ID

43488

Description

ODM derived from http://clinicaltrials.gov/show/NCT00858364

Link

http://clinicaltrials.gov/show/NCT00858364

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
  3. 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 NCT00858364 Non-Small Cell Lung Cancer

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
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
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Subjects with stage IV NSCLC (not recurrent or re-staged).
Description

Subjects with stage IV NSCLC (not recurrent or re-staged).

Data type

boolean

Alias
UMLS CUI 2011AA
C0278987
MedDRA 14.1
10025055
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL429630
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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C1517001
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C1524062
LOINC Version 232
MTHU013802
UMLS CUI 2011AA
C1302181
SNOMED CT 2011_0131
399042005
UMLS CUI 2011AA
C1708063
UMLS CUI 2011AA
C1513793
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C0034656
Eastern Cooperative Oncology Group performance status of 0 or 1 as assessed within 21 days prior to randomization.
Description

Eastern Cooperative Oncology Group performance status of 0 or 1 as assessed within 21 days prior to randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C1828127
SNOMED CT 2011_0131
424122007
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
Life expectancy > 6 months based on the judgment of the investigator and documented during screening.
Description

Life expectancy > 6 months based on the judgment of the investigator and documented during screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
LOINC Version 232
LP75025-4
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C1409616
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).
Description

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).

Data type

boolean

Alias
UMLS CUI 2011AA
C0019046
SNOMED CT 2011_0131
38082009
MedDRA 14.1
10019481
LOINC Version 232
LP14449-0
UMLS CUI 2011AA
C0456079
SNOMED CT 2011_0131
276625007
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
CL415116
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
Adequate serum folate (>= 2 ng/mL) and vitamin B12 (>= 200 pg/mL) levels assessed by central laboratory (supplementation and retest acceptable) during screening.
Description

Adequate serum folate (>= 2 ng/mL) and vitamin B12 (>= 200 pg/mL) levels assessed by central laboratory (supplementation and retest acceptable) during screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0202020
SNOMED CT 2011_0131
60306005
UMLS CUI 2011AA
C0042845
SNOMED CT 2011_0131
81064004
UMLS CUI 2011AA
C0456079
SNOMED CT 2011_0131
276625007
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
C1880016
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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C1442488
UMLS CUI 2011AA
C0441633
UMLS CUI 2011AA
C0040405
SNOMED CT 2011_0131
77477000
MedDRA 14.1
10010234
HL7 V3 2006_05
0002
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
UMLS CUI 2011AA
CL381767
UMLS CUI 2011AA
C0817096
SNOMED CT 2011_0131
51185008
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1708063
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0007131
SNOMED CT 2011_0131
254637007
MedDRA 14.1
10061873
UMLS CUI 2011AA
C1704922
UMLS CUI 2011AA
C1709940
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
Before any study-specific procedure, the appropriate written informed consent must be obtained from the subject or a legally accepted representative .
Description

Before any study-specific procedure, the appropriate written informed consent must be obtained from the subject or a legally accepted representative .

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Known primary benign or malignant hematologic disorder which can cause anemia.
Description

Known primary benign or malignant hematologic disorder which can cause anemia.

Data type

boolean

Alias
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0205183
SNOMED CT 2011_0131
30807003
UMLS CUI 2011AA
CL364385
UMLS CUI 2011AA
C0018939
SNOMED CT 2011_0131
191124002
MedDRA 14.1
10061590
ICD-10-CM Version 2010
D75.9
ICD-9-CM Version 2011
289.9
UMLS CUI 2011AA
C0678227
SNOMED CT 2011_0131
23981006
UMLS CUI 2011AA
C0002871
SNOMED CT 2011_0131
271737000
MedDRA 14.1
10002034
LOINC Version 232
MTHU020823
ICD-10-CM Version 2010
D64.9
ICD-9-CM Version 2011
285.9
CTCAE 1105E
E10010
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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
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
CL411789
UMLS CUI 2011AA
C0007131
SNOMED CT 2011_0131
254637007
MedDRA 14.1
10061873
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C1880198
UMLS CUI 2011AA
C0728940
SNOMED CT 2011_0131
65801008
UMLS CUI 2011AA
C0699893
MedDRA 14.1
10040810
UMLS CUI 2011AA
C1880198
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0851140
SNOMED CT 2011_0131
92564006
MedDRA 14.1
10061809
ICD-10-CM Version 2010
D06.9
ICD-9-CM Version 2011
233.1
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0280100
MedDRA 14.1
10065252
Received any prior adjuvant or neoadjuvant therapy for NSCLC.
Description

