ID
14112
Beschreibung
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
Stichworte
Versionen (1)
- 30.03.16 30.03.16 -
Rechteinhaber
CC BY-NC 3.0
Hochgeladen am
30. März 2016
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
VX-950HPC3006 NCT01571583 Targeted Physical Examination
VX-950HPC3006 NCT01571583 Targeted Physical Examination
- StudyEvent: ODM
Beschreibung
General Appearance
Alias
- UMLS CUI-1
- C1148438
Beschreibung
Not done
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
Normal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschreibung
Abnormal new finding
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
Beschreibung
abnormality clinically significant
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschreibung
Skin and mucous membranes
Alias
- UMLS CUI-1
- C1123023
- UMLS CUI-2
- C0026724
Beschreibung
not done
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
normal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschreibung
abnormal new finding
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
Beschreibung
abnormality clinically significant
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschreibung
Eyes
Alias
- UMLS CUI-1
- C0015392
Beschreibung
not done
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
normal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschreibung
abnormal new finding
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
Beschreibung
abnormality clinically significant
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschreibung
Ears, nose, throat
Alias
- UMLS CUI-1
- C0007222
Beschreibung
not done
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
normal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschreibung
abnormal new finding
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
Beschreibung
abnormality clinically significant
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschreibung
Cardiovascular system
Alias
- UMLS CUI-1
- C0007226
Beschreibung
not done
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
normal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschreibung
abnormal new finding
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
Beschreibung
abnormality clinically significant?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschreibung
Respiratory system
Alias
- UMLS CUI-1
- C0035237
Beschreibung
not done
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
normal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschreibung
abnormal new finding
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
Beschreibung
abnormality clinically significant
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschreibung
Gastrointestinal system
Alias
- UMLS CUI-1
- C0012240
Beschreibung
not done
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
normal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschreibung
abnormal new finding
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
Beschreibung
abnormality clinically significant
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschreibung
Genito-urinary system
Alias
- UMLS CUI-1
- C0260313
Beschreibung
not done
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
normal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschreibung
abnormal new finding
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
Beschreibung
is the abnormality clinically significant?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschreibung
neurological system
Alias
- UMLS CUI-1
- C0027853
Beschreibung
not done
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
normal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschreibung
abnormal new finding
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
Beschreibung
abnormality clinically significant
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschreibung
musculo-skeletal system
Alias
- UMLS CUI-1
- C0026860
Beschreibung
not done
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
normal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschreibung
abnormal new finding
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
Beschreibung
abnormality clinically significant
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschreibung
lymph nodes
Alias
- UMLS CUI-1
- C0024204
Beschreibung
not done
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
normal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschreibung
abnormal new finding
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
Beschreibung
abnormality clinically significant
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschreibung
anorectal
Alias
- UMLS CUI-1
- C3870603
Beschreibung
not done
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
normal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0205307
Beschreibung
abnormal new finding
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C2585997
Beschreibung
abnormality clinically significant
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschreibung
other abnormality
Alias
- UMLS CUI-1
- C1704258
- UMLS CUI-2
- C0205394
Beschreibung
new finding only please only one abnormality per row
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0205394
Beschreibung
abnormality clinically significant
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
Beschreibung
row number
Datentyp
text
Alias
- UMLS CUI [1]
- C0237753
Ähnliche Modelle
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])