ID

5106

Description

ODM derived from http://clinicaltrials.gov/show/NCT01234311

Link

http://clinicaltrials.gov/show/NCT01234311

Keywords

Versions (3)
  1. 2/12/13 2/12/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

April 19, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00006523 NCT01234311 Prostate Cancer

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Age at least 18 years at the time of signing the informed consent form. For patients in Taiwan the minimum age is 20 years.
Description

Age at least 18 years at the time of signing the informed consent form. For patients in Taiwan the minimum age is 20 years.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Histologically confirmed diagnosis of adenocarcinoma of the prostate.
Description

Histologically confirmed diagnosis of adenocarcinoma of the prostate.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0007112
SNOMED CT 2011_0131
399490008
MedDRA 14.1
10001186
Evidence of bone metastatic disease on radiographic examination, whether from bone scan or other imaging modality.
Description

Evidence of bone metastatic disease on radiographic examination, whether from bone scan or other imaging modality.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0153690
SNOMED CT 2011_0131
94222008
MedDRA 14.1
10055101
ICD-10-CM Version 2010
C79.51
ICD-9-CM Version 2011
198.5
UMLS CUI 2011AA
C0444708
SNOMED CT 2011_0131
258106000
UMLS CUI 2011AA
C0582103
SNOMED CT 2011_0131
225886003
UMLS CUI 2011AA
C0203668
SNOMED CT 2011_0131
41747008
MedDRA 14.1
10006009
ICD-9-CM Version 2011
92.14
UMLS CUI 2011AA
C1518654
Castrate levels of serum testosterone (≤50 ng/dL or 1.7 nmol/L).
Description

Castrate levels of serum testosterone (≤50 ng/dL or 1.7 nmol/L).

Data type

boolean

Alias
UMLS CUI 2011AA
C1319065
SNOMED CT 2011_0131
405242009
HL7 V3 2006_05
N
UMLS CUI 2011AA
C0428413
SNOMED CT 2011_0131
270973006
MedDRA 14.1
10040409
Evidence of progressive disease.
Description

Evidence of progressive disease.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C1335499
Karnofsky performance status (assessment scale)
Description

Karnofsky score ≥70%.

Data type

boolean

Alias
UMLS CUI 2011AA
C0206065
SNOMED CT 2011_0131
273546003
Meet screening laboratory values as specified in the protocol.
Description

Meet screening laboratory values as specified in the protocol.

Data type

boolean

Alias
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
C1522609
UMLS CUI 2011AA
C0205369
SNOMED CT 2011_0131
69658003
UMLS CUI 2011AA
C2348563
If sexually active with partner of childbearing potential, patient will agree to use adequate contraceptive methods (barrier contraceptive with spermicide or vasectomy) while on study drug. The adequate contraceptive method should be continued for 14 days after the patient stops taking study drug.
Description

If sexually active with partner of childbearing potential, patient will agree to use adequate contraceptive methods (barrier contraceptive with spermicide or vasectomy) while on study drug. The adequate contraceptive method should be continued for 14 days after the patient stops taking study drug.

Data type

boolean

Alias
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0241028
SNOMED CT 2011_0131
228453005
MedDRA 14.1
10066098
UMLS CUI 2011AA
C0682323
SNOMED CT 2011_0131
262043009
HL7 V3 2006_05
SIGOTHR
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0004764
SNOMED CT 2011_0131
225370004
UMLS CUI 2011AA
C0037862
SNOMED CT 2011_0131
425484006
UMLS CUI 2011AA
C0042387
SNOMED CT 2011_0131
22523008
MedDRA 14.1
10047133
ICD-9-CM Version 2011
63.73
No evidence (within 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin).
Description

No evidence (within 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin).

Data type

boolean

Alias
UMLS CUI 2011AA
C0332125
SNOMED CT 2011_0131
41647002
UMLS CUI 2011AA
C2735088
LOINC Version 232
MTHU034770
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C1272703
SNOMED CT 2011_0131
385669000
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0553723
SNOMED CT 2011_0131
254651007
MedDRA 14.1
10041834
Able to swallow and retain oral medication.
Description

Able to swallow and retain oral medication.

Data type

boolean

Alias
UMLS CUI 2011AA
C0566356
SNOMED CT 2011_0131
288936000
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0333118
SNOMED CT 2011_0131
397909002
UMLS CUI 2011AA
CL436624
Able to adhere to the study visit schedule and other protocol requirements.
Description

Able to adhere to the study visit schedule and other protocol requirements.

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0086960
UMLS CUI 2011AA
C0525058
Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study.
Description

Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study.

Data type

boolean

Alias
UMLS CUI 2011AA
C1273101
SNOMED CT 2011_0131
395659009
UMLS CUI 2011AA
C0681832
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
UMLS CUI 2011AA
CL330043
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0392337
UMLS CUI 2011AA
CL102947
Able (or patient's legal guardian, if applicable) to sign and date the written informed consent after being informed of the full nature and purpose of the study, including possible risks and side effects, and given ample time and opportunity to read and understand this information.
Description

Able (or patient's legal guardian, if applicable) to sign and date the written informed consent after being informed of the full nature and purpose of the study, including possible risks and side effects, and given ample time and opportunity to read and understand this information.

