Long-Term Safety and Efficacy Study of Deucravacitinib in... | NCT03920267 | Trialant
NCT03920267
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Mar 20, 2026Actual
Enrollment
261Actual
Phase
Phase 2
Conditions
Systemic Lupus Erythematosus
Interventions
BMS-986165
Countries
United States
Argentina
Brazil
Canada
Colombia
Hungary
Japan
Mexico
Poland
Romania
Russia
South Korea
Spain
Taiwan
Protocol Section
Identification Module
NCT ID
NCT03920267
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
IM011-074
Secondary IDs
ID
Type
Description
Link
2018-003471-35
EudraCT Number
Brief Title
Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus
Official Title
A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus Erythematosus
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Feb 2026
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
Mar 26, 2019Actual
Primary Completion Date
Mar 21, 2025Actual
Completion Date
Mar 21, 2025Actual
First Submitted Date
Mar 27, 2019
First Submission Date that Met QC Criteria
Apr 16, 2019
First Posted Date
Apr 18, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Feb 28, 2026
Results First Submitted that Met QC Criteria
Feb 28, 2026
Results First Posted Date
Mar 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
Feb 28, 2026
Last Update Posted Date
Mar 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)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The main objective of the trial is to characterize the long-term safety and tolerability of BMS-986165 in subjects with Systemic Lupus Erythematosus (SLE).
Detailed Description
Not provided
Conditions Module
Conditions
Systemic Lupus Erythematosus
Keywords
Systemic Lupus Erythematosus
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
261Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
BMS-986165 Dose 1
Experimental
Drug: BMS-986165
BMS-986165 Dose 2
Experimental
Drug: BMS-986165
BMS-986165 Dose 3
Experimental
Drug: BMS-986165
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BMS-986165
Drug
Specified dose on specified days
BMS-986165 Dose 1
BMS-986165 Dose 2
BMS-986165 Dose 3
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events and Treatment Emergent Serious Adverse Events
A Treatment-Emergent Adverse Event (TEAE) is any untoward medical occurrence that begins or worsens after the first dose of study treatment, including any unfavorable sign, symptom, disease, or abnormal lab finding, whether or not related to the product, and may include worsening of pre-existing conditions. A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered an important medical event requiring intervention to prevent these outcomes.
From Day 1 until 30 days after last dose (up to approximately 42 months)
Number of Participants With Abnormalities in Vital Signs
From Day 1 until 30 days after last dose (up to approximately 42 months)
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
Blood samples were collected to assess laboratory parameters. Grade 3 = Severe laboratory abnormality Grade 4 = Life-threatening or very severe laboratory abnormality
From Day 1 until 30 days after last dose (up to approximately 42 months)
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Completion of SLE Study (NCT03252587) through the protocol-required treatment period, and currently receiving blinded study drug. Note: If a subject is not receiving blinded study drug due to exceptional circumstances (eg, missed investigational product [IP] due to COVID-19 pandemic, delays in study approval, etc), the subject may be allowed to enroll with approval from the BMS Clinical Trial Physician or designee.
Exclusion Criteria:
Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or considered unsuitable by the investigator for any other reason
Evidence of active tuberculosis (TB)
Other protocol-defined inclusion/exclusion criteria apply
Qualified participants who completed the study IM011-021 (NCT03252587) were randomized in this study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
DEUC 12mg QD - DEUC 12mg QD
Participants with Systemic Lupus Erythematosus who received 12 mg of deucravacitinib once daily (QD) orally in the study IM011-021 received 12 mg tablet QD orally.
FG001
DEUC 6mg BID - DEUC 6mg BID
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jan 15, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Australia
Germany
Israel
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants who successfully complete the protocol-required treatment period of the Phase 2 SLE study (NCT03252587) will be offered the opportunity to continue this study.
