ID
14112
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)
- 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 Targeted Physical Examination
VX-950HPC3006 NCT01571583 Targeted 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 new finding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
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 new finding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
Beschrijving
abnormality clinically significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
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 new finding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
Beschrijving
abnormality clinically significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
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 new finding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
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 new finding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
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 new finding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
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 new finding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
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 new finding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
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 new finding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
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 new finding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
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 new finding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
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 new finding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
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 NCT01571583 Targeted Physical Examination
- StudyEvent: ODM
C1320303 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2585997 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C0026724 (UMLS CUI-2)
C2585997 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2585997 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2585997 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2585997 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2585997 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2585997 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2585997 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2585997 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2585997 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2585997 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C2585997 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])