age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Subjects with stage IV NSCLC (not recurrent or re-staged).
Item
Subjects with stage IV NSCLC (not recurrent or re-staged).
boolean
C0278987 (UMLS CUI 2011AA)
10025055 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1518422 (UMLS CUI 2011AA)
CL429630 (UMLS CUI 2011AA)
Expected to receive at least 2 additional cycles (at least 6 total weeks) of first line myelosuppressive cyclic chemotherapy after randomization. Subjects should not be expected to receive only maintenance chemotherapy.
Item
Expected to receive at least 2 additional cycles (at least 6 total weeks) of first line myelosuppressive cyclic chemotherapy after randomization. Subjects should not be expected to receive only maintenance chemotherapy.
boolean
C1517001 (UMLS CUI 2011AA)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C1302181 (UMLS CUI 2011AA)
399042005 (SNOMED CT 2011_0131)
C1708063 (UMLS CUI 2011AA)
C1513793 (UMLS CUI 2011AA)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Eastern Cooperative Oncology Group performance status of 0 or 1 as assessed within 21 days prior to randomization.
Item
Eastern Cooperative Oncology Group performance status of 0 or 1 as assessed within 21 days prior to randomization.
boolean
C1828127 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
C1516048 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Life expectancy > 6 months based on the judgment of the investigator and documented during screening.
Item
Life expectancy > 6 months based on the judgment of the investigator and documented during screening.
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Hemoglobin level <= 11.0 g/dL as assessed by the local laboratory, sample obtained within 7 days prior to randomization (retest in screening is acceptable).
Item
Hemoglobin level <= 11.0 g/dL as assessed by the local laboratory, sample obtained within 7 days prior to randomization (retest in screening is acceptable).
boolean
C0019046 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
C1516048 (UMLS CUI 2011AA)
CL415116 (UMLS CUI 2011AA)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
Adequate serum folate (>= 2 ng/mL) and vitamin B12 (>= 200 pg/mL) levels assessed by central laboratory (supplementation and retest acceptable) during screening.
Item
Adequate serum folate (>= 2 ng/mL) and vitamin B12 (>= 200 pg/mL) levels assessed by central laboratory (supplementation and retest acceptable) during screening.
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0202020 (UMLS CUI 2011AA)
60306005 (SNOMED CT 2011_0131)
C0042845 (UMLS CUI 2011AA)
81064004 (SNOMED CT 2011_0131)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
C1516048 (UMLS CUI 2011AA)
C1880016 (UMLS CUI 2011AA)
Subjects must have had a baseline scan (CT, MRI, or PET/CT) of the chest to assess disease burden before starting on first line chemotherapy for NSCLC and those images must have been reviewed by the investigator prior to randomization. If the scan was performed more than 28 days prior to randomization, an additional scan must be performed and reviewed by the investigator to confirm that the patient has not progressed before randomization.
Item
Subjects must have had a baseline scan (CT, MRI, or PET/CT) of the chest to assess disease burden before starting on first line chemotherapy for NSCLC and those images must have been reviewed by the investigator prior to randomization. If the scan was performed more than 28 days prior to randomization, an additional scan must be performed and reviewed by the investigator to confirm that the patient has not progressed before randomization.
boolean
C1442488 (UMLS CUI 2011AA)
C0441633 (UMLS CUI 2011AA)
C0040405 (UMLS CUI 2011AA)
77477000 (SNOMED CT 2011_0131)
10010234 (MedDRA 14.1)
0002 (HL7 V3 2006_05)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
CL381767 (UMLS CUI 2011AA)
C0817096 (UMLS CUI 2011AA)
51185008 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1708063 (UMLS CUI 2011AA)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0007131 (UMLS CUI 2011AA)
254637007 (SNOMED CT 2011_0131)
10061873 (MedDRA 14.1)
C1704922 (UMLS CUI 2011AA)
C1709940 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Before any study-specific procedure, the appropriate written informed consent must be obtained from the subject or a legally accepted representative .
Item
Before any study-specific procedure, the appropriate written informed consent must be obtained from the subject or a legally accepted representative .
boolean
C0021430 (UMLS CUI 2011AA)
Known primary benign or malignant hematologic disorder which can cause anemia.
