ID

4399

Description

ODM derived from http://clinicaltrials.gov/show/NCT00876031

Link

http://clinicaltrials.gov/show/NCT00876031

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

December 9, 2013

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00876031 Soft Tissue Sarcoma

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 6 Months to 21 Years
Description

age 6 Months to 21 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
written informed consent for registration, randomisation, data collection/transfer, and tumour material asservation available
Description

written informed consent for registration, randomisation, data collection/transfer, and tumour material asservation available

Data type

boolean

Alias
UMLS CUI 2011AA
C1576874
HL7 V3 2006_05
WRITTEN
UMLS CUI 2011AA
C0021430
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C0010995
UMLS CUI 2011AA
C1511726
UMLS CUI 2011AA
C1705822
LOINC Version 232
MTHU034962
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
C0520510
SNOMED CT 2011_0131
260769002
LOINC Version 232
MTHU013790
HL7 V3 2006_05
MAT
UMLS CUI 2011AA
C0470187
SNOMED CT 2011_0131
103328004
pathologically (including molecular pathology) proven diagnosis of rhabdomyosarcoma (RMS) or RMS-like soft tissue sarcoma (STS) and tumour material available for pathology review
Description

pathologically (including molecular pathology) proven diagnosis of rhabdomyosarcoma (RMS) or RMS-like soft tissue sarcoma (STS) and tumour material available for pathology review

Data type

boolean

Alias
UMLS CUI 2011AA
C1521733
SNOMED CT 2011_0131
29458008
UMLS CUI 2011AA
C1979599
LOINC Version 232
MTHU000098
UMLS CUI 2011AA
C0456369
SNOMED CT 2011_0131
277025001
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0035412
SNOMED CT 2011_0131
302847003
MedDRA 14.1
10039022
UMLS CUI 2011AA
C2348205
UMLS CUI 2011AA
CL353068
SNOMED CT 2011_0131
2424003
Rhabdomyosarcoma of the High Risk Group, i.e.:
Description

Rhabdomyosarcoma of the High Risk Group, i.e.:

Data type

boolean

Alias
UMLS CUI 2011AA
C0035412
SNOMED CT 2011_0131
302847003
MedDRA 14.1
10039022
UMLS CUI 2011AA
C0332167
SNOMED CT 2011_0131
15508007
UMLS CUI 2011AA
CL415249
HL7 V3 2006_05
RGRP
RME, N0, M0, IRS II&III, >5 cm or >10 years in EXT, HN-PM, OTH, UG-BP
Description

RME, N0, M0, IRS II&III, >5 cm or >10 years in EXT, HN-PM, OTH, UG-BP

Data type

boolean

Alias
UMLS CUI 2011AA
C0206656
SNOMED CT 2011_0131
404051002
MedDRA 14.1
10065868
UMLS CUI 2011AA
C0035412
SNOMED CT 2011_0131
302847003
MedDRA 14.1
10039022
UMLS CUI 2011AA
C0441959
SNOMED CT 2011_0131
62455006
UMLS CUI 2011AA
C0445034
SNOMED CT 2011_0131
30893008
UMLS CUI 2011AA
C1320617
SNOMED CT 2011_0131
405916000
UMLS CUI 2011AA
C0439069
SNOMED CT 2011_0131
257470002
UMLS CUI 2011AA
C0439070
SNOMED CT 2011_0131
257471003
RME, N1, M0, any IRS-group, any size or age
Description

RME, N1, M0, any IRS-group, any size or age

Data type

boolean

Alias
UMLS CUI 2011AA
C0206656
SNOMED CT 2011_0131
404051002
MedDRA 14.1
10065868
UMLS CUI 2011AA
C0441962
SNOMED CT 2011_0131
53623008
UMLS CUI 2011AA
C0445034
SNOMED CT 2011_0131
30893008
UMLS CUI 2011AA
CL407060
UMLS CUI 2011AA
C1320617
SNOMED CT 2011_0131
405916000
UMLS CUI 2011AA
CL407060
UMLS CUI 2011AA
C0456389
SNOMED CT 2011_0131
246115007
LOINC Version 232
MTHU010347
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
RMA, NO, M0, any IRS-group, any size or age (exception: paratesticular RMA are not eligible) or
Description

