An Investigational Immunotherapy Study of BMS-986288 Alon... | NCT03994601 | Trialant
NCT03994601
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Jan 20, 2026Actual
Enrollment
219Actual
Phase
Phase 1Phase 2
Conditions
Advanced Cancer
Interventions
BMS-986288
Nivolumab
Regorafenib
Countries
United States
Argentina
Canada
Chile
France
Italy
Spain
Protocol Section
Identification Module
NCT ID
NCT03994601
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA043-001
Secondary IDs
ID
Type
Description
Link
2021-004284-27
EudraCT Number
Brief Title
An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
Official Title
A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Dec 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 6, 2019Actual
Primary Completion Date
Aug 31, 2024Actual
Completion Date
Aug 31, 2024Actual
First Submitted Date
Jun 17, 2019
First Submission Date that Met QC Criteria
Jun 20, 2019
First Posted Date
Jun 21, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Aug 28, 2025
Results First Submitted that Met QC Criteria
Dec 29, 2025
Results First Posted Date
Jan 20, 2026Actual
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
Dec 29, 2025
Last Update Posted Date
Jan 20, 2026Actual
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 determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
219Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm A: BMS-986288 Monotherapy
Experimental
Drug: BMS-986288
Arm B: BMS-986288 in combination with Nivolumab
Experimental
Drug: BMS-986288
Drug: Nivolumab
Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib
Experimental
Drug: BMS-986288
Drug: Nivolumab
Drug: Regorafenib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BMS-986288
Drug
Specified dose on specified days
Arm A: BMS-986288 Monotherapy
Arm B: BMS-986288 in combination with Nivolumab
Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Safety Related Events for Cohorts 1A, 1B and 2B.
Safety releated events for Cohorts 1A, 1B and 2B.
approximately 6 months
Dose Limiting Toxicities Cohorts 1A, 1B and 2B.
A DLT is an adverse event or abnormal lab value not related to disease progression, illness, or other medications. The DLT evaluation period is 5 weeks (35 days) for both BMS-986288 monotherapy and combination dose escalation. Toxicities beyond this period will inform final dose decisions. Participants who discontinue due to a DLT or complete the 5-week period after receiving at least 2 doses are considered DLT-evaluable. Those who withdraw early or receive fewer than 2 doses for non-DLT reasons are not evaluable and may be replaced. Participants with dose delays for non-DLT reasons remain evaluable if they receive at least 2 doses within 8 weeks.
approximately 5 weeks
Objective Response Rate by BICR in Cohort 2C
The percentage of all treated participants whose BOR is either CR or PR by BICR per RECIST v1.1.
approximately 2.15 Months
Secondary Outcomes
Measure
Description
Time Frame
Objective Response Rate in Cohorts 1A, 1B and 2B
The percentage of all treated participants whose BOR is either CR or PR by Investigator per RECIST v1.1.
approximately 2.15 Months
Duration of Response in Cohorts 1A, 1B and 2B
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies
Exclusion Criteria:
Active, known or suspected autoimmune disease
Active malignancy requiring concurrent intervention
Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis as the only site of disease, will be excluded
Other protocol-defined inclusion/exclusion criteria apply
Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib
Opdivo
BMS-936558
Regorafenib
Drug
Specified dose on specified days
Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib
Duration of response is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the 1st objectively documented tumor progression as determined by Investigator (per RECIST 1.1), or death due to any cause, whichever occurs first.
approximately 2.15 Months
Time to Response in Cohorts 1A, 1B and 2B
Time to response (TTR) assessed by investigator is defined as the time between the date of randomization and the first confirmed documented response (CR or PR) per RECIST 1.1 criteria.
approximately 2.15 Months
Progression Free Survival in Cohorts 1A, 1B and 2B
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by investigator or death due to any cause, whichever is earlier.
approximately 2.15 Months
Duration of Response by BICR in Cohort 2C
Duration of response is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the 1st objectively documented tumor progression as determined by BICR (per RECIST 1.1), or death due to any cause, whichever occurs first.
approximately 2.5 Months
PFS by BICR in Cohort 2C
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier.
approximately 2.5 Months
Overall Survival in Cohort 2C
OS is defined as the time from randomization to the time of death due to any cause.
approximately 2.5 Months
Objective Response Rate by Investigator in Cohort 2C
The percentage of all treated participants whose BOR is either CR or PR by Investigator per RECIST v1.1.
