A Study of BMS-986148 in Patients With Select Advanced So... | NCT02341625 | Trialant
NCT02341625
Sponsor
Bristol-Myers Squibb
Status
Terminated
Last Update Posted
Aug 18, 2022Actual
Enrollment
126Actual
Phase
Phase 1Phase 2
Conditions
Advanced Cancer
Interventions
BMS-986148
Nivolumab
Countries
United States
Australia
Belgium
Canada
Italy
Netherlands
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02341625
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA008-002
Secondary IDs
ID
Type
Description
Link
2014-002485-70
EudraCT Number
Brief Title
A Study of BMS-986148 in Patients With Select Advanced Solid Tumors
Official Title
A Phase I/IIa Study of BMS-986148, a Mesothelin Directed Antibody Drug Conjugate, in Subjects With Select Advanced Solid Tumors
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Jul 2022
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Study terminated for business reasons not related to safety.
Expanded Access Info
No
Start Date
Jun 19, 2015Actual
Primary Completion Date
Feb 25, 2019Actual
Completion Date
May 7, 2020Actual
First Submitted Date
Jan 14, 2015
First Submission Date that Met QC Criteria
Jan 14, 2015
First Posted Date
Jan 19, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 11, 2022
Results First Submitted that Met QC Criteria
Jul 21, 2022
Results First Posted Date
Aug 18, 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
Jul 21, 2022
Last Update Posted Date
Aug 18, 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, immunogenicity, antitumor activity and pharmacodynamics of BMS-986148 administered alone and in combination with nivolumab in patients with mesothelioma, non-small cell lung cancer, ovarian cancer, pancreatic cancer and gastric cancer.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
126Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: Ascending dose of BMS-986148
Experimental
BMS-986148 Intravenous injection at increasing doses on specific days until the maximum tolerated dose is reached. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer. Alternate dose and schedules may be explored.
Drug: BMS-986148
Part 2: Expansion dose of BMS-986148
Experimental
BMS-986148 Intravenous injection of Maximum tolerated dose (MTD) on specific days. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer.
Drug: BMS-986148
Part 3A: Ascending dose of BMS-986148
Experimental
Set dose of nivolumab and BMS-986148 intravenous injection at increasing doses on specific days until the maximum tolerated dose is reached. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer.
Drug: BMS-986148
Biological: Nivolumab
Part 3B: Expansion dose of BMS-986148
Experimental
Set dose of nivolumab and BMS-986148 intravenous injection at or below maximum tolerated dose on specific days. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer.
Drug: BMS-986148
Biological: Nivolumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BMS-986148
Drug
Part 1: Ascending dose of BMS-986148
Part 2: Expansion dose of BMS-986148
Part 3A: Ascending dose of BMS-986148
Part 3B: Expansion dose of BMS-986148
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events at Worst CTC Grade
Number of participants with adverse events at worst CTC grade including any grade adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuations, and deaths grouped by dose + dose regimen.
From first dose to up to 100 days post last dose (Up to 6 months)
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline
Number of participants with laboratory test toxicity grade (Grade 0, 1, 2, 3, and 4) in hematology and chemistry shifting from baseline. An increase in baseline indicates a shift of participant to a greater toxicity grade. A decrease in baseline indicates a shift of participant to a lesser toxicity grade. Participants are grouped by dose + dose regimen assessed by NCT CTCAE V 4.03.
From first dose to up to 100 days post last dose (Up to 6 months)
Secondary Outcomes
Measure
Description
Time Frame
Maximum Observed Serum Concentration (Cmax)
Maximum observed serum concentration (Cmax) of BMS-986148 grouped by dose + dose regimen.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
PK blood assessed on cycle 1, day 1
Time of Maximum Observed Serum Concentration (Tmax)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Must have pancreatic, ovarian, gastric, non-small cell cancer or mesothelioma. For dose expansion, must have tumor that is positive for mesothelin
Expected to have life expectancy of at least 3 months
Men and women 18 years old or older (or local age of majority)
Must have measurable tumor per Response Evaluation Criteria In Solid Tumors (RECIST) or modified RECIST for malignant pleural mesothelioma
ECOG of 0 to 1
Exclusion Criteria:
Cancer metastases in the brain
Moderate eye disorders
Active infection or past hepatitis B or C infection
Major surgery less than 1 month before the start of the study
Uncontrolled heart disease
Impaired liver or bone marrow function
History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies, nivolumab or related compounds
Rottey S, Clarke J, Aung K, Machiels JP, Markman B, Heinhuis KM, Millward M, Lolkema M, Patel SP, de Souza P, Duca M, Curigliano G, Santoro A, Koyama T, Brown M, Vezina H, He C, Chu QS. Phase I/IIa Trial of BMS-986148, an Anti-mesothelin Antibody-drug Conjugate, Alone or in Combination with Nivolumab in Patients with Advanced Solid Tumors. Clin Cancer Res. 2022 Jan 1;28(1):95-105. doi: 10.1158/1078-0432.CCR-21-1181. Epub 2021 Oct 6.
Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle
FG001
BMS-986148 0.2MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Nov 2, 2016
Apr 11, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Hong Kong
South Korea
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Nivolumab
Biological
Part 3A: Ascending dose of BMS-986148
Part 3B: Expansion dose of BMS-986148
Opdivo
Time of maximum observed serum concentration (Tmax) of BMS-986148 grouped by dose + dose regimen.
PK blood assessed on cycle 1, day 1
Concentration at the End of a Dosing Interval (Ctau)
Concentration at the end of a dosing interval (Ctau) of BMS-986148 grouped by dose + dose regimen.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
PK blood assessed on cycle 1, day 1
Trough Observed Serum Concentration (Ctrough)
Trough observed serum concentration (Ctrough) of BMS-986148 grouped by dose + dose regimen.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
PK blood assessment include cycle 2-day 1 and cycle 1-day 8
Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t))
Area under the concentration-time curve from time Zero to time T (AUC(0-t)) of BMS-986148 grouped by dose + dose regimen.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
PK blood assessment include cycle 1-day 1
Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])
Area under the concentration-time curve in one dosing interval (AUC[TAU]) of BMS-986148 grouped by dose + dose regimen Note: The geometric CV was not calculated. Arithmetic % CV is reported instead
PK blood assessment include cycle 1-day 1
Best Overall Response (BOR)
Best overall response is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Up to 58 months
Objective Response Rate (ORR)
Objective response rate is defined as the total percentage of participants whose best overall response (BOR) is either a complete response or partial response divided by the total percentage of participants who are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Up to 58 months
Duration of Response (DoR)
Duration of response is defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
Up to 58 months
Progression Free Survival (PFS)
Progression Free Survival 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. Progression is defined with at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. Participants who did not progress nor died will be censored on the date of their last tumor assessment. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
Up to 58 months
Progression Free Survival Rate (PFSR) at Week t
Progression free survival rate is defined as the proportion of participants who remain progression free and surviving at 't' weeks (t=4-12 months). The proportion will be calculated by the product-limit method (Kaplan-Meier estimate) which takes into account censored data. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
Total PFS assessed between 4 and 12 months, PFSR at months 4 and 6 to be reported
Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times
Changes of participants in QT corrected by the fridericia formula (QTcF) Interval from baseline at <= 30 msec, >30 - <= 60 msec, and > 60 msec grouped by dose + dose regimen
Up to 58 months
Number of Participants With Anti-Drug Antibody (ADA)
Number of participants with anti-drug antibody (ADA) status grouped by dose + dose regimen.
Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle
FG003
BMS-986148 0.8MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle
FG004
BMS-986148 1.2MG/KG Q3W Es
Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W
FG005
BMS-986148 1.6MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle
FG006
BMS-986148 1.2MG/KG Q3W Ex
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
FG007
BMS-986148 0.4MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
FG008
BMS-986148 0.6MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
FG009
BMS-986148 0.8MG/KG Q3W+Nivolumab
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
FG0002 subjects
FG0012 subjects
FG0023 subjects
FG0038 subjects
FG0048 subjects
FG00510 subjects
FG00651 subjects
FG0078 subjects
FG0084 subjects
FG00930 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0002 subjects
FG0012 subjects
FG0023 subjects
FG0038 subjects
FG0048 subjects
FG00510 subjects
FG00651 subjects
FG0078 subjects
FG0084 subjects
FG00930 subjects
Type
Comment
Reasons
Disease Progression
FG0002 subjects
FG0012 subjects
FG0023 subjects
FG0036 subjects
FG0047 subjects
FG0057 subjects
FG00628 subjects
FG0075 subjects
FG0084 subjects
FG00919 subjects
Study Drug Toxicity
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Adverse Event Unrelated to Study Drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Participant Request to Discontinue Study Treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Participant Withdrew Consent
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Completed Treatment as per Protocol
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other Reasons
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Not Reported
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
BMS-986148 0.1MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle
BG001
BMS-986148 0.2MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle
BG002
BMS-986148 0.4MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle
BG003
BMS-986148 0.8MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle
BG004
BMS-986148 1.2MG/KG Q3W Es
Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W
BG005
BMS-986148 1.6MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle
BG006
BMS-986148 1.2MG/KG Q3W Ex
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
BG007
BMS-986148 0.4MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
BG008
BMS-986148 0.6MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
BG009
BMS 0.8MG/KG + Nivolumab Q3W
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0002
BG0012
BG0023
BG0038
BG0048
BG00510
BG00651
BG0078
BG0084
BG00930
BG010126
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00059.5± 0.7
BG00170.5± 0.7
BG00265.3± 5.8
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Adverse Events at Worst CTC Grade
Number of participants with adverse events at worst CTC grade including any grade adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuations, and deaths grouped by dose + dose regimen.
All treated participants
Posted
Count of Participants
Participants
From first dose to up to 100 days post last dose (Up to 6 months)
ID
Title
Description
OG000
BMS-986148 0.1MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle
OG001
BMS-986148 0.2MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle
OG002
BMS-986148 0.4MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle
OG003
BMS-986148 0.8MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle
OG004
BMS-986148 1.6MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle
OG005
BMS-986148 1.2MG/KG Q3W Es
Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG006
BMS-986148 0.4MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG007
BMS-986148 0.6MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG008
BMS-986148 0.8MG/KG Q3W+Nivolumab
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
Units
Counts
Participants
OG0002
OG0012
OG0023
OG003
Title
Denominators
Categories
Adverse Events (AEs)
Title
Measurements
OG0001
OG0012
OG0023
OG003
Primary
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline
Number of participants with laboratory test toxicity grade (Grade 0, 1, 2, 3, and 4) in hematology and chemistry shifting from baseline. An increase in baseline indicates a shift of participant to a greater toxicity grade. A decrease in baseline indicates a shift of participant to a lesser toxicity grade. Participants are grouped by dose + dose regimen assessed by NCT CTCAE V 4.03.
All treated participants
Posted
Count of Participants
Participants
From first dose to up to 100 days post last dose (Up to 6 months)
ID
Title
Description
OG000
BMS-986148 0.1MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle
OG001
BMS-986148 0.2MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle
OG002
BMS-986148 0.4MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle
OG003
BMS-986148 0.8MG/KG Q3W
Secondary
Maximum Observed Serum Concentration (Cmax)
Maximum observed serum concentration (Cmax) of BMS-986148 grouped by dose + dose regimen.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
PK blood assessed on cycle 1, day 1
ID
Title
Description
OG000
BMS-986148 0.1MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle
OG001
BMS-986148 0.2MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle
OG002
BMS-986148 0.4MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle
OG003
BMS-986148 0.8MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle
Secondary
Time of Maximum Observed Serum Concentration (Tmax)
Time of maximum observed serum concentration (Tmax) of BMS-986148 grouped by dose + dose regimen.
All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data
Posted
Median
Full Range
Hours
PK blood assessed on cycle 1, day 1
ID
Title
Description
OG000
BMS-986148 0.1MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle
OG001
BMS-986148 0.2MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle
OG002
BMS-986148 0.4MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle
OG003
BMS-986148 0.8MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle
OG004
BMS-986148 1.6MG/KG Q3W
Secondary
Concentration at the End of a Dosing Interval (Ctau)
Concentration at the end of a dosing interval (Ctau) of BMS-986148 grouped by dose + dose regimen.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
PK blood assessed on cycle 1, day 1
ID
Title
Description
OG000
BMS-986148 0.1MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle
OG001
BMS-986148 0.2MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle
OG002
BMS-986148 0.4MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle
OG003
BMS-986148 0.8MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle
Secondary
Trough Observed Serum Concentration (Ctrough)
Trough observed serum concentration (Ctrough) of BMS-986148 grouped by dose + dose regimen.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
PK blood assessment include cycle 2-day 1 and cycle 1-day 8
ID
Title
Description
OG000
BMS-986148 0.1MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle
OG001
BMS-986148 0.2MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle
OG002
BMS-986148 0.4MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle
OG003
BMS-986148 0.8MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle
Secondary
Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t))
Area under the concentration-time curve from time Zero to time T (AUC(0-t)) of BMS-986148 grouped by dose + dose regimen.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ug/mL
PK blood assessment include cycle 1-day 1
ID
Title
Description
OG000
BMS-986148 0.1MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle
OG001
BMS-986148 0.2MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle
OG002
BMS-986148 0.4MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle
OG003
BMS-986148 0.8MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle
Secondary
Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])
Area under the concentration-time curve in one dosing interval (AUC[TAU]) of BMS-986148 grouped by dose + dose regimen Note: The geometric CV was not calculated. Arithmetic % CV is reported instead
All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ug/mL
PK blood assessment include cycle 1-day 1
ID
Title
Description
OG000
BMS-986148 0.1MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle
OG001
BMS-986148 0.2MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle
OG002
BMS-986148 0.4MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle
OG003
BMS-986148 0.8MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle
Secondary
Best Overall Response (BOR)
Best overall response is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All treated participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric)
Posted
Count of Participants
Participants
Up to 58 months
ID
Title
Description
OG000
BMS-986148 Mesothelioma
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
Secondary
Objective Response Rate (ORR)
Objective response rate is defined as the total percentage of participants whose best overall response (BOR) is either a complete response or partial response divided by the total percentage of participants who are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All treated participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric)
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 58 months
ID
Title
Description
OG000
BMS-986148 Mesothelioma
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG001
BMS-986148+Nivolumab Mesothelioma
Secondary
Duration of Response (DoR)
Duration of response is defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All response evaluable participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric).
Posted
Median
Full Range
Months
Up to 58 months
ID
Title
Description
OG000
BMS-986148 Mesothelioma
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG001
BMS-986148+Nivolumab Mesothelioma
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
Secondary
Progression Free Survival (PFS)
Progression Free Survival 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. Progression is defined with at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. Participants who did not progress nor died will be censored on the date of their last tumor assessment. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All treated participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric).
Posted
Median
95% Confidence Interval
Months
Up to 58 months
ID
Title
Description
OG000
BMS-986148 Mesothelioma
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG001
BMS-986148+Nivolumab Mesothelioma
Secondary
Progression Free Survival Rate (PFSR) at Week t
Progression free survival rate is defined as the proportion of participants who remain progression free and surviving at 't' weeks (t=4-12 months). The proportion will be calculated by the product-limit method (Kaplan-Meier estimate) which takes into account censored data. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All treated participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric).
Posted
Number
95% Confidence Interval
Proportion of participants
Total PFS assessed between 4 and 12 months, PFSR at months 4 and 6 to be reported
ID
Title
Description
OG000
BMS-986148 Mesothelioma
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG001
BMS-986148+Nivolumab Mesothelioma
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
Secondary
Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times
Changes of participants in QT corrected by the fridericia formula (QTcF) Interval from baseline at <= 30 msec, >30 - <= 60 msec, and > 60 msec grouped by dose + dose regimen
All treated participants
Posted
Count of Participants
Participants
Up to 58 months
ID
Title
Description
OG000
BMS-986148 0.1MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle
OG001
BMS-986148 0.2MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle
OG002
BMS-986148 0.4MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle
OG003
BMS-986148 0.8MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle
OG004
Secondary
Number of Participants With Anti-Drug Antibody (ADA)
Number of participants with anti-drug antibody (ADA) status grouped by dose + dose regimen.
Data was not collected for this outcome measure.
All ADA evaluable participants
Posted
Up to 58 months
ID
Title
Description
OG000
BMS-986148 0.1MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle
OG001
BMS-986148 0.2MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle
OG002
BMS-986148 0.4MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle
OG003
BMS-986148 0.8MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle
OG004
BMS-986148 1.6MG/KG Q3W
Time Frame
From first dose to 100 days post last dose (Up to 6 months)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
BMS-986148 0.1MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle
1
2
1
2
1
2
EG001
BMS-986148 0.2MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle
2
2
1
2
2
2
EG002
BMS-986148 0.4MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle
3
3
1
3
3
3
EG003
BMS-986148 0.8MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle
5
8
5
8
8
8
EG004
BMS-986148 1.6MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle
7
10
4
10
10
10
EG005
BMS-986148 1.2MG/KG Q3W
Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
38
59
32
59
57
59
EG006
BMS-986148 0.4MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
7
8
6
8
8
8
EG007
BMS-986148 0.6MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
4
4
3
4
4
4
EG008
BMS-986148 0.8MG/KG Q3W+Nivolumab
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
22
30
21
30
27
30
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG0030 affected8 at risk
EG0040 affected10 at risk
EG0051 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
Atrial fibrillation
Cardiac disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Atrial flutter
Cardiac disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cardiac failure
Cardiac disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pericardial effusion
Cardiac disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pericarditis
Cardiac disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Tachycardia
Cardiac disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
23.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Duodenal obstruction
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Gastrointestinal obstruction
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Ileus
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Ileus paralytic
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Intra-abdominal haemorrhage
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Subileus
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Chest pain
General disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Infusion site extravasation
General disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Malaise
General disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Performance status decreased
General disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cholangitis
Hepatobiliary disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hepatitis
Hepatobiliary disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Immune-mediated hepatitis
Hepatobiliary disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Jaundice
Hepatobiliary disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Abdominal infection
Infections and infestations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Lymphangitis
Infections and infestations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Peritonitis
Infections and infestations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
23.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Sepsis
Infections and infestations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood creatinine increased
Investigations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Myocardial necrosis marker increased
Investigations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Transaminases increased
Investigations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
23.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Depressed level of consciousness
Nervous system disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Neuralgia
Nervous system disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Paraparesis
Nervous system disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Syncope
Nervous system disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Venous thrombosis
Vascular disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG0030 affected8 at risk
EG0041 affected10 at risk
EG0055 affected59 at risk
EG0062 affected8 at risk
EG0071 affected4 at risk
EG0082 affected30 at risk
Lymphopenia
Blood and lymphatic system disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Mitral valve incompetence
Cardiac disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pericarditis
Cardiac disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Sinus bradycardia
Cardiac disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Tachycardia
Cardiac disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blepharitis
Eye disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cataract
Eye disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Chalazion
Eye disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dry eye
Eye disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Eye pain
Eye disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Lacrimation increased
Eye disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Narrow anterior chamber angle
Eye disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Strabismus
Eye disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Swelling of eyelid
Eye disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Vision blurred
Eye disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Visual impairment
Eye disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Vitreous floaters
Eye disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Breath odour
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Eructation
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
23.0
Systematic Assessment
EG0001 affected2 at risk
EG0011 affected2 at risk
EG0023 affected3 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Retching
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
23.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Swollen tongue
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0022 affected3 at risk
EG003
Asthenia
General disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Chest discomfort
General disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Chest pain
General disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Early satiety
General disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0021 affected3 at risk
EG003
Influenza like illness
General disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Malaise
General disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Mucosal inflammation
General disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Oedema peripheral
General disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
23.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypersensitivity
Immune system disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Conjunctivitis
Infections and infestations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cystitis
Infections and infestations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Lower respiratory tract infection
Infections and infestations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Oral herpes
Infections and infestations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pneumonia
Infections and infestations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Respiratory tract infection
Infections and infestations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Head injury
Injury, poisoning and procedural complications
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood bilirubin increased
Investigations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Blood creatinine increased
Investigations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Blood sodium increased
Investigations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Electrocardiogram QT prolonged
Investigations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Liver function test increased
Investigations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Platelet count decreased
Investigations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Weight decreased
Investigations
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0021 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
23.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
23.0
Systematic Assessment
EG0001 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Dysarthria
Nervous system disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Horner's syndrome
Nervous system disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Seizure
Nervous system disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Somnolence
Nervous system disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Abnormal dreams
Psychiatric disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Confusional state
Psychiatric disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Delirium
Psychiatric disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Depression
Psychiatric disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hallucination
Psychiatric disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Hallucination, auditory
Psychiatric disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Chromaturia
Renal and urinary disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Nocturia
Renal and urinary disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Urinary retention
Renal and urinary disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Urine odour abnormal
Renal and urinary disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Testicular pain
Reproductive system and breast disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0001 affected2 at risk
EG0011 affected2 at risk
EG0020 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected3 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Skin odour abnormal
Skin and subcutaneous tissue disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Flushing
Vascular disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Systolic hypertension
Vascular disorders
23.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle
OG004
BMS-986148 1.6MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle
OG005
BMS-986148 1.2MG/KG Q3W Es
Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG006
BMS-986148 0.4MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG007
BMS-986148 0.6MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG008
BMS-986148 0.8MG/KG Q3W+Nivolumab
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
Units
Counts
Participants
OG0002
OG0012
OG0023
OG0038
OG00410
OG00559
OG0068
OG0074
OG00830
Title
Denominators
Categories
Hemoglobin increase from baseline
Title
Measurements
OG0001
OG0011
OG0020
OG0033
OG0043
OG00520
OG0062
OG0071
OG00812
Hemoglobin decrease from baseline
Title
Measurements
OG0000
OG0010
OG0021
OG003
Platelet Count increase from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Platelet Count decrease from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Leukocytes increase from baseline
Title
Measurements
OG0000
OG0010
OG0021
OG003
Leukocytes decrease from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophils increase from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophils decrease from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes increase from baseline
Title
Measurements
OG0001
OG0012
OG0021
OG003
Lymphocytes decrease from baseline
Title
Measurements
OG0000
OG0010
OG0021
OG003
Absolute Neutrophil increase from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Absolute Neutrophil decrease from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Alkaline Phosphatase (ALP) increase from baseline
Title
Measurements
OG0000
OG0011
OG0021
OG003
Alkaline Phosphatase (ALP) decrease from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Aspartate Aminotransferase (AST) increase from baseline
Title
Measurements
OG0000
OG0011
OG0021
OG003
Aspartate Aminotransferase (AST) decrease from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Alanine Aminotransferase (ALT) increase from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Alanine Aminotransferase (ALT) decrease from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Bilirubin increase from baseline
Title
Measurements
OG0000
OG0011
OG0020
OG003
Bilirubin decrease from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatinine increase from baseline
Title
Measurements
OG0000
OG0010
OG0021
OG003
Creatinine decrease from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium increase from baseline
Title
Measurements
OG0000
OG0011
OG0021
OG003
Sodium decrease from baseline
Title
Measurements
OG0001
OG0010
OG0020
OG003
Potassium increase from baseline
Title
Measurements
OG0001
OG0010
OG0020
OG003
Potassium decrease from baseline
Title
Measurements
OG0000
OG0011
OG0020
OG003
Calcium Total increase from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Calcium Total decrease from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Calcium Corrected increase from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Calcium Corrected decrease from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Phosphorus increase from baseline
Title
Measurements
OG0002
OG0010
OG0022
OG003
Phosphorus decrease from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Magnesium increase from baseline
Title
Measurements
OG0000
OG0011
OG0021
OG003
Magnesium decrease from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Glucose Fasting Serum increase from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Glucose Fasting Serum decrease from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Albumin increase from baseline
Title
Measurements
OG0000
OG0011
OG0020
OG003
Albumin decrease from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Amylase increase from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Amylase decrease from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lipase increase from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lipase decrease from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatine Kinase increase from baseline
Title
Measurements
OG0000
OG0010
OG0021
OG003
Creatine Kinase decrease from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Uric Acid increase from baseline
Title
Measurements
OG0000
OG0010
OG0021
OG003
Uric Acid decrease from baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG004
BMS-986148 1.6MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle
OG005
BMS-986148 1.2MG/KG Q3W Es
Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W
OG006
BMS 1.2MG/KG Q3W Ex
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG007
BMS-986148 0.4MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG008
BMS-986148 0.6MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG009
BMS 0.8MG/KG Q3W+Nivolumab Es
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
OG010
BMS 0.8MG/KG Q3W+Nivolumab Ex
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
Units
Counts
Participants
OG0002
OG0012
OG0023
OG0038
OG00410
OG0058
OG00649
OG0078
OG0084
OG00911
OG01017
Title
Denominators
Categories
Total Antibody
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0038
ParticipantsOG00410
ParticipantsOG0057
ParticipantsOG00649
ParticipantsOG0078
ParticipantsOG0084
ParticipantsOG00911
ParticipantsOG01017
Title
Measurements
OG0002.3± 31.4
OG0012.8± 7.6
OG0023.3± 76.7
OG003
Active Antibody-Drug Conjugate (ADC)
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0038
Unconjugated Tubulysin
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0034
Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle
OG005
BMS-986148 1.2MG/KG Q3W Es
Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W
OG006
BMS 1.2MG/KG Q3W Ex
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG007
BMS-986148 0.4MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG008
BMS-986148 0.6MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG009
BMS 0.8MG/KG Q3W+Nivolumab Es
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
OG010
BMS 0.8MG/KG Q3W+Nivolumab Ex
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
Units
Counts
Participants
OG0002
OG0012
OG0023
OG0038
OG00410
OG0058
OG00649
OG0078
OG0084
OG00911
OG01017
Title
Denominators
Categories
Total Antibody
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0038
ParticipantsOG00410
ParticipantsOG0057
ParticipantsOG00649
ParticipantsOG0078
ParticipantsOG0084
ParticipantsOG00911
ParticipantsOG01017
Title
Measurements
OG0002.2(0.3 to 4.0)
OG0012.2(0.3 to 4.1)
OG0023.9(0.5 to 4.7)
OG003
Active Antibody-Drug Conjugate (ADC)
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0038
Unconjugated Tubulysin
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0034
OG004
BMS-986148 1.6MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle
OG005
BMS-986148 1.2MG/KG Q3W Es
Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W
OG006
BMS 1.2MG/KG Q3W Ex
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG007
BMS-986148 0.4MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG008
BMS-986148 0.6MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG009
BMS 0.8MG/KG Q3W+Nivolumab Es
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
OG010
BMS 0.8MG/KG Q3W+Nivolumab Ex
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0038
OG00410
OG0057
OG00646
OG0078
OG0083
OG00910
OG01017
Title
Denominators
Categories
Total Antibody
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG00646
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0099
ParticipantsOG01017
Title
Measurements
OG0000.0035± 112.0
OG0010.0333± 115.7
OG0020.8233± 131.8
OG003
Active Antibody-Drug Conjugate (ADC)
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0038
Unconjugated Tubulysin
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG004
BMS-986148 1.6MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle
OG005
BMS-986148 1.2MG/KG Q3W Es
Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W
OG006
BMS 1.2MG/KG Q3W Ex
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG007
BMS-986148 0.4MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG008
BMS-986148 0.6MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG009
BMS 0.8MG/KG Q3W+Nivolumab Es
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
OG010
BMS 0.8MG/KG Q3W+Nivolumab Ex
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
Units
Counts
Participants
OG0002
OG0012
OG0023
OG0037
OG0046
OG0058
OG00639
OG0078
OG0083
OG00910
OG01013
Title
Denominators
Categories
Total Antibody
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0037
ParticipantsOG0046
ParticipantsOG0058
ParticipantsOG00638
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG00910
ParticipantsOG01012
Title
Measurements
OG0000.1± 0.0
OG0010.1± 0.00
OG0020.1± 0.00
OG003
Active Antibody-Drug Conjugate (ADC)
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0037
Unconjugated Tubulysin
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0037
OG004
BMS-986148 1.6MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle
OG005
BMS-986148 1.2MG/KG Q3W Es
Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W
OG006
BMS 1.2MG/KG Q3W Ex
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG007
BMS-986148 0.4MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG008
BMS-986148 0.6MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG009
BMS-986148 0.8MG/KG Q3W+Nivolumab
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG010
BMS 0.8MG/KG Q3W+Nivolumab Ex
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
Units
Counts
Participants
OG0002
OG0012
OG0023
OG0038
OG00410
OG0058
OG00651
OG0078
OG0084
OG00911
OG01019
Title
Denominators
Categories
Total Antibody
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0038
ParticipantsOG00410
ParticipantsOG0057
ParticipantsOG00649
ParticipantsOG0078
ParticipantsOG0084
ParticipantsOG00911
ParticipantsOG01017
Title
Measurements
OG000152.6± 31.6
OG001232.5± 17.5
OG002129.6± 131.3
OG003
Active Antibody-Drug Conjugate (ADC)
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0038
Unconjugated Tubulysin
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0034
OG004
BMS-986148 1.6MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle
OG005
BMS-986148 1.2MG/KG Q3W Es
Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W
OG006
BMS 1.2MG/KG Q3W Ex
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG007
BMS-986148 0.4MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG008
BMS-986148 0.6MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG009
BMS 0.8MG/KG Q3W+Nivolumab Es
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
OG010
BMS 0.8MG/KG Q3W+Nivolumab Ex
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0038
OG00410
OG0057
OG00646
OG0078
OG0083
OG00910
OG01017
Title
Denominators
Categories
Total Antibody
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG00646
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0099
ParticipantsOG01017
Title
Measurements
OG000179.3± 34.8
OG001265.7± 13.3
OG002344.6± 98.5
OG003
Active Antibody-Drug Conjugate (ADC)
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0038
Unconjugated Tubulysin
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG001
BMS-986148+Nivolumab Mesothelioma
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG002
BMS-986148 Ovarian
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer.
OG003
BMS-986148+Nivolumab Ovarian
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG004
BMS-986148 Pancreatic
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer.
OG005
BMS-986148+Nivolumab Pancreatic
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG006
BMS-986148 NSCLC
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer.
OG007
BMS-986148+Nivolumab NSCLC
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG008
BMS-986148 Gastric
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG009
BMS-986148+Nivolumab Gastric
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
Units
Counts
Participants
OG00025
OG00113
OG00222
OG0032
OG00418
OG0056
OG0064
OG0072
OG0083
OG0091
Title
Denominators
Categories
Complete Response (CR)
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
Partial Response (PR)
Title
Measurements
OG0001
OG0013
OG0022
OG003
Stable Disease (SD)
Title
Measurements
OG00013
OG0018
OG00211
OG003
Progressive Disease (PD)
Title
Measurements
OG0007
OG0011
OG0027
OG003
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG002
BMS-986148 Ovarian
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer.
OG003
BMS-986148+Nivolumab Ovarian
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG004
BMS-986148 Pancreatic
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer.
OG005
BMS-986148+Nivolumab Pancreatic
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG006
BMS-986148 NSCLC
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer.
OG007
BMS-986148+Nivolumab NSCLC
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG008
BMS-986148 Gastric
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG009
BMS-986148+Nivolumab Gastric
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
Units
Counts
Participants
OG00025
OG00113
OG00222
OG0032
OG00418
OG0056
OG0064
OG0072
OG0083
OG0091
Title
Denominators
Categories
Title
Measurements
OG0004.0(0.1 to 20.4)
OG00123.1(5.0 to 53.8)
OG0029.1(1.1 to 29.2)
OG0030(0 to 0)
OG0040(0 to 0)
OG0050(0 to 0)
OG0060(0 to 0)
OG0070(0 to 0)
OG0080(0 to 0)
OG0090(0 to 0)
OG002
BMS-986148 Ovarian
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer.
OG003
BMS-986148+Nivolumab Ovarian
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG004
BMS-986148 Pancreatic
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer.
OG005
BMS-986148+Nivolumab Pancreatic
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG006
BMS-986148 NSCLC
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer.
OG007
BMS-986148+Nivolumab NSCLC
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG008
BMS-986148 Gastric
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG009
BMS-986148+Nivolumab Gastric
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
Units
Counts
Participants
OG0001
OG0013
OG0022
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
Title
Denominators
Categories
Title
Measurements
OG00029.7(29.7 to 29.7)
OG0018.97(5.1 to 13.3)
OG002NA(3.0 to 20.0)Median not reached due to insufficient number of events
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG002
BMS-986148 Ovarian
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer.
OG003
BMS-986148+Nivolumab Ovarian
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG004
BMS-986148 Pancreatic Part 1B
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG005
BMS-986148 Pancreatic
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG006
BMS-986148+Nivolumab Pancreatic
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG007
BMS-986148 NSCLC
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer.
OG008
BMS-986148+Nivolumab NSCLC
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG009
BMS-986148 Gastric
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG010
BMS-986148+Nivolumab Gastric
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
Units
Counts
Participants
OG00025
OG00113
OG00222
OG0032
OG0047
OG00511
OG0066
OG0074
OG0082
OG0093
OG0101
Title
Denominators
Categories
Title
Measurements
OG0002.56(1.41 to 4.01)
OG0015.19(2.56 to 12.06)
OG0022.79(1.28 to 4.17)
OG003NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
OG0041.64(1.45 to 1.71)
OG005NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
OG0061.66(1.22 to 2.14)
OG0071.49(1.15 to 5.65)
OG008NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
OG009NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
OG010NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
OG002
BMS-986148 Ovarian
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer.
OG003
BMS-986148+Nivolumab Ovarian
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG004
BMS-986148 Pancreatic Part 1B
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG005
BMS-986148 Pancreatic
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG006
BMS-986148+Nivolumab Pancreatic
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG007
BMS-986148 NSCLC
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer.
OG008
BMS-986148+Nivolumab NSCLC
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG009
BMS-986148 Gastric
Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle
Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG010
BMS-986148+Nivolumab Gastric
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
Units
Counts
Participants
OG00025
OG00113
OG00222
OG0032
OG0047
OG00511
OG0066
OG0074
OG0082
OG0093
OG0101
Title
Denominators
Categories
4 months
Title
Measurements
OG0000.35(0.15 to 0.54)
OG0010.65(0.37 to 0.93)
OG0020.40(0.18 to 0.62)
OG003NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
OG004NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
OG005NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
OG006NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
OG007NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
OG008NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
OG009NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
OG010NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
6 months
Title
Measurements
OG0000.30(0.11 to 0.49)
OG0010.47(0.17 to 0.76)
OG002NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
OG003
BMS-986148 1.6MG/KG Q3W
Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle
OG005
BMS-986148 1.2MG/KG Q3W Es
Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W
OG006
BMS 1.2MG/KG Q3W Ex
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG007
BMS-986148 0.4MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG008
BMS-986148 0.6MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG009
BMS-986148 0.8MG/KG Q3W+Nivolumab
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
Units
Counts
Participants
OG0002
OG0012
OG0023
OG0038
OG00410
OG0058
OG00651
OG0078
OG0084
OG00930
Title
Denominators
Categories
<= 30 msec,
Title
Measurements
OG0001
OG0012
OG0022
OG0036
OG0049
OG0058
OG00637
OG0075
OG0083
OG00923
>30 - <= 60 msec
Title
Measurements
OG0001
OG0010
OG0021
OG003
> 60 msec
Title
Measurements
OG0000
OG0010
OG0020
OG003
Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle
OG005
BMS-986148 1.2MG/KG Q3W Es
Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG006
BMS-986148 0.4MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG007
BMS-986148 0.6MG/KG QW
Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle
OG008
BMS-986148 0.8MG/KG Q3W+Nivolumab
Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle
Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
OG009
BMS 1.2MG/KG Q3W Ex
Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
Title
Denominators
Categories
ADA positive
ADA negative
0 affected
8 at risk
EG0041 affected10 at risk
EG0050 affected59 at risk
EG0061 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0081 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0081 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0051 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0041 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0052 affected59 at risk
EG0061 affected8 at risk
EG0070 affected4 at risk
EG0081 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0081 affected30 at risk
1 affected
8 at risk
EG0042 affected10 at risk
EG0053 affected59 at risk
EG0060 affected8 at risk
EG0071 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0053 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0083 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0051 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
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EG0060 affected8 at risk
EG0070 affected4 at risk
EG0082 affected30 at risk
1 affected
8 at risk
EG0041 affected10 at risk
EG0054 affected59 at risk
EG0060 affected8 at risk
EG0071 affected4 at risk
EG0084 affected30 at risk
1 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0042 affected10 at risk
