ID

43457

Description

Chronic Hepatitis C: Optimization of Treatment for Patients infected With HCV-genotype 2 or 3: 12 vs. 24 Weeks of Treatment Extension for Patients Without Rapid Virological Response see http://clinicaltrials.gov/show/NCT00803309

Link

http://clinicaltrials.gov/show/NCT00803309

Keywords

Versions (4)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 3/25/14 3/25/14 - Martin Dugas
  3. 4/16/14 4/16/14 - Julian Varghese
  4. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00803309 Hepatitis C, Chronic

German English

Eligibility Hepatitis C NCT00803309

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
SNOMED CT 2011_0131
397669002
UMLS CUI-1
C0001779
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

Chronic hepatitis C, HCV-genotype 2/3, HCV RNA and anti-HCV positive

Data type

boolean

Alias
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
SNOMED CT 2011_0131
62944002
MedDRA 14.1
10019752
SNOMED CT 2011_0131
19338005
SNOMED CT 2011_0131
421291004
SNOMED CT 2011_0131
128302006
MedDRA 14.1
10008912
ICD-10-CM Version 2010
B18.2
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
SNOMED CT 2011_0131
50863008
LOINC Version 232
MTHU002157
SNOMED CT 2011_0131
121204002
LOINC Version 232
MTHU001816
MedDRA 14.1
10019747
UMLS CUI-1
C0524910
UMLS CUI-2
C0369335
UMLS CUI-3
C0281863
Compensated liver disease (Child-Pugh Grade A clinical classification)
Description

Compensated liver disease

Data type

boolean

Alias
SNOMED CT 2011_0131
17275008
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
SNOMED CT 2011_0131
258349007
LOINC Version 232
MTHU003112
SNOMED CT 2011_0131
422097006
UMLS CUI-1
C0205432
UMLS CUI-2
C0023895
UMLS CUI-3
C4050412
UMLS CUI-4
C0441800
UMLS CUI-5
C1706281
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

Non-pregnant, effective contraception

Data type

boolean

Alias
SNOMED CT 2011_0131
224526002
SNOMED CT 2011_0131
167254001
MedDRA 14.1
10036577
SNOMED CT 2011_0131
166435006
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
SNOMED CT 2011_0131
59261009
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
SNOMED CT 2011_0131
20359006
MedDRA 14.1
10062116
SNOMED CT 2011_0131
76498008
SNOMED CT 2011_0131
225370004
UMLS CUI-1
C0043210
UMLS CUI-2
C1148523
UMLS CUI-3
C0237399
UMLS CUI-4
C0430057
UMLS CUI-5
C0430061
UMLS CUI-6
CL426012
UMLS CUI-7
C0086287
UMLS CUI-8
C0086582
UMLS CUI-9
C0700589
UMLS CUI-10
C0009905
UMLS CUI-11
C0021900
UMLS CUI-12
C0677582
UMLS CUI-13
C0042241
UMLS CUI-14
CL424925
UMLS CUI-15
C0038288
UMLS CUI-16
C0232970
UMLS CUI-17
C0004764
Ongoing treatment with 1.5 µg/kg Peg-Interferon alpha-2b (PegIntron) and > 10.6 mg/kg ribavirin (Rebetol)
Description

Current therapy with Peg-Interferon alpha-2b and ribavirin

Data type

boolean

Alias
SNOMED CT 2011_0131
395823000
SNOMED CT 2011_0131
387188005
LOINC Version 232
MTHU018696
UMLS CUI-1
C2827774
UMLS CUI-2
C0796545
UMLS CUI-3
C0035525
No rapid virological response (HCV-RNA positive after week 4 of the ongoing therapy)
Description

No rapid virological response

Data type

boolean

Alias
SNOMED CT 2011_0131
255358001
MedDRA 14.1
10019750
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
SNOMED CT 2011_0131
9362000
UMLS CUI-1
C1518422
UMLS CUI-2
C0456962
UMLS CUI-3
C1155328
Willingness to give written informed consent and willingness to participate to and to comply with the study protocol
Description

Willingness to comply with study protocol

Data type

boolean

Alias
UMLS CUI-4
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

Ongoing pregnancy or breast feeding

Data type

boolean

Alias
SNOMED CT 2011_0131
224526002
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
MedDRA 14.1
10006247
UMLS CUI-1
C0032961
UMLS CUI-2
C0006147
Male partners of women who are pregnant
Description

Male partners of women who are pregnant

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
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 for Hepatitis A/B/C, HIV

