Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlu... | NCT03955146 | Trialant
NCT03955146
Sponsor
Kyntra Bio
Status
Terminated
Last Update Posted
Sep 19, 2024Actual
Enrollment
393Actual
Phase
Phase 3
Conditions
Idiopathic Pulmonary Fibrosis
Interventions
Pamrevlumab
Placebo
Countries
United States
Argentina
Australia
Chile
China
Hong Kong
Russia
South Korea
Taiwan
Protocol Section
Identification Module
NCT ID
NCT03955146
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
FGCL-3019-091
Secondary IDs
Not provided
Brief Title
Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Acronym
Not provided
Organization
Kyntra BioINDUSTRY
Status Module
Record Verification Date
Sep 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Study did not meet its primary endpoint.
Expanded Access Info
No
Start Date
Jun 18, 2019Actual
Primary Completion Date
Mar 20, 2023Actual
Completion Date
Aug 28, 2023Actual
First Submitted Date
May 16, 2019
First Submission Date that Met QC Criteria
May 16, 2019
First Posted Date
May 17, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Aug 22, 2024
Results First Submitted that Met QC Criteria
Sep 16, 2024
Results First Posted Date
Sep 19, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Mar 15, 2024
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Dec 15, 2023Actual
Last Update Submitted Date
Sep 16, 2024
Last Update Posted Date
Sep 19, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Kyntra BioINDUSTRY
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
This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram (kg) intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with IPF.
Detailed Description
This is a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial to evaluate the efficacy and safety of pamrevlumab in participants with IPF.
Participants who are not being treated with approved IPF therapies (that is, nintedanib or pirfenidone) may be eligible for screening. Examples of reasons participants may not be treated with approved IPF therapies include but are not limited to:
Intolerant or not responsive to approved IPF therapies
Ineligible to receive these therapies
Participant voluntarily declines to receive approved IPF therapies after being fully informed of the potential benefits/risks
NOTE: No participant should discontinue an approved IPF therapy for the purpose of enrolling in this study.
The study consists of the following study periods:
Main (double blind, placebo-controlled) phase:
Screening period: Up to 6 weeks
Treatment period: 48 weeks
Optional, open-label extension (OLE) phase of pamrevlumab:
o Access to pamrevlumab will be available until the last participant completes 48 weeks of treatment in the OLE phase, or pamrevlumab is commercially available for the indication of IPF, or the Sponsor decides to end the OLE phase, whichever occurs first.
Follow-up period/final safety assessments:
28 days after last dose
60 days after last dose: follow-up phone call, for a final safety assessment
During the treatment period, co-administration of an approved IPF therapy (that is, pirfenidone or nintedanib) is acceptable if clinically indicated in the Investigator's opinion, provided that the Investigator assesses the potential risks/benefits of combining approved IPF therapies with blinded study treatment.
Participants who discontinue study treatment for any reason should be encouraged to remain in the study and be followed for all study visits and assessments.
Participants who complete the Week 48 visit of the main study (regardless of the number of study drug infusions received) will be eligible to participate in the optional OLE phase of the study that offers continuing access to pamrevlumab regardless of randomization assignment in the main study.
Participants will receive pamrevlumab 30 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion every 3 weeks for up to 48 weeks in the DB period.
Drug: Pamrevlumab
Main Study Cohort: Placebo
Placebo Comparator
Participants will receive placebo matching to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks in the DB period.
Drug: Placebo
Japan Extension Cohort: Pamrevlumab
Experimental
Participants will receive pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
Drug: Pamrevlumab
Japan Extension Cohort: Placebo
Placebo Comparator
Participants will receive placebo matching to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
Drug: Placebo
OLE Period: Pamrevlumab/Pamrevlumab
Experimental
Participants who receive pamrevlumab in the DB period will continue to receive the same dose of pamrevlumab for up to 48 weeks in the OLE period or until pamrevlumab is commercially available for the indication of IPF, or the sponsor decides to end the OLE period, whichever occurrs first.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pamrevlumab
Drug
Pamrevlumab will be administered per dose and schedule specified in the arm description.