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0023226
SNOMED CT 2011_0131
58626002
LOINC Version 232
MTHU020628
UMLS CUI 2011AA
C1519316
UMLS CUI 2011AA
C0011008
SNOMED CT 2011_0131
410671006
LOINC Version 232
MTHU021546
UMLS CUI 2011AA
C1576874
HL7 V3 2006_05
WRITTEN
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Prior cytotoxic chemotherapy for the treatment of prostate ca within 2 years or within 4 weeks for Estracyt (estramustine) prior to study treatment.
Description

Prior cytotoxic chemotherapy for the treatment of prostate ca within 2 years or within 4 weeks for Estracyt (estramustine) prior to study treatment.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0677881
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0600139
SNOMED CT 2011_0131
254900004
MedDRA 14.1
10036921
UMLS CUI 2011AA
C0014922
SNOMED CT 2011_0131
108769008
UMLS CUI 2011AA
C0014921
SNOMED CT 2011_0131
108768000
Previous anticancer therapy using radiation, biologics or vaccines, including abiraterone, TAK-700 (Orteronel), or MDV3100 within 4 weeks prior or sipuleucel-T (Provenge) within 2 weeks prior to the start of study treatment. If radiation therapy is applied after baseline scan, a new baseline scan needs to be done at least 4 weeks after the radiation therapy.
Description

Previous anticancer therapy using radiation, biologics or vaccines, including abiraterone, TAK-700 (Orteronel), or MDV3100 within 4 weeks prior or sipuleucel-T (Provenge) within 2 weeks prior to the start of study treatment. If radiation therapy is applied after baseline scan, a new baseline scan needs to be done at least 4 weeks after the radiation therapy.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0920425
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C2979985
UMLS CUI 2011AA
C0042210
SNOMED CT 2011_0131
71181003
LOINC Version 232
MTHU014526
UMLS CUI 2011AA
C0754011
UMLS CUI 2011AA
CL383463
UMLS CUI 2011AA
C2348174
UMLS CUI 2011AA
C1706668
Previous therapy with antiandrogens within 4 weeks (within 6 weeks for bicalutamide eg, Casodex) prior to study treatment.
Description

Previous therapy with antiandrogens within 4 weeks (within 6 weeks for bicalutamide eg, Casodex) prior to study treatment.

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0002842
SNOMED CT 2011_0131
346324007
UMLS CUI 2011AA
C0285590
SNOMED CT 2011_0131
108766001
Concurrent use of other anticancer agents or treatments, with the following exceptions:
Description

Concurrent use of other anticancer agents or treatments, with the following exceptions:

Data type

boolean

Alias
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0003392
SNOMED CT 2011_0131
372688009
UMLS CUI 2011AA
C0920425
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
Ongoing treatment with luteinizing hormone-releasing hormone agonists or antagonists, denosumab (Prolia) or bisphosphonate (eg, zoledronic acid) is allowed. Ongoing treatment should be kept at a stable schedule; however, if medically required, a change of dose, compound, or both is allowed.
Description

Ongoing treatment with luteinizing hormone-releasing hormone agonists or antagonists, denosumab (Prolia) or bisphosphonate (eg, zoledronic acid) is allowed. Ongoing treatment should be kept at a stable schedule; however, if medically required, a change of dose, compound, or both is allowed.

Data type

boolean

Alias
UMLS CUI 2011AA
C0750536
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1518041
UMLS CUI 2011AA
C1276926
SNOMED CT 2011_0131
326082006
UMLS CUI 2011AA
C1524004
UMLS CUI 2011AA
C1690432
SNOMED CT 2011_0131
446457007
UMLS CUI 2011AA
C0012544
SNOMED CT 2011_0131
372907000
UMLS CUI 2011AA
C0257685
SNOMED CT 2011_0131
395926009
Any treatment modalities involving major surgery within 4 weeks prior to the start of study treatment.
Description

Any treatment modalities involving major surgery within 4 weeks prior to the start of study treatment.

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0695347
LOINC Version 232
MTHU010422
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C0679637
Prostate ca pain that requires ongoing treatment with narcotic analgesics or warrants the initiation of radio- or chemotherapy.
Description

Prostate ca pain that requires ongoing treatment with narcotic analgesics or warrants the initiation of radio- or chemotherapy.

Data type

boolean

Alias
UMLS CUI 2011AA
C0600139
SNOMED CT 2011_0131
254900004
MedDRA 14.1
10036921
UMLS CUI 2011AA
C0030193
SNOMED CT 2011_0131
22253000
MedDRA 14.1
10033371
LOINC Version 232
MTHU029813
ICD-10-CM Version 2010
R52
ICD-9-CM Version 2011
338-338.9
CTCAE 1105E
E11167
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0027409
SNOMED CT 2011_0131
360204007
UMLS CUI 2011AA
C1552821
HL7 V3 2006_05
justify
UMLS CUI 2011AA
C1704686
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
Ongoing treatment with warfarin unless the international normalized ratio (INR) is well controlled and below 4 (Section 4.6.8.1).
Description

Ongoing treatment with warfarin unless the international normalized ratio (INR) is well controlled and below 4 (Section 4.6.8.1).