Data type

boolean

Alias
SNOMED CT 2011_0131
32609007
LOINC Version 232
MTHU004541
LOINC Version 232
MTHU021816
SNOMED CT 2011_0131
22290004
LOINC Version 232
MTHU001814
MedDRA 14.1
10052020
LOINC Version 232
MTHU021816
SNOMED CT 2011_0131
60605004
LOINC Version 232
MTHU004548
MedDRA 14.1
10002725
MedDRA 14.1
10049826
UMLS CUI-1
C1335447
UMLS CUI-2
C1409616
UMLS CUI-3
C0062524
UMLS CUI-4
C1442155
UMLS CUI-5
C0019168
UMLS CUI-6
C0948759
UMLS CUI-7
C1442155
UMLS CUI-8
C0019167
UMLS CUI-9
C0856918
UMLS CUI-10
C0877327
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

non-HCV chronic liver disease

Data type

boolean

Alias
HL7 V3 2006_05
MEDCCAT
SNOMED CT 2011_0131
328383001
MedDRA 14.1
10008953
SNOMED CT 2011_0131
62944002
MedDRA 14.1
10019752
SNOMED CT 2011_0131
399187006
MedDRA 14.1
10018872
ICD-10-CM Version 2010
E83.119
SNOMED CT 2011_0131
408335007
MedDRA 14.1
10003827
ICD-10-CM Version 2010
K75.4
ICD-9-CM Version 2011
571.42
SNOMED CT 2011_0131
41309000
MedDRA 14.1
10001627
ICD-10-CM Version 2010
K70.9
ICD-9-CM Version 2011
571.3
SNOMED CT 2011_0131
420239005
UMLS CUI-1
C1699700
UMLS CUI-2
C0341439
UMLS CUI-3
CL411789
UMLS CUI-4
C0220847
UMLS CUI-5
C0018995
UMLS CUI-6
C0241910
UMLS CUI-7
C0023896
UMLS CUI-8
C0040537
History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
Description

Bleeding from esophageal varices, decompensated liver disease

Data type

boolean

Alias
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
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
SNOMED CT 2011_0131
385433004
MedDRA 14.1
10050060
UMLS CUI-1
C0155789
UMLS CUI-2
C0348080
UMLS CUI-3
C0332290
UMLS CUI-4
C0745744
Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening
Description

Liver cirrhosis and suspected hepatic malignancy

Data type

boolean

Alias
SNOMED CT 2011_0131
19943007
MedDRA 14.1
10019641
ICD-10-CM Version 2010
K74.60
SNOMED CT 2011_0131
49755003
SNOMED CT 2011_0131
126851005
MedDRA 14.1
10019695
ICD-10-CM Version 2010
C22.0
UMLS CUI-1
C0023890
UMLS CUI-2
C0221198
UMLS CUI-3
C0242114
UMLS CUI-4
C0023903
UMLS CUI-5
C1409616
Absolute neutrophil count (ANC) <750 cells/mm3 at screening
Description

Neutropenia

Data type

boolean

Alias
MedDRA 14.1
10052033
UMLS CUI-1
C0948762
UMLS CUI-2
C1409616
Platelet count <50,000 cells/mm3 at screening
Description

Low platelet count

Data type

boolean

Alias
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
UMLS CUI-1
C1287267
UMLS CUI-2
C1409616
Hb <10 g/dl at screening
Description

Anemia

Data type

boolean

Alias
SNOMED CT 2011_0131
38082009
MedDRA 14.1
10019481
LOINC Version 232
LP14449-0
UMLS CUI-1
C0019046
UMLS CUI-2
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 or ribavirin

Data type

boolean

Alias
SNOMED CT 2011_0131
395823000
SNOMED CT 2011_0131
387188005
LOINC Version 232
MTHU018696
SNOMED CT 2011_0131
255216001
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI-1
C1707811
UMLS CUI-2
C0796545
UMLS CUI-3
C0035525
UMLS CUI-4
C0205435
UMLS CUI-5
C0439231
UMLS CUI-6
C0039798
Interferon alpha or ribavirin therapy at any time point before the actual ongoing treatment
Description

Previous therapy with Interferon alpha or ribavirin

Data type

boolean

Alias
SNOMED CT 2011_0131
387188005
LOINC Version 232
MTHU018696
SNOMED CT 2011_0131
288556008
UMLS CUI-1
C1610033
UMLS CUI-2
C0035525
UMLS CUI-3
C0039798
UMLS CUI-4
C0332152
UMLS CUI-5
C0237400
UMLS CUI-6
C0039798
< 80% adherence to treatment of the ongoing treatment until randomization (week 20-22 of ongoing treatment)
Description

