Efficacy and Safety of SAR156597 in the Treatment of Idio... | NCT02345070

ID	Type	Description	Link
2014-003933-24	EudraCT Number
U1111-1154-6083	Other Identifier	UTN

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo qw	Placebo Comparator	Participants received one injection of placebo (matched to SAR156597) subcutaneously once every week (qw) for 52 weeks.	Drug: placebo
SAR156597 200 mg q2w	Experimental	Participants received one injection of SAR156597 200 mg subcutaneously once every 2 weeks (q2w) alternating with placebo (matched to SAR156597) for 52 weeks.	Drug: SAR156597 Drug: placebo
SAR156597 200 mg qw	Experimental	Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.	Drug: SAR156597

Name	Type	Description	Arm Group Labels	Other Names
SAR156597	Drug	Pharmaceutical form: solution for injection Route of administration: subcutaneous	SAR156597 200 mg q2w SAR156597 200 mg qw

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52	FVC is a standard pulmonary function parameter measured by spirometry and used to quantify respiratory capacity (inspiration and expiration). It is a widely used objective measure of disease status in participants with Idiopathic Pulmonary Fibrosis (IPF). The primary variable was recorded as percent (%) of predicted value, which takes into account the height, gender, and age of the participant. The outcome measure measured the change in lung function from baseline at week 52.	Baseline, Week 52

Secondary Outcomes

Measure	Description	Time Frame
Time to Disease Progression: Kaplan-Meier Estimates of Probability of Disease Progression at Week 52	Disease progression was defined as the time from randomization to the first occurrence of any of the following events: decrease in absolute percent predicted FVC greater than or equal to (>=) 10%, decrease in absolute percent predicted Carbon monoxide diffusing lung capacity >=15%, lung transplant, or death. The median time to disease progression was not estimated because the number of occurrence of events was too low in the SAR156597 200 mg arms.

Eligibility Module

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site Number 840003		Phoenix	Arizona	85006	United States
Investigational Site Number 840020

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo qw	Participants received one injection of placebo (matched to SAR156597) subcutaneously qw for 52 weeks.
FG001	SAR156597 200mg q2w	Participants received one injection of SAR156597 200 mg subcutaneously q2w alternating with placebo (matched to SAR156597) for 52 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	Jul 21, 2015	May 8, 2020

Arm/Group Information

ID	Title	Description
BG000	Placebo qw	Participants received one injection of placebo (matched to SAR156597) subcutaneously qw for 52 weeks.
BG001	SAR156597 200mg q2w	Participants received one injection of SAR156597 200 mg subcutaneously q2w alternating with placebo (matched to SAR156597) for 52 weeks.
BG002	SAR156597 200mg qw	Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.
BG003	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
	BG00069.0± 8.6 BG00167.4± 7.2 BG00268.0± 7.6 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00022 BG00132 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

Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52

FVC is a standard pulmonary function parameter measured by spirometry and used to quantify respiratory capacity (inspiration and expiration). It is a widely used objective measure of disease status in participants with Idiopathic Pulmonary Fibrosis (IPF). The primary variable was recorded as percent (%) of predicted value, which takes into account the height, gender, and age of the participant. The outcome measure measured the change in lung function from baseline at week 52.

Modified intent-to-treat (mITT) population: All participants who received at least 1 study injection, had valid baseline percent predicted FVC measurement, and had at least 1 post-baseline percent predicted FVC measurement. Here, 'Overall number of participants analyzed' = participants with available data for this outcome measure.

Posted

Least Squares Mean

Standard Error

percent predicted FVC

Baseline, Week 52

ID	Title	Description
OG000	Placebo qw	Participants received one injection of placebo (matched to SAR156597) subcutaneously qw for 52 weeks.
OG001	SAR156597 200mg q2w	Participants received one injection of SAR156597 200 mg subcutaneously q2w alternating with placebo (matched to SAR156597) for 52 weeks.
OG002	SAR156597 200mg qw	Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.