Japan Extension Cohort: Pamrevlumab
Main Study Cohort: Pamrevlumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
DB Period (Main Study Cohort): Change From Baseline in FVC at Week 48
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that could forcibly be blown out after full inspiration in the upright position, measured in liters. Least square (LS) mean and standard error (SE) were calculated using mixed model for repeated measures (MMRM).
Baseline, Week 48
DB Period (Japan Extension Cohort): Change From Baseline in FVC at Week 48
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that could forcibly be blown out after full inspiration in the upright position, measured in liters.
Baseline, Week 48
Secondary Outcomes
Measure
Description
Time Frame
DB Period (Main Study Cohort): Time to Disease Progression
Time to disease progression was defined as the number of weeks from randomization to either the first occurrence of an absolute ≥10% decline from baseline in percent predicted FVC (FVCpp) or all-cause death, whichever occurred first. Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Diagnosis of IPF as defined by American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japan Radiological Society (JRS)/Latin American Thoracic Association (ALAT) guidelines within the past 7 years prior to study participation.
High-resolution computed tomography (HRCT) scan at screening, with ≥10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing.
FVCpp value >45% and <95% at screening and Day 1 (prior to randomization).
Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted and corrected by hemoglobin (Hb) value ≥25% and ≤90% at screening (determined locally).
Not currently receiving treatment for IPF with an approved therapy (that is, pirfenidone or nintedanib) for any reason, including prior intolerance or lack of response to an approved IPF therapy, or choice to forego treatment with an approved IPF therapy after a full discussion with the Investigator regarding risks/benefits of such therapy.
Key Exclusion Criteria:
Previous exposure to pamrevlumab.
Evidence of significant obstructive lung disease.
Female participants who are pregnant or nursing.
Smoking within 3 months of screening and/or unwilling to avoid smoking throughout the study.
Interstitial lung disease other than IPF.
Sustained improvement in the severity of IPF during the 12 months prior to screening.
History of other types of respiratory diseases including diseases or disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall.
Medical conditions (for example, myocardial infarction [MI]/stroke within the past 6 month), or logistical challenges that in the opinion of the Investigator preclude the participant's adequate participation in the study.
Acute IPF exacerbation during screening or randomization.
Use of any investigational drugs or unapproved therapies, or participation in any clinical trial with an investigational new drug within 30 days prior to screening. Or use of approved IPF therapies (that is, pirfenidone or nintedanib) within 1 week prior to screening.
History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies, or to any component of the excipient.
The study included a double-blind (DB) period (main study cohort and Japan extension cohort) and an open-label extension (OLE) period. OLE period was not conducted in Japan.
The efficacy outcome measures data were not collected for Japan cohorts due to early termination of study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Main Study Cohort: Pamrevlumab
Participants received pamrevlumab 30 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion every 3 weeks for up to 48 weeks in the DB period and continued to receive the same dose of pamrevlumab for up to 48 weeks in the OLE period or until pamrevlumab was commercially available for the indication of idiopathic pulmonary fibrosis (IPF), or the sponsor decided to end the OLE period, whichever occurred first.
Participants who receive placebo matching to pamrevlumab in the DB period, will receive pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks in the OLE period or until pamrevlumab is commercially available for the indication of IPF, or the sponsor decides to end the OLE period, whichever occurrs first.
Drug: Pamrevlumab
OLE Period: Pamrevlumab/Pamrevlumab
OLE Period: Placebo/Pamrevlumab
FG-3019
Placebo
Drug
Placebo matching to pamrevlumab will be administered per schedule specified in the arm description.
Japan Extension Cohort: Placebo
Main Study Cohort: Placebo
Up to Week 48
DB Period (Main Study Cohort): Time to First Occurrence of Any Component of the Clinical Composite Endpoint
The components of the clinical composite endpoint included acute IPF exacerbation, respiratory hospitalization, or death. Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.
Up to Week 48
DB Period (Main Study Cohort and Japan Extension Cohort): Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48
The QLF volume was calculated as QLF = total lung capacity volume multiplied by percentage (%) of quantitative lung fibrosis for fibrosis of the whole lung. LS mean and SE was calculated using MMRM.
Baseline, Week 48
DB Period (Main Study Cohort): Time to First Acute IPF Exacerbation
Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.