National Hospital Organization Chibahigashi National Hospital
Chiba
Chiba
260-8712
Japan
Local Institution - 0092
Kitakyushu
Fukuoka
807-8556
Japan
Local Institution - 0119
Sapporo
Hokkaido
060-8604
Japan
Hokkaido University Hospital
Sapporo
Hokkaido
060-8648
Japan
Local Institution - 0063
Sendai
Miyagi
9808574
Japan
Local Institution - 0069
Shimotsuke
Tochigi
329-0498
Japan
Local Institution - 0065
Chuo-ku
Tokyo
104-8560
Japan
Local Institution - 0078
Tokyo
113-8431
Japan
Local Institution - 0066
Tokyo
162-8655
Japan
Local Institution - 0093
Tokyo
173-8610
Japan
Local Institution - 0080
León
Guanajuato
37000
Mexico
Local Institution - 0086
León
Guanajuato
37160
Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
Zapopan
Jalisco
45070
Mexico
Local Institution - 0087
Mexico City
Mexico City
06760
Mexico
Local Institution - 0084
Monterrey
Nuevo León
64000
Mexico
Local Institution - 0082
San Luis Potosà City
78213
Mexico
Local Institution - 0025
Bydgoszcz
85-168
Poland
Local Institution - 0015
Kościan
64-000
Poland
Local Institution - 0014
Krakow
30-363
Poland
Local Institution - 0027
Krakow
31-011
Poland
Local Institution - 0018
Krakow
31-637
Poland
Local Institution - 0016
Lublin
20-607
Poland
Local Institution - 0024
Poznan
60-218
Poland
Local Institution - 0029
Sosnowiec
41-200
Poland
Local Institution - 0019
Warsaw
02-172
Poland
Local Institution - 0022
Warsaw
02-665
Poland
Local Institution - 0010
Wroclaw
50-363
Poland
Local Institution - 0023
Wroclaw
52-416
Poland
Local Institution - 0033
Brasov
500283
Romania
Local Institution - 0004
Galati
800578
Romania
Local Institution - 0002
Râmnicu Vâlcea
240277
Romania
Local Institution - 0056
Kemerovo
650066
Russia
Local Institution - 0072
Novosibirsk
630099
Russia
Local Institution - 0057
Orenburg
460018
Russia
Local Institution - 0062
Saint Petersburg
191045
Russia
Local Institution - 0058
Saint Petersburg
197341
Russia
Local Institution - 0070
Smolensk
214025
Russia
Local Institution - 0055
Vladimir
600005
Russia
Local Institution - 0068
Yaroslavl
150023
Russia
Local Institution - 0060
Yaroslavl
150030
Russia
Local Institution - 0061
Yekaterinburg
620043
Russia
Local Institution
Seoul
110-744
South Korea
Local Institution - 0053
Suwon
16499
South Korea
Local Institution - 0126
Málaga
29010
Spain
Local Institution - 0138
Sabadell
08208
Spain
Local Institution - 0124
Seville
41014
Spain
Local Institution - 0052
Taichung
40201
Taiwan
Local Institution - 0051
Taipei
10002
Taiwan
Local Institution
Taipei
10630
Taiwan
Local Institution - 0137
Taipei
110
Taiwan
Participants with Systemic Lupus Erythematosus who received 6 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
FG002
DEUC 3mg BID - DEUC 3mg BID
Participants with Systemic Lupus Erythematosus who received 3 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
FG003
PBO BID - DEUC 12mg QD
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 12 mg tablet QD orally.
FG004
PBO BID - DEUC 6mg BID
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
FG005
PBO BID - DEUC 3mg BID
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
FG00058 subjects
FG00173 subjects
FG00267 subjects
FG00321 subjects
FG00421 subjects
FG00521 subjects
COMPLETED
FG00035 subjects
FG00144 subjects
FG00242 subjects
FG0038 subjects
FG00413 subjects
FG0059 subjects
NOT COMPLETED
FG00023 subjects
FG00129 subjects
FG00225 subjects
FG00313 subjects
FG0048 subjects
FG00512 subjects
Type
Comment
Reasons
Other reasons
FG00011 subjects
FG00111 subjects
FG00211 subjects
FG0036 subjects
FG0044 subjects
FG0055 subjects
Withdrawal by Subject
FG0003 subjects
FG0016 subjects
FG0024 subjects
FG0035 subjects
FG004
Site terminated by sponsor
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Pregnancy
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0002 subjects
FG0014 subjects
FG0021 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Adverse Event
FG0005 subjects
FG0017 subjects
FG0024 subjects
FG0032 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
DEUC 12mg QD - DEUC 12mg QD
Participants with Systemic Lupus Erythematosus who received 12 mg of deucravacitinib once daily (QD) orally in the study IM011-021 received 12 mg tablet QD orally.
BG001
DEUC 6mg BID - DEUC 6mg BID
Participants with Systemic Lupus Erythematosus who received 6 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
BG002
DEUC 3mg BID - DEUC 3mg BID
Participants with Systemic Lupus Erythematosus who received 3 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
BG003
PBO BID - DEUC 12mg QD
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 12 mg tablet QD orally.
BG004
PBO BID - DEUC 6mg BID
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
BG005
PBO BID - DEUC 3mg BID
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00058
BG00173
BG00267
BG00321
BG00421
BG00521
BG006261
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
BG00038.0± 9.56
BG00143.4± 11.87
BG00241.1± 12.32
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00051
BG00168
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00019
BG00120
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0002
BG0014
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
Number of Participants With Treatment-Emergent Adverse Events and Treatment Emergent Serious Adverse Events
A Treatment-Emergent Adverse Event (TEAE) is any untoward medical occurrence that begins or worsens after the first dose of study treatment, including any unfavorable sign, symptom, disease, or abnormal lab finding, whether or not related to the product, and may include worsening of pre-existing conditions. A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered an important medical event requiring intervention to prevent these outcomes.
