q3W
BG010
A, A2 10 mg/kg Q3W
Parts A & A2 10 mg/kg Q3W
BG011
C1 4 mg/kg Q2W
Part C1 4 mg/kg Q2W
BG012
C1 6 mg/kg Q2W
Part C1 6 mg/kg Q2W
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0013
BG0023
BG0033
BG00410
BG0059
BG0069
BG00712
BG00822
BG0099
BG0108
BG0114
BG0126
BG01399
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00054(54 to 54)
BG00160(52 to 68)
BG00259(31 to 62)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
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
The Number of Subjects Experiencing a Dose Limiting Toxicity at Various Dose Levels When Given CX-2009 as a Monotherapy
All AEs will be captured according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 and considered for assessment of DLTs as outlined by the criteria in Protocol Table 5.
A DLT-evaluable subject is defined as one having received at least 1 dose of CX-2009 (or CX 2009 and CX-072) and then having completed the full DLT observation period (either 21 or 28 days depending on the schedule), or one who subsequently withdrew due to a drug-related toxicity.
Posted
Count of Participants
Participants
21 days for the Q3W schedule, 28 days for the Q2W schedule
ID
Title
Description
OG000
A 0.25 mg/kg Q3W
Part A 0.25 mg/kg Q3W
OG001
A 0.5 mg/kg Q3W
Part A 0.5 mg/kg Q3W
OG002
A 1 mg/kg Q3W
Part A 1 mg/kg Q3W
OG003
A 2 mg/kg Q3W
Part A 2 mg/kg Q3W
OG004
A, A2 4 mg/kg Q3W
Parts A & A2 4 mg/kg Q3W
OG005
A, A2 5 mg/kg Q3W
Parts A & A2 5 mg/kg Q3W
OG006
A, A2 6 mg/kg Q3W
Parts A & A2 6 mg/kg Q3W
OG007
A, A2, B 7 mg/kg Q3W
Parts A, A2 & B 7 mg/kg Q3W
OG008
A, A2 8 mg/kg Q3W
Parts A & A2 8 mg/kg Q3W
OG009
A, A2 9 mg/kg Q3W
Parts A & A2 9 mg/kg Q3W
OG010
A, A2 10 mg/kg Q3W
Parts A & A2 10 mg/kg Q3W
OG011
C1 4 mg/kg Q2W
Part C1 4 mg/kg Q2W
OG012
C1 6 mg/kg Q2W
Part C1 6 mg/kg Q2W
Units
Counts
Participants
OG0001
OG0013
OG0023
OG003
Title
Denominators
Categories
Participants not experiencing DLTs
Title
Measurements
OG0001
OG0013
OG0023
OG003
Secondary
Subjects Experiencing Anti-cancer Activity (ORR) at Various Dose Levels When Given CX-2009 as a Monotherapy
Efficacy will be assessed via objective response rate (ORR) by RECIST version 1.1. ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) on two consecutive tumor assessments with scan dates at least 4 weeks apart according to RECIST (version 1.1, refer to SAP section 13.1.1). Complete criteria for RECIST 1.1 are provided as an appendix to the protocol.
>
> For as long as a subject continues follow-up for response in the study, CT/MRI/Tumor assessment are to be conducted every 8 (+/- 1) weeks from the first dose of CX 2009 with assessment for response per
> RECIST Version 1.1
The response evaluable population includes all subjects in the safety analysis population who have an adequate baseline disease assessment and at least one post-baseline disease assessment.
Posted
Count of Participants
Participants
Median total on-study follow-up of 18.4 weeks.
ID
Title
Description
OG000
A 0.25 Q3W
Part A 0.25 mg/kg Q3W
OG001
A 0.5 mg/kg Q3W
Part A 0.5 mg/kg Q3W
OG002
A 1 mg/kg Q3W
Part A 1 mg/kg Q3W
Time Frame
AEs occurring after the ICF was signed and up to 30 days after the last dose of the study drug were reported (i.e. up to 62 weeks).
Description
Adverse events are reported by dose level. For tables by dose level, all available data from Parts A, A2, and B has been pooled (i.e. dose, schedule, and inclusion criteria are comparable).