Up to Week 48
DB Period (Main Study Cohort): Time to All-Cause Mortality
Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.
Up to Week 48
DB Period (Main Study Cohort): Time to First Respiratory Hospitalizations
Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.
Up to Week 48
Phoenix
Arizona
85006
United States
Norton Thoracic Institute
Phoenix
Arizona
85013
United States
Pulmonary Associates, PA - Research
Phoenix
Arizona
85032
United States
University of Arizona
Tucson
Arizona
85724
United States
J&L Research
Conway
Arkansas
72032
United States
Loma Linda University Health
Loma Linda
California
92354
United States
David Geffen School of Medicine at UCLA
Los Angeles
California
90095
United States
UC Davis Medical Center
Sacramento
California
95817
United States
University of California San Diego
San Diego
California
92103
United States
Stanford University Medical Center
Stanford
California
94305
United States
University of Colorado Denver
Aurora
Colorado
80045
United States
National Jewish Health
Denver
Colorado
80207
United States
Yale University School of Medicine
New Haven
Connecticut
06510
United States
Medstar Georgetown University Hospital
Washington D.C.
District of Columbia
20007
United States
St. Francis Medical Center
Clearwater
Florida
33765
United States
University of Florida Pulmonary, Critical Care & Sleep Medicine Division
Gainesville
Florida
32610
United States
University of Florida Health, Jacksonville
Jacksonville
Florida
32209
United States
Mayo Clinic
Jacksonville
Florida
32224
United States
Pulmonary Disease Specialist, PA d/b/a, PDS Research
Kissimmee
Florida
34741
United States
University of South Florida
Tampa
Florida
33606
United States
Emory University
Atlanta
Georgia
30322
United States
Piedmont Healthcare, Inc.
Austell
Georgia
30106
United States
Northwestern University
Chicago
Illinois
60612
United States
Loyola University of Chicago
Maywood
Illinois
60153
United States
Indiana University School of Medicine
Indianapolis
Indiana
46202
United States
The University of Kansas Medical Center
Kansas City
Kansas
66160
United States
University of Maryland, Baltimore
Baltimore
Maryland
21201
United States
University of Michigan
Ann Arbor
Michigan
48109
United States
Henry Ford Hospital
Detroit
Michigan
48202
United States
Spectrum Health
Grand Rapids
Michigan
49546
United States
University of Minnesota
Minneapolis
Minnesota
55455
United States
The Lung Research Center, LLC
Chesterfield
Missouri
63017
United States
Dartmouth-Hitchcock Medical Center
Lebanon
New Hampshire
03756
United States
Albany Medical College
Albany
New York
12208
United States
Pulmonary Health Physicians, PC
Liverpool
New York
13088
United States
Pulmonix, LLC
Greensboro
North Carolina
27403
United States
University of Cincinnati
Cincinnati
Ohio
45267
United States
Ohio State University
Columbus
Ohio
43221
United States
INTEGRIS Baptist Medical Center
Oklahoma City
Oklahoma
73112
United States
Legacy Research Institute
Portland
Oregon
97210
United States
The Oregon Clinic
Portland
Oregon
97220
United States
Penn State Milton S. Hershey Medical Center
Hershey
Pennsylvania
17033
United States
Temple University
Philadelphia
Pennsylvania
19140
United States
Rhode Island Hospital
Providence
Rhode Island
02903
United States
Lowcountry Lung and Critical Care, PA
Charleston
South Carolina
29406
United States
Medical University of South Carolina
Charleston
South Carolina
29425
United States
Tennessee Comprehensive Lung and Sleep Center
Hendersonville
Tennessee
37075
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37204
United States
Houston Pulmonary Sleep, Allergy and Asthma Associates
Consultorios Medicos. Organización del Buen Ayre. SRL
Ciudad Autonoma de Buenos Aires
Buenos Aires
C1425FVH
Argentina
Centro Medico de Enfermedades Respiratorias
Florida
Buenos Aires
B1602DQD
Argentina
Centro Platense en Investigaciones Respiratorias
La Plata
Buenos Aires
1900
Argentina
Instituto ave Pulmo Fundacion enfisema
Mar del Plata
Buenos Aires
B7602DCK
Argentina
Respira Salud Clinica Integral
Godoy Cruz
Mendoza Province
M5501GCA
Argentina
INSARES
Mendoza
Mendoza Province
M5500CCG
Argentina
