A Study Measuring the Effectiveness, Safety, and Tolerabi... | NCT04308681 | Trialant
NCT04308681
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Feb 3, 2026Actual
Enrollment
403Actual
Phase
Phase 2
Conditions
Pulmonary Fibrosis
Interventions
BMS-986278 Placebo
BMS-986278
Countries
United States
Argentina
Australia
Belgium
Brazil
Canada
Chile
China
France
Germany
Israel
Italy
Japan
Mexico
South Korea
Spain
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT04308681
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
IM027-040
Secondary IDs
ID
Type
Description
Link
2019-003992-21
EudraCT Number
Brief Title
A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants With Pulmonary Fibrosis
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Jan 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 29, 2020Actual
Primary Completion Date
Aug 4, 2022Actual
Completion Date
Sep 22, 2023Actual
First Submitted Date
Mar 12, 2020
First Submission Date that Met QC Criteria
Mar 12, 2020
First Posted Date
Mar 16, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Sep 23, 2024
Results First Submitted that Met QC Criteria
Feb 21, 2025
Results First Posted Date
Feb 24, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 26, 2023
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Feb 24, 2025Actual
Last Update Submitted Date
Jan 15, 2026
Last Update Posted Date
Feb 3, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to provide an initial evaluation of the effectiveness of BMS-986278 in participants with lung fibrosis, to demonstrate the safety of BMS-986278, and provide information on the drug levels of BMS-986278 in these participants.
Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in IPF Participants
Percent predicted forced vital capacity (ppFVC) is the percentage of predicted value per participant of forced vital capacity (FVC). FVC is defined as the maximum capacity of air that a participant can exhale after a maximum inspiration as measured by the volume of air exhaled in a spirometer. The data is reported as percent change from baseline in ppFVC. Percent change from baseline is a calculation that expresses the change in a value compared to its initial starting point (baseline) as a percentage, showing how much a value has increased or decreased relative to its original level; it's calculated by subtracting the baseline value from the new value, dividing by the baseline value, and then multiplying by 100%. The percent change in this endpoint was calculated from ppFVC values taken at baseline, which is defined as the measurement of ppFVC taken at first dose, and ppFVC values taken at Week 26. This endpoint reports data for the IPF cohort only as pre-specified in the protocol.
From baseline (first dose) up to week 26
Secondary Outcomes
Measure
Description
Time Frame
The 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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
For the idiopathic pulmonary fibrosis (IPF) Cohort
Diagnosis of IPF within 7 years of screening
Female and males ≥ 40 years of age
For the progressive fibrotic interstitial lung disease (PF-ILD) Cohort
Evidence of progressive ILD within the 24 months before screening
Female and male ≥ 21 years of age.
Exclusion Criteria:
Women of childbearing potential (WOCBP)
Active Smokers
Current malignancy or previous malignancy up to 5 years prior to screening
History of allergy to BMS-986278 or related compounds
Other protocol-defined inclusion/exclusion criteria apply
Kreuter M, Maher TM, Wuyts WA, Valenzuela C, Hamblin M, Kim S, Patel A, Elpers B, Richeldi L. Effect of Admilparant, a Lysophosphatidic Acid Receptor 1 Antagonist, on Disease Progression in Pulmonary Fibrosis. Chest. 2025 Sep;168(3):677-687. doi: 10.1016/j.chest.2025.04.003. Epub 2025 Apr 8.
Participants who received 30 mg or 60 mg BMS-986278 in the 26-week long main study phase and met low BP criteria were given the option to receive 10 mg of BMS-986278 in the optional treatment extension (OTE), which lasted an additional 26 weeks.
Participants who received placebo during the main study phase were re-randomized to receive either 30 mg or 60 mg of BMS-986278 in OTE.
No participants received a 10 mg dose during the main study and no participants received placebo during the OTE.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
FG001
IPF Cohort: 30 mg BMS-986278
Periods
Title
Milestones
Reasons Not Completed
Pre-Treatment
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
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
Sep 22, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
BMS-986278
Drug
Specified Dose on Specified Days
IPF Dose 1 + Post Treatment Follow-up or OTE
IPF Dose 2 + Post Treatment Follow-up or OTE
PF-ILD Dose 1 + Post Treatment Follow-up or OTE
PF-ILD Dose 2 + Post Treatment Follow-up or OTE
From first dose up to 30 days after last dose during the main study treatment phase
The 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 30 days after last dose during the main study treatment phase
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
The number of participants who discontinued study treatment due to adverse events (AEs)
From first dose up to 30 days after last dose during the main study treatment phase
The Number of Participants Who Died Due to Adverse Events (AEs)
The number of participants who died while receiving study treatment due to an adverse event
From first dose up to 30 days after last dose during the main study treatment phase
Maximum Concentration (Cmax)
Cmax is defined as the maximum concentration of the analyte recorded in the participants. Cmax of BMS-986278 and BMT-327319 was derived from plasma concentration versus time data.
On Day 1 and Week 4 (Day 29)
Time to Maximum Concentration (Tmax)
Tmax is defined as the amount of time until the maximum concentration of the analyte is recorded in the participants
On Day 1 and Week 4 (Day 29)
Area Under Curve (AUC0-8)
Area under the plasma concentration-time curve (AUC) from the timepoint of 0 hours to 24 hours post dose as measured on Day 1 and Week 4.
On Day 1 and Week 4 (Day 29)
Concentration Trough (Ctrough)
Ctrough is defined as the lowerst concentration of drug in the blood immediately before the next dose is administered
On Week 4 (Day 29) and Week 12 (Day 85)
The Number of Participants Experiencing Electrocardiogram (ECG) Abnormalities
A frequency summary of investigator clinical interpretation of ECG abnormal findings is listed.
At Week 26
Change From Baseline in Vital Sign Measurements
The change from baseline in select vital sign measurements. Baseline is defined as first dose.
At baseline and Week 26
Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in PF-ILD Participants
Percent predicted forced vital capacity (ppFVC) is the percentage of predicted value per participant of forced vital capacity (FVC). FVC is defined as the maximum capacity of air that a participant can exhale after a maximum inspiration as measured by the volume of air exhaled in a spirometer. The data is reported as percent change from baseline in ppFVC. Percent change from baseline is a calculation that expresses the change in a value compared to its initial starting point (baseline) as a percentage, showing how much a value has increased or decreased relative to its original level; it's calculated by subtracting the baseline value from the new value, dividing by the baseline value, and then multiplying by 100%. The percent change in this endpoint was calculated from ppFVC values taken at baseline, which is defined as the measurement of ppFVC taken at first dose, and ppFVC values taken at Week 26. This endpoint reports data for PF-ILD cohort only as pre-specified in the protocol.
At baseline and Week 26
The Number of Participants With ≥ 10% Absolute Decline in ppFVC (%)
The number of participants with ≥ 10% absolute decline in percent predicted forced vital capacity (ppFVC) at pre-specified timepoints.
ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participant.
The number of participants represented signify the number of participants with applicable data during the specific visit at the specific timepoint.
At Weeks 4, 8, 12, 16, 20, and 26
The Number of Participants With 0% Change in ppFVC (%)
The number of participants with 0% change in percent predicted forced vital capacity (ppFVC) at pre-specified timepoints.
ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participant.
