A Study of Sotatercept for the Treatment of Pulmonary Art... | NCT03496207 | Trialant
NCT03496207
Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Status
Completed
Last Update Posted
Apr 19, 2023Actual
Enrollment
106Actual
Phase
Phase 2
Conditions
Pulmonary Arterial Hypertension
Interventions
Placebo
Sotatercept
SOC
Countries
United States
Australia
Brazil
France
Germany
Israel
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03496207
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A011-09
Secondary IDs
ID
Type
Description
Link
2017-004738-27
EudraCT Number
Brief Title
A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)
Official Title
A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)
Acronym
PULSAR
Organization
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USAINDUSTRY
Status Module
Record Verification Date
Mar 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 13, 2018Actual
Primary Completion Date
Mar 9, 2022Actual
Completion Date
Mar 9, 2022Actual
First Submitted Date
Mar 29, 2018
First Submission Date that Met QC Criteria
Apr 11, 2018
First Posted Date
Apr 12, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Feb 28, 2023
Results First Submitted that Met QC Criteria
Mar 28, 2023
Results First Posted Date
Apr 19, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 28, 2023
Last Update Posted Date
Apr 19, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USAINDUSTRY
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
Study A011-09 is designed to assesses the efficacy and safety of sotatercept (ACE-011) relative to placebo in adults with pulmonary arterial hypertension (PAH). Eligible participants will receive study treatment for 24 weeks during the placebo-controlled treatment period, and then will be eligible to enroll into a 30-month extension period during which all participants will receive sotatercept. All treated patients will also undergo a follow-up period after last study drug treatment.
Detailed Description
This is a Phase 2, double-blind, randomized, placebo-controlled, parallel-group study of sotatercept plus standard of care (SOC) versus placebo plus SOC in participants with PAH of World Health Organization (WHO) Group 1, functional class II-III. Participants will be randomly assigned in a 3:3:4 ratio to receive placebo, sotatercept 0.3 mg/kg, or sotatercept 0.7 mg/kg by subcutaneous (SC) injection every 21 days for a period of 24 weeks in the placebo-controlled treatment period of the study while on SOC therapy. Evaluations will include changes in pulmonary vascular resistance (PVR), 6-minute walk distance (6MWD), quality of life questionnaires, echocardiographic parameters, and safety. Participants who have not discontinued early from the placebo-controlled treatment period and have had their post-treatment period PVR assessment will be able to continue into the 30-month extension period in which sotatercept-treated participants will receive their latest dose level of sotatercept SC every 21 days and placebo-treated participants will be re-randomized 1:1 to receive sotatercept 0.3 mg/kg SC or sotatercept 0.7 mg/kg SC every 21 days while on SOC therapy.
Conditions Module
Conditions
Pulmonary Arterial Hypertension
Keywords
PAH
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
106Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Participants will receive placebo plus SOC by SC injection during the 24-week treatment period. Dosing will occur once every 3 weeks.
Drug: Placebo
Other: SOC
Sotatercept 0.3 mg/kg
Experimental
Participants will receive sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period. Per protocol, participants may have their doses titrated. Dosing will occur once every 3 weeks.
Drug: Sotatercept
Other: SOC
Sotatercept 0.7 mg/kg
Experimental
Participants will receive sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period. Per protocol, participants may have their doses titrated. Dosing will occur once every 3 weeks.
Drug: Sotatercept
Other: SOC
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Placebo
Placebo
Sotatercept
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Base Study: Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks
Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and at 24 weeks.
Baseline and 24 weeks
Extension Period: Change From Baseline in PVR (Delayed-Start Analysis)
Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24.
Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
Extension Period: Change From Baseline in PVR (Placebo-Crossed Analysis)
Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24.
Baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24.
Extension Period: Number of Participants Who Experienced One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Up to approximately 32 months
Extension Period: Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Secondary Outcomes
Measure
Description
Time Frame
Base Study: Change From Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks
6MWD is measured by an exercise test known as 6-Minute Walk Test (6MWT) that assesses aerobic capacity and endurance. It measures the distance covered over a time of 6 minutes and is used as an outcome measure by which to compare changes in performance capacity. Each participant's 6MWD was measured at baseline and at 24 weeks. An increase in the distance walked during the 6MWT indicates improvement in basic mobility.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years
Documented diagnostic right heart catheterization (RHC) at any time prior to Screening confirming diagnosis of WHO diagnostic pulmonary hypertension Group I: PAH in any of the following subtypes:
i. Idiopathic ii. Heritable PAH iii. Drug- or toxin-induced PAH iv. PAH associated with connective tissue disease v. PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following shunt repair
Symptomatic pulmonary hypertension classified as WHO functional class II or III
Screening RHC documenting a minimum PVR of ≥400 dyn·sec/cm5 (5 Wood units)
Pulmonary function tests (PFTs) within 6 months prior to Screening as follows:
Total lung capacity (TLC) >70% predicted; or if between 60 to 70% predicted, or not possible to be determined, confirmatory high-resolution computed tomography (CT) indicating no more than mild interstitial lung disease (ILD), per investigator interpretation, or
Ventilation-perfusion (VQ) scan (or, if unavailable a negative CT pulmonary angiogram [CTPA] result, or pulmonary angiography result), any time prior to Screening Visit or conducted during the Screening Period, with normal or low probability result),
No contraindication per investigator for RHC during the study
6MWD ≥150 and ≤550 meters repeated twice at Screening and both values within 15% of each other, calculated from the highest value
PAH therapy at stable (per investigator) dose levels of SOC therapies
Exclusion Criteria:
Stopped receiving any pulmonary hypertension chronic general supportive therapy (e.g, diuretics, oxygen, anticoagulants, digoxin) within 60 days prior to study visit Cycle 1 Day 1 (C1D1)
Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to study visit C1D1
History of atrial septostomy within 180 days prior to Screening
History of more than mild obstructive sleep apnea that is untreated
Known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C)
History of human immunodeficiency virus infection-associated PAH
Prior exposure to sotatercept (ACE-011) or luspatercept (ACE-536)
Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to C1D1 or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible).
Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) >160 mm Hg or sitting diastolic blood pressure >100 mm Hg during Screening Visit after a period of rest
Systolic BP <90 mmHg during Screening or at baseline
History of known pericardial constriction
Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) >480 msec during Screening Period or C1D1
Personal or family history of long QTc syndrome or sudden cardiac death
Cerebrovascular accident within 3 months of C1D1
History of restrictive or congestive cardiomyopathy
Left ventricular ejection fraction (LVEF) <45% on historical echocardiogram (ECHO) within 6 months prior to Screening Period (or done as a part of the Screening Period) or pulmonary capillary wedge pressure (PCWP) >15 mmHg as determined in the Screening Period RHC.