Low adherence to ongoing treatment

Data type

boolean

Alias
SNOMED CT 2011_0131
71978007
UMLS CUI-1
C0205412
UMLS CUI-2
C1171369
UMLS CUI-3
CL415091
UMLS CUI-4
C0034656
Serum creatinine level >1.5 times the upper limit of normal at screening
Description

Serum creatinine elevated

Data type

boolean

Alias
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI-1
C0201976
UMLS CUI-2
C1519815
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

Data type

boolean

Alias
SNOMED CT 2011_0131
161464003
SNOMED CT 2011_0131
310497006
SNOMED CT 2011_0131
372720008
LOINC Version 232
MTHU006782
SNOMED CT 2011_0131
10784006
LOINC Version 232
MTHU003337
ICD-10-CM Version 2010
Z91.5
SNOMED CT 2011_0131
394656005
MedDRA 14.1
10054112
SNOMED CT 2011_0131
21134002
MedDRA 14.1
10013050
HL7 V3 2006_05
DIS
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
UMLS CUI-1
C0455498
UMLS CUI-2
C0588008
UMLS CUI-3
C0003289
UMLS CUI-4
C0040615
UMLS CUI-5
C2911479
UMLS CUI-6
C0019993
UMLS CUI-7
C1948053
UMLS CUI-8
C0231170
UMLS CUI-9
CL420107
UMLS CUI-10
C0004936
History of a severe seizure disorder or current anticonvulsant use
Description

History of a severe seizure disorder or current anticonvulsant use

Data type

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

Data type

boolean

Alias
SNOMED CT 2011_0131
392521001
SNOMED CT 2011_0131
64572001
SNOMED CT 2011_0131
47429007
SNOMED CT 2011_0131
116003000
LOINC Version 232
MTHU013246
SNOMED CT 2011_0131
24526004
MedDRA 14.1
10021972
SNOMED CT 2011_0131
32273002
MedDRA 14.1
10021245
ICD-10-CM Version 2010
D69.3
SNOMED CT 2011_0131
200936003
MedDRA 14.1
10025134
ICD-10-CM Version 2010
L93
ICD-9-CM Version 2011
695.4
SNOMED CT 2011_0131
413603009
MedDRA 14.1
10002046
ICD-9-CM Version 2011
283.0
SNOMED CT 2011_0131
89155008
MedDRA 14.1
10039710
SNOMED CT 2011_0131
24484000
SNOMED CT 2011_0131
9014002
MedDRA 14.1
10037153
ICD-10-CM Version 2010
L40
SNOMED CT 2011_0131
69896004
MedDRA 14.1
10039073
ICD-10-CM Version 2010
M06.9
ICD-9-CM Version 2011
714.0
UMLS CUI-1
CL421546
UMLS CUI-2
C0012634
UMLS CUI-3
C0332281
UMLS CUI-4
C0020962
UMLS CUI-5
C0021390
UMLS CUI-6
C0398650
UMLS CUI-7
C0409974
UMLS CUI-8
C0002880
UMLS CUI-9
C0011644
UMLS CUI-10
C0205082
UMLS CUI-11
C0033860
UMLS CUI-12
C0003873
History or any other evidence of autoimmune diseases
Description

History or any other evidence of autoimmune diseases

Data type

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

Chronic pulmonary disease

Data type

boolean

Alias
SNOMED CT 2011_0131
392521001
SNOMED CT 2011_0131
18669006
SNOMED CT 2011_0131
413839001
SNOMED CT 2011_0131
47429007
SNOMED CT 2011_0131
40143009
SNOMED CT 2011_0131
246175000
UMLS CUI-1
CL421546
UMLS CUI-2
C0332120
UMLS CUI-3
C0746102
UMLS CUI-4
C0332281
UMLS CUI-5
C0205245
UMLS CUI-6
C0449295
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

