Administration of medication Complete | Clinical Trial Specified
Item
subjects who complete the 24-week administration of the phase ii/iii study (study no.amb107816)
boolean
C3469597 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Patients Appropriate Ambrisentan Long-term drug therapy
Item
subjects who are assessed that the long-term extension administration of gsk1325760a is appropriate in the judgement of the investigator or subinvestigator
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C1176329 (UMLS CUI [1,3])
C0420257 (UMLS CUI [1,4])
Ambrisentan Long-term drug therapy Requested by patient | Informed Consent
Item
subjects who request the long-term extension administration of gsk1325760a, and agree to newly sign the informed consent form
boolean
C1176329 (UMLS CUI [1,1])
C0420257 (UMLS CUI [1,2])
C0332153 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2])
Patient withdrawn from trial Specified
Item
subjects who have been withdrawn from the phase ii/iii study.
boolean
C0422727 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Gender Planned Pregnancy
Item
female subjects who wish to become pregnant.
boolean
C0079399 (UMLS CUI [1,1])
C0032992 (UMLS CUI [1,2])
Pharmaceutical Preparations Other Pulmonary arterial hypertension
Item
treatment with other pah medication is needed.
boolean
C0013227 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2973725 (UMLS CUI [1,3])
Worsening Level Quantity WHO classification
Item
a worsening of 2 or more levels of the who functional classification (see appendix 2.1) comparing with the baseline of phase ii/iii study (study no.amb107816).
boolean
C0332271 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C4267671 (UMLS CUI [1,4])
Worsening Right ventricular failure | Raised jugular venous pressure | HEPATOMEGALY NEW | Hepatomegaly Worsened | Ascites | Peripheral edema
Item
worsening of right ventricular failure (e.g. as indicated by increased jugular venous pressure, new/worsened hepatomegaly, ascites, or peripheral edema) during phase ii/iii study (study no.amb107816).
boolean
C0332271 (UMLS CUI [1,1])
C2939447 (UMLS CUI [1,2])
C0520861 (UMLS CUI [2])
C0744872 (UMLS CUI [3])
C0019209 (UMLS CUI [4,1])
C1457868 (UMLS CUI [4,2])
C0003962 (UMLS CUI [5])
C0085649 (UMLS CUI [6])
Heart failure Rapidly progressive | Liver Failure Rapidly progressive | Kidney Failure Rapidly progressive
Item
rapidly progressing cardiac, hepatic or renal failure during phase ii/iii study (study no.amb107816).
boolean
C0018801 (UMLS CUI [1,1])
C1838681 (UMLS CUI [1,2])
C0085605 (UMLS CUI [2,1])
C1838681 (UMLS CUI [2,2])
C0035078 (UMLS CUI [3,1])
C1838681 (UMLS CUI [3,2])
Study Subject Participation Status Inappropriate | Clinical Trial Long-term
Item
participation to the long-term extension study is considered as inappropriate in the judgment of the investigator or subinvestigator.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0008976 (UMLS CUI [2,1])
C0443252 (UMLS CUI [2,2])