Units	Counts
Participants	OG00081 OG00189 OG00275

Title

Denominators

Categories

Title	Measurements
	OG000-5.81± 0.74 OG001-5.24± 0.73 OG002-6.31± 0.75

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 OG002	A hierarchical testing procedure was used to control type I error. Testing was done sequentially in order the outcome measures were reported. Analyzed using Mixed Model for Repeated Measurements (MMRM) with fixed categorical effects of treatment arm, stratification factor (with/without background therapy), time point, treatment-by-time point interaction, stratification factor-by-treatment-by-time point interaction, and continuous fixed covariate of percent predicted FVC baseline.	Mixed Models Analysis		= 0.6339	Threshold for significance at 0.05 level.	Least Square (LS) Mean Difference	-0.5	Standard Error of the Mean	1.05	2-Sided	95	-2.56	1.56			SAR156597 200mg qw versus Placebo qw

Secondary

Time to Disease Progression: Kaplan-Meier Estimates of Probability of Disease Progression at Week 52

Disease progression was defined as the time from randomization to the first occurrence of any of the following events: decrease in absolute percent predicted FVC greater than or equal to (>=) 10%, decrease in absolute percent predicted Carbon monoxide diffusing lung capacity >=15%, lung transplant, or death. The median time to disease progression was not estimated because the number of occurrence of events was too low in the SAR156597 200 mg arms.

Analysis was performed on mITT population.

Posted

Number

probability of disease progression

From randomization to disease progression (up to Week 52)

ID	Title	Description
OG000	Placebo qw	Participants received one injection of placebo (matched to SAR156597) subcutaneously qw for 52 weeks.
OG001	SAR156597 200mg q2w	Participants received one injection of SAR156597 200 mg subcutaneously q2w alternating with placebo (matched to SAR156597) for 52 weeks.
OG002	SAR156597 200mg qw	Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.

Secondary

Time to Event: Kaplan-Meier Estimates of Probability of All Cause Mortality (Deaths) at Week 52

All-cause mortality was considered for this outcome measure which was defined as the time from randomization to the date of death. The median time to event was not estimated because the number of all cause mortality was too low in the SAR156597 200 mg arms.

Analysis was performed on mITT population.

Posted

Number

probability of deaths

From randomization up to Week 52

ID	Title	Description
OG000	Placebo qw	Participants received one injection of placebo (matched to SAR156597) subcutaneously qw for 52 weeks.
OG001	SAR156597 200mg q2w	Participants received one injection of SAR156597 200 mg subcutaneously q2w alternating with placebo (matched to SAR156597) for 52 weeks.
OG002	SAR156597 200mg qw	Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.

Units	Counts

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	Placebo qw	Participants received one injection of placebo (matched to SAR156597) subcutaneously qw for 52 weeks.	9	109	26	109	81	109
EG001	SAR156597 200mg q2w	Participants received one injection of SAR156597 200 mg subcutaneously q2w alternating with placebo (matched to SAR156597) for 52 weeks.	6	108	27	108	86	108
EG002	SAR156597 200mg qw	Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.	13	108	46	108	79	108

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0010 affected108 at risk EG0022 affected108 at risk
Acute right ventricular failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0020 affected108 at risk
Arrhythmia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0021 affected108 at risk
Atrial flutter	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Cardiac failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0011 affected108 at risk EG0021 affected108 at risk
Myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Right ventricular failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0020 affected108 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0020 affected108 at risk
Duodenal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Ileus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0020 affected108 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Oesophageal achalasia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0010 affected108 at risk EG0020 affected108 at risk
Volvulus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Death	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Non-cardiac chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0020 affected108 at risk
Hepatic congestion	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0022 affected108 at risk
Hepatic mass	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0020 affected108 at risk
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0010 affected108 at risk EG0022 affected108 at risk
Bronchitis bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0020 affected108 at risk
Diverticulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Gastroenteritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Herpes zoster	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Influenza	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0010 affected108 at risk EG0020 affected108 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0011 affected108 at risk EG0020 affected108 at risk
Lung infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0012 affected108 at risk EG0020 affected108 at risk
Metapneumovirus infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0020 affected108 at risk
Ophthalmic herpes zoster	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0020 affected108 at risk
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0004 affected109 at risk EG0013 affected108 at risk EG0028 affected108 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Pneumonia viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0010 affected108 at risk EG0020 affected108 at risk
Sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0020 affected108 at risk
Septic shock	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Tracheobronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0010 affected108 at risk EG0020 affected108 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0010 affected108 at risk EG0020 affected108 at risk
Stress fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0010 affected108 at risk EG0020 affected108 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0020 affected108 at risk
Ejection fraction decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0020 affected108 at risk
General physical condition abnormal	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Weight decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0020 affected108 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0010 affected108 at risk EG0020 affected108 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0020 affected108 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0020 affected108 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Neuroendocrine carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0010 affected108 at risk EG0020 affected108 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0010 affected108 at risk EG0020 affected108 at risk
T-cell prolymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0020 affected108 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0010 affected108 at risk EG0020 affected108 at risk
Postresuscitation encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Quadriparesis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Syncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0021 affected108 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0021 affected108 at risk
Anxiety	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Assisted suicide	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0020 affected108 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0010 affected108 at risk EG0020 affected108 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0011 affected108 at risk EG0020 affected108 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0010 affected108 at risk EG0020 affected108 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00010 affected109 at risk EG0019 affected108 at risk EG00222 affected108 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected109 at risk EG0010 affected108 at risk EG0021 affected108 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0012 affected108 at risk EG0022 affected108 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0010 affected108 at risk EG0022 affected108 at risk
Rheumatoid lung	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0010 affected108 at risk EG0020 affected108 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0012 affected108 at risk EG0027 affected108 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00016 affected109 at risk EG00123 affected108 at risk EG00212 affected108 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected109 at risk EG0016 affected108 at risk EG0020 affected108 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0009 affected109 at risk EG0019 affected108 at risk EG0029 affected108 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0006 affected109 at risk EG0018 affected108 at risk EG0026 affected108 at risk
Asthenia	General disorders	MedDRA 20.0	Systematic Assessment	EG0006 affected109 at risk EG0014 affected108 at risk EG0023 affected108 at risk
Injection site erythema	General disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected109 at risk EG0017 affected108 at risk EG00210 affected108 at risk
Injection site haematoma	General disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected109 at risk EG0015 affected108 at risk EG0026 affected108 at risk
Injection site reaction	General disorders	MedDRA 20.0	Systematic Assessment	EG0006 affected109 at risk EG00111 affected108 at risk EG00210 affected108 at risk
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG0008 affected109 at risk EG0011 affected108 at risk EG0020 affected108 at risk
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00012 affected109 at risk EG00118 affected108 at risk EG00210 affected108 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected109 at risk EG00111 affected108 at risk EG0026 affected108 at risk
Respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0007 affected109 at risk EG0015 affected108 at risk EG0023 affected108 at risk
Rhinitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0018 affected108 at risk EG0022 affected108 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00013 affected109 at risk EG00110 affected108 at risk EG0028 affected108 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0006 affected109 at risk EG0014 affected108 at risk EG0027 affected108 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00015 affected109 at risk EG00118 affected108 at risk EG00212 affected108 at risk
Weight decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0009 affected109 at risk EG0019 affected108 at risk EG0028 affected108 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected109 at risk EG0017 affected108 at risk EG0022 affected108 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected109 at risk EG0016 affected108 at risk EG0022 affected108 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0009 affected109 at risk EG00113 affected108 at risk EG0029 affected108 at risk
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0007 affected109 at risk EG0015 affected108 at risk EG0029 affected108 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00012 affected109 at risk EG00122 affected108 at risk EG00218 affected108 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00011 affected109 at risk EG00110 affected108 at risk EG00213 affected108 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00010 affected109 at risk EG00111 affected108 at risk EG0028 affected108 at risk

ID	Term
D011658	Pulmonary Fibrosis
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases