A Study of BMS-813160 in Combination With Chemotherapy or... | NCT03184870 | Trialant
NCT03184870
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Oct 9, 2025Actual
Enrollment
332Actual
Phase
Phase 1Phase 2
Conditions
Colorectal Cancer
Pancreatic Cancer
Interventions
BMS-813160
Nivolumab
Nab-paclitaxel
Gemcitabine
5-fluorouracil (5-FU)
Leucovorin
Irinotecan
Countries
United States
Australia
Belgium
Canada
Germany
Spain
Protocol Section
Identification Module
NCT ID
NCT03184870
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CV202-103
Secondary IDs
ID
Type
Description
Link
2017-001725-40
EudraCT Number
Brief Title
A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors
Official Title
A Phase 1b/2 Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Sep 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 8, 2017Actual
Primary Completion Date
Apr 6, 2023Actual
Completion Date
Jun 14, 2023Actual
First Submitted Date
Jun 9, 2017
First Submission Date that Met QC Criteria
Jun 9, 2017
First Posted Date
Jun 14, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Jun 14, 2024
Results First Submitted that Met QC Criteria
Sep 22, 2025
Results First Posted Date
Oct 9, 2025Actual
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
Sep 22, 2025
Last Update Posted Date
Oct 9, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the safety profile, tolerability, drug levels, drug effects, and preliminary efficacy of BMS-813160 alone or in combination with either chemotherapy or nivolumab or chemotherapy plus nivolumab in participants with metastatic colorectal and pancreatic cancers.
Detailed Description
Not provided
Conditions Module
Conditions
Colorectal Cancer
Pancreatic 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
332Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1 Arm A [First-line (1L) Colorectal]: BMS-813160 followed by BMS-813160 + FOLFIRI
Experimental
FOLFIRI: FOL (folinic acid [leucovorin]) F (fluorouracil [5-fluorouracil]) IRI (irinotecan [CAMPTOSAR])
Drug: BMS-813160
Drug: 5-fluorouracil (5-FU)
Drug: Leucovorin
Drug: Irinotecan
Part 1 Arm B [1L Pancreatic]: BMS-813160 followed by BMS-813160 + Gemcitabine/Nab-paclitaxel
Experimental
Drug: BMS-813160
Drug: Nab-paclitaxel
Drug: Gemcitabine
Part 1 Arm C [2L Pancreatic & 2/3L Colorectal MSS]: BMS-813160 followed by BMS-813160 + Nivolumab
Part 2 Arm A Cohort 1a [2L Colorectal]: BMS-813160 + FOLFIRI
Experimental
Drug: BMS-813160
Drug: 5-fluorouracil (5-FU)
Drug: Leucovorin
Drug: Irinotecan
Part 2 Arm A Cohort 1b [2L Colorectal]: BMS-813160 + FOLFIRI
Experimental
Drug: BMS-813160
Drug: 5-fluorouracil (5-FU)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BMS-813160
Drug
Specified dose on specified days
Part 1 Arm A [First-line (1L) Colorectal]: BMS-813160 followed by BMS-813160 + FOLFIRI
Part 1 Arm B [1L Pancreatic]: BMS-813160 followed by BMS-813160 + Gemcitabine/Nab-paclitaxel
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Experiencing Adverse Events (AEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
From first dose up to 100 days post last dose, up to approximately 3 years
Number of Participants Experiencing Serious Adverse Events (SAEs)
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.
From first dose up to 100 days post last dose, up to approximately 3 years
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Dose-limiting toxicities (DLTs) are severe adverse effects (AEs) that are attributed to BMS-813160 or the combination regimen and define the maximum tolerated dose of a medicine. DLTs will be defined based on the incidence, duration and grade of AEs for which no alternate cause can be identified. AEs will be evaluated according to the NCI CTCAE v4.03. The incidence of DLT(s) during the first 6 weeks of treatment in Part 1 (the DLT evaluation period) and 4 weeks for Part 2 will be used.
From first dose up to 100 days post last dose, up to approximately 3 years
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
Secondary Outcomes
Measure
Description
Time Frame
Maximim Concentration (Cmax)
Cmax is defined as the maximum plasma concentration of the analytes at the prespecified timepoints.
From first dose up to the prespecified timepoints, C0D1, C0D14, and C2D1
Time to Maximum Concentration (Tmax)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Must have metastatic colorectal or pancreatic cancer
Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
Ability to swallow pills or capsules
Required to undergo mandatory pre and on-treatment biopsies
Adequate marrow function
Adequate other organ functions
Ability to comply with study visits, treatment, procedures, pharmacokinetic (PK) and pharmacodynamic (PD) sample collection, and required study follow-up
Exclusion Criteria:
Histology other than adenocarcinoma (neuroendocrine or acinar cell)
Suspected, known, or central nervous system (CNS) metastases (Imaging required only if participants are symptomatic)
Active, known or suspected autoimmune disease
Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity
Le DT, Folprecht G, Varghese AM, Gutierrez M, Noel M, Trikalinos NA, Chen E, Dayyani F, Davis SL, Ma WW, BasuMallick A, Garrido-Laguna I, Osawa M, O'Brien S, Novosiadly RD, Xu K, Greenawalt DM, Dutta S, Twyman Saint Victor C, Lenz HJ. Phase 1b/2 study of BMS-813160, a CCR2/5 dual antagonist, in combination with chemotherapy or nivolumab in patients with advanced pancreatic or colorectal cancer. J Immunother Cancer. 2026 Jan 22;14(1):e011284. doi: 10.1136/jitc-2024-011284.
Two additional cohorts (Part 2-Arm D-Cohorts 7 and 8) with 300 mg BMS-813160 twice per day were planned according to a previous version of the protocol. However, these cohorts did not open for enrollment due to Cohort 4 being closed due to futility per Revised Protocol 06.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
FG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
Periods
Title
Milestones
Reasons Not Completed
Initial Treatment
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Dec 5, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
France
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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
Drug: Leucovorin
Drug: Irinotecan
Part 2 Arm A Cohort 1c [2L Colorectal]: FOLFIRI
Experimental
Drug: 5-fluorouracil (5-FU)
Drug: Leucovorin
Drug: Irinotecan
Part 2 Arm B Cohort 3a [1L Pancreatic]: BMS-813160 + Gemcitabine/Nab-paclitaxel
Experimental
Drug: BMS-813160
Drug: Nab-paclitaxel
Drug: Gemcitabine
Part 2 Arm B Cohort 3b [1L Pancreatic]: BMS-813160 + Nivolumab + Gemcitabine/Nab-paclitaxel
Experimental
Drug: BMS-813160
Biological: Nivolumab
Drug: Nab-paclitaxel
Drug: Gemcitabine
Part 2 Arm B Cohort 3c [1L Pancreatic]: Gemcitabine/Nab-paclitaxel
Experimental
Drug: Nab-paclitaxel
Drug: Gemcitabine
Part 2 Arm C Cohort 4 [2L Pancreatic]: BMS-813160 + Nivolumab
Experimental
Drug: BMS-813160
Biological: Nivolumab
Part 2 Arm C Cohort 5 [2/3L Colorectal MSS]: BMS-813160 + Nivolumab
Experimental
Drug: BMS-813160
Biological: Nivolumab
Part 2 Arm D Cohort 7 [2L Pancreatic]: BMS-813160 Monotherapy
Experimental
Drug: BMS-813160
Part 2 Arm D Cohort 8 [2/3L Colorectal MSS]: BMS-813160 Monotherapy
Experimental
Drug: BMS-813160
Part 1 Arm C [2L Pancreatic & 2/3L Colorectal MSS]: BMS-813160 followed by BMS-813160 + Nivolumab
Part 2 Arm A Cohort 1a [2L Colorectal]: BMS-813160 + FOLFIRI
Part 2 Arm A Cohort 1b [2L Colorectal]: BMS-813160 + FOLFIRI
Part 2 Arm B Cohort 3a [1L Pancreatic]: BMS-813160 + Gemcitabine/Nab-paclitaxel
Part 2 Arm B Cohort 3b [1L Pancreatic]: BMS-813160 + Nivolumab + Gemcitabine/Nab-paclitaxel
Part 2 Arm C Cohort 4 [2L Pancreatic]: BMS-813160 + Nivolumab
Part 2 Arm C Cohort 5 [2/3L Colorectal MSS]: BMS-813160 + Nivolumab
Part 2 Arm D Cohort 7 [2L Pancreatic]: BMS-813160 Monotherapy
Part 2 Arm D Cohort 8 [2/3L Colorectal MSS]: BMS-813160 Monotherapy
Nivolumab
Biological
Specified dose on specified days
Part 1 Arm C [2L Pancreatic & 2/3L Colorectal MSS]: BMS-813160 followed by BMS-813160 + Nivolumab
Part 2 Arm B Cohort 3b [1L Pancreatic]: BMS-813160 + Nivolumab + Gemcitabine/Nab-paclitaxel
Part 2 Arm C Cohort 4 [2L Pancreatic]: BMS-813160 + Nivolumab
Part 2 Arm C Cohort 5 [2/3L Colorectal MSS]: BMS-813160 + Nivolumab
Opdivo
BMS-936558
Nab-paclitaxel
Drug
Specified dose on specified days
Part 1 Arm B [1L Pancreatic]: BMS-813160 followed by BMS-813160 + Gemcitabine/Nab-paclitaxel
Part 2 Arm B Cohort 3a [1L Pancreatic]: BMS-813160 + Gemcitabine/Nab-paclitaxel
Part 2 Arm B Cohort 3b [1L Pancreatic]: BMS-813160 + Nivolumab + Gemcitabine/Nab-paclitaxel
Part 2 Arm B Cohort 3c [1L Pancreatic]: Gemcitabine/Nab-paclitaxel
Gemcitabine
Drug
Specified dose on specified days
Part 1 Arm B [1L Pancreatic]: BMS-813160 followed by BMS-813160 + Gemcitabine/Nab-paclitaxel
Part 2 Arm B Cohort 3a [1L Pancreatic]: BMS-813160 + Gemcitabine/Nab-paclitaxel
Part 2 Arm B Cohort 3b [1L Pancreatic]: BMS-813160 + Nivolumab + Gemcitabine/Nab-paclitaxel
Part 2 Arm B Cohort 3c [1L Pancreatic]: Gemcitabine/Nab-paclitaxel
5-fluorouracil (5-FU)
Drug
Specified dose on specified days
Part 1 Arm A [First-line (1L) Colorectal]: BMS-813160 followed by BMS-813160 + FOLFIRI
Part 2 Arm A Cohort 1a [2L Colorectal]: BMS-813160 + FOLFIRI
Part 2 Arm A Cohort 1b [2L Colorectal]: BMS-813160 + FOLFIRI
Part 2 Arm A Cohort 1c [2L Colorectal]: FOLFIRI
Leucovorin
Drug
Specified dose on specified days
Part 1 Arm A [First-line (1L) Colorectal]: BMS-813160 followed by BMS-813160 + FOLFIRI
Part 2 Arm A Cohort 1a [2L Colorectal]: BMS-813160 + FOLFIRI
Part 2 Arm A Cohort 1b [2L Colorectal]: BMS-813160 + FOLFIRI
Part 2 Arm A Cohort 1c [2L Colorectal]: FOLFIRI
Irinotecan
Drug
Specified dose on specified days
Part 1 Arm A [First-line (1L) Colorectal]: BMS-813160 followed by BMS-813160 + FOLFIRI
Part 2 Arm A Cohort 1a [2L Colorectal]: BMS-813160 + FOLFIRI
Part 2 Arm A Cohort 1b [2L Colorectal]: BMS-813160 + FOLFIRI
Part 2 Arm A Cohort 1c [2L Colorectal]: FOLFIRI
An Adverse Event (AE) leading to discontinuation is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment that leads to the discontinuation of study treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
From first dose up to 100 days post last dose, up to approximately 3 years
Number of Participants Who Died
The number of participants who died within 100 days after receiving their last dose