Data type

boolean

Alias
SNOMED CT 2011_0131
392521001
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
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
SNOMED CT 2011_0131
288556008
SNOMED CT 2011_0131
387188005
LOINC Version 232
MTHU018696
SNOMED CT 2011_0131
25569003
MedDRA 14.1
10065341
ICD-10-CM Version 2010
I47.2
CTCAE 1105E
E10239
SNOMED CT 2011_0131
4557003
MedDRA 14.1
10002388
ICD-10-CM Version 2010
I20.0
ICD-9-CM Version 2011
411.1
UMLS CUI-1
CL421546
UMLS CUI-2
C0018799
UMLS CUI-3
C1319795
UMLS CUI-4
C1319796
UMLS CUI-5
C0027051
UMLS CUI-6
C0332152
UMLS CUI-7
C0982327
UMLS CUI-8
C0035525
UMLS CUI-9
C0039798
UMLS CUI-10
C0042514
UMLS CUI-11
C0002965
Evidence of thyroid disease that is poorly controlled on prescribed medications
Description

Poorly controlled thyroid disease

Data type

boolean

Alias
SNOMED CT 2011_0131
14304000
MedDRA 14.1
10043709
ICD-10-CM Version 2010
E00-E07
ICD-9-CM Version 2011
240-246.99
SNOMED CT 2011_0131
556001
SNOMED CT 2011_0131
31509003
UMLS CUI-1
C0040128
UMLS CUI-2
C0205169
UMLS CUI-3
C2587213
UMLS CUI-4
C0013227
Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)
Description

Severe retinopathy

Data type

boolean

Alias
SNOMED CT 2011_0131
24484000
SNOMED CT 2011_0131
399625000
MedDRA 14.1
10038923
CTCAE 1105E
E10432
SNOMED CT 2011_0131
22455005
MedDRA 14.1
10011835
SNOMED CT 2011_0131
422338006
MedDRA 14.1
10025409
LOINC Version 232
MTHU020821
UMLS CUI-1
C0205082
UMLS CUI-2
CL365148
UMLS CUI-3
C0206178
UMLS CUI-4
C0024437
History of major organ transplantation with an existing functional graft
Description

Major organ transplantation

Data type

boolean

Alias
SNOMED CT 2011_0131
392521001
SNOMED CT 2011_0131
255603008
MedDRA 14.1
10061890
LOINC Version 232
MTHU000173
SNOMED CT 2011_0131
40143009
SNOMED CT 2011_0131
24486003
UMLS CUI-1
CL421546
UMLS CUI-2
C0205164
UMLS CUI-3
C0029216
UMLS CUI-4
C0205245
UMLS CUI-5
C0332835
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

Severe illness

Data type

boolean

Alias
SNOMED CT 2011_0131
24484000
SNOMED CT 2011_0131
39104002
MedDRA 14.1
10040658
ICD-10-CM Version 2010
R69
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
SNOMED CT 2011_0131
23981006
SNOMED CT 2011_0131
116154003
SNOMED CT 2011_0131
110465008
UMLS CUI-1
C0205082
UMLS CUI-2
C0221423
UMLS CUI-3
C0006826
UMLS CUI-4
C0348080
UMLS CUI-5
C0678227
UMLS CUI-6
C0030705
UMLS CUI-7
C1548788
UMLS CUI-8
C0008976
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

Systemic anti-neoplastic or immunomodulatory treatment

Data type

boolean

Alias
SNOMED CT 2011_0131
392521001
SNOMED CT 2011_0131
31099001
SNOMED CT 2011_0131
116566001
UMLS CUI-1
CL421546
UMLS CUI-2
C0205373
UMLS CUI-3
C0920425
UMLS CUI-4
CL412323
UMLS CUI-5
C0038317
UMLS CUI-6
C0034619
Patients with evidence for tuberculosis
Description

Tuberculosis

Data type

boolean

Alias
SNOMED CT 2011_0131
18669006
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
UMLS CUI-1
C0041296
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

Data type

boolean

Alias
SNOMED CT 2011_0131
26416006
MedDRA 14.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
SNOMED CT 2011_0131
160592001
HL7 V3 2006_05
E
SNOMED CT 2011_0131
51758009
LOINC Version 232
MTHU001002
SNOMED CT 2011_0131
31684002
LOINC Version 232
MTHU006723
UMLS CUI-1
C0013146
UMLS CUI-2
C0560219
UMLS CUI-3
C1554961
UMLS CUI-4
C0025605
UMLS CUI-5
C0006405
Any investigational drug and/or participation in another clinical study prior 6 months to the actual ongoing antiviral treatment
Description