Data type

boolean

Alias
UMLS CUI 2011AA
C0750536
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0043031
SNOMED CT 2011_0131
48603004
LOINC Version 232
MTHU003212
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0525032
SNOMED CT 2011_0131
165581004
MedDRA 14.1
10022400
Maintenance treatment with corticosteroids corresponding to a prednisolone or prednisone dose above 10 mg/day. The dose must have been stable for at least 5 days.
Description

Maintenance treatment with corticosteroids corresponding to a prednisolone or prednisone dose above 10 mg/day. The dose must have been stable for at least 5 days.

Data type

boolean

Alias
UMLS CUI 2011AA
C0677908
SNOMED CT 2011_0131
314122007
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
CL415123
UMLS CUI 2011AA
C0032950
SNOMED CT 2011_0131
116601002
LOINC Version 232
MTHU003522
UMLS CUI 2011AA
C0032952
SNOMED CT 2011_0131
116602009
LOINC Version 232
MTHU003245
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
Systemic exposure to ketoconazole or other strong cytochrome P450 (CYP) 3A4 isozyme inhibitors or inducers within 14 days prior to the start of study treatment. Systemic exposure to amiodarone is not allowed within 1 year prior to the start of study treatment.
Description

Systemic exposure to ketoconazole or other strong cytochrome P450 (CYP) 3A4 isozyme inhibitors or inducers within 14 days prior to the start of study treatment. Systemic exposure to amiodarone is not allowed within 1 year prior to the start of study treatment.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0332157
SNOMED CT 2011_0131
24932003
UMLS CUI 2011AA
C0022625
SNOMED CT 2011_0131
387216007
LOINC Version 232
MTHU002299
UMLS CUI 2011AA
C2962753
UMLS CUI 2011AA
C0002598
SNOMED CT 2011_0131
372821002
LOINC Version 232
MTHU004841
Ongoing treatment with sensitive CYP1A2 substrate or CYP1A2 substrate with narrow therapeutic range at the start of study treatment.
Description

Ongoing treatment with sensitive CYP1A2 substrate or CYP1A2 substrate with narrow therapeutic range at the start of study treatment.

Data type

boolean

Alias
UMLS CUI 2011AA
C0750536
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0332324
SNOMED CT 2011_0131
83185005
UMLS CUI 2011AA
C0207509
SNOMED CT 2011_0131
424020001
UMLS CUI 2011AA
C0178623
Ongoing treatment with CYP3A4 substrate with narrow therapeutic range at the start of study treatment.
Description

Ongoing treatment with CYP3A4 substrate with narrow therapeutic range at the start of study treatment.

Data type

boolean

Alias
UMLS CUI 2011AA
C0750536
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1142644
SNOMED CT 2011_0131
422741004
UMLS CUI 2011AA
C0178623
UMLS CUI 2011AA
CL407604
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1514721
Simultaneous participation in any other study involving treatment with investigational drugs or having received treatment with investigational drugs < 4 weeks prior to the start of study treatment.
Description

Simultaneous participation in any other study involving treatment with investigational drugs or having received treatment with investigational drugs < 4 weeks prior to the start of study treatment.

Data type

boolean

Alias
UMLS CUI 2011AA
C0521115
SNOMED CT 2011_0131
79970003
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0013230
Myocardial infarction, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass graft, class III/IV congestive heart failure, cerebrovascular accident, transient ischemic attack, or limb claudication at rest, within 6 months prior to start of study treatment and ongoing symptomatic dysrhythmias, unstable angina, uncontrolled hypertension, and uncontrolled atrial or ventricular arrhythmias.
Description

Myocardial infarction, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass graft, class III/IV congestive heart failure, cerebrovascular accident, transient ischemic attack, or limb claudication at rest, within 6 months prior to start of study treatment and ongoing symptomatic dysrhythmias, unstable angina, uncontrolled hypertension, and uncontrolled atrial or ventricular arrhythmias.