Output for the all-cause mortality table includes deaths secondary to progression of disease.
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
Part A 0.25 mg/kg Q3W
A 0.25 mg/kg (Q3W)
1
1
0
1
1
1
EG001
Part A 0.5 mg/kg Q3W
A 0.5 mg/kg (Q3W)
3
3
0
3
3
3
EG002
Part A 1 mg/kg Q3W
A 1 mg/kg (Q3W)
3
3
0
3
2
3
EG003
Part A 2 mg/kg Q3W
A 2 mg/kg (Q3W)
2
3
1
3
3
3
EG004
Parts A & A2 4 mg/kgQ3W (4 in Part A, 6 inPart A2)
A, A2 4 mg/kg Q3W
6
10
2
10
10
10
EG005
Parts A & A2 5 mg/kgQ3W (3 in Part A, 6 inPart A2)
A, A2 5 mg/kg Q3W
4
9
2
9
9
9
EG006
Parts A & A2 6 mg/kgQ3W (3 in Part A, 6 inPart A2)
A, A2 6 mg/kg Q3W
6
9
3
9
9
9
EG007
Parts A, A2 & B 7mg/kg Q3W (3 in PartA, 6 in Part A2, 3 inPart B)
A, A2, B 7 mg/kg Q3W
6
12
5
12
12
12
EG008
Parts A & A2 8 mg/kgQ3W (16 in Part A, 6 inPart A2)
A, A2 8 mg/kg Q3W
13
22
10
22
22
22
EG009
Parts A & A2 9 mg/kgQ3W (3 in Part A, 6 inPart A2)
A, A2 9 mg/kg Q3W
7
9
5
9
9
9
EG010
Parts A & A2 10 mg/kgQ3W (5 in Part A, 3 inPart A2)
A, A2 10 mg/kg Q3W
6
8
3
8
8
8
EG011
Part C1 4 mg/kg Q2W
C1 4 mg/kg Q2W
1
4
1
4
4
4
EG012
Part C1 6 mg/kg Q2W
C1 6 mg/kg Q2W
2
6
1
6
6
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected12 at risk
EG0081 events1 affected22 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected4 at risk
EG0120 events0 affected6 at risk
Cardiac tamponade
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Keratitis
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
General physical health deterioration
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cellulitis orbital
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Device related infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Large intestine infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Septic shock
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haematoma muscle
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tumour ulceration
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Intracranial haematoma
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Seizure
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory arrest
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Embolism
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0046 events2 affected10 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected9 at risk
EG0076 events2 affected12 at risk
EG00813 events5 affected22 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected8 at risk
EG0110 events0 affected4 at risk
EG0120 events0 affected6 at risk
Lymph node pain
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ear disorder
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Primary adrenal insufficiency
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Asthenopia
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Astigmatism
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cataract
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Chalazion
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Corneal infiltrates
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dry eye
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eye pain
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eyelid ptosis
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Keratitis
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Keratopathy
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Orbital cyst
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Photophobia
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Presbyopia
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Punctate keratitis
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pupillary reflex impaired
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Retinal degeneration
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Visual impairment
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events2 affected3 at risk
EG0022 events2 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0024 events1 affected3 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events1 affected3 at risk
EG0022 events2 affected3 at risk
EG003
Feeling cold
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gait disturbance
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Infusion site erythema
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Infusion site phlebitis
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Malaise
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oedema
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral swelling
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Secretion discharge
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Adenoviral conjunctivitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Candida infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lip infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ophthalmic herpes zoster
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Stoma site infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Oral contusion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ammonia increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood calcium increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood glucose increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood iron decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Transaminases increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events2 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Seizure
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tremor
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Bladder pain
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vulvovaginal pain
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Allergic bronchitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Laryngeal oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pharyngeal hypoaesthesia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tooth extraction
Surgical and medical procedures
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Flushing
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hot flush
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
This study was terminated early due to the Covid Pandemic and the company's business decision to separate the Phase 2 (part B) course of the study to a separate, new Phase 2 study. The Phase 1 (part A) course of the study was completed and the RP2D was determined. Part B only enrolled 3 patients and the Secondary and other Outcomes were not analyzed.