Weeks 4, 8, 12, 16, 20, and 26
Time to First Occurrence ≥ 10% Absolute Decline in ppFVC (%)
The amount of time in weeks to the participant's first occurrence ≥ 10% absolute decline in Percent Predicted Forced Vital Capacity (ppFVC). A participant's time is censored at the last observed time prior to discontinuation if a participant discontinues study without event, or at week 26 if a participant does not experience the event until the end of week 26. Kaplan-Meier product limit method will be employed to estimate the survival curves.
ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participant.
From first dose up to the first occurrence of ≥ 10% absolute decline in ppFVC
Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC)
The absolute change in ppFVC (%) is measured from baseline up to the pre-specified timepoints of Weeks 4, 8, 12, 16, 20, and 26.
ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air (mL) exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participant.
From baseline up to Weeks 4, 8, 12, 16, 20, and 26
Absolute Change From Baseline in Forced Vital Capacity (FVC)
Forced vital capacity (FVC) is defined as the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible. The absolute change in FVC (mL) is measured from baseline up to Weeks 4, 8, 12, 16, 20, and 26.
From baseline up to Weeks 4, 8, 12, 16, 20, and 26
Absolute Change From Baseline in Single Breath Diffusing Capacity of Carbon Monoxide (DLCO SB)
The absolute change in single breath diffusing capacity of carbon monoxide (DLCO SB) (mL/min/mmHg) (corrected for hemoglobin) from baseline to Week 26. DLCO is defined as a measurement of the extent to which oxygen passes from the alveoli into the blood. Baseline is defined as first dose.
From baseline up to Week 26
Absolute Change From Baseline in Percent Predicted Single Breath Diffusing Capacity of Carbon Monoxide (ppDLCO SB)
The absolute change in percent predicted single breath diffusing capacity of carbon monoxide (DLCO SB) (mL/min/mmHg) (corrected for hemoglobin) from baseline to Week 26. DLCO is defined as a measurement of the extent to which oxygen passes from the alveoli into the blood. Baseline is defined as first dose.
From baseline up to Week 26
Absolute Change From Baseline in Walking Endurance/Distance
The absolute change in walking endurance/distance as determined by the 6-minute walk test (6MWT) from baseline to Week 26. The 6-Minute Walk Test (6MWT) is a submaximal exercise test used to assess aerobic capacity and endurance. Baseline is defined as first dose.
From baseline up to Week 26
Time to First Acute Exacerbation
Time to first acute exacerbations of lung fibrosis was measured from the day of first dose up to the day of first acute exacerbation. Participants who discontinued the study treatment prior to the end of the main study without experiencing the event were excluded from the analysis. A participant's time was censored at the last observed time prior to discontinuation if a participant discontinued study without event, or at week 26 if a participant did not experience the event until the end of week 26.
Acute exacerbations were defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality, as follows:
Acute worsening or development of dyspnea (< 1 month duration)
Imaging with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia
Respiratory deterioration not fully explained by cardiac failure or fluid overload
From the first dose up to the day of the first acute exacerbation or Week 26, whichever comes first
The Number of Participants Experiencing Acute Exacerbation
The number of participants experiencing acute exacerbations of lung fibrosis.
Acute exacerbations were defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality, as follows:
Acute worsening or development of dyspnea (< 1 month duration)
Imaging with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia
Respiratory deterioration not fully explained by cardiac failure or fluid overload
From the first dose up to the day of the first acute exacerbation or Week 26, whichever comes first
Phoenix
Arizona
85006
United States
Local Institution - 0028
Los Angeles
California
90024
United States
Local Institution - 0043
Stanford
California
94305-528
United States
University of Colorado Anschutz Medical Campus-Department of Medicine
Aurora
Colorado
80045
United States
Local Institution - 0006
Denver
Colorado
80206
United States
Local Institution - 0171
New Haven
Connecticut
06520
United States
Local Institution - 0035
Gainesville
Florida
32610
United States
Local Institution - 0166
Orlando
Florida
32803
United States
Local Institution - 0078
Atlanta
Georgia
30309
United States
Local Institution - 0031
Kansas City
Kansas
66160
United States
Local Institution - 0154
Baltimore
Maryland
21224
United States
Local Institution - 0003
Boston
Massachusetts
02135
United States
Local Institution - 0030
Chesterfield
Missouri
63017
United States
Local Institution - 0036
St Louis
Missouri
63110
United States
Local Institution - 0029
Cincinnati
Ohio
45267
United States
Local Institution - 0164
Columbus
Ohio
43221
United States
Local Institution
Hershey
Pennsylvania
17033
United States
Local Institution
Nashville
Tennessee
37232
United States
Local Institution - 0096
Charlottesville
Virginia
22908
United States
Local Institution
Falls Church
Virginia
22042
United States
Local Institution - 0049
Buenos Aires
Distrito Federal
1425
Argentina
Local Institution - 0103
Rosario
Santa Fe Province
S2000DTC
Argentina
Local Institution - 0097
San Miguel de Tucumán
Tucumán Province
T4000IAR
Argentina
Local Institution - 0115
Buenos Aires
1056
Argentina
Local Institution - 0048
Buenos Aires
1638
Argentina
Local Institution - 0122
Mendoza
5500
Argentina
Local Institution - 0045
Camperdown
New South Wales
2050
Australia
Local Institution - 0025
Westmead
New South Wales
2145
Australia
Local Institution - 0026
Brisbane
Queensland
4032
Australia
Local Institution - 0046
Greenslopes
Queensland
4120
Australia
Local Institution - 0022
Adelaide
South Australia
5000
Australia
Local Institution - 0023
Heidelberg
Victoria
3084
Australia
Local Institution - 0021
Murdoch
Western Australia
6150
Australia
Local Institution - 0044
Nedlands
Western Australia
6009
Australia
Local Institution - 0074
Brussels
1200
Belgium
Local Institution - 0065
Leuven
3000
Belgium
Local Institution - 0051
Liège
4000
Belgium
Local Institution
Porto Alegre
Rio Grande do Sul
91350-200
Brazil
Local Institution
São Paulo
São Paulo
04266-010
Brazil
Local Institution
São Paulo
São Paulo
04520-013
Brazil
Local Institution - 0076
São Paulo
01323020
Brazil
Local Institution - 0141
Vancouver
British Columbia
V5Z 1M9
Canada
Local Institution
Vancouver
British Columbia
V5Z 1M9
Canada
Local Institution - 0134
Toronto
Ontario
M5T 3A9
Canada
Local Institution - 0094
Montreal
Quebec
H2X 3E4
Canada
Local Institution - 0127
Québec
Quebec
G1V 2G5
Canada
Local Institution - 0144
Sherbrooke
Quebec
J1H 5N4
Canada
Local Institution - 0108
Curicó
Maule Region
3341643
Chile
Local Institution - 0054
Talca
Maule Region
3481349
Chile
Local Institution - 0038
Quillota
Valparaiso
0
Chile
Local Institution - 0187
Beijing
Beijing Municipality
100020
China
Local Institution - 0183
Beijing
Beijing Municipality
100730
China
Local Institution - 0188
Wuhan
Hubei
430022
China
Local Institution - 0189
Shanghai
Shanghai Municipality
200030
China
Local Institution - 0120
Bobigny
93000
France
Local Institution - 0066
Bron
69677
France
Local Institution - 0136
Dijon
21000
France
Local Institution - 0162
Marseille
13915
France
Hopital Europeen Georges Pompidou
Paris
75015
France
Local Institution - 0143
Paris
75018
France
Local Institution - 0067
Rennes
35033
France
Local Institution - 0132
Toulouse
31059
France
Local Institution - 0111
Hanover
Lower Saxony
30459
Germany
Local Institution - 0107
Essen
45239
Germany
Local Institution
Freiburg im Breisgau
79106
Germany
Local Institution - 0093
Großhansdorf
22927
Germany
Local Institution - 0110
Heidelberg
69126
Germany
Local Institution - 0121
Munich
81377
Germany
Local Institution - 0119
Stuttgart
70736
Germany
Local Institution - 0145
Tel Aviv
Tel Aviv
6423906
Israel
Local Institution - 0113
Haifa
34362
Israel
Local Institution - 0149
Jerusalem
9112001
Israel
Local Institution - 0114
Petah Tikva
4941492
Israel
Local Institution - 0148
Ramat Gan
5262100
Israel
Local Institution - 0073
Catania
95123
Italy
Local Institution - 0077
Modena
41125
Italy
Local Institution - 0089
Monza
20900
Italy
Local Institution - 0072
Roma
00168
Italy
Local Institution - 0155
Seto
Aichi-ken
489-8642
Japan
Local Institution - 0106
Kōriyama
Fukushima
963-0197
Japan
Local Institution - 0180
Sapporo
Hokkaido
060-8543
Japan
Local Institution - 0095
Kobe
Hyōgo
6500047
Japan
Local Institution - 0169
Kobe
Hyōgo
653-0013
Japan
Local Institution - 0071
Yokohama
Kanagawa
236-0051
Japan
Local Institution - 0112
Sakai
Osaka
591-8555
Japan
Local Institution - 0128
Izumo
Shimane
693-0021
Japan
Local Institution - 0064
Hamamatasu
Shizuoka
431-3192
Japan
Local Institution - 0080
Bunkyo-ku
Tokyo
113-8510
Japan
Local Institution - 0153
Minato-ku
Tokyo
1058470
Japan
Local Institution - 0177
Shinjyuku-ku
Tokyo
162-8655
Japan
Local Institution - 0117
Kumamoto
861-4193
Japan
Local Institution - 0146
Nagasaki
852-8102
Japan
Local Institution - 0170
Saitama
330-8553
Japan
Local Institution - 0173
Tokyo
143-8541
Japan
Local Institution
Mexico City
Mexico City
06700
Mexico
Local Institution - 0081
Monterrey
Nuevo León
64718
Mexico
Local Institution - 0109
Monterrey, N.l.
Nuevo León
64460
Mexico
Local Institution - 0083
San Nicolás de los Garza
Nuevo León
66465
Mexico
Local Institution - 0156
Oaxaca City
Oaxaca
68020
Mexico
Local Institution - 0087
Seoul
03722
South Korea
Local Institution - 0086
Seoul
05505
South Korea
Local Institution
Seoul
06355
South Korea
Local Institution
Barcelona
08035
Spain
Local Institution - 0116
Barcelona
08036
Spain
Local Institution - 0140
L'Hospitalet de Llobregat
08907
Spain
Local Institution
Madrid
28034
Spain
Local Institution - 0137
Madrid
28040
Spain
Local Institution
Marbella Málaga
29603
Spain
Local Institution - 0039
Pozuelo de Alarcón
28223
Spain
Local Institution - 0147
Santander
39008
Spain
Local Institution - 0176
Kaohsiung City
0
Taiwan
Local Institution - 0174
Taipei
10002
Taiwan
Local Institution - 0175
Taipei
11217
Taiwan
Local Institution - 0050
Cambridge
CB2 0AY
United Kingdom
Local Institution - 0163
Edinburgh
EH16 4SA
United Kingdom
Local Institution - 0041
London
SE1 9RT
United Kingdom
Local Institution - 0092
London
SW3 6HP
United Kingdom
Local Institution
London
WC1E 6JF
United Kingdom
Corte TJ, Behr J, Cottin V, Glassberg MK, Kreuter M, Martinez FJ, Ogura T, Suda T, Wijsenbeek M, Berkowitz E, Elpers B, Kim S, Watanabe H, Fischer A, Maher TM. Efficacy and Safety of Admilparant, an LPA1 Antagonist, in Pulmonary Fibrosis: A Phase 2 Randomized Clinical Trial. Am J Respir Crit Care Med. 2025 Feb;211(2):230-238. doi: 10.1164/rccm.202405-0977OC.
Cheng PTW, Kaltenbach RF 3rd, Zhang H, Shi J, Tao S, Li J, Kennedy LJ, Walker SJ, Shi Y, Wang Y, Dhanusu S, Reddigunta R, Kumaravel S, Jusuf S, Smith D, Krishnananthan S, Li J, Wang T, Heiry R, Sum CS, Kalinowski SS, Hung CP, Chu CH, Azzara AV, Ziegler M, Burns L, Zinker BA, Boehm S, Taylor J, Sapuppo J, Mosure K, Everlof G, Guarino V, Zhang L, Yang Y, Ruan Q, Xu C, Apedo A, Traeger SC, Cvijic ME, Lentz KA, Tirucherai G, Sivaraman L, Robl J, Ellsworth BA, Rosen G, Gordon DA, Soars MG, Gill M, Murphy BJ. Discovery of an Oxycyclohexyl Acid Lysophosphatidic Acid Receptor 1 (LPA1) Antagonist BMS-986278 for the Treatment of Pulmonary Fibrotic Diseases. J Med Chem. 2021 Nov 11;64(21):15549-15581. doi: 10.1021/acs.jmedchem.1c01256. Epub 2021 Oct 28.
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
FG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
FG003
IPF Cohort - BMS-986278 10mg
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received 10 mg of BMS-986278 twice per day during the Optional Treatment Extension (OTE) phase only.
FG004
PF-ILD Cohort: Placebo
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
FG005
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
FG006
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
FG007
PF-ILD Cohort - 10mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received 10 mg of BMS-986278 during the Optional Treatment Extension (OTE) phase only. This arm includes participants who received 30 mg or 60 mg BMS-986278 BID in the main study who meet low BP criteria and were dose reduced to 10 mg BMS-986278 BID for the OTE.
FG00093 subjects
FG00192 subjects
FG00293 subjects
FG0030 subjects10 mg treatment was offered only in the OTE phase. No participants received 10 mg treatment during the Pre-Treatment Phase.
FG00441 subjects
FG00542 subjects
FG00642 subjects
FG0070 subjects10 mg treatment was offered only in the OTE phase. No participants received 10 mg treatment during the Pre-Treatment Phase.
COMPLETED
FG00092 subjects
FG00191 subjects
FG00293 subjects
FG0030 subjects
FG00441 subjects
FG00540 subjects
FG00642 subjects
FG0070 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
Type
Comment
Reasons
Not reported
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
Treatment up to Week 26
Type
Comment
Milestone Data
STARTED
FG00092 subjects
FG00191 subjects
FG00293 subjects
FG0030 subjects10 mg treatment was offered only in the OTE phase. No participants received 10 mg treatment during the Main Study.
FG00441 subjects
FG00540 subjects
FG00642 subjects
FG0070 subjects10 mg treatment was offered only in the OTE phase. No participants received 10 mg treatment during the Main Study.
COMPLETED
FG00082 subjects
FG00182 subjects
FG00284 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG00010 subjects
FG0019 subjects
FG0029 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by participant
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG003
OTE - 26 Weeks
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants who received placebo in the Main Treatment phase were re-randomized to receive 30 mg or 60 mg BMS-986278 during the OTE.
FG001100 subjects
FG002102 subjects
FG00311 subjects10 mg treatment was offered only in the OTE phase. No participants received 10 mg treatment during the Main Study.
FG0040 subjectsParticipants who received placebo in the Main Treatment phase were re-randomized to receive 30 mg or 60 mg BMS-986278 during the OTE.
FG00541 subjects
FG00646 subjects
FG0074 subjects10 mg treatment was offered only in the OTE phase. No participants received 10 mg treatment during the Main Study.
PBO BMS-986278 30 mg
Participants who received placebo treatment in the Main Study and received 30 mg of BMS-986278 in the Optional Treatment Extension (OTE) phase
FG0000 subjects
FG00133 subjects
FG0020 subjects
FG003
PBO BMS-986278 60 mg
Participants who received placebo treatment in the Main Study and received 60 mg of BMS-986278 in the Optional Treatment Extension (OTE) phase
FG0000 subjects
FG0010 subjects
FG00230 subjects
FG003
COMPLETED
FG0000 subjects
FG00196 subjects
FG00289 subjects
FG0038 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0014 subjects
FG00213 subjects
FG0033 subjects
FG004
Type
Comment
Reasons
Withdrawal by participant
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG003
The baseline characteristics are reported for the safety population which is all treated participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
BG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
BG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
BG003
PF-ILD Cohort: Placebo
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
BG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
BG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00092
BG00191
BG00293
BG00341
BG00440
BG00542
BG006399
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00069.0± 6.70
BG00169.5± 7.31
BG00268.8± 7.85
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00016
BG00114
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00021
BG00118
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in IPF Participants
Percent predicted forced vital capacity (ppFVC) is the percentage of predicted value per participant of forced vital capacity (FVC). FVC is defined as the maximum capacity of air that a participant can exhale after a maximum inspiration as measured by the volume of air exhaled in a spirometer. The data is reported as percent change from baseline in ppFVC. Percent change from baseline is a calculation that expresses the change in a value compared to its initial starting point (baseline) as a percentage, showing how much a value has increased or decreased relative to its original level; it's calculated by subtracting the baseline value from the new value, dividing by the baseline value, and then multiplying by 100%. The percent change in this endpoint was calculated from ppFVC values taken at baseline, which is defined as the measurement of ppFVC taken at first dose, and ppFVC values taken at Week 26. This endpoint reports data for the IPF cohort only as pre-specified in the protocol.
All treated participants in the IPF Cohort with baseline and week 26 results. Prespecified to be collected for IPF Cohort only.
Posted
Mean
Standard Error
Percent change from baseline in ppFVC
From baseline (first dose) up to week 26
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
OG003
PF-ILD Cohort: Placebo
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG00070
OG00159
OG00267
OG003
Title
Denominators
Categories
Title
Measurements
OG000-2.807± 0.7286
OG001-3.068± 0.7335
OG002-1.120± 0.6691
Secondary
The 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 30 days after last dose during the main study treatment phase
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Secondary
The 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 30 days after last dose during the main study treatment phase
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
Secondary
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
The number of participants who discontinued study treatment due to adverse events (AEs)
All treated participants
Posted
Count of Participants
Participants
From first dose up to 30 days after last dose during the main study treatment phase
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
OG003
PF-ILD Cohort: Placebo
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
Secondary
The Number of Participants Who Died Due to Adverse Events (AEs)
The number of participants who died while receiving study treatment due to an adverse event
All treated participants
Posted
Count of Participants
Participants
From first dose up to 30 days after last dose during the main study treatment phase
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
OG003
PF-ILD Cohort: Placebo
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
Secondary
Maximum Concentration (Cmax)
Cmax is defined as the maximum concentration of the analyte recorded in the participants. Cmax of BMS-986278 and BMT-327319 was derived from plasma concentration versus time data.
All randomized participants who received at least one administration of BMS-986278 and had quantifiable concentration data
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
On Day 1 and Week 4 (Day 29)
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
OG003
PF-ILD Cohort: Placebo
Secondary
Time to Maximum Concentration (Tmax)
Tmax is defined as the amount of time until the maximum concentration of the analyte is recorded in the participants
All randomized participants who received at least one administration of BMS-986278 and had quantifiable concentration data
Posted
Median
Full Range
Hours
On Day 1 and Week 4 (Day 29)
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
OG003
PF-ILD Cohort: Placebo
Secondary
Area Under Curve (AUC0-8)
Area under the plasma concentration-time curve (AUC) from the timepoint of 0 hours to 24 hours post dose as measured on Day 1 and Week 4.
All randomized participants who received at least one administration of BMS-986278 and had quantifiable concentration data
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
On Day 1 and Week 4 (Day 29)
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
OG003
PF-ILD Cohort: Placebo
Secondary
Concentration Trough (Ctrough)
Ctrough is defined as the lowerst concentration of drug in the blood immediately before the next dose is administered
All randomized participants who received at least one administration of BMS-986278 and had quantifiable concentration data
Posted
Median
Full Range
ng/mL
On Week 4 (Day 29) and Week 12 (Day 85)
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
OG003
PF-ILD Cohort: Placebo
Secondary
The Number of Participants Experiencing Electrocardiogram (ECG) Abnormalities
A frequency summary of investigator clinical interpretation of ECG abnormal findings is listed.
All treated participants
Posted
Count of Participants
Participants
At Week 26
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
OG003
PF-ILD Cohort: Placebo
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
Secondary
Change From Baseline in Vital Sign Measurements
The change from baseline in select vital sign measurements. Baseline is defined as first dose.
All treated participants with baseline and week 26 vital sign measurement results.
Posted
Median
Full Range
Change from baseline in mmHg
At baseline and Week 26
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
OG003
PF-ILD Cohort: Placebo
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
Secondary
Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in PF-ILD Participants
Percent predicted forced vital capacity (ppFVC) is the percentage of predicted value per participant of forced vital capacity (FVC). FVC is defined as the maximum capacity of air that a participant can exhale after a maximum inspiration as measured by the volume of air exhaled in a spirometer. The data is reported as percent change from baseline in ppFVC. Percent change from baseline is a calculation that expresses the change in a value compared to its initial starting point (baseline) as a percentage, showing how much a value has increased or decreased relative to its original level; it's calculated by subtracting the baseline value from the new value, dividing by the baseline value, and then multiplying by 100%. The percent change in this endpoint was calculated from ppFVC values taken at baseline, which is defined as the measurement of ppFVC taken at first dose, and ppFVC values taken at Week 26. This endpoint reports data for PF-ILD cohort only as pre-specified in the protocol.
All treated participants in the PF-ILD Cohort with baseline and week 26 results. Pre-specified to be collected for PF-ILD Cohort only.
Posted
Mean
Standard Error
Percent change from baseline
At baseline and Week 26
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Secondary
The Number of Participants With ≥ 10% Absolute Decline in ppFVC (%)
The number of participants with ≥ 10% absolute decline in percent predicted forced vital capacity (ppFVC) at pre-specified timepoints.
ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participant.
The number of participants represented signify the number of participants with applicable data during the specific visit at the specific timepoint.
All treated participants with ppFVC data during visits at the specific time windows of Weeks 4, 8, 12, 16, 20, and 26.
Posted
Count of Participants
Participants
At Weeks 4, 8, 12, 16, 20, and 26
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Secondary
The Number of Participants With 0% Change in ppFVC (%)
The number of participants with 0% change in percent predicted forced vital capacity (ppFVC) at pre-specified timepoints.
ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participant.
All treated participants with ppFVC data at the prespecified timepoints Weeks 4, 8, 12, 16, 20, and 26.
Posted
Count of Participants
Participants
Weeks 4, 8, 12, 16, 20, and 26
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
Secondary
Time to First Occurrence ≥ 10% Absolute Decline in ppFVC (%)
The amount of time in weeks to the participant's first occurrence ≥ 10% absolute decline in Percent Predicted Forced Vital Capacity (ppFVC). A participant's time is censored at the last observed time prior to discontinuation if a participant discontinues study without event, or at week 26 if a participant does not experience the event until the end of week 26. Kaplan-Meier product limit method will be employed to estimate the survival curves.
ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participant.
The total accumulated number of participants with ≥ 10% Absolute Decline in ppFVC events at any time from first dose up to Week 26. A participant's time was censored at the last observed time prior to discontinuation if a participant discontinues study without event, or at week 26 if a participant does not experience the event until the end of week 26.
Posted
Median
95% Confidence Interval
Weeks
From first dose up to the first occurrence of ≥ 10% absolute decline in ppFVC
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Secondary
Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC)
The absolute change in ppFVC (%) is measured from baseline up to the pre-specified timepoints of Weeks 4, 8, 12, 16, 20, and 26.
ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air (mL) exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participant.
All treated participants with ppFVC data at Weeks 4, 8, 12, 16, 20, and 26
Posted
Mean
Standard Deviation
Percentage of predicted value
From baseline up to Weeks 4, 8, 12, 16, 20, and 26
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
Secondary
Absolute Change From Baseline in Forced Vital Capacity (FVC)
Forced vital capacity (FVC) is defined as the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible. The absolute change in FVC (mL) is measured from baseline up to Weeks 4, 8, 12, 16, 20, and 26.
All treated participants with FVC data at Weeks 4, 8, 12, 16, 20, and 26
Posted
Mean
Standard Deviation
mL
From baseline up to Weeks 4, 8, 12, 16, 20, and 26
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
OG003
PF-ILD Cohort: Placebo
Secondary
Absolute Change From Baseline in Single Breath Diffusing Capacity of Carbon Monoxide (DLCO SB)
The absolute change in single breath diffusing capacity of carbon monoxide (DLCO SB) (mL/min/mmHg) (corrected for hemoglobin) from baseline to Week 26. DLCO is defined as a measurement of the extent to which oxygen passes from the alveoli into the blood. Baseline is defined as first dose.
All treated participants with DLCO SB data at Week 26
Posted
Median
Full Range
mL/min/mmHg
From baseline up to Week 26
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
OG003
Secondary
Absolute Change From Baseline in Percent Predicted Single Breath Diffusing Capacity of Carbon Monoxide (ppDLCO SB)
The absolute change in percent predicted single breath diffusing capacity of carbon monoxide (DLCO SB) (mL/min/mmHg) (corrected for hemoglobin) from baseline to Week 26. DLCO is defined as a measurement of the extent to which oxygen passes from the alveoli into the blood. Baseline is defined as first dose.
All treated participants with ppDLCO SB data at Week 26
Posted
Median
Full Range
Percentage of predicted value
From baseline up to Week 26
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
Secondary
Absolute Change From Baseline in Walking Endurance/Distance
The absolute change in walking endurance/distance as determined by the 6-minute walk test (6MWT) from baseline to Week 26. The 6-Minute Walk Test (6MWT) is a submaximal exercise test used to assess aerobic capacity and endurance. Baseline is defined as first dose.
All participants with evaluable 6MWT data at Week 26
Posted
Median
Full Range
Meters
From baseline up to Week 26
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
OG003
PF-ILD Cohort: Placebo
Secondary
Time to First Acute Exacerbation
Time to first acute exacerbations of lung fibrosis was measured from the day of first dose up to the day of first acute exacerbation. Participants who discontinued the study treatment prior to the end of the main study without experiencing the event were excluded from the analysis. A participant's time was censored at the last observed time prior to discontinuation if a participant discontinued study without event, or at week 26 if a participant did not experience the event until the end of week 26.
Acute exacerbations were defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality, as follows:
Acute worsening or development of dyspnea (< 1 month duration)
Imaging with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia
Respiratory deterioration not fully explained by cardiac failure or fluid overload
All participants who experienced acute exacerbation
Posted
Median
95% Confidence Interval
Weeks
From the first dose up to the day of the first acute exacerbation or Week 26, whichever comes first
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
Secondary
The Number of Participants Experiencing Acute Exacerbation
The number of participants experiencing acute exacerbations of lung fibrosis.
Acute exacerbations were defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality, as follows:
Acute worsening or development of dyspnea (< 1 month duration)
Imaging with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia
Respiratory deterioration not fully explained by cardiac failure or fluid overload
All treated participants
Posted
Count of Participants
Participants
From the first dose up to the day of the first acute exacerbation or Week 26, whichever comes first
ID
Title
Description
OG000
IPF Cohort: Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
OG001
IPF Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Time Frame
Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 58 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 58 weeks).
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
IPF Cohort - Main Study - Placebo
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received placebo twice a day for up to 26 weeks.
4
92
16
92
57
92
EG001
IPF Cohort - Main Study - 30 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
4
91
10
91
54
91
EG002
IPF Cohort - Main Study - BMS-986278 60mg
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
5
93
10
93
51
93
EG003
IPF Cohort - BMS-986278 10mg
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort who received 10 mg of BMS-986278 twice per day during the Optional Treatment Extension (OTE) phase only.
3
11
4
11
8
11
EG004
IPF Cohort - OTE Phase - PBO BMS-986278 30 mg
Participants who received placebo treatment in the Main Study and received 30 mg of BMS-986278 in the Optional Treatment Extension (OTE)
4
100
19
100
40
100
EG005
IPF Cohort - OTE Phase - PBO BMS-986278 60mg
Participants who received placebo treatment in the Main Study and received 60 mg of BMS-986278 in the Optional Treatment Extension (OTE)
6
102
23
102
43
102
EG006
PF-ILD Cohort - Main Study - Placebo
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
4
41
13
41
19
41
EG007
PF-ILD Cohort - Main Study - BMS-986278 30mg
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
0
40
4
40
23
40
EG008
PF-ILD Cohort - Main Study - BMS-986278 60mg
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received 60 mg BMS-986278 twice per day for up to 26 weeks.
0
42
6
42
24
42
EG009
PF-ILD Cohort - OTE Phase - BMS-986278 10mg
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received 10 mg of BMS-986278 during the Optional Treatment Extension (OTE) phase only.
0
4
0
4
4
4
EG010
PF-ILD Cohort - OTE Phase - PBO BMS-986278 30mg
Participants who received placebo treatment in the Main Study and received 30 mg of BMS-986278 in the Optional Treatment Extension (OTE)
1
41
8
41
18
41
EG011
PF-ILD Cohort - OTE Phase - PBO BMS-986278 60mg
Participants who received placebo treatment in the Main Study and received 60 mg of BMS-986278 in the Optional Treatment Extension (OTE)
3
46
7
46
23
46
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG0030 affected11 at risk
EG0041 affected100 at risk
EG0050 affected102 at risk
EG0060 affected41 at risk
EG0070 affected40 at risk
EG0080 affected42 at risk
EG0090 affected4 at risk
EG0100 affected41 at risk
EG0110 affected46 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected91 at risk
EG0020 affected93 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected91 at risk
EG0021 affected93 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected91 at risk
EG0020 affected93 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected91 at risk
EG0020 affected93 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected91 at risk
EG0020 affected93 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Cataract
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Inguinal hernia, obstructive
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0021 affected93 at risk
EG003
Asthenia
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Biliary dyskinesia
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0021 affected93 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected91 at risk
EG0020 affected93 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected91 at risk
EG0020 affected93 at risk
EG003
Bronchitis bacterial
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Diabetic foot infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected91 at risk
EG0021 affected93 at risk
EG003
Pneumonia legionella
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Forced vital capacity decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Weight decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0021 affected93 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Adenocarcinoma gastric
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected91 at risk
EG0020 affected93 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Gastric adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0021 affected93 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Intraductal proliferative breast lesion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Lung neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0021 affected93 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Lung squamous cell carcinoma stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Paraneoplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected91 at risk
EG0020 affected93 at risk
EG003
Sciatic nerve palsy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Syncope
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected91 at risk
EG0020 affected93 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Scrotal dermatitis
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0011 affected91 at risk
EG0021 affected93 at risk
EG003
Hypersensitivity pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Idiopathic interstitial pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Idiopathic pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected92 at risk
EG0014 affected91 at risk
EG0020 affected93 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0011 affected91 at risk
EG0020 affected93 at risk
EG003
Lung opacity
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0021 affected93 at risk
EG003
Pulmonary arterial hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0021 affected93 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0021 affected93 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0021 affected93 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0021 affected93 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected91 at risk
EG0020 affected93 at risk
EG003
Granulomatosis with polyangiitis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Vasculitis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Supraventricular extrasystoles
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG0031 affected11 at risk
EG0041 affected100 at risk
EG0050 affected102 at risk
EG0060 affected41 at risk
EG0070 affected40 at risk
EG0080 affected42 at risk
EG0090 affected4 at risk
EG0100 affected41 at risk
EG0110 affected46 at risk
Cataract
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0005 affected92 at risk
EG0010 affected91 at risk
EG0025 affected93 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0021 affected93 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG00012 affected92 at risk
EG00110 affected91 at risk
EG00211 affected93 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected92 at risk
EG0015 affected91 at risk
EG0024 affected93 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0004 affected92 at risk
EG0010 affected91 at risk
EG0022 affected93 at risk
EG003
Asthenia
General disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected92 at risk
EG0012 affected91 at risk
EG0020 affected93 at risk
EG003
Fatigue
General disorders
MedDRA 26.0
Systematic Assessment
EG0004 affected92 at risk
EG0015 affected91 at risk
EG0021 affected93 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0014 affected91 at risk
EG0021 affected93 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0007 affected92 at risk
EG0013 affected91 at risk
EG0029 affected93 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Influenza
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0021 affected93 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0021 affected93 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 affected92 at risk
EG0016 affected91 at risk
EG0023 affected93 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0013 affected91 at risk
EG0021 affected93 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0011 affected91 at risk
EG0024 affected93 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0005 affected92 at risk
EG0014 affected91 at risk
EG0024 affected93 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0014 affected91 at risk
EG0023 affected93 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected92 at risk
EG0012 affected91 at risk
EG0022 affected93 at risk
EG003
Dizziness exertional
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected92 at risk
EG0016 affected91 at risk
EG0025 affected93 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0005 affected92 at risk
EG0016 affected91 at risk
EG00210 affected93 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0008 affected92 at risk
EG0014 affected91 at risk
EG0024 affected93 at risk
EG003
Idiopathic pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected92 at risk
EG0013 affected91 at risk
EG0022 affected93 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0012 affected91 at risk
EG0021 affected93 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0011 affected91 at risk
EG0022 affected93 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0012 affected91 at risk
EG0022 affected93 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected91 at risk
EG0020 affected93 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected91 at risk
EG0020 affected93 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0013 affected91 at risk
EG0027 affected93 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected92 at risk
EG0012 affected91 at risk
EG0024 affected93 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0009 affected92 at risk
EG0017 affected91 at risk
EG0025 affected93 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.
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
OG003
PF-ILD Cohort: Placebo
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG00092
OG00191
OG00293
OG00341
OG00440
OG00542
Title
Denominators
Categories
Title
Measurements
OG00074
OG00169
OG00269
OG00332
OG00433
OG00528
OG003
PF-ILD Cohort: Placebo
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG00092
OG00191
OG00293
OG00341
OG00440
OG00542
Title
Denominators
Categories
Title
Measurements
OG00016
OG00110
OG00210
OG00313
OG0044
OG0056
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG00092
OG00191
OG00293
OG00341
OG00440
OG00542
Title
Denominators
Categories
Title
Measurements
OG0009
OG0019
OG0026
OG0037
OG0041
OG0050
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG00092
OG00191
OG00293
OG00341
OG00440
OG00542
Title
Denominators
Categories
Title
Measurements
OG0002
OG0013
OG0024
OG0033
OG0040
OG0050
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG0000
OG0018
OG00213
OG0030
OG0042