Data type

boolean

Alias
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C1532338
SNOMED CT 2011_0131
415070008
MedDRA 14.1
10065608
UMLS CUI 2011AA
C0948089
SNOMED CT 2011_0131
394659003
MedDRA 14.1
10051592
CTCAE 1105E
E10066
UMLS CUI 2011AA
C0010055
SNOMED CT 2011_0131
232717009
MedDRA 14.1
10011077
ICD-9-CM Version 2011
36.10
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
UMLS CUI 2011AA
C1319795
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
UMLS CUI 2011AA
C1319796
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
UMLS CUI 2011AA
C0038454
SNOMED CT 2011_0131
230690007
MedDRA 14.1
10042244
ICD-10-CM Version 2010
I63.9
CTCAE 1105E
E12826
UMLS CUI 2011AA
C0007787
SNOMED CT 2011_0131
266257000
MedDRA 14.1
10044390
LOINC Version 232
MTHU020810
ICD-10-CM Version 2010
G45.9
ICD-9-CM Version 2011
435.9
CTCAE 1105E
E12834
UMLS CUI 2011AA
C0015385
SNOMED CT 2011_0131
66019005
LOINC Version 232
MTHU001429
UMLS CUI 2011AA
C0311395
SNOMED CT 2011_0131
275520000
MedDRA 14.1
10009240
UMLS CUI 2011AA
C0443144
SNOMED CT 2011_0131
263678003
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
UMLS CUI 2011AA
C0002965
SNOMED CT 2011_0131
4557003
MedDRA 14.1
10002388
ICD-10-CM Version 2010
I20.0
ICD-9-CM Version 2011
411.1
UMLS CUI 2011AA
C1868885
MedDRA 14.1
10066860
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0085611
SNOMED CT 2011_0131
17366009
MedDRA 14.1
10003656
UMLS CUI 2011AA
C0085612
SNOMED CT 2011_0131
44103008
MedDRA 14.1
10047281
ICD-10-CM Version 2010
I49.01
CTCAE 1105E
E10230
History of pancreatitis.
Description

History of pancreatitis.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0030305
SNOMED CT 2011_0131
75694006
MedDRA 14.1
10033645
ICD-10-CM Version 2010
K85.9
ICD-9-CM Version 2011
577.0
CTCAE 1105E
E10930
Known brain or epidural metastases.
Description

Known brain or epidural metastases.

Data type

boolean

Alias
UMLS CUI 2011AA
C0220650
MedDRA 14.1
10006128
UMLS CUI 2011AA
CL337434
UMLS CUI 2011AA
C0027627
SNOMED CT 2011_0131
128462008
MedDRA 14.1
10027449
Known positive serology for HIV (patients with known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in an immunocompromised host).
Description

Known positive serology for HIV (patients with known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in an immunocompromised host).

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
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0019682
SNOMED CT 2011_0131
19030005
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0040539
UMLS CUI 2011AA
C0220880
UMLS CUI 2011AA
C0085393
SNOMED CT 2011_0131
370388006
Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of a chronic viral hepatitis or known viral hepatitis carrier (patients who have recovered from hepatitis will be allowed to enter the study).
Description

Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of a chronic viral hepatitis or known viral hepatitis carrier (patients who have recovered from hepatitis will be allowed to enter the study).

Data type

boolean

Alias
UMLS CUI 2011AA
C0019189
SNOMED CT 2011_0131
76783007
MedDRA 14.1
10008909
ICD-10-CM Version 2010
K73.9
ICD-9-CM Version 2011
571.40
UMLS CUI 2011AA
C0205179
SNOMED CT 2011_0131
86005002
UMLS CUI 2011AA
C0745744
MedDRA 14.1
10050060
UMLS CUI 2011AA
C0023890
SNOMED CT 2011_0131
19943007
MedDRA 14.1
10019641
ICD-10-CM Version 2010
K74.60
UMLS CUI 2011AA
C0276623
SNOMED CT 2011_0131
10295004
ICD-10-CM Version 2010
B18
UMLS CUI 2011AA
C0733680
SNOMED CT 2011_0131
170489004
MedDRA 14.1
10047458
Patients with active tuberculosis (TB), or with known, untreated latent TB. (Country-specific TB therapy should have been given for at least 30 days prior to the start of study treatment and the patient should intend to complete the entire course of that therapy.)
Description

Patients with active tuberculosis (TB), or with known, untreated latent TB. (Country-specific TB therapy should have been given for at least 30 days prior to the start of study treatment and the patient should intend to complete the entire course of that therapy.)

Data type

boolean

Alias
UMLS CUI 2011AA
C0151332
SNOMED CT 2011_0131
427099000
MedDRA 14.1
10071157
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C1609538
MedDRA 14.1
10065048
Any condition, including other active or latent infections, medical or psychiatric conditions, or the presence of laboratory abnormalities, which could confound the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study.
Description

Any condition, including other active or latent infections, medical or psychiatric conditions, or the presence of laboratory abnormalities, which could confound the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0021311
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C0278060
SNOMED CT 2011_0131
36456004
LOINC Version 232
MTHU001424
CTCAE 1105E
MTHU117157
UMLS CUI 2011AA
C0438215
SNOMED CT 2011_0131
165346000
MedDRA 14.1
10023547
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0459471
SNOMED CT 2011_0131
280452008
LOINC Version 232
MTHU003869
UMLS CUI 2011AA
C0681873
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C1883420
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
Any patient who in the opinion of the investigator should not participate
Description

