ID

42362

Description

SYMPHONY: A Study of Macitentan in Pulmonary Arterial Hypertension to Validate the PAH-SYMPACT; ODM derived from: https://clinicaltrials.gov/show/NCT01841762

Link

https://clinicaltrials.gov/show/NCT01841762

Keywords

Versions (1)
  1. 6/23/21 6/23/21 -
Copyright Holder

Actelion

Uploaded on

June 23, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Pulmonary Arterial Hypertension NCT01841762

English

Eligibility Pulmonary Arterial Hypertension NCT01841762

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. signed informed consent prior to initiation of any study mandated procedure
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. patients with symptomatic pah in world health organization (who) functional class (fc) ii to iv
Description

Pulmonary arterial hypertension symptomatic | WHO functional class

Data type

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0043237
UMLS CUI [2,2]
C0456387
UMLS CUI [2,3]
C0205245
3. patients with pah belonging to one of the following subgroups of the dana point clinical classification group 1: a. idiopathic, or b. heritable, or c. drug or toxin induced, or d. associated with one of the following: i. connective tissue disease ii. congenital heart disease with simple systemic-to-pulmonary shunt at least one year after surgical repair iii. hiv infection
Description

Pulmonary arterial hypertension classification | idiopathic pah | familial pah | drug-induced pah | toxin-induced pah | pah associated with connective tissue disease, congenital heart disease or HIV infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0008902
UMLS CUI [2]
C3203102
UMLS CUI [3]
C0340543
UMLS CUI [4]
C0340544
UMLS CUI [5]
C3697954
UMLS CUI [6]
C3697982
UMLS CUI [7]
C3697119
UMLS CUI [8]
C3697673
4. documented hemodynamic diagnosis of pah by right heart catheterization - performed at any time prior to screening showing: a. resting mean pulmonary arterial pressure (mpap) ≥ 25 mmhg and b. resting pulmonary vascular resistance (pvr) > 240 dyn•s•cm-5 and c. pulmonary capillary wedge pressure (pcwp) or left ventricular end diastolic pressure (lvedp) ≤ 15 mmhg
Description

PAH right heart catheterization | Mean pulmonary arterial pressure at rest | Pulmonary vascular resistance at rest | Pulmonary capillary wedge pressure | left ventricular end-diastolic pressure level

Data type

boolean

Alias
UMLS CUI [1,1]
C2973725
UMLS CUI [1,2]
C0189896
UMLS CUI [2,1]
C3854605
UMLS CUI [2,2]
C0443144
UMLS CUI [3,1]
C0456261
UMLS CUI [3,2]
C0443144
UMLS CUI [4]
C0086879
UMLS CUI [5]
C0456190
5. 6-minute walk distance (6mwd) ≥ 150 m at screening
Description

6-minute walk test distance

Data type

boolean

Alias
UMLS CUI [1,1]
C0430515
UMLS CUI [1,2]
C0012751
6. able to fluently speak and read english
Description

Able to speak and read English

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
7. for patients on phosphodiesterase type-5 inhibitors (pde5i), inhaled prostacyclin analogues, or calcium channel blockers, stable doses for at least 3 months prior to visit 2
Description

Phosphodiesterase type-5 inhibitors (pde5i), inhaled prostacyclin analogues, or calcium channel blockers stable medication dose duration

Data type

boolean

Alias
UMLS CUI [1,1]
C1318700
UMLS CUI [1,2]
C3174092
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0449238
UMLS CUI [2,1]
C0205911
UMLS CUI [2,2]
C0243071
UMLS CUI [2,3]
C0205535
UMLS CUI [2,4]
C3174092
UMLS CUI [2,5]
C0205360
UMLS CUI [2,6]
C0449238
UMLS CUI [3,1]
C0006684
UMLS CUI [3,2]
C3174092
UMLS CUI [3,3]
C0205360
UMLS CUI [3,4]
C0449238
UMLS CUI [3,5]
C0449238
8. for patients on oral diuretics, stable doses for at least 4 weeks prior to visit 2
Description

Stable medication dose of oral diuretics duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0012798
UMLS CUI [1,2]
C0442027
UMLS CUI [1,3]
C3174092
UMLS CUI [1,4]
C0205360
UMLS CUI [1,5]
C0449238
9. men or women aged 18 or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
a. a woman is considered to be of childbearing potential unless she: has not yet entered puberty, or does not have a uterus, or has gone through menopause (has not had a period for at least 12 months for natural reasons, or who has had their ovaries removed) b. a women of childbearing potential is eligible only if she meets both criteria below: has a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline and agree to perform monthly urine pregnancy tests, and agrees to use two methods of contraception (one method for patients with a progesterone implant or an intrauterine device or tubal sterilization) from the screening visit 1 until one month after study drug discontinuation
Description

Pre-pubertal | uterus not present | postmenopausal state | no period | status post ovariectomy | negative serum pregnancy test | negative urine pregnancy test | willingness urine pregnancy tests monthly | willingness contraceptive methods during clinical trial period | progesterone implant | IUD | tubal sterilization

Data type

boolean

Alias
UMLS CUI [1]
C1628325
UMLS CUI [2,1]
C0042149
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0002453
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0029936
UMLS CUI [6]
C0430061
UMLS CUI [7]
C0430057
UMLS CUI [8,1]
C0600109
UMLS CUI [8,2]
C0430056
UMLS CUI [8,3]
C0332177
UMLS CUI [9,1]
C0600109
UMLS CUI [9,2]
C0700589
UMLS CUI [9,3]
C0347984
UMLS CUI [9,4]
C2347804
UMLS CUI [10,1]
C0021102
UMLS CUI [10,2]
C0033308
UMLS CUI [11]
C0021900
UMLS CUI [12]
C0038289
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. moderate to severe obstructive lung disease: forced expiratory volume in one second (fev1) / forced vital capacity < 70 percent and fev1 < 65 percent of predicted value after bronchodilator administration
Description

Moderate to severe obstructive lung disease: FEV1 / FVC percent post bronchodilator | FEV1 predicted percent post bronchodilator

Data type

boolean

Alias
UMLS CUI [1,1]
C0600260
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0600260
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0730560
UMLS CUI [3,2]
C2599594
UMLS CUI [4,1]
C0730561
UMLS CUI [4,2]
C2599594
2. moderate to severe restrictive lung disease: total lung capacity < 60 percent of predicted value
Description

Moderate to severe restrictive lung disease | percent predicted total lung capacity

Data type

boolean

Alias
UMLS CUI [1,1]
C0085581
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0205082
UMLS CUI [2,2]
C0085581
UMLS CUI [3]
C3828589
3. hemoglobin < 75 percent of the lower limit of the normal range at screening
Description

Hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0019046
4. serum aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) > 3 times the upper limit of normal (uln) at screening
Description

Aspartate aminotransferase measurement | alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
5. estimated creatinine clearance < 30 ml/min at screening
Description

Estimated creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C1273051
6. systolic blood pressure (sbp) < 90 mmhg at screening
Description

Systolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
7. body weight < 40 kg at screening
Description

Body weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
8. known concomitant life-threatening diseases with a life expectancy of < 12 months
Description

Comorbidity life threatening | life expectancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2826244
UMLS CUI [2]
C0023671
9. any condition that prevents compliance with the protocol or adherence to therapy
Description

Disease preventing protocol compliance or adherence to therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C1510802
10. treatment with endothelin receptor antagonists (eras) within 3 months prior to visit 2, or scheduled to receive any of these compounds, other than macitentan, during the trial
Description

Endothelin receptor antagonists | exception macitentan

Data type

boolean

Alias
UMLS CUI [1]
C1134681
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2606556
11. treatment with intravenous or subcutaneous prostacyclin or prostacyclin analogs within 3 months prior to visit 2, or scheduled to receive any of these compounds during the trial
Description

Intravenous or subcutaneous prostacyclin or prostacyclin analogs recent or planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0205911
UMLS CUI [1,2]
C1522726
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0205911
UMLS CUI [2,2]
C1522726
UMLS CUI [2,3]
C1301732
UMLS CUI [3,1]
C0205911
UMLS CUI [3,2]
C0243071
UMLS CUI [3,3]
C1522726
UMLS CUI [3,4]
C0332185
UMLS CUI [4,1]
C0205911
UMLS CUI [4,2]
C0243071
UMLS CUI [4,3]
C1522726
UMLS CUI [4,4]
C1301732
UMLS CUI [5,1]
C0205911
UMLS CUI [5,2]
C1522438
UMLS CUI [5,3]
C0332185
UMLS CUI [6,1]
C0205911
UMLS CUI [6,2]
C1522438
UMLS CUI [6,3]
C1301732
UMLS CUI [7,1]
C0205911
UMLS CUI [7,2]
C0243071
UMLS CUI [7,3]
C1522438
UMLS CUI [7,4]
C0332185
UMLS CUI [8,1]
C0205911
UMLS CUI [8,2]
C0243071
UMLS CUI [8,3]
C1522438
UMLS CUI [8,4]
C1301732
12. treatment with riociguat within 3 months prior to visit 2, or scheduled to receive riociguat during the trial
Description

Riociguat recent or planned

Data type

boolean

Alias
UMLS CUI [1,1]
C2717561
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C2717561
UMLS CUI [2,2]
C1301732
13. treatment with strong cytochrome p450 (cyp) 3a4 inducers or inhibitors within 4 weeks prior to visit 2
Description

Strong cytochrome p450 (cyp) 3a4 inducers or inhibitors recent

Data type

boolean

Alias
UMLS CUI [1,1]
C3850041
UMLS CUI [1,2]
C0442821
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C3850053
UMLS CUI [2,2]
C0442821
UMLS CUI [2,3]
C0332185
14. recently started (< 8 weeks prior to visit 2) or planned cardio-pulmonary rehabilitation program based on exercise
Description

Cardio-pulmonary rehabilitation program based on exercise recently started or planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0700431
UMLS CUI [1,4]
C0015259
UMLS CUI [2,1]
C0700431
UMLS CUI [2,2]
C0015259
UMLS CUI [2,3]
C1301732
UMLS CUI [3,1]
C0332185
UMLS CUI [3,2]
C0439659
UMLS CUI [3,3]
C0199529
UMLS CUI [3,4]
C0015259
UMLS CUI [4,1]
C0199529
UMLS CUI [4,2]
C0015259
UMLS CUI [4,3]
C1301732
15. females who are lactating or pregnant (positive screening or baseline pregnancy test) or plan to become pregnant during the study
Description

Lactating | pregnancy | pregnancy test positive | pregnancy intention

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0240802
UMLS CUI [4,1]
C0032961
UMLS CUI [4,2]
C0162425
16. known hypersensitivity to macitentan or its excipients or drugs of the same class
Description

Hypersensitivity macitentan | macitentan excipients | endothelin receptor antagonist

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2606556
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0015237
UMLS CUI [2,3]
C2606556
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1134681
17. treatment with another investigational drug within 3 months prior to visit 2
Description

Investigational new drugs recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332185
18. any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease
Description

Factor or disease interferes with treatment compliance, completion of clinical trial or interpretation of research results | drug or alcohol dependence | mental disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C4319828
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2732579
UMLS CUI [3,1]
C1521761
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C3526596
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C4319828
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C2732579
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C3526596
UMLS CUI [7]
C0038580
UMLS CUI [8]
C0004936
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Eligibility Pulmonary Arterial Hypertension NCT01841762

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
1. signed informed consent prior to initiation of any study mandated procedure
boolean
C0021430 (UMLS CUI [1])
Pulmonary arterial hypertension symptomatic | WHO functional class
Item
2. patients with symptomatic pah in world health organization (who) functional class (fc) ii to iv
boolean
C2973725 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0043237 (UMLS CUI [2,1])
C0456387 (UMLS CUI [2,2])
C0205245 (UMLS CUI [2,3])
Pulmonary arterial hypertension classification | idiopathic pah | familial pah | drug-induced pah | toxin-induced pah | pah associated with connective tissue disease, congenital heart disease or HIV infection
Item
3. patients with pah belonging to one of the following subgroups of the dana point clinical classification group 1: a. idiopathic, or b. heritable, or c. drug or toxin induced, or d. associated with one of the following: i. connective tissue disease ii. congenital heart disease with simple systemic-to-pulmonary shunt at least one year after surgical repair iii. hiv infection
boolean
C0020542 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
C3203102 (UMLS CUI [2])
C0340543 (UMLS CUI [3])
C0340544 (UMLS CUI [4])
C3697954 (UMLS CUI [5])
C3697982 (UMLS CUI [6])
C3697119 (UMLS CUI [7])
C3697673 (UMLS CUI [8])
PAH right heart catheterization | Mean pulmonary arterial pressure at rest | Pulmonary vascular resistance at rest | Pulmonary capillary wedge pressure | left ventricular end-diastolic pressure level
Item
4. documented hemodynamic diagnosis of pah by right heart catheterization - performed at any time prior to screening showing: a. resting mean pulmonary arterial pressure (mpap) ≥ 25 mmhg and b. resting pulmonary vascular resistance (pvr) > 240 dyn•s•cm-5 and c. pulmonary capillary wedge pressure (pcwp) or left ventricular end diastolic pressure (lvedp) ≤ 15 mmhg
boolean
C2973725 (UMLS CUI [1,1])
C0189896 (UMLS CUI [1,2])
C3854605 (UMLS CUI [2,1])
C0443144 (UMLS CUI [2,2])
C0456261 (UMLS CUI [3,1])
C0443144 (UMLS CUI [3,2])
C0086879 (UMLS CUI [4])
C0456190 (UMLS CUI [5])
6-minute walk test distance
Item
5. 6-minute walk distance (6mwd) ≥ 150 m at screening
boolean
C0430515 (UMLS CUI [1,1])
C0012751 (UMLS CUI [1,2])
Able to speak and read English
Item
6. able to fluently speak and read english
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Phosphodiesterase type-5 inhibitors (pde5i), inhaled prostacyclin analogues, or calcium channel blockers stable medication dose duration
Item
7. for patients on phosphodiesterase type-5 inhibitors (pde5i), inhaled prostacyclin analogues, or calcium channel blockers, stable doses for at least 3 months prior to visit 2
boolean
C1318700 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
C0205911 (UMLS CUI [2,1])
C0243071 (UMLS CUI [2,2])
C0205535 (UMLS CUI [2,3])
C3174092 (UMLS CUI [2,4])
C0205360 (UMLS CUI [2,5])
C0449238 (UMLS CUI [2,6])
C0006684 (UMLS CUI [3,1])
C3174092 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0449238 (UMLS CUI [3,4])
C0449238 (UMLS CUI [3,5])
Stable medication dose of oral diuretics duration
Item
8. for patients on oral diuretics, stable doses for at least 4 weeks prior to visit 2
boolean
C0012798 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0449238 (UMLS CUI [1,5])
Age
Item
9. men or women aged 18 or older
boolean
C0001779 (UMLS CUI [1])
Pre-pubertal | uterus not present | postmenopausal state | no period | status post ovariectomy | negative serum pregnancy test | negative urine pregnancy test | willingness urine pregnancy tests monthly | willingness contraceptive methods during clinical trial period | progesterone implant | IUD | tubal sterilization
Item
a. a woman is considered to be of childbearing potential unless she: has not yet entered puberty, or does not have a uterus, or has gone through menopause (has not had a period for at least 12 months for natural reasons, or who has had their ovaries removed) b. a women of childbearing potential is eligible only if she meets both criteria below: has a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline and agree to perform monthly urine pregnancy tests, and agrees to use two methods of contraception (one method for patients with a progesterone implant or an intrauterine device or tubal sterilization) from the screening visit 1 until one month after study drug discontinuation
boolean
C1628325 (UMLS CUI [1])
C0042149 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3])
C0002453 (UMLS CUI [4])
C0231290 (UMLS CUI [5,1])
C0029936 (UMLS CUI [5,2])
C0430061 (UMLS CUI [6])
C0430057 (UMLS CUI [7])
C0600109 (UMLS CUI [8,1])
C0430056 (UMLS CUI [8,2])
C0332177 (UMLS CUI [8,3])
C0600109 (UMLS CUI [9,1])
C0700589 (UMLS CUI [9,2])
C0347984 (UMLS CUI [9,3])
C2347804 (UMLS CUI [9,4])
C0021102 (UMLS CUI [10,1])
C0033308 (UMLS CUI [10,2])
C0021900 (UMLS CUI [11])
C0038289 (UMLS CUI [12])
Item Group
C0680251 (UMLS CUI)
Moderate to severe obstructive lung disease: FEV1 / FVC percent post bronchodilator | FEV1 predicted percent post bronchodilator
Item
1. moderate to severe obstructive lung disease: forced expiratory volume in one second (fev1) / forced vital capacity < 70 percent and fev1 < 65 percent of predicted value after bronchodilator administration
boolean
C0600260 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0600260 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0730560 (UMLS CUI [3,1])
C2599594 (UMLS CUI [3,2])
C0730561 (UMLS CUI [4,1])
C2599594 (UMLS CUI [4,2])
Moderate to severe restrictive lung disease | percent predicted total lung capacity
Item
2. moderate to severe restrictive lung disease: total lung capacity < 60 percent of predicted value
boolean
C0085581 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0205082 (UMLS CUI [2,1])
C0085581 (UMLS CUI [2,2])
C3828589 (UMLS CUI [3])
Hemoglobin
Item
3. hemoglobin < 75 percent of the lower limit of the normal range at screening
boolean
C0019046 (UMLS CUI [1])
Aspartate aminotransferase measurement | alanine aminotransferase measurement
Item
4. serum aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) > 3 times the upper limit of normal (uln) at screening
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Estimated creatinine clearance
Item
5. estimated creatinine clearance < 30 ml/min at screening
boolean
C1273051 (UMLS CUI [1])
Systolic blood pressure
Item
6. systolic blood pressure (sbp) < 90 mmhg at screening
boolean
C0871470 (UMLS CUI [1])
Body weight
Item
7. body weight < 40 kg at screening
boolean
C0005910 (UMLS CUI [1])
Comorbidity life threatening | life expectancy
Item
8. known concomitant life-threatening diseases with a life expectancy of < 12 months
boolean
C0009488 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0023671 (UMLS CUI [2])
Disease preventing protocol compliance or adherence to therapy
Item
9. any condition that prevents compliance with the protocol or adherence to therapy
boolean
C0012634 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C1510802 (UMLS CUI [2,3])
Endothelin receptor antagonists | exception macitentan
Item
10. treatment with endothelin receptor antagonists (eras) within 3 months prior to visit 2, or scheduled to receive any of these compounds, other than macitentan, during the trial
boolean
C1134681 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2606556 (UMLS CUI [2,2])
Intravenous or subcutaneous prostacyclin or prostacyclin analogs recent or planned
Item
11. treatment with intravenous or subcutaneous prostacyclin or prostacyclin analogs within 3 months prior to visit 2, or scheduled to receive any of these compounds during the trial
boolean
C0205911 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0205911 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0205911 (UMLS CUI [3,1])
C0243071 (UMLS CUI [3,2])
C1522726 (UMLS CUI [3,3])
C0332185 (UMLS CUI [3,4])
C0205911 (UMLS CUI [4,1])
C0243071 (UMLS CUI [4,2])
C1522726 (UMLS CUI [4,3])
C1301732 (UMLS CUI [4,4])
C0205911 (UMLS CUI [5,1])
C1522438 (UMLS CUI [5,2])
C0332185 (UMLS CUI [5,3])
C0205911 (UMLS CUI [6,1])
C1522438 (UMLS CUI [6,2])
C1301732 (UMLS CUI [6,3])
C0205911 (UMLS CUI [7,1])
C0243071 (UMLS CUI [7,2])
C1522438 (UMLS CUI [7,3])
C0332185 (UMLS CUI [7,4])
C0205911 (UMLS CUI [8,1])
C0243071 (UMLS CUI [8,2])
C1522438 (UMLS CUI [8,3])
C1301732 (UMLS CUI [8,4])
Riociguat recent or planned
Item
12. treatment with riociguat within 3 months prior to visit 2, or scheduled to receive riociguat during the trial
boolean
C2717561 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C2717561 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Strong cytochrome p450 (cyp) 3a4 inducers or inhibitors recent
Item
13. treatment with strong cytochrome p450 (cyp) 3a4 inducers or inhibitors within 4 weeks prior to visit 2
boolean
C3850041 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C3850053 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
Cardio-pulmonary rehabilitation program based on exercise recently started or planned
Item
14. recently started (< 8 weeks prior to visit 2) or planned cardio-pulmonary rehabilitation program based on exercise
boolean
C0332185 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0700431 (UMLS CUI [1,3])
C0015259 (UMLS CUI [1,4])
C0700431 (UMLS CUI [2,1])
C0015259 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0332185 (UMLS CUI [3,1])
C0439659 (UMLS CUI [3,2])
C0199529 (UMLS CUI [3,3])
C0015259 (UMLS CUI [3,4])
C0199529 (UMLS CUI [4,1])
C0015259 (UMLS CUI [4,2])
C1301732 (UMLS CUI [4,3])
Lactating | pregnancy | pregnancy test positive | pregnancy intention
Item
15. females who are lactating or pregnant (positive screening or baseline pregnancy test) or plan to become pregnant during the study
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0240802 (UMLS CUI [3])
C0032961 (UMLS CUI [4,1])
C0162425 (UMLS CUI [4,2])
Hypersensitivity macitentan | macitentan excipients | endothelin receptor antagonist
Item
16. known hypersensitivity to macitentan or its excipients or drugs of the same class
boolean
C0020517 (UMLS CUI [1,1])
C2606556 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0015237 (UMLS CUI [2,2])
C2606556 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C1134681 (UMLS CUI [3,2])
Investigational new drugs recent
Item
17. treatment with another investigational drug within 3 months prior to visit 2
boolean
C0013230 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Factor or disease interferes with treatment compliance, completion of clinical trial or interpretation of research results | drug or alcohol dependence | mental disorders
Item
18. any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease
boolean
C1521761 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C4319828 (UMLS CUI [1,3])
C1521761 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C1521761 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C3526596 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C4319828 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2732579 (UMLS CUI [5,3])
C0012634 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C3526596 (UMLS CUI [6,3])
C0038580 (UMLS CUI [7])
C0004936 (UMLS CUI [8])
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