Study of BMS-986158 in Subjects With Select Advanced Cancers | NCT02419417 | Trialant
NCT02419417
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Jun 16, 2022Actual
Enrollment
83Actual
Phase
Phase 1Phase 2
Conditions
Advanced Tumors
Interventions
BMS-986158
Nivolumab
Countries
United States
Australia
Canada
France
Spain
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT02419417
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA011-001
Secondary IDs
ID
Type
Description
Link
2015-000324-29
EudraCT Number
Brief Title
Study of BMS-986158 in Subjects With Select Advanced Cancers
Official Title
A Phase I/IIa Trial With BMS-986158, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, as Monotherapy or in Combination With Nivolumab in Subjects With Selected Advanced Solid Tumors or Hematologic Malignancies
Acronym
BET
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
May 2022
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
Jun 19, 2015Actual
Primary Completion Date
Mar 17, 2021Actual
Completion Date
Mar 17, 2021Actual
First Submitted Date
Apr 2, 2015
First Submission Date that Met QC Criteria
Apr 14, 2015
First Posted Date
Apr 17, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 10, 2022
Results First Submitted that Met QC Criteria
May 23, 2022
Results First Posted Date
Jun 16, 2022Actual
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
May 23, 2022
Last Update Posted Date
Jun 16, 2022Actual
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 the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986158 in subjects with select advanced cancers
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Tumors
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
83Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Monotherapy Treatment
Experimental
Patients treated at various doses and schedules
Drug: BMS-986158
Combination Therapy
Experimental
Patients treated at selected doses and schdules
Drug: BMS-986158
Biological: Nivolumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BMS-986158
Drug
Specified dose on specified days
Combination Therapy
Monotherapy Treatment
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Experiencing Adverse Events
Number of participants experiencing different types of events, including Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation and deaths.
Events are classified based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
From first dose to 30 days following last dose (up to approximately 29 months)
Number of Participants With Abnormal Hepatic Test Values
Number of participants experiencing abnormal hepatic function, as measured by different parameters.
ALT = Alanine aminotransferase AST = Aspartate aminotransferase ULN = Upper Limit of Normal
From first dose to 30 days following last dose (up to approximately 29 months)
Secondary Outcomes
Measure
Description
Time Frame
Best Overall Response (BOR)
BOR, as assessed by the investigator, is defined as the best response designation, recorded between the dates of first dose and the date of first objectively documented progression (per RECIST v1.1 for solid tumors, Lugano 2014 criteria for hematologic malignancies or PCWG3 for prostate cancer) or the date of subsequent therapy, whichever occurs first.
From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Must have select advanced cancers with specific genetic profiles
Must have received appropriate standard of care
At least one measurable lesion at baseline
Expected to have life expectancy of at least 3 months
Eastern Cooperative Oncology Group (ECOG) of 0 to 1
Exclusion Criteria:
Concomitant second malignancies
Uncontrolled or significant cardiovascular disease
Inadequate bone marrow function
Chronic gastrointestinal illness
Prior treatment with Bromodomain and Extra-Terminal (BET) inhibitor
Other protocol defined inclusion/exclusion criteria could apply
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
FG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
FG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
FG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
FG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
FG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
FG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
FG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
FG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
FG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
FG010
Part 2 Schedule A
BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses.
Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0005 subjects
FG0014 subjects
FG00213 subjects
FG00310 subjects
FG00413 subjects
FG0054 subjects
FG0064 subjects
FG0076 subjects
FG00813 subjects
FG00910 subjects
FG0101 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0005 subjects
FG0014 subjects
FG00213 subjects
FG00310 subjects
FG004
Type
Comment
Reasons
Disease progression
FG0005 subjects
FG0014 subjects
FG00213 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
BG001
Part 1 Schedule A - BMS-986158 1.25 mg
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Outcome Measures Module
Outcome Measures
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 Experiencing Adverse Events
Number of participants experiencing different types of events, including Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation and deaths.
Events are classified based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
All treated participants
Posted
Count of Participants
Participants
From first dose to 30 days following last dose (up to approximately 29 months)
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Adverse Events Module
Frequency Threshold
5
Time Frame
All-cause mortality was assessed from date of first dose to study completion (up to approximately 68 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 29 months).
Description
All treated participants
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
ORR is defined as the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR)
From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)
Duration of Response (DOR)
DOR is defined as the time between the date of first response and the date of the first objectively documented disease progression (as determined by RECIST v1.1 for solid tumors, Lugano 2014 criteria for hematologic malignancies, or PCWG3 (including PSA assessments) for prostate cancer [CRPC or NEPC]), or death due to any cause, whichever occurs first.
From date of first response to date of first objectively documented disease progression or death (up to approximately 42 weeks)
Progression Free Survival (PFS)
PFS is defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause.
From first dose to date of first objectively documented disease progression or death (up to approximately 28 months)
Progression Free Survival Rate (PFSR)
PFSR is defined as the percentage of participants who remain progression free and surviving at the specified timepoints (12 weeks, 24 weeks, and 48 weeks).
Reported values are estimates derived from Kaplan-Meier analyses
From first dose to 12 weeks, to 24 weeks, and to 48 weeks after first dose
Maximum Observed Plasma Concentration (Cmax) - Single Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Apparent Terminal Phase Half-Life (T-HALF) - Single Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Apparent Total Body Clearance (CLT/F) - Single Dose Administration
Values are reported only for the parent BMS-986158
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Apparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose Administration
Values are reported only for the parent BMS-986158
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
Maximum Observed Plasma Concentration (Cmax) - Multiple Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Time to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Minimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are reported only for the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Concentration at the End of Dosing Interval (C24) - Multiple Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are also reported separately for the first and last collection
From Cycle (C)2 Day (D)2 to C2D5 (Schedule A) or from C2D14 to C4D8 (Schedule B) or from C2D7 to C8D8 (Schedule C)
Accumulation Index (AI) - Multiple Dose Administration
AI is defined as the ratio of an exposure measure at steady-state to that after the first dose. Reported exposure measures include Cmax, C24 and AUC24.
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Cycle 2 Day 5 (Schedule A) or Cycle 2 Day 14 (Schedule B) or Cycle 2 Day 7 (Schedule C)
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Cycle 2 Day 5 (Schedule A) or Cycle 2 Day 14 (Schedule B) or Cycle 2 Day 7 (Schedule C)
Ratio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose Administration
Values are reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose Administration
Values are reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose Administration
Cycle 1 Day 1
Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose Administration
Values are reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
Change From Baseline in Electrocardiogram Parameter QTcF
QT Interval corrected for Fridericia's Formula. Change from baseline is calculated from pre-dose at the indicated timepoints.
From Cycle 1 Day 1 to last dosing day in Cycle 2 (C2D8 for Schedule A, C2D14 for Schedule B, C2D7 for Schedule C).
Aurora
Colorado
80045
United States
Dana Farber Cancer Institute.
Boston
Massachusetts
02215
United States
Oregon Health & Science University
Portland
Oregon
97239
United States
Univ. Of Pa
Philadelphia
Pennsylvania
19104
United States
Institute for Translational Oncology Research-ITOR
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
BG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
BG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
BG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
BG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
BG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
BG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
BG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
BG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
BG010
Part 2 Schedule A
BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses.
Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
BG011
Total
Total of all reporting groups
5
BG0014
BG00213
BG00310
BG00413
BG0054
BG0064
BG0076
BG00813
BG00910
BG0101
BG01183
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
Between 18 and 65 years
BG0004
BG0014
BG0027
BG0037
BG004
>=65 years
BG0001
BG0010
BG0026
BG0033
BG004
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00061.4± 7.2
BG00145.0± 9.4
BG00263.2± 12.1
BG00354.3± 16.4
BG00455.5± 15.4
BG00561.3± 3.0
BG00668.5± 5.4
BG00758.8± 2.7
BG00853.6± 9.1
BG00958.1± 9.9
BG01030.0± NAOnly 1 participant was treated in this arm
BG01157.3± 12.2
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0013
BG00212
BG0037
BG0049
BG0052
BG0063
BG0075
BG0089
BG0099
BG0100
BG01164
Male
BG0000
BG0011
BG0021
BG0033
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0071
BG0081
BG0091
BG0100
BG0113
Not Hispanic or Latino
BG0000
BG0011
BG0026
BG0036
BG004
Unknown or Not Reported
BG0005
BG0013
BG0027
BG0034
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
Asian
BG0000
BG0010
BG0021
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0011
BG0020
BG0030
BG004
White
BG0005
BG0013
BG00211
BG00310
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0021
BG0030
BG004
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG010
Part 2 Schedule A
BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses.
Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Units
Counts
Participants
OG0005
OG0014
OG00213
OG00310
OG00413
OG0054
OG0064
OG0076
OG00813
OG00910
OG0101
Title
Denominators
Categories
Adverse Events (AEs)
Title
Measurements
OG0005
OG0014
OG00213
OG00310
OG00413
OG0054
OG0064
OG0076
OG00813
OG0099
OG0101
Serious Adverse Events (SAEs)
Title
Measurements
OG0003
OG0013
OG0027
OG003
AEs leading to discontinuation
Title
Measurements
OG0000
OG0010
OG0020
OG003
Deaths
Title
Measurements
OG0000
OG0011
OG0022
OG003
Primary
Number of Participants With Abnormal Hepatic Test Values
Number of participants experiencing abnormal hepatic function, as measured by different parameters.
ALT = Alanine aminotransferase AST = Aspartate aminotransferase ULN = Upper Limit of Normal
All treated participants
Posted
Count of Participants
Participants
From first dose to 30 days following last dose (up to approximately 29 months)
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG010
Part 2 Schedule A
BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses.
Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Units
Counts
Participants
OG0005
OG0014
OG00213
OG003
Title
Denominators
Categories
ALT OR AST > 3XULN
Title
Measurements
OG0002
OG0011
OG0022
OG003
Secondary
Best Overall Response (BOR)
BOR, as assessed by the investigator, is defined as the best response designation, recorded between the dates of first dose and the date of first objectively documented progression (per RECIST v1.1 for solid tumors, Lugano 2014 criteria for hematologic malignancies or PCWG3 for prostate cancer) or the date of subsequent therapy, whichever occurs first.
All treated participants
Posted
Count of Participants
Participants
From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG010
Part 2 Schedule A
BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses.
Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Units
Counts
Participants
OG0005
OG0014
OG00213
OG003
Title
Denominators
Categories
Complete Response
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR)
All treated participants
Posted
Number
95% Confidence Interval
Percent of Participants
From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG010
Part 2 Schedule A
BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses.
Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Units
Counts
Participants
OG0005
OG0014
OG00213
OG003
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 52.2)
OG0010(0.0 to 60.2)
OG0020(0.0 to 24.7)
OG003
Secondary
Duration of Response (DOR)
DOR is defined as the time between the date of first response and the date of the first objectively documented disease progression (as determined by RECIST v1.1 for solid tumors, Lugano 2014 criteria for hematologic malignancies, or PCWG3 (including PSA assessments) for prostate cancer [CRPC or NEPC]), or death due to any cause, whichever occurs first.
All participants who achieved a Complete Response (CR) or Partial Response (PR)
Posted
Mean
Standard Deviation
Weeks
From date of first response to date of first objectively documented disease progression or death (up to approximately 42 weeks)
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG010
Part 2 Schedule A
BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses.
Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
Title
Measurements
OG00422.3± NAOnly 1 participant was analyzed in this cohort
OG01042.4± NAOnly 1 participant was analyzed in this cohort
Secondary
Progression Free Survival (PFS)
PFS is defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause.
All treated participants.
Posted
Median
95% Confidence Interval
Weeks
From first dose to date of first objectively documented disease progression or death (up to approximately 28 months)
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG010
Part 2 Schedule A
BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses.
Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Units
Counts
Participants
OG0005
OG0014
OG00213
OG003
Title
Denominators
Categories
Title
Measurements
OG0004.57(2.86 to 14.43)
OG0019.71(6.57 to 25.43)
OG0027.57(3.57 to 15.86)
OG003
Secondary
Progression Free Survival Rate (PFSR)
PFSR is defined as the percentage of participants who remain progression free and surviving at the specified timepoints (12 weeks, 24 weeks, and 48 weeks).
Reported values are estimates derived from Kaplan-Meier analyses
All treated participants.
Posted
Number
95% Confidence Interval
Percent of participants
From first dose to 12 weeks, to 24 weeks, and to 48 weeks after first dose
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG010
Part 2 Schedule A
BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses.
Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
Units
Counts
Participants
OG0005
OG0014
OG00213
OG003
Title
Denominators
Categories
12 weeks
Title
Measurements
OG00020.0(0.8 to 58.2)
OG00133.3(0.9 to 77.4)
OG00227.3(6.5 to 53.9)
OG003
Secondary
Maximum Observed Plasma Concentration (Cmax) - Single Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485
All treated participants with available measurements
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
ID
Title
Description
OG000
BMS-986158 0.75 mg
All participants treated with BMS-986158 at 0.75 mg dose, regardless of the dosing schedule.
OG001
BMS-986158 1.25 mg
All participants treated with BMS-986158 at 1.25 mg dose, regardless of the dosing schedule.
OG002
BMS-986158 2 mg
All participants treated with BMS-986158 at 2 mg dose, regardless of the dosing schedule.
OG003
BMS-986158 3 mg
All participants treated with BMS-986158 at 3 mg dose, regardless of the dosing schedule.
OG004
BMS-986158 4.5 mg
All participants treated with BMS-986158 at 4.5 mg dose, regardless of the dosing schedule.
Units
Counts
Participants
OG0005
OG0013
OG00216
OG003
Title
Denominators
Categories
Parent BMS-986158
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG00216
ParticipantsOG003
Secondary
Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485
All treated participants with available measurements
Posted
Median
Full Range
Hours
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
ID
Title
Description
OG000
BMS-986158 0.75 mg
All participants treated with BMS-986158 at 0.75 mg dose, regardless of the dosing schedule.
OG001
BMS-986158 1.25 mg
All participants treated with BMS-986158 at 1.25 mg dose, regardless of the dosing schedule.
OG002
BMS-986158 2 mg
All participants treated with BMS-986158 at 2 mg dose, regardless of the dosing schedule.
OG003
BMS-986158 3 mg
All participants treated with BMS-986158 at 3 mg dose, regardless of the dosing schedule.
OG004
BMS-986158 4.5 mg
All participants treated with BMS-986158 at 4.5 mg dose, regardless of the dosing schedule.
Units
Counts
Participants
OG0005
OG0013
OG00216
OG003
Title
Denominators
Categories
Parent BMS-986158
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG00216
ParticipantsOG003
Secondary
Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485
All treated participants with available measurements
Posted
Geometric Mean
Geometric Coefficient of Variation
hr*ng/mL
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
ID
Title
Description
OG000
BMS-986158 0.75 mg
All participants treated with BMS-986158 at 0.75 mg dose, regardless of the dosing schedule.
OG001
BMS-986158 1.25 mg
All participants treated with BMS-986158 at 1.25 mg dose, regardless of the dosing schedule.
OG002
BMS-986158 2 mg
All participants treated with BMS-986158 at 2 mg dose, regardless of the dosing schedule.
OG003
BMS-986158 3 mg
All participants treated with BMS-986158 at 3 mg dose, regardless of the dosing schedule.
OG004
BMS-986158 4.5 mg
All participants treated with BMS-986158 at 4.5 mg dose, regardless of the dosing schedule.
Units
Counts
Participants
OG0005
OG0013
OG00216
OG003
Title
Denominators
Categories
Parent BMS-986158
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG00216
ParticipantsOG003
Secondary
Apparent Terminal Phase Half-Life (T-HALF) - Single Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485
All treated participants with available measurements
Posted
Mean
Standard Deviation
hr
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
ID
Title
Description
OG000
BMS-986158 0.75 mg
All participants treated with BMS-986158 at 0.75 mg dose, regardless of the dosing schedule.
OG001
BMS-986158 1.25 mg
All participants treated with BMS-986158 at 1.25 mg dose, regardless of the dosing schedule.
