ID

4425

Description

ODM derived from http://clinicaltrials.gov/show/NCT00803309

Lien

http://clinicaltrials.gov/show/NCT00803309

Mots-clés

Versions (4)
  1. 09/12/2013 09/12/2013 - Martin Dugas
  2. 25/03/2014 25/03/2014 - Martin Dugas
  3. 16/04/2014 16/04/2014 - Julian Varghese
  4. 20/09/2021 20/09/2021 -
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9 décembre 2013

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00803309 Hepatitis C, Chronic

Allemand Anglais

Eligibility

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Description

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter mindestens 18 Jahre
Description

age at least 18 Years

Type de données

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Male and female patients with HCV-genotype 2/3 chronic hepatitis C documented by detectable plasma HCV RNA (> 15 IU/mL) and positivity of anti-HCV antibodies
Description

Male and female patients with HCV-genotype 2/3 chronic hepatitis C documented by detectable plasma HCV RNA (> 15 IU/mL) and positivity of anti-HCV antibodies

Type de données

boolean

Alias
UMLS CUI 2011AA
C0024554
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0220847
SNOMED CT 2011_0131
62944002
MedDRA 14.1
10019752
UMLS CUI 2011AA
C0017431
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0524910
SNOMED CT 2011_0131
128302006
MedDRA 14.1
10008912
ICD-10-CM Version 2010
B18.2
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0032105
SNOMED CT 2011_0131
50863008
LOINC Version 232
MTHU002157
UMLS CUI 2011AA
C0369335
SNOMED CT 2011_0131
121204002
LOINC Version 232
MTHU001816
UMLS CUI 2011AA
C0281863
MedDRA 14.1
10019747
Compensated liver disease (Child-Pugh Grade A clinical classification)
Description

Compensated liver disease (Child-Pugh Grade A clinical classification)

Type de données

boolean

Alias
UMLS CUI 2011AA
C0205432
SNOMED CT 2011_0131
17275008
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
UMLS CUI 2011AA
C2347612
UMLS CUI 2011AA
C0441800
SNOMED CT 2011_0131
258349007
LOINC Version 232
MTHU003112
UMLS CUI 2011AA
C1706281
SNOMED CT 2011_0131
422097006
Negative urine or blood pregnancy test (one of the both, for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 7 months after treatment end. This includes using birth control pills (no interaction with investigational drugs), IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state. At least one contraception method must be of barrier method
Description

Negative urine or blood pregnancy test (one of the both, for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 7 months after treatment end. This includes using birth control pills (no interaction with investigational drugs), IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state. At least one contraception method must be of barrier method

Type de données

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0430057
SNOMED CT 2011_0131
167254001
MedDRA 14.1
10036577
UMLS CUI 2011AA
C0430061
SNOMED CT 2011_0131
166435006
UMLS CUI 2011AA
CL426012
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0024554
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0009905
SNOMED CT 2011_0131
59261009
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
C0677582
UMLS CUI 2011AA
C0042241
SNOMED CT 2011_0131
20359006
UMLS CUI 2011AA
CL424925
UMLS CUI 2011AA
C0038288
MedDRA 14.1
10062116
UMLS CUI 2011AA
C0232970
SNOMED CT 2011_0131
76498008
UMLS CUI 2011AA
C0004764
SNOMED CT 2011_0131
225370004
Ongoing treatment with 1.5 µg/kg Peg-Interferon alpha-2b (PegIntron) and > 10.6 mg/kg ribavirin (Rebetol)
Description

Ongoing treatment with 1.5 µg/kg Peg-Interferon alpha-2b (PegIntron) and > 10.6 mg/kg ribavirin (Rebetol)

Type de données

boolean

Alias
UMLS CUI 2011AA
C0750536
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0796545
SNOMED CT 2011_0131
395823000
UMLS CUI 2011AA
C0035525
SNOMED CT 2011_0131
387188005
LOINC Version 232
MTHU018696
No rapid virological response (HCV-RNA positive after week 4 of the ongoing therapy)
Description

No rapid virological response (HCV-RNA positive after week 4 of the ongoing therapy)

Type de données

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0439831
SNOMED CT 2011_0131
255358001
UMLS CUI 2011AA
C1155328
UMLS CUI 2011AA
C0855842
MedDRA 14.1
10019750
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0039798
Willingness to give written informed consent and willingness to participate to and to comply with the study protocol
Description

Willingness to give written informed consent and willingness to participate to and to comply with the study protocol

Type de données

boolean

Alias
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0184704
SNOMED CT 2011_0131
55149002
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0525058
Ausschlusskriterien
Description

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Women with ongoing pregnancy or breast feeding
Description

Women with ongoing pregnancy or breast feeding

Type de données

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Male partners of women who are pregnant
Description

Male partners of women who are pregnant

Type de données

boolean

Alias
UMLS CUI 2011AA
C0024554
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0682323
SNOMED CT 2011_0131
262043009
HL7 V3 2006_05
SIGOTHR
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
Positive tests at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg, anti-HIV, HIV-RNA
Description

Positive tests at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg, anti-HIV, HIV-RNA

Type de données

boolean

Alias
UMLS CUI 2011AA
C1335447
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0062524
SNOMED CT 2011_0131
32609007
LOINC Version 232
MTHU004541
UMLS CUI 2011AA
C1442155
LOINC Version 232
MTHU021816
UMLS CUI 2011AA
C0019168
SNOMED CT 2011_0131
22290004
LOINC Version 232
MTHU001814
UMLS CUI 2011AA
C0948759
MedDRA 14.1
10052020
UMLS CUI 2011AA
C1442155
LOINC Version 232
MTHU021816
UMLS CUI 2011AA
C0019167
SNOMED CT 2011_0131
60605004
LOINC Version 232
MTHU004548
UMLS CUI 2011AA
C0856918
MedDRA 14.1
10002725
UMLS CUI 2011AA
C0877327
MedDRA 14.1
10049826
History or other evidence of a medical condition associated with chronic liver disease other than HCV associated (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
Description

History or other evidence of a medical condition associated with chronic liver disease other than HCV associated (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)

Type de données

boolean

Alias
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C0341439
SNOMED CT 2011_0131
328383001
MedDRA 14.1
10008953
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0220847
SNOMED CT 2011_0131
62944002
MedDRA 14.1
10019752
UMLS CUI 2011AA
C0018995
SNOMED CT 2011_0131
399187006
MedDRA 14.1
10018872
ICD-10-CM Version 2010
E83.119
UMLS CUI 2011AA
C0241910
SNOMED CT 2011_0131
408335007
MedDRA 14.1
10003827
ICD-10-CM Version 2010
K75.4
ICD-9-CM Version 2011
571.42
UMLS CUI 2011AA
C0023896
SNOMED CT 2011_0131
41309000
MedDRA 14.1
10001627
ICD-10-CM Version 2010
K70.9
ICD-9-CM Version 2011
571.3
UMLS CUI 2011AA
C0040537
SNOMED CT 2011_0131
420239005
History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
Description

History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease

Type de données

boolean

Alias
UMLS CUI 2011AA
C0155789
SNOMED CT 2011_0131
17709002
MedDRA 14.1
10030210
ICD-10-CM Version 2010
I85.01
ICD-9-CM Version 2011
456.0
CTCAE 1105E
E10682
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0745744
MedDRA 14.1
10050060
Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening
Description

Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening

Type de données

boolean

Alias
UMLS CUI 2011AA
C0023890
SNOMED CT 2011_0131
19943007
MedDRA 14.1
10019641
ICD-10-CM Version 2010
K74.60
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0242114
UMLS CUI 2011AA
C0023903
SNOMED CT 2011_0131
126851005
MedDRA 14.1
10019695
ICD-10-CM Version 2010
C22.0
UMLS CUI 2011AA
C1409616
Absolute neutrophil count (ANC) <750 cells/mm3 at screening
Description

Absolute neutrophil count (ANC) <750 cells/mm3 at screening

Type de données

boolean

Alias
UMLS CUI 2011AA
C0948762
MedDRA 14.1
10052033
UMLS CUI 2011AA
C1409616
Platelet count <50,000 cells/mm3 at screening
Description

Platelet count <50,000 cells/mm3 at screening

Type de données

boolean

Alias
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
UMLS CUI 2011AA
C1409616
Hb <10 g/dl at screening
Description

Hb <10 g/dl at screening

Type de données

boolean

Alias
UMLS CUI 2011AA
C0019046
SNOMED CT 2011_0131
38082009
MedDRA 14.1
10019481
LOINC Version 232
LP14449-0
UMLS CUI 2011AA
C1409616
Dose modification of Peg-Interferon alpha-2b (PegIntron) or ribavirin (Rebetol) during the first 4 weeks of the ongoing therapy
Description

Dose modification of Peg-Interferon alpha-2b (PegIntron) or ribavirin (Rebetol) during the first 4 weeks of the ongoing therapy

Type de données

boolean

Alias
UMLS CUI 2011AA
C1707811
UMLS CUI 2011AA
C0796545
SNOMED CT 2011_0131
395823000
UMLS CUI 2011AA
C0035525
SNOMED CT 2011_0131
387188005
LOINC Version 232
MTHU018696
UMLS CUI 2011AA
C0205435
SNOMED CT 2011_0131
255216001
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0039798
Interferon alpha or ribavirin therapy at any time point before the actual ongoing treatment
Description

Interferon alpha or ribavirin therapy at any time point before the actual ongoing treatment

Type de données

boolean

Alias
UMLS CUI 2011AA
C1610033
UMLS CUI 2011AA
C0035525
SNOMED CT 2011_0131
387188005
LOINC Version 232
MTHU018696
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0237400
UMLS CUI 2011AA
C0039798
< 80% adherence to treatment of the ongoing treatment until randomization (week 20-22 of ongoing treatment)
Description

< 80% adherence to treatment of the ongoing treatment until randomization (week 20-22 of ongoing treatment)

Type de données

boolean

Alias
UMLS CUI 2011AA
C0205412
SNOMED CT 2011_0131
71978007
UMLS CUI 2011AA
C1171369
UMLS CUI 2011AA
CL415091
UMLS CUI 2011AA
C0034656
Serum creatinine level >1.5 times the upper limit of normal at screening
Description

Serum creatinine level >1.5 times the upper limit of normal at screening

Type de données

boolean

Alias
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C1409616
History of severe psychiatric disease, especially depression (ICD 10 codes F30-F33). Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time. Patients are excluded if any history of suicidal attempts is evident. If hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease are documented, psychiatric consultation is mandatory. Patients with a mild or moderate psychiatric disease (ICD 10 codes F32.0, F32.1, F33.0, F33.1) are only allowed to be included into the trial if a regular monitoring by a psychiatrist is performed during the trial
Description

History of severe psychiatric disease, especially depression (ICD 10 codes F30-F33). Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time. Patients are excluded if any history of suicidal attempts is evident. If hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease are documented, psychiatric consultation is mandatory. Patients with a mild or moderate psychiatric disease (ICD 10 codes F32.0, F32.1, F33.0, F33.1) are only allowed to be included into the trial if a regular monitoring by a psychiatrist is performed during the trial

Type de données

boolean

Alias
UMLS CUI 2011AA
C0455498
SNOMED CT 2011_0131
161464003
UMLS CUI 2011AA
C0588008
SNOMED CT 2011_0131
310497006
UMLS CUI 2011AA
C0003289
SNOMED CT 2011_0131
372720008
LOINC Version 232
MTHU006782
UMLS CUI 2011AA
C0040615
SNOMED CT 2011_0131
10784006
LOINC Version 232
MTHU003337
UMLS CUI 2011AA
C2911479
ICD-10-CM Version 2010
Z91.5
UMLS CUI 2011AA
C0019993
SNOMED CT 2011_0131
394656005
MedDRA 14.1
10054112
UMLS CUI 2011AA
C1948053
UMLS CUI 2011AA
C0231170
SNOMED CT 2011_0131
21134002
MedDRA 14.1
10013050
HL7 V3 2006_05
DIS
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
History of a severe seizure disorder or current anticonvulsant use
Description

History of a severe seizure disorder or current anticonvulsant use

Type de données

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0852425
MedDRA 14.1
10039912
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0003299
SNOMED CT 2011_0131
255632006
LOINC Version 232
MTHU006781
History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
Description

History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)

Type de données

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
C0020962
SNOMED CT 2011_0131
116003000
LOINC Version 232
MTHU013246
UMLS CUI 2011AA
C0021390
SNOMED CT 2011_0131
24526004
MedDRA 14.1
10021972
UMLS CUI 2011AA
C0043117
SNOMED CT 2011_0131
32273002
MedDRA 14.1
10021245
ICD-10-CM Version 2010
D69.3
UMLS CUI 2011AA
C0409974
SNOMED CT 2011_0131
200936003
MedDRA 14.1
10025134
ICD-10-CM Version 2010
L93
ICD-9-CM Version 2011
695.4
UMLS CUI 2011AA
C0002880
SNOMED CT 2011_0131
413603009
MedDRA 14.1
10002046
ICD-9-CM Version 2011
283.0
UMLS CUI 2011AA
C0011644
SNOMED CT 2011_0131
89155008
MedDRA 14.1
10039710
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0033860
SNOMED CT 2011_0131
9014002
MedDRA 14.1
10037153
ICD-10-CM Version 2010
L40
UMLS CUI 2011AA
C0003873
SNOMED CT 2011_0131
69896004
MedDRA 14.1
10039073
ICD-10-CM Version 2010
M06.9
ICD-9-CM Version 2011
714.0
History or any other evidence of autoimmune diseases
Description