OG0052
Title
Denominators
Categories
Day 1; Analyte: BMS-986278
ParticipantsOG0000
ParticipantsOG0017
ParticipantsOG00213
ParticipantsOG0030
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG001465.0± 36.23
OG0021089.8± 42.06
OG004715.4± 2.87
OG005
Day 1; Analyte: BMT-323719
ParticipantsOG0000
ParticipantsOG0017
ParticipantsOG00213
ParticipantsOG0030
Day 29; Analyte: BMS-986278
ParticipantsOG0000
ParticipantsOG0018
ParticipantsOG00213
ParticipantsOG0030
Day 29; Analyte: BMT-323719
ParticipantsOG0000
ParticipantsOG0018
ParticipantsOG00213
ParticipantsOG0030
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG0000
OG0018
OG00213
OG0030
OG0042
OG0052
Title
Denominators
Categories
Day 1; Analyte: BMS-986278
ParticipantsOG0000
ParticipantsOG0017
ParticipantsOG00213
ParticipantsOG0030
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0012.0170(1.567 to 4.100)
OG0021.6670(1.283 to 5.917)
OG0041.55(1.50 to 1.60)
OG005
Day 1; Analyte: BMT-323719
ParticipantsOG0000
ParticipantsOG0017
ParticipantsOG00213
ParticipantsOG0030
Day 29; Analyte: BMS-986278
ParticipantsOG0000
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG0030
Day 29; Analyte: BMT-323719
ParticipantsOG0000
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG0030
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG0000
OG0017
OG00212
OG0030
OG0042
OG0052
Title
Denominators
Categories
Day 1; Analyte: BMS-986278
ParticipantsOG0000
ParticipantsOG0016
ParticipantsOG0029
ParticipantsOG0030
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0011990.4530± 20.78185
OG0024430.5891± 31.16188
OG0043358± 8.7
OG005
Day 1; Analyte: BMT-323719
ParticipantsOG0000
ParticipantsOG0015
ParticipantsOG0026
ParticipantsOG0030
Day 29; Analyte: BMS-986278
ParticipantsOG0000
ParticipantsOG0017
ParticipantsOG00212
ParticipantsOG0030
Day 29; Analyte: BMT-323719
ParticipantsOG0000
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0030
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG0000
OG00156
OG00260
OG0030
OG00428
OG00531
Title
Denominators
Categories
Day 29-BMS-986278
ParticipantsOG0000
ParticipantsOG00151
ParticipantsOG00248
ParticipantsOG0030
ParticipantsOG00424
ParticipantsOG00531
Title
Measurements
OG00192.1(13.5 to 433)
OG002217(32.4 to 1540)
OG004116.0000(26.300 to 392.000)
OG005
Day 85-BMS-986278
ParticipantsOG0000
ParticipantsOG00156
ParticipantsOG00260
ParticipantsOG0030
Day 29-BMT-323719
ParticipantsOG0000
ParticipantsOG00149
ParticipantsOG00247
ParticipantsOG0030
Day 85-BMT-323719
ParticipantsOG0000
ParticipantsOG00156
ParticipantsOG00260
ParticipantsOG0030
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG00092
OG00191
OG00293
OG00341
OG00440
OG00542
Title
Denominators
Categories
Title
Measurements
OG00027
OG00118
OG00231
OG0035
OG0049
OG00512
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
OG003
PF-ILD Cohort: Placebo
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG00322
OG00429
OG00531
Title
Denominators
Categories
Title
Measurements
OG003-2.681± 1.4730
OG0042.717± 0.9054
OG005-1.203± 0.8808
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
OG003
PF-ILD Cohort: Placebo
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG00078
OG00175
OG00275
OG00335
OG00430
OG00536
Title
Denominators
Categories
Week 4
ParticipantsOG00078
ParticipantsOG00175
ParticipantsOG00275
ParticipantsOG00335
ParticipantsOG00430
ParticipantsOG00536
Title
Measurements
OG0003
OG0010
OG0022
OG003
Week 8
ParticipantsOG00077
ParticipantsOG00172
ParticipantsOG00269
ParticipantsOG00334
Week 12
ParticipantsOG00076
ParticipantsOG00169
ParticipantsOG00274
ParticipantsOG00332
Week 16
ParticipantsOG00078
ParticipantsOG00171
ParticipantsOG00271
ParticipantsOG00330
Week 20
ParticipantsOG00075
ParticipantsOG00160
ParticipantsOG00266
ParticipantsOG00328
Week 26
ParticipantsOG00070
ParticipantsOG00159
ParticipantsOG00267
ParticipantsOG00322
OG003
PF-ILD Cohort: Placebo
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG00078
OG00175
OG00275
OG00335
OG00430
OG00536
Title
Denominators
Categories
Week 4
ParticipantsOG00078
ParticipantsOG00175
ParticipantsOG00275
ParticipantsOG00335
ParticipantsOG00430
ParticipantsOG00536
Title
Measurements
OG00048
OG00141
OG00233
OG003
Week 8
ParticipantsOG00077
ParticipantsOG00172
ParticipantsOG00269
ParticipantsOG00334
Week 12
ParticipantsOG00076
ParticipantsOG00169
ParticipantsOG00274
ParticipantsOG00332
Week 16
ParticipantsOG00078
ParticipantsOG00171
ParticipantsOG00271
ParticipantsOG00330
Week 20
ParticipantsOG00075
ParticipantsOG00160
ParticipantsOG00266
ParticipantsOG00328
Week 26
ParticipantsOG00070
ParticipantsOG00159
ParticipantsOG00267
ParticipantsOG00322
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
OG003
PF-ILD Cohort: Placebo
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG00016
OG0019
OG0026
OG0035
OG0045
OG0051
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median, lower limit, and upper limit not calculated due to insufficient number of events.
OG001NA(NA to NA)Median, lower limit, and upper limit not calculated due to insufficient number of events.
OG002NA(NA to NA)Median, lower limit, and upper limit not calculated due to insufficient number of events.
OG003NA(NA to NA)Median, lower and upper limit not calculated due to insufficient number of events.
OG004NA(26.3 to NA)Median, lower limit, and upper limit not calculated due to insufficient number of events.
OG005NA(NA to NA)Median, lower limit, and upper limit not calculated due to insufficient number of events.
OG003
PF-ILD Cohort: Placebo
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG00078
OG00175
OG00275
OG00335
OG00430
OG00536
Title
Denominators
Categories
Absolute change from Baseline to Week 4
ParticipantsOG00078
ParticipantsOG00175
ParticipantsOG00275
ParticipantsOG00335
ParticipantsOG00430
ParticipantsOG00536
Title
Measurements
OG000-1.491± 4.3773
OG001-0.482± 4.2499
OG0020.023± 5.4007
OG003
Absolute change from Baseline to Week 8
ParticipantsOG00077
ParticipantsOG00172
ParticipantsOG00269
ParticipantsOG00334
Absolute change from Baseline to Week 12
ParticipantsOG00076
ParticipantsOG00169
ParticipantsOG00274
ParticipantsOG00332
Absolute change from Baseline to Week 16
ParticipantsOG00078
ParticipantsOG00171
ParticipantsOG00271
ParticipantsOG00330
Absolute change from Baseline to Week 20
ParticipantsOG00075
ParticipantsOG00160
ParticipantsOG00266
ParticipantsOG00328
Absolute change from Baseline to Week 26
ParticipantsOG00070
ParticipantsOG00159
ParticipantsOG00267
ParticipantsOG00322
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG00078
OG00175
OG00275
OG00335
OG00430
OG00536
Title
Denominators
Categories
Absolute change from Baseline to Week 4
ParticipantsOG00078
ParticipantsOG00175
ParticipantsOG00275
ParticipantsOG00335
ParticipantsOG00430
ParticipantsOG00536
Title
Measurements
OG000-54.7± 153.50
OG001-21.2± 142.25
OG0024.3± 181.75
OG003
Absolute change from Baseline to Week 8
ParticipantsOG00077
ParticipantsOG00172
ParticipantsOG00269
ParticipantsOG00334
Absolute change from Baseline to Week 12
ParticipantsOG00076
ParticipantsOG00169
ParticipantsOG00274
ParticipantsOG00332
Absolute change from Baseline to Week 16
ParticipantsOG00078
ParticipantsOG00171
ParticipantsOG00271
ParticipantsOG00330
Absolute change from Baseline to Week 20
ParticipantsOG00075
ParticipantsOG00160
ParticipantsOG00266
ParticipantsOG00328
Absolute change from Baseline to Week 26
ParticipantsOG00070
ParticipantsOG00159
ParticipantsOG00267
ParticipantsOG00322
PF-ILD Cohort: Placebo
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG00043
OG00140
OG00244
OG00320
OG00432
OG00532
Title
Denominators
Categories
Title
Measurements
OG000-0.4664(-17.023 to 5.725)
OG001-0.3418(-14.024 to 3.190)
OG002-0.4518(-5.449 to 3.888)
OG003-0.2352(-15.031 to 9.564)
OG004-0.3269(-8.902 to 2.086)
OG005-0.1829(-12.766 to 7.063)
OG003
PF-ILD Cohort: Placebo
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG00044
OG00140
OG00244
OG00321
OG00433
OG00534
Title
Denominators
Categories
Title
Measurements
OG000-1.4634(-38.133 to 64.451)
OG001-0.3470(-26.548 to 51.300)
OG002-3.2455(-48.939 to 35.463)
OG003-1.000(-22.176 to 11.587)
OG004-1.4683(-62.971 to 13.767)
OG005-1.4609(-13.016 to 20.997)
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG00067
OG00162
OG00270
OG00325
OG00433
OG00537
Title
Denominators
Categories
Title
Measurements
OG0000.0(-495 to 119)
OG0013.0(-260 to 138)
OG0026.0(-370 to 92)
OG00311.0000(-315.833 to 175.000)
OG0040.0000(-220.000 to 188.400)
OG005-14.0000(-173.000 to 242.857)
OG002
IPF Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
OG003
PF-ILD Cohort: Placebo
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG0002
OG0013
OG0021
OG0033
OG0040
OG0051
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median, lower limit, and upper limit not calculated due to insufficient number of events.
OG001NA(NA to NA)Median, lower limit, and upper limit not calculated due to insufficient number of events.
OG002NA(NA to NA)Median, lower limit, and upper limit not calculated due to insufficient number of events.
OG003NA(NA to NA)Median, lower limit, and upper limit not calculated due to insufficient number of events.
OG005NA(NA to NA)Median, lower limit, and upper limit not calculated due to insufficient number of events.
Participants in the Progressive Fibrotic Idiopathic Pulmonary Fibrosis (IPF) cohort received 60 mg BMS-986278 twice per day for up to 26 weeks.
OG003
PF-ILD Cohort: Placebo
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received placebo twice a day for up to 26 weeks.
OG004
PF-ILD Cohort: 30 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 30 mg BMS-986278 and placebo twice per day for up to 26 weeks.
OG005
PF-ILD Cohort: 60 mg BMS-986278
Participants in the Progressive Fibrotic Interstitial Lung Disease (PF-ILD) cohort who received both 60 mg BMS-986278 twice per day for up to 26 weeks.
Units
Counts
Participants
OG00092
OG00191
OG00293
OG00341
OG00440
OG00542
Title
Denominators
Categories
Title
Measurements
OG0002
OG0013
OG0021
OG0033
OG0040
OG0051
0 affected
11 at risk
EG0041 affected100 at risk
EG0050 affected102 at risk
EG0060 affected41 at risk
EG0070 affected40 at risk
EG0080 affected42 at risk
EG0090 affected4 at risk
EG0100 affected41 at risk
EG0110 affected46 at risk
0 affected
11 at risk
EG0040 affected100 at risk
EG0050 affected102 at risk
EG0060 affected41 at risk
EG0070 affected40 at risk
EG0080 affected42 at risk
EG0090 affected4 at risk
EG0101 affected41 at risk
EG0110 affected46 at risk
0 affected
11 at risk
EG0040 affected100 at risk
EG0050 affected102 at risk
EG0060 affected41 at risk
EG0070 affected40 at risk
EG0081 affected42 at risk
EG0090 affected4 at risk
EG0100 affected41 at risk
EG0111 affected46 at risk
0 affected
11 at risk
EG0040 affected100 at risk
EG0050 affected102 at risk
EG0060 affected41 at risk
EG0070 affected40 at risk
EG0080 affected42 at risk
EG0090 affected4 at risk
EG0100 affected41 at risk
EG0110 affected46 at risk
0 affected
11 at risk
EG0040 affected100 at risk
EG0050 affected102 at risk
EG0060 affected41 at risk
EG0070 affected40 at risk
EG0080 affected42 at risk
EG0090 affected4 at risk
EG0100 affected41 at risk
EG0110 affected46 at risk
0 affected
11 at risk
EG0040 affected100 at risk
EG0050 affected102 at risk
EG0060 affected41 at risk
EG0070 affected40 at risk
EG0080 affected42 at risk
EG0090 affected4 at risk
EG0100 affected41 at risk
EG0110 affected46 at risk
0 affected
11 at risk
EG0040 affected100 at risk
EG0050 affected102 at risk
EG0060 affected41 at risk
EG0070 affected40 at risk
EG0080 affected42 at risk
EG0090 affected4 at risk
EG0100 affected41 at risk
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0 affected
11 at risk
EG0041 affected100 at risk
EG0051 affected102 at risk
EG0060 affected41 at risk
EG0070 affected40 at risk
EG0083 affected42 at risk
EG0090 affected4 at risk
EG0100 affected41 at risk
EG0110 affected46 at risk
1 affected
11 at risk
EG0041 affected100 at risk
EG0051 affected102 at risk
EG0061 affected41 at risk
EG0070 affected40 at risk
EG0080 affected42 at risk
EG0090 affected4 at risk
EG0101 affected41 at risk
EG0110 affected46 at risk
0 affected
11 at risk
EG0040 affected100 at risk
EG0050 affected102 at risk
EG0060 affected41 at risk
EG0073 affected40 at risk
EG0080 affected42 at risk
EG0090 affected4 at risk
EG0100 affected41 at risk
EG0110 affected46 at risk
1 affected
11 at risk
EG0040 affected100 at risk
EG0050 affected102 at risk
EG0060 affected41 at risk
EG0070 affected40 at risk
EG0080 affected42 at risk
EG0090 affected4 at risk
EG0100 affected41 at risk
EG0110 affected46 at risk
1 affected
11 at risk
EG0040 affected100 at risk
EG0050 affected102 at risk
EG0060 affected41 at risk
EG0070 affected40 at risk
EG0080 affected42 at risk
EG0090 affected4 at risk
EG0101 affected41 at risk
EG0110 affected46 at risk
0 affected
11 at risk
EG0043 affected100 at risk
EG0051 affected102 at risk
EG0060 affected41 at risk
EG0070 affected40 at risk
EG0081 affected42 at risk
EG0090 affected4 at risk
EG0100 affected41 at risk
EG0110 affected46 at risk
1 affected
11 at risk
EG0040 affected100 at risk
EG0053 affected102 at risk
EG0060 affected41 at risk
EG0074 affected40 at risk
EG0083 affected42 at risk
EG0090 affected4 at risk
EG0100 affected41 at risk
EG0110 affected46 at risk
1 affected
11 at risk
EG0043 affected100 at risk
EG0050 affected102 at risk
EG0061 affected41 at risk
EG0072 affected40 at risk
EG0084 affected42 at risk
EG0090 affected4 at risk
EG0102 affected41 at risk
EG0111 affected46 at risk
1112.3
± 77.45
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG001114.66± 32.147
OG002167.35± 39.538
OG00494.8± 10.39
OG005189.6± 86.07
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG001641.0± 27.68
OG0021301.3± 20.80
OG004691.9± 2.04
OG0051247.80± 29.84
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG001169.30± 28.104
OG002275.82± 34.554
OG004161.9± 30.60
OG005433.5± 58.73
2.01
(1.83 to 2.18)
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0014.0670(1.867 to 7.900)
OG0024.0330(1.900 to 8.000)
OG0047.96(7.92 to 8.00)
OG0054.10(3.98 to 4.22)
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0011.9080(1.450 to 4.117)
OG0021.6750(1.317 to 4.000)
OG0042.68(1.533 to 3.82)
OG0054.06(3.98 to 4.13)
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0014.0670(2.083 to 6.000)
OG0022.0085(1.417 to 7.850)
OG0045.79(4.10 to 7.48)
OG0053.74(1.48 to 6.00)
4347
± 61.3
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG001686.2045± 32.95587
OG002913.4300± 50.72949
OG004532± NAGeometric coefficient of variation not calculated due to insufficient number of events
OG0052081± NAGeometric coefficient of variation not calculated due to insufficient number of events
ParticipantsOG0042
ParticipantsOG0052
Title
Measurements
OG0012853.9081± 21.72108
OG0025433.1662± 25.62819
OG0043591± NAGeometric coefficient of variation not calculated due to insufficient number of events
OG0058107± NAGeometric coefficient of variation not calculated due to insufficient number of events