ID

31696

Beskrivning

A Study to Evaluate GSK1325760A - a Long-Term Extension Study; ODM derived from: https://clinicaltrials.gov/show/NCT00554619

Länk

https://clinicaltrials.gov/show/NCT00554619

Nyckelord

Versioner (1)
  1. 2018-09-21 2018-09-21 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

21 september 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Pulmonary Arterial Hypertension NCT00554619

Engelsk

Eligibility Pulmonary Arterial Hypertension NCT00554619

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who complete the 24-week administration of the phase ii/iii study (study no.amb107816)
Beskrivning

Administration of medication Complete | Clinical Trial Specified

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
subjects who are assessed that the long-term extension administration of gsk1325760a is appropriate in the judgement of the investigator or subinvestigator
Beskrivning

Patients Appropriate Ambrisentan Long-term drug therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C1176329
UMLS CUI [1,4]
C0420257
subjects who request the long-term extension administration of gsk1325760a, and agree to newly sign the informed consent form
Beskrivning

Ambrisentan Long-term drug therapy Requested by patient | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1176329
UMLS CUI [1,2]
C0420257
UMLS CUI [1,3]
C0332153
UMLS CUI [2]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who have been withdrawn from the phase ii/iii study.
Beskrivning

Patient withdrawn from trial Specified

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0205369
female subjects who wish to become pregnant.
Beskrivning

Gender Planned Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0032992
treatment with other pah medication is needed.
Beskrivning

Pharmaceutical Preparations Other Pulmonary arterial hypertension

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2973725
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).
Beskrivning

Worsening Level Quantity WHO classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332271
UMLS CUI [1,2]
C0441889
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C4267671
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).
Beskrivning

Worsening Right ventricular failure | Raised jugular venous pressure | HEPATOMEGALY NEW | Hepatomegaly Worsened | Ascites | Peripheral edema

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332271
UMLS CUI [1,2]
C2939447
UMLS CUI [2]
C0520861
UMLS CUI [3]
C0744872
UMLS CUI [4,1]
C0019209
UMLS CUI [4,2]
C1457868
UMLS CUI [5]
C0003962
UMLS CUI [6]
C0085649
rapidly progressing cardiac, hepatic or renal failure during phase ii/iii study (study no.amb107816).
Beskrivning

Heart failure Rapidly progressive | Liver Failure Rapidly progressive | Kidney Failure Rapidly progressive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1838681
UMLS CUI [2,1]
C0085605
UMLS CUI [2,2]
C1838681
UMLS CUI [3,1]
C0035078
UMLS CUI [3,2]
C1838681
participation to the long-term extension study is considered as inappropriate in the judgment of the investigator or subinvestigator.
Beskrivning

Study Subject Participation Status Inappropriate | Clinical Trial Long-term

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0443252
Tillbaka till toppen

Similar models

Eligibility Pulmonary Arterial Hypertension NCT00554619

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial