ID

43429

Descripción

ODM derived from http://clinicaltrials.gov/show/NCT00349076

Link

http://clinicaltrials.gov/show/NCT00349076

Palabras clave

Versiones (3)
  1. 9/12/13 9/12/13 - Martin Dugas
  2. 16/4/14 16/4/14 - Julian Varghese
  3. 20/9/21 20/9/21 -
Subido en

20 de septiembre de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility DRKS00003645 NCT00349076 Rectal Neoplasms

Alemán Inglés

Eligibility

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Descripción

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter mindestens 18 Jahre
Descripción

age at least 18 Years

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Histologically proven, advanced primary carcinoma of the rectum (tumor ? 12cm from the anal verge, with clinically staged T3/4 or any node-positive disease
Descripción

Histologically proven, advanced primary carcinoma of the rectum (tumor ? 12cm from the anal verge, with clinically staged T3/4 or any node-positive disease

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0456369
SNOMED CT 2011_0131
277025001
UMLS CUI 2011AA
C0205179
SNOMED CT 2011_0131
86005002
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0007113
SNOMED CT 2011_0131
254582000
MedDRA 14.1
10038038
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0475374
SNOMED CT 2011_0131
14410001
UMLS CUI 2011AA
C0475751
SNOMED CT 2011_0131
65565005
UMLS CUI 2011AA
C1300126
SNOMED CT 2011_0131
371490004
UMLS CUI 2011AA
C0746319
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
No prior therapy except a diverting stoma
Descripción

No prior therapy except a diverting stoma

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0741847
SNOMED CT 2011_0131
88834003
UMLS CUI 2011AA
C0029473
SNOMED CT 2011_0131
75506009
ECOG Status <= 2
Descripción

ECOG PS <= 2

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C1520224
SNOMED CT 2011_0131
424122007
Adequate bone marrow function: Leukocytes > 3,5 x 10^9/L Absolute neutrophil count > 1,5 x 10^9/L Platelet count > 100 x 10^9/L Hemoglobin > 10 g/dl
Descripción

Adequate bone marrow function: Leukocytes > 3,5 x 10^9/L Absolute neutrophil count > 1,5 x 10^9/L Platelet count > 100 x 10^9/L Hemoglobin > 10 g/dl

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0542341
SNOMED CT 2011_0131
246464006
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
C0019046
SNOMED CT 2011_0131
38082009
MedDRA 14.1
10019481
LOINC Version 232
LP14449-0
Adequate hepatic function: Total bilirubin < 2,0 mg/dl ALAT, ASAT, alkaline phosphatase, gamma-GT < 3 x ULN 7. Serum creatinine < 1,5 mg/dl, creatinine-clearance > 50 ml/min
Descripción

Adequate hepatic function: Total bilirubin < 2,0 mg/dl ALAT, ASAT, alkaline phosphatase, gamma-GT < 3 x ULN 7. Serum creatinine < 1,5 mg/dl, creatinine-clearance > 50 ml/min

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
UMLS CUI 2011AA
C0201913
SNOMED CT 2011_0131
359986008
MedDRA 14.1
10004696
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
C0002059
SNOMED CT 2011_0131
57056007
LOINC Version 232
MTHU005195
UMLS CUI 2011AA
C0017040
SNOMED CT 2011_0131
60153001
LOINC Version 232
MTHU001941
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
Written informed consent before randomization
Descripción

Written informed consent before randomization

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0021430
Ausschlusskriterien
Descripción

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Pregnant or breast feeding women
Descripción

Pregnant or breast feeding women

Tipo de datos

boolean

Alias
UMLS CUI 1
C0549206
MedDRA 1
10036586
UMLS CUI 2
C0006147
MedDRA 2
10006247
Fertile patients without adequate contraception during therapy
Descripción

Fertile patients without adequate contraception during therapy

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
CL426012
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0420844
SNOMED CT 2011_0131
169450001
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0039798
Past or ongoing drug abuse or alcoholic excess
Descripción

Past or ongoing drug abuse or alcoholic excess

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C1444637
SNOMED CT 2011_0131
410513005
UMLS CUI 2011AA
C0549178
UMLS CUI 2011AA
C0013146
SNOMED CT 2011_0131
26416006
MedDRA 14.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
UMLS CUI 2011AA
C0560219
SNOMED CT 2011_0131
160592001
frühere Chemotherapie
Descripción

Prior chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C1514457
Prior radiotherapy to the pelvis
Descripción

Prior radiotherapy to the pelvis

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C0030797
SNOMED CT 2011_0131
12921003
LOINC Version 232
MTHU001438
Prior (within 4 weeks) or concurrent treatment with any other investigational agent
Descripción

Prior (within 4 weeks) or concurrent treatment with any other investigational agent

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0009429
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0013230
Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Descripción

Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0205486
SNOMED CT 2011_0131
60224009
UMLS CUI 2011AA
C0241888
SNOMED CT 2011_0131
255401001
UMLS CUI 2011AA
C0037468
UMLS CUI 2011AA
C0017447
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0525058
UMLS CUI 2011AA
C1522577
UMLS CUI 2011AA
C0086960
History of severe somatic or psychological diseases: - instable cardiac disease not well controlled with medication, myocardial infarction within the last 6 months:* Central nervous system disorders or psychiatric disability including dementia or epileptic disease. * active uncontrolled intercurrent infections or sepsis
Descripción

History of severe somatic or psychological diseases: - instable cardiac disease not well controlled with medication, myocardial infarction within the last 6 months:* Central nervous system disorders or psychiatric disability including dementia or epileptic disease. * active uncontrolled intercurrent infections or sepsis

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
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
C0443343
SNOMED CT 2011_0131
263922001
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
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
C0007682
SNOMED CT 2011_0131
23853001
MedDRA 14.1
10007943
ICD-10-CM Version 2010
G96.9
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
MedDRA 14.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0240021
UMLS CUI 2011AA
C0243026
SNOMED CT 2011_0131
91302008
MedDRA 14.1
10040047
ICD-9-CM Version 2011
995.91
Peripheral neuropathy > 2 (NCI CTC AE grading)
Descripción

Peripheral neuropathy > 2 (NCI CTC AE grading)

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0031117
MedDRA 14.1
10029331
ICD-10-CM Version 2010
G64
ICD-9-CM Version 2011
350-359.99
UMLS CUI 2011AA
C1557260
CTCAE 1105E
MTHU114803
UMLS CUI 2011AA
C1557261
CTCAE 1105E
MTHU115776
UMLS CUI 2011AA
C1557262
CTCAE 1105E
MTHU116556
UMLS CUI 2011AA
C1557255
CTCAE 1105E
MTHU114539
UMLS CUI 2011AA
C1557256
CTCAE 1105E
MTHU115527
UMLS CUI 2011AA
C1557257
CTCAE 1105E
MTHU116371
Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. The inclusion of patients with other adequately treated tumors within the last 5 years has to be discussed with the principal investigator
Descripción

Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. The inclusion of patients with other adequately treated tumors within the last 5 years has to be discussed with the principal investigator

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C2735088
LOINC Version 232
MTHU034770
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
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
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007
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
Chronic diarrhea (> NCI CTC AE-Grad 1)
Descripción

Chronic diarrhea (> NCI CTC AE-Grad 1)

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0401151
SNOMED CT 2011_0131
236071009
MedDRA 14.1
10066556
UMLS CUI 2011AA
C0441800
SNOMED CT 2011_0131
258349007
LOINC Version 232
MTHU003112
Known allergy to substances containing platinum compounds
Descripción

Known allergy to substances containing platinum compounds

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0206135
SNOMED CT 2011_0131
11996000
Concurrent use of the antiviral agent sorivudine or chemically related analogues
Descripción

Concurrent use of the antiviral agent sorivudine or chemically related analogues

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0205420
SNOMED CT 2011_0131
68405009
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0003451
SNOMED CT 2011_0131
372701006
UMLS CUI 2011AA
C0207628
UMLS CUI 2011AA
C0445223
SNOMED CT 2011_0131
262094002
UMLS CUI 2011AA
C0243071
Known deficiency of dehydropyrimidindehydrogenase (DPD)
Descripción

Known deficiency of dehydropyrimidindehydrogenase (DPD)