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán
Tucumán Province
T4000IAR
Argentina
Royal Prince Alfred Hospital
Sydney
New South Wales
2050
Australia
Westmead Hospital
Westmead
New South Wales
2145
Australia
Mater Health Services Adult Hospital
South Brisbane
Queensland
4101
Australia
Royal Adelaide Hospital
Adelaide
South Australia
5000
Australia
Box Hill Hospital
Box Hill
Victoria
3128
Australia
The Alfred Hospital
Melbourne
Victoria
3004
Australia
Centro Investigacion del Maule CIM
Talca
Maule Region
3465586
Chile
Instituto Nacional del Torax
Santiago
Santiago Metropolitan
7500691
Chile
CIMER
Santiago
Santiago Metropolitan
7500692
Chile
M y F estudios clinicos
Santiago
Santiago Metropolitan
7750495
Chile
Second Affiliated Hospital of Anhui Medical University
Hefei
Anhui
230000
China
BeiJing Chao-Yang Hospital,Capital medical university
Beijing
Beijing Municipality
100020
China
China-Japan friendship hospital
Beijing
Beijing Municipality
100029
China
Peking Union Medical College Hospital
Beijing
Beijing Municipality
100730
China
Nanfang Hospital of Southern Medical University
Guangzhou
Guangdong
510000
China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Guangdong
510120
China
Shenzhen people's hospital
Shenzhen
Guangdong
518020
China
Henan Provincial People's Hospital
Zhengzhou
Henan
450000
China
Henan Provincial chest hospital
Zhengzhou
Henan
450003
China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan
Hubei
430022
China
Union Hospital,Tongji Medical College of Huazhong University of Science and Technology
Wuhan
Hubei
430022
China
The Second Xiangya Hospital of Central South University
Changsha
Hunan
410011
China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot
Inner Mongolia
10010
China
People's Hospital of Inner Mongolia Autonomous Region
Hohhot
Inner Mongolia
10020
China
The second hospital of Dalian medical university
Dalian
Liaoning
116001
China
The First Hospital of China Medical University
Shenyang
Liaoning
110001
China
General Hospital of Ningxia Medical University
Yinchuan
Ningxia
750004
China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
Shanghai Municipality
200025
China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an
Shanxi
710004
China
Huaxi Hospital of Sichuan University.
Chengdu
Sichuan
6100141
China
General Hospital of Tianjin Medical University
Tianjin
Tianjin Municipality
300052
China
Hangzhou First People's Hospital
Hangzhou
Zhejiang
310006
China
Queen Mary Hospital
Central
Hong Kong
Tuen Mun Hospital
Hong Kong
Hong Kong
Regional Clinical Hospital #3
Chelyabinsk
454106
Russia
Kazan State Medical University based on Republican Clinical Hospital
Kazan'
420029
Russia
Clinical Hospital #3
Kemerovo
650000
Russia
Euromedservice, Clinical and Diagnostic Center
Moscow
115419
Russia
MONIKI
Moscow
129110
Russia
City Clinical Hospital #1 n.a. A.N. Kabanov
Omsk
644112
Russia
Vvedenskaya hospital
Saint Petersburg
191180
Russia
Medical Center "Reavita Med SPb"
Saint Petersburg
194354
Russia
FSBEI HE First Pavlov Medical University
Saint Petersburg
197022
Russia
Medical Association "NEW HOSPITAL"
Yekaterinburg
620109
Russia
Soonchunhyang University Bucheon Hospital
Bucheon-si
Gyeonggi-do
14579
South Korea
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si
Gyeonggi-do
14647
South Korea
Seoul National University Bundang Hospital
Seongnam-si
Gyeonggi-do
13620
South Korea
Ajou University Hospital
Suwon
Gyeonggi-do
16499
South Korea
Inje University Busan Paik Hospital
Busan
47392
South Korea
Gachon University Gil Medical Center
Incheon
21565
South Korea
Korea University Anam Hospital
Seoul
2841
South Korea
Seoul National University Hospital
Seoul
3080
South Korea
Asan Medical Center
Seoul
5505
South Korea
Samsung Medical Centerx
Seoul
6351
South Korea
Taichung Veterans General Hospital
Taichung
40705
Taiwan
Taipei Medical University - Shuang-Ho Hospital, Ministry of Health and Welfare
Taipei
23561
Taiwan
Rayego-Mateos S, Morgado-Pascual JL, Lavoz C, Rodrigues-Diez RR, Marquez-Exposito L, Tejera-Munoz A, Tejedor-Santamaria L, Rubio-Soto I, Marchant V, Ruiz-Ortega M. CCN2 Binds to Tubular Epithelial Cells in the Kidney. Biomolecules. 2022 Feb 3;12(2):252. doi: 10.3390/biom12020252.