RMA, NO, M0, any IRS-group, any size or age (exception: paratesticular RMA are not eligible) or

Data type

boolean

Alias
UMLS CUI 2011AA
C0206655
SNOMED CT 2011_0131
404053004
MedDRA 14.1
10065867
UMLS CUI 2011AA
C0441959
SNOMED CT 2011_0131
62455006
UMLS CUI 2011AA
C0445034
SNOMED CT 2011_0131
30893008
UMLS CUI 2011AA
CL407060
UMLS CUI 2011AA
C1320617
SNOMED CT 2011_0131
405916000
UMLS CUI 2011AA
CL407060
UMLS CUI 2011AA
C0456389
SNOMED CT 2011_0131
246115007
LOINC Version 232
MTHU010347
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C1562297
SNOMED CT 2011_0131
415990002
UMLS CUI 2011AA
C0206655
SNOMED CT 2011_0131
404053004
MedDRA 14.1
10065867
Rhabdomyosarcoma of the Very High Risk Group, i.e.:
Description

Rhabdomyosarcoma of the Very High Risk Group, i.e.:

Data type

boolean

Alias
UMLS CUI 2011AA
C0035412
SNOMED CT 2011_0131
302847003
MedDRA 14.1
10039022
UMLS CUI 2011AA
C0442824
SNOMED CT 2011_0131
260358002
UMLS CUI 2011AA
C0332167
SNOMED CT 2011_0131
15508007
UMLS CUI 2011AA
CL415249
HL7 V3 2006_05
RGRP
RMA, N1, MO, IRS II&III, any size or age or
Description

RMA, N1, MO, IRS II&III, any size or age or

Data type

boolean

Alias
UMLS CUI 2011AA
C0206655
SNOMED CT 2011_0131
404053004
MedDRA 14.1
10065867
UMLS CUI 2011AA
C0441962
SNOMED CT 2011_0131
53623008
UMLS CUI 2011AA
C0445034
SNOMED CT 2011_0131
30893008
UMLS CUI 2011AA
C1320617
SNOMED CT 2011_0131
405916000
UMLS CUI 2011AA
C0439069
SNOMED CT 2011_0131
257470002
UMLS CUI 2011AA
C0439070
SNOMED CT 2011_0131
257471003
UMLS CUI 2011AA
CL407060
UMLS CUI 2011AA
C0456389
SNOMED CT 2011_0131
246115007
LOINC Version 232
MTHU010347
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
localised high-risk RMS-like Soft Tissue Sarcoma, i.e.:
Description

localised high-risk RMS-like Soft Tissue Sarcoma, i.e.:

Data type

boolean

Alias
UMLS CUI 2011AA
C0392752
SNOMED CT 2011_0131
255471002
UMLS CUI 2011AA
C0332167
SNOMED CT 2011_0131
15508007
UMLS CUI 2011AA
C0035412
SNOMED CT 2011_0131
302847003
MedDRA 14.1
10039022
UMLS CUI 2011AA
C2348205
UMLS CUI 2011AA
CL353068
SNOMED CT 2011_0131
2424003
EES, pPNET, UDS: any N, M0, any IRS-group, any size or age
Description

EES, pPNET, UDS: any N, M0, any IRS-group, any size or age

Data type

boolean

Alias
UMLS CUI 2011AA
C0852530
MedDRA 14.1
10015759
UMLS CUI 2011AA
C0206663
SNOMED CT 2011_0131
39781001
MedDRA 14.1
10057846
UMLS CUI 2011AA
CL364379
Synovioma, malignant
Description

SySa, any N, M0, any size or age (exception: SySa IRSI&II, not T2b, N0, M0 are not eligible)

Data type

boolean

Alias
UMLS CUI 2011AA
C0039101
SNOMED CT 2011_0131
63211008
MedDRA 14.1
10042863
no pre-existing illness preventing treatment (esp. those listed in the medicinal product information, e.g. cardiac, hepatic, metabolic, or renal dysfunction, hypersensitivity)
Description

no pre-existing illness preventing treatment (esp. those listed in the medicinal product information, e.g. cardiac, hepatic, metabolic, or renal dysfunction, hypersensitivity)

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C2347662
UMLS CUI 2011AA
C0221423
SNOMED CT 2011_0131
39104002
MedDRA 14.1
10040658
ICD-10-CM Version 2010
R69
UMLS CUI 2011AA
CL414898
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1522601
UMLS CUI 2011AA
C0311400
UMLS CUI 2011AA
C0277785
SNOMED CT 2011_0131
386585008
UMLS CUI 2011AA
C0086565
SNOMED CT 2011_0131
75183008
MedDRA 14.1
10019670
UMLS CUI 2011AA
C1848822
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
no previous malignant tumours
Description

no previous malignant tumours

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
available for long term follow up through the treating centre
Description

available for long term follow up through the treating centre

Data type

boolean

Alias
UMLS CUI 2011AA
C0470187
SNOMED CT 2011_0131
103328004
UMLS CUI 2011AA
C1517942
in remission (according to the CWS-2007-HR definition (see X7.1.8X)) at the time of randomisation after standard multimodal therapy e.g. according to the CWS-guidance
Description

in remission (according to the CWS-2007-HR definition (see X7.1.8X)) at the time of randomisation after standard multimodal therapy e.g. according to the CWS-guidance

Data type

boolean

Alias
UMLS CUI 2011AA
C0544452
SNOMED CT 2011_0131
277022003
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C2828392
UMLS CUI 2011AA
C0009429
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
pregnant or lactating women
Description

pregnant or lactating women

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
other medical condition precluding treatment with protocol therapy (e.g. HIV, psychiatric disorder, etc.)
Description

other medical condition precluding treatment with protocol therapy (e.g. HIV, psychiatric disorder, etc.)

Data type

boolean

Alias
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C2348563
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0019682
SNOMED CT 2011_0131
19030005
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
for sexually active females and males in Arm B (O-TIE treatment): refusal to use effective contraception (e.g. oral, IUD)
Description

for sexually active females and males in Arm B (O-TIE treatment): refusal to use effective contraception (e.g. oral, IUD)