Received any prior adjuvant or neoadjuvant therapy for NSCLC.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0677850
MedDRA 14.1
10068969
UMLS CUI 2011AA
C0600558
UMLS CUI 2011AA
C0007131
SNOMED CT 2011_0131
254637007
MedDRA 14.1
10061873
Subjects with a history of brain metastasis .
Description

Subjects with a history of brain metastasis .

Data type

boolean

Alias
UMLS CUI 2011AA
C0220650
Uncontrolled hypertension (systolic BP > 160 mmHg or diastolic BP > 100 mmHg), or as determined by the investigator during screening.
Description

Uncontrolled hypertension (systolic BP > 160 mmHg or diastolic BP > 100 mmHg), or as determined by the investigator during screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C1868885
MedDRA 14.1
10066860
UMLS CUI 2011AA
C0871470
SNOMED CT 2011_0131
271649006
UMLS CUI 2011AA
C0428883
SNOMED CT 2011_0131
271650006
History of neutralizing antibody activity to rHuEPO or darbepoetin alfa.
Description

History of neutralizing antibody activity to rHuEPO or darbepoetin alfa.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0475463
SNOMED CT 2011_0131
260212000
UMLS CUI 2011AA
C0441655
SNOMED CT 2011_0131
257733005
LOINC Version 232
MTHU002837
ICD-9-CM Version 2011
E001-E030.9
UMLS CUI 2011AA
C0376541
UMLS CUI 2011AA
C0937950
SNOMED CT 2011_0131
385608005
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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0002962
SNOMED CT 2011_0131
194828000
MedDRA 14.1
10002383
ICD-10-CM Version 2010
I20
ICD-9-CM Version 2011
413
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0018801
SNOMED CT 2011_0131
155374007
MedDRA 14.1
10019279
ICD-9-CM Version 2011
428
CTCAE 1105E
E10124
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
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
Subjects with a history of seizure disorder taking anti-seizure medication within 30 days prior to randomization.
Description

Subjects with a history of seizure disorder taking anti-seizure medication within 30 days prior to randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0014544
SNOMED CT 2011_0131
84757009
MedDRA 14.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0003299
SNOMED CT 2011_0131
255632006
LOINC Version 232
MTHU006781
Clinically significant systemic infection or uncontrolled chronic inflammatory disease (eg, rheumatoid arthritis, inflammatory bowel disease) as determined by the investigator during screening.
Description

Clinically significant systemic infection or uncontrolled chronic inflammatory disease (eg, rheumatoid arthritis, inflammatory bowel disease) as determined by the investigator during screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0243026
SNOMED CT 2011_0131
91302008
MedDRA 14.1
10040047
ICD-9-CM Version 2011
995.91
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C1290886
SNOMED CT 2011_0131
128294001
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
UMLS CUI 2011AA
C0021390
SNOMED CT 2011_0131
24526004
MedDRA 14.1
10021972
Known seropositivity for HIV or diagnosis of AIDS, positive for hepatitis B surface antigen, or seropositive for hepatitis C virus
Description

Known seropositivity for HIV or diagnosis of AIDS, positive for hepatitis B surface antigen, or seropositive for hepatitis C virus

Data type

boolean

Alias
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0001175
SNOMED CT 2011_0131
62479008
MedDRA 14.1
10000565
ICD-10-CM Version 2010
B20
ICD-9-CM Version 2011
042
UMLS CUI 2011AA
C0149709
SNOMED CT 2011_0131
165806002
MedDRA 14.1
10019742
UMLS CUI 2011AA
C0521143
SNOMED CT 2011_0131
4879001
UMLS CUI 2011AA
C0220847
SNOMED CT 2011_0131
62944002
MedDRA 14.1
10019752
History of pure red cell aplasia
Description