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0011155
SNOMED CT 2011_0131
129453003
UMLS CUI 2011AA
C0058126
SNOMED CT 2011_0131
259519002
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Similar models

Eligibility

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Histologically proven, advanced primary carcinoma of the rectum (tumor ? 12cm from the anal verge, with clinically staged T3/4 or any node-positive disease
Item
Histologically proven, advanced primary carcinoma of the rectum (tumor ? 12cm from the anal verge, with clinically staged T3/4 or any node-positive disease
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0456369 (UMLS CUI 2011AA)
277025001 (SNOMED CT 2011_0131)
C0205179 (UMLS CUI 2011AA)
86005002 (SNOMED CT 2011_0131)
CL414904 (UMLS CUI 2011AA)
C0007113 (UMLS CUI 2011AA)
254582000 (SNOMED CT 2011_0131)
10038038 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0475374 (UMLS CUI 2011AA)
14410001 (SNOMED CT 2011_0131)
C0475751 (UMLS CUI 2011AA)
65565005 (SNOMED CT 2011_0131)
C1300126 (UMLS CUI 2011AA)
371490004 (SNOMED CT 2011_0131)
C0746319 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
No prior therapy except a diverting stoma
Item
No prior therapy except a diverting stoma
boolean
C1518422 (UMLS CUI 2011AA)
C1514463 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0741847 (UMLS CUI 2011AA)
88834003 (SNOMED CT 2011_0131)
C0029473 (UMLS CUI 2011AA)
75506009 (SNOMED CT 2011_0131)
ECOG PS <= 2
Item
ECOG Status <= 2
boolean
C1520224 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
Adequate bone marrow function: Leukocytes > 3,5 x 10^9/L Absolute neutrophil count > 1,5 x 10^9/L Platelet count > 100 x 10^9/L Hemoglobin > 10 g/dl
Item
Adequate bone marrow function: Leukocytes > 3,5 x 10^9/L Absolute neutrophil count > 1,5 x 10^9/L Platelet count > 100 x 10^9/L Hemoglobin > 10 g/dl
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0542341 (UMLS CUI 2011AA)
246464006 (SNOMED CT 2011_0131)
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)
C0019046 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
Adequate hepatic function: Total bilirubin < 2,0 mg/dl ALAT, ASAT, alkaline phosphatase, gamma-GT < 3 x ULN 7. Serum creatinine < 1,5 mg/dl, creatinine-clearance > 50 ml/min
Item
Adequate hepatic function: Total bilirubin < 2,0 mg/dl ALAT, ASAT, alkaline phosphatase, gamma-GT < 3 x ULN 7. Serum creatinine < 1,5 mg/dl, creatinine-clearance > 50 ml/min
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0002059 (UMLS CUI 2011AA)
57056007 (SNOMED CT 2011_0131)
MTHU005195 (LOINC Version 232)
C0017040 (UMLS CUI 2011AA)
60153001 (SNOMED CT 2011_0131)
MTHU001941 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
Written informed consent before randomization
Item
Written informed consent before randomization
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Pregnant or breast feeding women
Item
Pregnant or breast feeding women
boolean
C0549206 (UMLS CUI 1)
10036586 (MedDRA 1)
C0006147 (UMLS CUI 2)
10006247 (MedDRA 2)
Fertile patients without adequate contraception during therapy
Item
Fertile patients without adequate contraception during therapy
boolean
CL426012 (UMLS CUI 2011AA)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Past or ongoing drug abuse or alcoholic excess
Item
Past or ongoing drug abuse or alcoholic excess
boolean
C1444637 (UMLS CUI 2011AA)
410513005 (SNOMED CT 2011_0131)
C0549178 (UMLS CUI 2011AA)
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
C0560219 (UMLS CUI 2011AA)
160592001 (SNOMED CT 2011_0131)
Prior chemotherapy
Item
frühere Chemotherapie
boolean
C1514457 (UMLS CUI 2011AA)
Prior radiotherapy to the pelvis
Item
Prior radiotherapy to the pelvis
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
C0030797 (UMLS CUI 2011AA)
12921003 (SNOMED CT 2011_0131)
MTHU001438 (LOINC Version 232)
Prior (within 4 weeks) or concurrent treatment with any other investigational agent
Item
Prior (within 4 weeks) or concurrent treatment with any other investigational agent
boolean