Any patient who in the opinion of the investigator should not participate

Data type

boolean

Alias
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0034866
LOINC Version 232
MTHU036724
HL7 V3 2006_05
RMD
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Age at least 18 years at the time of signing the informed consent form. For patients in Taiwan the minimum age is 20 years.
Item
Age at least 18 years at the time of signing the informed consent form. For patients in Taiwan the minimum age is 20 years.
boolean
C0021430 (UMLS CUI 2011AA)
Histologically confirmed diagnosis of adenocarcinoma of the prostate.
Item
Histologically confirmed diagnosis of adenocarcinoma of the prostate.
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0007112 (UMLS CUI 2011AA)
399490008 (SNOMED CT 2011_0131)
10001186 (MedDRA 14.1)
Evidence of bone metastatic disease on radiographic examination, whether from bone scan or other imaging modality.
Item
Evidence of bone metastatic disease on radiographic examination, whether from bone scan or other imaging modality.
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0153690 (UMLS CUI 2011AA)
94222008 (SNOMED CT 2011_0131)
10055101 (MedDRA 14.1)
C79.51 (ICD-10-CM Version 2010)
198.5 (ICD-9-CM Version 2011)
C0444708 (UMLS CUI 2011AA)
258106000 (SNOMED CT 2011_0131)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
C0203668 (UMLS CUI 2011AA)
41747008 (SNOMED CT 2011_0131)
10006009 (MedDRA 14.1)
92.14 (ICD-9-CM Version 2011)
C1518654 (UMLS CUI 2011AA)
Castrate levels of serum testosterone (≤50 ng/dL or 1.7 nmol/L).
Item
Castrate levels of serum testosterone (≤50 ng/dL or 1.7 nmol/L).
boolean
C1319065 (UMLS CUI 2011AA)
405242009 (SNOMED CT 2011_0131)
N (HL7 V3 2006_05)
C0428413 (UMLS CUI 2011AA)
270973006 (SNOMED CT 2011_0131)
10040409 (MedDRA 14.1)
Evidence of progressive disease.
Item
Evidence of progressive disease.
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C1335499 (UMLS CUI 2011AA)
Karnofsky score ≥70%.
Item
Karnofsky performance status (assessment scale)
boolean
C0206065 (UMLS CUI 2011AA)
273546003 (SNOMED CT 2011_0131)
Meet screening laboratory values as specified in the protocol.
Item
Meet screening laboratory values as specified in the protocol.
boolean
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C1409616 (UMLS CUI 2011AA)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1522609 (UMLS CUI 2011AA)
C0205369 (UMLS CUI 2011AA)
69658003 (SNOMED CT 2011_0131)
C2348563 (UMLS CUI 2011AA)
If sexually active with partner of childbearing potential, patient will agree to use adequate contraceptive methods (barrier contraceptive with spermicide or vasectomy) while on study drug. The adequate contraceptive method should be continued for 14 days after the patient stops taking study drug.
Item
If sexually active with partner of childbearing potential, patient will agree to use adequate contraceptive methods (barrier contraceptive with spermicide or vasectomy) while on study drug. The adequate contraceptive method should be continued for 14 days after the patient stops taking study drug.
boolean
C0750557 (UMLS CUI 2011AA)
C0241028 (UMLS CUI 2011AA)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
C0682323 (UMLS CUI 2011AA)
262043009 (SNOMED CT 2011_0131)
SIGOTHR (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
C0037862 (UMLS CUI 2011AA)
425484006 (SNOMED CT 2011_0131)
C0042387 (UMLS CUI 2011AA)
22523008 (SNOMED CT 2011_0131)
10047133 (MedDRA 14.1)
63.73 (ICD-9-CM Version 2011)
No evidence (within 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin).
Item
No evidence (within 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin).
boolean
C0332125 (UMLS CUI 2011AA)
41647002 (SNOMED CT 2011_0131)
C2735088 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C1272703 (UMLS CUI 2011AA)
385669000 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
Able to swallow and retain oral medication.
Item
Able to swallow and retain oral medication.
boolean
C0566356 (UMLS CUI 2011AA)
288936000 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0333118 (UMLS CUI 2011AA)
397909002 (SNOMED CT 2011_0131)
CL436624 (UMLS CUI 2011AA)
Able to adhere to the study visit schedule and other protocol requirements.
Item
Able to adhere to the study visit schedule and other protocol requirements.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0086960 (UMLS CUI 2011AA)
C0525058 (UMLS CUI 2011AA)
Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study.
Item
Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study.
boolean
C1273101 (UMLS CUI 2011AA)
395659009 (SNOMED CT 2011_0131)
C0681832 (UMLS CUI 2011AA)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
CL330043 (UMLS CUI 2011AA)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0392337 (UMLS CUI 2011AA)
CL102947 (UMLS CUI 2011AA)
Able (or patient's legal guardian, if applicable) to sign and date the written informed consent after being informed of the full nature and purpose of the study, including possible risks and side effects, and given ample time and opportunity to read and understand this information.