Any current or prior history of symptomatic coronary disease (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain)
Acutely decompensated heart failure within 30 days prior to study visit C1D1, as per investigator assessment
Any of the following clinical laboratory values during the Screening Period prior to C1D1:
Baseline Hgb >16.0 g/dL
Serum alanine aminotransferase or aspartate aminotransferase levels >3X upper limit of normal (ULN) or total bilirubin >1.5X ULN within 28 days of C1D1
Estimated glomerular filtration rate <30 ml/min/1.73m2 (4-variable Modification of Diet in Renal Disease equation) within 28 days of C1D1 or required renal replacement therapy within 90 days
WBC count <4000/mm3
Platelets <100,000/μL
Absolute neutrophil count <1500/mm3
History of opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia) within 6 months prior to Screening; serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to Screening
History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in the investigational product
Major surgery within 8 weeks prior to C1D1. Participants must have completely recovered from any previous surgery prior to C1D1.
Prior heart or heart-lung transplants or life expectancy of <12 month
Pregnant or breastfeeding females
If on corticosteroids, and at any time in the last 30 days prior to the Screening Period: have been receiving doses of >20 mg/day of prednisone (or equivalent) or on a new or changing dose of ≤20 mg/day; only participants receiving stable doses of ≤20 mg prednisone (or equivalent) in last 30 days prior to the Screening Period permitted in the study
History of active malignancy, with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in-situ, or ≤2 squamous cell carcinomas of the skin
History of clinically significant (as determined by the investigator) non-PAH related cardiac, endocrine, hematologic, hepatic, (auto)immune, metabolic, urologic, pulmonary, neurologic, neuromuscular, dermatologic, psychiatric, renal, and/or another disease that may limit participation in the study. Autoimmune diseases are excluded with the exception of those related to PAH etiologies included in this study.
Participation in another clinical trial involving intervention with another investigational drug, approved therapy for investigational use, or investigational device within 4 weeks prior to C1D1, or if the half-life of the previous product is known, within 5 times the half-life prior to C1D1, whichever is longer
Humbert M, McLaughlin V, Gibbs JSR, Gomberg-Maitland M, Hoeper MM, Preston IR, Souza R, Waxman AB, Ghofrani HA, Escribano Subias P, Feldman J, Meyer G, Montani D, Olsson KM, Manimaran S, de Oliveira Pena J, Badesch DB. Sotatercept for the treatment of pulmonary arterial hypertension: PULSAR open-label extension. Eur Respir J. 2023 Jan 6;61(1):2201347. doi: 10.1183/13993003.01347-2022. Print 2023 Jan.
This treatment group represents participants from the Placebo arm who received placebo plus standard of care (SOC) by subcutaneous (SC) injection during the 24-week treatment period (Base Study; Cycles 1-8), then transitioned to the 30-month extension period (Cycles 9-51), during which they received sotatercept 0.3 mg/kg plus SOC by SC injection. Each cycle was 21 days. Dosing occurred once every 3 weeks.
Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.
Sotatercept 0.3 mg/kg
Sotatercept 0.7 mg/kg
ACE-011
SOC
Other
SOC therapy refers to approved PAH-specific medications and may consist of monotherapy or combination therapy with endothelin-receptor antagonists, phosphodiesterase 5 (PDE5) inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogues or receptor agonists.
Placebo
Sotatercept 0.3 mg/kg
Sotatercept 0.7 mg/kg
Up to 30 months
Baseline and 24 weeks
Base Study: Change From Baseline in Concentration of Amino-Terminal Brain Natriuretic Propeptide (NT-proBNP) at 24 Weeks
Each participant's laboratory biomarkers N-terminal prohormone brain-type natriuretic peptide (NT-proBNP) or brain-type natriuretic peptide (BNP) were measured at baseline and at 24 weeks.
Baseline and 24 Weeks
Base Study: Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at 24 Weeks
Each participant's TAPSE, which is commonly used to evaluate tricuspid valve annulus movement as an indicator of right heart function, was measured by echocardiography at baseline and 24 weeks.
Baseline and 24 weeks
Base Study: Change From Baseline in Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Score at Cycle 9
The CAMPHOR is participant-reported questionnaire that contains 65 items in total, 25 relating to symptoms, 25 relating to quality of life (QoL), and 15 relating to activities. Symptom items are scored from 0-25, with a higher score indicating worse symptoms. QoL items are also scored from 0-25, with a higher score indicating a worse QoL and greater functional limitation. Activity items are scored from 0-30, with a higher score indicating poorer functioning. The combined score is obtained by summing up the symptoms score, QoL score and activity score. The lowest combined score possible is 0, while the highest combined score possible is 80. Each participant's CAMPHOR score was recorded at baseline and on Day 1 of Cycle 9.
Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
Base Study: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score
The SF-36 questionnaire is a participant-reported survey of a participant's health. The survey evaluates 8 aspects of functional health and well-being that relate to either physical health or mental health. The physical component summary is based primarily on physical functioning, bodily pain, and general health. The mental component summary encompasses vitality, social functioning, and emotional and mental health. Total scores for the physical component range from 0-100, with 100 representing the highest level of physical functioning. The total scores for the mental component also range from 0-100, with 100 representing the highest level of mental functioning. Each participant's SF-36 was recorded at baseline and on Day 1 of Cycle 9. Each cycle was 21 days.
Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
Base Study: Number of Participants Who Experienced Events Indicative of Clinical Worsening of Pulmonary Arterial Hypertension (PAH)
Events that indicate clinical worsening of PAH include death, need for and/or worsening-related listing for lung and/or heart transplant, need to initiate an approved PAH SOC rescue therapy, PAH-specific hospitalization, or functional deterioration (worsened WHO Functional Class AND 15% decrease in 6MWD).
Up to 24 weeks
Base Study: Number of Participants Who Experienced an Improvement From Baseline in World Health Organization (WHO) Functional Class at 24 Weeks
The WHO Functional Class describes the severity of a person's pulmonary hypertension symptoms. There are four different classes: I is the mildest and IV the most severe form of pulmonary hypertension.
Baseline and 24 Weeks
Base Study: Number of Participants Who Experienced One or More AEs
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Up to 24 weeks
Base Study: Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Up to 24 weeks
Base Study: Change From Baseline in Body Mass Index (BMI) at Cycle 9
Each participant's BMI was measured at baseline and at 24 weeks.
Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
Base Study: Change From Baseline in Systolic and Diastolic Blood Pressure at Cycle 9
Each participant's systolic and diastolic blood pressure was taken at baseline and on Day 1 of Cycle 9. Each cycle was 21 days.
Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
Base Study: Change From Baseline in Respiratory Rate at Cycle 9
Each participant's respiratory rate (number of breaths per minute) was measured at baseline and on Day 1 of Cycle 9. Each cycle was 21 days.
Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
Base Study: Change From Baseline in QTcF Interval at Cycle 9
Each participant's QTcF Interval was measured at baseline and on Day 1 of Cycle 9.
Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
Base Study: Maximum Plasma Concentration (Cmax) of Sotatercept
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Based on population pharmacokinetic (PopPK) modeling of previous sotatercept studies, Cmax occurs at Day 8 of Cycle 1 after a sotatercept dose is given. The sotatercept concentration at Day 8 of Cycle 1 (each cycle was 21 days) is presented here as Cmax.
Day 8 of Cycle 1 (Each cycle was 21 days.)
Extension Period: Change From Baseline in 6MWD (Delayed-Start Analysis)
6MWD is measured by an exercise test known as 6MWT that assesses aerobic capacity and endurance. It measures the distance covered over a time of 6 minutes and is used as an outcome measure by which to compare changes in performance capacity. Each participant's 6MWD was measured at baseline and the timepoint at which the third RCH was performed. This occurred between Month 18 and Month 24, at which time each participant's 6MWD was also measured. An increase in the distance walked during the 6MWT indicates improvement in basic mobility.
Baseline and the timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
Extension Period: Change From Baseline in 6MWD (Placebo-Crossed Analysis)
6MWD is measured by an exercise test known as 6MWT that assesses aerobic capacity and endurance. It measures the distance covered over a time of 6 minutes and is used as an outcome measure by which to compare changes in performance capacity. Each participant's 6MWD was measured at baseline and the timepoint at which the third right heart catheterization was performed. This occurred between Month 18 and Month 24, at which time each participant's 6MWD was also measured. An increase in the distance walked during the 6MWT indicates improvement in basic mobility.
Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
Extension Period: Number of Participants Who Experienced an Improvement From Baseline in WHO Functional Class (Delayed-Start Analysis)
The WHO Functional Class describes the severity of a person's pulmonary hypertension symptoms. There are four different classes: I is the mildest and IV the most severe form of pulmonary hypertension. Each participant's WHO Functional Class was assessed at baseline and the timepoint at which the third right heart catheterization was performed. This occurred between Month 18 and Month 24, at which time each participant's WHO Functional Class was also assessed.
Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
Extension Period: Change From Baseline in WHO Functional Class (Placebo-Crossed Analysis)
The WHO Functional Class describes the severity of a person's pulmonary hypertension symptoms. There are four different classes: I is the mildest and IV the most severe form of pulmonary hypertension. Each participant's WHO Functional Class was assessed at baseline and the timepoint at which the third right heart catheterization was performed. This occurred between Month 18 and Month 24, at which time each participant's WHO Functional Class was also assessed.
Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
Phoenix
Arizona
85012
United States
Banner-University Medical Center Phoenix
Phoenix
Arizona
85381
United States
University of Arizona
Tucson
Arizona
85724
United States
University of California, San Francisco Medical Center
San Francisco
California
94143
United States
University of Colorado Hospital
Aurora
Colorado
80045
United States
UF Health Shands Hospital
Gainesville
Florida
32610
United States
University of Kansas Medical Center
Kansas City
Kansas
66160
United States
University of Michigan
Ann Arbor
Michigan
48109
United States
Lindner Clinical Trial Center
Cincinnati
Ohio
45129
United States
Medical University of South Carolina
Charleston
South Carolina
29425
United States
Houston Methodist Hospital
Houston
Texas
77030
United States
St. Vincent's Hospital Sydney
Darlinghurst
New South Wales
2010
Australia
Westmead Hospital
Westmead
New South Wales
2145
Australia
John Hunter Hospital
New Lambton
New South Whales
2305
Australia
Prince Charles Hospital
Chermside
Queensland
4032
Australia
Hospital Madre Teresa
Belo Horizonte
Minas Gerais
30430
Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre
Riogrande Do Sul
90035
Brazil
Hospital Dia do Pulmão
Blumenau
Santa Catarina
89010
Brazil
Instituto do Coracao - HCFMUSP
Cerqueira César
05403-900
Brazil
Hospital Sao Lucas da PUCRS
Jardim Botânico
05403-900
Brazil
Hospital São Paulo
São Paulo
04037
Brazil
Hôpital Arnaud de Villeneuve
Montpellier
Hérault
34295
France
CHU Michallon
La Tronche
38700
France
Centre Hospitalier Universitaire de Bicêtre
Le Kremlin-Bicêtre
94275
France
Centre Hospitalier Universitaire de Saint Etienne
Saint-Etienne
42055
France
Medizinische Hochschule Hannover
Hanover
Lower Saxony
30625
Germany
Universitatsklinikum Leipzig
Leipzig
Saxony
04103
Germany
Universitatsklinikum Halle (Saale)
Halle
Saxony-Anhalt
06120
Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden
01307
Germany
Barzilai Medical Center
Ashkelon
78278
Israel
Lady Davis Carmel Medical Center
Haifa
34362
Israel
Meir Medical Center
Kefar Sava
4428100
Israel
Rabin Medical Center - PPDS
Petah Tikva
49100
Israel
Chaim Sheba Medical Center
Ramat Gan
52621
Israel
Hospital Universitario Marques de Valdecilla
Santander
Cantabria
39008
Spain
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda
Madrid
28222
Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona
08035
Spain
Hospital Clinic de Barcelona
Barcelona
08036
Spain
Hospital Universitario 12 de Octubre
Madrid
28041
Spain
Golden Jubilee National Hospital - PPDS
Clydebank
G81 4DY
United Kingdom
Royal Free London NHS Foundation Trust
London
NW32QG
United Kingdom
Imperial College Healthcare NHS Trust
London
W2 1NY
United Kingdom
Derived
Dutta S, Shah R, Singhal S, Singh M, Dholariya S, Chawla S, Katoch C. A systematic review and meta-analysis of safety and efficacy parameters of sotatercept in the therapy of pulmonary arterial hypertension. Expert Opin Drug Saf. 2026 Jun 9:1-13. doi: 10.1080/14740338.2026.2685360. Online ahead of print.
Montani D, McLaughlin VV, Gibbs JSR, Gomberg-Maitland M, Hoeper MM, Preston IR, Souza R, Waxman AB, Escribano Subias P, Feldman J, Meyer GM, Olsson KM, Coulet F, Manimaran S, Zhao Y, Lau A, de Oliveira Pena J, Badesch DB, Humbert M. Consistent Safety and Efficacy of Sotatercept for Pulmonary Arterial Hypertension in BMPR2 Mutation Carriers and Noncarriers: A Planned Analysis of a Phase II, Double-Blind, Placebo-controlled Clinical Trial (PULSAR). Am J Respir Crit Care Med. 2025 Jun;211(6):1028-1037. doi: 10.1164/rccm.202409-1698OC.
Humbert M, McLaughlin V, Gibbs JSR, Gomberg-Maitland M, Hoeper MM, Preston IR, Souza R, Waxman A, Escribano Subias P, Feldman J, Meyer G, Montani D, Olsson KM, Manimaran S, Barnes J, Linde PG, de Oliveira Pena J, Badesch DB; PULSAR Trial Investigators. Sotatercept for the Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2021 Apr 1;384(13):1204-1215. doi: 10.1056/NEJMoa2024277.
FG001
Extension Period: Placebo→Sotatercept 0.7 mg/kg
This treatment group represents participants from the Placebo arm who received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8), then transitioned to the 30-month extension period (Cycles 9-51), during which they received sotatercept 0.7 mg/kg plus SOC by SC injection. Each cycle was 21 days. Dosing occurred once every 3 weeks.
FG002
Placebo
Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
FG003
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) and 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
FG004
Sotatercept 0.7 mg/kg
Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) and 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
FG0000 subjects
FG0010 subjects
FG00232 subjects
FG00332 subjects
FG00442 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG00230 subjects
FG00331 subjects
FG00436 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG0046 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0044 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Extension Period
Type
Comment
Milestone Data
STARTED
FG00015 subjects
FG00115 subjects
FG0020 subjects
FG00331 subjects
FG00436 subjects
COMPLETED
FG00013 subjects
FG00115 subjects
FG0020 subjects
FG00328 subjects
FG004
NOT COMPLETED
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
BG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) and 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
BG002
Sotatercept 0.7 mg/kg
Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) and 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00032
BG00132
BG00242
BG003106
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
BG00045.6± 13.38
BG00149.1± 14.34
BG00249.8± 15.05
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00026
BG00129
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00010
BG0019
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
Base Study: Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks
Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and at 24 weeks.
All randomized participants administered their assigned treatment who received at least 6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and End of Treatment (EOT) assessment. Note: Data from participants whose dose was down-titrated were analyzed according to dose received at least 6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed.
Posted
Mean
Standard Deviation
dynes*sec/cm^5
Baseline and 24 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG002
Sotatercept 0.7 mg/kg
Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Units
Counts
Participants
OG00030
OG00127
OG00230
Title
Denominators
Categories
Base Study: Change from Baseline in PVR at 24 Weeks
Title
Measurements
OG000-27.6± 251.08
OG001-168.4± 262.93
OG002-258.9± 169.42
Baseline
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
Analysis based on calculated LS means.
ANCOVA
ANCOVA was used to compare change from baseline values with randomization stratification factor (WHO functional class) and baseline PVR as covariate.
0.0030
Difference in Least Squares Means
-151.1
Standard Error of the Mean
49.53
2-Sided
95
-249.59
-52.63
Superiority
Primary
Extension Period: Change From Baseline in PVR (Delayed-Start Analysis)
Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24.
All randomized participants who received their assigned treatment, transitioned to the extension period, and had data for the respective timepoints
Posted
Mean
Standard Deviation
dynes*sec/cm^5
Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
ID
Title
Description
OG000
Placebo-Crossed Treatment Group
Participants who received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) were re-randomized to receive either 0.3 mg/kg or 0.7 mg/kg of sotatercept plus SOC during 30-month extension period (Cycles 9-51). Per protocol, for Delayed-Start Analysis, the Placebo-Crossed Treatment Group included all participants who received 0.3 mg/kg plus SOC or 0.7 mg/kg of sotatercept plus SOC after a full course of placebo, regardless of their dose level. Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG001
Continued Sotatercept Treatment Group
Participants who were randomized to receive either 0.3 mg/kg or 0.7 mg/kg of sotatercept plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.3 mg/kg or 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Per protocol, for Delayed-Start Analysis, the Continued Sotatercept Treatment Group combined participants who received 0.3 mg/kg or 0.7 mg/kg of sotatercept plus SOC. Each cycle was 21 days. Dosing occurred once every 3 weeks.
Primary
Extension Period: Change From Baseline in PVR (Placebo-Crossed Analysis)
Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24.
All randomized participants who received their assigned treatment, transitioned to the extension period, and had data for the respective timepoints
Posted
Mean
Standard Deviation
dynes*sec/cm^5
Baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24.
ID
Title
Description
OG000
Placebo-Crossed Treatment Group
Participants who received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) were re-randomized to receive either 0.3 mg/kg or 0.7 mg/kg of sotatercept plus SOC during 30-month extension period (Cycles 9-51). Per protocol, for Placebo-Crossed Analysis, the Placebo-Crossed Treatment Group included all participants who received 0.3 mg/kg plus SOC or 0.7 mg/kg of sotatercept plus SOC after a full course of placebo, regardless of their dose level. Each cycle was 21 days. Dosing occurred once every 3 weeks.
Units
Counts
Participants
Primary
Extension Period: Number of Participants Who Experienced One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
All randomized participants who transitioned to the extension period and received at least 1 dose of study treatment
Posted
Count of Participants
Participants
Up to approximately 32 months
ID
Title
Description
OG000
Extension Period: Placebo→Sotatercept 0.3 mg/kg
This treatment group represents participants from the Placebo arm who received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8), then transitioned to the 30-month extension period (Cycles 9-51), during which they received sotatercept 0.3 mg/kg plus SOC by SC injection. Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG001
Extension Period: Placebo→Sotatercept 0.7 mg/kg
This treatment group represents participants from the Placebo arm who received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8), then transitioned to the 30-month extension period (Cycles 9-51), during which they received sotatercept 0.7 mg/kg plus SOC by SC injection. Each cycle was 21 days. Dosing occurred once every 3 weeks.
Primary
Extension Period: Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
All randomized participants who transitioned to the extension period and received at least 1 dose of study treatment
Posted
Count of Participants
Participants
Up to 30 months
ID
Title
Description
OG000
Extension Period: Placebo→Sotatercept 0.3 mg/kg
This treatment group represents participants from the Placebo arm who received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8), then transitioned to the 30-month extension period (Cycles 9-51), during which they received sotatercept 0.3 mg/kg plus SOC by SC injection. Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG001
Extension Period: Placebo→Sotatercept 0.7 mg/kg
This treatment group represents participants from the Placebo arm who received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8), then transitioned to the 30-month extension period (Cycles 9-51), during which they received sotatercept 0.7 mg/kg plus SOC by SC injection. Each cycle was 21 days. Dosing occurred once every 3 weeks.
