ID
13898
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
Versies (1)
- 14-03-16 14-03-16 -
Houder van rechten
CC BY-NC 3.0
Geüploaded op
14 maart 2016
DOI
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Licentie
Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Screening Physical Examination
VX-950HPC3006 Screening Physical Examination
- StudyEvent: ODM
Beschrijving
General Appearance
Alias
- UMLS CUI-1
- C1148438
Beschrijving
Not done
Datatype
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
Normal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschrijving
Abnormal
Datatype
text
Alias
- UMLS CUI [1]
- C0205161
Beschrijving
abnormality clinically significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschrijving
Skin and mucous membranes
Alias
- UMLS CUI-1
- C1123023
- UMLS CUI-2
- C0026724
Beschrijving
not done
Datatype
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
normal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschrijving
abnormal
Datatype
text
Alias
- UMLS CUI [1]
- C0205161
Beschrijving
abnormality clinically significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschrijving
one or more patches of dermatitis affecting any of the following sites: behind the knees, fronts of ankles, fronts of elbows (antecubital fossae), sides or front of the neck, or around the ears or eyes. Dermatitis may be defined as 'poorly demarcated erythema with surfacing change'. Surface change can mean scalling, crusting, vesicles or lichenification.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0011603
- UMLS CUI [1,2]
- C0439748
Beschrijving
Eyes
Alias
- UMLS CUI-1
- C0015392
Beschrijving
not done
Datatype
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
normal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschrijving
abnormal
Datatype
text
Alias
- UMLS CUI [1]
- C0205161
Beschrijving
abnormality clinically significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschrijving
Funduscopic exam
Alias
- UMLS CUI-1
- C0029090
Beschrijving
funduscopic exam and clearance by an ophthalmologist or a similarly qualified healthcare provider is required within 3 months prior to the screening visit or within the screening period for all subjects with diabetes mellitus, hypertension, or known retinal disorders.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
normal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschrijving
abnormal
Datatype
text
Alias
- UMLS CUI [1]
- C0205161
Beschrijving
if yes, subject is screening failure
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschrijving
date of funduscopic exam
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0029090
- UMLS CUI [1,2]
- C0011008
Beschrijving
Ears, nose, throat
Alias
- UMLS CUI-1
- C0007222
Beschrijving
not done
Datatype
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
normal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschrijving
abnormal
Datatype
text
Alias
- UMLS CUI [1]
- C0205161
Beschrijving
abnormality clinically significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschrijving
Cardiovascular system
Alias
- UMLS CUI-1
- C0007226
Beschrijving
not done
Datatype
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
normal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschrijving
abnormal
Datatype
text
Alias
- UMLS CUI [1]
- C0205161
Beschrijving
abnormality clinically significant?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschrijving
Respiratory system
Alias
- UMLS CUI-1
- C0035237
Beschrijving
not done
Datatype
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
normal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschrijving
abnormal
Datatype
text
Alias
- UMLS CUI [1]
- C0205161
Beschrijving
abnormality clinically significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschrijving
Gastrointestinal system
Alias
- UMLS CUI-1
- C0012240
Beschrijving
not done
Datatype
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
normal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschrijving
abnormal
Datatype
text
Alias
- UMLS CUI [1]
- C0205161
Beschrijving
abnormality clinically significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschrijving
Genito-urinary system
Alias
- UMLS CUI-1
- C0260313
Beschrijving
not done
Datatype
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
normal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschrijving
abnormal
Datatype
text
Alias
- UMLS CUI [1]
- C0205161
Beschrijving
is the abnormality clinically significant?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschrijving
neurological system
Alias
- UMLS CUI-1
- C0027853
Beschrijving
not done
Datatype
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
normal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschrijving
abnormal
Datatype
text
Alias
- UMLS CUI [1]
- C0205161
Beschrijving
abnormality clinically significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschrijving
musculo-skeletal system
Alias
- UMLS CUI-1
- C0026860
Beschrijving
not done
Datatype
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
normal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschrijving
abnormal
Datatype
text
Alias
- UMLS CUI [1]
- C0205161
Beschrijving
abnormality clinically significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschrijving
lymph nodes
Alias
- UMLS CUI-1
- C0024204
Beschrijving
not done
Datatype
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
normal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschrijving
abnormal
Datatype
text
Alias
- UMLS CUI [1]
- C0205161
Beschrijving
abnormality clinically significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschrijving
anorectal
Alias
- UMLS CUI-1
- C3870603
Beschrijving
not done
Datatype
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschrijving
normal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschrijving
abnormal
Datatype
text
Alias
- UMLS CUI [1]
- C0205161
Beschrijving
abnormality clinically significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschrijving
other abnormality
Alias
- UMLS CUI-1
- C1704258
- UMLS CUI-2
- C0205394
Beschrijving
new finding only please only one abnormality per row
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0205394
Beschrijving
abnormality clinically significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschrijving
row number
Datatype
text
Alias
- UMLS CUI [1]
- C0237753
Similar models
VX-950HPC3006 Screening Physical Examination
- StudyEvent: ODM
C1320303 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C0026724 (UMLS CUI-2)
C2985739 (UMLS CUI [1,2])
C0439748 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])