Zephyrus II: Efficacy and Safety Study of Pamrevlumab in... | NCT04419558

NCT04419558

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pamrevlumab	Experimental	Treatment phase: Pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks. Open-label extension phase: Pamrevlumab 30 mg/kg administered by intravenous infusion, every 3 weeks for up to 48 weeks	Drug: Pamrevlumab
Placebo	Experimental	Pamrevlumab-matching placebo administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Pamrevlumab	Drug	Sterile solution for injection	Pamrevlumab	FG-3019

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
DB Period: Change From Baseline in FVC at Week 48	FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Least square (LS) mean and standard error (SE) were analyzed using mixed model repeated measures (MMRM).	Baseline, Week 48

Secondary Outcomes

Measure	Description	Time Frame
DB Period: Time to Disease Progression	Time to disease progression was defined as time from randomization to either the first occurrence of an absolute FVC percent predicted (FVCpp) decline of ≥10% from baseline or death, whichever occurred first. 'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) guidelines within the past 7 years prior to study participation.
High-resolution computed tomography (HRCT) scan at Screening, with ≥10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing.
FVCpp value >45% and <95% at Screening and Day 1 (prior to randomization).
Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and ≤90%.
Not currently receiving treatment for IPF with an approved therapy for IPF (such as, pirfenidone or nintedanib) for any reason, including prior intolerance or lack of response to an approved IPF therapy, or choice to forego treatment with an approved IPF therapy after a full discussion with the Investigator regarding risks/benefits of such therapy.

Key Exclusion Criteria:

Previous exposure to pamrevlumab.
Evidence of significant obstructive lung disease, as evidenced by spirometry or HRCT.
Female participants who are pregnant or nursing.
Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the study.
Interstitial lung disease other than IPF.
Sustained improvement in the severity of IPF during the 12 months prior to screening.
Other types of respiratory diseases that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude participation in the study, including diseases of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall.
Certain medical conditions, that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude participation in the study (such as, myocardial infarction/stroke, severe chronic heart failure, pulmonary hypertension, or cancers).
Acute IPF exacerbation during Screening or Randomization including hospitalization due to acute IPF exacerbation within 4 weeks prior to or during screening.
Use of any investigational drugs or unapproved therapies, or participation in any clinical trial with an investigational new drug within 30 days prior to screening. Or use of approved IPF therapies (such as, pirfenidone or nintedanib) within 1 week prior to screening.
History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies, or to any component of the excipient.

Facility	Status	City	State	ZIP	Country	Contacts
UAB Lung Health Center		Birmingham	Alabama	35294	United States
UC San Francisco

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Pamrevlumab	Participants received pamrevlumab 30 milligrams (mg)/kilogram (kg), administered by intravenous (IV) infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, continued to receive pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 9, 2023	Jun 26, 2024

Arm/Group Information

ID	Title	Description
BG000	Pamrevlumab	Participants received pamrevlumab 30 mg/kg, administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, continued to receive pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.
BG001	Placebo	Participants received pamrevlumab-matching placebo, administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, received pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.
BG002	Total	Total of all reporting groups

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
	OG000-0.30± 0.057 OG001-0.33± 0.059

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis		0.6579		LS Mean Difference	0.03	Standard Error of the Mean	0.077	2-Sided	95	-0.12	0.19					Other

Secondary

DB Period: Time to Disease Progression

Time to disease progression was defined as time from randomization to either the first occurrence of an absolute FVC percent predicted (FVCpp) decline of ≥10% from baseline or death, whichever occurred first. 'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.

The ITT population included all randomized participants.

Posted

Median

95% Confidence Interval

weeks

Up to Week 48

ID	Title	Description
OG000	Pamrevlumab	Participants received pamrevlumab 30 mg/kg, administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, continued to receive pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.
OG001	Placebo	Participants received pamrevlumab-matching placebo, administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, received pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.

Secondary

DB Period: Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48

The QLF volume is calculated as QLF=total lung capacity volume (TLC) * % of quantitative lung fibrosis for fibrosis of the whole lung. LS mean and SE were analyzed using MMRM.

The ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

milliliters

Baseline, Week 48

ID	Title	Description
OG000	Pamrevlumab	Participants received pamrevlumab 30 mg/kg, administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, continued to receive pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.
OG001	Placebo	Participants received pamrevlumab-matching placebo, administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, received pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.

Secondary

DB Period: Time to First Occurrence of Any Component of the Clinical Composite Endpoint, Whichever Occurred First

The components of the clinical composite endpoints included acute idiopathic pulmonary fibrosis (IPF) exacerbation, respiratory hospitalization, or death. 'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.

The ITT population included all randomized participants.