Item
Known primary benign or malignant hematologic disorder which can cause anemia.
boolean
CL414904 (UMLS CUI 2011AA)
C0205183 (UMLS CUI 2011AA)
30807003 (SNOMED CT 2011_0131)
CL364385 (UMLS CUI 2011AA)
C0018939 (UMLS CUI 2011AA)
191124002 (SNOMED CT 2011_0131)
10061590 (MedDRA 14.1)
D75.9 (ICD-10-CM Version 2010)
289.9 (ICD-9-CM Version 2011)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C0002871 (UMLS CUI 2011AA)
271737000 (SNOMED CT 2011_0131)
10002034 (MedDRA 14.1)
MTHU020823 (LOINC Version 232)
D64.9 (ICD-10-CM Version 2010)
285.9 (ICD-9-CM Version 2011)
E10010 (CTCAE 1105E)
History of, or current active cancer other than NSCLC, with the exception of curatively resected non-melanomatous skin cancer, curatively treated cervical carcinoma in situ, or other primary solid tumors curatively treated with no known active disease present and no curative treatment administered for the last 3 years.
Item
History of, or current active cancer other than NSCLC, with the exception of curatively resected non-melanomatous skin cancer, curatively treated cervical carcinoma in situ, or other primary solid tumors curatively treated with no known active disease present and no curative treatment administered for the last 3 years.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
CL411789 (UMLS CUI 2011AA)
C0007131 (UMLS CUI 2011AA)
254637007 (SNOMED CT 2011_0131)
10061873 (MedDRA 14.1)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C1880198 (UMLS CUI 2011AA)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C0699893 (UMLS CUI 2011AA)
10040810 (MedDRA 14.1)
C1880198 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
CL414904 (UMLS CUI 2011AA)
C0280100 (UMLS CUI 2011AA)
10065252 (MedDRA 14.1)
Received any prior adjuvant or neoadjuvant therapy for NSCLC.
Item
Received any prior adjuvant or neoadjuvant therapy for NSCLC.
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0677850 (UMLS CUI 2011AA)
10068969 (MedDRA 14.1)
C0600558 (UMLS CUI 2011AA)
C0007131 (UMLS CUI 2011AA)
254637007 (SNOMED CT 2011_0131)
10061873 (MedDRA 14.1)
Subjects with a history of brain metastasis .
Item
Subjects with a history of brain metastasis .
boolean
C0220650 (UMLS CUI 2011AA)
Uncontrolled hypertension (systolic BP > 160 mmHg or diastolic BP > 100 mmHg), or as determined by the investigator during screening.
Item
Uncontrolled hypertension (systolic BP > 160 mmHg or diastolic BP > 100 mmHg), or as determined by the investigator during screening.
boolean
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
C0871470 (UMLS CUI 2011AA)
271649006 (SNOMED CT 2011_0131)
C0428883 (UMLS CUI 2011AA)
271650006 (SNOMED CT 2011_0131)
History of neutralizing antibody activity to rHuEPO or darbepoetin alfa.
Item
History of neutralizing antibody activity to rHuEPO or darbepoetin alfa.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0475463 (UMLS CUI 2011AA)
260212000 (SNOMED CT 2011_0131)
C0441655 (UMLS CUI 2011AA)
257733005 (SNOMED CT 2011_0131)
MTHU002837 (LOINC Version 232)
E001-E030.9 (ICD-9-CM Version 2011)
C0376541 (UMLS CUI 2011AA)
C0937950 (UMLS CUI 2011AA)
385608005 (SNOMED CT 2011_0131)
Uncontrolled angina, uncontrolled heart failure, or uncontrolled cardiac arrhythmia as determined by the investigator at screening. Subjects with known myocardial infarction within 6 months prior to randomization.
Item
Uncontrolled angina, uncontrolled heart failure, or uncontrolled cardiac arrhythmia as determined by the investigator at screening. Subjects with known myocardial infarction within 6 months prior to randomization.
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0002962 (UMLS CUI 2011AA)
194828000 (SNOMED CT 2011_0131)
10002383 (MedDRA 14.1)
I20 (ICD-10-CM Version 2010)
413 (ICD-9-CM Version 2011)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
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)
Subjects with a history of seizure disorder taking anti-seizure medication within 30 days prior to randomization.
Item
Subjects with a history of seizure disorder taking anti-seizure medication within 30 days prior to randomization.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0014544 (UMLS CUI 2011AA)
84757009 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
C1512806 (UMLS CUI 2011AA)
C0003299 (UMLS CUI 2011AA)
255632006 (SNOMED CT 2011_0131)
MTHU006781 (LOINC Version 232)
Clinically significant systemic infection or uncontrolled chronic inflammatory disease (eg, rheumatoid arthritis, inflammatory bowel disease) as determined by the investigator during screening.
Item
Clinically significant systemic infection or uncontrolled chronic inflammatory disease (eg, rheumatoid arthritis, inflammatory bowel disease) as determined by the investigator during screening.
boolean
C0243026 (UMLS CUI 2011AA)
91302008 (SNOMED CT 2011_0131)
10040047 (MedDRA 14.1)
995.91 (ICD-9-CM Version 2011)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C1290886 (UMLS CUI 2011AA)
128294001 (SNOMED CT 2011_0131)
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)
C0021390 (UMLS CUI 2011AA)
24526004 (SNOMED CT 2011_0131)
10021972 (MedDRA 14.1)
Known seropositivity for HIV or diagnosis of AIDS, positive for hepatitis B surface antigen, or seropositive for hepatitis C virus
Item
Known seropositivity for HIV or diagnosis of AIDS, positive for hepatitis B surface antigen, or seropositive for hepatitis C virus
boolean
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0001175 (UMLS CUI 2011AA)
62479008 (SNOMED CT 2011_0131)
10000565 (MedDRA 14.1)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
C0149709 (UMLS CUI 2011AA)
165806002 (SNOMED CT 2011_0131)
10019742 (MedDRA 14.1)
C0521143 (UMLS CUI 2011AA)
4879001 (SNOMED CT 2011_0131)
C0220847 (UMLS CUI 2011AA)
62944002 (SNOMED CT 2011_0131)
10019752 (MedDRA 14.1)
History of pure red cell aplasia
Item
History of pure red cell aplasia
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0034902 (UMLS CUI 2011AA)
50715003 (SNOMED CT 2011_0131)
10002965 (MedDRA 14.1)
History of deep venous thrombosis or embolic event (eg, pulmonary embolism) within 6 months prior to randomization.
Item
History of deep venous thrombosis or embolic event (eg, pulmonary embolism) within 6 months prior to randomization.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0149871 (UMLS CUI 2011AA)
128053003 (SNOMED CT 2011_0131)
10051055 (MedDRA 14.1)
I82.40 (ICD-10-CM Version 2010)
C0013922 (UMLS CUI 2011AA)
414086009 (SNOMED CT 2011_0131)
10061169 (MedDRA 14.1)
C0034065 (UMLS CUI 2011AA)
59282003 (SNOMED CT 2011_0131)
10037377 (MedDRA 14.1)
I26 (ICD-10-CM Version 2010)
415.1 (ICD-9-CM Version 2011)
Transferrin saturation < 20% and ferritin < 50 ng/mL as assessed by the central laboratory during screening. Subjects must have both to be excluded (supplementation and retest acceptable).
Item
Transferrin saturation < 20% and ferritin < 50 ng/mL as assessed by the central laboratory during screening. Subjects must have both to be excluded (supplementation and retest acceptable).
boolean
C1277709 (UMLS CUI 2011AA)
165730006 (SNOMED CT 2011_0131)
10051007 (MedDRA 14.1)
MTHU023012 (LOINC Version 232)
C1550557 (UMLS CUI 2011AA)
AND (HL7 V3 2006_05)
C0015879 (UMLS CUI 2011AA)
32789000 (SNOMED CT 2011_0131)
MTHU004940 (LOINC Version 232)
C1516048 (UMLS CUI 2011AA)
C1880016 (UMLS CUI 2011AA)
Abnormal renal function (serum creatinine level > 2X ULN) as assessed by the central laboratory during screening.