Participation in another clinical study

Data type

boolean

Alias
SNOMED CT 2011_0131
74964007
HL7 V3 2006_05
PART
SNOMED CT 2011_0131
74964007
SNOMED CT 2011_0131
110465008
SNOMED CT 2011_0131
288556008
SNOMED CT 2011_0131
68244004
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI-1
C0205394
UMLS CUI-2
C0013230
UMLS CUI-3
C0679823
UMLS CUI-4
C0205394
UMLS CUI-5
C0008976
UMLS CUI-6
C0332152
UMLS CUI-7
C0205452
UMLS CUI-8
C0439231
Limited contractual capability
Description

Limited contractual capability

Data type

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 Hepatitis C NCT00803309

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
397669002 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI-1)
Chronic hepatitis C, HCV-genotype 2/3, HCV RNA and anti-HCV positive
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
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
62944002 (SNOMED CT 2011_0131)
10019752 (MedDRA 14.1)
19338005 (SNOMED CT 2011_0131)
421291004 (SNOMED CT 2011_0131)
128302006 (SNOMED CT 2011_0131)
10008912 (MedDRA 14.1)
B18.2 (ICD-10-CM Version 2010)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
50863008 (SNOMED CT 2011_0131)
MTHU002157 (LOINC Version 232)
121204002 (SNOMED CT 2011_0131)
MTHU001816 (LOINC Version 232)
10019747 (MedDRA 14.1)
C0524910 (UMLS CUI-1)
C0369335 (UMLS CUI-2)
C0281863 (UMLS CUI-3)
Compensated liver disease
Item
Compensated liver disease (Child-Pugh Grade A clinical classification)
boolean
17275008 (SNOMED CT 2011_0131)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
422097006 (SNOMED CT 2011_0131)
C0205432 (UMLS CUI-1)
C0023895 (UMLS CUI-2)
C4050412 (UMLS CUI-3)
C0441800 (UMLS CUI-4)
C1706281 (UMLS CUI-5)
Non-pregnant, effective contraception
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
224526002 (SNOMED CT 2011_0131)
167254001 (SNOMED CT 2011_0131)
10036577 (MedDRA 14.1)
166435006 (SNOMED CT 2011_0131)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
59261009 (SNOMED CT 2011_0131)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
20359006 (SNOMED CT 2011_0131)
10062116 (MedDRA 14.1)
76498008 (SNOMED CT 2011_0131)
225370004 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI-1)
C1148523 (UMLS CUI-2)
C0237399 (UMLS CUI-3)
C0430057 (UMLS CUI-4)
C0430061 (UMLS CUI-5)
CL426012 (UMLS CUI-6)
C0086287 (UMLS CUI-7)
C0086582 (UMLS CUI-8)
C0700589 (UMLS CUI-9)
C0009905 (UMLS CUI-10)
C0021900 (UMLS CUI-11)
C0677582 (UMLS CUI-12)
C0042241 (UMLS CUI-13)
CL424925 (UMLS CUI-14)
C0038288 (UMLS CUI-15)
C0232970 (UMLS CUI-16)
C0004764 (UMLS CUI-17)
Current therapy with Peg-Interferon alpha-2b and ribavirin
Item
Ongoing treatment with 1.5 µg/kg Peg-Interferon alpha-2b (PegIntron) and > 10.6 mg/kg ribavirin (Rebetol)
boolean
395823000 (SNOMED CT 2011_0131)
387188005 (SNOMED CT 2011_0131)
MTHU018696 (LOINC Version 232)
C2827774 (UMLS CUI-1)
C0796545 (UMLS CUI-2)
C0035525 (UMLS CUI-3)
No rapid virological response
Item
No rapid virological response (HCV-RNA positive after week 4 of the ongoing therapy)
boolean
255358001 (SNOMED CT 2011_0131)
10019750 (MedDRA 14.1)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
9362000 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI-1)
C0456962 (UMLS CUI-2)
C1155328 (UMLS CUI-3)
Willingness to comply with study protocol
Item
Willingness to give written informed consent and willingness to participate to and to comply with the study protocol
boolean
C0021430 (UMLS CUI-4)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Ongoing pregnancy or breast feeding
Item
Women with ongoing pregnancy or breast feeding
boolean
