ID

5140

Description

ODM derived from http://clinicaltrials.gov/show/NCT01374789

Link

http://clinicaltrials.gov/show/NCT01374789

Keywords

Versions (3)
  1. 4/11/13 4/11/13 - Martin Dugas
  2. 4/20/14 4/20/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

April 20, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00003516 NCT01374789 Urinary Bladder 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
Histologically or cytologically confirmed, unresectable urothelial carcinoma of the bladder or the upper urinary tract
Description

Histologically or cytologically confirmed, unresectable urothelial carcinoma of the bladder or the upper urinary tract

Data type

boolean

Alias
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
C1519810
UMLS CUI 2011AA
C0279680
SNOMED CT 2011_0131
255109008
MedDRA 14.1
10046714
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
CL363966
UMLS CUI 2011AA
C0729865
Wild-type HRAS
Description

Wild-type HRAS

Data type

boolean

Alias
UMLS CUI 2011AA
C0678926
UMLS CUI 2011AA
C0079471
General condition ECOG 0-1
Description

General condition ECOG 0-1

Data type

boolean

Alias
UMLS CUI 2011AA
C0947124
LOINC Version 232
MTHU001443
UMLS CUI 2011AA
C1828078
SNOMED CT 2011_0131
425389002
UMLS CUI 2011AA
C1827388
SNOMED CT 2011_0131
422512005
Life expectancy at least 12 weeks
Description

Life expectancy at least 12 weeks

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
Women of child-bearing potential: negative pregnancy test and use of effective contraception(oral contraceptive, coil). Men: use of adequate male contraception (condom) for up to 3 months after discontinuation of panitumumab therapy
Description

Women of child-bearing potential: negative pregnancy test and use of effective contraception(oral contraceptive, coil). Men: use of adequate male contraception (condom) for up to 3 months after discontinuation of panitumumab therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0427780
SNOMED CT 2011_0131
250425007
MedDRA 14.1
10036574
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0009905
SNOMED CT 2011_0131
59261009
UMLS CUI 2011AA
C0419518
SNOMED CT 2011_0131
312082008
MedDRA 14.1
10009849
UMLS CUI 2011AA
C0025266
SNOMED CT 2011_0131
339947000
UMLS CUI 2011AA
C0086580
MedDRA 14.1
10065589
UMLS CUI 2011AA
C0677582
Locally advanced or metastatic disease (T3b,T4 and/or N+ and/or M+)
Description

Locally advanced or metastatic disease (T3b,T4 and/or N+ and/or M+)

Data type

boolean

Alias
UMLS CUI 2011AA
C0677984
UMLS CUI 2011AA
C0027627
MedDRA 14.1
10027478
UMLS CUI 2011AA
C0475391
SNOMED CT 2011_0131
261655000
UMLS CUI 2011AA
C0475751
SNOMED CT 2011_0131
65565005
UMLS CUI 2011AA
C0441922
SNOMED CT 2011_0131
258310009
UMLS CUI 2011AA
C0441923
SNOMED CT 2011_0131
258311008
At least one unidimensionally measurable lesion detectable in CT or MRI corresponding to the RECIST criteria
Description

At least one unidimensionally measurable lesion detectable in CT or MRI corresponding to the RECIST criteria

Data type

boolean

Alias
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439534
SNOMED CT 2011_0131
255506008
UMLS CUI 2011AA
C1513040
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C1511790
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
C1709926
Adequate haematological, hepatic, renal and metabolic function parameters:
Description

Adequate haematological, hepatic, renal and metabolic function parameters:

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0449381
SNOMED CT 2011_0131
252116004
UMLS CUI 2011AA
C0221130
SNOMED CT 2011_0131
86084001
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
UMLS CUI 2011AA
C0438212
SNOMED CT 2011_0131
165105001
Leukocytes > 3000/mm³, ANC >= 1500/mm³, platelets >= 100,000/mm³, hemoglobin > 9 g/dl Creatinine clearance >= 50 ml/min and serum creatinine <= 1.5 x upper limit of normal Bilirubin <= 1.5 x upper limit of normal, GOT-GPT <= 2.5 x upper limit of normal in absence of liver metastases, or <= 5 x upper limit of normal in presence of liver metastases, AP <= 5 x upper limit of normal Magnesium >= lower limit of normal. Calcium >= lower limit of normal INR and PTT < 1.5 x the upper limit of the normal reference range
Description

