Study Subject Participation Status | Investigational New Drugs
Item
have been randomized to the protocol for amb115811 and have met one of the following: completed the week 16 visit in amb115811; or prematurely withdrew from amb115811 for whatever reason (where investigational product [ip] has been stopped due to safety or efficacy reasons, the subject may still enter into the open label study regardless of what treatment they are receiving [other treatments will not be supplied by the sponsor]. the investigator will decide whether or not the subject will receive the ip
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Informed Consent | Childbearing Potential Information Risk Teratogenesis | Childbearing Potential Information Contraceptive methods | Gender Information Risk Atrophy of testis | Gender Information Risk Aspermia
Item
subject is able and willing to give written informed consent. as part of the consent, female subjects of childbearing potential will be informed of the risk of teratogenicity and will need to be counseled in a developmentally appropriate manner on the importance of pregnancy prevention; and male subjects will need to be informed of potential risk of testicular tubular atrophy and aspermia.
boolean
C0021430 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C1533716 (UMLS CUI [2,2])
C0035647 (UMLS CUI [2,3])
C0232910 (UMLS CUI [2,4])
C3831118 (UMLS CUI [3,1])
C1533716 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C1533716 (UMLS CUI [4,2])
C0035647 (UMLS CUI [4,3])
C0156312 (UMLS CUI [4,4])
C0079399 (UMLS CUI [5,1])
C1533716 (UMLS CUI [5,2])
C0035647 (UMLS CUI [5,3])
C1704202 (UMLS CUI [5,4])
Information Investigational New Drugs | Information Investigational Therapy
Item
specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the gsk investigational product or other study treatment that may impact subject eligibility is provided in the investigators brochure and product label for pah indication.
boolean
C1533716 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1533716 (UMLS CUI [2,1])
C0949266 (UMLS CUI [2,2])
Social Security Affiliated | Social Security beneficiary
Item
in france, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category
boolean
C0037435 (UMLS CUI [1,1])
C1510826 (UMLS CUI [1,2])
C0037435 (UMLS CUI [2,1])
C1550502 (UMLS CUI [2,2])
ambrisentan
Item
subject meeting any of the following criteria must not receive ambrisentan, however may still be followed-up as part of the study and be treated according to best clinical practice as decided by the investigator:
boolean
C1176329 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Metabolite | Hypersensitivity Formulation Excipient
Item
subject has a known hypersensitivity to the investigational products, the metabolites, or formulation excipients
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0870883 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0524527 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
Pregnancy | Breast Feeding | Gender Contraceptive methods Refused
Item
female subjects who are pregnant or breastfeeding or no-longer agree to comply with using effective contraception as defined in the protocol.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1705116 (UMLS CUI [3,3])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
subjects with alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) >= 3x upper limit of normal (uln)
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Elevated total bilirubin | Bilirubin, direct measurement
Item
subjects with bilirubin >= 2xuln (>35% direct bilirubin)
boolean
C0741494 (UMLS CUI [1])
C0201916 (UMLS CUI [2])
Renal Insufficiency Severe | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
subjects with severe renal impairment (estimated creatinine clearance <30 millilitre per minute (ml/min) assessed within the previous 45 days) at the point of transition from study amb115811
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2711451 (UMLS CUI [2])
Hepatic impairment Moderate Child-Pugh Classification | Hepatic impairment Severe Child-Pugh Classification | Liver Cirrhosis | Liver Cirrhosis Absent
Item
subject has moderate - severe hepatic impairment (child-pugh class b-c with or without cirrhosis) at the point of transition from study amb115811
boolean
C0948807 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C4050412 (UMLS CUI [1,3])
C0948807 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C4050412 (UMLS CUI [2,3])
C0023890 (UMLS CUI [3])
C0023890 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Body fluid retention
Item
subject with clinically significant fluid retention in the opinion of the investigator
boolean
C0268000 (UMLS CUI [1])
Anemia
Item
subject with clinically significant anemia in the opinion of the investigator
boolean
C0002871 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
subjects who are to enter another clinical trial or be treated with another investigational product after exiting study amb115811.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])