Posted

Median

95% Confidence Interval

weeks

Up to Week 48

ID	Title	Description
OG000	Pamrevlumab	Participants received pamrevlumab 30 mg/kg, administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, continued to receive pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.
OG001	Placebo	Participants received pamrevlumab-matching placebo, administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, received pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.

Secondary

DB Period: Time to First Acute IPF Exacerbation

'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.

The ITT population included all randomized participants.

Posted

Median

95% Confidence Interval

weeks

Up to Week 48

ID	Title	Description
OG000	Pamrevlumab	Participants received pamrevlumab 30 mg/kg, administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, continued to receive pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.
OG001	Placebo	Participants received pamrevlumab-matching placebo, administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, received pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.

Units	Counts

Secondary

DB Period: Time to All-Cause Mortality

The ITT population included all randomized participants.

Posted

Median

95% Confidence Interval

weeks

Up to Week 48

ID	Title	Description
OG000	Pamrevlumab	Participants received pamrevlumab 30 mg/kg, administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, continued to receive pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.
OG001	Placebo	Participants received pamrevlumab-matching placebo, administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, received pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.

Units	Counts

Secondary

DB Period: Time to First Respiratory Hospitalization

The ITT population included all randomized participants.

Posted

Median

95% Confidence Interval

weeks

Up to Week 48

ID	Title	Description
OG000	Pamrevlumab	Participants received pamrevlumab 30 mg/kg, administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, continued to receive pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.
OG001	Placebo	Participants received pamrevlumab-matching placebo, administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks in the DB period. Participants who completed the treatment in DB period and entered in the OLE period, received pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.

Units

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	DB Period: Pamrevlumab	Participants received pamrevlumab 30 mg/kg, administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks in the DB period.	16	184	38	183	83	183
EG001	DB Period: Placebo	Participants received pamrevlumab-matching placebo, administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks in the DB period.	15	188	37	188	74	188
EG002	OLE Period: Pamrevlumab	Participants who completed the treatment in DB period and entered in the OLE period, received pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks for up to 48 weeks.	12	86	20	86	21	86

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0010 affected188 at risk EG0021 affected86 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Cardiac failure	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0010 affected188 at risk EG0021 affected86 at risk
Left ventricular failure	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
Myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Scleritis	Eye disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
Non-cardiac chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Sudden death	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0010 affected188 at risk EG0021 affected86 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0010 affected188 at risk EG0021 affected86 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
Empyema	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Herpes zoster	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
Nasal abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0009 affected183 at risk EG00110 affected188 at risk EG0020 affected86 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
Respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0011 affected188 at risk EG0021 affected86 at risk
Sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0010 affected188 at risk EG0021 affected86 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Skin injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0010 affected188 at risk EG0021 affected86 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0010 affected188 at risk EG0021 affected86 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0010 affected188 at risk EG0021 affected86 at risk
Intestinal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0010 affected188 at risk EG0021 affected86 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Cerebral infarction	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
Epilepsy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0010 affected188 at risk EG0021 affected86 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Parkinson's disease	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
Syncope	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0012 affected188 at risk EG0020 affected86 at risk
Vertebrobasilar stroke	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Autoimmune nephritis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0020 affected86 at risk
Urinary retention	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
and mediastinal disorders	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected183 at risk EG0012 affected188 at risk EG0022 affected86 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0011 affected188 at risk EG0021 affected86 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0009 affected183 at risk EG00110 affected188 at risk EG00212 affected86 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0012 affected188 at risk EG0020 affected86 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 affected183 at risk EG0010 affected188 at risk EG0021 affected86 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 affected183 at risk EG0011 affected188 at risk EG0020 affected86 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0010 affected188 at risk EG0021 affected86 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 affected183 at risk EG0011 affected188 at risk EG0022 affected86 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 affected183 at risk EG0010 affected188 at risk EG0021 affected86 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00014 affected183 at risk EG00115 affected188 at risk EG0024 affected86 at risk
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG00011 affected183 at risk EG0017 affected188 at risk EG0024 affected86 at risk
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG00011 affected183 at risk EG0015 affected188 at risk EG0020 affected86 at risk
Bronchitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0009 affected183 at risk EG00112 affected188 at risk EG0020 affected86 at risk
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00020 affected183 at risk EG00116 affected188 at risk EG0028 affected86 at risk
Nasopharyngitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00013 affected183 at risk EG00114 affected188 at risk EG0024 affected86 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00026 affected183 at risk EG00124 affected188 at risk EG0025 affected86 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00016 affected183 at risk EG00112 affected188 at risk EG0025 affected86 at risk

ID	Term
D054990	Idiopathic Pulmonary Fibrosis
D054988	Idiopathic Interstitial Pneumonias
D017563	Lung Diseases, Interstitial
D011658	Pulmonary Fibrosis

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms