An Investigational Immuno-therapy Study of Experimental M... | NCT02598960 | Trialant
NCT02598960
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Mar 6, 2023Actual
Enrollment
295Actual
Phase
Phase 1Phase 2
Conditions
Solid Tumors
Interventions
BMS-986156
Nivolumab
Countries
United States
Australia
Belgium
Canada
France
Germany
Italy
Netherlands
Spain
Switzerland
Protocol Section
Identification Module
NCT ID
NCT02598960
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA009-002
Secondary IDs
ID
Type
Description
Link
2015-002505-11
EudraCT Number
Brief Title
An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.
Official Title
A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination With Nivolumab (BMS-936558, Anti PD-1 Monoclonal Antibody) in Advanced Solid Tumors
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Feb 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 14, 2015Actual
Primary Completion Date
Dec 16, 2019Actual
Completion Date
Dec 16, 2019Actual
First Submitted Date
Oct 21, 2015
First Submission Date that Met QC Criteria
Nov 5, 2015
First Posted Date
Nov 6, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 15, 2022
Results First Submitted that Met QC Criteria
Feb 3, 2023
Results First Posted Date
Mar 6, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Dec 15, 2020
Certification/Extension First Submitted that Passed QC Review
Dec 15, 2020
Certification/Extension First Posted Date
Dec 21, 2020Actual
Last Update Submitted Date
Feb 3, 2023
Last Update Posted Date
Mar 6, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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 study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or cancers that have spread.
Detailed Description
Not provided
Conditions Module
Conditions
Solid Tumors
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
295Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
BMS-986156: Dose Escalation
Experimental
Drug: BMS-986156
BMS-986156 + nivolumab (nivo): Dose Escalation
Experimental
Drug: BMS-986156
Drug: Nivolumab
BMS-986156: Dose Expansion
Experimental
Drug: BMS-986156
BMS-986156 + nivolumab (nivo): Dose Expansion
Experimental
Drug: BMS-986156
Drug: Nivolumab
BMS986156 + Nivo: Cohort Expansion
Experimental
Drug: BMS-986156
Drug: Nivolumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BMS-986156
Drug
BMS-986156 + nivolumab (nivo): Dose Escalation
BMS-986156 + nivolumab (nivo): Dose Expansion
BMS-986156: Dose Escalation
BMS-986156: Dose Expansion
BMS986156 + Nivo: Cohort Expansion
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths
Number of participants with all cause adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and number of participant deaths.
AEs and laboratory values will be graded according to the NCI CTCAE version 4.03.
From first treatment to 100 days post last dose. Approximately 29 months
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Number of Participants with laboratory abnormalities in specific thyroid tests.
TSH = Thyroid stimulating hormone ULN = Upper limit number LLN = Lower limit number
From first treatment to 100 days post last dose. Approximately 29 months
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Number of Participants with laboratory abnormalities in specific liver tests.
ALT = alanine aminotransferase AST = aspartate aminotransferase ALP = alkaline phosphatase
From first treatment to 100 days post last dose. Approximately 29 months
Secondary Outcomes
Measure
Description
Time Frame
Best Overall Response
BOR will be defined by CR, PR, PD and SD
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
For Dose Escalation:
Subjects with any previously treated advanced (metastatic or refractory) solid tumor
For Cohort Expansion:
Subjects must have a previously treated advanced solid tumor to be eligible
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men
Exclusion Criteria:
Known central nervous system metastases or central nervous system as the only source of disease
Other concomitant malignancies (with some exceptions per protocol)
Active, known or suspected autoimmune disease
Uncontrolled or significant cardiovascular disease
History of active or chronic hepatitis (e.g. Hep B or C)
Impaired liver or bone marrow function
Major surgery less than 1 month before start of the study
Wang R, Baxi V, Li Z, Locke D, Hedvat C, Sun Y, Walsh AM, Shao X, Basavanhally T, Greenawalt DM, Patah P, Novosiadly R. Pharmacodynamic activity of BMS-986156, a glucocorticoid-induced TNF receptor-related protein agonist, alone or in combination with nivolumab in patients with advanced solid tumors. ESMO Open. 2023 Apr;8(2):100784. doi: 10.1016/j.esmoop.2023.100784. Epub 2023 Feb 28.
From first dose to a response or progressive disease (Approximately 50 Months)
Overall Response Rate
Defined as the percentage of all treated participants whose BOR is either a complete response(CR) or partial response(PR).
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose to CR and PR (Approximately 50 Months)
Progression Free Survival (PFS)
The time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first.
Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
From first dose to disease progression (Approximately 50 Months)
Duration of Response
All treated participants with a BOR of CR or PR, is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose to disease progression after a response (Approximately 50 Months)
Number of Participants With Anti-Drug Antibody Response
Number of participants with a positive Anti-Drug Antibody to BMS-986156 or nivolumab
At Cycle 3 Day 1; where each treatment cycle was 8 weeks
La Jolla
California
92093-0698
United States
Emory University
Atlanta
Georgia
30322
United States
The Ohio State University
Columbus
Ohio
43210
United States
Providence Portland Medical Center
Portland
Oregon
97213
United States
Thomas Jefferson University Hospital
Philadelphia
Pennsylvania
19107
United States
The West Clinic, P.C.
Germantown
Tennessee
38138
United States
Liverpool Cancer Therapy Center
Liverpool
New South Wales
2170
Australia
Local Institution
Westmead
New South Wales
2145
Australia
Princess Alexandra Hospital
Brisbane
Queensland
4102
Australia
Linear Clinical Research Ltd
Nedlands
Western Australia
6009
Australia
Local Institution - 0012
Ghent
9000
Belgium
Local Institution
Edmonton
Alberta
T6G 1Z2
Canada
Local Institution
Toronto
Ontario
M5G 1Z5
Canada
Local Institution
Paris
75248
France
Institut Claudius Regaud
Toulouse
31059
France
Institut Gustave Roussy
Vlllejuif
94800
France
Local Institution
Bonn
53127
Germany
Local Institution
Freiburg im Breisgau
79106
Germany
Local Institution
Würzburg
97080
Germany
Local Institution - 0015
Milan
Lombardy
20141
Italy
Local Institution - 0014
Milan
20133
Italy
Local Institution
Amsterdam
1066CX
Netherlands
Local Institution
Madrid
28040
Spain
Local Institution
Madrid
28041
Spain
Cantonal Hospital St. Gallen
Sankt Gallen
9007
Switzerland
Local Institution
Zurich
8091
Switzerland
Derived
Heinhuis KM, Carlino M, Joerger M, Di Nicola M, Meniawy T, Rottey S, Moreno V, Gazzah A, Delord JP, Paz-Ares L, Britschgi C, Schilder RJ, O'Byrne K, Curigliano G, Romano E, Patah P, Wang R, Liu Y, Bajaj G, Siu LL. Safety, Tolerability, and Potential Clinical Activity of a Glucocorticoid-Induced TNF Receptor-Related Protein Agonist Alone or in Combination With Nivolumab for Patients With Advanced Solid Tumors: A Phase 1/2a Dose-Escalation and Cohort-Expansion Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):100-107. doi: 10.1001/jamaoncol.2019.3848.
Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths
Number of participants with all cause adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and number of participant deaths.
AEs and laboratory values will be graded according to the NCI CTCAE version 4.03.
All Treated Participants
Posted
Count of Participants
Participants
From first treatment to 100 days post last dose. Approximately 29 months
ID
Title
Description
OG000
Part A: BMS-986156 10mg
BMS-986156 10mg Q2W
OG001
Part A: BMS-986156 30mg
BMS-986156 30mg Q2W
OG002
Part A: BMS-986156 100mg
BMS-986156 100mg Q2W
OG003
Part A: BMS-986156 240mg
BMS-986156 240mg Q2W
OG004
Part A: BMS-986156 800mg
BMS-986156 800mg Q2W
OG005
Part C: BMS-986156 240mg
BMS-986156 240mg Q2W
OG006
Part C: BMS-986156 800mg
BMS-986156 800mg Q2W
OG007
Part B: BMS-986156 30mg + Nivo 240mg
BMS986156 30mg Q2W + Nivo 240mg Q2W
OG008
Part B: BMS-986156 100mg + Nivo 240mg
BMS986156 100mg Q2W + Nivo 240mg Q2W
OG009
Part B: BMS-986156 240mg + Nivo 240mg
BMS986156 240mg Q2W + Nivo 240mg Q2W
OG010
Part B: BMS-986156 800mg + Nivo 240mg
BMS986156 800mg Q2W + Nivo 240mg Q2W
OG011
Part D: BMS-986156 240mg + Nivo 240mg
BMS986156 240mg Q2W + Nivo 240mg Q2W
OG012
Part E: BMS-986156 480mg + Nivo 480mg
BMS986156 480mg Q4W + Nivo 480mg Q4W
Units
Counts
Participants
OG0004
OG0016
OG0024
OG003
Title
Denominators
Categories
Adverse Events (AEs)
Title
Measurements
OG0004
OG0016
OG0024
OG003
Primary
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Number of Participants with laboratory abnormalities in specific thyroid tests.
