ID

13838

Description

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

Keywords

Versions (1)
  1. 3/10/16 3/10/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 10, 2016

DOI

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License

Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Vital Signs / Anthropometric Measurements

English

VX-950HPC3006 Vital Sign / Anthropometric Measurements

1 forms  
Vital signs and anthropometric measurements
Description

Vital signs and anthropometric measurements

Date performed
Description

Date performed

Data type

integer

Alias
UMLS CUI [1]
C0011008
height
Description

Height

Data type

text

Alias
UMLS CUI [1]
C0005890
Weight
Description

Weight

Data type

text

Alias
UMLS CUI [1]
C0005910
Body Mass Index
Description

Body Mass Index

Data type

text

Measurement units
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Pulse supine
Description

after 5 minutes in supine position at rest

Data type

text

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0038846
beats/min
Blood pressure supine
Description

after 5 minutes in supine position at rest

Data type

text

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0038846
mmHg
Clinically significant abnormalities
Description

Clinically significant abnormalities

Data type

boolean

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

VX-950HPC3006 Vital Sign / Anthropometric Measurements

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Vital signs and anthropometric measurements
Item
Date performed
integer
C0011008 (UMLS CUI [1])
Date performed
Code List
Date performed
CL Item
Same date as visit date (1)
CL Item
other date please specify (2)
Height
Item
height
text
C0005890 (UMLS CUI [1])
Weight
Item
Weight
text
C0005910 (UMLS CUI [1])
Body Mass Index
Item
Body Mass Index
text
C1305855 (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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