All treated participants
Posted
Count of Participants
Participants
From Day 1 until 30 days after last dose (up to approximately 42 months)
ID
Title
Description
OG000
DEUC 12mg QD - DEUC 12mg QD
Participants with Systemic Lupus Erythematosus who received 12 mg of deucravacitinib once daily (QD) orally in the study IM011-021 received 12 mg tablet QD orally.
OG001
DEUC 6mg BID - DEUC 6mg BID
Participants with Systemic Lupus Erythematosus who received 6 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
OG002
DEUC 3mg BID - DEUC 3mg BID
Participants with Systemic Lupus Erythematosus who received 3 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
OG003
PBO BID - DEUC 12mg QD
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 12 mg tablet QD orally.
OG004
PBO BID - DEUC 6mg BID
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
OG005
PBO BID - DEUC 3mg BID
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
Units
Counts
Participants
OG00058
OG00173
OG00267
OG003
Title
Denominators
Categories
Treatment Emergent Adverse Events
Title
Measurements
OG00051
OG00163
OG00262
OG003
Primary
Number of Participants With Abnormalities in Vital Signs
From Day 1 until 30 days after last dose (up to approximately 42 months)
ID
Title
Description
OG000
DEUC 12mg QD - DEUC 12mg QD
Participants with Systemic Lupus Erythematosus who received 12 mg of deucravacitinib once daily (QD) orally in the study IM011-021 received 12 mg tablet QD orally.
OG001
DEUC 6mg BID - DEUC 6mg BID
Participants with Systemic Lupus Erythematosus who received 6 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
OG002
DEUC 3mg BID - DEUC 3mg BID
Participants with Systemic Lupus Erythematosus who received 3 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
OG003
PBO BID - DEUC 12mg QD
Primary
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
Blood samples were collected to assess laboratory parameters. Grade 3 = Severe laboratory abnormality Grade 4 = Life-threatening or very severe laboratory abnormality
All treated participants
Posted
Count of Participants
Participants
From Day 1 until 30 days after last dose (up to approximately 42 months)
ID
Title
Description
OG000
DEUC 12mg QD - DEUC 12mg QD
Participants with Systemic Lupus Erythematosus who received 12 mg of deucravacitinib once daily (QD) orally in the study IM011-021 received 12 mg tablet QD orally.
OG001
DEUC 6mg BID - DEUC 6mg BID
Participants with Systemic Lupus Erythematosus who received 6 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
OG002
DEUC 3mg BID - DEUC 3mg BID
Participants with Systemic Lupus Erythematosus who received 3 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
OG003
PBO BID - DEUC 12mg QD
Time Frame
All cause mortality was collected from first dose (Day 1) until study completion (up to approximately 312 weeks). AEs and SAEs were collected from first dose (Day 1) till 30 days after last dose (up to approximately 42 months).
Description
All treated population
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
DEUC 12mg QD - DEUC 12mg QD
Participants with Systemic Lupus Erythematosus who received 12 mg of deucravacitinib once daily (QD) orally in the study IM011-021 received 12 mg tablet QD orally.
0
58
13
58
43
58
EG001
DEUC 6mg BID - DEUC 6mg BID
Participants with Systemic Lupus Erythematosus who received 6 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
0
73
9
73
53
73
EG002
DEUC 3mg BID - DEUC 3mg BID
Participants with Systemic Lupus Erythematosus who received 3 mg of deucravacitinib twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
1
67
11
67
51
67
EG003
PBO BID - DEUC 12mg QD
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 12 mg tablet QD orally.
0
21
4
21
16
21
EG004
PBO BID - DEUC 6mg BID
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 6 mg tablet BID orally.
0
21
0
21
16
21
EG005
PBO BID - DEUC 3mg BID
Participants with Systemic Lupus Erythematosus who received placebo twice a day (BID) orally in the study IM011-021 received 3 mg tablet BID orally.
0
21
3
21
16
21
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Thrombotic thrombocytopenic purpura
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected73 at risk
EG0020 affected67 at risk
EG0030 affected21 at risk
EG004
Acute myocardial infarction
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0021 affected67 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0021 affected67 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0020 affected67 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected73 at risk
EG0020 affected67 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0020 affected67 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0021 affected67 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected73 at risk
EG0020 affected67 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 affected58 at risk
EG0010 affected73 at risk
EG0020 affected67 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected73 at risk
EG0021 affected67 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0012 affected73 at risk
EG0021 affected67 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0021 affected67 at risk
EG003
Device related infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected73 at risk
EG0020 affected67 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected73 at risk
EG0020 affected67 at risk
EG003
Infected dermal cyst
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0020 affected67 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected73 at risk
EG0020 affected67 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected73 at risk
EG0020 affected67 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected73 at risk
EG0020 affected67 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected73 at risk
EG0020 affected67 at risk
EG003
Acetabulum fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected73 at risk
EG0020 affected67 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected73 at risk
EG0020 affected67 at risk
EG003
Fracture displacement
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0020 affected67 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0021 affected67 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected73 at risk
EG0020 affected67 at risk
EG003
Anticoagulation drug level above therapeutic
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected73 at risk
EG0020 affected67 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected73 at risk
EG0020 affected67 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected73 at risk
EG0020 affected67 at risk
EG003
Systemic lupus erythematosus
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected58 at risk
EG0011 affected73 at risk
EG0021 affected67 at risk
EG003
Pancreatic neuroendocrine tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0021 affected67 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0020 affected67 at risk
EG003
Thymoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected73 at risk
EG0020 affected67 at risk
EG003
Cerebellar stroke
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0021 affected67 at risk
EG003
Intraventricular haemorrhage
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected73 at risk
EG0020 affected67 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected73 at risk
EG0020 affected67 at risk
EG003
Nervous system disorder
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected73 at risk
EG0020 affected67 at risk
EG003
Seizure
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0021 affected67 at risk
EG003
Thalamus haemorrhage
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected73 at risk
EG0020 affected67 at risk
EG003
Lupus nephritis
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0021 affected67 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected73 at risk
EG0020 affected67 at risk
EG003
Adnexa uteri cyst
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0020 affected67 at risk
EG003
Endometriosis
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0021 affected67 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0021 affected67 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected73 at risk
EG0020 affected67 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0021 affected67 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0015 affected73 at risk
EG0020 affected67 at risk
EG0031 affected21 at risk
EG0040 affected21 at risk
EG0051 affected21 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0011 affected73 at risk
EG0024 affected67 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0012 affected73 at risk
EG0023 affected67 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0003 affected58 at risk
EG0015 affected73 at risk
EG0023 affected67 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0014 affected73 at risk
EG0022 affected67 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0004 affected58 at risk
EG0012 affected73 at risk
EG0020 affected67 at risk
EG003
Chest pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected58 at risk
EG0010 affected73 at risk
EG0020 affected67 at risk
EG003
Asymptomatic bacteriuria
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0021 affected67 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0005 affected58 at risk
EG0011 affected73 at risk
EG0024 affected67 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00016 affected58 at risk
EG00121 affected73 at risk
EG00224 affected67 at risk
EG003
Cystitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0014 affected73 at risk
EG0025 affected67 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0003 affected58 at risk
EG0013 affected73 at risk
EG0023 affected67 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0003 affected58 at risk
EG0019 affected73 at risk
EG0025 affected67 at risk
EG003
Influenza
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 affected58 at risk
EG0014 affected73 at risk
EG0024 affected67 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00013 affected58 at risk
EG00110 affected73 at risk
EG00213 affected67 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0004 affected58 at risk
EG0015 affected73 at risk
EG0022 affected67 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0013 affected73 at risk
EG0024 affected67 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0010 affected73 at risk
EG0021 affected67 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 affected58 at risk
EG0016 affected73 at risk
EG0022 affected67 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0011 affected73 at risk
EG0027 affected67 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00011 affected58 at risk
EG00111 affected73 at risk
EG00213 affected67 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0008 affected58 at risk
EG00116 affected73 at risk
EG00211 affected67 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0012 affected73 at risk
EG0022 affected67 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0014 affected73 at risk
EG0022 affected67 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0021 affected67 at risk
EG003
Vaccination complication
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0014 affected73 at risk
EG0022 affected67 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0003 affected58 at risk
EG0010 affected73 at risk
EG0024 affected67 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0021 affected67 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0010 affected73 at risk
EG0020 affected67 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0015 affected73 at risk
EG0021 affected67 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0004 affected58 at risk
EG0017 affected73 at risk
EG0022 affected67 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected58 at risk
EG0012 affected73 at risk
EG0021 affected67 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0007 affected58 at risk
EG0015 affected73 at risk
EG0027 affected67 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected58 at risk
EG0013 affected73 at risk
EG0020 affected67 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected73 at risk
EG0022 affected67 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0003 affected58 at risk
EG0013 affected73 at risk
EG0021 affected67 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0011 affected73 at risk
EG0020 affected67 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected58 at risk
EG0014 affected73 at risk
EG0025 affected67 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