ID

43483

Description

ODM derived from http://clinicaltrials.gov/show/NCT00844064

Link

http://clinicaltrials.gov/show/NCT00844064

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 NCT00844064 Pancreatic Neoplasms, Melanoma, Colorectal Neoplasms

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 75 Years
Description

age 18 Years to 75 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Written informed consent.
Description

Written informed consent.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Male or non-pregnant, non-lactating female.
Description

Male or non-pregnant, non-lactating female.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0232973
SNOMED CT 2011_0131
60001007
UMLS CUI 2011AA
C2826207
Pancreatic cancer: Histologically or cytologically confirmed diagnosis, stage IVA or IVB (AJCC, 1997).
Description

Pancreatic cancer: Histologically or cytologically confirmed diagnosis, stage IVA or IVB (AJCC, 1997).

Data type

boolean

Alias
UMLS CUI 2011AA
C0346647
SNOMED CT 2011_0131
363418001
MedDRA 14.1
10033604
ICD-10-CM Version 2010
C25
ICD-9-CM Version 2011
157
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0205471
SNOMED CT 2011_0131
40413002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0854775
MedDRA 14.1
10059326
UMLS CUI 2011AA
CL108563
Melanoma: Histologically or cytologically confirmed diagnosis, stage III or IV (AJCC, UICC)
Description

Melanoma: Histologically or cytologically confirmed diagnosis, stage III or IV (AJCC, UICC)

Data type

boolean

Alias
UMLS CUI 2011AA
C0025202
SNOMED CT 2011_0131
2092003
MedDRA 14.1
10025650
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0205471
SNOMED CT 2011_0131
40413002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0855027
MedDRA 14.1
10025670
UMLS CUI 2011AA
C0854698
MedDRA 14.1
10025671
Colorectal cancer: Histologically or cytologically confirmed diagnosis, stage III or IV (AJCC, UICC), excluded from the last cohort.
Description

Colorectal cancer: Histologically or cytologically confirmed diagnosis, stage III or IV (AJCC, UICC), excluded from the last cohort.

Data type

boolean

Alias
UMLS CUI 2011AA
C0009402
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0205471
SNOMED CT 2011_0131
40413002
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0677949
MedDRA 14.1
10010034
UMLS CUI 2011AA
C0677950
MedDRA 14.1
10010035
Patient is not or no longer amenable to established forms of therapy.
Description

Patient is not or no longer amenable to established forms of therapy.

Data type

boolean

Alias
UMLS CUI 2011AA
CL426127
UMLS CUI 2011AA
C0438286
SNOMED CT 2011_0131
266721009
MedDRA 14.1
10063670
At least one measurable lesion.
Description

At least one measurable lesion.

Data type

boolean

Alias
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C1513040
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
Karnofsky performance status of at least 80%.
Description

Karnofsky performance status of at least 80%.

Data type

boolean

Alias
UMLS CUI 2011AA
C0206065
Recovery from acute toxicity caused by any previous therapy.
Description

Recovery from acute toxicity caused by any previous therapy.

Data type

boolean

Alias
UMLS CUI 2011AA
C2004454
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C0040539
UMLS CUI 2011AA
C1314792
SNOMED CT 2011_0131
134198009
UMLS CUI 2011AA
C1514463
Adequate organ function as assessed by the following laboratory values:
Description

Adequate organ function as assessed by the following laboratory values:

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0178784
LOINC Version 232
MTHU020170
UMLS CUI 2011AA
C0542341
SNOMED CT 2011_0131
246464006
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
C1522609
Serum creatinine and urea < 2 times the upper limit of normal (ULN).
Description

Serum creatinine and urea < 2 times the upper limit of normal (ULN).

Data type

boolean

Alias
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C0856666
MedDRA 14.1
10040426
UMLS CUI 2011AA
C1519815
ALT and AST < 3 ULN (in case of a liver metastasis: < 5x ULN); alkaline phosphatase < 3 ULN; and bilirubin < 2.5 mg/dL.
Description

ALT and AST < 3 ULN (in case of a liver metastasis: < 5x ULN); alkaline phosphatase < 3 ULN; and bilirubin < 2.5 mg/dL.