History of pure red cell aplasia

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0034902
SNOMED CT 2011_0131
50715003
MedDRA 14.1
10002965
History of deep venous thrombosis or embolic event (eg, pulmonary embolism) within 6 months prior to randomization.
Description

History of deep venous thrombosis or embolic event (eg, pulmonary embolism) within 6 months prior to randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0149871
SNOMED CT 2011_0131
128053003
MedDRA 14.1
10051055
ICD-10-CM Version 2010
I82.40
UMLS CUI 2011AA
C0013922
SNOMED CT 2011_0131
414086009
MedDRA 14.1
10061169
UMLS CUI 2011AA
C0034065
SNOMED CT 2011_0131
59282003
MedDRA 14.1
10037377
ICD-10-CM Version 2010
I26
ICD-9-CM Version 2011
415.1
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).
Description

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).

Data type

boolean

Alias
UMLS CUI 2011AA
C1277709
SNOMED CT 2011_0131
165730006
MedDRA 14.1
10051007
LOINC Version 232
MTHU023012
UMLS CUI 2011AA
C1550557
HL7 V3 2006_05
AND
UMLS CUI 2011AA
C0015879
SNOMED CT 2011_0131
32789000
LOINC Version 232
MTHU004940
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
C1880016
Abnormal renal function (serum creatinine level > 2X ULN) as assessed by the central laboratory during screening.
Description

Abnormal renal function (serum creatinine level > 2X ULN) as assessed by the central laboratory during screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0151746
UMLS CUI 2011AA
C0600061
SNOMED CT 2011_0131
365757006
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
C1880016
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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086565
SNOMED CT 2011_0131
75183008
MedDRA 14.1
10019670
UMLS CUI 2011AA
C0201913
SNOMED CT 2011_0131
359986008
MedDRA 14.1
10004696
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C0857093
MedDRA 14.1
10014480
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C0494165
SNOMED CT 2011_0131
94381002
MedDRA 14.1
10027457
ICD-10-CM Version 2010
C78.7
ICD-9-CM Version 2011
197.7
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
C1880016
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
UMLS CUI 2011AA
C0017551
SNOMED CT 2011_0131
27503000
MedDRA 14.1
10018267
ICD-10-CM Version 2010
E80.4
Erythrocyte Transfusion
Description

Received any RBC transfusion within 28 days prior to randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086252
SNOMED CT 2011_0131
116863004
Plan to receive any RBC transfusion between randomization and study day 1.
Description

Plan to receive any RBC transfusion between randomization and study day 1.

Data type

boolean

Alias
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
UMLS CUI 2011AA
C0086252
SNOMED CT 2011_0131
116863004
Known previous treatment failure to ESAs (eg, rHuEPO, darbepoetin alfa).
Description

Known previous treatment failure to ESAs (eg, rHuEPO, darbepoetin alfa).

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0162643
MedDRA 14.1
10066901
UMLS CUI 2011AA
C2917382
UMLS CUI 2011AA
C0376541
UMLS CUI 2011AA
C0937950
SNOMED CT 2011_0131
385608005
ESA therapy within the 28 days prior to randomization.
Description

ESA therapy within the 28 days prior to randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C2917382
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
Known hypersensitivity to recombinant ESAs or the excipients contained within the investigational product.
Description

Known hypersensitivity to recombinant ESAs or the excipients contained within the investigational product.

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C1514798
UMLS CUI 2011AA
C2917382
UMLS CUI 2011AA
C0015237
SNOMED CT 2011_0131
360215002
UMLS CUI 2011AA
C0013230
< 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.
Description

< 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.

Data type

boolean

Alias
UMLS CUI 2011AA
C0439092
SNOMED CT 2011_0131
276139006
HL7 V3 2006_05
LT
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C2346570
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).
Description

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).

Data type

boolean

Alias
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0035150
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C0558080
SNOMED CT 2011_0131
225465005
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Previously randomized to this study.
Description

Previously randomized to this study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
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Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
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
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)
Item Group
Exclusion Criteria
CL425201 (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
C0151746 (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)
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