FG001
Main Study Cohort: Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks in the DB period. Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks in the OLE period or until pamrevlumab was commercially available for the indication of IPF, or the sponsor decided to end the OLE period, whichever occurred first.
FG002
Japan Extension Cohort: Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
FG003
Japan Extension Cohort: Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
FG000181 subjects
FG001175 subjects
FG00218 subjects
FG00319 subjects
Received at Least 1 Dose of Study Drug
FG000181 subjects
FG001175 subjects
FG00218 subjects
FG00319 subjects
COMPLETED
FG000146 subjects
FG001134 subjects
FG00214 subjects
FG00311 subjects
NOT COMPLETED
FG00035 subjects
FG00141 subjects
FG0024 subjects
FG0038 subjects
Type
Comment
Reasons
Study terminated by sponsor
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0034 subjects
Adverse Event
FG0002 subjects
FG0015 subjects
FG0021 subjects
FG0032 subjects
Death
FG00013 subjects
FG00117 subjects
FG0021 subjects
FG0030 subjects
Investigator Decision
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
Disease Progression
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Withdrawal by Subject
FG0006 subjects
FG0013 subjects
FG0020 subjects
FG0031 subjects
Noncompliance with the Study Drug
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Lung Transplant
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Participant Decision
FG0009 subjects
FG00112 subjects
FG0021 subjects
FG0031 subjects
OLE (Maximum Exposure: 153.1 Weeks)
Type
Comment
Milestone Data
STARTED
FG000129 subjects17 participants who completed DB period did not continue in to the OLE period.
FG001123 subjects11 participants who completed DB period did not continue in to the OLE period.
FG0020 subjects
FG0030 subjects
Received at Least 1 Dose of Study Drug
FG000129 subjects
FG001123 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG000129 subjects
FG001123 subjects
FG0020 subjects
FG0030 subjects
Type
Comment
Reasons
Adverse Event
FG0007 subjects
FG0011 subjects
FG0020 subjects
FG003
The intent-to-treat (ITT) population included all randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
DB Period (Main Study Cohort): Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks in the DB period and continued to receive the same dose of pamrevlumab for up to 48 weeks in the OLE period or until pamrevlumab was commercially available for the indication of IPF, or the sponsor decided to end the OLE period, whichever occurred first.
BG001
DB Period (Main Study Cohort): Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks in the DB period. Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks in the OLE period or until pamrevlumab was commercially available for the indication of IPF, or the sponsor decided to end the OLE period, whichever occurred first.
BG002
DB Period (Japan Extension Cohort): Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
BG003
DB Period (Japan Extension Cohort): Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000181
BG001175
BG00218
BG00319
BG004393
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000181
ParticipantsBG001175
ParticipantsBG00218
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000181
ParticipantsBG001175
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000181
ParticipantsBG001175
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000181
ParticipantsBG001175
ParticipantsBG002
Forced Vital Capacity (FVC)
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that could forcibly be blown out after full inspiration in the upright position, measured in liters.
Per planned analysis, the Baseline characteristics data for 'main study cohort' and 'Japan extension cohort' was collected and reported separately.