C1514463 (UMLS CUI 2011AA)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0009429 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Item
Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
boolean
C0205486 (UMLS CUI 2011AA)
60224009 (SNOMED CT 2011_0131)
C0241888 (UMLS CUI 2011AA)
255401001 (SNOMED CT 2011_0131)
C0037468 (UMLS CUI 2011AA)
C0017447 (UMLS CUI 2011AA)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
C1522577 (UMLS CUI 2011AA)
C0086960 (UMLS CUI 2011AA)
History of severe somatic or psychological diseases: - instable cardiac disease not well controlled with medication, myocardial infarction within the last 6 months:* Central nervous system disorders or psychiatric disability including dementia or epileptic disease. * active uncontrolled intercurrent infections or sepsis
Item
History of severe somatic or psychological diseases: - instable cardiac disease not well controlled with medication, myocardial infarction within the last 6 months:* Central nervous system disorders or psychiatric disability including dementia or epileptic disease. * active uncontrolled intercurrent infections or sepsis
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
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)
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
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)
C0007682 (UMLS CUI 2011AA)
23853001 (SNOMED CT 2011_0131)
10007943 (MedDRA 14.1)
G96.9 (ICD-10-CM Version 2010)
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 (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)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0240021 (UMLS CUI 2011AA)
C0243026 (UMLS CUI 2011AA)
91302008 (SNOMED CT 2011_0131)
10040047 (MedDRA 14.1)
995.91 (ICD-9-CM Version 2011)
Peripheral neuropathy > 2 (NCI CTC AE grading)
Item
Peripheral neuropathy > 2 (NCI CTC AE grading)
boolean
C0031117 (UMLS CUI 2011AA)
10029331 (MedDRA 14.1)
G64 (ICD-10-CM Version 2010)
350-359.99 (ICD-9-CM Version 2011)
C1557260 (UMLS CUI 2011AA)
MTHU114803 (CTCAE 1105E)
C1557261 (UMLS CUI 2011AA)
MTHU115776 (CTCAE 1105E)
C1557262 (UMLS CUI 2011AA)
MTHU116556 (CTCAE 1105E)
C1557255 (UMLS CUI 2011AA)
MTHU114539 (CTCAE 1105E)
C1557256 (UMLS CUI 2011AA)
MTHU115527 (CTCAE 1105E)
C1557257 (UMLS CUI 2011AA)
MTHU116371 (CTCAE 1105E)
Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. The inclusion of patients with other adequately treated tumors within the last 5 years has to be discussed with the principal investigator
Item
Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. The inclusion of patients with other adequately treated tumors within the last 5 years has to be discussed with the principal investigator
boolean
C2735088 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
C0205420 (UMLS CUI 2011AA)
68405009 (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)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007 (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)
Chronic diarrhea (> NCI CTC AE-Grad 1)
Item
Chronic diarrhea (> NCI CTC AE-Grad 1)
boolean
C0401151 (UMLS CUI 2011AA)
236071009 (SNOMED CT 2011_0131)
10066556 (MedDRA 14.1)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
Known allergy to substances containing platinum compounds
Item
Known allergy to substances containing platinum compounds
boolean
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0206135 (UMLS CUI 2011AA)
11996000 (SNOMED CT 2011_0131)
Concurrent use of the antiviral agent sorivudine or chemically related analogues
Item
Concurrent use of the antiviral agent sorivudine or chemically related analogues
boolean
C0205420 (UMLS CUI 2011AA)
68405009 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0003451 (UMLS CUI 2011AA)
372701006 (SNOMED CT 2011_0131)
C0207628 (UMLS CUI 2011AA)
C0445223 (UMLS CUI 2011AA)
262094002 (SNOMED CT 2011_0131)
C0243071 (UMLS CUI 2011AA)
Known deficiency of dehydropyrimidindehydrogenase (DPD)
Item
Known deficiency of dehydropyrimidindehydrogenase (DPD)
boolean
C0011155 (UMLS CUI 2011AA)
129453003 (SNOMED CT 2011_0131)
C0058126 (UMLS CUI 2011AA)
259519002 (SNOMED CT 2011_0131)
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