224526002 (SNOMED CT 2011_0131)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
10006247 (MedDRA 14.1)
C0032961 (UMLS CUI-1)
C0006147 (UMLS CUI-2)
Male partners of women who are pregnant
Item
Male partners of women who are pregnant
boolean
C0086582 (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 for Hepatitis A/B/C, HIV
Item
Positive tests at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg, anti-HIV, HIV-RNA
boolean
32609007 (SNOMED CT 2011_0131)
MTHU004541 (LOINC Version 232)
MTHU021816 (LOINC Version 232)
22290004 (SNOMED CT 2011_0131)
MTHU001814 (LOINC Version 232)
10052020 (MedDRA 14.1)
MTHU021816 (LOINC Version 232)
60605004 (SNOMED CT 2011_0131)
MTHU004548 (LOINC Version 232)
10002725 (MedDRA 14.1)
10049826 (MedDRA 14.1)
C1335447 (UMLS CUI-1)
C1409616 (UMLS CUI-2)
C0062524 (UMLS CUI-3)
C1442155 (UMLS CUI-4)
C0019168 (UMLS CUI-5)
C0948759 (UMLS CUI-6)
C1442155 (UMLS CUI-7)
C0019167 (UMLS CUI-8)
C0856918 (UMLS CUI-9)
C0877327 (UMLS CUI-10)
non-HCV chronic liver disease
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
MEDCCAT (HL7 V3 2006_05)
328383001 (SNOMED CT 2011_0131)
10008953 (MedDRA 14.1)
62944002 (SNOMED CT 2011_0131)
10019752 (MedDRA 14.1)
399187006 (SNOMED CT 2011_0131)
10018872 (MedDRA 14.1)
E83.119 (ICD-10-CM Version 2010)
408335007 (SNOMED CT 2011_0131)
10003827 (MedDRA 14.1)
K75.4 (ICD-10-CM Version 2010)
571.42 (ICD-9-CM Version 2011)
41309000 (SNOMED CT 2011_0131)
10001627 (MedDRA 14.1)
K70.9 (ICD-10-CM Version 2010)
571.3 (ICD-9-CM Version 2011)
420239005 (SNOMED CT 2011_0131)
C1699700 (UMLS CUI-1)
C0341439 (UMLS CUI-2)
CL411789 (UMLS CUI-3)
C0220847 (UMLS CUI-4)
C0018995 (UMLS CUI-5)
C0241910 (UMLS CUI-6)
C0023896 (UMLS CUI-7)
C0040537 (UMLS CUI-8)
Bleeding from esophageal varices, decompensated liver disease
Item
History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
boolean
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)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
385433004 (SNOMED CT 2011_0131)
10050060 (MedDRA 14.1)
C0155789 (UMLS CUI-1)
C0348080 (UMLS CUI-2)
C0332290 (UMLS CUI-3)
C0745744 (UMLS CUI-4)
Liver cirrhosis and suspected hepatic malignancy
Item
Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening
boolean
19943007 (SNOMED CT 2011_0131)
10019641 (MedDRA 14.1)
K74.60 (ICD-10-CM Version 2010)
49755003 (SNOMED CT 2011_0131)
126851005 (SNOMED CT 2011_0131)
10019695 (MedDRA 14.1)
C22.0 (ICD-10-CM Version 2010)
C0023890 (UMLS CUI-1)
C0221198 (UMLS CUI-2)
C0242114 (UMLS CUI-3)
C0023903 (UMLS CUI-4)
C1409616 (UMLS CUI-5)
Neutropenia
Item
Absolute neutrophil count (ANC) <750 cells/mm3 at screening
boolean
10052033 (MedDRA 14.1)
C0948762 (UMLS CUI-1)
C1409616 (UMLS CUI-2)
Low platelet count
Item
Platelet count <50,000 cells/mm3 at screening
boolean
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C1287267 (UMLS CUI-1)
C1409616 (UMLS CUI-2)
Anemia
Item
Hb <10 g/dl at screening
boolean
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
C0019046 (UMLS CUI-1)
C1409616 (UMLS CUI-2)
Dose modification of Peg-Interferon alpha-2b or ribavirin
Item
Dose modification of Peg-Interferon alpha-2b (PegIntron) or ribavirin (Rebetol) during the first 4 weeks of the ongoing therapy
boolean
395823000 (SNOMED CT 2011_0131)
387188005 (SNOMED CT 2011_0131)
MTHU018696 (LOINC Version 232)
255216001 (SNOMED CT 2011_0131)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C1707811 (UMLS CUI-1)
C0796545 (UMLS CUI-2)
C0035525 (UMLS CUI-3)
C0205435 (UMLS CUI-4)
C0439231 (UMLS CUI-5)
C0039798 (UMLS CUI-6)
Previous therapy with Interferon alpha or ribavirin
Item