EG0057 affected59 at risk
EG0061 affected8 at risk
EG0072 affected4 at risk
EG0083 affected30 at risk
0 affected
8 at risk
EG0041 affected10 at risk
EG0053 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0082 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0053 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0081 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0054 affected59 at risk
EG0060 affected8 at risk
EG0071 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0041 affected10 at risk
EG0051 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
2 affected
8 at risk
EG0043 affected10 at risk
EG0055 affected59 at risk
EG0060 affected8 at risk
EG0071 affected4 at risk
EG0081 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0061 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0056 affected59 at risk
EG0061 affected8 at risk
EG0072 affected4 at risk
EG0084 affected30 at risk
1 affected
8 at risk
EG0043 affected10 at risk
EG0056 affected59 at risk
EG0060 affected8 at risk
EG0071 affected4 at risk
EG0084 affected30 at risk
0 affected
8 at risk
EG0041 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
1 affected
8 at risk
EG0040 affected10 at risk
EG0054 affected59 at risk
EG0060 affected8 at risk
EG0071 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0053 affected59 at risk
EG0061 affected8 at risk
EG0070 affected4 at risk
EG0081 affected30 at risk
1 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0061 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0041 affected10 at risk
EG0053 affected59 at risk
EG0060 affected8 at risk
EG0071 affected4 at risk
EG0081 affected30 at risk
1 affected
8 at risk
EG0040 affected10 at risk
EG0052 affected59 at risk
EG0061 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0061 affected8 at risk
EG0071 affected4 at risk
EG0080 affected30 at risk
1 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0051 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0061 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
2 affected
8 at risk
EG0040 affected10 at risk
EG0054 affected59 at risk
EG0061 affected8 at risk
EG0070 affected4 at risk
EG0086 affected30 at risk
0 affected
8 at risk
EG0041 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0071 affected4 at risk
EG0081 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0051 affected59 at risk
EG0061 affected8 at risk
EG0071 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0051 affected59 at risk
EG0061 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0051 affected59 at risk
EG0060 affected8 at risk
EG0071 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0041 affected10 at risk
EG0051 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0071 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0071 affected4 at risk
EG0080 affected30 at risk
3 affected
8 at risk
EG0042 affected10 at risk
EG00513 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0085 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0051 affected59 at risk
EG0061 affected8 at risk
EG0071 affected4 at risk
EG0081 affected30 at risk
1 affected
8 at risk
EG0045 affected10 at risk
EG00519 affected59 at risk
EG0061 affected8 at risk
EG0071 affected4 at risk
EG0085 affected30 at risk
1 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0061 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0041 affected10 at risk
EG0053 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0082 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0051 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
1 affected
8 at risk
EG0042 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0081 affected30 at risk
0 affected
8 at risk
EG0041 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0081 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0041 affected10 at risk
EG0051 affected59 at risk
EG0060 affected8 at risk
EG0071 affected4 at risk
EG0081 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0054 affected59 at risk
EG0062 affected8 at risk
EG0070 affected4 at risk
EG0083 affected30 at risk
1 affected
8 at risk
EG0043 affected10 at risk
EG0057 affected59 at risk
EG0062 affected8 at risk
EG0071 affected4 at risk
EG0083 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0057 affected59 at risk
EG0061 affected8 at risk
EG0070 affected4 at risk
EG0081 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0071 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0071 affected4 at risk
EG0081 affected30 at risk
1 affected
8 at risk
EG0041 affected10 at risk
EG0051 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0083 affected30 at risk
0 affected
8 at risk
EG0042 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0081 affected30 at risk
0 affected
8 at risk
EG0041 affected10 at risk
EG0052 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0086 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0054 affected59 at risk
EG0060 affected8 at risk
EG0071 affected4 at risk
EG0084 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0081 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0083 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0060 affected8 at risk
EG0071 affected4 at risk
EG0080 affected30 at risk
1 affected
8 at risk
EG0040 affected10 at risk
EG0051 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0052 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0082 affected30 at risk
1 affected
8 at risk
EG0042 affected10 at risk
EG0051 affected59 at risk
EG0060 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
0 affected
8 at risk
EG0040 affected10 at risk
EG0050 affected59 at risk
EG0061 affected8 at risk
EG0070 affected4 at risk
EG0080 affected30 at risk
1
OG0040
OG0053
OG0060
OG0070
OG0080
3
OG0044
OG00514
OG0060
OG0071
OG0086
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0042
OG0051
OG0061
OG0070
OG0082
0
OG0040
OG0051
OG0061
OG0070
OG0080
0
OG0041
OG0053
OG0060
OG0070
OG0081
0
OG0040
OG0051
OG0060
OG0070
OG0080
3
OG0046
OG00527
OG0066
OG0073
OG00819
0
OG0040
OG0050
OG0061
OG0070
OG0080
0
OG0042
OG0053
OG0060
OG0070
OG0082
0
OG0040
OG0051
OG0060
OG0070
OG0080
6
OG00410
OG00546
OG0065
OG0074
OG00824
0
OG0040
OG0050
OG0060
OG0070
OG0080
6
OG00410
OG00553
OG0066
OG0074
OG00826
0
OG0040
OG0050
OG0060
OG0070
OG0080
7
OG00410
OG00550
OG0065
OG0073
OG00825
0
OG0040
OG0051
OG0060
OG0070
OG0080
2
OG0043
OG00516
OG0062
OG0072
OG0087
0
OG0040
OG0050
OG0060
OG0070
OG0080
2
OG0042
OG0057
OG0061
OG0073
OG0085
0
OG0040
OG0050
OG0060
OG0070
OG0080
4
OG0044
OG00523
OG0061
OG0072
OG00817
0
OG0040
OG0050
OG0060
OG0070
OG0080
3
OG0045
OG00524
OG0061
OG0072
OG0089
0
OG0040
OG0053
OG0060
OG0070
OG0080
5
OG0044
OG00517
OG0063
OG0071
OG00810
0
OG0040
OG0050
OG0060
OG0070
OG0081
2
OG0041
OG0050
OG0060
OG0070
OG0081
0
OG0040
OG0050
OG0060
OG0070
OG0080
3
OG0044
OG00524
OG0061
OG0072
OG0087
0
OG0040
OG0050
OG0061
OG0070
OG0080
2
OG0044
OG00522
OG0061
OG0072
OG0085
0
OG0040
OG0053
OG0060
OG0070
OG0081
0
OG0040
OG0056
OG0060
OG0071
OG0085
0
OG0040
OG0051
OG0060
OG0070
OG0081
7
OG0048
OG00537
OG0066
OG0072
OG00819
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0081
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0081
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0059
OG0060
OG0070
OG0083
0
OG0040
OG0051
OG0060
OG0070
OG0080
1
OG0042
OG0056
OG0060
OG0072
OG0086
0
OG0040
OG0050
OG0060
OG0070
OG0080
16.4
± 47.2
OG00439.8± 24.5
OG00528.5± 14.0
OG00628.3± 22.5
OG0079.3± 21.3
OG00814.5± 22.3
OG00916.7± 19.7
OG01018.8± 22.4
ParticipantsOG00410
ParticipantsOG0057
ParticipantsOG00649
ParticipantsOG0078
ParticipantsOG0084
ParticipantsOG00911
ParticipantsOG01017
Title
Measurements
OG0002.0± 29.8
OG0012.2± 8.2
OG0022.6± 76.1
OG00315.8± 46.4
OG00440.0± 26.3
OG00527.0± 18.6
OG00627.5± 22.6
OG0078.8± 20.3
OG00813.6± 31.0
OG00915.3± 27.6
OG01017.8± 24.6
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00645
ParticipantsOG0072
ParticipantsOG0082
ParticipantsOG0095
ParticipantsOG01011
Title
Measurements
OG0020.5± NAToo few events to calculate arithmetic coefficient of variation
OG0030.2± 17.1
OG0040.4± 52.3
OG0050.4± 70.9
OG0060.3± 58.2
OG0070.1± 36.0
OG0080.4± 75.0
OG0090.2± 42.5
OG0100.2± 42.5
4.0
(0.2 to 4.8)
OG0043.9(0.9 to 4.3)
OG0054.1(1.1 to 4.1)
OG0064.0(0.8 to 24.1)
OG0074.0(0.6 to 4.1)
OG0083.8(1.1 to 3.9)
OG0091.1(0.6 to 24.1)
OG0104.0(0.9 to 23.8)
ParticipantsOG00410
ParticipantsOG0057
ParticipantsOG00649
ParticipantsOG0078
ParticipantsOG0084
ParticipantsOG00911
ParticipantsOG01017
Title
Measurements
OG0000.2(0.1 to 0.3)
OG0012.2(0.3 to 4.1)
OG0020.5(0.1 to 3.9)
OG0032.5(0.2 to 4.0)
OG0041.5(0.8 to 4.3)
OG0053.8(1.0 to 4.1)
OG0063.9(0.8 to 4.7)
OG0074.0(0.6 to 4.1)
OG0083.8(1.1 to 3.9)
OG0091.0(0.6 to 4.2)
OG0104.0(0.9 to 4.0)
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00645
ParticipantsOG0072
ParticipantsOG0082
ParticipantsOG0095
ParticipantsOG01011
Title
Measurements
OG00225.5(25.5 to 25.5)
OG003120.2(71.8 to 169.7)
OG004167.3(71.4 to 170.0)
OG005168.8(48.0 to 335.5)
OG006166.1(24.3 to 338.8)
OG007168.2(166.9 to 169.4)
OG008166.7(94.7 to 238.7)
OG009165.1(48.0 to 170.9)
OG010166.5(47.8 to 335.9)
0.4426
± 106.1
OG0041.4101± 101.8
OG0051.0917± 91.9
OG0061.1938± 98.7
OG0073.2035± 20.2
OG0083.8872± 46.1
OG0090.2133± 114.0
OG0100.7544± 83.5
ParticipantsOG00410
ParticipantsOG0057
ParticipantsOG00646
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG00910
ParticipantsOG01017
Title
Measurements
OG0000.0633± 141.3
OG0020.0058± NAToo few events to calculate arithmetic coefficient of variation
OG0030.0309± 123.8
OG0040.3049± 110.0
OG0050.2121± 111.3
OG0060.1558± 123.4
OG0071.2705± 39.5
OG0081.9068± 59.1
OG0090.1119± 187.1
OG0100.0797± 103.7
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0082
ParticipantsOG0090
ParticipantsOG0101
Title
Measurements
OG0040.1630± 0.9
OG0050.2590± 77.1
OG0060.1634± 48.2
OG0070.1388± 36.0
OG0080.3539± 75.0
OG0100.1330± NAToo few events to calculate arithmetic coefficient of variation
0.79676
± 92.4
OG0040.92146± 125.9
OG0051.23291± 81.7
OG0061.14568± 104.4
OG0073.20352± 20.2
OG0083.88717± 46.1
OG0090.33875± 122.1
OG0100.77912± 79.1
ParticipantsOG0046
ParticipantsOG0058
ParticipantsOG00638
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG00910
ParticipantsOG01012
Title
Measurements
OG0000.1± 0.0
OG0010.1± 0.00
OG0020.1± 0.00
OG0030.27671± 95.3
OG0040.21835± 152.7
OG0050.36894± 90.7
OG0060.31524± 111.4
OG0071.27047± 39.5
OG0081.90678± 59.1
OG0090.18096± 97.4
OG0100.24389± 81.0
ParticipantsOG0046
ParticipantsOG0058
ParticipantsOG00639
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG00910
ParticipantsOG01013
Title
Measurements
OG0000.00005± 0.0
OG0010.00005± 0.0
OG0020.00005± 0.0
OG0030.00005± 0.0
OG0040.00007± 66.6
OG0050.00009± 127.6
OG0060.00006± 80.7
OG0070.00006± 64.7
OG0080.00018± 104.0
OG0090.00005± 0.0
OG0100.00005± 40.8
1979.5
± 69.6
OG0045399.8± 40.1
OG0054285.7± 29.3
OG0063472.6± 47.1
OG007858.0± 22.9
OG0081278.8± 35.1
OG0091815.8± 43.4
OG0102611.3± 33.5
ParticipantsOG00410
ParticipantsOG0057
ParticipantsOG00649
ParticipantsOG0078
ParticipantsOG0084
ParticipantsOG00911
ParticipantsOG01017
Title
Measurements
OG00088.6± 48.7
OG00170.7± 42.9
OG00260.8± 136.2
OG0031042.1± 68.6
OG0043083.6± 32.3
OG0052493.1± 25.1
OG0061984.7± 45.7
OG007565.4± 30.3
OG008927.3± 38.7
OG0091059.0± 44.8
OG0101447.5± 36.2
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00645
ParticipantsOG0072
ParticipantsOG0082
ParticipantsOG0095
ParticipantsOG01011
Title
Measurements
OG00249.6± NAToo few events to calculate arithmetic coefficient of variation
OG00329.6± 42.8
OG00480.1± 73.4
OG005197.0± 59.4
OG00642.3± 80.4
OG0079.3± 73.0
OG00842.5± 84.3
OG00925.5± 58.8
OG01017.7± 110.3
2059.3
± 68.7
OG0045318.6± 36.9
OG0054316.1± 28.8
OG0064159.4± 39.5
OG007858.0± 22.9
OG0081533.5± 19.2
OG0091839.0± 45.4
OG0102689.9± 34.0
ParticipantsOG00410
ParticipantsOG0057
ParticipantsOG00646
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG00910
ParticipantsOG01017
Title
Measurements
OG000109.0± 35.2
OG002371.6± NAToo few events to calculate arithmetic coefficient of variation
OG0031098.7± 67.5
OG0043246.0± 36.6
OG0052507.2± 24.7
OG0062271.7± 40.1
OG007565.4± 30.3
OG0081063.9± 32.2
OG0091094.9± 48.0
OG0101478.1± 36.6
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0066
ParticipantsOG0072
ParticipantsOG0082
ParticipantsOG0090
ParticipantsOG0101
Title
Measurements
OG004173.4± 48.2
OG005197.0± 59.4
OG006148.9± 30.3
OG0079.3± 73.0
OG00842.5± 84.3
OG010102.4± NAToo few events to calculate arithmetic coefficient of variation
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
2
OG0044
OG0051
OG0061
OG0071
OG0081
OG0090
0
OG00411
OG0052
OG0062
OG0071
OG0082
OG0091
NA
(NA to NA)
Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
OG004NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
OG005NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
OG006NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
OG007NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
OG008NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
OG009NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
OG010NA(NA to NA)Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)