approximately 2.5 Months
Duration of Response by Investigator in Cohort 2C
Duration of response is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the 1st objectively documented tumor progression as determined by Investigator (per RECIST 1.1), or death due to any cause, whichever occurs first.
approximately 2.5 Months
PFS by Investigator in Cohort 2C
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by investigator or death due to any cause, whichever is earlier.
approximately 2.5 Months
Safety Related Events in Cohort 2C
Safety Related Events in Cohort 2C
approximately 6 Months
Dose Limiting Toxicities in Cohort 2C
A DLT is an adverse event or abnormal lab value not related to disease progression, illness, or other medications. The DLT evaluation period is 5 weeks (35 days) for both BMS-986288 monotherapy and combination dose escalation. Toxicities beyond this period will inform final dose decisions. Participants who discontinue due to a DLT or complete the 5-week period after receiving at least 2 doses are considered DLT-evaluable. Those who withdraw early or receive fewer than 2 doses for non-DLT reasons are not evaluable and may be replaced. Participants with dose delays for non-DLT reasons remain evaluable if they receive at least 2 doses within 8 weeks.
approximately 5 weeks
Cmax for Cohorts 1A, 1B and 2B
Cmax is defined as maximum plasma concentration of the drug.
On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
Tmax for Cohorts 1A, 1B and 2B
Tmax is defined is the time to maximum plasma concentration
On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
AUC(0-T) for Cohorts 1A, 1B and 2B
Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration.
On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
AUC(Tau) for Cohorts 1A, 1B and 2B
Area under the plasma concentration time-curve. AUC over the dosing interval.
On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
C(Tau) for Cohorts 1A, 1B and 2B
Ctau is defined as the concentration of study drug at the end of the dosing interval
On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
Orange
California
92868-3201
United States
Local Institution - 0005
Aurora
Colorado
80045
United States
Local Institution - 0002
Baltimore
Maryland
21287
United States
Local Institution - 0004
St Louis
Missouri
63110
United States
Local Institution - 0001
Hackensack
New Jersey
07601
United States
Local Institution - 0011
Ciudad Autónoma de Buenos Aires
Buenos Aires
1426
Argentina
Local Institution - 0074
Buenos Aires
Buenos Aires F.D.
C1096AAS
Argentina
Local Institution - 0014
Córdoba
Córdoba Province
X5000HXL
Argentina
Local Institution - 0013
Río Cuarto
Córdoba Province
5800
Argentina
Local Institution - 0008
ABB
Distrito Federal
C1199
Argentina
Local Institution - 0012
CABA
Distrito Federal
C1430
Argentina
Local Institution - 0017
Buenos Aires
1431
Argentina
Local Institution - 0016
Buenos Aires
C1280AEB
Argentina
Local Institution - 0006
Toronto
Ontario
M5G 2M9
Canada
Local Institution - 0042
Montreal
Quebec
H2X 0A9
Canada
Local Institution - 0046
Montreal
Quebec
H3T 1E2
Canada
Local Institution - 0036
Santiago
Santiago Metropolitan
7500921
Chile
Local Institution - 0019
Santiago
Santiago Metropolitan
7510032
Chile
Local Institution - 0035
Santiago
Santiago Metropolitan
7620002
Chile
Local Institution - 0009
Santiago
Santiago Metropolitan
8420383
Chile
Local Institution - 0010
Viña del Mar
Valparaiso
2520598
Chile
Local Institution - 0034
Bordeaux
Gironde
33075
France
Local Institution - 0022
Saint-Herblain
Loire-Atlantique
44800
France
Local Institution - 0018
Bron
69677
France
Local Institution - 0026
Marseille
13915
France
Local Institution - 0015
Paris
75248
France
Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
Toulon
83100
France
Local Institution - 0040
Milan
Lombardy
20133
Italy
Local Institution - 0038
Padova
Veneto
35128
Italy
Local Institution - 0028
Ancona
60126
Italy
Local Institution - 0033
Catanzaro
88100
Italy
Local Institution - 0031
Milan
20162
Italy
Local Institution - 0039
Roma
00168
Italy
Local Institution - 0056
Barcelona
Barcelona [Barcelona]
08035
Spain
Local Institution - 0054
Barcelona
Catalunya [Cataluña]
08036
Spain
Local Institution - 0023
Madrid
28041
Spain
Local Institution - 0024
Majadahonda
28222
Spain
Local Institution - 0055
Seville
41013
Spain
Local Institution - 0025
Valencia
46026
Spain
FG002
Treatment 1A: Cohort 3
BMS-986288 80mg Q4W
FG003
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
FG004
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
FG005
Treatment 1A: Cohort 6
BMS-986288 480mg Q4W
FG006
Treatment 1B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
FG007
Treatment 1B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
FG008
Treatment 1B: Cohort 3
BMS-986288 160mg + Nivo 480mg Q4W
FG009
Treatment 2B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
FG010
Treatment 2B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
FG011
Treatment 2C: Cohort 1
BMS-986288 120mg + Nivo 480mg Q4W
FG012
Treatment 2C: Cohort 2
Regorafenib 160mg PO QD first 21 days of 28-day cycle
FG0004 subjects
FG0014 subjects
FG0025 subjects
FG0036 subjects
FG0045 subjects
FG0055 subjects
FG0069 subjects
FG00740 subjects
FG0083 subjects
FG00947 subjects
FG01039 subjects
FG01134 subjects
FG01212 subjects
Crossing Over
Crossing over to Treatment 2C: Cohort 3 (BMS-986288 120mg + Nivo 480mg Q4W)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0124 subjectsOption to crossing over to Treatment 2C: Cohort 3 due to disease progression
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
NOT COMPLETED
FG0004 subjects
FG0014 subjects
FG0025 subjects
FG0036 subjects
FG0045 subjects
FG0055 subjects
FG0069 subjects
FG00740 subjects
FG0083 subjects
FG00947 subjects
FG01039 subjects
FG01133 subjects
FG01212 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0082 subjects
FG0097 subjects
FG0104 subjects
FG0111 subjects
FG0120 subjects
Withdrew Consent
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other Reasons
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Disease Progression
FG0003 subjects
FG0013 subjects
FG0024 subjects
FG0036 subjects
FG004
Study Drug Toxicity
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
AE Unrelated to Study Drug
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Request to Discontinue
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Treatment 1A: Cohort 1
BMS-986288 BMS 20mg Q4W
BG001
Treatment 1A: Cohort 2
BMS-986288 40mg Q4W
BG002
Treatment 1A: Cohort 3
BMS-986288 80mg Q4W
BG003
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
BG004
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
BG005
Treatment 1A: Cohort 6
BMS-986288 480mg Q4W
BG006
Treatment 1B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
BG007
Treatment 1B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
BG008
Treatment 1B: Cohort 3
BMS-986288 160mg + Nivo 480mg Q4W
BG009
Treatment 2B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
BG010
Treatment 2B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
BG011
Treatment 2C: Cohort 1
BMS-986288 120mg + Nivo 480mg Q4W
BG012
Treatment 2C: Cohort 2
Regorafenib 160mg PO QD first 21 days of 28-day cycle
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0014
BG0025
BG0036
BG0045
BG0055
BG0069
BG00740
BG0083
BG00947
BG01039
BG01134
BG01212
BG013213
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00064.8± 18.10
BG00161.3± 7.46
BG00263.4± 9.37
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0013
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
Safety Related Events for Cohorts 1A, 1B and 2B.
Safety releated events for Cohorts 1A, 1B and 2B.
Safety Population
Posted
Count of Participants
Participants
approximately 6 months
ID
Title
Description
OG000
Treatment 1A: Cohort 1
BMS-986288 BMS 20mg Q4W
OG001
Treatment 1A: Cohort 2
BMS-986288 40mg Q4W
OG002
Treatment 1A: Cohort 3
BMS-986288 80mg Q4W
OG003
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
OG004
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
OG005
Treatment 1A: Cohort 6
BMS-986288 480mg Q4W
OG006
Treatment 1B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
OG007
Treatment 1B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
OG008
Treatment 1B: Cohort 3
BMS-986288 160mg + Nivo 480mg Q4W
OG009
Treatment 2B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
OG010
Treatment 2B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
Units
Counts
Participants
OG0004
OG0014
OG0025
OG003
Title
Denominators
Categories
AEs
Title
Measurements
OG0004
OG0014
OG0025
OG003
Primary
Dose Limiting Toxicities Cohorts 1A, 1B and 2B.
A DLT is an adverse event or abnormal lab value not related to disease progression, illness, or other medications. The DLT evaluation period is 5 weeks (35 days) for both BMS-986288 monotherapy and combination dose escalation. Toxicities beyond this period will inform final dose decisions. Participants who discontinue due to a DLT or complete the 5-week period after receiving at least 2 doses are considered DLT-evaluable. Those who withdraw early or receive fewer than 2 doses for non-DLT reasons are not evaluable and may be replaced. Participants with dose delays for non-DLT reasons remain evaluable if they receive at least 2 doses within 8 weeks.