History or any other evidence of autoimmune diseases

Type de données

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0004364
SNOMED CT 2011_0131
85828009
MedDRA 14.1
10061664
ICD-10-CM Version 2010
M30-M36
CTCAE 1105E
E11258
History or other evidence of chronic pulmonary disease associated with functional limitation
Description

History or other evidence of chronic pulmonary disease associated with functional limitation

Type de données

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0746102
SNOMED CT 2011_0131
413839001
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
C0205245
SNOMED CT 2011_0131
40143009
UMLS CUI 2011AA
C0449295
SNOMED CT 2011_0131
246175000
History of significant cardiac disease that could be worsened by acute anemia (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months prior to treatment with Peg-Interferon/ribavirin therapy, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
Description

History of significant cardiac disease that could be worsened by acute anemia (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months prior to treatment with Peg-Interferon/ribavirin therapy, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)

Type de données

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
UMLS CUI 2011AA
C1319795
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
UMLS CUI 2011AA
C1319796
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0982327
UMLS CUI 2011AA
C0035525
SNOMED CT 2011_0131
387188005
LOINC Version 232
MTHU018696
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0042514
SNOMED CT 2011_0131
25569003
MedDRA 14.1
10065341
ICD-10-CM Version 2010
I47.2
CTCAE 1105E
E10239
UMLS CUI 2011AA
C0002965
SNOMED CT 2011_0131
4557003
MedDRA 14.1
10002388
ICD-10-CM Version 2010
I20.0
ICD-9-CM Version 2011
411.1
Evidence of thyroid disease that is poorly controlled on prescribed medications
Description

Evidence of thyroid disease that is poorly controlled on prescribed medications

Type de données

boolean

Alias
UMLS CUI 2011AA
C0040128
SNOMED CT 2011_0131
14304000
MedDRA 14.1
10043709
ICD-10-CM Version 2010
E00-E07
ICD-9-CM Version 2011
240-246.99
UMLS CUI 2011AA
C0205169
SNOMED CT 2011_0131
556001
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
UMLS CUI 2011AA
C0013227
Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)
Description

Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)

Type de données

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
CL365148
SNOMED CT 2011_0131
399625000
MedDRA 14.1
10038923
CTCAE 1105E
E10432
UMLS CUI 2011AA
C0206178
SNOMED CT 2011_0131
22455005
MedDRA 14.1
10011835
UMLS CUI 2011AA
C0024437
SNOMED CT 2011_0131
422338006
MedDRA 14.1
10025409
LOINC Version 232
MTHU020821
History of major organ transplantation with an existing functional graft
Description

History of major organ transplantation with an existing functional graft

Type de données

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205164
SNOMED CT 2011_0131
255603008
UMLS CUI 2011AA
C0029216
MedDRA 14.1
10061890
LOINC Version 232
MTHU000173
UMLS CUI 2011AA
C0205245
SNOMED CT 2011_0131
40143009
UMLS CUI 2011AA
C0332835
SNOMED CT 2011_0131
24486003
History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
Description

History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study

Type de données

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0221423
SNOMED CT 2011_0131
39104002
MedDRA 14.1
10040658
ICD-10-CM Version 2010
R69
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0678227
SNOMED CT 2011_0131
23981006
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1548788
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
Description

History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study

Type de données

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0920425
UMLS CUI 2011AA
CL412323
UMLS CUI 2011AA
C0038317
SNOMED CT 2011_0131
116566001
UMLS CUI 2011AA
C0034619
Patients with evidence for tuberculosis
Description

Patients with evidence for tuberculosis

Type de données

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0041296
SNOMED CT 2011_0131
56717001
MedDRA 14.1
10044755
LOINC Version 232
MTHU020835
ICD-10-CM Version 2010
A15-A19
ICD-9-CM Version 2011
010-018.99
Drug abuse within 6 months prior to the first dose of study drug and excessive alcohol consumption. Patients on methadone/polamidone/buprenorphine programs are not excluded
Description

Drug abuse within 6 months prior to the first dose of study drug and excessive alcohol consumption. Patients on methadone/polamidone/buprenorphine programs are not excluded

Type de données

boolean

Alias
UMLS CUI 2011AA
C0013146
SNOMED CT 2011_0131
26416006
MedDRA 14.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
UMLS CUI 2011AA
C0560219
SNOMED CT 2011_0131
160592001
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0025605
SNOMED CT 2011_0131
51758009
LOINC Version 232
MTHU001002
UMLS CUI 2011AA
C0006405
SNOMED CT 2011_0131
31684002
LOINC Version 232
MTHU006723
Any investigational drug and/or participation in another clinical study prior 6 months to the actual ongoing antiviral treatment
Description

Any investigational drug and/or participation in another clinical study prior 6 months to the actual ongoing antiviral treatment

Type de données

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Limited contractual capability
Description

Limited contractual capability

Type de données

boolean

Alias
UMLS CUI 2011AA
C0439801
SNOMED CT 2011_0131
255469002
UMLS CUI 2011AA
C0332522
HL7 V3 2006_05
CNTRCT
UMLS CUI 2011AA
C2698977
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Similar models

Eligibility

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Male and female patients with HCV-genotype 2/3 chronic hepatitis C documented by detectable plasma HCV RNA (> 15 IU/mL) and positivity of anti-HCV antibodies
Item
Male and female patients with HCV-genotype 2/3 chronic hepatitis C documented by detectable plasma HCV RNA (> 15 IU/mL) and positivity of anti-HCV antibodies
boolean
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0220847 (UMLS CUI 2011AA)
62944002 (SNOMED CT 2011_0131)
10019752 (MedDRA 14.1)
C0017431 (UMLS CUI 2011AA)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0524910 (UMLS CUI 2011AA)
128302006 (SNOMED CT 2011_0131)
10008912 (MedDRA 14.1)
B18.2 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0032105 (UMLS CUI 2011AA)
50863008 (SNOMED CT 2011_0131)
MTHU002157 (LOINC Version 232)
C0369335 (UMLS CUI 2011AA)
121204002 (SNOMED CT 2011_0131)
MTHU001816 (LOINC Version 232)
C0281863 (UMLS CUI 2011AA)
10019747 (MedDRA 14.1)
Compensated liver disease (Child-Pugh Grade A clinical classification)
Item
Compensated liver disease (Child-Pugh Grade A clinical classification)
boolean
C0205432 (UMLS CUI 2011AA)
17275008 (SNOMED CT 2011_0131)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C2347612 (UMLS CUI 2011AA)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
C1706281 (UMLS CUI 2011AA)
422097006 (SNOMED CT 2011_0131)
Negative urine or blood pregnancy test (one of the both, for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 7 months after treatment end. This includes using birth control pills (no interaction with investigational drugs), IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state. At least one contraception method must be of barrier method
Item
Negative urine or blood pregnancy test (one of the both, for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 7 months after treatment end. This includes using birth control pills (no interaction with investigational drugs), IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state. At least one contraception method must be of barrier method
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0430057 (UMLS CUI 2011AA)
167254001 (SNOMED CT 2011_0131)
10036577 (MedDRA 14.1)
C0430061 (UMLS CUI 2011AA)
166435006 (SNOMED CT 2011_0131)
CL426012 (UMLS CUI 2011AA)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0009905 (UMLS CUI 2011AA)
59261009 (SNOMED CT 2011_0131)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0677582 (UMLS CUI 2011AA)
C0042241 (UMLS CUI 2011AA)
20359006 (SNOMED CT 2011_0131)
CL424925 (UMLS CUI 2011AA)
C0038288 (UMLS CUI 2011AA)
10062116 (MedDRA 14.1)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
Ongoing treatment with 1.5 µg/kg Peg-Interferon alpha-2b (PegIntron) and > 10.6 mg/kg ribavirin (Rebetol)
Item
Ongoing treatment with 1.5 µg/kg Peg-Interferon alpha-2b (PegIntron) and > 10.6 mg/kg ribavirin (Rebetol)
boolean
C0750536 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0796545 (UMLS CUI 2011AA)
395823000 (SNOMED CT 2011_0131)
C0035525 (UMLS CUI 2011AA)
387188005 (SNOMED CT 2011_0131)
MTHU018696 (LOINC Version 232)
No rapid virological response (HCV-RNA positive after week 4 of the ongoing therapy)
Item
No rapid virological response (HCV-RNA positive after week 4 of the ongoing therapy)
boolean
C1518422 (UMLS CUI 2011AA)
C0439831 (UMLS CUI 2011AA)
255358001 (SNOMED CT 2011_0131)
C1155328 (UMLS CUI 2011AA)
C0855842 (UMLS CUI 2011AA)
10019750 (MedDRA 14.1)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Willingness to give written informed consent and willingness to participate to and to comply with the study protocol
Item
Willingness to give written informed consent and willingness to participate to and to comply with the study protocol
boolean
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0525058 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Women with ongoing pregnancy or breast feeding