Secondary
Base Study: Change From Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks
6MWD is measured by an exercise test known as 6-Minute Walk Test (6MWT) that assesses aerobic capacity and endurance. It measures the distance covered over a time of 6 minutes and is used as an outcome measure by which to compare changes in performance capacity. Each participant's 6MWD was measured at baseline and at 24 weeks. An increase in the distance walked during the 6MWT indicates improvement in basic mobility.
All randomized participants administered their assigned treatment who received at least 6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment. Note: Data from participants whose dose was down-titrated were analyzed according to dose received at least 6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed.
Posted
Least Squares Mean
Standard Error
meters
Baseline and 24 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Secondary
Base Study: Change From Baseline in Concentration of Amino-Terminal Brain Natriuretic Propeptide (NT-proBNP) at 24 Weeks
Each participant's laboratory biomarkers N-terminal prohormone brain-type natriuretic peptide (NT-proBNP) or brain-type natriuretic peptide (BNP) were measured at baseline and at 24 weeks.
All randomized participants administered their assigned treatment who received ≥6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment, and had data for the outcome measure. Note: Data from participants whose dose was down-titrated were analyzed according to dose received ≥6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed.
Posted
Mean
Standard Deviation
pg/mL
Baseline and 24 Weeks
ID
Title
Description
OG000
Placebo
Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG002
Secondary
Base Study: Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at 24 Weeks
Each participant's TAPSE, which is commonly used to evaluate tricuspid valve annulus movement as an indicator of right heart function, was measured by echocardiography at baseline and 24 weeks.
All randomized participants administered their assigned treatment who received ≥6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment, and had data for the outcome measure. Note: Data from participants whose dose was down-titrated were analyzed according to dose received ≥6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed.
Posted
Mean
Standard Deviation
cm
Baseline and 24 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG002
Sotatercept 0.7 mg/kg
Secondary
Base Study: Change From Baseline in Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Score at Cycle 9
The CAMPHOR is participant-reported questionnaire that contains 65 items in total, 25 relating to symptoms, 25 relating to quality of life (QoL), and 15 relating to activities. Symptom items are scored from 0-25, with a higher score indicating worse symptoms. QoL items are also scored from 0-25, with a higher score indicating a worse QoL and greater functional limitation. Activity items are scored from 0-30, with a higher score indicating poorer functioning. The combined score is obtained by summing up the symptoms score, QoL score and activity score. The lowest combined score possible is 0, while the highest combined score possible is 80. Each participant's CAMPHOR score was recorded at baseline and on Day 1 of Cycle 9.
All randomized participants administered their assigned treatment who received ≥6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment, and had data for the outcome measure. Note: Data from participants whose dose was down-titrated were analyzed according to dose received ≥6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed.
Posted
Mean
Standard Deviation
Score on a scale
Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
ID
Title
Description
OG000
Placebo
Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Secondary
Base Study: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score
The SF-36 questionnaire is a participant-reported survey of a participant's health. The survey evaluates 8 aspects of functional health and well-being that relate to either physical health or mental health. The physical component summary is based primarily on physical functioning, bodily pain, and general health. The mental component summary encompasses vitality, social functioning, and emotional and mental health. Total scores for the physical component range from 0-100, with 100 representing the highest level of physical functioning. The total scores for the mental component also range from 0-100, with 100 representing the highest level of mental functioning. Each participant's SF-36 was recorded at baseline and on Day 1 of Cycle 9. Each cycle was 21 days.
All randomized participants administered their assigned treatment who received ≥6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment, and had data for the outcome measure. Note: Data from participants whose dose was down-titrated were analyzed according to dose received ≥6 times rather than dose originally assigned. Per protocol, only participants who consistently received in 0.3 mg/kg or 0.7 mg/kg of sotatercept were planned to be analyzed.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
ID
Title
Description
OG000
Placebo
Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Secondary
Base Study: Number of Participants Who Experienced Events Indicative of Clinical Worsening of Pulmonary Arterial Hypertension (PAH)
Events that indicate clinical worsening of PAH include death, need for and/or worsening-related listing for lung and/or heart transplant, need to initiate an approved PAH SOC rescue therapy, PAH-specific hospitalization, or functional deterioration (worsened WHO Functional Class AND 15% decrease in 6MWD).
All randomized participants who received their assigned treatment and had data for Base Study: Number of Participants Who Experienced Events Indicative of Clinical Worsening of PAH
Posted
Count of Participants
Participants
Up to 24 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG002
Sotatercept 0.7 mg/kg
Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Secondary
Base Study: Number of Participants Who Experienced an Improvement From Baseline in World Health Organization (WHO) Functional Class at 24 Weeks
The WHO Functional Class describes the severity of a person's pulmonary hypertension symptoms. There are four different classes: I is the mildest and IV the most severe form of pulmonary hypertension.
All randomized participants who received their assigned treatment and at least 6 of the same doses during Base Study, had baseline and post-Base Study PVR assessment and EOT assessment, and had data for Base Study: Number of Participants Who Experienced an Improvement from Baseline in WHO Functional Class at 24 Weeks. Note: Data from participants whose dose was down-titrated were analyzed according to dose received at least 6 times rather than dose to which originally assigned.
Posted
Count of Participants
Participants
Baseline and 24 Weeks
ID
Title
Description
OG000
Placebo
Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG002
Secondary
Base Study: Number of Participants Who Experienced One or More AEs
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
All randomized participants who received at least 1 dose of study treatment
Posted
Count of Participants
Participants
Up to 24 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG002
Sotatercept 0.7 mg/kg
Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Secondary
Base Study: Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
All randomized participants who received at least 1 dose of study treatment
Posted
Count of Participants
Participants
Up to 24 weeks
ID
Title
Description
OG000
Placebo
Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG002
Sotatercept 0.7 mg/kg
Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Secondary
Base Study: Change From Baseline in Body Mass Index (BMI) at Cycle 9
Each participant's BMI was measured at baseline and at 24 weeks.
All randomized participants who received their assigned treatment and had data for Base Study: Change from Baseline in BMI at Cycle 9
Posted
Mean
Standard Deviation
kg/m^2
Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
ID
Title
Description
OG000
Placebo
Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG002
Sotatercept 0.7 mg/kg
Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Secondary
Base Study: Change From Baseline in Systolic and Diastolic Blood Pressure at Cycle 9
Each participant's systolic and diastolic blood pressure was taken at baseline and on Day 1 of Cycle 9. Each cycle was 21 days.
All randomized participants who received their assigned treatment and had data for Base Study: Change from Baseline in Systolic and Diastolic Blood Pressure at Cycle 9
Posted
Mean
Standard Deviation
mmHg
Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
ID
Title
Description
OG000
Placebo
Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG002
Sotatercept 0.7 mg/kg
Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Secondary
Base Study: Change From Baseline in Respiratory Rate at Cycle 9
Each participant's respiratory rate (number of breaths per minute) was measured at baseline and on Day 1 of Cycle 9. Each cycle was 21 days.
All randomized participants who received their assigned treatment and had data for Base Study: Change from Baseline in Respiratory Rate at Cycle 9
Posted
Mean
Standard Deviation
breaths/min
Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
ID
Title
Description
OG000
Placebo
Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG002
Sotatercept 0.7 mg/kg
Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Secondary
Base Study: Change From Baseline in QTcF Interval at Cycle 9
Each participant's QTcF Interval was measured at baseline and on Day 1 of Cycle 9.
All randomized participants who received their assigned treatment and had data for Base Study: Change from Baseline in QTcF Interval at Cycle 9
Posted
Mean
Standard Deviation
milliseconds
Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
ID
Title
Description
OG000
Placebo
Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG002
Sotatercept 0.7 mg/kg
Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Secondary
Base Study: Maximum Plasma Concentration (Cmax) of Sotatercept
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Based on population pharmacokinetic (PopPK) modeling of previous sotatercept studies, Cmax occurs at Day 8 of Cycle 1 after a sotatercept dose is given. The sotatercept concentration at Day 8 of Cycle 1 (each cycle was 21 days) is presented here as Cmax.
All randomized participants who received at least 1 dose of sotatercept and had sufficient pharmacokinetic samples collected and assayed for PK analysis
Posted
Mean
Standard Deviation
ng/mL
Day 8 of Cycle 1 (Each cycle was 21 days.)
ID
Title
Description
OG000
Sotatercept 0.3 mg/kg
Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG001
Sotatercept 0.7 mg/kg
Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Units
Counts
Participants
Secondary
Extension Period: Change From Baseline in 6MWD (Delayed-Start Analysis)
6MWD is measured by an exercise test known as 6MWT that assesses aerobic capacity and endurance. It measures the distance covered over a time of 6 minutes and is used as an outcome measure by which to compare changes in performance capacity. Each participant's 6MWD was measured at baseline and the timepoint at which the third RCH was performed. This occurred between Month 18 and Month 24, at which time each participant's 6MWD was also measured. An increase in the distance walked during the 6MWT indicates improvement in basic mobility.
All randomized participants who received their assigned treatment, transitioned to the extension period, and had data for Extension Period: Change from Baseline in 6MWD (Delayed-Start Analysis)
Posted
Least Squares Mean
Standard Error
meters
Baseline and the timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
ID
Title
Description
OG000
Placebo-Crossed Treatment Group
Participants who received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) were re-randomized to receive either 0.3 mg/kg or 0.7 mg/kg of sotatercept plus SOC during 30-month extension period (Cycles 9-51). Per protocol, for Delayed-Start Analysis, the Placebo-Crossed Treatment Group included all participants who received 0.3 mg/kg plus SOC or 0.7 mg/kg of sotatercept plus SOC after a full course of placebo, regardless of their dose level. Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG001
Secondary
Extension Period: Change From Baseline in 6MWD (Placebo-Crossed Analysis)
6MWD is measured by an exercise test known as 6MWT that assesses aerobic capacity and endurance. It measures the distance covered over a time of 6 minutes and is used as an outcome measure by which to compare changes in performance capacity. Each participant's 6MWD was measured at baseline and the timepoint at which the third right heart catheterization was performed. This occurred between Month 18 and Month 24, at which time each participant's 6MWD was also measured. An increase in the distance walked during the 6MWT indicates improvement in basic mobility.
All randomized participants who received their assigned treatment, transitioned to the extension period, and had data for Extension Period: Change from Baseline in 6MWD (Placebo-Crossed Analysis)
Posted
Mean
Standard Error
meters
Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
ID
Title
Description
OG000
Placebo-Crossed Treatment Group
Participants who received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) were re-randomized to receive either 0.3 mg/kg or 0.7 mg/kg of sotatercept plus SOC during 30-month extension period (Cycles 9-51). Per protocol, for Placebo-Crossed Analysis, the Placebo-Crossed Treatment Group included all participants who received 0.3 mg/kg plus SOC or 0.7 mg/kg of sotatercept plus SOC after a full course of placebo, regardless of their dose level. Each cycle was 21 days. Dosing occurred once every 3 weeks.
Secondary
Extension Period: Number of Participants Who Experienced an Improvement From Baseline in WHO Functional Class (Delayed-Start Analysis)
The WHO Functional Class describes the severity of a person's pulmonary hypertension symptoms. There are four different classes: I is the mildest and IV the most severe form of pulmonary hypertension. Each participant's WHO Functional Class was assessed at baseline and the timepoint at which the third right heart catheterization was performed. This occurred between Month 18 and Month 24, at which time each participant's WHO Functional Class was also assessed.
All randomized participants who received their assigned treatment, transitioned to the extension period, and had data for Extension Period: Number of Participants Who Experienced an Improvement from Baseline in WHO Functional Class (Delayed-Start Analysis)
Posted
Count of Participants
Participants
Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
ID
Title
Description
OG000
Placebo-Crossed Treatment Group
Participants who received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) were re-randomized to receive either 0.3 mg/kg or 0.7 mg/kg of sotatercept plus SOC during 30-month extension period (Cycles 9-51). Per protocol, for Delayed-Start Analysis, the Placebo-Crossed Treatment Group included all participants who received 0.3 mg/kg plus SOC or 0.7 mg/kg of sotatercept plus SOC after a full course of placebo, regardless of their dose level. Each cycle was 21 days. Dosing occurred once every 3 weeks.
Secondary
Extension Period: Change From Baseline in WHO Functional Class (Placebo-Crossed Analysis)
The WHO Functional Class describes the severity of a person's pulmonary hypertension symptoms. There are four different classes: I is the mildest and IV the most severe form of pulmonary hypertension. Each participant's WHO Functional Class was assessed at baseline and the timepoint at which the third right heart catheterization was performed. This occurred between Month 18 and Month 24, at which time each participant's WHO Functional Class was also assessed.
All randomized participants who received their assigned treatment, transitioned to the extension period, and had data for Extension Period: Change from Baseline in WHO Functional Class (Placebo-Crossed Analysis)
Posted
Mean
Standard Deviation
WHO functional class
Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
ID
Title
Description
OG000
Placebo-Crossed Treatment Group
Participants who received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) were re-randomized to receive either 0.3 mg/kg or 0.7 mg/kg of sotatercept plus SOC during 30-month extension period (Cycles 9-51). Per protocol, for Placebo-Crossed Analysis, the Placebo-Crossed Treatment Group included all participants who received 0.3 mg/kg plus SOC or 0.7 mg/kg of sotatercept plus SOC after a full course of placebo, regardless of their dose level. Each cycle was 21 days. Dosing occurred once every 3 weeks.
Time Frame
Treatment period: Up to 24 weeks; Extension period: Up to approximately 32 months.
Description
The safety analysis population included all participants who received at least 1 dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Base Study: Placebo
Participants received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
0
32
3
32
25
32
EG001
Base Study: Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
0
32
2
32
29
32
EG002
Base Study: Sotatercept 0.7 mg/kg
Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
1
42
10
42
33
42
EG003
Extension Period: Placebo→Sotatercept 0.3 mg/kg
This treatment group represents participants from the Placebo arm who received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8), then transitioned to the 30-month extension period (Cycles 9-51), during which they received sotatercept 0.3 mg/kg plus SOC by SC injection. Each cycle was 21 days. Dosing occurred once every 3 weeks.
1
15
6
15
14
15
EG004
Extension Period: Placebo→Sotatercept 0.7 mg/kg
This treatment group represents participants from the Placebo arm who received placebo plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8), then transitioned to the 30-month extension period (Cycles 9-51), during which they received sotatercept 0.7 mg/kg plus SOC by SC injection. Each cycle was 21 days. Dosing occurred once every 3 weeks.
0
15
4
15
15
15
EG005
Extension Period: Sotatercept 0.3 mg/kg
Participants who received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.3 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
1
32
10
31
30
31
EG006
Extension Period: Sotatercept 0.7 mg/kg
Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
2
42
12
36
36
36
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG0030 events0 affected15 at risk
EG0040 events0 affected15 at risk
EG0053 events2 affected31 at risk
EG0060 events0 affected36 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0022 events1 affected42 at risk
EG003
Right ventricular failure
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Tachyarrhythmia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Tachycardia paroxysmal
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Chorioretinopathy
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Chest discomfort
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Fatigue
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Malaise
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Oedema peripheral
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Pyrexia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Vessel puncture site haematoma
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Brain abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Device related infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Device related sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Influenza
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Infusion site infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Septic embolus
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Red blood cell count increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Systemic lupus erythematosus
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Colon neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Migraine
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Syncope
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Device breakage
Product Issues
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Device dislocation
Product Issues
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Device malfunction
Product Issues
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Device occlusion
Product Issues
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0013 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Pulmonary arterial hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Hypotension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0003 events2 affected32 at risk
EG0012 events1 affected32 at risk
EG0022 events2 affected42 at risk
EG0030 events0 affected15 at risk
EG0042 events2 affected15 at risk
EG00513 events8 affected31 at risk
EG0062 events1 affected36 at risk
Blood loss anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Polycythaemia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0013 events2 affected32 at risk
EG0028 events5 affected42 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Low cardiac output syndrome
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected32 at risk
EG0011 events1 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Right ventricular failure
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Tachycardia paroxysmal
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Cataract
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Dacryostenosis acquired
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Deposit eye
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Dry eye
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Glaucoma
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Keratitis
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Defaecation urgency
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Dental plaque
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0006 events5 affected32 at risk
EG0018 events7 affected32 at risk
EG0026 events6 affected42 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0022 events2 affected42 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0009 events5 affected32 at risk
EG0014 events3 affected32 at risk
EG0025 events5 affected42 at risk
EG003
Peptic ulcer
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG00010 events4 affected32 at risk
EG0013 events3 affected32 at risk
EG0023 events3 affected42 at risk
EG003
Application site pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Asthenia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Catheter site haemorrhage
General disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Chest discomfort
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Chest pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Chills
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0022 events1 affected42 at risk
EG003
Cyst
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Discomfort
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Face oedema
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Fatigue
General disorders
MedDRA 25.0
Systematic Assessment
EG0006 events6 affected32 at risk
EG0012 events2 affected32 at risk
EG0024 events4 affected42 at risk
EG003
Feeling abnormal
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Infusion site pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Injection site erythema
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Injection site pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0011 events1 affected32 at risk
EG0024 events4 affected42 at risk
EG003
Injection site pruritus
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Localised oedema
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Oedema peripheral
General disorders
MedDRA 25.0
Systematic Assessment
EG0005 events5 affected32 at risk
EG0013 events3 affected32 at risk
EG0026 events5 affected42 at risk
EG003
Pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Pyrexia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Vessel puncture site haematoma
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Gallbladder polyp
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
COVID-19
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Cystitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Ear infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Fungal pharyngitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0013 events2 affected32 at risk
EG0024 events4 affected42 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Influenza
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Labyrinthitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected32 at risk
EG0011 events1 affected32 at risk
EG0024 events4 affected42 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Tonsillitis bacterial
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0004 events3 affected32 at risk
EG0015 events4 affected32 at risk
EG0022 events2 affected42 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0013 events3 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Post-traumatic neck syndrome
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Vaccination complication
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0022 events2 affected42 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Blood bicarbonate decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Blood chloride increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Blood pressure increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Haematocrit increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Haemoglobin increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0027 events7 affected42 at risk
EG003
Intraocular pressure increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Reticulocyte count increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Urine albumin/creatinine ratio increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected32 at risk
EG0012 events2 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0003 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Folate deficiency
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0012 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0004 events4 affected32 at risk
EG0013 events3 affected32 at risk
EG0025 events5 affected42 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0005 events5 affected32 at risk
EG0012 events2 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0013 events3 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Fracture pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0024 events4 affected42 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0012 events2 affected32 at risk
EG0023 events3 affected42 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0014 events3 affected32 at risk
EG0026 events5 affected42 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0004 events3 affected32 at risk
EG0015 events5 affected32 at risk
EG0025 events4 affected42 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Headache
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG00010 events6 affected32 at risk
EG00116 events8 affected32 at risk
EG0028 events6 affected42 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Intention tremor
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Migraine
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0012 events1 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Syncope
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0003 events3 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Tension headache
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Tremor
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Device dislocation
Product Issues
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Device leakage
Product Issues
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Device occlusion
Product Issues
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0012 events2 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Depression
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Procedural anxiety
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Microalbuminuria
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Breast hyperplasia
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Breast swelling
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Heavy menstrual bleeding
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Vaginal ulceration
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0003 events1 affected32 at risk
EG0012 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0015 events4 affected32 at risk
EG0026 events5 affected42 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0022 events1 affected42 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Nasal turbinate hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Pulmonary arterial hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Hidradenitis
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Telangiectasia
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Flushing
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected42 at risk
EG003
Haematoma
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Hypertension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected32 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected42 at risk
EG003
Hypotension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected32 at risk
EG0012 events1 affected32 at risk
EG0022 events2 affected42 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
The sponsor will comply with the requirements for publication of study results. In accordance with standard editorial and ethical practice, the sponsor will generally support publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
ANCOVA was used to compare change from baseline values with randomization stratification factor (WHO functional class) and baseline PVR as covariate.
<.0001
Difference in Least Squares Means
-269.4
Standard Error of the Mean
48.48
2-Sided
95
-365.81
-173.03
Superiority
Units
Counts
Participants
OG00030
OG00167
Title
Denominators
Categories
Extension Period: Change from Baseline in PVR (Delayed-Start Analysis)
ParticipantsOG00025
ParticipantsOG00157
Title
Measurements
OG000-246.9± 300.01
OG001-212.6± 254.24
Baseline
ParticipantsOG00030
ParticipantsOG00167
Title
Measurements
OG000802.0± 331.05
OG001
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
Analysis based on calculated LS means.
ANCOVA
ANCOVA was used to compare change from baseline values with randomization stratification factor (WHO functional class) and baseline PVR as covariate.
0.7851
Difference in Least Squares Means
-13.9
Standard Error of the Mean
50.95
2-Sided
95
-113.85
86.06
Superiority
OG00030
Title
Denominators
Categories
Extension Period: Change from Baseline in PVR (Placebo-Crossed Analysis)
ParticipantsOG00025
Title
Measurements
OG000-246.9± 300.01
Baseline
ParticipantsOG00030
Title
Measurements
OG000802.0± 331.05
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
ANCOVA
<.0001
Comparison of baseline and final value
Multiple Imputation Mean Difference
-223.2
Standard Error of the Mean
57.45
2-Sided
95
-335.83
-110.49
Standard multiple imputations are done with imputed values that are within the range of the minimum and maximum observed values using linear regression including baseline measurements.
Superiority
OG002
Extension Period: Sotatercept 0.3 mg/kg
Participants who received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.3 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG003
Extension Period: Sotatercept 0.7 mg/kg
Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Units
Counts
Participants
OG00015
OG00115
OG00231
OG00336
Title
Denominators
Categories
Title
Measurements
OG00014
OG00115
OG00231
OG00336
OG002
Extension Period: Sotatercept 0.3 mg/kg
Participants who received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.3 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG003
Extension Period: Sotatercept 0.7 mg/kg
Participants who received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Units
Counts
Participants
OG00015
OG00115
OG00231
OG00336
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0021
OG0033
OG002
Sotatercept 0.7 mg/kg
Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Units
Counts
Participants
OG00030
OG00127
OG00230
Title
Denominators
Categories
Title
Measurements
OG00031.4± 9.69
OG00156.0± 10.07
OG00253.6± 9.84
Sotatercept 0.7 mg/kg
Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Units
Counts
Participants
OG00029
OG00125
OG00228
Title
Denominators
Categories
Title
Measurements
OG000195.9± 726.46
OG001-718.2± 965.12
OG002-359.0± 757.58
Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Units
Counts
Participants
OG00028
OG00124
OG00228
Title
Denominators
Categories
Title
Measurements
OG0000.0± 0.39
OG0010.1± 0.26
OG002-0.1± 0.34
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG002
Sotatercept 0.7 mg/kg
Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Units
Counts
Participants
OG00029
OG00123
OG00221
Title
Denominators
Categories
Title
Measurements
OG000-10.2± 12.91
OG001-6.9± 12.51
OG002-7.5± 7.96
OG001
Sotatercept 0.3 mg/kg
Participants received sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
OG002
Sotatercept 0.7 mg/kg
Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Units
Counts
Participants
OG00030
OG00127
OG00229
Title
Denominators
Categories
Physical component
Title
Measurements
OG0003.5± 1.07
OG0014.5± 1.12
OG0023.1± 1.11
Mental component
Title
Measurements
OG0003.2± 1.33
OG0013.6± 1.39
OG0020.0± 1.40
Units
Counts
Participants
OG00032
OG00132
OG00242
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
OG0021
Sotatercept 0.7 mg/kg
Participants received sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8). Each cycle was 21 days. Dosing occurred once every 3 weeks.
Units
Counts
Participants
OG00030
OG00127
OG00230
Title
Denominators
Categories
Title
Measurements
OG0004
OG0018
OG0026
Units
Counts
Participants
OG00032
OG00132
OG00242
Title
Denominators
Categories
Title
Measurements
OG00029
OG00129
OG00235
Units
Counts
Participants
OG00032
OG00132
OG00242
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0025
Units
Counts
Participants
OG00030
OG00131
OG00236
Title
Denominators
Categories
Title
Measurements
OG000-0.2± 1.25
OG0010.6± 0.89
OG0020.2± 1.07
Units
Counts
Participants
OG00030
OG00131
OG00236
Title
Denominators
Categories
Systolic blood pressure
Title
Measurements
OG000-0.8± 10.06
OG0013.4± 11.75
OG0022.6± 12.28
Diastolic blood pressure
Title
Measurements
OG0002.3± 8.06
OG0014.1± 8.64
OG0021.7± 8.69
Units
Counts
Participants
OG00029
OG00131
OG00236
Title
Denominators
Categories
Title
Measurements
OG000-0.3± 2.10
OG001-1.3± 3.72
OG002-0.3± 3.05
Units
Counts
Participants
OG00030
OG00131
OG00235
Title
Denominators
Categories
Title
Measurements
OG0000.7± 31.10
OG001-7.4± 20.57
OG002-9.1± 31.55
OG00032
OG00142
Title
Denominators
Categories
Title
Measurements
OG0001910.3± 715.86
OG0014598.5± 1622.59
Continued Sotatercept Treatment Group
Participants who were randomized to receive either 0.3 mg/kg or 0.7 mg/kg of sotatercept plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.3 mg/kg or 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Per protocol, for Delayed-Start Analysis, the Continued Sotatercept Treatment Group combined participants who received 0.3 mg/kg or 0.7 mg/kg of sotatercept plus SOC. Each cycle was 21 days. Dosing occurred once every 3 weeks.
Units
Counts
Participants
OG00030
OG00167
Title
Denominators
Categories
Title
Measurements
OG00060.1± 14.35
OG00155.7± 9.47
Units
Counts
Participants
OG00030
Title
Denominators
Categories
Title
Measurements
OG00060.5± 13.21
OG001
Continued Sotatercept Treatment Group
Participants who were randomized to receive either 0.3 mg/kg or 0.7 mg/kg of sotatercept plus SOC by SC injection during the 24-week treatment period (Base Study; Cycles 1-8) continued to receive sotatercept 0.3 mg/kg or 0.7 mg/kg plus SOC during the 30-month extension period (Cycles 9-51). Per protocol, for Delayed-Start Analysis, the Continued Sotatercept Treatment Group combined participants who received 0.3 mg/kg or 0.7 mg/kg of sotatercept plus SOC. Each cycle was 21 days. Dosing occurred once every 3 weeks.