ID

13833

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)
  1. 10.03.16 10.03.16 -
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CC BY-NC 3.0

Hochgeladen am

10. März 2016

DOI

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VX-950HPC3006 NCT01571583 Medical/Surgical History and Concomitant Disease

Englisch

VX-950HPC3006 Medical/Surgical History and Concomitant Disease

1 Formulare  
Medical/Surgical History and Concomitant Disease
Beschreibung

Medical/Surgical History and Concomitant Disease

Date of history collection
Beschreibung

Date of history collection

Datentyp

integer

Alias
UMLS CUI [1]
C2826918
Other date of history collection
Beschreibung

Other date of history collection

Datentyp

date

Alias
UMLS CUI [1]
C2826918
Does the subject have any history of Drug allergy/hypersensitivity?
Beschreibung

If yes, please indicate in the following item

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0019664
Sulfonamide allergy
Beschreibung

Sulfonamide allergy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038760
UMLS CUI [1,2]
C0020517
Penicillin allergy
Beschreibung

Penicillin allergy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0030840
Other drug allergy, please specify
Beschreibung

Other drug allergy

Datentyp

text

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0205394
Does the patient have congenital or acquired prolonged QT interval?
Beschreibung

Prolonged QT interval

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0151878
UMLS CUI [1,2]
C1744681
UMLS CUI [2,1]
C0151878
UMLS CUI [2,2]
C0439661
Does the subject have a history of nonsustained or sustained ventricular tachycardia?
Beschreibung

ventricular tachycardia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042514
UMLS CUI [1,2]
C0019664
Does the subject have a history of drug-induced QT prolongation and/or Torsade de Pointes?
Beschreibung

If yes please specify the drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040479
UMLS CUI [1,2]
C0458082
UMLS CUI [1,3]
C0019664
UMLS CUI [2,1]
C0151878
UMLS CUI [2,2]
C0458082
UMLS CUI [2,3]
C0019664
Drug name
Beschreibung

Specification of the drug inducing QT prolongation and/or Torsade de Pointes

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Does the subject have any indication of diabetes mellitus, hypertension or known retinal disorders?
Beschreibung

If yes, please provide details in the appropriate System section below. Please also provide details of fundoscopic exam and clearance by an ophthalmologist or a similarly qualified provider on the Screening Physical Examination Form

Datentyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0020538
UMLS CUI [3]
C0035309
Allergic/Immunologic Diseases
Beschreibung

Allergic/Immunologic Diseases

Allergic or Immunologic disease
Beschreibung

If yes, please specify in the following item

Datentyp

boolean

Alias
UMLS CUI [1]
C0021053
UMLS CUI [2]
C0020517
History and not active allergic/immunological diseases, specify
Beschreibung

History and not active allergic/immunological diseases, specify

Datentyp

text

Alias
UMLS CUI [1]
C0021053
UMLS CUI [2]
C0020517
Currently active allergic/immunological disease
Beschreibung

Currently active allergic/immunological disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0021053
UMLS CUI [1,2]
C0205177
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0205177
Dermatological diseases
Beschreibung

Dermatological diseases

Alias
UMLS CUI-1
C0037274
Dermatological disorders
Beschreibung

Dermatological disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0037274
History and not active dermatological disorder, specify
Beschreibung

History and not active dermatological disorder

Datentyp

text

Alias
UMLS CUI [1]
C0037274
Currently active dermatological disorder, specify
Beschreibung

Currently active dermatological disorder

Datentyp

text

Alias
UMLS CUI [1,1]
C0037274
UMLS CUI [1,2]
C0205177
Pruritic skin condition
Beschreibung

Pruritic skin condition

Has the subject had pruritic skin condition in past year?
Beschreibung

If yes, please specify in the following items

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033774
UMLS CUI [1,2]
C0037274
UMLS CUI [1,3]
C0040223
Age the pruritic skin condition first occurred
Beschreibung

Age the pruritic skin condition first occurred

Datentyp

integer

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0033774
UMLS CUI [1,3]
C0037274
Has this skin condition ever affected the skin creases in the past?
Beschreibung