From first dose up to 100 days post last dose, up to approximately 3 years
Number of Participants Experiencing Laboratory Abnormalities
The number of participants experiencing laboratory abnormalities in pre-specified selected parameters during the treatment period per CTCAE (Version 4). Laboratory abnormalities are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
From first dose up to 100 days post last dose, up to approximately 3 years
Vital Signs
Vital sign measurements at baseline and at the end of treatment. Baseline evaluations will be defined as evaluations with a date on or prior to the day of first dose of study treatment.
From first dose to 100 days post last dose, up to approximately 3 years
Number of Participants With Out-of-Range Electrocardiograms (ECG)
The number of participants with ECG measurements outside of the range pre-specified in the protocol.
From baseline up to 100 days post last dose
Percent Change in Regulatory T Cells (Treg) in Tumor Samples
The percent change in Regulatory T Cells (Treg) were taken at prespecified timepoints. Baseline is defined as the last non-missing value prior to the first dosing.
From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1)
Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples
The percent change in Tumor-Associated Macrophages (TAMs) were taken at prespecified timepoints. Baseline is defined as the last non-missing value prior to the first dosing.
From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1)
Objective Response Rate (ORR)
Objective Response Rate (ORR) as determined by Investigator was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. Progression is defined as at least 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm.
RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. Complete response (CR)= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial response (PR)= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose until disease progression, or the last response recorded (up to approximately 5 years)
Duration of Response (DoR)
Duration of Response (DOR), computed for all treated participants with a best overall response (BOR) of complete response (CR) or partial response (PR), is defined as the time between the date of first response (CR or PR) and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause, whichever occurs first, ie., DOR = disease progression date/death date -first response date + 1. For participants who remain alive and have not progressed, DOR will be censored on the date of their last tumor assessment.
CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose up to date of disease progression or death, whichever occurs first (up to approximately 5 years)
Progression Free Survival (PFS) Rate at 24 Weeks
PFS rate is defined as the proportion of participants who were progression free at Week 24. PFS is defined as the time from first dose to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Progression is defined at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm.
Complete response (CR)= Disappearance of all target lesions. Pathological lymph nodes must have short axis reduction to < 10 mm. Partial response (PR)= At least 30% decrease in sum of diameters of target lesions.
Participants who died w/o prior progression were considered progressed on death date. Those alive and not progressed were censored on the last tumor assessment date. Those who started subsequent therapy without reported progression were censored at last tumor assessment prior to subsequent therapy. Those without post-baseline tumor assessment and alive were censored at first dose.
From first dose up to Week 24
Tmax is defined as the time in hours of the maximum observed plasma concentration
From first dose up to the prespecified timpoints, C0D1, C0D14, AND C2D1
Trough Observed Plasma Concentration (Ctrough)
Ctrough is defined as the concentration reached by a drug immediately before the next dose is administered
From first dose up to prespecified timepoints, C0D1, C5D1, C0D1, C1D15, C5D1
Area Under Curve (AUC) 0-8
Area Under Curve (AUC) is defined as the area under the plot of plasma concentration of a drug versus time after dosage measured at 8 hours post-dose
From first dose up to prespecified timepoints- C0D1, C2D1
Area Under Curve (AUC) 0-24
Area Under Curve (AUC) is defined as the area under the plot of plasma concentration of a drug versus time after dosage measured at 8 hours post-dose
From first dose up to prespecified timepoints-C0D1, C2D1
Apparent Total Body Clearance (CLT/F)
The total body clearance (CLT/F) is defined as the volume of plasma completely cleared of drug per unit time
From first dose up to prespecified timepoints-C0D1, C2D14
Renal Clearance (CLR)
Renal clearance is defined as the rate at which the analytes were removed from the plasma by the kidneys.
From first dose up to prespecified timepoints-C0D1, C0D14
Number of Participants Who Were Anti-Drug Antibody (ADA) Positive
The number of participants who are anti-drug antibody positive. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment. ADA-positive sample is in a participant who is baseline ADA negative or with an ADA titer to be at least 4-fold or greater than baseline positive titer.
From first dose up to prespecified timepoints-C1D1, C1D15, C2D1, C3D1, C5D1, C9D1
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
FG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
FG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
FG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
FG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
FG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
FG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
FG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
FG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
FG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
FG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
FG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
FG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
FG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
FG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
FG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
FG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
FG00010 subjects
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FG01226 subjects9 of the original 26 participants in Cohort 1c were allowed to cross over to Cohort 5 if it was in their best interest as determined by their treating physician and participants meet all eligibility criteria.
FG01335 subjects
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COMPLETED
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NOT COMPLETED
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Type
Comment
Reasons
Death
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Other Reasons
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FG004
Lost to Follow-up
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FG004
Withdrawal by Subject
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FG004
Moved to crossover treatment
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FG004
Crossover Treatment
Type
Comment
Milestone Data
STARTED
Participants who received crossover treatment
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FG0179 subjects9 of the original 26 participants in Cohort 1c were allowed to cross over to Cohort 5 if it was in their best interest as determined by their treating physician and participants meet all eligibility criteria.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Other reasons
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
BG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
BG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
BG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
BG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
BG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
BG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
BG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
BG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
BG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
BG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
BG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
BG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
BG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
BG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
BG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
BG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
BG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
BG018
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00010
BG0018
BG00210
BG00311
BG0048
BG0057
BG0067
BG00711
BG0081
BG0092
BG01032
BG01132
BG01226
BG01335
BG01435
BG01532
BG01624
BG01733
BG018324
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
Mean
Full Range
Years
Title
Denominators
Categories
All Cohorts except Part 2-Arm C-Cohort 5
ParticipantsBG00010
ParticipantsBG0018
ParticipantsBG00210
ParticipantsBG003
Sex: Female, Male
9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
Count of Participants
Participants
Title
Denominators
Categories
All Cohorts except Part 2-Arm C-Cohort 5
ParticipantsBG00010
ParticipantsBG0018
ParticipantsBG002
Ethnicity (NIH/OMB)
9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
Count of Participants
Participants
Title
Denominators
Categories
All Cohorts except Part 2-Arm C-Cohort 5
ParticipantsBG00010
ParticipantsBG0018
ParticipantsBG002
Race (NIH/OMB)
9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
Count of Participants
Participants
Title
Denominators
Categories
All Cohorts except Part 2-Arm C-Cohort 5
ParticipantsBG00010
ParticipantsBG0018
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Experiencing Adverse Events (AEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
All treated participants
Posted
Count of Participants
Participants
From first dose up to 100 days post last dose, up to approximately 3 years
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
OG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG00010
OG0018
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG00010
OG0018
OG00210
OG003
Primary
Number of Participants Experiencing Serious Adverse Events (SAEs)
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.
