(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Eva... | NCT00768300

NCT00768300

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Ambrisentan	Experimental		Drug: Ambrisentan
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Ambrisentan	Drug	Ambrisentan (5mg or 10 mg tablet) was administered orally once daily.	Ambrisentan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Death or Disease (IPF) Progression.	The median time to death or disease progression was based on Kaplan-Meier (KM) estimates of pooling over strata, and was defined as the first occurrence of any of the following: Either 1) a decrease of ≥ 10% in FVC (L) and a decrease of ≥ 5% in diffuse lung capacity for carbon monoxide (DLCO) (ml/min/mmHg), or 2) a decrease of ≥ 5% in FVC (L) and a decrease of ≥ 15% in DLCO (ml/min/mmHg); deterioration in FVC and DLCO must be confirmed at the subsequent visit within 28 (± 14) days Respiratory hospitalization (hospitalization involving worsening of, or deterioration in respiratory symptoms, gas exchange/hypoxemia, or radiographic findings on chest x-ray or high-resolution computerised tomography (HRCT) scan All-cause mortality	Up to 48 months

Secondary Outcomes

Measure	Description	Time Frame
Proportion of Participants With No Disease Progression or Death at 48 Weeks	The proportion of participants with no disease progression or death is presented as a percentage using a Kaplan-Meier (KM) estimate of survival or not experiencing disease progression.	Baseline and Week 48
Change in FVC % Predicted at Week 48

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Ganesh Raghu, MD	University of Washington, Div. of Pulmonary and Critical Care Medicine Chair	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham Hospital		Birmingham	Alabama	35294	United States
Pulmonary Associates

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23648946	Result	Raghu G, Behr J, Brown KK, Egan JJ, Kawut SM, Flaherty KR, Martinez FJ, Nathan SD, Wells AU, Collard HR, Costabel U, Richeldi L, de Andrade J, Khalil N, Morrison LD, Lederer DJ, Shao L, Li X, Pedersen PS, Montgomery AB, Chien JW, O'Riordan TG; ARTEMIS-IPF Investigators*. Treatment of idiopathic pulmonary fibrosis with ambrisentan: a parallel, randomized trial. Ann Intern Med. 2013 May 7;158(9):641-9. doi: 10.7326/0003-4819-158-9-201305070-00003.
24717624

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Ambrisentan	Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
FG001	Placebo	Placebo to match ambrisentan administered orally once daily

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Full Analysis Set: participants who were randomized and treated

Arm/Group Information

ID	Title	Description
BG000	Ambrisentan	Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
BG001	Placebo	Placebo to match ambrisentan administered orally once daily
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
	BG00065.8± 7.4 BG00166.1± 7.1 BG00265.9± 7.3

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00085 BG00152 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Black or African Heritage

Title	Measurements
	BG0001 BG0010 BG002

Region of Enrollment

All participants who were randomized are presented in Region of Enrollment (ambrisentan = 330; placebo = 164)

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000141 BG00162 BG002

Baseline Pulmonary Hypertension (PH) per interactive voice response system (IVRS)

Number

participants

Title

Denominators

Categories

Title	Measurements
	BG000293 BG001145 BG002

Smoking status

Smoking status data is missing for one participant randomized to placebo.

Number

participants

Title

Denominators

Categories

Never

Title	Measurements
	BG000105 BG00153 BG002

Surgical lung biopsy (SLB) to Confirm Diagnosis of IPF (per IVRS)

Number

participants

Title

Denominators

Categories

Title	Measurements
	BG000175 BG00187 BG002

Disease duration

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0001.13± 1.39 BG0010.91± 1.19 BG002

Forced vital capacity (FVC) percent predicted

Least Squares Mean

Standard Deviation

percentage of FVC % predicted

Title

Denominators

Categories

Title	Measurements
	BG00068.74± 13.12 BG00169.86± 13.75 BG002

Six mile walk test (6MWT)

Mean

Standard Deviation

meters

Title

Denominators

Categories

Title	Measurements
	BG000410.4± 118.7 BG001420.5± 121.4 BG002

Hemoglobin Adjusted Diffusing lung capacity for carbon monoxide (DLCO) percent predicted

Least Squares Mean

Standard Deviation

percentage of DLCO % predicted

Title

Denominators

Categories

Title	Measurements
	BG00042.04± 13.77 BG00145.57± 13.25

Prior IPF Medications

Prior IPF Medications data is missing for one participant randomized to placebo.

Number

participants

Title

Denominators

Categories

Title	Measurements
	BG000205 BG00197 BG002

N-acetylcysteine (NAC) Use

NAC is a therapy commonly used in the treatment of IPF. NAC use data is missing for two participants randomized to placebo.

Number

participants

Title

Denominators

Categories

Title	Measurements
	BG000310 BG001153

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

Time to Death or Disease (IPF) Progression.

The median time to death or disease progression was based on Kaplan-Meier (KM) estimates of pooling over strata, and was defined as the first occurrence of any of the following:

Either 1) a decrease of ≥ 10% in FVC (L) and a decrease of ≥ 5% in diffuse lung capacity for carbon monoxide (DLCO) (ml/min/mmHg), or 2) a decrease of ≥ 5% in FVC (L) and a decrease of ≥ 15% in DLCO (ml/min/mmHg); deterioration in FVC and DLCO must be confirmed at the subsequent visit within 28 (± 14) days
Respiratory hospitalization (hospitalization involving worsening of, or deterioration in respiratory symptoms, gas exchange/hypoxemia, or radiographic findings on chest x-ray or high-resolution computerised tomography (HRCT) scan
All-cause mortality

Full Analysis Set: participants who were randomized and treated

Posted

Median

Inter-Quartile Range

weeks

Up to 48 months

ID	Title	Description
OG000	Ambrisentan	Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
OG001	Placebo	Placebo to match ambrisentan administered orally once daily

Units	Counts
Participants	OG000329 OG001163

Title

Denominators

Categories

Title	Measurements
	OG00084.14(36.00 to NA)Insufficient data for estimation due to study termination OG001NA(60.00 to NA)Insufficient data for estimation due to study termination

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		Log Rank		0.010	P-value was based on a stratified log-rank test with strata of baseline presence of pulmonary hypertension and whether a surgical lung biopsy was performed with definite or probable usual interstitial pneumonia (UIP) based on core pathology review.	Hazard Ratio (HR)	1.74			2-Sided	95	1.14	2.66			The hazard ratio was based on a stratified Cox proportional hazards model with strata of baseline presence of pulmonary hypertension and whether a surgical lung biopsy was performed with definite or probable UIP based on core pathology review.	No	Superiority or Other

Secondary

Proportion of Participants With No Disease Progression or Death at 48 Weeks

The proportion of participants with no disease progression or death is presented as a percentage using a Kaplan-Meier (KM) estimate of survival or not experiencing disease progression.

Full Analysis Set

Posted

Number

percentage of participants

Baseline and Week 48

ID	Title	Description
OG000	Ambrisentan	Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
OG001	Placebo	Placebo to match ambrisentan administered orally once daily

Units	Counts
Participants	OG000

Secondary

Change in FVC % Predicted at Week 48

FVC is defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted is defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition.

Participants in the Full Analysis Set with evaluable change data were analyzed.

Posted

Mean

Standard Deviation

percent change in FVC % predicted

Baseline and Week 48

ID	Title	Description
OG000	Ambrisentan	Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
OG001	Placebo	Placebo to match ambrisentan administered orally once daily

Units	Counts
Participants	OG000

Secondary

Change in DLCO % Predicted at Week 48

DLCO is the extent to which oxygen passes from the air sacs of the lungs into the blood. DLCO % predicted is defined as DLCO % of the participant divided by the average DLCO % in the population for any person of similar age, sex and body composition.

Participants in the Full Analysis Set with evaluable change data were analyzed.

Posted

Mean

Standard Deviation

percent change in DLCO % predicted

Baseline and Week 48

ID	Title	Description
OG000	Ambrisentan	Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
OG001	Placebo	Placebo to match ambrisentan administered orally once daily

Units	Counts
Participants	OG000

Secondary

Change in 6MWT at Week 48

The 6MWT is a measure of exercise tolerance, and measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.

Participants in the Full Analysis Set with evaluable change data were analyzed.

Posted

Mean

Standard Deviation

meters

Baseline and Week 48

ID	Title	Description
OG000	Ambrisentan	Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
OG001	Placebo	Placebo to match ambrisentan administered orally once daily

Units	Counts
Participants	OG000

Secondary

Change in Quality of Life (QOL) Score at Week 48 as Assessed by the Short-Form 36® (SF-36)

The range of each health domain score is 0-100, with 0 indicating a poorer health state and 100 indicating a better health state. An increase in score indicates an improvement in health state.

Participants in the Full Analysis Set with evaluable change data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

Baseline and Week 48

ID	Title	Description
OG000	Ambrisentan	Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
OG001	Placebo	Placebo to match ambrisentan administered orally once daily

Units	Counts
Participants	OG000

Secondary

Change in Quality of Life (QOL) Score at Week 48 as Assessed by the St. George's Respiratory Questionnaire (SGRQ)

The SGRQ is designed to measure impact on overall health, daily life, and perceived well-being in participants with obstructive airways disease. The range of each score is 0-100, with 0 indicating fewer limitations and 100 indicating more limitations; an increase in score indicates an increase in limitations.

Participants in the Full Analysis Set with evaluable change data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

Baseline and Week 48

ID	Title	Description
OG000	Ambrisentan	Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
OG001	Placebo	Placebo to match ambrisentan administered orally once daily

Units	Counts
Participants	OG000

Secondary

Change in Dyspnea Score at Week 48 as Assessed by the Transitional Dyspnea Index (TDI)

The transitional focal score (-9 to 9) is the sum of relative change from baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each -3 to 3 scale). A TDI score of -9 represents a maximum degradation of all three tests; a score of 9 represents a maximum improvement of all three tests.

Participants in the Full Analysis Set with evaluable change data were analyzed.

Posted

Mean

Standard Deviation

units on a scale

Baseline and Week 48

ID	Title	Description
OG000	Ambrisentan	Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
OG001	Placebo	Placebo to match ambrisentan administered orally once daily

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Developed PH on Study

The percentage of participants known to have developed pulmonary hypertension on study documented by right heart catheterization (RHC) was analyzed. RHC was done at baseline and 48 weeks, or at the early termination visit.

Participants in the Full Analysis Set without PH at baseline were analyzed.

Posted

Number

percentage of participants

Up to 48 weeks

ID	Title	Description
OG000	Ambrisentan	Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
OG001	Placebo	Placebo to match ambrisentan administered orally once daily

Units	Counts
Participants	OG000

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	Ambrisentan	Ambrisentan (5 mg or 10 mg tablet) administered orally once daily			73	329	227	329
EG001	Placebo	Placebo to match ambrisentan administered orally once daily			25	163	104	163

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0003 affected329 at risk EG0010 affected163 at risk
Angina pectoris	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Angina unstable	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected329 at risk EG0010 affected163 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0004 affected329 at risk EG0010 affected163 at risk
Cardiomegaly	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Dilatation atrial	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Palpitations	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Extrasystoles	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Electromechanical dissociation	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Acute vestibular syndrome	Ear and labyrinth disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Cataract	Eye disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected329 at risk EG0011 affected163 at risk
Choroidal haemorrage	Eye disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected329 at risk EG0011 affected163 at risk
Visual impairment	Eye disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Constipation	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0004 affected329 at risk EG0010 affected163 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected329 at risk EG0012 affected163 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0011 affected163 at risk
Colitis	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0011 affected163 at risk
Nausea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected329 at risk EG0010 affected163 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected329 at risk EG0011 affected163 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Aptyalism	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected329 at risk EG0011 affected163 at risk
Oedema peripheral	General disorders	MedDRA (11.1)	Systematic Assessment	EG0004 affected329 at risk EG0011 affected163 at risk
Oedema	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Chest pain	General disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected329 at risk EG0011 affected163 at risk
Pain	General disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected329 at risk EG0010 affected163 at risk
Pyrexia	General disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected329 at risk EG0010 affected163 at risk
Fatigue	General disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected329 at risk EG0010 affected163 at risk
Catheter site haemorrhage	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Influenza like illness	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Hyperthermia	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Nasopharyngitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 affected329 at risk EG0012 affected163 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0011 affected163 at risk
Pharyngitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Sinusitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Pneumonia	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0009 affected329 at risk EG0012 affected163 at risk
Bronchitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0003 affected329 at risk EG0010 affected163 at risk
Lobar pneumonia	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0011 affected163 at risk
Bronchopneumonia	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 affected329 at risk EG0011 affected163 at risk
Respiratory tract infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 affected329 at risk EG0011 affected163 at risk
Infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Cellulitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 affected329 at risk EG0010 affected163 at risk
Endocarditis bacterial	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0011 affected163 at risk
Sepsis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 affected329 at risk EG0010 affected163 at risk
Bacteraemia	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 affected329 at risk EG0011 affected163 at risk
Appendicitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 affected329 at risk EG0011 affected163 at risk
Influenza	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 affected329 at risk EG0010 affected163 at risk
Urinary tract infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Oral candidiasis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Conjunctivitis viral	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Alanine aminotransferase increased	Investigations	MedDRA (11.1)	Systematic Assessment	EG0000 affected329 at risk EG0012 affected163 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (11.1)	Systematic Assessment	EG0000 affected329 at risk EG0011 affected163 at risk
Hepatic enzyme increased	Investigations	MedDRA (11.1)	Systematic Assessment	EG0000 affected329 at risk EG0011 affected163 at risk
Electrocardiogram ST-T segment abnormal	Investigations	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Electrocardiogram T wave inversion	Investigations	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Computerised tomogram thorax abnormal	Investigations	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0004 affected329 at risk EG0010 affected163 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected329 at risk EG0010 affected163 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected329 at risk EG0010 affected163 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected329 at risk EG0011 affected163 at risk
Clubbing	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected329 at risk EG0011 affected163 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0000 affected329 at risk EG0011 affected163 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0000 affected329 at risk EG0011 affected163 at risk
Headache	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0005 affected329 at risk EG0011 affected163 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Syncope	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0011 affected163 at risk
Somnolence	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Coma	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Grand mal convulsion	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Nerve compression	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Anxiety	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0003 affected329 at risk EG0010 affected163 at risk
Delirium	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Insomnia	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected329 at risk EG0010 affected163 at risk
Renal failure	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected329 at risk EG0011 affected163 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG00020 affected329 at risk EG0014 affected163 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected329 at risk EG0010 affected163 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected329 at risk EG0010 affected163 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG00017 affected329 at risk EG0012 affected163 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0004 affected329 at risk EG0011 affected163 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0004 affected329 at risk EG0010 affected163 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0005 affected329 at risk EG0011 affected163 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0004 affected329 at risk EG0010 affected163 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0004 affected329 at risk EG0010 affected163 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Choking	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected329 at risk EG0011 affected163 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected329 at risk EG0011 affected163 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected329 at risk EG0011 affected163 at risk
Hypotension	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0004 affected329 at risk EG0011 affected163 at risk
Hypertension	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0003 affected329 at risk EG0010 affected163 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Flushing	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Hot flush	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Cardiac ventricular disorder	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected329 at risk EG0010 affected163 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Oedema peripheral	General disorders	MedDRA (11.1)	Systematic Assessment	EG00073 affected329 at risk EG00114 affected163 at risk
Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG00047 affected329 at risk EG00118 affected163 at risk
Headache	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG00047 affected329 at risk EG00117 affected163 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG00040 affected329 at risk EG00111 affected163 at risk
Nasopharyngitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00037 affected329 at risk EG00118 affected163 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG00034 affected329 at risk EG00120 affected163 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG00019 affected329 at risk EG0012 affected163 at risk
Bronchitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00023 affected329 at risk EG00115 affected163 at risk
Fatigue	General disorders	MedDRA (11.1)	Systematic Assessment	EG00022 affected329 at risk EG00114 affected163 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG00027 affected329 at risk EG0016 affected163 at risk
Constipation	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00019 affected329 at risk EG00110 affected163 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00020 affected329 at risk EG0018 affected163 at risk
Sinusitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00020 affected329 at risk EG0016 affected163 at risk
Respiratory tract infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0009 affected329 at risk EG00112 affected163 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG00018 affected329 at risk EG0015 affected163 at risk
Dizziness	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG00020 affected329 at risk EG0012 affected163 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0008 affected329 at risk EG0019 affected163 at risk
Nausea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00015 affected329 at risk EG0019 affected163 at risk

ID	Term
D054990	Idiopathic Pulmonary Fibrosis
D017563	Lung Diseases, Interstitial

ID	Term
C467894	ambrisentan

ID	Term
D011658	Pulmonary Fibrosis
D008171	Lung Diseases
D012140	Respiratory Tract Diseases