Has this skin condition ever affected the skin creases in the past

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033774
UMLS CUI [1,2]
C0037274
UMLS CUI [2]
C0459397
The last year, has subject suffered from a generally dry skin?
Beschreibung

dry skin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0151908
UMLS CUI [1,2]
C0040223
Respiratory diseases
Beschreibung

Respiratory diseases

Alias
UMLS CUI-1
C0035204
Respiratory disorders
Beschreibung

Respiratory disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0035204
History and not active respiratory disorder, specify
Beschreibung

History and not active respiratory disorder, specify

Datentyp

text

Alias
UMLS CUI [1]
C0035204
Currently active respiratory disorder, specify
Beschreibung

Currently active respiratory disorder, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0035204
UMLS CUI [1,2]
C0205177
Cardiovascular disease
Beschreibung

Cardiovascular disease

Alias
UMLS CUI-1
C0007222
Cardiovascular disease
Beschreibung

Cardiovascular disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
History and not active cardiovascular disease specify
Beschreibung

History and not active cardiovascular disease

Datentyp

text

Alias
UMLS CUI [1]
C0007222
Currently active cardiovascular disease specify
Beschreibung

Currently active cardiovascular disease specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205177
Endocrine disease
Beschreibung

Endocrine disease

Alias
UMLS CUI-1
C0014130
Endocrine disease
Beschreibung

Endocrine disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0014130
History and inactive endocrine disease specify
Beschreibung

History and inactive endocrine disease

Datentyp

text

Alias
UMLS CUI [1]
C0014130
Currently active endocrine disease
Beschreibung

Currently active endocrine disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0014130
UMLS CUI [1,2]
C0205177
Gastrointestinal disease
Beschreibung

Gastrointestinal disease

Alias
UMLS CUI-1
C0017178
Gastrointestinal disease
Beschreibung

Gastrointestinal disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0017178
History and inactive gastrointestinal disease
Beschreibung

History and inactive gastrointestinal disease

Datentyp

text

Alias
UMLS CUI [1]
C0017178
Currently active gastrointestinal disease specify
Beschreibung

Currently active gastrointestinal disease specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0205177
Genito-urinary disease
Beschreibung

Genito-urinary disease

Alias
UMLS CUI-1
C0080276
Genito-urinary disease
Beschreibung

Genito-urinary disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0080276
History and not active genito-urinary disease
Beschreibung

History and not active genito-urinary disease

Datentyp

text

Alias
UMLS CUI [1]
C0080276
Currently active genito-urinary disease specify
Beschreibung

Currently active genito-urinary disease specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0080276
UMLS CUI [1,2]
C0205177
Hematological disease
Beschreibung

Hematological disease

Alias
UMLS CUI-1
C0018939
Hematological disease
Beschreibung

Hematological disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0018939
History and not active hematological disease specify
Beschreibung

History and not active hematological disease

Datentyp

text

Alias
UMLS CUI [1]
C0018939
Currently active hematological disease specify
Beschreibung

Currently active hematological disease specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0018939
UMLS CUI [1,2]
C0205177
Muscuko-skeletal disease
Beschreibung

Muscuko-skeletal disease

Alias
UMLS CUI-1
C0026857
Muscuko-skeletal disease
Beschreibung

Muscuko-skeletal disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0026857
History and inactive musculoskeletal disease specify
Beschreibung

History and inactive musculoskeletal disease

Datentyp

text

Alias
UMLS CUI [1]
C0026857
Currently active musculoskeletal disease specify
Beschreibung

Currently active musculoskeletal disease specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0026857
UMLS CUI [1,2]
C0205177
Neurological Disease
Beschreibung

Neurological Disease

Alias
UMLS CUI-1
C0027765
Neurological disease
Beschreibung

Neurological disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0027765
History and not active neurological disease specify
Beschreibung

History and not active neurological disease

Datentyp

text

Alias
UMLS CUI [1]
C0027765
Currently active neurological disease
Beschreibung

Currently active neurological disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0205177
Psychiatric Disease
Beschreibung