Interferon alpha or ribavirin therapy at any time point before the actual ongoing treatment
boolean
387188005 (SNOMED CT 2011_0131)
MTHU018696 (LOINC Version 232)
288556008 (SNOMED CT 2011_0131)
C1610033 (UMLS CUI-1)
C0035525 (UMLS CUI-2)
C0039798 (UMLS CUI-3)
C0332152 (UMLS CUI-4)
C0237400 (UMLS CUI-5)
C0039798 (UMLS CUI-6)
Low adherence to ongoing treatment
Item
< 80% adherence to treatment of the ongoing treatment until randomization (week 20-22 of ongoing treatment)
boolean
71978007 (SNOMED CT 2011_0131)
C0205412 (UMLS CUI-1)
C1171369 (UMLS CUI-2)
CL415091 (UMLS CUI-3)
C0034656 (UMLS CUI-4)
Serum creatinine elevated
Item
Serum creatinine level >1.5 times the upper limit of normal at screening
boolean
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0201976 (UMLS CUI-1)
C1519815 (UMLS CUI-2)
History of severe psychiatric disease, especially depression
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
161464003 (SNOMED CT 2011_0131)
310497006 (SNOMED CT 2011_0131)
372720008 (SNOMED CT 2011_0131)
MTHU006782 (LOINC Version 232)
10784006 (SNOMED CT 2011_0131)
MTHU003337 (LOINC Version 232)
Z91.5 (ICD-10-CM Version 2010)
394656005 (SNOMED CT 2011_0131)
10054112 (MedDRA 14.1)
21134002 (SNOMED CT 2011_0131)
10013050 (MedDRA 14.1)
DIS (HL7 V3 2006_05)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0455498 (UMLS CUI-1)
C0588008 (UMLS CUI-2)
C0003289 (UMLS CUI-3)
C0040615 (UMLS CUI-4)
C2911479 (UMLS CUI-5)
C0019993 (UMLS CUI-6)
C1948053 (UMLS CUI-7)
C0231170 (UMLS CUI-8)
CL420107 (UMLS CUI-9)
C0004936 (UMLS CUI-10)
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
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
392521001 (SNOMED CT 2011_0131)
64572001 (SNOMED CT 2011_0131)
47429007 (SNOMED CT 2011_0131)
116003000 (SNOMED CT 2011_0131)
MTHU013246 (LOINC Version 232)
24526004 (SNOMED CT 2011_0131)
10021972 (MedDRA 14.1)
32273002 (SNOMED CT 2011_0131)
10021245 (MedDRA 14.1)
D69.3 (ICD-10-CM Version 2010)
200936003 (SNOMED CT 2011_0131)
10025134 (MedDRA 14.1)
L93 (ICD-10-CM Version 2010)
695.4 (ICD-9-CM Version 2011)
413603009 (SNOMED CT 2011_0131)
10002046 (MedDRA 14.1)
283.0 (ICD-9-CM Version 2011)
89155008 (SNOMED CT 2011_0131)
10039710 (MedDRA 14.1)
24484000 (SNOMED CT 2011_0131)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
69896004 (SNOMED CT 2011_0131)
10039073 (MedDRA 14.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
CL421546 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C0332281 (UMLS CUI-3)
C0020962 (UMLS CUI-4)
C0021390 (UMLS CUI-5)
C0398650 (UMLS CUI-6)
C0409974 (UMLS CUI-7)
C0002880 (UMLS CUI-8)
C0011644 (UMLS CUI-9)
C0205082 (UMLS CUI-10)
C0033860 (UMLS CUI-11)
C0003873 (UMLS CUI-12)
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)
Chronic pulmonary disease
Item
History or other evidence of chronic pulmonary disease associated with functional limitation
boolean
392521001 (SNOMED CT 2011_0131)
18669006 (SNOMED CT 2011_0131)
413839001 (SNOMED CT 2011_0131)
47429007 (SNOMED CT 2011_0131)
40143009 (SNOMED CT 2011_0131)
246175000 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI-1)
C0332120 (UMLS CUI-2)
C0746102 (UMLS CUI-3)
C0332281 (UMLS CUI-4)
C0205245 (UMLS CUI-5)
C0449295 (UMLS CUI-6)
History of significant cardiac disease
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
392521001 (SNOMED CT 2011_0131)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
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)
288556008 (SNOMED CT 2011_0131)
387188005 (SNOMED CT 2011_0131)
MTHU018696 (LOINC Version 232)
25569003 (SNOMED CT 2011_0131)
10065341 (MedDRA 14.1)
I47.2 (ICD-10-CM Version 2010)
E10239 (CTCAE 1105E)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
CL421546 (UMLS CUI-1)
C0018799 (UMLS CUI-2)
C1319795 (UMLS CUI-3)
C1319796 (UMLS CUI-4)
C0027051 (UMLS CUI-5)
C0332152 (UMLS CUI-6)
C0982327 (UMLS CUI-7)
C0035525 (UMLS CUI-8)
C0039798 (UMLS CUI-9)
C0042514 (UMLS CUI-10)
C0002965 (UMLS CUI-11)
Poorly controlled thyroid disease
Item
Evidence of thyroid disease that is poorly controlled on prescribed medications
boolean
14304000 (SNOMED CT 2011_0131)
10043709 (MedDRA 14.1)
E00-E07 (ICD-10-CM Version 2010)
240-246.99 (ICD-9-CM Version 2011)
556001 (SNOMED CT 2011_0131)
31509003 (SNOMED CT 2011_0131)
C0040128 (UMLS CUI-1)
C0205169 (UMLS CUI-2)
C2587213 (UMLS CUI-3)
C0013227 (UMLS CUI-4)
Severe retinopathy
Item
Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)
boolean
24484000 (SNOMED CT 2011_0131)
399625000 (SNOMED CT 2011_0131)
10038923 (MedDRA 14.1)
E10432 (CTCAE 1105E)
22455005 (SNOMED CT 2011_0131)
10011835 (MedDRA 14.1)
422338006 (SNOMED CT 2011_0131)
10025409 (MedDRA 14.1)
MTHU020821 (LOINC Version 232)
C0205082 (UMLS CUI-1)
CL365148 (UMLS CUI-2)
C0206178 (UMLS CUI-3)
C0024437 (UMLS CUI-4)
Major organ transplantation
Item
History of major organ transplantation with an existing functional graft
boolean
392521001 (SNOMED CT 2011_0131)
255603008 (SNOMED CT 2011_0131)
10061890 (MedDRA 14.1)
MTHU000173 (LOINC Version 232)
40143009 (SNOMED CT 2011_0131)
24486003 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI-1)
C0205164 (UMLS CUI-2)
C0029216 (UMLS CUI-3)
C0205245 (UMLS CUI-4)
C0332835 (UMLS CUI-5)
Severe illness
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
24484000 (SNOMED CT 2011_0131)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
23981006 (SNOMED CT 2011_0131)
116154003 (SNOMED CT 2011_0131)
110465008 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI-1)
C0221423 (UMLS CUI-2)
C0006826 (UMLS CUI-3)
C0348080 (UMLS CUI-4)
C0678227 (UMLS CUI-5)
C0030705 (UMLS CUI-6)
C1548788 (UMLS CUI-7)
C0008976 (UMLS CUI-8)
Systemic anti-neoplastic or immunomodulatory treatment
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
392521001 (SNOMED CT 2011_0131)
31099001 (SNOMED CT 2011_0131)
116566001 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI-1)
C0205373 (UMLS CUI-2)
C0920425 (UMLS CUI-3)
CL412323 (UMLS CUI-4)
C0038317 (UMLS CUI-5)
C0034619 (UMLS CUI-6)
Tuberculosis
Item
Patients with evidence for tuberculosis
boolean
18669006 (SNOMED CT 2011_0131)
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)
C0041296 (UMLS CUI-1)
Drug abuse
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
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
160592001 (SNOMED CT 2011_0131)
E (HL7 V3 2006_05)
51758009 (SNOMED CT 2011_0131)
MTHU001002 (LOINC Version 232)
31684002 (SNOMED CT 2011_0131)
MTHU006723 (LOINC Version 232)
C0013146 (UMLS CUI-1)
C0560219 (UMLS CUI-2)
C1554961 (UMLS CUI-3)
C0025605 (UMLS CUI-4)
C0006405 (UMLS CUI-5)
Participation in another clinical study
Item
Any investigational drug and/or participation in another clinical study prior 6 months to the actual ongoing antiviral treatment
boolean
74964007 (SNOMED CT 2011_0131)
PART (HL7 V3 2006_05)
74964007 (SNOMED CT 2011_0131)
110465008 (SNOMED CT 2011_0131)
288556008 (SNOMED CT 2011_0131)
68244004 (SNOMED CT 2011_0131)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0205394 (UMLS CUI-1)
C0013230 (UMLS CUI-2)
C0679823 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
C0008976 (UMLS CUI-5)
C0332152 (UMLS CUI-6)
C0205452 (UMLS CUI-7)
C0439231 (UMLS CUI-8)
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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