As Per Protocol, DLT Evaluable Participants in 1A, 1B and 2B.
Posted
Count of Participants
Participants
approximately 5 weeks
ID
Title
Description
OG000
Treatment 1A: Cohort 1
BMS-986288 BMS 20mg Q4W
OG001
Treatment 1A: Cohort 2
BMS-986288 40mg Q4W
OG002
Treatment 1A: Cohort 3
BMS-986288 80mg Q4W
OG003
Treatment 1A: Cohort 4
Primary
Objective Response Rate by BICR in Cohort 2C
The percentage of all treated participants whose BOR is either CR or PR by BICR per RECIST v1.1.
Safety Population
Posted
Number
95% Confidence Interval
Percentage or Participants
approximately 2.15 Months
ID
Title
Description
OG000
Treatment 2C: Cohort 1
BMS-986288 120mg + Nivo 480mg Q4W
OG001
Treatment 2C: Cohort 2
Regorafenib 160mg PO QD first 21 days of 28-day cycle
OG002
Treatment 2C: Cohort 3
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
Units
Counts
Participants
OG000
Secondary
Objective Response Rate in Cohorts 1A, 1B and 2B
The percentage of all treated participants whose BOR is either CR or PR by Investigator per RECIST v1.1.
All Treated Participants in Cohort 1A, 1B and 2B
Posted
Number
95% Confidence Interval
Percentage of Participants
approximately 2.15 Months
ID
Title
Description
OG000
Treatment 1A: Cohort 1
BMS-986288 BMS 20mg Q4W
OG001
Treatment 1A: Cohort 2
BMS-986288 40mg Q4W
OG002
Treatment 1A: Cohort 3
BMS-986288 80mg Q4W
OG003
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
OG004
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
Secondary
Duration of Response in Cohorts 1A, 1B and 2B
Duration of response is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the 1st objectively documented tumor progression as determined by Investigator (per RECIST 1.1), or death due to any cause, whichever occurs first.
All Treated Participants in Cohort 1A, 1B and 2B who achievied CR or PR
Posted
Median
95% Confidence Interval
months
approximately 2.15 Months
ID
Title
Description
OG000
Treatment 1A: Cohort 1
BMS-986288 BMS 20mg Q4W
OG001
Treatment 1A: Cohort 2
BMS-986288 40mg Q4W
OG002
Treatment 1A: Cohort 3
BMS-986288 80mg Q4W
OG003
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
OG004
Treatment 1A: Cohort 5
Secondary
Time to Response in Cohorts 1A, 1B and 2B
Time to response (TTR) assessed by investigator is defined as the time between the date of randomization and the first confirmed documented response (CR or PR) per RECIST 1.1 criteria.
All Treated Participants in Cohort 1A, 1B and 2B who achievied CR or PR
Posted
Mean
Standard Deviation
months
approximately 2.15 Months
ID
Title
Description
OG000
Treatment 1A: Cohort 1
BMS-986288 BMS 20mg Q4W
OG001
Treatment 1A: Cohort 2
BMS-986288 40mg Q4W
OG002
Treatment 1A: Cohort 3
BMS-986288 80mg Q4W
OG003
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
OG004
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
Secondary
Progression Free Survival in Cohorts 1A, 1B and 2B
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by investigator or death due to any cause, whichever is earlier.
All Treated Participants in Cohort 1A, 1B and 2B
Posted
Median
95% Confidence Interval
Months
approximately 2.15 Months
ID
Title
Description
OG000
Treatment 1A: Cohort 1
BMS-986288 BMS 20mg Q4W
OG001
Treatment 1A: Cohort 2
BMS-986288 40mg Q4W
OG002
Treatment 1A: Cohort 3
BMS-986288 80mg Q4W
OG003
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
OG004
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
Secondary
Duration of Response by BICR in Cohort 2C
Duration of response is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the 1st objectively documented tumor progression as determined by BICR (per RECIST 1.1), or death due to any cause, whichever occurs first.
All Treated Participants in Cohort 2C who achievied CR or PR
Posted
approximately 2.5 Months
ID
Title
Description
OG000
Treatment 2C: Cohort 1
BMS-986288 120mg + Nivo 480mg Q4W
OG001
Treatment 2C: Cohort 2
Regorafenib 160mg PO QD first 21 days of 28-day cycle
OG002
Treatment 2C: Cohort 3
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
Units
Counts
Participants
Secondary
PFS by BICR in Cohort 2C
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier.
Safety Population
Posted
Median
95% Confidence Interval
Months
approximately 2.5 Months
ID
Title
Description
OG000
Treatment 2C: Cohort 1
BMS-986288 120mg + Nivo 480mg Q4W
OG001
Treatment 2C: Cohort 2
Regorafenib 160mg PO QD first 21 days of 28-day cycle
OG002
Treatment 2C: Cohort 3
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
Units
Counts
Participants
OG000
Secondary
Overall Survival in Cohort 2C
OS is defined as the time from randomization to the time of death due to any cause.
Safety Population
Posted
Median
95% Confidence Interval
Months
approximately 2.5 Months
ID
Title
Description
OG000
Treatment 2C: Cohort 1
BMS-986288 120mg + Nivo 480mg Q4W
OG001
Treatment 2C: Cohort 2
Regorafenib 160mg PO QD first 21 days of 28-day cycle
OG002
Treatment 2C: Cohort 3
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
Units
Counts
Participants
OG000
Secondary
Objective Response Rate by Investigator in Cohort 2C
The percentage of all treated participants whose BOR is either CR or PR by Investigator per RECIST v1.1.
Safety Population
Posted
Number
95% Confidence Interval
Percentage or Participants
approximately 2.5 Months
ID
Title
Description
OG000
Treatment 2C: Cohort 1
BMS-986288 120mg + Nivo 480mg Q4W
OG001
Treatment 2C: Cohort 2
Regorafenib 160mg PO QD first 21 days of 28-day cycle
OG002
Treatment 2C: Cohort 3
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
Units
Counts
Participants
OG000
Secondary
Duration of Response by Investigator in Cohort 2C
Duration of response is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the 1st objectively documented tumor progression as determined by Investigator (per RECIST 1.1), or death due to any cause, whichever occurs first.
All Treated Participants in Cohort 2C who achievied CR or PR
Posted
approximately 2.5 Months
ID
Title
Description
OG000
Treatment 2C: Cohort 1
BMS-986288 120mg + Nivo 480mg Q4W
OG001
Treatment 2C: Cohort 2
Regorafenib 160mg PO QD first 21 days of 28-day cycle
OG002
Treatment 2C: Cohort 3
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
Units
Counts
Participants
Secondary
PFS by Investigator in Cohort 2C
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by investigator or death due to any cause, whichever is earlier.
Safety Population
Posted
Median
95% Confidence Interval
Months
approximately 2.5 Months
ID
Title
Description
OG000
Treatment 2C: Cohort 1
BMS-986288 120mg + Nivo 480mg Q4W
OG001
Treatment 2C: Cohort 2
Regorafenib 160mg PO QD first 21 days of 28-day cycle
OG002
Treatment 2C: Cohort 3
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
Units
Counts
Participants
OG000
Secondary
Safety Related Events in Cohort 2C
Safety Related Events in Cohort 2C
Safety Population
Posted
Count of Participants
Participants
approximately 6 Months
ID
Title
Description
OG000
Treatment 2C: Cohort 1
BMS-986288 120mg + Nivo 480mg Q4W
OG001
Treatment 2C: Cohort 2
Regorafenib 160mg PO QD first 21 days of 28-day cycle
OG002
Treatment 2C: Cohort 3
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
Units
Counts
Participants
OG000
Secondary
Dose Limiting Toxicities in Cohort 2C
A DLT is an adverse event or abnormal lab value not related to disease progression, illness, or other medications. The DLT evaluation period is 5 weeks (35 days) for both BMS-986288 monotherapy and combination dose escalation. Toxicities beyond this period will inform final dose decisions. Participants who discontinue due to a DLT or complete the 5-week period after receiving at least 2 doses are considered DLT-evaluable. Those who withdraw early or receive fewer than 2 doses for non-DLT reasons are not evaluable and may be replaced. Participants with dose delays for non-DLT reasons remain evaluable if they receive at least 2 doses within 8 weeks.
As Per Protocol, DLT Evaluable Participants in 2C.
Posted
Count of Participants
Participants
approximately 5 weeks
ID
Title
Description
OG000
Treatment 2C: Cohort 1
BMS-986288 120mg + Nivo 480mg Q4W
OG001
Treatment 2C: Cohort 2
Regorafenib 160mg PO QD first 21 days of 28-day cycle
OG002
Treatment 2C: Cohort 3
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
Secondary
Cmax for Cohorts 1A, 1B and 2B
Cmax is defined as maximum plasma concentration of the drug.
PK Evaluable Population
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
ID
Title
Description
OG000
Treatment 1A: Cohort 1
BMS-986288 BMS 20mg Q4W
OG001
Treatment 1A: Cohort 2
BMS-986288 40mg Q4W
OG002
Treatment 1A: Cohort 3
BMS-986288 80mg Q4W
OG003
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
OG004
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
OG005
Secondary
Tmax for Cohorts 1A, 1B and 2B
Tmax is defined is the time to maximum plasma concentration
PK Evaluable Population
Posted
Median
Full Range
Hours (H)
On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
ID
Title
Description
OG000
Treatment 1A: Cohort 1
BMS-986288 BMS 20mg Q4W
OG001
Treatment 1A: Cohort 2
BMS-986288 40mg Q4W
OG002
Treatment 1A: Cohort 3
BMS-986288 80mg Q4W
OG003
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
OG004
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
OG005
Treatment 1A: Cohort 6
Secondary
AUC(0-T) for Cohorts 1A, 1B and 2B
Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration.
PK Evaluable Population
Posted
Geometric Mean
Geometric Coefficient of Variation
H*ng/mL
On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
ID
Title
Description
OG000
Treatment 1A: Cohort 1
BMS-986288 BMS 20mg Q4W
OG001
Treatment 1A: Cohort 2
BMS-986288 40mg Q4W
OG002
Treatment 1A: Cohort 3
BMS-986288 80mg Q4W
OG003
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
OG004
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
Secondary
AUC(Tau) for Cohorts 1A, 1B and 2B
Area under the plasma concentration time-curve. AUC over the dosing interval.
PK Evaluable Population
Posted
Geometric Mean
Geometric Coefficient of Variation
H*ng/mL
On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
ID
Title
Description
OG000
Treatment 1A: Cohort 1
BMS-986288 BMS 20mg Q4W
OG001
Treatment 1A: Cohort 2
BMS-986288 40mg Q4W
OG002
Treatment 1A: Cohort 3
BMS-986288 80mg Q4W
OG003
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
OG004
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
OG005
Secondary
C(Tau) for Cohorts 1A, 1B and 2B
Ctau is defined as the concentration of study drug at the end of the dosing interval
PK Evaluable Population
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
On Cycle 1 Day 1 for Total and Intact, C4D1 for Intact
ID
Title
Description
OG000
Treatment 1A: Cohort 1
BMS-986288 BMS 20mg Q4W
OG001
Treatment 1A: Cohort 2
BMS-986288 40mg Q4W
OG002
Treatment 1A: Cohort 3
BMS-986288 80mg Q4W
OG003
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
OG004
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
OG005
Time Frame
Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
Description
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
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
Treatment 1A: Cohort 1
BMS-986288 BMS 20mg Q4W
3
4
3
4
4
4
EG001
Treatment 1A: Cohort 2
BMS-986288 40mg Q4W
4
4
3
4
4
4
EG002
Treatment 1A: Cohort 3
BMS-986288 80mg Q4W
5
5
4
5
5
5
EG003
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
2
6
3
6
6
6
EG004
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
3
5
5
5
5
5
EG005
Treatment 1A: Cohort 6
BMS-986288 480mg Q4W
5
5
5
5
5
5
EG006
Treatment 1B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
5
9
4
9
9
9
EG007
Treatment 1B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
26
40
29
40
40
40
EG008
Treatment 1B: Cohort 3
BMS-986288 160mg + Nivo 480mg Q4W
2
3
3
3
3
3
EG009
Treatment 2B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
34
47
34
47
47
47
EG010
Treatment 2B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
30
39
30
39
39
39
EG011
Treatment 2C: Cohort 1
BMS-986288 120mg + Nivo 480mg Q4W
12
34
24
34
34
34
EG012
Treatment 2C: Cohort 2
Regorafenib 160mg PO QD first 21 days of 28-day cycle
6
12
7
12
12
12
EG013
Treatment 2C: Cohort 3
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
1
4
3
4
4
4
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG0030 affected6 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected9 at risk
EG0070 affected40 at risk
EG0080 affected3 at risk
EG0091 affected47 at risk
EG0101 affected39 at risk
EG0111 affected34 at risk
EG0120 affected12 at risk
EG0130 affected4 at risk
Angina pectoris
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Immune-mediated myocarditis
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected5 at risk
EG003
Colonic fistula
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Gastrointestinal perforation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Immune-mediated enterocolitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Asthenia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Death
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Disease progression
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
General physical health deterioration
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Generalised oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Sudden death
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Immune-mediated hepatitis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Device related infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Large intestine infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Lung abscess
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected4 at risk
EG0021 affected5 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Skin infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Tracheitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Wound infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected5 at risk
EG003
Electrocardiogram T wave inversion
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Troponin I increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected5 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected5 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0002 affected4 at risk
EG0011 affected4 at risk
EG0020 affected5 at risk
EG003
Metastases to lymph nodes
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Tumour perforation
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Intracranial pressure increased
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Malignant spinal cord compression
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Seizure
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected5 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pulmonary thrombosis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Assisted suicide
Surgical and medical procedures
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG0030 affected6 at risk
EG0042 affected5 at risk
EG0052 affected5 at risk
EG0061 affected9 at risk
EG00715 affected40 at risk
EG0081 affected3 at risk
EG00911 affected47 at risk
EG0106 affected39 at risk
EG01117 affected34 at risk
EG0126 affected12 at risk
EG0131 affected4 at risk
Eosinophilia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Neutrophilia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected5 at risk
EG003
Atrial septal defect
Congenital, familial and genetic disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected5 at risk
EG003
Asthenopia
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Cataract
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Diplopia
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Dry eye
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected5 at risk
EG003
Glaucoma
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Iritis
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Keratitis
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Retinal vascular disorder
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Vision blurred
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected5 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Visual impairment
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Xerophthalmia
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected5 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected5 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0003 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected4 at risk
EG0021 affected5 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected5 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected5 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Immune-mediated enterocolitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Loose tooth
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Mucous stools
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected4 at risk
EG0010 affected4 at risk
EG0022 affected5 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Oral disorder
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Rectal discharge
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected4 at risk
EG0020 affected5 at risk
EG003
Asthenia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Catheter site pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Chest discomfort
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Chills
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Device related thrombosis
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Face oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG0002 affected4 at risk
EG0012 affected4 at risk
EG0021 affected5 at risk
EG003
Gait disturbance
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
General physical health deterioration
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Influenza like illness
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Localised oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected5 at risk
EG003
Pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Suprapubic pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Xerosis
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Ocular icterus
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Anorectal infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Candida infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Gastrointestinal viral infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Groin abscess
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Impetigo
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Influenza
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Lung abscess
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Oesophageal infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Oral fungal infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Perineal abscess
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Periodontitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Peritonitis bacterial
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pilonidal disease
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Skin infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected4 at risk
EG0020 affected5 at risk
EG003
Viral infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Craniofacial fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Radiation skin injury
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Scapula fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Amylase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood albumin increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood bilirubin abnormal
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood bilirubin unconjugated increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood calcium decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood calcium increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood glucose increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood potassium increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood sodium increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood thyroid stimulating hormone decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood urea increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Coagulation test abnormal
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Eosinophil count increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Lipase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Liver function test increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Monocyte count increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Neutrophil count increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pancreatic enzymes increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Transaminases increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Troponin I increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Troponin T increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Troponin increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Weight decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Weight increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Cell death
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected5 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hyperamylasaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hyperchloraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected5 at risk
EG003
Hyperlipasaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0022 affected5 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Underweight
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0013 affected4 at risk
EG0020 affected5 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected4 at risk
EG0020 affected5 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected5 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Metastatic malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected4 at risk
EG0021 affected5 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Fine motor skill dysfunction
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Myasthenic syndrome
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Paresis
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected5 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Syncope
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Vocal cord paralysis
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Depression
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected5 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Balanoposthitis
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Haematospermia
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Nipple pain
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Testicular pain
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Aphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 affected4 at risk
EG0012 affected4 at risk
EG0020 affected5 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pulmonary thrombosis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected5 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected5 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected5 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected5 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Skin toxicity
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected5 at risk
EG003
Embolism
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Flushing
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Hot flush
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected5 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected5 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Neurogenic shock
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Vena cava thrombosis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Venous thrombosis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected5 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.