TSH = Thyroid stimulating hormone ULN = Upper limit number LLN = Lower limit number
All treated participants with at least one on - treatment TSH measurement
Posted
Count of Participants
Participants
From first treatment to 100 days post last dose. Approximately 29 months
ID
Title
Description
OG000
Part A: BMS-986156 10mg
BMS-986156 10mg Q2W
OG001
Part A: BMS-986156 30mg
BMS-986156 30mg Q2W
OG002
Part A: BMS-986156 100mg
BMS-986156 100mg Q2W
OG003
Part A: BMS-986156 240mg
BMS-986156 240mg Q2W
OG004
Part A: BMS-986156 800mg
Primary
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Number of Participants with laboratory abnormalities in specific liver tests.
ALT = alanine aminotransferase AST = aspartate aminotransferase ALP = alkaline phosphatase
All treated participants with at least one on - treatment liver test measurement
Posted
Count of Participants
Participants
From first treatment to 100 days post last dose. Approximately 29 months
ID
Title
Description
OG000
Part A: BMS-986156 10mg
BMS-986156 10mg Q2W
OG001
Part A: BMS-986156 30mg
BMS-986156 30mg Q2W
OG002
Part A: BMS-986156 100mg
BMS-986156 100mg Q2W
OG003
Part A: BMS-986156 240mg
BMS-986156 240mg Q2W
OG004
Part A: BMS-986156 800mg
Secondary
Best Overall Response
BOR will be defined by CR, PR, PD and SD
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
All treated participants
Posted
Count of Participants
Participants
From first dose to a response or progressive disease (Approximately 50 Months)
ID
Title
Description
OG000
Part A: BMS-986156 10mg
BMS-986156 10mg Q2W
OG001
Part A: BMS-986156 30mg
BMS-986156 30mg Q2W
OG002
Part A: BMS-986156 100mg
Secondary
Overall Response Rate
Defined as the percentage of all treated participants whose BOR is either a complete response(CR) or partial response(PR).
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
All treated participants
Posted
Number
95% Confidence Interval
Percentage of participants
From first dose to CR and PR (Approximately 50 Months)
ID
Title
Description
OG000
Part A: BMS-986156 10mg
BMS-986156 10mg Q2W
OG001
Part A: BMS-986156 30mg
BMS-986156 30mg Q2W
OG002
Part A: BMS-986156 100mg
BMS-986156 100mg Q2W
OG003
Part A: BMS-986156 240mg
BMS-986156 240mg Q2W
OG004
Secondary
Progression Free Survival (PFS)
The time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first.
Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
All treated participants with evaluable PFS measures
Posted
Median
95% Confidence Interval
Months
From first dose to disease progression (Approximately 50 Months)
ID
Title
Description
OG000
Part A: BMS-986156 10mg
BMS-986156 10mg Q2W
OG001
Part A: BMS-986156 30mg
BMS-986156 30mg Q2W
OG002
Part A: BMS-986156 100mg
BMS-986156 100mg Q2W
OG003
Part A: BMS-986156 240mg
Secondary
Duration of Response
All treated participants with a BOR of CR or PR, is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
All treated participants with a CR or PR
Posted
Median
Full Range
Months
From first dose to disease progression after a response (Approximately 50 Months)
ID
Title
Description
OG000
Part A: BMS-986156 10mg
BMS-986156 10mg Q2W
OG001
Part A: BMS-986156 30mg
BMS-986156 30mg Q2W
OG002
Part A: BMS-986156 100mg
BMS-986156 100mg Q2W
OG003
Part A: BMS-986156 240mg
BMS-986156 240mg Q2W
Secondary
Number of Participants With Anti-Drug Antibody Response
Number of participants with a positive Anti-Drug Antibody to BMS-986156 or nivolumab
All BMS-986156 or Nivolumab Treated participants with Baseline and at Least One Post-baseline Assessment
Posted
Count of Participants
Participants
At Cycle 3 Day 1; where each treatment cycle was 8 weeks
ID
Title
Description
OG000
Part A: BMS-986156 10mg
BMS-986156 10mg Q2W
OG001
Part A: BMS-986156 30mg
BMS-986156 30mg Q2W
OG002
Part A: BMS-986156 100mg
BMS-986156 100mg Q2W
OG003
Part A: BMS-986156 240mg
BMS-986156 240mg Q2W
OG004
Part A: BMS-986156 800mg
BMS-986156 800mg Q2W
Time Frame
AEs/SAEs are collected from the first dose date until the last dose date + 100 days. (Approximately up to 29 months)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A: BMS-986156 10mg
BMS-986156 10mg Q2W
4
4
3
4
4
4
EG001
Part A: BMS-986156 30mg
Part A: BMS-986156 30mg Q2W
5
6
3
6
5
6
EG002
Part A: BMS-986156 100mg
BMS-986156 100mg Q2W
3
4
1
4
4
4
EG003
Part A: BMS-986156 240mg
Part A: BMS-986156 240mg Q2W
5
6
5
6
6
6
EG004
Part A: BMS-986156 800mg
BMS-986156 800mg Q2W
6
9
4
9
9
9
EG005
Part C: BMS-986156 240mg
BMS-986156 240mg Q2W
2
3
2
3
3
3
EG006
Part C: BMS-986156 800mg
BMS-986156 800mg Q2W
2
2
2
2
1
2
EG007
Part B: BMS-986156 30mg +Nivo 240mg
BMS-986156 30mg Q2W +Nivo 240mg Q2W
3
3
2
3
2
3
EG008
Part B: BMS-986156 100mg +Nivo 240mg
BMS-986156 100mg Q2W +Nivo 240mg Q2W
6
9
5
9
8
9
EG009
Part B: BMS-986156 240mg +Nivo 240mg
BMS-986156 240mg Q2W +Nivo 240mg Q2W
11
14
10
14
14
14
EG010
Part B: BMS-986156 800mg +Nivo 240mg
BMS-986156 800mg Q2W +Nivo 240mg Q2W
8
11
6
11
11
11
EG011
Part D: BMS-986156 240mg +Nivo 240mg
BMS-986156 240mg Q2W +Nivo 240mg Q2W
141
188
121
188
185
188
EG012
Part E: BMS-986156 480mg +Nivo 480mg
BMS-986156 480mg Q4W +Nivo 480mg Q4W
27
33
22
33
31
33
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG0030 affected6 at risk
EG0040 affected9 at risk
EG0050 affected3 at risk
EG0060 affected2 at risk
EG0070 affected3 at risk
EG0080 affected9 at risk
EG0090 affected14 at risk
EG0100 affected11 at risk
EG0112 affected188 at risk
EG0121 affected33 at risk