OG002
BMS-986158 2 mg
All participants treated with BMS-986158 at 2 mg dose, regardless of the dosing schedule.
OG003
BMS-986158 3 mg
All participants treated with BMS-986158 at 3 mg dose, regardless of the dosing schedule.
OG004
BMS-986158 4.5 mg
All participants treated with BMS-986158 at 4.5 mg dose, regardless of the dosing schedule.
Units
Counts
Participants
OG0004
OG0013
OG00211
OG003
Title
Denominators
Categories
Parent BMS-986158
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG003
Secondary
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485
All treated participants with available measurements
Posted
Geometric Mean
Geometric Coefficient of Variation
hr*ng/mL
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
ID
Title
Description
OG000
BMS-986158 0.75 mg
All participants treated with BMS-986158 at 0.75 mg dose, regardless of the dosing schedule.
OG001
BMS-986158 1.25 mg
All participants treated with BMS-986158 at 1.25 mg dose, regardless of the dosing schedule.
OG002
BMS-986158 2 mg
All participants treated with BMS-986158 at 2 mg dose, regardless of the dosing schedule.
OG003
BMS-986158 3 mg
All participants treated with BMS-986158 at 3 mg dose, regardless of the dosing schedule.
OG004
BMS-986158 4.5 mg
All participants treated with BMS-986158 at 4.5 mg dose, regardless of the dosing schedule.
Units
Counts
Participants
OG0004
OG0013
OG00211
OG003
Title
Denominators
Categories
Parent BMS-986158
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG003
Secondary
Apparent Total Body Clearance (CLT/F) - Single Dose Administration
Values are reported only for the parent BMS-986158
All treated participants with available measurements
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/min
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
ID
Title
Description
OG000
BMS-986158 0.75 mg
All participants treated with BMS-986158 at 0.75 mg dose, regardless of the dosing schedule.
OG001
BMS-986158 1.25 mg
All participants treated with BMS-986158 at 1.25 mg dose, regardless of the dosing schedule.
OG002
BMS-986158 2 mg
All participants treated with BMS-986158 at 2 mg dose, regardless of the dosing schedule.
OG003
BMS-986158 3 mg
All participants treated with BMS-986158 at 3 mg dose, regardless of the dosing schedule.
OG004
BMS-986158 4.5 mg
All participants treated with BMS-986158 at 4.5 mg dose, regardless of the dosing schedule.
Units
Counts
Participants
OG0005
OG0013
OG00216
OG003
Title
Denominators
Categories
Title
Measurements
OG0005.04± 17
OG0012.97± 18
OG0023.41± 56
OG003
Secondary
Apparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose Administration
Values are reported only for the parent BMS-986158
All treated participants with available measurements
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters
From drug administration in Cycle 1 Day 1 to 168 hours post drug administration
ID
Title
Description
OG000
BMS-986158 0.75 mg
All participants treated with BMS-986158 at 0.75 mg dose, regardless of the dosing schedule.
OG001
BMS-986158 1.25 mg
All participants treated with BMS-986158 at 1.25 mg dose, regardless of the dosing schedule.
OG002
BMS-986158 2 mg
All participants treated with BMS-986158 at 2 mg dose, regardless of the dosing schedule.
OG003
BMS-986158 3 mg
All participants treated with BMS-986158 at 3 mg dose, regardless of the dosing schedule.
OG004
BMS-986158 4.5 mg
All participants treated with BMS-986158 at 4.5 mg dose, regardless of the dosing schedule.
Units
Counts
Participants
OG0004
OG0013
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG00014.7± 21
OG00112.5± 18
OG00214.8± 27
OG003
Secondary
Maximum Observed Plasma Concentration (Cmax) - Multiple Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
Units
Counts
Participants
OG0005
OG0014
OG0029
OG003
Title
Denominators
Categories
Parent BMS-986158 - Cycle 1 Day 1
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0029
ParticipantsOG003
Secondary
Time to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort
Posted
Median
Full Range
Hours
From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
Units
Counts
Participants
OG0005
OG0014
OG0029
OG003
Title
Denominators
Categories
Parent BMS-986158 - Cycle 1 day 1
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0029
ParticipantsOG003
Secondary
Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
Units
Counts
Participants
OG0005
OG0014
OG0029
OG003
Title
Denominators
Categories
Parent BMS-986158 - Cycle 1 day 1
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0029
ParticipantsOG003
Secondary
Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
Units
Counts
Participants
OG0005
OG0013
OG0029
OG003
Title
Denominators
Categories
Parent BMS-986158 - Cycle 1 day 1
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0029
ParticipantsOG003
Secondary
Minimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are reported only for the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
Units
Counts
Participants
OG0004
OG0014
OG0027
OG003
Title
Denominators
Categories
Parent BMS-986158 - Latest timepoint
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG003
Secondary
Concentration at the End of Dosing Interval (C24) - Multiple Dose Administration
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
Values are also reported separately for the first and last collection
All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
From Cycle (C)2 Day (D)2 to C2D5 (Schedule A) or from C2D14 to C4D8 (Schedule B) or from C2D7 to C8D8 (Schedule C)
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
Units
Counts
Participants
OG0004
OG0013
OG0024
OG003
Title
Denominators
Categories
Parent BMS-986158 - First collection
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG003
Secondary
Accumulation Index (AI) - Multiple Dose Administration
AI is defined as the ratio of an exposure measure at steady-state to that after the first dose. Reported exposure measures include Cmax, C24 and AUC24.
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
Cycle 2 Day 5 (Schedule A) or Cycle 2 Day 14 (Schedule B) or Cycle 2 Day 7 (Schedule C)
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.
All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort
Posted
Mean
Standard Deviation
Hours
Cycle 2 Day 5 (Schedule A) or Cycle 2 Day 14 (Schedule B) or Cycle 2 Day 7 (Schedule C)
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
Units
Counts
Participants
OG0003
OG0010
OG0020
OG003
Title
Denominators
Categories
Parent BMS-986158
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Ratio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose Administration
Values are reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort
Posted
Mean
Standard Deviation
Ratio
From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
Units
Counts
Participants
OG0005
OG0014
OG0028
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG003
Secondary
Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose Administration
Values are reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort
Posted
Mean
Standard Deviation
Ratio
From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
Units
Counts
Participants
OG0005
OG0014
OG0028
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG003
Secondary
Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose Administration
All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort
Posted
Mean
Standard Deviation
Ratio
Cycle 1 Day 1
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
Units
Counts
Participants
OG0001
OG0013
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.177± NAOnly 1 participant analyzed in this cohort
OG0010.131± 0.0426
OG0020.120± 0.0286
Secondary
Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose Administration
Values are reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)
All treated participants with available measurements. PK data not collected for the participant in Part 2 Schedule A cohort
Posted
Mean
Standard Deviation
Ratio
From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
Units
Counts
Participants
OG0005
OG0013
OG0028
OG003
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG003
Secondary
Change From Baseline in Electrocardiogram Parameter QTcF
QT Interval corrected for Fridericia's Formula. Change from baseline is calculated from pre-dose at the indicated timepoints.
All treated participants with available measurements at the indicated timepoints. PK data not collected for the participant in Part 2 Schedule A cohort
Posted
Mean
Standard Deviation
msec
From Cycle 1 Day 1 to last dosing day in Cycle 2 (C2D8 for Schedule A, C2D14 for Schedule B, C2D7 for Schedule C).
ID
Title
Description
OG000
Part 1 Schedule A - BMS-986158 0.75 mg
Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
OG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
OG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
OG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
Units
Counts
Participants
OG0004
OG0011
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG000-6.8± 11.63
OG001-5.3± NAOnly 1 participant analyzed in this cohort
OG002-3.3± 22.48
5
5
3
5
5
5
EG001
Part 1 Schedule A - BMS-986158 1.25 mg
Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
3
4
3
4
4
4
EG002
Part 1 Schedule A - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
10
13
7
13
12
13
EG003
Part 1 Schedule A - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
8
10
7
10
10
10
EG004
Part 1 Schedule A - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
12
13
9
13
13
13
EG005
Part 1 Schedule B - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
3
4
2
4
4
4
EG006
Part 1 Schedule B - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle
3
4
2
4
4
4
EG007
Part 1 Schedule C - BMS-986158 2 mg
Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
4
6
4
6
6
6
EG008
Part 1 Schedule C - BMS-986158 3 mg
Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
10
13
5
13
13
13
EG009
Part 1 Schedule C - BMS-986158 4.5 mg
Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle
7
10
3
10
9
10
EG010
Part 2 Schedule A
BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses.
Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle
0
1
0
1
1
1
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Thrombocytopenia
Blood and lymphatic system disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0062 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Myocardial infarction
Cardiac disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Abdominal pain
Gastrointestinal disorders
24.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Ascites
Gastrointestinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Duodenal obstruction
Gastrointestinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Intestinal obstruction
Gastrointestinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0042 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Nausea
Gastrointestinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0042 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Small intestinal obstruction
Gastrointestinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0021 affected13 at risk
EG0031 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0072 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Non-cardiac chest pain
General disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Pyrexia
General disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Biliary obstruction
Hepatobiliary disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Jaundice cholestatic
Hepatobiliary disorders
24.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Pneumonia
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0031 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Pyelonephritis
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Sepsis
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Upper respiratory tract infection
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Femur fracture
Injury, poisoning and procedural complications
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Dehydration
Metabolism and nutrition disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Flank pain
Musculoskeletal and connective tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Pathological fracture
Musculoskeletal and connective tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0021 affected13 at risk
EG0033 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Cerebrovascular accident
Nervous system disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0042 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Haemorrhage intracranial
Nervous system disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0031 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Seizure
Nervous system disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Confusional state
Psychiatric disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0031 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Acute kidney injury
Renal and urinary disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Vaginal fistula
Reproductive system and breast disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Vulvovaginal pain
Reproductive system and breast disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
24.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Pneumothorax
Respiratory, thoracic and mediastinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Hypotension
Vascular disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0024 affected13 at risk
EG0031 affected10 at risk
EG0049 affected13 at risk
EG0051 affected4 at risk
EG0062 affected4 at risk
EG0071 affected6 at risk
EG0084 affected13 at risk
EG0093 affected10 at risk
EG0100 affected1 at risk
Leukopenia
Blood and lymphatic system disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0101 affected1 at risk
Lymphopenia
Blood and lymphatic system disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Neutropenia
Blood and lymphatic system disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0031 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0101 affected1 at risk
Thrombocytopenia
Blood and lymphatic system disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0012 affected4 at risk
EG0023 affected13 at risk
EG0036 affected10 at risk
EG0048 affected13 at risk
EG0052 affected4 at risk
EG0064 affected4 at risk
EG0070 affected6 at risk
EG0085 affected13 at risk
EG0093 affected10 at risk
EG0101 affected1 at risk
Atrial flutter
Cardiac disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0031 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Cardiomyopathy
Cardiac disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Sinus tachycardia
Cardiac disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Tachycardia
Cardiac disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Ventricular extrasystoles
Cardiac disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
External ear pain
Ear and labyrinth disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Meniere's disease
Ear and labyrinth disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Tinnitus
Ear and labyrinth disorders
24.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Vertigo
Ear and labyrinth disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Dry eye
Eye disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Eye pain
Eye disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Eyelid oedema
Eye disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Lacrimation increased
Eye disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Vision blurred
Eye disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0031 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Vitreous floaters
Eye disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Abdominal discomfort
Gastrointestinal disorders
24.0
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0081 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Abdominal distension
Gastrointestinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0022 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Abdominal pain
Gastrointestinal disorders
24.0
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected4 at risk
EG0022 affected13 at risk
EG0031 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0083 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Abdominal pain upper
Gastrointestinal disorders
24.0
Systematic Assessment
EG0003 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0051 affected4 at risk
EG0062 affected4 at risk
EG0070 affected6 at risk
EG0082 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Constipation
Gastrointestinal disorders
24.0
Systematic Assessment
EG0002 affected5 at risk
EG0012 affected4 at risk
EG0025 affected13 at risk
EG0030 affected10 at risk
EG0044 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0072 affected6 at risk
EG0083 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Diarrhoea
Gastrointestinal disorders
24.0
Systematic Assessment
EG0003 affected5 at risk
EG0011 affected4 at risk
EG0026 affected13 at risk
EG0037 affected10 at risk
EG00410 affected13 at risk
EG0053 affected4 at risk
EG0062 affected4 at risk
EG0074 affected6 at risk
EG0088 affected13 at risk
EG0097 affected10 at risk
EG0101 affected1 at risk
Dry mouth
Gastrointestinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0021 affected13 at risk
EG0031 affected10 at risk
EG0043 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Dyspepsia
Gastrointestinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Dysphagia
Gastrointestinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Eructation
Gastrointestinal disorders
24.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Flatulence
Gastrointestinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Gingival pain
Gastrointestinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Haemorrhoidal haemorrhage
Gastrointestinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Melaena
Gastrointestinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Nausea
Gastrointestinal disorders
24.0
Systematic Assessment
EG0003 affected5 at risk
EG0013 affected4 at risk
EG0028 affected13 at risk
EG0033 affected10 at risk
EG0047 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0076 affected6 at risk
EG0087 affected13 at risk
EG0095 affected10 at risk
EG0100 affected1 at risk
Small intestinal obstruction
Gastrointestinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Stomatitis
Gastrointestinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Vomiting
Gastrointestinal disorders
24.0
Systematic Assessment
EG0003 affected5 at risk
EG0013 affected4 at risk
EG0027 affected13 at risk
EG0032 affected10 at risk
EG0046 affected13 at risk
EG0051 affected4 at risk
EG0061 affected4 at risk
EG0075 affected6 at risk
EG0085 affected13 at risk
EG0093 affected10 at risk
EG0100 affected1 at risk
Asthenia
General disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0022 affected13 at risk
EG0032 affected10 at risk
EG0043 affected13 at risk
EG0050 affected4 at risk
EG0062 affected4 at risk
EG0071 affected6 at risk
EG0083 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Catheter site pain
General disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Chest discomfort
General disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0031 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Chest pain
General disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Chills
General disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Early satiety
General disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Fatigue
General disorders
24.0
Systematic Assessment
EG0003 affected5 at risk
EG0014 affected4 at risk
EG00210 affected13 at risk
EG0033 affected10 at risk
EG0045 affected13 at risk
EG0054 affected4 at risk
EG0061 affected4 at risk
EG0072 affected6 at risk
EG0085 affected13 at risk
EG0095 affected10 at risk
EG0100 affected1 at risk
Influenza like illness
General disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Malaise
General disorders
24.0
Systematic Assessment
EG0002 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Mucosal inflammation
General disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Non-cardiac chest pain
General disorders
24.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Oedema peripheral
General disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0022 affected13 at risk
EG0030 affected10 at risk
EG0044 affected13 at risk
EG0050 affected4 at risk
EG0062 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Pain
General disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0032 affected10 at risk
EG0041 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Pyrexia
General disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Suprapubic pain
General disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Hepatic pain
Hepatobiliary disorders
24.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Hepatomegaly
Hepatobiliary disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Hyperbilirubinaemia
Hepatobiliary disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0063 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Jaundice
Hepatobiliary disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Abdominal infection
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0031 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Bronchitis
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Candida infection
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Enteritis infectious
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Herpes zoster
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0031 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0101 affected1 at risk
Influenza
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0031 affected10 at risk
EG0042 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Localised infection
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Oral herpes
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Paronychia
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Pneumonia
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected13 at risk
EG0031 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Pyuria
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Tooth infection
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Upper respiratory tract infection
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0031 affected10 at risk
EG0042 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Urinary tract infection
Infections and infestations
24.0
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0043 affected13 at risk
EG0051 affected4 at risk
EG0061 affected4 at risk
EG0072 affected6 at risk
EG0082 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Urosepsis
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Vaginal infection
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Viral infection
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Viral upper respiratory tract infection
Infections and infestations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Contusion
Injury, poisoning and procedural complications