Mean
Standard Deviation
liters
Title
Denominators
Categories
Main Study Cohort
ParticipantsBG000181
ParticipantsBG001175
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
DB Period (Main Study Cohort): Change From Baseline in FVC at Week 48
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that could forcibly be blown out after full inspiration in the upright position, measured in liters. Least square (LS) mean and standard error (SE) were calculated using mixed model for repeated measures (MMRM).
ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Posted
Least Squares Mean
Standard Error
liters
Baseline, Week 48
ID
Title
Description
OG000
DB Period (Main Study Cohort) - Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
OG001
DB Period (Main Study Cohort) - Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
Units
Counts
Participants
OG000163
OG001149
Title
Denominators
Categories
Title
Measurements
OG000-0.26± 0.046
OG001-0.33± 0.050
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
0.2926
LS Mean Difference
0.07
Standard Error of the Mean
0.062
2-Sided
95
-0.06
0.19
Other
Primary
DB Period (Japan Extension Cohort): Change From Baseline in FVC at Week 48
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that could forcibly be blown out after full inspiration in the upright position, measured in liters.
ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
liters
Baseline, Week 48
ID
Title
Description
OG000
DB Period (Japan Extension Cohort) - Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
OG001
DB Period (Japan Extension Cohort) - Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
Units
Counts
Participants
OG000
Secondary
DB Period (Main Study Cohort): Time to Disease Progression
Time to disease progression was defined as the number of weeks from randomization to either the first occurrence of an absolute ≥10% decline from baseline in percent predicted FVC (FVCpp) or all-cause death, whichever occurred first. Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.
ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
weeks
Up to Week 48
ID
Title
Description
OG000
DB Period (Main Study Cohort) - Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
OG001
DB Period (Main Study Cohort) - Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
Units
Counts
Participants
Secondary
DB Period (Main Study Cohort): Time to First Occurrence of Any Component of the Clinical Composite Endpoint
The components of the clinical composite endpoint included acute IPF exacerbation, respiratory hospitalization, or death. Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.
ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
weeks
Up to Week 48
ID
Title
Description
OG000
DB Period (Main Study Cohort) - Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
OG001
DB Period (Main Study Cohort) - Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
Units
Counts
Participants
Secondary
DB Period (Main Study Cohort and Japan Extension Cohort): Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48
The QLF volume was calculated as QLF = total lung capacity volume multiplied by percentage (%) of quantitative lung fibrosis for fibrosis of the whole lung. LS mean and SE was calculated using MMRM.
ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Posted
Least Squares Mean
Standard Error
liters
Baseline, Week 48
ID
Title
Description
OG000
DB Period (Main Study Cohort) - Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
OG001
DB Period (Main Study Cohort) - Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
OG002
DB Period (Japan Extension Cohort): Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
OG003
DB Period (Japan Extension Cohort): Placebo
Secondary
DB Period (Main Study Cohort): Time to First Acute IPF Exacerbation
Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.
ITT population included all randomized participants.
Posted
Median
95% Confidence Interval
weeks
Up to Week 48
ID
Title
Description
OG000
DB Period (Main Study Cohort) - Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
OG001
DB Period (Main Study Cohort) - Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
Units
Counts
Participants
OG000
Secondary
DB Period (Main Study Cohort): Time to All-Cause Mortality
Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.
ITT population included all randomized participants.
Posted
Median
95% Confidence Interval
weeks
Up to Week 48
ID
Title
Description
OG000
DB Period (Main Study Cohort) - Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
OG001
DB Period (Main Study Cohort) - Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
Units
Counts
Participants
OG000
Secondary
DB Period (Main Study Cohort): Time to First Respiratory Hospitalizations
Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.
ITT population included all randomized participants.
Posted
Median
95% Confidence Interval
weeks
Up to Week 48
ID
Title
Description
OG000
DB Period (Main Study Cohort) - Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
OG001
DB Period (Main Study Cohort) - Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
Units
Counts
Participants
OG000
Time Frame
From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
Description
The safety analysis set included all participants who received any study drug.
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
DB Period (Main Study Cohort): Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks in the DB period.
23
181
51
181
129
181
EG001
DB Period (Main Study Cohort): Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks in the DB period.
22
175
60
175
121
175
EG002
DB Period (Japan Extension Cohort)Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
1
18
5
18
17
18
EG003
DB Period (Japan Extension Cohort): Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
2
19
8
19
16
19
EG004
OLE Period: Pamrevlumab/Pamrevlumab
Participants who received pamrevlumab in the DB period continued to receive the same dose of pamrevlumab for up to 48 weeks in the OLE period or until pamrevlumab was commercially available for the indication of IPF, or the sponsor decided to end the OLE period, whichever occurred first.
17
129
42
129
76
129
EG005
OLE Period: Placebo/Pamrevlumab
Participants who received placebo matched to pamrevlumab in the DB period, received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks in the OLE period or until pamrevlumab was commercially available for the indication of IPF, or the sponsor decided to end the OLE period, whichever occurred first.
14
123
33
123
75
123
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Melaena
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG0031 affected19 at risk
EG0040 affected129 at risk
EG0050 affected123 at risk
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0008 affected181 at risk
EG0018 affected175 at risk
EG0021 affected18 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0003 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Chemical peritonitis
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Metastases to liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0021 affected18 at risk
EG003
Idiopathic pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG00014 affected181 at risk
EG00118 affected175 at risk
EG0022 affected18 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0021 affected18 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0012 affected175 at risk
EG0020 affected18 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Cardiac perforation
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Left ventricular failure
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Right ventricular dysfunction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Right ventricular failure
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0013 affected175 at risk
EG0020 affected18 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0012 affected175 at risk
EG0020 affected18 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Cardiac discomfort
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Gastric polyps
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Obstructive pancreatitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Asthenia
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Death
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Peripheral swelling
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Inflammation
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Biliary dilatation
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Cholelithiasis obstructive
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Cystitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Epiglottitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Septic shock
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0015 affected175 at risk
EG0020 affected18 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0012 affected175 at risk
EG0020 affected18 at risk
EG003
Lyme carditis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Suspected COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Influenza
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Gangrene
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Metapneumovirus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Vaccine breakthrough infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0002 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Postoperative wound complication
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Ulna fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Squamous cell carcinoma of lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Lung neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Pancreatic carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Amyotrophic lateral sclerosis
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Cerebellar stroke
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Syncope
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0012 affected175 at risk
EG0020 affected18 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0004 affected181 at risk
EG0013 affected175 at risk
EG0020 affected18 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0004 affected181 at risk
EG0012 affected175 at risk
EG0020 affected18 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Bronchial secretion retention
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Chronic respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Epiglottic cyst
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0012 affected175 at risk
EG0020 affected18 at risk
EG003
Vocal cord polyp
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Varicose vein
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Pneumomediastinum
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Pneumothorax spontaneous
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Subcutaneous emphysema
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Hypertensive emergency
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Shock
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Shock haemorrhagic
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0021 affected18 at risk
EG0030 affected19 at risk
EG0040 affected129 at risk
EG0050 affected123 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected181 at risk
EG0011 affected175 at risk
EG0021 affected18 at risk
EG003
Cardiomegaly
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0021 affected18 at risk
EG003
Right ventricular failure
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Cataract
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Dry eye
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Scleritis
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0021 affected18 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected181 at risk
EG0011 affected175 at risk
EG0021 affected18 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0005 affected181 at risk
EG0012 affected175 at risk
EG0021 affected18 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG00010 affected181 at risk
EG00111 affected175 at risk
EG0024 affected18 at risk
EG003
Faeces soft
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0021 affected18 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected181 at risk
EG0011 affected175 at risk
EG0021 affected18 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0004 affected181 at risk
EG0017 affected175 at risk
EG0020 affected18 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0011 affected175 at risk
EG0021 affected18 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0007 affected181 at risk
EG0018 affected175 at risk
EG0020 affected18 at risk
EG003
Oesophageal polyp
