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)
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)