Item
Able (or patient's legal guardian, if applicable) to sign and date the written informed consent after being informed of the full nature and purpose of the study, including possible risks and side effects, and given ample time and opportunity to read and understand this information.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0023226 (UMLS CUI 2011AA)
58626002 (SNOMED CT 2011_0131)
MTHU020628 (LOINC Version 232)
C1519316 (UMLS CUI 2011AA)
C0011008 (UMLS CUI 2011AA)
410671006 (SNOMED CT 2011_0131)
MTHU021546 (LOINC Version 232)
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
Prior cytotoxic chemotherapy for the treatment of prostate ca within 2 years or within 4 weeks for Estracyt (estramustine) prior to study treatment.
Item
Prior cytotoxic chemotherapy for the treatment of prostate ca within 2 years or within 4 weeks for Estracyt (estramustine) prior to study treatment.
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0677881 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0600139 (UMLS CUI 2011AA)
254900004 (SNOMED CT 2011_0131)
10036921 (MedDRA 14.1)
C0014922 (UMLS CUI 2011AA)
108769008 (SNOMED CT 2011_0131)
C0014921 (UMLS CUI 2011AA)
108768000 (SNOMED CT 2011_0131)
Previous anticancer therapy using radiation, biologics or vaccines, including abiraterone, TAK-700 (Orteronel), or MDV3100 within 4 weeks prior or sipuleucel-T (Provenge) within 2 weeks prior to the start of study treatment. If radiation therapy is applied after baseline scan, a new baseline scan needs to be done at least 4 weeks after the radiation therapy.
Item
Previous anticancer therapy using radiation, biologics or vaccines, including abiraterone, TAK-700 (Orteronel), or MDV3100 within 4 weeks prior or sipuleucel-T (Provenge) within 2 weeks prior to the start of study treatment. If radiation therapy is applied after baseline scan, a new baseline scan needs to be done at least 4 weeks after the radiation therapy.
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0920425 (UMLS CUI 2011AA)
C0034619 (UMLS CUI 2011AA)
C2979985 (UMLS CUI 2011AA)
C0042210 (UMLS CUI 2011AA)
71181003 (SNOMED CT 2011_0131)
MTHU014526 (LOINC Version 232)
C0754011 (UMLS CUI 2011AA)
CL383463 (UMLS CUI 2011AA)
C2348174 (UMLS CUI 2011AA)
C1706668 (UMLS CUI 2011AA)
Previous therapy with antiandrogens within 4 weeks (within 6 weeks for bicalutamide eg, Casodex) prior to study treatment.
Item
Previous therapy with antiandrogens within 4 weeks (within 6 weeks for bicalutamide eg, Casodex) prior to study treatment.
boolean
C1514463 (UMLS CUI 2011AA)
C0002842 (UMLS CUI 2011AA)
346324007 (SNOMED CT 2011_0131)
C0285590 (UMLS CUI 2011AA)
108766001 (SNOMED CT 2011_0131)
Concurrent use of other anticancer agents or treatments, with the following exceptions:
Item
Concurrent use of other anticancer agents or treatments, with the following exceptions:
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0003392 (UMLS CUI 2011AA)
372688009 (SNOMED CT 2011_0131)
C0920425 (UMLS CUI 2011AA)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
Ongoing treatment with luteinizing hormone-releasing hormone agonists or antagonists, denosumab (Prolia) or bisphosphonate (eg, zoledronic acid) is allowed. Ongoing treatment should be kept at a stable schedule; however, if medically required, a change of dose, compound, or both is allowed.
Item
Ongoing treatment with luteinizing hormone-releasing hormone agonists or antagonists, denosumab (Prolia) or bisphosphonate (eg, zoledronic acid) is allowed. Ongoing treatment should be kept at a stable schedule; however, if medically required, a change of dose, compound, or both is allowed.
boolean
C0750536 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C1518041 (UMLS CUI 2011AA)
C1276926 (UMLS CUI 2011AA)
326082006 (SNOMED CT 2011_0131)
C1524004 (UMLS CUI 2011AA)
C1690432 (UMLS CUI 2011AA)
446457007 (SNOMED CT 2011_0131)
C0012544 (UMLS CUI 2011AA)
372907000 (SNOMED CT 2011_0131)
C0257685 (UMLS CUI 2011AA)
395926009 (SNOMED CT 2011_0131)
Any treatment modalities involving major surgery within 4 weeks prior to the start of study treatment.
Item
Any treatment modalities involving major surgery within 4 weeks prior to the start of study treatment.
boolean
C0039798 (UMLS CUI 2011AA)
C0695347 (UMLS CUI 2011AA)
MTHU010422 (LOINC Version 232)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0679637 (UMLS CUI 2011AA)
Prostate ca pain that requires ongoing treatment with narcotic analgesics or warrants the initiation of radio- or chemotherapy.
Item
Prostate ca pain that requires ongoing treatment with narcotic analgesics or warrants the initiation of radio- or chemotherapy.
boolean
C0600139 (UMLS CUI 2011AA)
254900004 (SNOMED CT 2011_0131)
10036921 (MedDRA 14.1)
C0030193 (UMLS CUI 2011AA)
22253000 (SNOMED CT 2011_0131)
10033371 (MedDRA 14.1)
MTHU029813 (LOINC Version 232)
R52 (ICD-10-CM Version 2010)
338-338.9 (ICD-9-CM Version 2011)
E11167 (CTCAE 1105E)
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0027409 (UMLS CUI 2011AA)
360204007 (SNOMED CT 2011_0131)
C1552821 (UMLS CUI 2011AA)
justify (HL7 V3 2006_05)
C1704686 (UMLS CUI 2011AA)
C0034619 (UMLS CUI 2011AA)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
Ongoing treatment with warfarin unless the international normalized ratio (INR) is well controlled and below 4 (Section 4.6.8.1).
Item
Ongoing treatment with warfarin unless the international normalized ratio (INR) is well controlled and below 4 (Section 4.6.8.1).
boolean
C0750536 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0043031 (UMLS CUI 2011AA)
48603004 (SNOMED CT 2011_0131)
MTHU003212 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0525032 (UMLS CUI 2011AA)
165581004 (SNOMED CT 2011_0131)
10022400 (MedDRA 14.1)
Maintenance treatment with corticosteroids corresponding to a prednisolone or prednisone dose above 10 mg/day. The dose must have been stable for at least 5 days.
Item
Maintenance treatment with corticosteroids corresponding to a prednisolone or prednisone dose above 10 mg/day. The dose must have been stable for at least 5 days.
boolean
C0677908 (UMLS CUI 2011AA)
314122007 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
CL415123 (UMLS CUI 2011AA)
C0032950 (UMLS CUI 2011AA)
116601002 (SNOMED CT 2011_0131)
MTHU003522 (LOINC Version 232)
C0032952 (UMLS CUI 2011AA)
116602009 (SNOMED CT 2011_0131)
MTHU003245 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
Systemic exposure to ketoconazole or other strong cytochrome P450 (CYP) 3A4 isozyme inhibitors or inducers within 14 days prior to the start of study treatment. Systemic exposure to amiodarone is not allowed within 1 year prior to the start of study treatment.
Item
Systemic exposure to ketoconazole or other strong cytochrome P450 (CYP) 3A4 isozyme inhibitors or inducers within 14 days prior to the start of study treatment. Systemic exposure to amiodarone is not allowed within 1 year prior to the start of study treatment.
boolean
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C0022625 (UMLS CUI 2011AA)
387216007 (SNOMED CT 2011_0131)
MTHU002299 (LOINC Version 232)
C2962753 (UMLS CUI 2011AA)
C0002598 (UMLS CUI 2011AA)
372821002 (SNOMED CT 2011_0131)
MTHU004841 (LOINC Version 232)
Ongoing treatment with sensitive CYP1A2 substrate or CYP1A2 substrate with narrow therapeutic range at the start of study treatment.
Item
Ongoing treatment with sensitive CYP1A2 substrate or CYP1A2 substrate with narrow therapeutic range at the start of study treatment.
boolean
C0750536 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0332324 (UMLS CUI 2011AA)
83185005 (SNOMED CT 2011_0131)
C0207509 (UMLS CUI 2011AA)
424020001 (SNOMED CT 2011_0131)
C0178623 (UMLS CUI 2011AA)
Ongoing treatment with CYP3A4 substrate with narrow therapeutic range at the start of study treatment.
Item
Ongoing treatment with CYP3A4 substrate with narrow therapeutic range at the start of study treatment.
boolean
C0750536 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C1142644 (UMLS CUI 2011AA)
422741004 (SNOMED CT 2011_0131)
C0178623 (UMLS CUI 2011AA)
CL407604 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C1514721 (UMLS CUI 2011AA)
Simultaneous participation in any other study involving treatment with investigational drugs or having received treatment with investigational drugs < 4 weeks prior to the start of study treatment.
Item
Simultaneous participation in any other study involving treatment with investigational drugs or having received treatment with investigational drugs < 4 weeks prior to the start of study treatment.
boolean
C0521115 (UMLS CUI 2011AA)
79970003 (SNOMED CT 2011_0131)
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)
C0039798 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
Myocardial infarction, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass graft, class III/IV congestive heart failure, cerebrovascular accident, transient ischemic attack, or limb claudication at rest, within 6 months prior to start of study treatment and ongoing symptomatic dysrhythmias, unstable angina, uncontrolled hypertension, and uncontrolled atrial or ventricular arrhythmias.
Item
Myocardial infarction, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass graft, class III/IV congestive heart failure, cerebrovascular accident, transient ischemic attack, or limb claudication at rest, within 6 months prior to start of study treatment and ongoing symptomatic dysrhythmias, unstable angina, uncontrolled hypertension, and uncontrolled atrial or ventricular arrhythmias.
boolean
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)
C1532338 (UMLS CUI 2011AA)
415070008 (SNOMED CT 2011_0131)
10065608 (MedDRA 14.1)
C0948089 (UMLS CUI 2011AA)
394659003 (SNOMED CT 2011_0131)
10051592 (MedDRA 14.1)
E10066 (CTCAE 1105E)
C0010055 (UMLS CUI 2011AA)
232717009 (SNOMED CT 2011_0131)
10011077 (MedDRA 14.1)
36.10 (ICD-9-CM Version 2011)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
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)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0007787 (UMLS CUI 2011AA)
266257000 (SNOMED CT 2011_0131)
10044390 (MedDRA 14.1)
MTHU020810 (LOINC Version 232)
G45.9 (ICD-10-CM Version 2010)
435.9 (ICD-9-CM Version 2011)
E12834 (CTCAE 1105E)
C0015385 (UMLS CUI 2011AA)
66019005 (SNOMED CT 2011_0131)
MTHU001429 (LOINC Version 232)
C0311395 (UMLS CUI 2011AA)
275520000 (SNOMED CT 2011_0131)
10009240 (MedDRA 14.1)
C0443144 (UMLS CUI 2011AA)
263678003 (SNOMED CT 2011_0131)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
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)
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0085611 (UMLS CUI 2011AA)
17366009 (SNOMED CT 2011_0131)
10003656 (MedDRA 14.1)
C0085612 (UMLS CUI 2011AA)
44103008 (SNOMED CT 2011_0131)
10047281 (MedDRA 14.1)
I49.01 (ICD-10-CM Version 2010)
E10230 (CTCAE 1105E)
History of pancreatitis.
Item
History of pancreatitis.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0030305 (UMLS CUI 2011AA)
75694006 (SNOMED CT 2011_0131)
10033645 (MedDRA 14.1)
K85.9 (ICD-10-CM Version 2010)
577.0 (ICD-9-CM Version 2011)
E10930 (CTCAE 1105E)
Known brain or epidural metastases.
Item
Known brain or epidural metastases.
boolean
C0220650 (UMLS CUI 2011AA)
10006128 (MedDRA 14.1)
CL337434 (UMLS CUI 2011AA)
C0027627 (UMLS CUI 2011AA)
128462008 (SNOMED CT 2011_0131)
10027449 (MedDRA 14.1)
Known positive serology for HIV (patients with known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in an immunocompromised host).
Item
Known positive serology for HIV (patients with known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in an immunocompromised host).
boolean
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
C0237399 (UMLS CUI 2011AA)
C0040539 (UMLS CUI 2011AA)
C0220880 (UMLS CUI 2011AA)
C0085393 (UMLS CUI 2011AA)
370388006 (SNOMED CT 2011_0131)
Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of a chronic viral hepatitis or known viral hepatitis carrier (patients who have recovered from hepatitis will be allowed to enter the study).
Item
Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of a chronic viral hepatitis or known viral hepatitis carrier (patients who have recovered from hepatitis will be allowed to enter the study).
boolean
C0019189 (UMLS CUI 2011AA)
76783007 (SNOMED CT 2011_0131)
10008909 (MedDRA 14.1)
K73.9 (ICD-10-CM Version 2010)
571.40 (ICD-9-CM Version 2011)
C0205179 (UMLS CUI 2011AA)
86005002 (SNOMED CT 2011_0131)
C0745744 (UMLS CUI 2011AA)
10050060 (MedDRA 14.1)
C0023890 (UMLS CUI 2011AA)
19943007 (SNOMED CT 2011_0131)
10019641 (MedDRA 14.1)
K74.60 (ICD-10-CM Version 2010)
C0276623 (UMLS CUI 2011AA)
10295004 (SNOMED CT 2011_0131)
B18 (ICD-10-CM Version 2010)
C0733680 (UMLS CUI 2011AA)
170489004 (SNOMED CT 2011_0131)
10047458 (MedDRA 14.1)
Patients with active tuberculosis (TB), or with known, untreated latent TB. (Country-specific TB therapy should have been given for at least 30 days prior to the start of study treatment and the patient should intend to complete the entire course of that therapy.)
Item
Patients with active tuberculosis (TB), or with known, untreated latent TB. (Country-specific TB therapy should have been given for at least 30 days prior to the start of study treatment and the patient should intend to complete the entire course of that therapy.)
boolean
C0151332 (UMLS CUI 2011AA)
427099000 (SNOMED CT 2011_0131)
10071157 (MedDRA 14.1)
C1518422 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
C1609538 (UMLS CUI 2011AA)
10065048 (MedDRA 14.1)
Any condition, including other active or latent infections, medical or psychiatric conditions, or the presence of laboratory abnormalities, which could confound the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study.
Item
Any condition, including other active or latent infections, medical or psychiatric conditions, or the presence of laboratory abnormalities, which could confound the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study.
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0278060 (UMLS CUI 2011AA)
36456004 (SNOMED CT 2011_0131)
MTHU001424 (LOINC Version 232)
MTHU117157 (CTCAE 1105E)
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0459471 (UMLS CUI 2011AA)
280452008 (SNOMED CT 2011_0131)
MTHU003869 (LOINC Version 232)
C0681873 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C1883420 (UMLS CUI 2011AA)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
Any patient who in the opinion of the investigator should not participate
Item
Any patient who in the opinion of the investigator should not participate
boolean
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C1518422 (UMLS CUI 2011AA)
C0034866 (UMLS CUI 2011AA)
MTHU036724 (LOINC Version 232)
RMD (HL7 V3 2006_05)
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