Item
Abnormal renal function (serum creatinine level > 2X ULN) as assessed by the central laboratory during screening.
boolean
C1848822 (UMLS CUI 2011AA)
C0600061 (UMLS CUI 2011AA)
365757006 (SNOMED CT 2011_0131)
C1519815 (UMLS CUI 2011AA)
C1516048 (UMLS CUI 2011AA)
C1880016 (UMLS CUI 2011AA)
Abnormal liver function (total bilirubin > 2X ULN or liver enzymes ALT or AST > 2.5X ULN for subjects without liver metastasis or >= 5X ULN for subjects with liver metastasis) as assessed by the central laboratory during screening. Subjects with documented Gilbert's Disease may be eligible.
Item
Abnormal liver function (total bilirubin > 2X ULN or liver enzymes ALT or AST > 2.5X ULN for subjects without liver metastasis or >= 5X ULN for subjects with liver metastasis) as assessed by the central laboratory during screening. Subjects with documented Gilbert's Disease may be eligible.
boolean
C0086565 (UMLS CUI 2011AA)
75183008 (SNOMED CT 2011_0131)
10019670 (MedDRA 14.1)
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C0857093 (UMLS CUI 2011AA)
10014480 (MedDRA 14.1)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0494165 (UMLS CUI 2011AA)
94381002 (SNOMED CT 2011_0131)
10027457 (MedDRA 14.1)
C78.7 (ICD-10-CM Version 2010)
197.7 (ICD-9-CM Version 2011)
C1516048 (UMLS CUI 2011AA)
C1880016 (UMLS CUI 2011AA)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C0017551 (UMLS CUI 2011AA)
27503000 (SNOMED CT 2011_0131)
10018267 (MedDRA 14.1)
E80.4 (ICD-10-CM Version 2010)
Received any RBC transfusion within 28 days prior to randomization.
Item
Erythrocyte Transfusion
boolean
C0086252 (UMLS CUI 2011AA)
116863004 (SNOMED CT 2011_0131)
Plan to receive any RBC transfusion between randomization and study day 1.
Item
Plan to receive any RBC transfusion between randomization and study day 1.
boolean
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0086252 (UMLS CUI 2011AA)
116863004 (SNOMED CT 2011_0131)
Known previous treatment failure to ESAs (eg, rHuEPO, darbepoetin alfa).
Item
Known previous treatment failure to ESAs (eg, rHuEPO, darbepoetin alfa).
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0162643 (UMLS CUI 2011AA)
10066901 (MedDRA 14.1)
C2917382 (UMLS CUI 2011AA)
C0376541 (UMLS CUI 2011AA)
C0937950 (UMLS CUI 2011AA)
385608005 (SNOMED CT 2011_0131)
ESA therapy within the 28 days prior to randomization.
Item
ESA therapy within the 28 days prior to randomization.
boolean
C2917382 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Known hypersensitivity to recombinant ESAs or the excipients contained within the investigational product.
Item
Known hypersensitivity to recombinant ESAs or the excipients contained within the investigational product.
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C1514798 (UMLS CUI 2011AA)
C2917382 (UMLS CUI 2011AA)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
< 30 days since receipt of any investigational product or device. Investigational use/receipt of a medicinal product or device that has been approved by the country's local regulatory authority for any indication is permitted.
Item
< 30 days since receipt of any investigational product or device. Investigational use/receipt of a medicinal product or device that has been approved by the country's local regulatory authority for any indication is permitted.
boolean
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C1514756 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
C2346570 (UMLS CUI 2011AA)
Subjects of reproductive potential who are pregnant, breast feeding or not willing to use effective contraceptive precautions during the study and for at least one month after the last dose of investigational product in the judgment of the investigator (including females of childbearing potential who are partners of male subjects).
Item
Subjects of reproductive potential who are pregnant, breast feeding or not willing to use effective contraceptive precautions during the study and for at least one month after the last dose of investigational product in the judgment of the investigator (including females of childbearing potential who are partners of male subjects).
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0035150 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Previously randomized to this study.
Item
Previously randomized to this study.
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Investigator has concerns regarding the ability of the subject to give written informed consent and/or to comply with study procedures (including availability for follow up visits.
Item
Investigator has concerns regarding the ability of the subject to give written informed consent and/or to comply with study procedures (including availability for follow up visits.
boolean
C0021430 (UMLS CUI 2011AA)