Data type

boolean

Alias
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
C1519815
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
C0002059
SNOMED CT 2011_0131
57056007
LOINC Version 232
MTHU005195
UMLS CUI 2011AA
C0011221
SNOMED CT 2011_0131
79706000
LOINC Version 232
1975-2
Prothrombin time < 1.5 INR and PTT < 1.5 times the upper limit of normal.
Description

Prothrombin time < 1.5 INR and PTT < 1.5 times the upper limit of normal.

Data type

boolean

Alias
UMLS CUI 2011AA
CL434069
UMLS CUI 2011AA
CL415281
UMLS CUI 2011AA
C0030605
SNOMED CT 2011_0131
42525009
MedDRA 14.1
10000630
UMLS CUI 2011AA
C1519815
Hemoglobin
Description

Hemoglobin > 9 g/dL.

Data type

boolean

Alias
UMLS CUI 2011AA
C0518015
SNOMED CT 2011_0131
38082009
MedDRA 14.1
10019481
LOINC Version 232
LP14449-0
Blood Platelets
Description

Platelets > 100 x 10E9/L.

Data type

boolean

Alias
UMLS CUI 2011AA
C0005821
SNOMED CT 2011_0131
16378004
LOINC Version 232
MTHU002432
White Blood Cell Count procedure (WBC)
Description

WBC > 3.0 x 10E9/L.

Data type

boolean

Alias
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
Absolute Neutrophil Count, ANC
Description

Absolute Neutrophil Count (ANC) > 1.5 x 10E9/L.

Data type

boolean

Alias
UMLS CUI 2011AA
C0948762
MedDRA 14.1
10052033
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Patient unable to comply with the protocol regulations.
Description

Patient unable to comply with the protocol regulations.

Data type

boolean

Alias
UMLS CUI 2011AA
C1321605
Pregnant or lactating female.
Description

Pregnant or lactating female.

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
Antitumor radiation therapy within 12 weeks, tumor surgery within 4 weeks or any other therapy with established antitumor effects within 2 weeks prior to study entry.
Description

Antitumor radiation therapy within 12 weeks, tumor surgery within 4 weeks or any other therapy with established antitumor effects within 2 weeks prior to study entry.

Data type

boolean

Alias
UMLS CUI 2011AA
C0597025
UMLS CUI 2011AA
C0597029
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0920425
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
The patient takes or is likely to need other prohibited concomitant medication. Administration of corticosteroids should be strictly avoided during the course of the study.
Description

The patient takes or is likely to need other prohibited concomitant medication. Administration of corticosteroids should be strictly avoided during the course of the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0683610
UMLS CUI 2011AA
C2347852
UMLS CUI 2011AA
C1533734
SNOMED CT 2011_0131
416118004
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
Patient's participation in another clinical trial with investigational medication within 30 days prior to study entry.
Description

Patient's participation in another clinical trial with investigational medication within 30 days prior to study entry.

Data type

boolean

Alias
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
C0013230
History of brain metastases. In the case of suspected brain metastases a CT scan of the skull will be performed (not mandatory in asymptomatic patients).
Description

History of brain metastases. In the case of suspected brain metastases a CT scan of the skull will be performed (not mandatory in asymptomatic patients).

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0220650
MedDRA 14.1
10006128
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0750491
SNOMED CT 2011_0131
415684004
UMLS CUI 2011AA
C0220650
MedDRA 14.1
10006128
UMLS CUI 2011AA
C0040405
MedDRA 14.1
10011603
UMLS CUI 2011AA
C0037303
SNOMED CT 2011_0131
89546000
LOINC Version 232
MTHU003024
Clinically significant cardiovascular abnormalities such as refractory hypertension, congestive heart failure, unstable angina, or poorly controlled arrhythmia, or a myocardial infarction within 6 months prior to treatment.
Description

Clinically significant cardiovascular abnormalities such as refractory hypertension, congestive heart failure, unstable angina, or poorly controlled arrhythmia, or a myocardial infarction within 6 months prior to treatment.

Data type

boolean

Alias
UMLS CUI 2011AA
C0243050
SNOMED CT 2011_0131
9904008
MedDRA 14.1
10061054
UMLS CUI 2011AA
C0860493
MedDRA 14.1
10038274
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
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
C0205169
SNOMED CT 2011_0131
556001
UMLS CUI 2011AA
C2587213
SNOMED CT 2011_0131
31509003
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
Gastric or duodenal ulcers within 6 months before study entry or is at risk of gastrointestinal ulceration due to high consumption of NSAIDs.
Description

Gastric or duodenal ulcers within 6 months before study entry or is at risk of gastrointestinal ulceration due to high consumption of NSAIDs.

Data type

boolean

Alias
UMLS CUI 2011AA
C0038358
SNOMED CT 2011_0131
397825006
MedDRA 14.1
10017822
ICD-10-CM Version 2010
K25
ICD-9-CM Version 2011
531
CTCAE 1105E
E10727
UMLS CUI 2011AA
C0013295
SNOMED CT 2011_0131
367474008
MedDRA 14.1
10013836
ICD-10-CM Version 2010
K26
ICD-9-CM Version 2011
532
CTCAE 1105E
E10611
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
UMLS CUI 2011AA
C1963975
MedDRA 14.1
20000106
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0003211
SNOMED CT 2011_0131
16403005, 372665008
An active infection with HIV, HBV, or HCV.
Description

An active infection with HIV, HBV, or HCV.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0019682
SNOMED CT 2011_0131
19030005
UMLS CUI 2011AA
C0019169
SNOMED CT 2011_0131
81665004
UMLS CUI 2011AA
C0220847
SNOMED CT 2011_0131
62944002
MedDRA 14.1
10019752
Clinically significant acute viral, bacterial, or fungal infection.
Description

Clinically significant acute viral, bacterial, or fungal infection.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C0042769
SNOMED CT 2011_0131
34014006
MedDRA 14.1
10047461
ICD-10-CM Version 2010
B34.9
UMLS CUI 2011AA
C0004623
SNOMED CT 2011_0131
87628006
MedDRA 14.1
10060945
ICD-10-CM Version 2010
A49.9
UMLS CUI 2011AA
C0026946
SNOMED CT 2011_0131
3218000
MedDRA 14.1
10017533
ICD-10-CM Version 2010
B35-B49
ICD-9-CM Version 2011
110-118.99
Acute medical problems that may be considered to become an unacceptable risk, or any conditions that might be contraindications for starting study treatment.
Description

Acute medical problems that may be considered to become an unacceptable risk, or any conditions that might be contraindications for starting study treatment.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C1715372
LOINC Version 232
44100-6
UMLS CUI 2011AA
C0678227
SNOMED CT 2011_0131
23981006
UMLS CUI 2011AA
C1883420
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
History of allergies to reagents used in this study.
Description

History of allergies to reagents used in this study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0489531
LOINC Version 232
MTHU001065
UMLS CUI 2011AA
C0034760
LOINC Version 232
MTHU019417
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Drug abuse or extensive use of alcohol.
Description

Drug abuse or extensive use of alcohol.

Data type

boolean

Alias
UMLS CUI 2011AA
C0237123
Significant psychiatric disorders/ legal incapacity or limited legal capacity.
Description

Significant psychiatric disorders/ legal incapacity or limited legal capacity.

Data type

boolean

Alias
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0683673
UMLS CUI 2011AA
C0439801
SNOMED CT 2011_0131
255469002
UMLS CUI 2011AA
C0683673
History of Long QT Syndrome or QTc time ≥ 480 msec in screening/baseline ECGs. The average QTc time is to be calculated from three separate ECGs performed prior to start of infusion: two ECGs performed at Screening/Baseline (with a minimum 1-hour interval in between) and one performed within 1 hour prior to start of infusion.
Description