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0042 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Eye contusion
Injury, poisoning and procedural complications
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Femur fracture
Injury, poisoning and procedural complications
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Post procedural haematoma
Injury, poisoning and procedural complications
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Post procedural haemorrhage
Injury, poisoning and procedural complications
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Postoperative ileus
Injury, poisoning and procedural complications
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Radiation retinopathy
Injury, poisoning and procedural complications
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Transfusion reaction
Injury, poisoning and procedural complications
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Alanine aminotransferase increased
Investigations
24.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0082 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Amylase increased
Investigations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0101 affected1 at risk
Aspartate aminotransferase increased
Investigations
24.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected4 at risk
EG0022 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0082 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Blood albumin decreased
Investigations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Blood bilirubin increased
Investigations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0044 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0101 affected1 at risk
Blood creatinine increased
Investigations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Blood uric acid increased
Investigations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Gamma-glutamyltransferase increased
Investigations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Haemoglobin decreased
Investigations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
International normalised ratio increased
Investigations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0042 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0101 affected1 at risk
Lipase increased
Investigations
24.0
Systematic Assessment
EG0003 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Lymphocyte count decreased
Investigations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Urine output decreased
Investigations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Weight decreased
Investigations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0021 affected13 at risk
EG0031 affected10 at risk
EG0045 affected13 at risk
EG0052 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0083 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
White blood cell count increased
Investigations
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Appetite disorder
Metabolism and nutrition disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Decreased appetite
Metabolism and nutrition disorders
24.0
Systematic Assessment
EG0002 affected5 at risk
EG0013 affected4 at risk
EG0026 affected13 at risk
EG0033 affected10 at risk
EG0047 affected13 at risk
EG0052 affected4 at risk
EG0062 affected4 at risk
EG0073 affected6 at risk
EG0083 affected13 at risk
EG0093 affected10 at risk
EG0100 affected1 at risk
Dehydration
Metabolism and nutrition disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0022 affected13 at risk
EG0031 affected10 at risk
EG0041 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0092 affected10 at risk
EG0100 affected1 at risk
Gout
Metabolism and nutrition disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Hyperglycaemia
Metabolism and nutrition disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Hyperkalaemia
Metabolism and nutrition disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Hypocalcaemia
Metabolism and nutrition disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0031 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0101 affected1 at risk
Hypokalaemia
Metabolism and nutrition disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected13 at risk
EG0032 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0071 affected6 at risk
EG0082 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0032 affected10 at risk
EG0043 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0082 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Hyponatraemia
Metabolism and nutrition disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0031 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Hypophosphataemia
Metabolism and nutrition disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0091 affected10 at risk
EG0101 affected1 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0031 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Arthritis
Musculoskeletal and connective tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0031 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Back pain
Musculoskeletal and connective tissue disorders
24.0
Systematic Assessment
EG0002 affected5 at risk
EG0011 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0043 affected13 at risk
EG0052 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0081 affected13 at risk
EG0092 affected10 at risk
EG0100 affected1 at risk
Flank pain
Musculoskeletal and connective tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Groin pain
Musculoskeletal and connective tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0031 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
24.0
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0043 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0092 affected10 at risk
EG0100 affected1 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0022 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Myalgia
Musculoskeletal and connective tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Neck pain
Musculoskeletal and connective tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0031 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Pain in jaw
Musculoskeletal and connective tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Balance disorder
Nervous system disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Dizziness
Nervous system disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0052 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0082 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Dysgeusia
Nervous system disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0031 affected10 at risk
EG0045 affected13 at risk
EG0052 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Headache
Nervous system disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0012 affected4 at risk
EG0024 affected13 at risk
EG0030 affected10 at risk
EG0042 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Migraine
Nervous system disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Neuralgia
Nervous system disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Neuropathy peripheral
Nervous system disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0031 affected10 at risk
EG0041 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Paraesthesia
Nervous system disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Parosmia
Nervous system disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Presyncope
Nervous system disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Somnolence
Nervous system disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Anxiety
Psychiatric disorders
24.0
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Confusional state
Psychiatric disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0031 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Insomnia
Psychiatric disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0052 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Mood altered
Psychiatric disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Acute kidney injury
Renal and urinary disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Chromaturia
Renal and urinary disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Chronic kidney disease
Renal and urinary disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Dysuria
Renal and urinary disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0082 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Hydronephrosis
Renal and urinary disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Pollakiuria
Renal and urinary disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Urinary retention
Renal and urinary disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Intermenstrual bleeding
Reproductive system and breast disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Pelvic pain
Reproductive system and breast disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Vaginal discharge
Reproductive system and breast disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Vaginal haemorrhage
Reproductive system and breast disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Vulvovaginal pain
Reproductive system and breast disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Cough
Respiratory, thoracic and mediastinal disorders
24.0
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected4 at risk
EG0023 affected13 at risk
EG0032 affected10 at risk
EG0044 affected13 at risk
EG0052 affected4 at risk
EG0060 affected4 at risk
EG0072 affected6 at risk
EG0083 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0031 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0012 affected4 at risk
EG0023 affected13 at risk
EG0031 affected10 at risk
EG0045 affected13 at risk
EG0052 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0086 affected13 at risk
EG0093 affected10 at risk
EG0100 affected1 at risk
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0044 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0101 affected1 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0022 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Sinus congestion
Respiratory, thoracic and mediastinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Wheezing
Respiratory, thoracic and mediastinal disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0072 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Alopecia
Skin and subcutaneous tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Decubitus ulcer
Skin and subcutaneous tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Dermatitis acneiform
Skin and subcutaneous tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0101 affected1 at risk
Dry skin
Skin and subcutaneous tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0034 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Erythema
Skin and subcutaneous tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Hyperkeratosis
Skin and subcutaneous tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Nail disorder
Skin and subcutaneous tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Night sweats
Skin and subcutaneous tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Photosensitivity reaction
Skin and subcutaneous tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Pruritus
Skin and subcutaneous tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0032 affected10 at risk
EG0041 affected13 at risk
EG0051 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0101 affected1 at risk
Rash
Skin and subcutaneous tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0021 affected13 at risk
EG0031 affected10 at risk
EG0043 affected13 at risk
EG0050 affected4 at risk
EG0062 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0091 affected10 at risk
EG0100 affected1 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0031 affected10 at risk
EG0042 affected13 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Skin disorder
Skin and subcutaneous tissue disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Deep vein thrombosis
Vascular disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0071 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Flushing
Vascular disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Hot flush
Vascular disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0051 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Hypertension
Vascular disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0061 affected4 at risk
EG0070 affected6 at risk
EG0082 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Hypotension
Vascular disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0041 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0080 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
Raynaud's phenomenon
Vascular disorders
24.0
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected4 at risk
EG0020 affected13 at risk
EG0030 affected10 at risk
EG0040 affected13 at risk
EG0050 affected4 at risk
EG0060 affected4 at risk
EG0070 affected6 at risk
EG0081 affected13 at risk
EG0090 affected10 at risk
EG0100 affected1 at risk
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.
