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ID
13833
Descrição
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
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Versões (1)
- 10/03/2016 10/03/2016 -
Titular dos direitos
CC BY-NC 3.0
Transferido a
10 de março de 2016
DOI
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Licença
Creative Commons BY-NC 3.0
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VX-950HPC3006 NCT01571583 Medical/Surgical History and Concomitant Disease
VX-950HPC3006 Medical/Surgical History and Concomitant Disease
- StudyEvent: ODM
Similar models
VX-950HPC3006 Medical/Surgical History and Concomitant Disease
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Medical/Surgical History and Concomitant Disease
CL Item
Same date as visit date (1)
CL Item
Other date (2)
Other date of history collection
Item
Other date of history collection
date
C2826918 (UMLS CUI [1])
History of drug allergy/hypersensitivity
Item
Does the subject have any history of Drug allergy/hypersensitivity?
boolean
C0013182 (UMLS CUI [1,1])
C0019664 (UMLS CUI [1,2])
C0019664 (UMLS CUI [1,2])
Sulfonamide allergy
Item
Sulfonamide allergy
boolean
C0038760 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,2])
Penicillin allergy
Item
Penicillin allergy
boolean
C0020517 (UMLS CUI [1,1])
C0030840 (UMLS CUI [1,2])
C0030840 (UMLS CUI [1,2])
Other drug allergy
Item
Other drug allergy, please specify
text
C0013182 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Prolonged QT interval
Item
Does the patient have congenital or acquired prolonged QT interval?
boolean
C0151878 (UMLS CUI [1,1])
C1744681 (UMLS CUI [1,2])
C0151878 (UMLS CUI [2,1])
C0439661 (UMLS CUI [2,2])
C1744681 (UMLS CUI [1,2])
C0151878 (UMLS CUI [2,1])
C0439661 (UMLS CUI [2,2])
ventricular tachycardia
Item
Does the subject have a history of nonsustained or sustained ventricular tachycardia?
boolean
C0042514 (UMLS CUI [1,1])
C0019664 (UMLS CUI [1,2])
C0019664 (UMLS CUI [1,2])
drug-induced qt prolongation and/or torsade de pointes
Item
Does the subject have a history of drug-induced QT prolongation and/or Torsade de Pointes?
boolean
C0040479 (UMLS CUI [1,1])
C0458082 (UMLS CUI [1,2])
C0019664 (UMLS CUI [1,3])
C0151878 (UMLS CUI [2,1])
C0458082 (UMLS CUI [2,2])
C0019664 (UMLS CUI [2,3])
C0458082 (UMLS CUI [1,2])
C0019664 (UMLS CUI [1,3])
C0151878 (UMLS CUI [2,1])
C0458082 (UMLS CUI [2,2])
C0019664 (UMLS CUI [2,3])
Drug
Item
Drug name
text
C0013227 (UMLS CUI [1])
Diabetes Mellitus, Hypertension or Retinal Disorders
Item
Does the subject have any indication of diabetes mellitus, hypertension or known retinal disorders?
boolean
C0011849 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C0035309 (UMLS CUI [3])
C0020538 (UMLS CUI [2])
C0035309 (UMLS CUI [3])
Allergic or Immunologic disease
Item
Allergic or Immunologic disease
boolean
C0021053 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
C0020517 (UMLS CUI [2])
History and not active allergic/immunological diseases, specify
Item
History and not active allergic/immunological diseases, specify
text
C0021053 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
C0020517 (UMLS CUI [2])
Currently active allergic/immunological disease
Item
Currently active allergic/immunological disease
text
C0021053 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0205177 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
Dermatological disorders
Item
Dermatological disorders
boolean
C0037274 (UMLS CUI [1])
History and not active dermatological disorder
Item
History and not active dermatological disorder, specify
text
C0037274 (UMLS CUI [1])
Currently active dermatological disorder
Item
Currently active dermatological disorder, specify
text
C0037274 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
Pruritic skin
Item
Has the subject had pruritic skin condition in past year?
boolean
C0033774 (UMLS CUI [1,1])
C0037274 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0037274 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Age the pruritic skin condition first occurred
integer
C0001779 (UMLS CUI [1,1])
C0033774 (UMLS CUI [1,2])
C0037274 (UMLS CUI [1,3])
C0033774 (UMLS CUI [1,2])
C0037274 (UMLS CUI [1,3])
Code List
Age the pruritic skin condition first occurred
CL Item
<2 (1)
CL Item
2-5 (2)
CL Item
6-10 (3)
CL Item
≥ 11 (4)
Has this skin condition ever affected the skin creases in the past
Item
Has this skin condition ever affected the skin creases in the past?
boolean
C0033774 (UMLS CUI [1,1])
C0037274 (UMLS CUI [1,2])
C0459397 (UMLS CUI [2])
C0037274 (UMLS CUI [1,2])
C0459397 (UMLS CUI [2])
dry skin
Item
The last year, has subject suffered from a generally dry skin?
boolean
C0151908 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Respiratory disorders
Item
Respiratory disorders
boolean
C0035204 (UMLS CUI [1])
History and not active respiratory disorder, specify
Item
History and not active respiratory disorder, specify
text
C0035204 (UMLS CUI [1])
Currently active respiratory disorder, specify
Item
Currently active respiratory disorder, specify
text
C0035204 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
Cardiovascular disease
Item
Cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
History and not active cardiovascular disease
Item
History and not active cardiovascular disease specify
text
C0007222 (UMLS CUI [1])
Currently active cardiovascular disease specify
Item
Currently active cardiovascular disease specify
text
C0007222 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
Endocrine disease
Item
Endocrine disease
boolean
C0014130 (UMLS CUI [1])
History and inactive endocrine disease
Item
History and inactive endocrine disease specify
text
C0014130 (UMLS CUI [1])
Currently active endocrine disease
Item
Currently active endocrine disease
text
C0014130 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
Gastrointestinal disease
Item
Gastrointestinal disease
boolean
C0017178 (UMLS CUI [1])
History and inactive gastrointestinal disease
Item
History and inactive gastrointestinal disease
text
C0017178 (UMLS CUI [1])
Currently active gastrointestinal disease specify
Item
Currently active gastrointestinal disease specify
text
C0017178 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
Genito-urinary disease
Item
Genito-urinary disease
boolean
C0080276 (UMLS CUI [1])
History and not active genito-urinary disease
Item
History and not active genito-urinary disease
text
C0080276 (UMLS CUI [1])
Currently active genito-urinary disease specify
Item
Currently active genito-urinary disease specify
text
C0080276 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
Hematological disease
Item
Hematological disease
boolean
C0018939 (UMLS CUI [1])
History and not active hematological disease
Item
History and not active hematological disease specify
text
C0018939 (UMLS CUI [1])
Currently active hematological disease specify
Item
Currently active hematological disease specify
text
C0018939 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
Muscuko-skeletal disease
Item
Muscuko-skeletal disease
boolean
C0026857 (UMLS CUI [1])
History and inactive musculoskeletal disease
Item
History and inactive musculoskeletal disease specify
text
C0026857 (UMLS CUI [1])
Currently active musculoskeletal disease specify
Item
Currently active musculoskeletal disease specify
text
C0026857 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
Neurological disease
Item
Neurological disease
boolean
C0027765 (UMLS CUI [1])
History and not active neurological disease
Item
History and not active neurological disease specify
text
C0027765 (UMLS CUI [1])
Currently active neurological disease
Item
Currently active neurological disease
text
C0027765 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
Psychiatric diseases
Item
Psychiatric diseases
boolean
C0004936 (UMLS CUI [1])
History and not active psychiatric disease
Item
History and not active psychiatric disease specify
text
C0004936 (UMLS CUI [1])
Currently active psychiatric disease
Item
Currently active psychiatric disease specify
text
C0004936 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
Ophthalmological disorders
Item
Ophthalmological disorders
boolean
C0015397 (UMLS CUI [1])
History and not active ophthalmological disorders
Item
History and not active ophthalmological disorders
text
C0015397 (UMLS CUI [1])
Current active ophthalmological disorders
Item
Current active ophthalmological disorders
text
C0015397 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
ENT disorders
Item
ENT disorders
boolean
C0029896 (UMLS CUI [1])
History and inactive ent disorders
Item
History and inactive ent disorders specify
text
C0029896 (UMLS CUI [1])
Currently active ent disorders
Item
Currently active ent disorders specify
text
C0029896 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
other comorbidity
Item
other comorbidity
boolean
C0009488 (UMLS CUI [1])
History and not active other comorbidity specify
Item
History and not active other comorbidity specify
text
C0009488 (UMLS CUI [1])
Currently active other comorbidity
Item
Currently active other comorbidity specify
text
C0009488 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
Row number
Item
Row number
text
C0237753 (UMLS CUI [1])