All treated participants
Posted
Count of Participants
Participants
From first dose up to 100 days post last dose, up to approximately 3 years
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
Primary
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Dose-limiting toxicities (DLTs) are severe adverse effects (AEs) that are attributed to BMS-813160 or the combination regimen and define the maximum tolerated dose of a medicine. DLTs will be defined based on the incidence, duration and grade of AEs for which no alternate cause can be identified. AEs will be evaluated according to the NCI CTCAE v4.03. The incidence of DLT(s) during the first 6 weeks of treatment in Part 1 (the DLT evaluation period) and 4 weeks for Part 2 will be used.
All treated participants who completed the DLT evaluation period
Posted
Count of Participants
Participants
From first dose up to 100 days post last dose, up to approximately 3 years
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
Primary
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
An Adverse Event (AE) leading to discontinuation is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment that leads to the discontinuation of study treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
All treated participants
Posted
Count of Participants
Participants
From first dose up to 100 days post last dose, up to approximately 3 years
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG002
Primary
Number of Participants Who Died
The number of participants who died within 100 days after receiving their last dose
All treated participants
Posted
Count of Participants
Participants
From first dose up to 100 days post last dose, up to approximately 3 years
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
OG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
Primary
Number of Participants Experiencing Laboratory Abnormalities
The number of participants experiencing laboratory abnormalities in pre-specified selected parameters during the treatment period per CTCAE (Version 4). Laboratory abnormalities are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
All treated participants
Posted
Count of Participants
Participants
From first dose up to 100 days post last dose, up to approximately 3 years
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
Primary
Vital Signs
Vital sign measurements at baseline and at the end of treatment. Baseline evaluations will be defined as evaluations with a date on or prior to the day of first dose of study treatment.
All treated participants with vital sign measurements
Posted
Mean
Standard Deviation
mmHg
From first dose to 100 days post last dose, up to approximately 3 years
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
OG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
Primary
Number of Participants With Out-of-Range Electrocardiograms (ECG)
The number of participants with ECG measurements outside of the range pre-specified in the protocol.
All treated participants with out-of-range ECGs
Posted
Count of Participants
Participants
From baseline up to 100 days post last dose
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
OG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
Primary
Percent Change in Regulatory T Cells (Treg) in Tumor Samples
The percent change in Regulatory T Cells (Treg) were taken at prespecified timepoints. Baseline is defined as the last non-missing value prior to the first dosing.
All treated participants with immunohistochemistry data
Posted
Median
Full Range
Percent change in Treg
From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1)
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
OG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
Primary
Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples
The percent change in Tumor-Associated Macrophages (TAMs) were taken at prespecified timepoints. Baseline is defined as the last non-missing value prior to the first dosing.
All treated participants with immunohistochemistry data
Posted
Median
Full Range
Percent change in TAM
From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1)
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
OG003
Primary
Objective Response Rate (ORR)
Objective Response Rate (ORR) as determined by Investigator was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. Progression is defined as at least 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm.
RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. Complete response (CR)= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial response (PR)= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
All treated participants
Posted
Number
95% Confidence Interval
Percent of participants
From first dose until disease progression, or the last response recorded (up to approximately 5 years)
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
Primary
Duration of Response (DoR)
Duration of Response (DOR), computed for all treated participants with a best overall response (BOR) of complete response (CR) or partial response (PR), is defined as the time between the date of first response (CR or PR) and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause, whichever occurs first, ie., DOR = disease progression date/death date -first response date + 1. For participants who remain alive and have not progressed, DOR will be censored on the date of their last tumor assessment.
CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
All treated participants who achieved complete or partial response and were not censored
Posted
Median
95% Confidence Interval
Weeks
From first dose up to date of disease progression or death, whichever occurs first (up to approximately 5 years)
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
Primary
Progression Free Survival (PFS) Rate at 24 Weeks
PFS rate is defined as the proportion of participants who were progression free at Week 24. PFS is defined as the time from first dose to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Progression is defined at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm.
Complete response (CR)= Disappearance of all target lesions. Pathological lymph nodes must have short axis reduction to < 10 mm. Partial response (PR)= At least 30% decrease in sum of diameters of target lesions.
Participants who died w/o prior progression were considered progressed on death date. Those alive and not progressed were censored on the last tumor assessment date. Those who started subsequent therapy without reported progression were censored at last tumor assessment prior to subsequent therapy. Those without post-baseline tumor assessment and alive were censored at first dose.
All treated participants who were assessed for progression free survival at Week 24
Posted
Number
95% Confidence Interval
Proportion of Participants
From first dose up to Week 24
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
Secondary
Maximim Concentration (Cmax)
Cmax is defined as the maximum plasma concentration of the analytes at the prespecified timepoints.
Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.
Posted
Mean
Standard Deviation
ng/mL
From first dose up to the prespecified timepoints, C0D1, C0D14, and C2D1
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
OG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
Secondary
Time to Maximum Concentration (Tmax)
Tmax is defined as the time in hours of the maximum observed plasma concentration
Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.
Posted
Median
Full Range
Hours
From first dose up to the prespecified timpoints, C0D1, C0D14, AND C2D1
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
OG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
Secondary
Trough Observed Plasma Concentration (Ctrough)
Ctrough is defined as the concentration reached by a drug immediately before the next dose is administered
Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.
Posted
Mean
Standard Deviation
ng/mL
From first dose up to prespecified timepoints, C0D1, C5D1, C0D1, C1D15, C5D1
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
OG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
Secondary
Area Under Curve (AUC) 0-8
Area Under Curve (AUC) is defined as the area under the plot of plasma concentration of a drug versus time after dosage measured at 8 hours post-dose
Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.
Posted
Mean
Standard Deviation
ug*h/mL
From first dose up to prespecified timepoints- C0D1, C2D1
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
OG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
Secondary
Area Under Curve (AUC) 0-24
Area Under Curve (AUC) is defined as the area under the plot of plasma concentration of a drug versus time after dosage measured at 8 hours post-dose
Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.
Posted
Mean
Standard Deviation
ug*h/mL
From first dose up to prespecified timepoints-C0D1, C2D1
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
OG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
Secondary
Apparent Total Body Clearance (CLT/F)
The total body clearance (CLT/F) is defined as the volume of plasma completely cleared of drug per unit time
Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.
Posted
Mean
Standard Deviation
mL/min
From first dose up to prespecified timepoints-C0D1, C2D14
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
OG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
Secondary
Renal Clearance (CLR)
Renal clearance is defined as the rate at which the analytes were removed from the plasma by the kidneys.
Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.
Posted
Mean
Standard Deviation
mL/min
From first dose up to prespecified timepoints-C0D1, C0D14
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
OG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
Secondary
Number of Participants Who Were Anti-Drug Antibody (ADA) Positive
The number of participants who are anti-drug antibody positive. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment. ADA-positive sample is in a participant who is baseline ADA negative or with an ADA titer to be at least 4-fold or greater than baseline positive titer.