Item
Women with ongoing pregnancy or breast feeding
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Male partners of women who are pregnant
Item
Male partners of women who are pregnant
boolean
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0682323 (UMLS CUI 2011AA)
262043009 (SNOMED CT 2011_0131)
SIGOTHR (HL7 V3 2006_05)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
Positive tests at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg, anti-HIV, HIV-RNA
Item
Positive tests at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg, anti-HIV, HIV-RNA
boolean
C1335447 (UMLS CUI 2011AA)
C1409616 (UMLS CUI 2011AA)
C0062524 (UMLS CUI 2011AA)
32609007 (SNOMED CT 2011_0131)
MTHU004541 (LOINC Version 232)
C1442155 (UMLS CUI 2011AA)
MTHU021816 (LOINC Version 232)
C0019168 (UMLS CUI 2011AA)
22290004 (SNOMED CT 2011_0131)
MTHU001814 (LOINC Version 232)
C0948759 (UMLS CUI 2011AA)
10052020 (MedDRA 14.1)
C1442155 (UMLS CUI 2011AA)
MTHU021816 (LOINC Version 232)
C0019167 (UMLS CUI 2011AA)
60605004 (SNOMED CT 2011_0131)
MTHU004548 (LOINC Version 232)
C0856918 (UMLS CUI 2011AA)
10002725 (MedDRA 14.1)
C0877327 (UMLS CUI 2011AA)
10049826 (MedDRA 14.1)
History or other evidence of a medical condition associated with chronic liver disease other than HCV associated (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
Item
History or other evidence of a medical condition associated with chronic liver disease other than HCV associated (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
boolean
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0341439 (UMLS CUI 2011AA)
328383001 (SNOMED CT 2011_0131)
10008953 (MedDRA 14.1)
CL411789 (UMLS CUI 2011AA)
C0220847 (UMLS CUI 2011AA)
62944002 (SNOMED CT 2011_0131)
10019752 (MedDRA 14.1)
C0018995 (UMLS CUI 2011AA)
399187006 (SNOMED CT 2011_0131)
10018872 (MedDRA 14.1)
E83.119 (ICD-10-CM Version 2010)
C0241910 (UMLS CUI 2011AA)
408335007 (SNOMED CT 2011_0131)
10003827 (MedDRA 14.1)
K75.4 (ICD-10-CM Version 2010)
571.42 (ICD-9-CM Version 2011)
C0023896 (UMLS CUI 2011AA)
41309000 (SNOMED CT 2011_0131)
10001627 (MedDRA 14.1)
K70.9 (ICD-10-CM Version 2010)
571.3 (ICD-9-CM Version 2011)
C0040537 (UMLS CUI 2011AA)
420239005 (SNOMED CT 2011_0131)
History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
Item
History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
boolean
C0155789 (UMLS CUI 2011AA)
17709002 (SNOMED CT 2011_0131)
10030210 (MedDRA 14.1)
I85.01 (ICD-10-CM Version 2010)
456.0 (ICD-9-CM Version 2011)
E10682 (CTCAE 1105E)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0745744 (UMLS CUI 2011AA)
10050060 (MedDRA 14.1)
Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening
Item
Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening
boolean
C0023890 (UMLS CUI 2011AA)
19943007 (SNOMED CT 2011_0131)
10019641 (MedDRA 14.1)
K74.60 (ICD-10-CM Version 2010)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0242114 (UMLS CUI 2011AA)
C0023903 (UMLS CUI 2011AA)
126851005 (SNOMED CT 2011_0131)
10019695 (MedDRA 14.1)
C22.0 (ICD-10-CM Version 2010)
C1409616 (UMLS CUI 2011AA)
Absolute neutrophil count (ANC) <750 cells/mm3 at screening
Item
Absolute neutrophil count (ANC) <750 cells/mm3 at screening
boolean
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
Platelet count <50,000 cells/mm3 at screening
Item
Platelet count <50,000 cells/mm3 at screening
boolean
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C1409616 (UMLS CUI 2011AA)
Hb <10 g/dl at screening
Item
Hb <10 g/dl at screening
boolean
C0019046 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
C1409616 (UMLS CUI 2011AA)
Dose modification of Peg-Interferon alpha-2b (PegIntron) or ribavirin (Rebetol) during the first 4 weeks of the ongoing therapy
Item
Dose modification of Peg-Interferon alpha-2b (PegIntron) or ribavirin (Rebetol) during the first 4 weeks of the ongoing therapy
boolean
C1707811 (UMLS CUI 2011AA)
C0796545 (UMLS CUI 2011AA)
395823000 (SNOMED CT 2011_0131)
C0035525 (UMLS CUI 2011AA)
387188005 (SNOMED CT 2011_0131)
MTHU018696 (LOINC Version 232)
C0205435 (UMLS CUI 2011AA)
255216001 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0039798 (UMLS CUI 2011AA)
Interferon alpha or ribavirin therapy at any time point before the actual ongoing treatment
Item
Interferon alpha or ribavirin therapy at any time point before the actual ongoing treatment