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
10
BG0053
BG0062
BG0076
BG00812
BG0097
BG0101
BG01163
3
BG0051
BG0062
BG0070
BG0081
BG0093
BG0100
BG01120
4
BG0052
BG0061
BG0071
BG0084
BG0091
BG0101
BG01119
5
BG0052
BG0062
BG0074
BG0084
BG0096
BG0101
BG01137
8
BG0052
BG0062
BG0071
BG0088
BG0093
BG0100
BG01143
0
BG0050
BG0060
BG0070
BG0081
BG0091
BG0101
BG0114
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
1
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0112
10
BG0054
BG0064
BG0076
BG0088
BG0098
BG0100
BG01169
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
2
BG0050
BG0060
BG0070
BG0084
BG0091
BG0100
BG0118
7
OG0049
OG0052
OG0062
OG0074
OG0085
OG0093
OG0100
1
OG0043
OG0051
OG0060
OG0071
OG0080
OG0090
OG0100
4
OG0043
OG0050
OG0060
OG0071
OG0082
OG0090
OG0100
10
OG00413
OG0054
OG0064
OG0076
OG00813
OG00910
OG0101
2
OG0042
OG0050
OG0061
OG0070
OG0082
OG0092
OG0100
ALT OR AST > 5XULN
Title
Measurements
OG0001
OG0010
OG0022
OG0031
OG0042
OG0050
OG0060
OG0070
OG0082
OG0091
OG0100
ALT OR AST > 10XULN
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
ALT OR AST > 20XULN
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
TOTAL BILIRUBIN > 2XULN
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0044
OG0050
OG0061
OG0070
OG0080
OG0091
OG0101
CONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 1 DAY
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0070
OG0080
OG0091
OG0100
CONCURRENT ALT OR AST > 3XULN AND BILIRUB > 2XULN WITHIN 30 DAYS
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0040
OG0050
OG0061
OG0070
OG0080
OG0091
OG0100
10
OG00413
OG0054
OG0064
OG0076
OG00813
OG00910
OG0101
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Partial Response
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
Stable Disease
Title
Measurements
OG0001
OG0011
OG0022
OG0031
OG0047
OG0052
OG0061
OG0071
OG0084
OG0094
OG0100
Progressive Disease
Title
Measurements
OG0004
OG0012
OG0028
OG0037
OG0043
OG0052
OG0062
OG0072
OG0089
OG0094
OG0100
Unable to determine
Title
Measurements
OG0000
OG0011
OG0023
OG0032
OG0042
OG0050
OG0061
OG0073
OG0080
OG0092
OG0100
10
OG00413
OG0054
OG0064
OG0076
OG00813
OG00910
OG0101
0
(0.0 to 30.8)
OG0047.7(0.2 to 36.0)
OG0050(0.0 to 60.2)
OG0060(0.0 to 60.2)
OG0070(0.0 to 45.9)
OG0080(0.0 to 24.7)
OG0090(0.0 to 30.8)
OG010100.0(2.5 to 100.0)
0
OG0041
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
10
OG00413
OG0054
OG0064
OG0076
OG00813
OG00910
OG0101
7.43
(2.57 to 8.43)
OG00413.79(5.14 to 24.57)
OG00524.29(6.29 to 120.14)
OG0066.57(5.57 to 40.14)
OG0078.29(5.29 to NA)Insufficient number of events
OG0088.43(7.43 to 13.29)
OG0099.14(4.57 to 18.14)
OG010NA(NA to NA)Insufficient number of events
10
OG00413
OG0054
OG0064
OG0076
OG00813
OG00910
OG0101
11.1
(0.6 to 38.8)
OG00450.0(18.4 to 75.3)
OG00550.0(5.8 to 84.5)
OG00633.3(0.9 to 77.4)
OG00720.0(0.8 to 58.2)
OG00827.5(6.6 to 54.2)
OG00945.7(11.0 to 75.7)
OG010100.0(100.0 to 100.0)
24 weeks
Title
Measurements
OG0000.0(NA to NA)Insufficient number of events
OG00133.3(0.9 to 77.4)
OG0029.1(0.5 to 33.3)
OG00311.1(0.6 to 38.8)
OG00430.0(7.1 to 57.8)
OG00550.0(5.8 to 84.5)
OG00633.3(0.9 to 77.4)
OG0070.0(NA to NA)Insufficient number of events
OG00818.3(2.9 to 44.4)
OG0090.0(NA to NA)Insufficient number of events
OG010100.0(100.0 to 100.0)
48 weeks
Title
Measurements
OG0000.0(NA to NA)Insufficient number of events
OG0010.0(NA to NA)Insufficient number of events
OG0020.0(NA to NA)Insufficient number of events
OG0030.0(NA to NA)Insufficient number of events
OG0040.0(NA to NA)Insufficient number of events
OG00525.0(0.9 to 66.5)
OG0060.0(NA to NA)Insufficient number of events
OG0070.0(NA to NA)Insufficient number of events
OG0089.2(0.5 to 33.5)
OG0090.0(NA to NA)Insufficient number of events
OG010100.0(100.0 to 100.0)
25
OG00417
25
ParticipantsOG00417
Title
Measurements
OG00068.8± 23
OG001175± 36
OG002269± 25
OG003368± 30
OG004513± 25
Metabolite BMT-161485
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG00215
ParticipantsOG00324
ParticipantsOG00417
Title
Measurements
OG0005.00± 30
OG00110.0± 29
OG00218.2± 36
OG003
25
OG00417
25
ParticipantsOG00417
Title
Measurements
OG0004.00(2.00 to 4.02)
OG0011.00(1.00 to 2.00)
OG0021.04(0.500 to 4.03)
OG0031.02(0.500 to 6.15)
OG0042.02(1.00 to 4.03)
Metabolite BMT-161485
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG00215
ParticipantsOG00324
ParticipantsOG00417
Title
Measurements
OG00024.0(2.55 to 24.2)
OG0012.00(2.00 to 24.0)
OG0026.00(1.00 to 72.0)
OG003
25
OG00417
25
ParticipantsOG00417
Title
Measurements
OG0001027± 16
OG0012309± 13
OG0023533± 25
OG0034989± 38
OG0047039± 34
Metabolite BMT-161485
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG00215
ParticipantsOG00324
ParticipantsOG00417
Title
Measurements
OG00098.2± 34
OG001188± 11
OG002310± 35
OG003
18
OG00414
18
ParticipantsOG00414
Title
Measurements
OG00033.7± 1.41
OG00148.7± 6.66
OG00254.3± 19.87
OG00342.7± 19.56
OG00443.8± 15.75
Metabolite BMT-161485
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG00311
ParticipantsOG00410
Title
Measurements
OG00035.3± NAOnly 1 participants analyzed in this cohort
OG00150.8± 6.26
OG00248.8± 18.78
OG003
18
OG00414
18
ParticipantsOG00414
Title
Measurements
OG0002479± 18
OG0017013± 17
OG0029775± 56
OG00311677± 44
OG00418974± 40
Metabolite BMT-161485
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG00311
ParticipantsOG00410
Title
Measurements
OG000409± NAOnly 1 participants analyzed in this cohort
OG001892± 13
OG002944± 73
OG003
25
OG00417
4.28
± 62
OG0043.95± 33
18
OG00414
14.4
± 28
OG00414.1± 31
10
OG00410
OG0051
OG0064
OG0076
OG00811
OG0097
10
ParticipantsOG00410
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0076
ParticipantsOG00811
ParticipantsOG0097
Title
Measurements
OG00068.8± 23
OG001175± 36
OG002260± 20
OG003328± 36
OG004478± 24
OG005207± NAOnly 1 participant analyzed in this cohort
OG006481± 25
OG007295± 29
OG008370± 22
OG009567± 24
Parent BMS-986158 - Latest timepoint
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG000136± 43
OG001284± 16
OG002442± 29
OG003
Metabolite BMT-161485 - Cycle 1 Day 1
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0076
ParticipantsOG00811
ParticipantsOG0097
Title
Measurements
OG0005.00± 30
OG00110.0± 29
OG00216.9± 32
OG003
Metabolite BMT-161485 -Latest timepoint
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG00025.8± 82
OG00131.0± 25
OG00249.4± 46
OG003
10
OG00410
OG0051
OG0064
OG0076
OG00811
OG0097
10
ParticipantsOG00410
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0076
ParticipantsOG00811
ParticipantsOG0097
Title
Measurements
OG0004.00(2.00 to 4.02)
OG0011.00(1.00 to 2.00)
OG0022.00(1.00 to 4.03)
OG0032.00(0.983 to 6.15)