All treated participants with baseline measurements and at least one positive ADA assessment of Nivolumab
Posted
Count of Participants
Participants
From first dose up to prespecified timepoints-C1D1, C1D15, C2D1, C3D1, C5D1, C9D1
ID
Title
Description
OG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
Time Frame
Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
Description
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIR
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
6
10
5
10
10
10
EG001
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
6
8
5
8
8
8
EG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
8
10
5
10
9
10
EG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
8
11
7
11
11
11
EG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
6
8
5
8
8
8
EG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
6
7
6
7
7
7
EG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
6
7
6
7
7
7
EG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
7
11
6
11
10
11
EG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
1
1
1
1
1
1
EG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
2
2
2
2
2
2
EG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
26
32
12
32
32
32
EG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
28
32
12
32
31
32
EG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
17
26
6
26
25
26
EG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
33
35
24
35
35
35
EG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
34
35
22
35
34
35
EG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
26
32
15
32
31
32
EG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
20
24
17
24
19
24
EG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
25
33
19
33
30
33
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0101 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0132 affected35 at risk
EG0141 affected35 at risk
EG0151 affected32 at risk
EG0161 affected24 at risk
EG0170 affected33 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Left ventricular failure
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Stress cardiomyopathy
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected8 at risk
EG0021 affected10 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Duodenal stenosis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Malignant gastrointestinal obstruction
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Death
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Fatigue
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Gait disturbance
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
General physical health deterioration
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Influenza like illness
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Oedema peripheral
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Peripheral swelling
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Portal hypertension
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Bronchitis viral
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Cholangitis infective
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Fournier's gangrene
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Gastroenteritis sapovirus
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hepatic infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Klebsiella bacteraemia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Lymphangitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Peritonitis bacterial
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Rectal abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Scrotal abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Skin infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Splenic infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Spontaneous bacterial peritonitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Suspected COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Post procedural bile leak
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Wrong product administered
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Streptococcus test positive
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
White blood cell count increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Histiocytic necrotising lymphadenitis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Intracranial mass
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Seizure
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Balanoposthitis
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Prostatic haemorrhage
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0022 affected10 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Panniculitis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Embolism
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0004 affected10 at risk
EG0014 affected8 at risk
EG0025 affected10 at risk
EG0035 affected11 at risk
EG0044 affected8 at risk
EG0053 affected7 at risk
EG0062 affected7 at risk
EG0071 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0105 affected32 at risk
EG0115 affected32 at risk
EG0125 affected26 at risk
EG01321 affected35 at risk
EG01420 affected35 at risk
EG01520 affected32 at risk
EG0167 affected24 at risk
EG0176 affected33 at risk
Cytopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected10 at risk
EG0012 affected8 at risk
EG0021 affected10 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Cardiac dysfunction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Dry eye
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Eye irritation
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Photophobia
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Photopsia
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Vision blurred
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected8 at risk
EG0021 affected10 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0013 affected8 at risk
EG0024 affected10 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Anal rash
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Anorectal discomfort
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected10 at risk
EG0014 affected8 at risk
EG0025 affected10 at risk
EG003
Defaecation urgency
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0007 affected10 at risk
EG0014 affected8 at risk
EG0023 affected10 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Dyschezia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Large intestinal haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Lip pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0005 affected10 at risk
EG0016 affected8 at risk
EG0024 affected10 at risk
EG003
Oesophageal spasm
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Oral dysaesthesia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected10 at risk
EG0012 affected8 at risk
EG0020 affected10 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected10 at risk
EG0011 affected8 at risk
EG0024 affected10 at risk
EG003
Asthenia
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Chest discomfort
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Chills
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Cyst
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Fatigue
General disorders
MedDRA 26.0
Systematic Assessment
EG0006 affected10 at risk
EG0014 affected8 at risk
EG0027 affected10 at risk
EG003
Gait disturbance
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Generalised oedema
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Influenza like illness
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Localised oedema
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Malaise
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Oedema peripheral
General disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Peripheral swelling
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0021 affected10 at risk
EG003
Temperature intolerance
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Anorectal infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0022 affected10 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Enterobacter infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Paronychia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Pyuria
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0013 affected8 at risk
EG0021 affected10 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Stoma site pain
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Stoma site ulcer
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Vascular access site pain
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Vascular access site rash
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected8 at risk
EG0023 affected10 at risk
EG003
Amylase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0023 affected10 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0022 affected10 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0003 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Lipase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0004 affected10 at risk
EG0011 affected8 at risk
EG0021 affected10 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected8 at risk
EG0022 affected10 at risk
EG003
Platelet count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected8 at risk
EG0022 affected10 at risk
EG003
Transaminases increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Weight decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0023 affected10 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0002 affected10 at risk
EG0012 affected8 at risk
EG0022 affected10 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected10 at risk
EG0013 affected8 at risk
EG0022 affected10 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0022 affected10 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0023 affected10 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected8 at risk
EG0021 affected10 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0012 affected8 at risk
EG0022 affected10 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected8 at risk
EG0021 affected10 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0022 affected10 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0022 affected10 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Cerebellar infarction
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected10 at risk
EG0011 affected8 at risk
EG0021 affected10 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected8 at risk
EG0022 affected10 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0013 affected8 at risk
EG0022 affected10 at risk
EG003
Muscle contractions involuntary
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Narcolepsy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected8 at risk
EG0022 affected10 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected8 at risk
EG0021 affected10 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Syncope
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Tremor
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Delusion
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Depression
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0014 affected8 at risk