Psychiatric Disease

Alias
UMLS CUI-1
C0004936
Psychiatric diseases
Beschreibung

Psychiatric diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0004936
History and not active psychiatric disease specify
Beschreibung

History and not active psychiatric disease

Datentyp

text

Alias
UMLS CUI [1]
C0004936
Currently active psychiatric disease specify
Beschreibung

Currently active psychiatric disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205177
Ophthalmological disorders
Beschreibung

Ophthalmological disorders

Alias
UMLS CUI-1
C0015397
Ophthalmological disorders
Beschreibung

Ophthalmological disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0015397
History and not active ophthalmological disorders
Beschreibung

History and not active ophthalmological disorders

Datentyp

text

Alias
UMLS CUI [1]
C0015397
Current active ophthalmological disorders
Beschreibung

Current active ophthalmological disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C0015397
UMLS CUI [1,2]
C0205177
ENT disorder
Beschreibung

ENT disorder

Alias
UMLS CUI-1
C0029896
ENT disorders
Beschreibung

ENT disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0029896
History and inactive ent disorders specify
Beschreibung

History and inactive ent disorders

Datentyp

text

Alias
UMLS CUI [1]
C0029896
Currently active ent disorders specify
Beschreibung

Currently active ent disorders

Datentyp

text

Alias
UMLS CUI [1,1]
C0029896
UMLS CUI [1,2]
C0205177
Other comorbidity
Beschreibung

Other comorbidity

Alias
UMLS CUI-1
C0009488
other comorbidity
Beschreibung

other comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
History and not active other comorbidity specify
Beschreibung

History and not active other comorbidity specify

Datentyp

text

Alias
UMLS CUI [1]
C0009488
Currently active other comorbidity specify
Beschreibung

Currently active other comorbidity

Datentyp

text

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205177
Row number
Beschreibung

Row number

Datentyp

text

Alias
UMLS CUI [1]
C0237753
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Ähnliche Modelle

VX-950HPC3006 Medical/Surgical History and Concomitant Disease

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Medical/Surgical History and Concomitant Disease
Item
Date of history collection
integer
C2826918 (UMLS CUI [1])
Date of history collection
Code List
Date of history collection
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])
Sulfonamide allergy
Item
Sulfonamide allergy
boolean
C0038760 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Penicillin allergy
Item
Penicillin allergy
boolean
C0020517 (UMLS CUI [1,1])
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])
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])
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])
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])
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])
Item Group
Allergic/Immunologic Diseases
Allergic or Immunologic disease
Item
Allergic or Immunologic disease
boolean
C0021053 (UMLS CUI [1])
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])
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])
Item Group
Dermatological diseases
C0037274 (UMLS CUI-1)
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])
Item Group
Pruritic skin condition
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])
Item
Age the pruritic skin condition first occurred
integer
C0001779 (UMLS CUI [1,1])
C0033774 (UMLS CUI [1,2])
C0037274 (UMLS CUI [1,3])
Age the pruritic skin condition first occurred
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])
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])
Item Group
Respiratory diseases
C0035204 (UMLS CUI-1)
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])
Item Group
Cardiovascular disease
C0007222 (UMLS CUI-1)
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])
Item Group
Endocrine disease
C0014130 (UMLS CUI-1)
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])
Item Group
Gastrointestinal disease
C0017178 (UMLS CUI-1)
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])
Item Group
Genito-urinary disease
C0080276 (UMLS CUI-1)
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])
Item Group
Hematological disease
C0018939 (UMLS CUI-1)
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])
Item Group
Muscuko-skeletal disease
C0026857 (UMLS CUI-1)
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])
Item Group
Neurological Disease
C0027765 (UMLS CUI-1)
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])
Item Group
Psychiatric Disease
C0004936 (UMLS CUI-1)
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])
Item Group
Ophthalmological disorders
C0015397 (UMLS CUI-1)
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])
Item Group
ENT disorder
C0029896 (UMLS CUI-1)
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])
Item Group
Other comorbidity
C0009488 (UMLS CUI-1)
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])
Row number
Item
Row number
text
C0237753 (UMLS CUI [1])
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