ID

14122

Descripción

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

Palabras clave

  1. 30/3/16 30/3/16 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

30 de marzo de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0

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VX-950HPC3006 NCT01571583 Vital Signs / Anthropometric Measurements [FRMVS_VSRASH]

VX-950HPC3006 NCT01571583 Vital Signs / Anthropometric Measurements [FRMVS_VSRASH]

Vital signs and anthropometric measurements
Descripción

Vital signs and anthropometric measurements

rash or cutaneous event number
Descripción

rash or cutaneous event number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0237753
Date performed
Descripción

Date performed

Tipo de datos

integer

Alias
UMLS CUI [1]
C0011008
if other date, please specify
Descripción

other date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0205394
Weight
Descripción

Weight

Tipo de datos

text

Alias
UMLS CUI [1]
C0005910
Pulse supine
Descripción

after 5 minutes in supine position at rest

Tipo de datos

text

Unidades de medida
  • beats/min
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0038846
beats/min
Blood pressure supine
Descripción

after 5 minutes in supine position at rest

Tipo de datos

text

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0038846
mmHg
Clinically significant abnormalities
Descripción

Clinically significant abnormalities

Tipo de datos

boolean

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

Similar models

VX-950HPC3006 NCT01571583 Vital Signs / Anthropometric Measurements [FRMVS_VSRASH]

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Vital signs and anthropometric measurements
rash or cutaneous event number
Item
rash or cutaneous event number
text
C0015230 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
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)
other date
Item
if other date, please specify
date
C0011008 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Weight
Item
Weight
text
C0005910 (UMLS CUI [1])
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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