History of Long QT Syndrome or QTc time ≥ 480 msec in screening/baseline ECGs. The average QTc time is to be calculated from three separate ECGs performed prior to start of infusion: two ECGs performed at Screening/Baseline (with a minimum 1-hour interval in between) and one performed within 1 hour prior to start of infusion.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0023976
SNOMED CT 2011_0131
9651007
MedDRA 14.1
10024803
ICD-10-CM Version 2010
I45.81
ICD-9-CM Version 2011
426.82
UMLS CUI 2011AA
C0860814
MedDRA 14.1
10037707
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1442488
UMLS CUI 2011AA
C1623258
SNOMED CT 2011_0131
46825001
MedDRA 14.1
10014084
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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
CL425202 (UMLS CUI 2011AA)
age 18 Years to 75 Years
Item
age 18 Years to 75 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Written informed consent.
Item
Written informed consent.
boolean
C0021430 (UMLS CUI 2011AA)
Male or non-pregnant, non-lactating female.
Item
Male or non-pregnant, non-lactating female.
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0232973 (UMLS CUI 2011AA)
60001007 (SNOMED CT 2011_0131)
C2826207 (UMLS CUI 2011AA)
Pancreatic cancer: Histologically or cytologically confirmed diagnosis, stage IVA or IVB (AJCC, 1997).
Item
Pancreatic cancer: Histologically or cytologically confirmed diagnosis, stage IVA or IVB (AJCC, 1997).
boolean
C0346647 (UMLS CUI 2011AA)
363418001 (SNOMED CT 2011_0131)
10033604 (MedDRA 14.1)
C25 (ICD-10-CM Version 2010)
157 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0205471 (UMLS CUI 2011AA)
40413002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0854775 (UMLS CUI 2011AA)
10059326 (MedDRA 14.1)
CL108563 (UMLS CUI 2011AA)
Melanoma: Histologically or cytologically confirmed diagnosis, stage III or IV (AJCC, UICC)
Item
Melanoma: Histologically or cytologically confirmed diagnosis, stage III or IV (AJCC, UICC)
boolean
C0025202 (UMLS CUI 2011AA)
2092003 (SNOMED CT 2011_0131)
10025650 (MedDRA 14.1)
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0205471 (UMLS CUI 2011AA)
40413002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0855027 (UMLS CUI 2011AA)
10025670 (MedDRA 14.1)
C0854698 (UMLS CUI 2011AA)
10025671 (MedDRA 14.1)
Colorectal cancer: Histologically or cytologically confirmed diagnosis, stage III or IV (AJCC, UICC), excluded from the last cohort.
Item
Colorectal cancer: Histologically or cytologically confirmed diagnosis, stage III or IV (AJCC, UICC), excluded from the last cohort.
boolean
C0009402 (UMLS CUI 2011AA)
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0205471 (UMLS CUI 2011AA)
40413002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0677949 (UMLS CUI 2011AA)
10010034 (MedDRA 14.1)
C0677950 (UMLS CUI 2011AA)
10010035 (MedDRA 14.1)
Patient is not or no longer amenable to established forms of therapy.
Item
Patient is not or no longer amenable to established forms of therapy.
boolean
CL426127 (UMLS CUI 2011AA)
C0438286 (UMLS CUI 2011AA)
266721009 (SNOMED CT 2011_0131)
10063670 (MedDRA 14.1)
At least one measurable lesion.
Item
At least one measurable lesion.
boolean
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C1513040 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
Karnofsky performance status of at least 80%.
Item
Karnofsky performance status of at least 80%.
boolean
C0206065 (UMLS CUI 2011AA)
Recovery from acute toxicity caused by any previous therapy.
Item
Recovery from acute toxicity caused by any previous therapy.
boolean
C2004454 (UMLS CUI 2011AA)
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0040539 (UMLS CUI 2011AA)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI 2011AA)
Adequate organ function as assessed by the following laboratory values:
Item
Adequate organ function as assessed by the following laboratory values:
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0178784 (UMLS CUI 2011AA)
MTHU020170 (LOINC Version 232)
C0542341 (UMLS CUI 2011AA)
246464006 (SNOMED CT 2011_0131)
C1516048 (UMLS CUI 2011AA)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1522609 (UMLS CUI 2011AA)
Serum creatinine and urea < 2 times the upper limit of normal (ULN).
Item
Serum creatinine and urea < 2 times the upper limit of normal (ULN).
boolean
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0856666 (UMLS CUI 2011AA)
10040426 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
ALT and AST < 3 ULN (in case of a liver metastasis: < 5x ULN); alkaline phosphatase < 3 ULN; and bilirubin < 2.5 mg/dL.
Item
ALT and AST < 3 ULN (in case of a liver metastasis: < 5x ULN); alkaline phosphatase < 3 ULN; and bilirubin < 2.5 mg/dL.
boolean
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)
C1519815 (UMLS CUI 2011AA)
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)
C0002059 (UMLS CUI 2011AA)
57056007 (SNOMED CT 2011_0131)
MTHU005195 (LOINC Version 232)
C0011221 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
Prothrombin time < 1.5 INR and PTT < 1.5 times the upper limit of normal.
Item
Prothrombin time < 1.5 INR and PTT < 1.5 times the upper limit of normal.
boolean
CL434069 (UMLS CUI 2011AA)
CL415281 (UMLS CUI 2011AA)
C0030605 (UMLS CUI 2011AA)
42525009 (SNOMED CT 2011_0131)
10000630 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
Hemoglobin > 9 g/dL.
Item
Hemoglobin
boolean
C0518015 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
Platelets > 100 x 10E9/L.
Item
Blood Platelets
boolean
C0005821 (UMLS CUI 2011AA)
16378004 (SNOMED CT 2011_0131)
MTHU002432 (LOINC Version 232)
WBC > 3.0 x 10E9/L.
Item
White Blood Cell Count procedure (WBC)
boolean
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
Absolute Neutrophil Count (ANC) > 1.5 x 10E9/L.
Item
Absolute Neutrophil Count, ANC
boolean
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Patient unable to comply with the protocol regulations.
Item
Patient unable to comply with the protocol regulations.
boolean
C1321605 (UMLS CUI 2011AA)
Pregnant or lactating female.
Item
Pregnant or lactating female.
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
Antitumor radiation therapy within 12 weeks, tumor surgery within 4 weeks or any other therapy with established antitumor effects within 2 weeks prior to study entry.
Item
Antitumor radiation therapy within 12 weeks, tumor surgery within 4 weeks or any other therapy with established antitumor effects within 2 weeks prior to study entry.
boolean
C0597025 (UMLS CUI 2011AA)
C0597029 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0920425 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
The patient takes or is likely to need other prohibited concomitant medication. Administration of corticosteroids should be strictly avoided during the course of the study.
Item
The patient takes or is likely to need other prohibited concomitant medication. Administration of corticosteroids should be strictly avoided during the course of the study.
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0683610 (UMLS CUI 2011AA)
C2347852 (UMLS CUI 2011AA)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
Patient's participation in another clinical trial with investigational medication within 30 days prior to study entry.
Item
Patient's participation in another clinical trial with investigational medication within 30 days prior to study entry.
boolean
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)
C0013230 (UMLS CUI 2011AA)
History of brain metastases. In the case of suspected brain metastases a CT scan of the skull will be performed (not mandatory in asymptomatic patients).
Item
History of brain metastases. In the case of suspected brain metastases a CT scan of the skull will be performed (not mandatory in asymptomatic patients).
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0220650 (UMLS CUI 2011AA)
10006128 (MedDRA 14.1)
C0750557 (UMLS CUI 2011AA)
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
C0220650 (UMLS CUI 2011AA)
10006128 (MedDRA 14.1)
C0040405 (UMLS CUI 2011AA)
10011603 (MedDRA 14.1)
C0037303 (UMLS CUI 2011AA)
89546000 (SNOMED CT 2011_0131)
MTHU003024 (LOINC Version 232)
Clinically significant cardiovascular abnormalities such as refractory hypertension, congestive heart failure, unstable angina, or poorly controlled arrhythmia, or a myocardial infarction within 6 months prior to treatment.
Item
Clinically significant cardiovascular abnormalities such as refractory hypertension, congestive heart failure, unstable angina, or poorly controlled arrhythmia, or a myocardial infarction within 6 months prior to treatment.
boolean
C0243050 (UMLS CUI 2011AA)
9904008 (SNOMED CT 2011_0131)
10061054 (MedDRA 14.1)
C0860493 (UMLS CUI 2011AA)
10038274 (MedDRA 14.1)
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)
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)
C0205169 (UMLS CUI 2011AA)
556001 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (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)
Gastric or duodenal ulcers within 6 months before study entry or is at risk of gastrointestinal ulceration due to high consumption of NSAIDs.
Item
Gastric or duodenal ulcers within 6 months before study entry or is at risk of gastrointestinal ulceration due to high consumption of NSAIDs.
boolean
C0038358 (UMLS CUI 2011AA)
397825006 (SNOMED CT 2011_0131)
10017822 (MedDRA 14.1)
K25 (ICD-10-CM Version 2010)
531 (ICD-9-CM Version 2011)
E10727 (CTCAE 1105E)
C0013295 (UMLS CUI 2011AA)
367474008 (SNOMED CT 2011_0131)
10013836 (MedDRA 14.1)
K26 (ICD-10-CM Version 2010)
532 (ICD-9-CM Version 2011)
E10611 (CTCAE 1105E)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C1963975 (UMLS CUI 2011AA)
20000106 (MedDRA 14.1)
CL420107 (UMLS CUI 2011AA)
C0003211 (UMLS CUI 2011AA)
16403005, 372665008 (SNOMED CT 2011_0131)
An active infection with HIV, HBV, or HCV.
Item
An active infection with HIV, HBV, or HCV.
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
C0019169 (UMLS CUI 2011AA)
81665004 (SNOMED CT 2011_0131)
C0220847 (UMLS CUI 2011AA)
62944002 (SNOMED CT 2011_0131)
10019752 (MedDRA 14.1)
Clinically significant acute viral, bacterial, or fungal infection.
Item
Clinically significant acute viral, bacterial, or fungal infection.
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0042769 (UMLS CUI 2011AA)
34014006 (SNOMED CT 2011_0131)
10047461 (MedDRA 14.1)
B34.9 (ICD-10-CM Version 2010)
C0004623 (UMLS CUI 2011AA)
87628006 (SNOMED CT 2011_0131)
10060945 (MedDRA 14.1)
A49.9 (ICD-10-CM Version 2010)
C0026946 (UMLS CUI 2011AA)
3218000 (SNOMED CT 2011_0131)
10017533 (MedDRA 14.1)
B35-B49 (ICD-10-CM Version 2010)
110-118.99 (ICD-9-CM Version 2011)
Acute medical problems that may be considered to become an unacceptable risk, or any conditions that might be contraindications for starting study treatment.
Item
Acute medical problems that may be considered to become an unacceptable risk, or any conditions that might be contraindications for starting study treatment.
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C1715372 (UMLS CUI 2011AA)
44100-6 (LOINC Version 232)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C1883420 (UMLS CUI 2011AA)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
History of allergies to reagents used in this study.
Item
History of allergies to reagents used in this study.
boolean
C0489531 (UMLS CUI 2011AA)
MTHU001065 (LOINC Version 232)
C0034760 (UMLS CUI 2011AA)
MTHU019417 (LOINC Version 232)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Drug abuse or extensive use of alcohol.
Item
Drug abuse or extensive use of alcohol.
boolean
C0237123 (UMLS CUI 2011AA)
Significant psychiatric disorders/ legal incapacity or limited legal capacity.
Item
Significant psychiatric disorders/ legal incapacity or limited legal capacity.
boolean
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0683673 (UMLS CUI 2011AA)
C0439801 (UMLS CUI 2011AA)
255469002 (SNOMED CT 2011_0131)
C0683673 (UMLS CUI 2011AA)
History of Long QT Syndrome or QTc time ≥ 480 msec in screening/baseline ECGs. The average QTc time is to be calculated from three separate ECGs performed prior to start of infusion: two ECGs performed at Screening/Baseline (with a minimum 1-hour interval in between) and one performed within 1 hour prior to start of infusion.
Item
History of Long QT Syndrome or QTc time ≥ 480 msec in screening/baseline ECGs. The average QTc time is to be calculated from three separate ECGs performed prior to start of infusion: two ECGs performed at Screening/Baseline (with a minimum 1-hour interval in between) and one performed within 1 hour prior to start of infusion.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0023976 (UMLS CUI 2011AA)
9651007 (SNOMED CT 2011_0131)
10024803 (MedDRA 14.1)
I45.81 (ICD-10-CM Version 2010)
426.82 (ICD-9-CM Version 2011)
C0860814 (UMLS CUI 2011AA)
10037707 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
C1442488 (UMLS CUI 2011AA)
C1623258 (UMLS CUI 2011AA)
46825001 (SNOMED CT 2011_0131)
10014084 (MedDRA 14.1)
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