Leukocytes > 3000/mm³, ANC >= 1500/mm³, platelets >= 100,000/mm³, hemoglobin > 9 g/dl Creatinine clearance >= 50 ml/min and serum creatinine <= 1.5 x upper limit of normal Bilirubin <= 1.5 x upper limit of normal, GOT-GPT <= 2.5 x upper limit of normal in absence of liver metastases, or <= 5 x upper limit of normal in presence of liver metastases, AP <= 5 x upper limit of normal Magnesium >= lower limit of normal. Calcium >= lower limit of normal INR and PTT < 1.5 x the upper limit of the normal reference range

Data type

boolean

Alias
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
UMLS CUI 2011AA
C0948762
MedDRA 14.1
10052033
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
UMLS CUI 2011AA
C0518015
MedDRA 14.1
10018876
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C0011221
SNOMED CT 2011_0131
79706000
LOINC Version 232
1975-2
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C0002059
SNOMED CT 2011_0131
57056007
LOINC Version 232
MTHU005195
UMLS CUI 2011AA
C0373675
SNOMED CT 2011_0131
38151008
MedDRA 14.1
10025436
UMLS CUI 2011AA
C1518030
UMLS CUI 2011AA
C0201925
SNOMED CT 2011_0131
71878006
MedDRA 14.1
10006948
UMLS CUI 2011AA
C0525032
SNOMED CT 2011_0131
165581004
MedDRA 14.1
10022400
UMLS CUI 2011AA
C0030605
SNOMED CT 2011_0131
42525009
MedDRA 14.1
10000630
Exclusion Criteria
Description

Exclusion Criteria

HRAS mutation
Description

HRAS mutation

Data type

boolean

Alias
UMLS CUI 2011AA
C0079471
UMLS CUI 2011AA
C0026882
SNOMED CT 2011_0131
55446002
Absence of any of the above-listed inclusion criteria
Description

Absence of any of the above-listed inclusion criteria

Data type

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
CL407060
UMLS CUI 2011AA
CL425202
UMLS CUI 2011AA
CL384738
Dialysis-dependence following nephrectomy
Description

Dialysis-dependence following nephrectomy

Data type

boolean

Alias
UMLS CUI 2011AA
C0011946
SNOMED CT 2011_0131
108241001
MedDRA 14.1
10061105
UMLS CUI 2011AA
CL414916
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0027695
SNOMED CT 2011_0131
108022006
MedDRA 14.1
10029116
Patients with cerebral tumours and/or cerebral metastases
Description

Patients with cerebral tumours and/or cerebral metastases

Data type

boolean

Alias
UMLS CUI 2011AA
C1263885
SNOMED CT 2011_0131
126953009
UMLS CUI 2011AA
C0555278
SNOMED CT 2011_0131
94248000
Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) <= 1 year before enrolment.
Description

Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) <= 1 year before enrolment.

Data type

boolean

Alias
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
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
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
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
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
Patients with uncontrolled hypertension. Systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg despite optimal medical treatment
Description

Patients with uncontrolled hypertension. Systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg despite optimal medical treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C1868885
MedDRA 14.1
10066860
UMLS CUI 2011AA
C1306620
MedDRA 14.1
10005756
UMLS CUI 2011AA
C0428883
SNOMED CT 2011_0131
271650006
UMLS CUI 2011AA
C0162643
MedDRA 14.1
10066901
History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
Description