EG0023 affected10 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Bladder pain
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Perineal pain
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Scrotal pain
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected8 at risk
EG0022 affected10 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected8 at risk
EG0022 affected10 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Nasal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected10 at risk
EG0015 affected8 at risk
EG0022 affected10 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0013 affected8 at risk
EG0020 affected10 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected8 at risk
EG0021 affected10 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Nail ridging
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0021 affected10 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0022 affected10 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected8 at risk
EG0020 affected10 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Xeroderma
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Embolism
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Flushing
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Hot flush
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 at risk
EG003
Superficial vein thrombosis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0021 affected10 at risk
EG003
Venous thrombosis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected8 at risk
EG0020 affected10 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.
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG00010
OG0018
OG00210
OG00311
OG0048
OG0057
OG0067
OG00711
OG0081
OG0092
OG01032
OG01132
OG01226
OG01335
OG01435
OG01532
OG01624
OG01733
Title
Denominators
Categories
Title
Measurements
OG0005
OG0015
OG0025
OG0037
OG0045
OG0056
OG0066
OG0076
OG0081
OG0092
OG01012
OG01112
OG0126
OG01324
OG01422
OG01515
OG01617
OG01719
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
OG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG00010
OG0018
OG00210
OG00311
OG0048
OG0057
OG0067
OG00711
OG0081
OG0092
OG01032
OG01132
OG01226
OG01335
OG01435
OG01532
OG01624
OG01733
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0022
OG0032
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0141
OG0150
OG0160
OG0170
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
OG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG00010
OG0018
OG00210
OG00311
OG0048
OG0057
OG0067
OG00711
OG0081
OG0092
OG01032
OG01132
OG01226
OG01335
OG01435
OG01532
OG01624
OG01733
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
OG0021
OG0036
OG0040
OG0051
OG0060
OG0071
OG0080
OG0091
OG01010
OG0116
OG0122
OG01312
OG0148
OG0153
OG0164
OG0172
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG00010
OG0018
OG00210
OG00311
OG0048
OG0057
OG0067
OG00711
OG0081
OG0092
OG01032
OG01132
OG01226
OG01335
OG01435
OG01532
OG01624
OG01733
Title
Denominators
Categories
Title
Measurements
OG0006
OG0016
OG0028
OG0038
OG0046
OG0056
OG0066
OG0077
OG0081
OG0092
OG01026
OG01128
OG01217
OG01333
OG01434
OG01526
OG01620
OG01725
OG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG00010
OG0018
OG00210
OG00311
OG0048
OG0057
OG0067
OG00711
OG0081
OG0092
OG01032
OG01132
OG01226
OG01335
OG01435
OG01532
OG01624
OG01733
Title
Denominators
Categories
ALANINE AMINOTRANSFERASE (ALT), LOCAL LAB (U/L) - Abnormal High
ParticipantsOG00010
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00311
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG00711
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG01031
ParticipantsOG01132
ParticipantsOG01225
ParticipantsOG01334
ParticipantsOG01435
ParticipantsOG01531
ParticipantsOG01622
ParticipantsOG01733
Title
Measurements
OG0002
OG0014
OG0025
OG003
ASPARTATE AMINOTRANSFERASE (AST), LOCAL LAB (U/L) - Abnormal High
ParticipantsOG00010
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG003
Total Bilirubin (UMOL/L) - Abnormal High
ParticipantsOG00010
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00311
Neutrophils (Absolute) (10^9/L) - Abnormal Low
ParticipantsOG00010
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00311
PLATELET COUNT (10^9/L) - Abnormal Low
ParticipantsOG00010
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00311
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG0001
OG0013
OG0025
OG0034
OG0047
OG0053
OG0067
OG00710
OG0081
OG0091
OG0109
OG0119
OG0125
OG01321
OG01424
OG01516
OG01615
OG01724
Title
Denominators
Categories
Systolic Blood Pressure (mmHg) - End of Treatment
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0025
ParticipantsOG0034
ParticipantsOG0047
ParticipantsOG0053
ParticipantsOG0067
ParticipantsOG00710
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0103
ParticipantsOG0112
ParticipantsOG0121
ParticipantsOG01321
ParticipantsOG01424
ParticipantsOG01516
ParticipantsOG01615
ParticipantsOG01724
Title
Measurements
OG000133.0± NAStandard deviation not calculated due to insufficient number of events
OG001129.7± 6.7
OG002130.2± 21.8
OG003
Systolic Blood Pressure (mmHg) - Follow-up
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0034
Diastolic Blood Pressure (mmHg) - End of Treatment
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0025
ParticipantsOG003
Diastolic Blood Pressure (mmHg)- Follow-up
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0030
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG00010
OG0018
OG00210
OG00310
OG0048
OG0057
OG0067
OG00711
OG0081
OG0092
OG01032
OG01131
OG01225
OG01334
OG01434
OG01529
OG01624
OG01733
Title
Denominators
Categories
QTcF INTERVAL (MSEC) < 450
Title
Measurements
OG0007
OG0018
OG00210
OG0038
OG0048
OG0057
OG0067
OG00710
OG0081
OG0092
OG01031
OG01127
OG01223
OG01326
OG01430
OG01526
OG01624
OG01731
QTcF INTERVAL (MSEC): 450 <= QTcF < 480
Title
Measurements
OG0003
OG0010
OG0020
OG003
480<=QTcF<500 (MSEC)
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTcF>= 500 (MSEC)
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTcB INTERVAL (MSEC) < 450
Title
Measurements
OG0004
OG0017
OG0028
OG003
450<=QTcB<480 (MSEC)
Title
Measurements
OG0005
OG0011
OG0021
OG003
480<=QTcB<500 (MSEC)
Title
Measurements
OG0001
OG0010
OG0021
OG003
QTcB>= 500 (MSEC)
Title
Measurements
OG0000
OG0010
OG0020
OG003
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG0006
OG0014
OG0023
OG0033
OG0045
OG0055
OG0064
OG0076
OG0080
OG0091
OG0106
OG0113
OG0125
OG0135
OG0146
OG0153
OG0164
OG0175
Title
Denominators
Categories
FOXP3 - C0D7
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0080
ParticipantsOG0091
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG00026.6(-67 to 180)
OG001-43.8(-58 to -15)
OG002-22.9(-74 to -14)
OG003
FOXP3 - C0D14
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0032
FOXP3 - C1D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
FOXP3 - C1D15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
FOXP3 - C1D16
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
FOXP3 - C1D28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
FOXP3 - C2D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0064
OG0075
OG0080
OG0090
OG0106
OG0113
OG0124
OG0135
OG0146
OG0153
OG0160
OG0172
Title
Denominators
Categories
CD163 Positive - C0D7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG00613.1(2 to 808)
OG007-12.7(-67 to 231)
CD163 Positive - C0D14
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
CD163 Positive - C1D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
CD163 Positive - C1D15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
CD163 Positive - C1D16
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
CD163 Positive - C1D28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
CD163 Positive - C2D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
CD68 Positive - C0D7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
CD68 Positive - C0D14
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
CD68 Positive - C1D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
CD68 Positive - C1D15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
CD68 Positive - C1D16
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
CD68 Positive - C1D28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
CD68 Positive - C2D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
OG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG00010
OG0018
OG00210
OG00311
OG0048
OG0057
OG0067
OG00711
OG0081
OG0092
OG01032
OG01132
OG01226
OG01335
OG01435
OG01532
OG01624
OG01724
Title
Denominators
Categories
Title
Measurements
OG00060.0(26.2 to 87.8)
OG00125.0(3.2 to 65.1)
OG0020(0.0 to 30.8)
OG00318.2(2.3 to 51.8)
OG0040(0.0 to 36.9)
OG0050(0.0 to 41.0)
OG0060(0.0 to 41.0)
OG0070(0.0 to 28.5)
OG0080(0.0 to 97.5)
OG0090(0.0 to 84.2)
OG0109.4(2.0 to 25.0)
OG0119.4(2.0 to 25.0)
OG01219.2(6.6 to 39.4)
OG01322.9(10.4 to 40.1)
OG01417.1(6.6 to 33.6)
OG01521.9(9.3 to 40.0)
OG0160(0.0 to 14.2)
OG0178.3(1.0 to 27.0)
OG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
OG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG0006
OG0012
OG0020
OG0032
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0103
OG0113
OG0125
OG0137
OG0146
OG0157
OG0160
OG0172
Title
Denominators
Categories
Title
Measurements
OG000159.00(47.00 to NA)Upper limit not calculated due to insufficient number of events
OG001NA(16.43 to NA)Median and upper limit not calculated due to insufficient number of events
OG003NA(24.14 to NA)Median and upper limit not calculated due to insufficient number of events
OG01074.14(32.14 to NA)Upper limit not calculated due to insufficient number of events
OG01156.57(40.17 to NA)Upper limit not calculated due to insufficient number of events
OG01236.21(16.14 to NA)Upper limit not calculated due to insufficient number of events
OG01332.14(17.14 to 37.29)
OG01437.14(14.14 to NA)Upper limit not calculated due to insufficient number of events
OG01520.57(14.29 to 31.00)
OG017NA(41.00 to NA)Median and upper limit not calculated due to insufficient number of events
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
OG002
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
OG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG0007
OG0014
OG0025
OG0036
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
OG0107
OG01114
OG01213
OG01317
OG01421
OG01513
OG0160
OG0173
Title
Denominators
Categories
Title
Measurements
OG0000.778(0.3648 to 0.9393)
OG001NA(NA to NA)Not calculated due to insufficient number of participants who reached threshold
OG0020.556(0.2042 to 0.8045)
OG0030.800(0.4087 to 0.9459)
OG007NA(NA to NA)Not calculated due to insufficient number of participants who reached threshold
OG0100.357(0.1699 to 0.5490)
OG0110.536(0.3372 to 0.6996)
OG0120.691(0.4361 to 0.8478)
OG0130.535(0.3512 to 0.6888)
OG0140.636(0.4495 to 0.7746)
OG0150.467(0.2779 to 0.6358)
OG017NA(NA to NA)Not calculated due to insufficient number of participants who reached threshold
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG00010
OG0017
OG00210
OG00310
OG0048
OG0057
OG0067
OG0076
OG0081
OG0092
OG01018
OG01115
OG0120
OG01320
OG0140
OG0150
OG0160
OG0170
Title
Denominators
Categories
C0D1 - BMS-813160
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG00310
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG0076