Bone marrow failure
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Endocarditis noninfective
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Ectopic antidiuretic hormone secretion
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Thyroid mass
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Rectal perforation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Disease progression
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
General physical health deterioration
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Inflammation
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Performance status decreased
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Extradural abscess
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hepatobiliary infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Septic shock
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Spinal cord infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Streptococcal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Stoma obstruction
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Stoma site extravasation
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Stoma site pain
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
General physical condition abnormal
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Malignant ascites
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0003 affected4 at risk
EG0012 affected6 at risk
EG0021 affected4 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Metastases to pancreas
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Seizure
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Thalamus haemorrhage
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Nephritis
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Ureteric haemorrhage
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Urogenital fistula
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Perineal pain
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Uterine haemorrhage
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Obstructive airways disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Arterial occlusive disease
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 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 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG0030 affected6 at risk
EG0041 affected9 at risk
EG0051 affected3 at risk
EG0060 affected2 at risk
EG0071 affected3 at risk
EG0080 affected9 at risk
EG0093 affected14 at risk
EG0102 affected11 at risk
EG01130 affected188 at risk
EG0125 affected33 at risk
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Dry eye
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Eye discharge
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Eye pain
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Periorbital swelling
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Vision blurred
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Visual impairment
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0013 affected6 at risk
EG0020 affected4 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected4 at risk
EG0012 affected6 at risk
EG0021 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected6 at risk
EG0021 affected4 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Mesenteric vein thrombosis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected4 at risk
EG0013 affected6 at risk
EG0021 affected4 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected6 at risk
EG0021 affected4 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Catheter site erythema
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Chest discomfort
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Chills
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Early satiety
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected4 at risk
EG0012 affected6 at risk
EG0021 affected4 at risk
EG003
Feeling abnormal
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Feeling hot
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Gait disturbance
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Influenza like illness
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Malaise
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Ear infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Epididymitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Furuncle
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Otitis media
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Abdominal injury
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Stoma site pain
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Amylase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Lipase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Weight decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Weight increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0012 affected6 at risk
EG0020 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Steroid diabetes
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected6 at risk
EG0021 affected4 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0021 affected4 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected6 at risk
EG0020 affected4 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected4 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)