OG0042.04(1.00 to 4.03)
OG0051.00(1.00 to 1.00)
OG0061.03(1.00 to 4.03)
OG0071.00(0.500 to 2.03)
OG0081.00(0.500 to 2.02)
OG0092.02(1.00 to 4.00)
Parent BMS-986158 - Latest timepoint
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG0003.14(2.00 to 6.05)
OG0011.50(0.500 to 2.00)
OG0022.00(0.500 to 4.02)
OG003
Metabolite BMT-161485 - Cycle 1 Day 1
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0076
ParticipantsOG00811
ParticipantsOG0097
Title
Measurements
OG00024.0(2.55 to 24.2)
OG0012.00(2.00 to 24.0)
OG0025.08(2.00 to 72.0)
OG003
Metabolite BMT-161485 -Latest timepoint
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG00024.0(24.0 to 24.0)
OG0014.00(1.50 to 6.00)
OG0022.07(0 to 4.02)
OG003
10
OG00410
OG0051
OG0064
OG0076
OG00811
OG0097
10
ParticipantsOG00410
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0076
ParticipantsOG00811
ParticipantsOG0097
Title
Measurements
OG0002150± 15
OG0016372± 14
OG0028564± 48
OG00310452± 50
OG00419124± 46
OG0055202± NAOnly 1 participant analyzed in this cohort
OG00625852± 41
OG00710931± 43
OG00811493± 54
OG00917220± 84
Parent BMS-986158 - Latest timepoint
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG0003449± 93
OG0014961± 73
OG0027612± 71
OG003
Metabolite BMT-161485 - Cycle 1 day 1
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0076
ParticipantsOG00811
ParticipantsOG0097
Title
Measurements
OG000314± 32
OG001790± 14
OG002992± 65
OG003
Metabolite BMT-161485 -Latest timepoint
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG0001474± 89
OG001691± 73
OG0021110± 89
OG003
10
OG00410
OG0051
OG0064
OG0076
OG00811
OG0097
10
ParticipantsOG00410
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0076
ParticipantsOG00811
ParticipantsOG0097
Title
Measurements
OG0001027± 16
OG0012309± 13
OG0023610± 22
OG0034942± 43
OG0046786± 24
OG0052358± NAOnly 1 participant analyzed in this cohort
OG0066921± 28
OG0073660± 27
OG0084468± 29
OG0097418± 43
Parent BMS-986158 - Latest timepoint
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG0002716± 51
OG0013852± NAOnly 1 participant analyzed in this cohort
OG0039817± 56
OG004
Metabolite BMT-161485 - Cycle 1 Day 1
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0076
ParticipantsOG00811
ParticipantsOG0097
Title
Measurements
OG00098.2± 34
OG001188± 11
OG002290± 22
OG003
Metabolite BMT-161485 -Latest timepoint
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG000550± 81
OG001500± NAOnly 1 participant analyzed in this cohort
OG0031746± 64
OG004
8
OG0048
OG0051
OG0061
OG0075
OG0088
OG0097
8
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG00073.7± 45
OG001141± 17
OG002208± 53
OG003227± 76
OG004428± 41
OG00585.1± NAOnly 1 participant analyzed in this cohort
OG006435± NAOnly 1 participant analyzed in this cohort
OG007270± 42
OG008238± 94
OG009253± 125
Metabolite BMT-161485 -Latest timepoint
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG00016.4± 91
OG00122.3± 22
OG00233.7± 55
OG003
10
OG00410
OG0051
OG0064
OG0076
OG00811
OG0097
10
ParticipantsOG00410
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0076
ParticipantsOG00811
ParticipantsOG0097
Title
Measurements
OG00033.5± 18
OG00167.4± 12
OG002108± 36
OG003143± 50
OG004210± 32
OG00566.1± NAOnly 1 participant analyzed in this cohort
OG006232± 30
OG007112± 33
OG008125± 43
OG009185± 68
Parent BMS-986158 - Latest timepoint
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG00087.9± 63
OG001116± NAOnly 1 participant analyzed in this cohort
OG003280± 64
OG004
Metabolite BMT-161485 - Cycle 1 Day 1
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0076
ParticipantsOG00811
ParticipantsOG0097
Title
Measurements
OG0004.85± 29
OG0017.92± 8
OG00212.0± 37
OG003
Metabolite BMT-161485 -Latest timepoint
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG00016.4± 91
OG00122.3± 22
OG00233.7± 55
OG003
8
OG0049
OG0051
OG0061
OG0073
OG0086
OG0097
8
ParticipantsOG0049
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0073
ParticipantsOG0086
ParticipantsOG0097
Title
Measurements
OG00035.7± 25
OG00179.6± 10
OG002142± 51
OG003138± 48
OG004257± 27
OG005109± NAOnly 1 participant analyzed in this cohort
OG006435± NAOnly 1 participant analyzed in this cohort
OG007242± 58
OG008282± 98
OG009284± 119
Parent BMS-986158 -Last collection
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0090
Title
Measurements
OG00087.9± 63
OG001116± NAOnly 1 participant analyzed in this cohort
OG003280± 64
OG004
Metabolite BMT-161485 - First collection
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0073
ParticipantsOG0086
ParticipantsOG0097
Title
Measurements
OG0007.78± 36
OG0019.42± 19
OG00211.4± 51
OG003
Metabolite BMT-161485 - Last collection
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0081
ParticipantsOG0090
Title
Measurements
OG00025.8± 82
OG00120.1± NAOnly 1 participant analyzed in this cohort
OG00365.8± 63
OG004
8
OG0048
OG0051
OG0061
OG0075
OG0088
OG0097
8
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG0001.89± 20
OG0011.72± 20
OG0021.76± 34
OG0031.94± 42
OG0041.79± 29
OG0051.35± NAOnly 1 participant analyzed in this cohort
OG0062.37± NAOnly 1 participant analyzed in this cohort
OG0071.65± 13
OG0081.50± 38
OG0091.59± 47
Parent BMS-986158 - C24
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG0002.58± 51
OG0031.79± 38
OG0042.24± 29
OG005
Parent BMS-986158 - AUC24
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG0002.60± 35
OG0031.95± 38
OG0042.15± 23
OG005
Metabolite BMT-161485 - Cmax
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG0004.53± 54
OG0013.44± 38
OG0022.91± 27
OG003
Metabolite BMT-161485 - C24
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG0004.63± 58
OG0033.18± 38
OG0044.33± 39
OG005
Metabolite BMT-161485 - AUC24
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG0005.06± 45
OG0034.20± 55
OG0045.03± 34
OG005
7
OG0048
OG0051
OG0061
OG0075
OG0088
OG0097
7
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0087
ParticipantsOG0095
Title
Measurements
OG00036.0± 15.99
OG00325.7± 14.86
OG00427.3± 8.72
OG00514.4± NAOnly 1 participant analyzed in this cohort
OG00637.3± NAOnly 1 participant analyzed in this cohort
OG00731.6± 10.48
OG00827.3± 15.15
OG00927.6± 19.11
Metabolite BMT-161485
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG00080.9± 40.42
OG00372.1± 47.11
OG00480.4± 29.59
OG005
9
OG00410
OG0051
OG0064
OG0076
OG00811
OG0097
9
ParticipantsOG00410
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0076
ParticipantsOG00811
ParticipantsOG0097
Title
Measurements
OG0000.073± 0.0104
OG0010.057± 0.0052
OG0020.068± 0.0204
OG0030.078± 0.0268
OG0040.068± 0.0303
OG0050.066± NAOnly 1 participant analyzed in this cohort
OG0060.059± 0.0247
OG0070.077± 0.0373
OG0080.056± 0.0187
OG0090.083± 0.0209
Latest timepoint
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG0000.179± 0.0726
OG0010.112± 0.0329
OG0020.115± 0.0290
OG003
9
OG00410
OG0051
OG0064
OG0076
OG00811
OG0097
9
ParticipantsOG00410
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0076
ParticipantsOG00811
ParticipantsOG0097
Title
Measurements
OG0000.154± 0.0504
OG0010.127± 0.0369
OG0020.125± 0.0262
OG0030.152± 0.0572
OG0040.151± 0.0558
OG0050.081± NAOnly 1 participant analyzed in this cohort
OG0060.099± 0.0279
OG0070.182± 0.0632
OG0080.114± 0.0473
OG0090.170± 0.0821
Latest timepoint
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG0000.247± 0.1000
OG0010.141± 0.0248
OG0020.150± 0.0377
OG003
4
OG0045
OG0051
OG0061
OG0073
OG0086
OG0095
OG003
0.158
± 0.0307
OG0040.164± 0.0809
OG0050.080± NAOnly 1 participant analyzed in this cohort
OG0060.106± NAOnly 1 participant analyzed in this cohort
OG0070.139± 0.0401
OG0080.103± 0.0357
OG0090.184± 0.0947
9
OG00410
OG0051
OG0064
OG0076
OG00811
OG0097
9
ParticipantsOG00410
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0076
ParticipantsOG00811
ParticipantsOG0097
Title
Measurements
OG0000.099± 0.0290
OG0010.081± 0.0055
OG0020.086± 0.0208
OG0030.097± 0.0425
OG0040.087± 0.0347
OG0050.081± NAOnly 1 participant analyzed in this cohort
OG0060.066± 0.0221
OG0070.102± 0.0178
OG0080.080± 0.0283
OG0090.108± 0.0445
Latest timepoint
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0037
ParticipantsOG0048
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0075
ParticipantsOG0088
ParticipantsOG0097
Title
Measurements
OG0000.213± 0.0786
OG0010.130± NAOnly 1 participant analyzed in this cohort
OG0030.192± 0.0697
OG004
8
OG00411
OG0053
OG0061
OG0074
OG0088
OG0098
OG003
-5.4
± 18.45
OG004-10.2± 22.43
OG005-10.7± 15.10
OG006-16.7± NAOnly 1 participant analyzed in this cohort
OG007-7.7± 10.98
OG00814.3± 14.03
OG009-0.6± 10.75
21.6
± 47
OG00435.6± 41
3.03
(0.983 to 48.0)
OG0046.27(1.00 to 48.0)
377
± 44
OG004629± 41
39.4
± 13.80
OG00438.7± 13.66
1128
± 46
OG0042231± 67
624
± 44
OG004898± 39
OG005279± NAOnly 1 participant analyzed in this cohort
OG006855± NAOnly 1 participant analyzed in this cohort
OG007520± 34
OG008588± 47
OG009901± 62
22.5
± 38
OG00430.0± 41
OG00513.6± NAOnly 1 participant analyzed in this cohort
OG00626.3± 63
OG00721.1± 35
OG00819.4± 44
OG00945.5± 32
83.3
± 57
OG004126± 50
OG00532.7± NAOnly 1 participant analyzed in this cohort
OG006127± NAOnly 1 participant analyzed in this cohort
OG00780.7± 53
OG00864.5± 55
OG009146± 83
2.01
(0.500 to 2.10)
OG0042.00(1.00 to 4.05)
OG0051.00(1.00 to 1.00)
OG0061.00(1.00 to 1.00)
OG0071.00(0.833 to 4.00)
OG0081.66(0.967 to 2.03)
OG0092.00(0.167 to 2.03)
23.9
(0.983 to 48.0)
OG00415.1(1.00 to 48.0)
OG0051.00(1.00 to 1.00)
OG0061.52(1.00 to 47.4)
OG00714.9(1.00 to 71.5)
OG0082.02(1.00 to 48.0)
OG0096.27(1.00 to 45.6)
2.01
(1.00 to 6.10)
OG0044.00(1.00 to 24.0)
OG0051.00(1.00 to 1.00)
OG0061.00(1.00 to 1.00)
OG0074.08(3.83 to 24.0)
OG0084.00(0 to 6.32)
OG0094.00(1.00 to 27.1)
13378
± 77
OG00429517± 36
OG0056321± NAOnly 1 participant analyzed in this cohort
OG00633978± NAOnly 1 participant analyzed in this cohort
OG00719868± 45
OG00818266± 97
OG00919995± 135
1305
± 48
OG0042748± 64
OG005424± NAOnly 1 participant analyzed in this cohort
OG0062467± 61
OG0071895± 58
OG0081219± 73
OG0092645± 77
2925
± 85
OG0046691± 49
OG0051000± NAOnly 1 participant analyzed in this cohort
OG0067339± NAOnly 1 participant analyzed in this cohort
OG0075022± 62
OG0083458± 96
OG0095719± 134
14551
± 32
OG0053430± NAOnly 1 participant analyzed in this cohort
OG00613305± NAOnly 1 participant analyzed in this cohort
OG0078561± 36
OG0088637± 71
OG00911286± 104
404
± 39
OG004560± 42
OG005191± NAOnly 1 participant analyzed in this cohort
OG006439± 52
OG007367± 36
OG008337± 46
OG009741± 38
2649
± 48
OG005505± NAOnly 1 participant analyzed in this cohort
OG0062551± NAOnly 1 participant analyzed in this cohort
OG0071765± 51
OG0081299± 63
OG0092616± 102
54.0
± 73
OG00489.6± 55
OG00514.4± NAOnly 1 participant analyzed in this cohort
OG00679.5± NAOnly 1 participant analyzed in this cohort
OG00759.7± 54
OG00844.2± 74
OG00971.1± 115
461
± 36
OG00585.1± NAOnly 1 participant analyzed in this cohort
OG006463± NAOnly 1 participant analyzed in this cohort
OG007276± 45
OG008244± 93
OG009263± 131
18.8
± 40
OG00427.0± 44
OG0055.23± NAOnly 1 participant analyzed in this cohort
OG00619.0± 42
OG00716.3± 37
OG00812.9± 58
OG00929.1± 53
54.0
± 73
OG00489.6± 55
OG00514.4± NAOnly 1 participant analyzed in this cohort
OG006104± NAOnly 1 participant analyzed in this cohort
OG00769.4± 62
OG00847.8± 74
OG00984.5± 120
461
± 36
OG005289± NAOnly 1 participant analyzed in this cohort
OG00769.1± NAOnly 1 participant analyzed in this cohort
OG008370± NAOnly 1 participant analyzed in this cohort
22.2
± 48
OG00436.5± 44
OG00516.9± NAOnly 1 participant analyzed in this cohort
OG00679.5± NAOnly 1 participant analyzed in this cohort
OG00751.2± 68
OG00849.4± 81
OG00975.3± 110
108
± 47
OG00536.4± NAOnly 1 participant analyzed in this cohort
OG00710.8± NAOnly 1 participant analyzed in this cohort
OG00824.5± NAOnly 1 participant analyzed in this cohort
1.29
± NA
Only 1 participant analyzed in this cohort
OG0063.05± NAOnly 1 participant analyzed in this cohort
OG0072.55± 24
OG0081.98± 54
OG0091.42± 72
1.45
± NA
Only 1 participant analyzed in this cohort
OG0062.78± NAOnly 1 participant analyzed in this cohort
OG0072.34± 22
OG0081.90± 46
OG0091.52± 59
3.46
± 33
OG0044.45± 30
OG0052.40± NAOnly 1 participant analyzed in this cohort
OG0066.35± NAOnly 1 participant analyzed in this cohort
OG0074.12± 36
OG0083.08± 59
OG0093.21± 64
2.76
± NA
Only 1 participant analyzed in this cohort
OG0066.23± NAOnly 1 participant analyzed in this cohort
OG0074.46± 31
OG0084.02± 42
OG0092.91± 79
2.64
± NA
Only 1 participant analyzed in this cohort
OG0066.85± NAOnly 1 participant analyzed in this cohort
OG0074.66± 25
OG0083.87± 54
OG0093.53± 87
35.2
± NA
Only 1 participant analyzed in this cohort
OG006105± NAOnly 1 participant analyzed in this cohort
OG00772.7± 19.42
OG00863.5± 39.53
OG00972.8± 74.17
0.144
± 0.0528
OG0040.142± 0.0260
OG0050.117± NAOnly 1 participant analyzed in this cohort
OG0060.149± NAOnly 1 participant analyzed in this cohort
OG0070.163± 0.0536
OG0080.115± 0.0371
OG0090.173± 0.0576
0.234
± 0.0787
OG0040.233± 0.0558
OG0050.158± NAOnly 1 participant analyzed in this cohort
OG0060.216± NAOnly 1 participant analyzed in this cohort
OG0070.274± 0.1184
OG0080.203± 0.0788
OG0090.320± 0.1552
0.187
± 0.0475
OG0050.147± NAOnly 1 participant analyzed in this cohort
OG0060.192± NAOnly 1 participant analyzed in this cohort