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG000620.4± 250.60
OG0012204.1± 961.90
OG002828.4± 458.03
OG003
C0D1 - BMS-939429
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG00310
C0D14 - BMS-813160
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0035
C0D14 - BMS-939429
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0035
C2D1 - BMS-813160
ParticipantsOG0007
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0030
C2D1 - BMS-939429
ParticipantsOG0007
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0030
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG00010
OG0017
OG00210
OG00310
OG0048
OG0057
OG0067
OG0076
OG0081
OG0092
OG01018
OG01115
OG0120
OG01320
OG0140
OG0150
OG0160
OG0170
Title
Denominators
Categories
C0D1 - BMS-813160
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG00310
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG0076
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG0002.000(0.50 to 4.00)
OG0010.500(0.47 to 4.00)
OG0023.017(2.00 to 4.02)
OG003
C0D1 - BMS-939429
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG00310
C0D14 - BMS-813160
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0035
C0D14 - BMS-939429
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0035
C2D1 - BMS-813160
ParticipantsOG0007
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0030
C2D1 - BMS-939429
ParticipantsOG0007
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0030
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG0006
OG0013
OG0024
OG0034
OG0045
OG0051
OG0062
OG0072
OG0081
OG0092
OG01011
OG01116
OG0123
OG0137
OG0146
OG0150
OG0161
OG0171
Title
Denominators
Categories
C0D1 - BMS-813160
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG0045
ParticipantsOG0051
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG000283.70± 207.784
OG00184.30± 46.169
OG002292.0± 154.31
OG003
C5D1 - BMS-813160
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0034
C0D1 - BMS-939429
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0034
C1D15 - BMS 939429
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
C5D1 - BMS-939429
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0034
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG00010
OG0017
OG00210
OG00310
OG0048
OG0057
OG0067
OG0076
OG0081
OG0091
OG0109
OG01113
OG0120
OG01314
OG0140
OG0150
OG0161
OG0170
Title
Denominators
Categories
C0D1 - BMS-813160
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG00310
ParticipantsOG0048
ParticipantsOG0056
ParticipantsOG0067
ParticipantsOG0076
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG0002300.018± 976.4608
OG0017069.265± 2452.4213
OG0022725.390± 1365.3562
OG003
C0D1 - BMS-939429
ParticipantsOG0009
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG00310
C2D1 - BMS-813160
ParticipantsOG0007
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0030
C2D1 - BMS-939429
ParticipantsOG0007
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0030
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG0000
OG0017
OG0020
OG0039
OG0040
OG0055
OG0067
OG0076
OG0080
OG0091
OG0100
OG01111
OG0120
OG0130
OG0140
OG0150
OG0160
OG0170
Title
Denominators
Categories
C0D1 - BMS-813160
ParticipantsOG0000
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0039
ParticipantsOG0040
ParticipantsOG0055
ParticipantsOG0067
ParticipantsOG0076
ParticipantsOG0080
ParticipantsOG0091
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG0019383.385± 2842.8397
OG00311726.669± 6439.1376
OG00510447.179± 2995.9347
OG006
C0D1 - BMS-939429
ParticipantsOG0000
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0038
C2D1 - BMS-813160
ParticipantsOG0000
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0030
C2D1 - BMS-939429
ParticipantsOG0000
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0030
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG0008
OG0015
OG0027
OG0034
OG0046
OG0052
OG0063
OG0072
OG0081
OG0092
OG0109
OG01113
OG0120
OG01310
OG0140
OG0150
OG0160
OG0170
Title
Denominators
Categories
C0D14 - BMS-813160
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0034
ParticipantsOG0046
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0072
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG0001163.173± 588.1385
OG001744.746± 361.5390
OG0021521.863± 1277.8075
OG003
C2D1 - BMS-813160
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0030
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG0007
OG0014
OG0026
OG0033
OG0047
OG0053
OG0065
OG0074
OG0080
OG0091
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
OG0170
Title
Denominators
Categories
C0D1 - BMS-813160
ParticipantsOG0007
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG0033
ParticipantsOG0047
ParticipantsOG0053
ParticipantsOG0065
ParticipantsOG0074
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG000212.411± 191.8961
OG001275.309± 277.2659
OG002139.012± 107.2006
OG003
C0D1 - BMS-939429
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG0033
C0D14 - BMS-813160
ParticipantsOG0007
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0032
C0D14 - BMS-939429
ParticipantsOG0007
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0032
OG003
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
OG004
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG005
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG006
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG007
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
OG008
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG009
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
OG010
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
OG011
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
OG012
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
OG013
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
OG014
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
OG015
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
OG016
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
OG017
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
Units
Counts
Participants
OG00010
OG0018
OG00210
OG00311
OG0048
OG0057
OG0067
OG00711
OG0081
OG0092
OG01032
OG01132
OG01226
OG01335
OG01435
OG01532
OG01624
OG01733
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
OG0170
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0071 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0101 affected32 at risk
EG0111 affected32 at risk
EG0120 affected26 at risk
EG0132 affected35 at risk
EG0142 affected35 at risk
EG0151 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
1 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0131 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0171 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0101 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0141 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
1 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
1 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0101 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
1 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0061 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0103 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0132 affected35 at risk
EG0143 affected35 at risk
EG0152 affected32 at risk
EG0163 affected24 at risk
EG0172 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0101 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0131 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0121 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0161 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0151 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
1 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0131 affected35 at risk
EG0143 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0131 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0141 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0051 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0131 affected35 at risk
EG0141 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0172 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0161 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0131 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0111 affected32 at risk
EG0121 affected26 at risk
EG0131 affected35 at risk
EG0140 affected35 at risk
EG0151 affected32 at risk
EG0160 affected24 at risk
EG0171 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0101 affected32 at risk
EG0110 affected32 at risk
EG0121 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0171 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0141 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0111 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0171 affected33 at risk
2 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0132 affected35 at risk
EG0141 affected35 at risk
EG0151 affected32 at risk
EG0163 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0121 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
1 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0051 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0171 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0051 affected7 at risk
EG0061 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0103 affected32 at risk
EG0112 affected32 at risk
EG0120 affected26 at risk
EG0131 affected35 at risk
EG0140 affected35 at risk
EG0151 affected32 at risk
EG0160 affected24 at risk
EG0172 affected33 at risk
1 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0071 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0132 affected35 at risk
EG0141 affected35 at risk
EG0150 affected32 at risk
EG0162 affected24 at risk
EG0171 affected33 at risk
0 affected
11 at risk
EG0041 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0131 affected35 at risk
EG0141 affected35 at risk
EG0151 affected32 at risk
EG0163 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0151 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0091 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
1 affected
11 at risk
EG0040 affected8 at risk
EG0051 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0121 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
1 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0131 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0161 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0051 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
2 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0134 affected35 at risk
EG0145 affected35 at risk
EG0152 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0141 affected35 at risk
EG0150 affected32 at risk
EG0161 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
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EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0101 affected32 at risk
EG0113 affected32 at risk
EG0123 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0152 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0041 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0134 affected35 at risk
EG0141 affected35 at risk
EG0151 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0103 affected32 at risk
EG0113 affected32 at risk
EG0120 affected26 at risk
EG0131 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0141 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
1 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