History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0206062
SNOMED CT 2011_0131
233703007
MedDRA 14.1
10022611
ICD-10-CM Version 2010
J84.9
UMLS CUI 2011AA
C1442488
UMLS CUI 2011AA
C0202823
SNOMED CT 2011_0131
169069000
MedDRA 14.1
10053875
ICD-9-CM Version 2011
87.41
UMLS CUI 2011AA
C0032285
SNOMED CT 2011_0131
233604007
MedDRA 14.1
10035664
LOINC Version 232
MTHU020831
ICD-10-CM Version 2010
J18.9
CTCAE 1105E
E13502
UMLS CUI 2011AA
C0034069
SNOMED CT 2011_0131
51615001
MedDRA 14.1
10037383
ICD-10-CM Version 2010
J84.1
CTCAE 1105E
E13527
Patients with thrombotic or embolic events, such as stroke or pulmonary embolism
Description

Patients with thrombotic or embolic events, such as stroke or pulmonary embolism

Data type

boolean

Alias
UMLS CUI 2011AA
C0040038
Patients with recent or known history of haemorrhagic diathesis
Description

Patients with recent or known history of haemorrhagic diathesis

Data type

boolean

Alias
UMLS CUI 2011AA
C0332185
SNOMED CT 2011_0131
6493001
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0019087
MedDRA 14.1
10019009
ICD-10-CM Version 2010
D69.9
ICD-9-CM Version 2011
287.9
Known significant neurological or psychiatric disorders, including dementia and epileptic seizures
Description

Known significant neurological or psychiatric disorders, including dementia and epileptic seizures

Data type

boolean

Alias
UMLS CUI 2011AA
C0027765
SNOMED CT 2011_0131
118940003
MedDRA 14.1
10029202
ICD-10-CM Version 2010
G98.8
ICD-9-CM Version 2011
349.9
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
C0497327
SNOMED CT 2011_0131
52448006
MedDRA 14.1
10012267
ICD-10-CM Version 2010
F03
ICD-9-CM Version 2011
290
UMLS CUI 2011AA
C0014544
SNOMED CT 2011_0131
84757009, 313307000
MedDRA 14.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
Serious inflammatory eye conditions, hearing impairment
Description

Serious inflammatory eye conditions, hearing impairment

Data type

boolean

Alias
UMLS CUI 2011AA
C0333348
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C1384666
CTCAE 1105E
E10276
Pulmonary (pO2 < 60 mmHg), haemopoietic (e.g. serious bone marrow aplasia), hepatic or renal disorders
Description

Pulmonary (pO2 < 60 mmHg), haemopoietic (e.g. serious bone marrow aplasia), hepatic or renal disorders

Data type

boolean

Alias
UMLS CUI 2011AA
C0024115
SNOMED CT 2011_0131
19829001
MedDRA 14.1
10025082
ICD-10-CM Version 2010
J98.4
UMLS CUI 2011AA
C0202155
SNOMED CT 2011_0131
25579001
MedDRA 14.1
10035766
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
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0243065
SNOMED CT 2011_0131
45486003
MedDRA 14.1
10002961
UMLS CUI 2011AA
C1869009
MedDRA 14.1
20000005
UMLS CUI 2011AA
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
Diabetes mellitus poor control
Description

Patients with poorly controlled diabetes mellitus

Data type

boolean

Alias
UMLS CUI 2011AA
C0860161
MedDRA 14.1
10012619
Serious bacterial or fungal infections (>grade 2 NCI CTC Version 3)
Description

Serious bacterial or fungal infections (>grade 2 NCI CTC Version 3)

Data type

boolean

Alias
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
UMLS CUI 2011AA
C1560948
CTCAE 1105E
MTHU114619
UMLS CUI 2011AA
C1560949
CTCAE 1105E
MTHU115603
UMLS CUI 2011AA
C1560950
CTCAE 1105E
MTHU116429
Chronic hepatitis B or C. HIV infection
Description

Chronic hepatitis B or C. HIV infection

Data type

boolean

Alias
UMLS CUI 2011AA
C0524909
SNOMED CT 2011_0131
61977001
MedDRA 14.1
10008910
ICD-10-CM Version 2010
B18.1
UMLS CUI 2011AA
C0524910
SNOMED CT 2011_0131
128302006
MedDRA 14.1
10008912
ICD-10-CM Version 2010
B18.2
UMLS CUI 2011AA
C0019693
SNOMED CT 2011_0131
86406008
MedDRA 14.1
10020161
LOINC Version 232
MTHU020829
ICD-10-CM Version 2010
B20
ICD-9-CM Version 2011
042
Autoimmune Disease
Description

Autoimmune disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0004364
SNOMED CT 2011_0131
85828009
MedDRA 14.1
10061664
ICD-10-CM Version 2010
M30-M36
CTCAE 1105E
E11258
Allergic reaction to one of the medications to be used
Description

Allergic reaction to one of the medications to be used

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
Status post organ transplantation
Description

Status post organ transplantation

Data type

boolean

Alias
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C0029216
MedDRA 14.1
10061890
LOINC Version 232
MTHU000173
Status post autologous bone marrow transplantation or stem cell transplantation in the 4 months prior to study commencement
Description

Status post autologous bone marrow transplantation or stem cell transplantation in the 4 months prior to study commencement

Data type

boolean

Alias
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C0194037
SNOMED CT 2011_0131
58776007
UMLS CUI 2011AA
C1831743
Manifest secondary malignancy or other form of cancer in the previous 5 years (excluding basalioma, in situ cervical cancer, incidental prostatic cancer)
Description

Manifest secondary malignancy or other form of cancer in the previous 5 years (excluding basalioma, in situ cervical cancer, incidental prostatic cancer)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205319
SNOMED CT 2011_0131
250255003
UMLS CUI 2011AA
C0751623
MedDRA 14.1
10039801
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
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
C0007117
SNOMED CT 2011_0131
1338007, 254701007
MedDRA 14.1
10004146
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
C0444507
SNOMED CT 2011_0131
261087003
UMLS CUI 2011AA
C0600139
SNOMED CT 2011_0131
254900004
MedDRA 14.1
10036921
Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
Description

Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C0032992
SNOMED CT 2011_0131
169565003
Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 3 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
Description

Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 3 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).

Data type

boolean

Alias
UMLS CUI 2011AA
C0024554
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0558080
SNOMED CT 2011_0131
225465005
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0009905
SNOMED CT 2011_0131
59261009
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
C0004764
SNOMED CT 2011_0131
225370004
UMLS CUI 2011AA
C2699427
UMLS CUI 2011AA
C2985330
Active participation in other clinical studies in the previous 4 weeks
Description

Active participation in other clinical studies in the previous 4 weeks

Data type

boolean

Alias
UMLS CUI 2011AA
C2348568
Prior systemic therapy with cytostatics or immunotherapeutic agents
Description

Prior systemic therapy with cytostatics or immunotherapeutic agents

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1515119
UMLS CUI 2011AA
C0010858
SNOMED CT 2011_0131
373221003
UMLS CUI 2011AA
C0876248
SNOMED CT 2011_0131
255683006
Concurrent use of other anticancer treatments after study commencement
Description

Concurrent use of other anticancer treatments after study commencement

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
C0920425
intravesical chemotherapy
Description

Intravesical chemotherapy in the previous 4 weeks

Data type

boolean

Alias
UMLS CUI 2011AA
CL388462
radiation therapy, RT
Description

Radiotherapy in the previous 4 weeks

Data type

boolean

Alias
UMLS CUI 2011AA
C0034619
Previous radiotherapy in which all lesions to be used for the evaluation of tumour response were irradiated
Description

Previous radiotherapy in which all lesions to be used for the evaluation of tumour response were irradiated

Data type

boolean

Alias
UMLS CUI 2011AA
CL414551
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0220825
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
C0871261
Patients in a closed institution according to an authority or court decision
Description

