ID

14047

Beskrivning

This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. NCT01571583

Nyckelord

Versioner (1)
  1. 2016-03-23 2016-03-23 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

23 mars 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
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.

VX-950HPC3006 NCT01571583 Study Drug Termination Peg-IFN

Engelsk

VX-950HPC3006 NCT01571583 Study Drug Termination Peg-IFN

1 Formulär  
Study Drug Completion/Discontinuation
Beskrivning

Study Drug Completion/Discontinuation

Completed
Beskrivning

Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

Datatyp

boolean

Alias
UMLS CUI [1]
C0205197
Early drug discontinuation without trial termination due to an Adverse Event related event (including abnormal lab values, intercurrent illness and pregnancy), please specify AE#(s) - as recorded on AE form:
Beskrivning

Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

Datatyp

text

Alias
UMLS CUI [1,1]
C0558681
UMLS CUI [1,2]
C1279919
UMLS CUI [2]
C0877248
UMLS CUI [3]
C2718058
Discontinued, subject non-compliant
Beskrivning

Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C1444662
Discontinued, subject ineligible to continue the protocol treatment
Beskrivning

Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

Datatyp

boolean

Alias
UMLS CUI [1]
C1444662
UMLS CUI [2]
C1512714
Discontinued, subject reached a virologic endpoint
Beskrivning

Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

Datatyp

boolean

Alias
UMLS CUI [1]
C1444662
UMLS CUI [2,1]
C2349179
UMLS CUI [2,2]
C0205466
Other reason, specify - only applicable for early drug discontinuation without trial termination:
Beskrivning

Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

Datatyp

text

Alias
UMLS CUI [1]
C3840932
Early trial termination due to reasons other than listed above
Beskrivning

Please specify if the subject completed the entire course of the Investigational Medication as specified in the protocol or if the subject discontinued the Investigational Medication early

Datatyp

boolean

Alias
UMLS CUI [1]
C2718058
UMLS CUI [2]
C3840932
Office use only
Beskrivning

Office use only

Datatyp

text

Tillbaka till toppen

Similar models

VX-950HPC3006 NCT01571583 Study Drug Termination Peg-IFN

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Study Drug Completion/Discontinuation
Completed
Item
Completed
boolean
C0205197 (UMLS CUI [1])
Early drug discontinuation
Item
Early drug discontinuation without trial termination due to an Adverse Event related event (including abnormal lab values, intercurrent illness and pregnancy), please specify AE#(s) - as recorded on AE form:
text
C0558681 (UMLS CUI [1,1])
C1279919 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2])
C2718058 (UMLS CUI [3])
Discontinued, subject non-compliant
Item
Discontinued, subject non-compliant
boolean
C1321605 (UMLS CUI [1])
C1444662 (UMLS CUI [2])
Discontinued, subject ineligible to continue the protocol treatment
Item
Discontinued, subject ineligible to continue the protocol treatment
boolean
C1444662 (UMLS CUI [1])
C1512714 (UMLS CUI [2])
Discontinued, subject reached a virologic endpoint
Item
Discontinued, subject reached a virologic endpoint
boolean
C1444662 (UMLS CUI [1])
C2349179 (UMLS CUI [2,1])
C0205466 (UMLS CUI [2,2])
Other reason
Item
Other reason, specify - only applicable for early drug discontinuation without trial termination:
text
C3840932 (UMLS CUI [1])
Early trial termination
Item
Early trial termination due to reasons other than listed above
boolean
C2718058 (UMLS CUI [1])
C3840932 (UMLS CUI [2])
Office use only
Item
Office use only
text
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