1 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0101 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0061 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0132 affected35 at risk
EG0142 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0131 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0041 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0121 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0161 affected24 at risk
EG0170 affected33 at risk
1 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
1 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
2 affected
11 at risk
EG0041 affected8 at risk
EG0051 affected7 at risk
EG0060 affected7 at risk
EG0071 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0103 affected32 at risk
EG0110 affected32 at risk
EG0121 affected26 at risk
EG0133 affected35 at risk
EG0145 affected35 at risk
EG0153 affected32 at risk
EG0160 affected24 at risk
EG0174 affected33 at risk
3 affected
11 at risk
EG0041 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0101 affected32 at risk
EG0111 affected32 at risk
EG0123 affected26 at risk
EG0139 affected35 at risk
EG01413 affected35 at risk
EG0153 affected32 at risk
EG0160 affected24 at risk
EG0172 affected33 at risk
0 affected
11 at risk
EG0041 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0141 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
3 affected
11 at risk
EG0041 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0111 affected32 at risk
EG0120 affected26 at risk
EG0137 affected35 at risk
EG0148 affected35 at risk
EG0154 affected32 at risk
EG0160 affected24 at risk
EG0174 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0151 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
1 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0131 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0101 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0151 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0111 affected32 at risk
EG0120 affected26 at risk
EG0133 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
1 affected
11 at risk
EG0041 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0071 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0102 affected32 at risk
EG0111 affected32 at risk
EG0120 affected26 at risk
EG0131 affected35 at risk
EG0143 affected35 at risk
EG0152 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0132 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0061 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0101 affected32 at risk
EG0111 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0151 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0071 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0131 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0171 affected33 at risk
0 affected
11 at risk
EG0041 affected8 at risk
EG0051 affected7 at risk
EG0062 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0101 affected32 at risk
EG0112 affected32 at risk
EG0122 affected26 at risk
EG0134 affected35 at risk
EG0143 affected35 at risk
EG0154 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
3 affected
11 at risk
EG0041 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0111 affected32 at risk
EG0120 affected26 at risk
EG0134 affected35 at risk
EG0143 affected35 at risk
EG0154 affected32 at risk
EG0161 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0040 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
0 affected
11 at risk
EG0041 affected8 at risk
EG0050 affected7 at risk
EG0060 affected7 at risk
EG0070 affected11 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
EG0100 affected32 at risk
EG0110 affected32 at risk
EG0120 affected26 at risk
EG0130 affected35 at risk
EG0140 affected35 at risk
EG0150 affected32 at risk
EG0160 affected24 at risk
EG0170 affected33 at risk
6
BG0054
BG0064
BG0078
BG0080
BG0092
BG01019
BG01121
BG01217
BG01320
BG01420
BG01517
BG01616
BG018176
15
8
BG0057
BG0066
BG0077
BG0080
BG0092
BG01021
BG01126
BG01217
BG01328
BG01430
BG01524
BG01621
BG018227
0
BG0050
BG0061
BG0071
BG0081
BG0090
BG0104
BG0114
BG0127
BG0135
BG0144
BG0154
BG0163
BG01841
23
Unknown or Not Reported
BG0176
BG0186
0
BG0051
BG0060
BG0072
BG0080
BG0090
BG0102
BG0112
BG0121
BG0132
BG0141
BG0151
BG0161
BG01817
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0180
0
BG0051
BG0060
BG0070
BG0080
BG0090
BG0101
BG0113
BG0122
BG0130
BG0140
BG0152
BG0160
BG01810
8
BG0055
BG0067
BG0077
BG0081
BG0092
BG01028
BG01126
BG01222
BG01332
BG01434
BG01527
BG01622
BG018254
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0180
0
BG0050
BG0060
BG0072
BG0080
BG0090
BG0101
BG0111
BG0121
BG0131
BG0140
BG0152
BG0161
BG01810
1
Native Hawaiian or Other Pacific Islander
BG0170
BG0180
Black or African American
BG0173
BG0183
White
BG01728
BG01828
More than one race
BG0170
BG0180
Unknown or Not Reported
BG0171
BG0181
7
OG0042
OG0051
OG0063
OG0076
OG0081
OG0091
OG01015
OG0119
OG01210
OG01324
OG01428
OG01524
OG01610
OG01713
11
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG00711
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG01031
ParticipantsOG01132
ParticipantsOG01225
ParticipantsOG01334
ParticipantsOG01435
ParticipantsOG01531
ParticipantsOG01621
ParticipantsOG01733
Title
Measurements
OG0002
OG0014
OG0025
OG0037
OG0043
OG0053
OG0065
OG0075
OG0081
OG0091
OG01015
OG01112
OG0129
OG01321
OG01426
OG01524
OG01612
OG01719
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG00711
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG01031
ParticipantsOG01132
ParticipantsOG01225
ParticipantsOG01334
ParticipantsOG01435
ParticipantsOG01531
ParticipantsOG01622
ParticipantsOG01733
Title
Measurements
OG0002
OG0014
OG0025
OG0032
OG0041
OG0051
OG0064
OG0073
OG0081
OG0091
OG0105
OG0115
OG0122
OG0138
OG0147
OG0155
OG0166
OG0177
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG00711
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG01031
ParticipantsOG01132
ParticipantsOG01225
ParticipantsOG01335
ParticipantsOG01435
ParticipantsOG01531
ParticipantsOG01622
ParticipantsOG01733
Title
Measurements
OG0006
OG0014
OG0025
OG0039
OG0042
OG0051
OG0061
OG0072
OG0080
OG0090
OG01025
OG01120
OG01218
OG01322
OG01425
OG01525
OG0161
OG0174
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG00711
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG01031
ParticipantsOG01132
ParticipantsOG01225
ParticipantsOG01335
ParticipantsOG01435
ParticipantsOG01531
ParticipantsOG01622
ParticipantsOG01733
Title
Measurements
OG0005
OG0011
OG0025
OG0035
OG0042
OG0051
OG0061
OG0073
OG0080
OG0090
OG01011
OG01115
OG0128
OG01324
OG01428
OG01526
OG01610
OG0175
143.0
± 34.0
OG004114.0± 15.0
OG005125.0± 6.1
OG006140.3± 18.0
OG007124.0± 23.7
OG008151.0± NAStandard deviation not calculated due to insufficient number of events
OG009107.0± NAStandard deviation not calculated due to insufficient number of events
OG010126.0± 15.9
OG011113.0± NAStandard deviation not calculated due to insufficient number of events
OG012113.0± NAStandard deviation not calculated due to insufficient number of events
OG013123.2± 18.8
OG014128.9± 17.8
OG015118.8± 15.9
OG016112.6± 11.6
OG017123.1± 13.6
ParticipantsOG0042
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0109
ParticipantsOG0119
ParticipantsOG0125
ParticipantsOG0135
ParticipantsOG0145
ParticipantsOG0153
ParticipantsOG0161
ParticipantsOG0172
Title
Measurements
OG000140.0± 8.5
OG001124.5± 2.1
OG002100.0± NAStandard deviation not calculated due to insufficient number of events
OG003143.0± 34.0
OG004140.0± 8.5
OG005108.0± NAStandard deviation not calculated due to insufficient number of events
OG006148.0± NAStandard deviation not calculated due to insufficient number of events
OG007129.5± 29.0
OG010127.9± 13.2
OG011131.3± 20.6
OG012113.6± 8.1
OG013119.2± 15.1
OG014142.6± 16.0
OG015108.3± 30.1
OG016113.0± NAStandard deviation not calculated due to insufficient number of events
OG017113.5± 6.4
4
ParticipantsOG0047
ParticipantsOG0053
ParticipantsOG0067
ParticipantsOG00710
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0103
ParticipantsOG0112
ParticipantsOG0121
ParticipantsOG01321
ParticipantsOG01424
ParticipantsOG01516
ParticipantsOG01615
ParticipantsOG01724
Title
Measurements
OG00083.0± NAStandard deviation not calculated due to insufficient number of events
OG00173.3± 7.2
OG00275.4± 12.4
OG00380.8± 17.7
OG00469.6± 9.4
OG00586.0± 18.2
OG00689.7± 11.1
OG00774.3± 11.3
OG00886.0± NAStandard deviation not calculated due to insufficient number of events
OG00967.0± NAStandard deviation not calculated due to insufficient number of events
OG01079.0± 11.5
OG01174.5± 3.5
OG01275.0± NAStandard deviation not calculated due to insufficient number of events
OG01369.2± 8.2
OG01474.3± 8.6
OG01570.2± 8.6
OG01668.1± 6.5
OG01774.3± 9.7
ParticipantsOG0042
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0109
ParticipantsOG0119
ParticipantsOG0125
ParticipantsOG0135
ParticipantsOG0145
ParticipantsOG0153
ParticipantsOG0161
ParticipantsOG0172
Title
Measurements
OG00079.0± NAStandard deviation not calculated due to insufficient number of events
OG00171.5± 14.8
OG00259.0± NAStandard deviation not calculated due to insufficient number of events
OG00485.0± 2.8
OG00569.0± NAStandard deviation not calculated due to insufficient number of events
OG00698.0± NAStandard deviation not calculated due to insufficient number of events
OG00772.5± 4.9
OG01076.6± 14.6
OG01176.1± 11.0
OG01278.2± 7.3
OG01368.0± 9.9
OG01470.2± 10.5
OG01566.7± 20.1
OG01685.0± NAStandard deviation not calculated due to insufficient number of events
OG01769.0± 2.8
1
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
OG0100
OG0114
OG0122
OG0136
OG0144
OG0153
OG0160
OG0172
1
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0131
OG0140
OG0150
OG0160
OG0170
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
OG0110
OG0120
OG0131
OG0140
OG0150
OG0160
OG0170
5
OG0047
OG0053
OG0063
OG0077
OG0081
OG0092
OG01020
OG01121
OG01215
OG01314
OG01417
OG01519
OG01621
OG01715
3
OG0041
OG0054
OG0063
OG0072
OG0080
OG0090
OG01011
OG0117
OG01210
OG01314
OG01414
OG0158
OG0163
OG01718
2
OG0040
OG0050
OG0061
OG0072
OG0080
OG0090
OG0100
OG0113
OG0120
OG0134
OG0143
OG0152
OG0160
OG0170
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0101
OG0110
OG0120
OG0132
OG0140
OG0150
OG0160
OG0170
156.4
(-12 to 177)
OG00457.3(-76 to 116)
OG005-18.4(-27 to -9)
OG006-92.2(-94 to 27)
OG00796.4(14 to 152)
OG009101.0(101 to 101)
Participants
OG004
1
ParticipantsOG0055
ParticipantsOG0062
ParticipantsOG0073
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG00026.5(-50 to 103)
OG001-19.8(-78 to 53)
OG00260.0(60 to 60)
OG003-41.6(-67 to -16)
OG004-41(-41 to -41)
OG005-26.5(-57 to 249)
OG006180.2(-60 to 421)
OG007-3.7(-9 to 25)
Participants
OG004
2
ParticipantsOG0051
ParticipantsOG0062
ParticipantsOG0076
ParticipantsOG0080
ParticipantsOG0091
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG00434.7(-58 to 128)
OG00549(49 to 49)
OG006147.4(20 to 275)
OG00733.0(-51 to 338)
OG00931.0(31 to 31)
Participants
OG004
3
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0112
ParticipantsOG0121
ParticipantsOG0132
ParticipantsOG0140
ParticipantsOG0152
ParticipantsOG0161
ParticipantsOG0170
Title
Measurements
OG004-25.9(-48 to -6)
OG00514.5(-90 to 322)
OG00639.1(4 to 74)
OG007-33(-33 to -33)
OG011-39.1(-46 to -32)
OG01260(60 to 60)
OG013113.6(-1 to 228)
OG01517.0(-39 to 73)
OG016-64(-64 to -64)
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG010-21(-21 to -21)
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0106
ParticipantsOG0112
ParticipantsOG0125
ParticipantsOG0135
ParticipantsOG0146
ParticipantsOG0153
ParticipantsOG0164
ParticipantsOG0175
Title
Measurements
OG010-7.4(-26 to 113)
OG011-77.0(-93 to -61)
OG01212.0(-73 to 152)
OG013-36.0(-77 to -5)
OG01499.4(-96 to 2199)
OG015-46.6(-55 to 551)
OG016216.7(98 to 363)
OG017-13.6(-78 to 149)
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0102
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0151
ParticipantsOG0162
ParticipantsOG0172
Title
Measurements
OG010305.2(-73 to 683)
OG015184(184 to 184)
OG016-2.4(-37 to 32)
OG017156.2(13 to 299)
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0062
ParticipantsOG0073
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG00695.4(34 to 157)
OG007133.6(0 to 286)
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG006477.5(334 to 621)
OG00722.1(-28 to 520)
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0063
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0113
ParticipantsOG0121
ParticipantsOG0132
ParticipantsOG0140
ParticipantsOG0152
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG0067.6(-37 to 53)
OG007-93(-93 to -93)
OG01189.8(35 to 132)
OG012-61(-61 to -61)
OG013145.7(43 to 248)
OG01560.3(1 to 120)
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG0101369(1369 to 1369)
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0106
ParticipantsOG0112
ParticipantsOG0124
ParticipantsOG0135
ParticipantsOG0145
ParticipantsOG0153
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG010-4.1(-21 to 1072)
OG011-58.4(-98 to -19)
OG012106.3(-67 to 511)
OG013-14.7(-57 to 91)
OG01465.5(-31 to 666)
OG0151.0(-96 to 61)
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0102
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0153
ParticipantsOG0160
ParticipantsOG0172
Title
Measurements
OG010-58.3(-94 to -22)
OG015-41.3(-61 to -33)
OG01739.3(-1 to 79)
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0063
ParticipantsOG0074
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG006-70.2(-91 to 107)
OG007-17.1(-64 to -2)
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG00657.7(-12 to 128)
OG0077.9(-8 to 24)
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0062
ParticipantsOG0075
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG006294.2(203 to 385)
OG00717.8(-39 to 102)
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0063
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0113
ParticipantsOG0121
ParticipantsOG0132
ParticipantsOG0140
ParticipantsOG0152
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG0062.9(-26 to 185)
OG007-26(-26 to -26)
OG011-4.0(-27 to 58)
OG01281(81 to 81)
OG013162.4(150 to 175)
OG01592.5(20 to 165)
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0101
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG010272(272 to 272)
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0106
ParticipantsOG0112
ParticipantsOG0124
ParticipantsOG0135
ParticipantsOG0146
ParticipantsOG0153
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG01031.5(-60 to 296)
OG011-70.7(-92 to -49)
OG01296.2(-50 to 1106)
OG013-38.3(-88 to 121)
OG01496.2(-25 to 179)
OG015-4.3(-46 to 102)
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0102
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0153
ParticipantsOG0160
ParticipantsOG0171
Title
Measurements
OG010-26.9(-50 to -4)
OG015-40.0(-54 to -33)
OG017-66(-66 to -66)
2419.0
± 1203.53
OG004486.3± 137.69
OG0051896.3± 1421.89
OG0061179.1± 605.50
OG007276.28± 141.915
OG0081580.0± NAStandard deviation not calculated due to insufficient number of events
OG009807.0± NAStandard deviation not calculated due to insufficient number of events
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG0076
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG000172.23± 103.837
OG001435.6± 284.14
OG002207.63± 142.559
OG003545.7± 218.89
OG00492.33± 50.015
OG005539.1± 465.93
OG006237.63± 188.286
OG00754.82± 23.716
OG008504.0± NAStandard deviation not calculated due to insufficient number of events
OG00972.50± NAStandard deviation not calculated due to insufficient number of events
ParticipantsOG0046
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG000927.1± 513.88
OG0014152.5± 2010.23
OG0021060.3± 830.04
OG0033274.0± 884.15
OG004701.5± 284.59
OG0051793.5± 1607.25
OG006653.3± 298.08
OG00780.00± 19.408
OG0081370.0± NAStandard deviation not calculated due to insufficient number of events
OG0091680.0± 961.67
ParticipantsOG0046
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG000317.90± 290.209
OG001658.3± 143.17
OG002409.63± 382.471
OG003792.2± 503.92
OG004183.08± 190.050
OG005326.0± 241.83
OG006165.83± 92.914
OG00725.307± 16.6021
OG008498.0± NAStandard deviation not calculated due to insufficient number of events
OG009265.40± 235.608
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG01018
ParticipantsOG01115
ParticipantsOG0120
ParticipantsOG01320
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG0001153.1± 617.97
OG0013280.0± 777.82
OG010903.9± 578.56
OG011357.55± 264.384
OG013796.2± 472.48
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG000254.1± 140.73
OG001571.0± 376.42
2.492
(0.73 to 5.98)
OG0042.492(0.52 to 11.92)
OG0052.983(0.58 to 8.92)
OG0063.00(0.50 to 6.00)
OG0071.992(0.50 to 3.00)
OG0082.0(2 to 2)
OG0093.950(3.95 to 3.95)
ParticipantsOG0048
ParticipantsOG0057
ParticipantsOG0067
ParticipantsOG0076
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG0003.500(0.50 to 6.25)
OG0011.000(0.50 to 4.00)
OG0023.508(1.00 to 11.98)
OG0033.000(0.73 to 5.98)
OG0043.000(1.0 to 11.92)
OG0052.083(1.08 to 8.92)
OG0063.000(1.00 to 6.00)
OG0072.000(0.98 to 4.00)
OG0082.0(2 to 2)
OG0091.950(1.95 to 1.95)
ParticipantsOG0046
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG0003.000(0.55 to 3.03)
OG0011.825(0.50 to 3.00)
OG0022.917(0.92 to 15.70)
OG0032.983(0.50 to 4.00)
OG0042.875(0.50 to 3.00)
OG0052.0(1 to 3)
OG0062.000(1.00 to 3.02)
OG0071.00(0.5 to 4.0)
OG0082.02(2.02 to 2.02)
OG0092.542(2.00 to 3.08)
ParticipantsOG0046
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG0003.000(0.98 to 4.00)
OG0011.825(0.50 to 3.00)
OG0023.000(1.08 to 15.70)
OG0032.983(1.00 to 4.00)
OG0042.875(1.17 to 3.00)
OG0052.492(1.98 to 3.00)
OG0063.000(1.00 to 4.02)
OG0071.0(1 to 6)
OG0082.02(2.02 to 2.02)
OG0093.117(2.00 to 4.23)
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG01018
ParticipantsOG01115
ParticipantsOG0120
ParticipantsOG01320
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG0003.000(0.98 to 4.23)
OG0011.000(0.47 to 4.03)
OG0102.033(0.50 to 14.10)
OG0112.067(0.50 to 8.10)
OG0133.992(0.50 to 16.17)
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG0003.000(2.00 to 4.23)
OG0011.000(0.97 to 4.03)
74.05
± 72.127
OG004157.28± 92.311
OG005137.0± NAStandard deviation not calculated due to insufficient number of events
OG00657.10± 54.871
OG0075.485± 2.4395
OG00877.40± NAStandard deviation not calculated due to insufficient number of events
OG009154.05± 139.936
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG000268.80± 216.882
OG001129.40± 89.944
OG002176.0± NAStandard deviation not calculated due to insufficient number of events
OG00315.30± NAStandard deviation not calculated due to insufficient number of events
OG004323.0± NAStandard deviation not calculated due to insufficient number of events
ParticipantsOG0045
ParticipantsOG0051
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0081
ParticipantsOG0092
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG000172.63± 264.187
OG00131.40± 10.689
OG002180.88± 195.959
OG00372.95± 55.542
OG00447.60± 10.412
OG00531.50± NAStandard deviation not calculated due to insufficient number of events
OG00663.45± 60.175
OG0074.950± 2.3052
OG00890.30± NAStandard deviation not calculated due to insufficient number of events
OG00971.65± 55.649
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG01011
ParticipantsOG01116
ParticipantsOG0123
ParticipantsOG0137
ParticipantsOG0145
ParticipantsOG0150
ParticipantsOG0161
ParticipantsOG0170
Title
Measurements
OG010191.33± 84.266
OG01124.106± 18.445
OG012275.7± 164.34
OG013116.04± 29.696
OG014145.00± 99.293
OG016283.0± NAStandard deviation not calculated due to insufficient number of events
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG01011
ParticipantsOG01112
ParticipantsOG0121
ParticipantsOG0135
ParticipantsOG0146
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0171
Title
Measurements
OG00055.78± 31.877
OG00115.95± 4.172
OG002155.0± NAStandard deviation not calculated due to insufficient number of events
OG00310.50± NAStandard deviation not calculated due to insufficient number of events
OG00465.20± NAStandard deviation not calculated due to insufficient number of events
OG010186.21± 131.457
OG01112.439± 6.9685
OG012195.0± NAStandard deviation not calculated due to insufficient number of events
OG013191.44± 113.725
OG014222.65± 154.316
OG017390.0± NAStandard deviation not calculated due to insufficient number of events
7884.381
± 3968.4940
OG0041534.932± 518.2172
OG0056593.904± 3603.5286
OG0063533.737± 1931.7752
OG007878.051± 535.3197
OG0084440.313± NAStandard deviation not calculated due to insufficient number of events
OG0093656.713± NAStandard deviation not calculated due to insufficient number of events
ParticipantsOG0048
ParticipantsOG0056
ParticipantsOG0067
ParticipantsOG0076
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG000652.848± 363.5925
OG0011783.336± 856.0103
OG002936.394± 826.5807
OG0032302.092± 1023.3978
OG004342.534± 157.1350
OG0052147.888± 1415.6386
OG006942.398± 620.1018
OG007210.938± 106.5352
OG0081919.228± NAStandard deviation not calculated due to insufficient number of events
OG009411.410± NAStandard deviation not calculated due to insufficient number of events
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0109
ParticipantsOG01113
ParticipantsOG0120
ParticipantsOG01314
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG0005348.973± 2506.2558
OG00111967.560± 4586.3823
OG0104838.264± 2750.7756
OG0111483.423± 1236.0374
OG0133821.887± 2221.2474
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG0001410.415± 837.4895
OG0012403.182± 1144.3271
4829.881
± 2696.4668
OG0071275.314± 799.8262
OG0097687.658± NAStandard deviation not calculated due to insufficient number of events
ParticipantsOG0040
ParticipantsOG0055
ParticipantsOG0067
ParticipantsOG0076
ParticipantsOG0080
ParticipantsOG0091
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG0012638.062± 977.2502
OG0033991.522± 1636.3573
OG0053905.941± 1852.8415
OG0061660.159± 991.0121
OG007341.0396± 160.4425
OG009940.294± NAStandard deviation not calculated due to insufficient number of events
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG01111
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG00117890.458± 9212.5646
OG0112050.804± 997.6990
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
Title
Measurements
OG0013958.779± 1632.3781
826.468
± 300.1738
OG0041602.009± 1123.8919
OG005961.379± 235.4622
OG0061688.813± 1022.7160
OG0074950.110± 781.0155
OG0081135.947± NAStandard deviation not calculated due to insufficient number of events