Patients in a closed institution according to an authority or court decision

Data type

boolean

Alias
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0587267
SNOMED CT 2011_0131
29179001
UMLS CUI 2011AA
C0021622
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0599437
UMLS CUI 2011AA
C0242364
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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)
Histologically or cytologically confirmed, unresectable urothelial carcinoma of the bladder or the upper urinary tract
Item
Histologically or cytologically confirmed, unresectable urothelial carcinoma of the bladder or the upper urinary tract
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0205471 (UMLS CUI 2011AA)
40413002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C1519810 (UMLS CUI 2011AA)
C0279680 (UMLS CUI 2011AA)
255109008 (SNOMED CT 2011_0131)
10046714 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
CL363966 (UMLS CUI 2011AA)
C0729865 (UMLS CUI 2011AA)
Wild-type HRAS
Item
Wild-type HRAS
boolean
C0678926 (UMLS CUI 2011AA)
C0079471 (UMLS CUI 2011AA)
General condition ECOG 0-1
Item
General condition ECOG 0-1
boolean
C0947124 (UMLS CUI 2011AA)
MTHU001443 (LOINC Version 232)
C1828078 (UMLS CUI 2011AA)
425389002 (SNOMED CT 2011_0131)
C1827388 (UMLS CUI 2011AA)
422512005 (SNOMED CT 2011_0131)
Life expectancy at least 12 weeks
Item
Life expectancy at least 12 weeks
boolean
C0023671 (UMLS CUI 2011AA)
Women of child-bearing potential: negative pregnancy test and use of effective contraception(oral contraceptive, coil). Men: use of adequate male contraception (condom) for up to 3 months after discontinuation of panitumumab therapy
Item
Women of child-bearing potential: negative pregnancy test and use of effective contraception(oral contraceptive, coil). Men: use of adequate male contraception (condom) for up to 3 months after discontinuation of panitumumab therapy
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0009905 (UMLS CUI 2011AA)
59261009 (SNOMED CT 2011_0131)
C0419518 (UMLS CUI 2011AA)
312082008 (SNOMED CT 2011_0131)
10009849 (MedDRA 14.1)
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0086580 (UMLS CUI 2011AA)
10065589 (MedDRA 14.1)
C0677582 (UMLS CUI 2011AA)
Locally advanced or metastatic disease (T3b,T4 and/or N+ and/or M+)
Item
Locally advanced or metastatic disease (T3b,T4 and/or N+ and/or M+)
boolean
C0677984 (UMLS CUI 2011AA)
C0027627 (UMLS CUI 2011AA)
10027478 (MedDRA 14.1)
C0475391 (UMLS CUI 2011AA)
261655000 (SNOMED CT 2011_0131)
C0475751 (UMLS CUI 2011AA)
65565005 (SNOMED CT 2011_0131)
C0441922 (UMLS CUI 2011AA)
258310009 (SNOMED CT 2011_0131)
C0441923 (UMLS CUI 2011AA)
258311008 (SNOMED CT 2011_0131)
At least one unidimensionally measurable lesion detectable in CT or MRI corresponding to the RECIST criteria
Item
At least one unidimensionally measurable lesion detectable in CT or MRI corresponding to the RECIST criteria
boolean
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439534 (UMLS CUI 2011AA)
255506008 (SNOMED CT 2011_0131)
C1513040 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C1511790 (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)
C1709926 (UMLS CUI 2011AA)
Adequate haematological, hepatic, renal and metabolic function parameters:
Item
Adequate haematological, hepatic, renal and metabolic function parameters:
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0449381 (UMLS CUI 2011AA)
252116004 (SNOMED CT 2011_0131)
C0221130 (UMLS CUI 2011AA)
86084001 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C0438212 (UMLS CUI 2011AA)
165105001 (SNOMED CT 2011_0131)
Leukocytes > 3000/mm³, ANC >= 1500/mm³, platelets >= 100,000/mm³, hemoglobin > 9 g/dl Creatinine clearance >= 50 ml/min and serum creatinine <= 1.5 x upper limit of normal Bilirubin <= 1.5 x upper limit of normal, GOT-GPT <= 2.5 x upper limit of normal in absence of liver metastases, or <= 5 x upper limit of normal in presence of liver metastases, AP <= 5 x upper limit of normal Magnesium >= lower limit of normal. Calcium >= lower limit of normal INR and PTT < 1.5 x the upper limit of the normal reference range
Item
Leukocytes > 3000/mm³, ANC >= 1500/mm³, platelets >= 100,000/mm³, hemoglobin > 9 g/dl Creatinine clearance >= 50 ml/min and serum creatinine <= 1.5 x upper limit of normal Bilirubin <= 1.5 x upper limit of normal, GOT-GPT <= 2.5 x upper limit of normal in absence of liver metastases, or <= 5 x upper limit of normal in presence of liver metastases, AP <= 5 x upper limit of normal Magnesium >= lower limit of normal. Calcium >= lower limit of normal INR and PTT < 1.5 x the upper limit of the normal reference range
boolean
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C0518015 (UMLS CUI 2011AA)
10018876 (MedDRA 14.1)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C0011221 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0002059 (UMLS CUI 2011AA)
57056007 (SNOMED CT 2011_0131)
MTHU005195 (LOINC Version 232)
C0373675 (UMLS CUI 2011AA)
38151008 (SNOMED CT 2011_0131)
10025436 (MedDRA 14.1)
C1518030 (UMLS CUI 2011AA)
C0201925 (UMLS CUI 2011AA)
71878006 (SNOMED CT 2011_0131)
10006948 (MedDRA 14.1)
C0525032 (UMLS CUI 2011AA)
165581004 (SNOMED CT 2011_0131)
10022400 (MedDRA 14.1)
C0030605 (UMLS CUI 2011AA)
42525009 (SNOMED CT 2011_0131)
10000630 (MedDRA 14.1)
Item Group
Exclusion Criteria
HRAS mutation
Item
HRAS mutation
boolean
C0079471 (UMLS CUI 2011AA)
C0026882 (UMLS CUI 2011AA)
55446002 (SNOMED CT 2011_0131)
Absence of any of the above-listed inclusion criteria
Item
Absence of any of the above-listed inclusion criteria
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
CL407060 (UMLS CUI 2011AA)
CL425202 (UMLS CUI 2011AA)
CL384738 (UMLS CUI 2011AA)
Dialysis-dependence following nephrectomy
Item
Dialysis-dependence following nephrectomy
boolean
C0011946 (UMLS CUI 2011AA)
108241001 (SNOMED CT 2011_0131)
10061105 (MedDRA 14.1)
CL414916 (UMLS CUI 2011AA)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0027695 (UMLS CUI 2011AA)
108022006 (SNOMED CT 2011_0131)
10029116 (MedDRA 14.1)
Patients with cerebral tumours and/or cerebral metastases
Item
Patients with cerebral tumours and/or cerebral metastases
boolean
C1263885 (UMLS CUI 2011AA)
126953009 (SNOMED CT 2011_0131)
C0555278 (UMLS CUI 2011AA)
94248000 (SNOMED CT 2011_0131)
Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) <= 1 year before enrolment.
Item
Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) <= 1 year before enrolment.
boolean
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (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)
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)
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)
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)
Patients with uncontrolled hypertension. Systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg despite optimal medical treatment
Item
Patients with uncontrolled hypertension. Systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg despite optimal medical treatment
boolean
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
C1306620 (UMLS CUI 2011AA)
10005756 (MedDRA 14.1)
C0428883 (UMLS CUI 2011AA)
271650006 (SNOMED CT 2011_0131)
C0162643 (UMLS CUI 2011AA)
10066901 (MedDRA 14.1)
History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
Item
History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0206062 (UMLS CUI 2011AA)
233703007 (SNOMED CT 2011_0131)
10022611 (MedDRA 14.1)
J84.9 (ICD-10-CM Version 2010)
C1442488 (UMLS CUI 2011AA)
C0202823 (UMLS CUI 2011AA)
169069000 (SNOMED CT 2011_0131)
10053875 (MedDRA 14.1)
87.41 (ICD-9-CM Version 2011)
C0032285 (UMLS CUI 2011AA)
233604007 (SNOMED CT 2011_0131)
10035664 (MedDRA 14.1)
MTHU020831 (LOINC Version 232)
J18.9 (ICD-10-CM Version 2010)
E13502 (CTCAE 1105E)
C0034069 (UMLS CUI 2011AA)
51615001 (SNOMED CT 2011_0131)
10037383 (MedDRA 14.1)
J84.1 (ICD-10-CM Version 2010)
E13527 (CTCAE 1105E)
Patients with thrombotic or embolic events, such as stroke or pulmonary embolism
Item
Patients with thrombotic or embolic events, such as stroke or pulmonary embolism
boolean
C0040038 (UMLS CUI 2011AA)
Patients with recent or known history of haemorrhagic diathesis
Item
Patients with recent or known history of haemorrhagic diathesis
boolean
C0332185 (UMLS CUI 2011AA)
6493001 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0019087 (UMLS CUI 2011AA)
10019009 (MedDRA 14.1)
D69.9 (ICD-10-CM Version 2010)
287.9 (ICD-9-CM Version 2011)
Known significant neurological or psychiatric disorders, including dementia and epileptic seizures
Item
Known significant neurological or psychiatric disorders, including dementia and epileptic seizures
boolean
C0027765 (UMLS CUI 2011AA)
118940003 (SNOMED CT 2011_0131)
10029202 (MedDRA 14.1)
G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
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)
C0497327 (UMLS CUI 2011AA)
52448006 (SNOMED CT 2011_0131)
10012267 (MedDRA 14.1)
F03 (ICD-10-CM Version 2010)
290 (ICD-9-CM Version 2011)
C0014544 (UMLS CUI 2011AA)
84757009, 313307000 (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)
Serious inflammatory eye conditions, hearing impairment
Item
Serious inflammatory eye conditions, hearing impairment
boolean
C0333348 (UMLS CUI 2011AA)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C1384666 (UMLS CUI 2011AA)
E10276 (CTCAE 1105E)
Pulmonary (pO2 < 60 mmHg), haemopoietic (e.g. serious bone marrow aplasia), hepatic or renal disorders
Item
Pulmonary (pO2 < 60 mmHg), haemopoietic (e.g. serious bone marrow aplasia), hepatic or renal disorders
boolean
C0024115 (UMLS CUI 2011AA)
19829001 (SNOMED CT 2011_0131)
10025082 (MedDRA 14.1)
J98.4 (ICD-10-CM Version 2010)
C0202155 (UMLS CUI 2011AA)
25579001 (SNOMED CT 2011_0131)
10035766 (MedDRA 14.1)
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)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0243065 (UMLS CUI 2011AA)
45486003 (SNOMED CT 2011_0131)
10002961 (MedDRA 14.1)
C1869009 (UMLS CUI 2011AA)
20000005 (MedDRA 14.1)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
Patients with poorly controlled diabetes mellitus
Item
Diabetes mellitus poor control
boolean
C0860161 (UMLS CUI 2011AA)
10012619 (MedDRA 14.1)
Serious bacterial or fungal infections (>grade 2 NCI CTC Version 3)
Item
Serious bacterial or fungal infections (>grade 2 NCI CTC Version 3)
boolean
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)
C1560948 (UMLS CUI 2011AA)
MTHU114619 (CTCAE 1105E)
C1560949 (UMLS CUI 2011AA)
MTHU115603 (CTCAE 1105E)
C1560950 (UMLS CUI 2011AA)
MTHU116429 (CTCAE 1105E)
Chronic hepatitis B or C. HIV infection
Item
Chronic hepatitis B or C. HIV infection
boolean
C0524909 (UMLS CUI 2011AA)
61977001 (SNOMED CT 2011_0131)
10008910 (MedDRA 14.1)
B18.1 (ICD-10-CM Version 2010)
C0524910 (UMLS CUI 2011AA)
128302006 (SNOMED CT 2011_0131)
10008912 (MedDRA 14.1)
B18.2 (ICD-10-CM Version 2010)
C0019693 (UMLS CUI 2011AA)
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.1)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
Autoimmune disease
Item
Autoimmune Disease
boolean
C0004364 (UMLS CUI 2011AA)
85828009 (SNOMED CT 2011_0131)
10061664 (MedDRA 14.1)
M30-M36 (ICD-10-CM Version 2010)
E11258 (CTCAE 1105E)
Allergic reaction to one of the medications to be used
Item
Allergic reaction to one of the medications to be used
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Status post organ transplantation
Item
Status post organ transplantation
boolean
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0029216 (UMLS CUI 2011AA)
10061890 (MedDRA 14.1)
MTHU000173 (LOINC Version 232)
Status post autologous bone marrow transplantation or stem cell transplantation in the 4 months prior to study commencement
Item
Status post autologous bone marrow transplantation or stem cell transplantation in the 4 months prior to study commencement
boolean
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0194037 (UMLS CUI 2011AA)
58776007 (SNOMED CT 2011_0131)
C1831743 (UMLS CUI 2011AA)
Manifest secondary malignancy or other form of cancer in the previous 5 years (excluding basalioma, in situ cervical cancer, incidental prostatic cancer)
Item
Manifest secondary malignancy or other form of cancer in the previous 5 years (excluding basalioma, in situ cervical cancer, incidental prostatic cancer)
boolean
C0205319 (UMLS CUI 2011AA)
250255003 (SNOMED CT 2011_0131)
C0751623 (UMLS CUI 2011AA)
10039801 (MedDRA 14.1)
C0205394 (UMLS CUI 2011AA)
74964007 (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)
C0007117 (UMLS CUI 2011AA)
1338007, 254701007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
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)
C0444507 (UMLS CUI 2011AA)
261087003 (SNOMED CT 2011_0131)
C0600139 (UMLS CUI 2011AA)
254900004 (SNOMED CT 2011_0131)
10036921 (MedDRA 14.1)
Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
Item
Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0032992 (UMLS CUI 2011AA)
169565003 (SNOMED CT 2011_0131)
Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 3 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
Item
Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 3 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
boolean
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0009905 (UMLS CUI 2011AA)
59261009 (SNOMED CT 2011_0131)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
C2699427 (UMLS CUI 2011AA)
C2985330 (UMLS CUI 2011AA)
Active participation in other clinical studies in the previous 4 weeks
Item
Active participation in other clinical studies in the previous 4 weeks
boolean
C2348568 (UMLS CUI 2011AA)
Prior systemic therapy with cytostatics or immunotherapeutic agents
Item
Prior systemic therapy with cytostatics or immunotherapeutic agents
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1515119 (UMLS CUI 2011AA)
C0010858 (UMLS CUI 2011AA)
373221003 (SNOMED CT 2011_0131)
C0876248 (UMLS CUI 2011AA)
255683006 (SNOMED CT 2011_0131)
Concurrent use of other anticancer treatments after study commencement
Item
Concurrent use of other anticancer treatments after study commencement
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)
C0920425 (UMLS CUI 2011AA)
Intravesical chemotherapy in the previous 4 weeks
Item
intravesical chemotherapy
boolean
CL388462 (UMLS CUI 2011AA)
Radiotherapy in the previous 4 weeks
Item
radiation therapy, RT
boolean
C0034619 (UMLS CUI 2011AA)
Previous radiotherapy in which all lesions to be used for the evaluation of tumour response were irradiated
Item
Previous radiotherapy in which all lesions to be used for the evaluation of tumour response were irradiated
boolean
CL414551 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0220825 (UMLS CUI 2011AA)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0871261 (UMLS CUI 2011AA)
Patients in a closed institution according to an authority or court decision
Item
Patients in a closed institution according to an authority or court decision
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0587267 (UMLS CUI 2011AA)
29179001 (SNOMED CT 2011_0131)
C0021622 (UMLS CUI 2011AA)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0599437 (UMLS CUI 2011AA)
C0242364 (UMLS CUI 2011AA)
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