ID

14111

Beschrijving

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

Trefwoorden

  1. 30-03-16 30-03-16 -
Houder van rechten

CC BY-NC 3.0

Geüploaded op

30 maart 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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VX-950HPC3006 NCT01571583 Vital Signs / Anthropometric Measurements (VS) [FRMVS_VS2]

VX-950HPC3006 NCT01571583 Vital Signs / Anthropometric Measurements (VS) [FRMVS_VS2]

Vital signs and anthropometric measurements
Beschrijving

Vital signs and anthropometric measurements

Date performed
Beschrijving

Date performed

Datatype

integer

Alias
UMLS CUI [1]
C0011008
Pulse supine
Beschrijving

after 5 minutes in supine position at rest

Datatype

text

Maateenheden
  • beats/min
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0038846
beats/min
Blood pressure supine
Beschrijving

after 5 minutes in supine position at rest

Datatype

text

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0038846
mmHg
Clinically significant abnormalities
Beschrijving

Clinically significant abnormalities

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739

Similar models

VX-950HPC3006 NCT01571583 Vital Signs / Anthropometric Measurements (VS) [FRMVS_VS2]

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Vital signs and anthropometric measurements
Item
Date performed
integer
C0011008 (UMLS CUI [1])
Code List
Date performed
CL Item
Same date as visit date (1)
CL Item
other date please specify (2)
Pulse supine
Item
Pulse supine
text
C0232117 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Blood pressure supine
Item
Blood pressure supine
text
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Clinically significant abnormalities
Item
Clinically significant abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])

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