ID

14107

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. 3/30/16 3/30/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 30, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

VX-950HPC3006 NCT01571583 Rash or cutaneous event follow-up

English

VX-950HPC3006 NCT01571583 Rash or cutaneous event follow-up

1 forms  
Rash or cutaneous event follow-up
Description

Rash or cutaneous event follow-up

date of visit
Description

date of visit

Data type

datetime

Alias
UMLS CUI [1]
C1320303
should this visit be marked as deleted?
Description

if yes, please complete the check box, else leave blank

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1880274
rash or cutaneous event number for this subject
Description

rash or cutaneous event number

Data type

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0237753
symptoms
Description

in case AE grade changed please report as new event on the AE form please also complete the final evaluation follow-up. enter outcome and end date on the AE form

Data type

integer

Alias
UMLS CUI [1]
C1457887
is there lymph node involvement?
Description

lymph node involvement

Data type

integer

Alias
UMLS CUI [1]
C0806692
office use only
Description

office use only

Data type

text

Back to the top of the page

Similar models

VX-950HPC3006 NCT01571583 Rash or cutaneous event follow-up

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Rash or cutaneous event follow-up
date of visit
Item
date of visit
datetime
C1320303 (UMLS CUI [1])
Item
should this visit be marked as deleted?
integer
C0545082 (UMLS CUI [1,1])
C1880274 (UMLS CUI [1,2])
deleted visit
Code List
should this visit be marked as deleted?
CL Item
deleted (1)
rash or cutaneous event number
Item
rash or cutaneous event number for this subject
text
C0015230 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
symptoms
integer
C1457887 (UMLS CUI [1])
symptoms
Code List
symptoms
CL Item
rash or cutaneous symptoms have worsened since the previous visit (1)
CL Item
rash or cutaneous symptoms have not changed since the previous visit (2)
CL Item
rash or cutaneous symptoms have improved since the previous visit (3)
CL Item
rash or cutaneous symptoms have resolved since the previous visit (4)
Item
is there lymph node involvement?
integer
C0806692 (UMLS CUI [1])
lymph node involvement
Code List
is there lymph node involvement?
CL Item
no (1)
CL Item
yes, please describe (i.e. location, single or multiple) (2)
office use only
Item
office use only
text
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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