boolean
C1610033 (UMLS CUI 2011AA)
C0035525 (UMLS CUI 2011AA)
387188005 (SNOMED CT 2011_0131)
MTHU018696 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0237400 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
< 80% adherence to treatment of the ongoing treatment until randomization (week 20-22 of ongoing treatment)
Item
< 80% adherence to treatment of the ongoing treatment until randomization (week 20-22 of ongoing treatment)
boolean
C0205412 (UMLS CUI 2011AA)
71978007 (SNOMED CT 2011_0131)
C1171369 (UMLS CUI 2011AA)
CL415091 (UMLS CUI 2011AA)
C0034656 (UMLS CUI 2011AA)
Serum creatinine level >1.5 times the upper limit of normal at screening
Item
Serum creatinine level >1.5 times the upper limit of normal at screening
boolean
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C1409616 (UMLS CUI 2011AA)
History of severe psychiatric disease, especially depression (ICD 10 codes F30-F33). Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time. Patients are excluded if any history of suicidal attempts is evident. If hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease are documented, psychiatric consultation is mandatory. Patients with a mild or moderate psychiatric disease (ICD 10 codes F32.0, F32.1, F33.0, F33.1) are only allowed to be included into the trial if a regular monitoring by a psychiatrist is performed during the trial
Item
History of severe psychiatric disease, especially depression (ICD 10 codes F30-F33). Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time. Patients are excluded if any history of suicidal attempts is evident. If hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease are documented, psychiatric consultation is mandatory. Patients with a mild or moderate psychiatric disease (ICD 10 codes F32.0, F32.1, F33.0, F33.1) are only allowed to be included into the trial if a regular monitoring by a psychiatrist is performed during the trial
boolean
C0455498 (UMLS CUI 2011AA)
161464003 (SNOMED CT 2011_0131)
C0588008 (UMLS CUI 2011AA)
310497006 (SNOMED CT 2011_0131)
C0003289 (UMLS CUI 2011AA)
372720008 (SNOMED CT 2011_0131)
MTHU006782 (LOINC Version 232)
C0040615 (UMLS CUI 2011AA)
10784006 (SNOMED CT 2011_0131)
MTHU003337 (LOINC Version 232)
C2911479 (UMLS CUI 2011AA)
Z91.5 (ICD-10-CM Version 2010)
C0019993 (UMLS CUI 2011AA)
394656005 (SNOMED CT 2011_0131)
10054112 (MedDRA 14.1)
C1948053 (UMLS CUI 2011AA)
C0231170 (UMLS CUI 2011AA)
21134002 (SNOMED CT 2011_0131)
10013050 (MedDRA 14.1)
DIS (HL7 V3 2006_05)
CL420107 (UMLS CUI 2011AA)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
History of a severe seizure disorder or current anticonvulsant use
Item
History of a severe seizure disorder or current anticonvulsant use
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0852425 (UMLS CUI 2011AA)
10039912 (MedDRA 14.1)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0003299 (UMLS CUI 2011AA)
255632006 (SNOMED CT 2011_0131)
MTHU006781 (LOINC Version 232)
History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
Item
History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0020962 (UMLS CUI 2011AA)
116003000 (SNOMED CT 2011_0131)
MTHU013246 (LOINC Version 232)
C0021390 (UMLS CUI 2011AA)
24526004 (SNOMED CT 2011_0131)
10021972 (MedDRA 14.1)
C0043117 (UMLS CUI 2011AA)
32273002 (SNOMED CT 2011_0131)
10021245 (MedDRA 14.1)
D69.3 (ICD-10-CM Version 2010)
C0409974 (UMLS CUI 2011AA)
200936003 (SNOMED CT 2011_0131)
10025134 (MedDRA 14.1)
L93 (ICD-10-CM Version 2010)
695.4 (ICD-9-CM Version 2011)
C0002880 (UMLS CUI 2011AA)
413603009 (SNOMED CT 2011_0131)
10002046 (MedDRA 14.1)
283.0 (ICD-9-CM Version 2011)
C0011644 (UMLS CUI 2011AA)
89155008 (SNOMED CT 2011_0131)
10039710 (MedDRA 14.1)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0033860 (UMLS CUI 2011AA)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
C0003873 (UMLS CUI 2011AA)
69896004 (SNOMED CT 2011_0131)
10039073 (MedDRA 14.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
History or any other evidence of autoimmune diseases
Item
History or any other evidence of autoimmune diseases
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0004364 (UMLS CUI 2011AA)
85828009 (SNOMED CT 2011_0131)
10061664 (MedDRA 14.1)
M30-M36 (ICD-10-CM Version 2010)
E11258 (CTCAE 1105E)
History or other evidence of chronic pulmonary disease associated with functional limitation
Item
History or other evidence of chronic pulmonary disease associated with functional limitation
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0746102 (UMLS CUI 2011AA)
413839001 (SNOMED CT 2011_0131)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0205245 (UMLS CUI 2011AA)
40143009 (SNOMED CT 2011_0131)
C0449295 (UMLS CUI 2011AA)
246175000 (SNOMED CT 2011_0131)
History of significant cardiac disease that could be worsened by acute anemia (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months prior to treatment with Peg-Interferon/ribavirin therapy, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
Item
History of significant cardiac disease that could be worsened by acute anemia (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months prior to treatment with Peg-Interferon/ribavirin therapy, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0982327 (UMLS CUI 2011AA)
C0035525 (UMLS CUI 2011AA)
387188005 (SNOMED CT 2011_0131)
MTHU018696 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
C0042514 (UMLS CUI 2011AA)
25569003 (SNOMED CT 2011_0131)
10065341 (MedDRA 14.1)
I47.2 (ICD-10-CM Version 2010)
E10239 (CTCAE 1105E)
C0002965 (UMLS CUI 2011AA)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
Evidence of thyroid disease that is poorly controlled on prescribed medications
Item
Evidence of thyroid disease that is poorly controlled on prescribed medications
boolean
C0040128 (UMLS CUI 2011AA)
14304000 (SNOMED CT 2011_0131)
10043709 (MedDRA 14.1)
E00-E07 (ICD-10-CM Version 2010)
240-246.99 (ICD-9-CM Version 2011)
C0205169 (UMLS CUI 2011AA)
556001 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)
Item
Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
CL365148 (UMLS CUI 2011AA)
399625000 (SNOMED CT 2011_0131)
10038923 (MedDRA 14.1)
E10432 (CTCAE 1105E)
C0206178 (UMLS CUI 2011AA)
22455005 (SNOMED CT 2011_0131)
10011835 (MedDRA 14.1)
C0024437 (UMLS CUI 2011AA)
422338006 (SNOMED CT 2011_0131)
10025409 (MedDRA 14.1)
MTHU020821 (LOINC Version 232)
History of major organ transplantation with an existing functional graft
Item
History of major organ transplantation with an existing functional graft
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C0029216 (UMLS CUI 2011AA)
10061890 (MedDRA 14.1)
MTHU000173 (LOINC Version 232)
C0205245 (UMLS CUI 2011AA)
40143009 (SNOMED CT 2011_0131)
C0332835 (UMLS CUI 2011AA)
24486003 (SNOMED CT 2011_0131)
History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
Item
History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0221423 (UMLS CUI 2011AA)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1548788 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
Item
History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0920425 (UMLS CUI 2011AA)
CL412323 (UMLS CUI 2011AA)
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
Patients with evidence for tuberculosis
Item
Patients with evidence for tuberculosis
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0041296 (UMLS CUI 2011AA)
56717001 (SNOMED CT 2011_0131)
10044755 (MedDRA 14.1)
MTHU020835 (LOINC Version 232)
A15-A19 (ICD-10-CM Version 2010)
010-018.99 (ICD-9-CM Version 2011)
Drug abuse within 6 months prior to the first dose of study drug and excessive alcohol consumption. Patients on methadone/polamidone/buprenorphine programs are not excluded
Item
Drug abuse within 6 months prior to the first dose of study drug and excessive alcohol consumption. Patients on methadone/polamidone/buprenorphine programs are not excluded
boolean
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
C0560219 (UMLS CUI 2011AA)
160592001 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0025605 (UMLS CUI 2011AA)
51758009 (SNOMED CT 2011_0131)
MTHU001002 (LOINC Version 232)
C0006405 (UMLS CUI 2011AA)
31684002 (SNOMED CT 2011_0131)
MTHU006723 (LOINC Version 232)
Any investigational drug and/or participation in another clinical study prior 6 months to the actual ongoing antiviral treatment
Item
Any investigational drug and/or participation in another clinical study prior 6 months to the actual ongoing antiviral treatment
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Limited contractual capability
Item
Limited contractual capability
boolean
C0439801 (UMLS CUI 2011AA)
255469002 (SNOMED CT 2011_0131)
C0332522 (UMLS CUI 2011AA)
CNTRCT (HL7 V3 2006_05)
C2698977 (UMLS CUI 2011AA)
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