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0022 affected18 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0021 affected18 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0021 affected18 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected181 at risk
EG0015 affected175 at risk
EG0020 affected18 at risk
EG003
Chest pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected181 at risk
EG0014 affected175 at risk
EG0021 affected18 at risk
EG003
Fatigue
General disorders
MedDRA 26.0
Systematic Assessment
EG00012 affected181 at risk
EG00110 affected175 at risk
EG0020 affected18 at risk
EG003
Feeling abnormal
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Infusion site erythema
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0022 affected18 at risk
EG003
Injection site pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Malaise
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Oedema peripheral
General disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected181 at risk
EG0012 affected175 at risk
EG0020 affected18 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0017 affected175 at risk
EG0021 affected18 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0011 affected175 at risk
EG0021 affected18 at risk
EG003
Sarcoidosis
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0021 affected18 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG00014 affected181 at risk
EG00114 affected175 at risk
EG0020 affected18 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG00022 affected181 at risk
EG00116 affected175 at risk
EG0025 affected18 at risk
EG003
Cystitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0021 affected18 at risk
EG003
Cytomegalovirus enterocolitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0021 affected18 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0003 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG00010 affected181 at risk
EG0016 affected175 at risk
EG0021 affected18 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0006 affected181 at risk
EG0017 affected175 at risk
EG0020 affected18 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0004 affected181 at risk
EG0015 affected175 at risk
EG0021 affected18 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0021 affected18 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG00011 affected181 at risk
EG0015 affected175 at risk
EG0020 affected18 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0003 affected181 at risk
EG0013 affected175 at risk
EG0020 affected18 at risk
EG003
Chemical peritonitis
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0004 affected181 at risk
EG0012 affected175 at risk
EG0020 affected18 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0021 affected18 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0021 affected18 at risk
EG003
Blood pressure decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0013 affected175 at risk
EG0020 affected18 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0021 affected18 at risk
EG003
Platelet count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0021 affected18 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA 26.0
Systematic Assessment
EG0002 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Weight decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0006 affected181 at risk
EG00111 affected175 at risk
EG0020 affected18 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0021 affected18 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0006 affected181 at risk
EG0012 affected175 at risk
EG0020 affected18 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0021 affected18 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected181 at risk
EG0012 affected175 at risk
EG0021 affected18 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0009 affected181 at risk
EG0013 affected175 at risk
EG0021 affected18 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0006 affected181 at risk
EG0018 affected175 at risk
EG0021 affected18 at risk
EG003
Muscle fatigue
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected181 at risk
EG0013 affected175 at risk
EG0020 affected18 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0021 affected18 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0021 affected18 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0021 affected18 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG00010 affected181 at risk
EG0017 affected175 at risk
EG0020 affected18 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG00013 affected181 at risk
EG00112 affected175 at risk
EG0020 affected18 at risk
EG003
Olfactory dysfunction
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Depression
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0011 affected175 at risk
EG0021 affected18 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0005 affected181 at risk
EG0012 affected175 at risk
EG0021 affected18 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0011 affected175 at risk
EG0021 affected18 at risk
EG003
Bronchitis chronic
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected181 at risk
EG0012 affected175 at risk
EG0021 affected18 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG00037 affected181 at risk
EG00125 affected175 at risk
EG0023 affected18 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG00018 affected181 at risk
EG00116 affected175 at risk
EG0020 affected18 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0021 affected18 at risk
EG003
Idiopathic pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG00019 affected181 at risk
EG00117 affected175 at risk
EG0021 affected18 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected181 at risk
EG0011 affected175 at risk
EG0022 affected18 at risk
EG003
Pneumomediastinum
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0012 affected175 at risk
EG0021 affected18 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 affected181 at risk
EG0011 affected175 at risk
EG0020 affected18 at risk
EG003
Sputum increased
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected181 at risk
EG0013 affected175 at risk
EG0022 affected18 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0021 affected18 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0021 affected18 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected181 at risk
EG0013 affected175 at risk
EG0021 affected18 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Subcutaneous emphysema
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0011 affected175 at risk
EG0021 affected18 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected181 at risk
EG0010 affected175 at risk
EG0020 affected18 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG00011 affected181 at risk
EG0015 affected175 at risk
EG0020 affected18 at risk
EG003
Study did not meet its primary endpoint; hence, it was terminated early. The Japan extension cohort and OLE period were halted due to futility.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The multisite consortium can publish any time after the data is collected and analyzed by FibroGen. The investigator can only publish after the multisite consortium publishes (or tries to publish and fails). FibroGen has 60 days to review a publication and can extend the embargo up to an additional 120 days (or 180 total).