Data type

boolean

Alias
UMLS CUI 2011AA
C0241028
SNOMED CT 2011_0131
228453005
MedDRA 14.1
10066098
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0024554
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C0077375
UMLS CUI 2011AA
C0020789
SNOMED CT 2011_0131
372539000
UMLS CUI 2011AA
C0015133
SNOMED CT 2011_0131
56928005
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C2733540
SNOMED CT 2011_0131
443390004
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
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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 6 Months to 21 Years
Item
age 6 Months to 21 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
written informed consent for registration, randomisation, data collection/transfer, and tumour material asservation available
Item
written informed consent for registration, randomisation, data collection/transfer, and tumour material asservation available
boolean
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
C1516879 (UMLS CUI 2011AA)
C0034656 (UMLS CUI 2011AA)
C0010995 (UMLS CUI 2011AA)
C1511726 (UMLS CUI 2011AA)
C1705822 (UMLS CUI 2011AA)
MTHU034962 (LOINC Version 232)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0520510 (UMLS CUI 2011AA)
260769002 (SNOMED CT 2011_0131)
MTHU013790 (LOINC Version 232)
MAT (HL7 V3 2006_05)
C0470187 (UMLS CUI 2011AA)
103328004 (SNOMED CT 2011_0131)
pathologically (including molecular pathology) proven diagnosis of rhabdomyosarcoma (RMS) or RMS-like soft tissue sarcoma (STS) and tumour material available for pathology review
Item
pathologically (including molecular pathology) proven diagnosis of rhabdomyosarcoma (RMS) or RMS-like soft tissue sarcoma (STS) and tumour material available for pathology review
boolean
C1521733 (UMLS CUI 2011AA)
29458008 (SNOMED CT 2011_0131)
C1979599 (UMLS CUI 2011AA)
MTHU000098 (LOINC Version 232)
C0456369 (UMLS CUI 2011AA)
277025001 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0035412 (UMLS CUI 2011AA)
302847003 (SNOMED CT 2011_0131)
10039022 (MedDRA 14.1)
C2348205 (UMLS CUI 2011AA)
CL353068 (UMLS CUI 2011AA)
2424003 (SNOMED CT 2011_0131)
Rhabdomyosarcoma of the High Risk Group, i.e.:
Item
Rhabdomyosarcoma of the High Risk Group, i.e.:
boolean
C0035412 (UMLS CUI 2011AA)
302847003 (SNOMED CT 2011_0131)
10039022 (MedDRA 14.1)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
CL415249 (UMLS CUI 2011AA)
RGRP (HL7 V3 2006_05)
RME, N0, M0, IRS II&III, >5 cm or >10 years in EXT, HN-PM, OTH, UG-BP
Item
RME, N0, M0, IRS II&III, >5 cm or >10 years in EXT, HN-PM, OTH, UG-BP
boolean
C0206656 (UMLS CUI 2011AA)
404051002 (SNOMED CT 2011_0131)
10065868 (MedDRA 14.1)
C0035412 (UMLS CUI 2011AA)
302847003 (SNOMED CT 2011_0131)
10039022 (MedDRA 14.1)
C0441959 (UMLS CUI 2011AA)
62455006 (SNOMED CT 2011_0131)
C0445034 (UMLS CUI 2011AA)
30893008 (SNOMED CT 2011_0131)
C1320617 (UMLS CUI 2011AA)
405916000 (SNOMED CT 2011_0131)
C0439069 (UMLS CUI 2011AA)
257470002 (SNOMED CT 2011_0131)
C0439070 (UMLS CUI 2011AA)
257471003 (SNOMED CT 2011_0131)
RME, N1, M0, any IRS-group, any size or age
Item
RME, N1, M0, any IRS-group, any size or age
boolean
C0206656 (UMLS CUI 2011AA)
404051002 (SNOMED CT 2011_0131)
10065868 (MedDRA 14.1)
C0441962 (UMLS CUI 2011AA)
53623008 (SNOMED CT 2011_0131)
C0445034 (UMLS CUI 2011AA)
30893008 (SNOMED CT 2011_0131)
CL407060 (UMLS CUI 2011AA)
C1320617 (UMLS CUI 2011AA)
405916000 (SNOMED CT 2011_0131)
CL407060 (UMLS CUI 2011AA)
C0456389 (UMLS CUI 2011AA)
246115007 (SNOMED CT 2011_0131)
MTHU010347 (LOINC Version 232)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
RMA, NO, M0, any IRS-group, any size or age (exception: paratesticular RMA are not eligible) or
Item
RMA, NO, M0, any IRS-group, any size or age (exception: paratesticular RMA are not eligible) or
boolean
C0206655 (UMLS CUI 2011AA)
404053004 (SNOMED CT 2011_0131)
10065867 (MedDRA 14.1)
C0441959 (UMLS CUI 2011AA)
62455006 (SNOMED CT 2011_0131)
C0445034 (UMLS CUI 2011AA)
30893008 (SNOMED CT 2011_0131)
CL407060 (UMLS CUI 2011AA)
C1320617 (UMLS CUI 2011AA)
405916000 (SNOMED CT 2011_0131)
CL407060 (UMLS CUI 2011AA)
C0456389 (UMLS CUI 2011AA)
246115007 (SNOMED CT 2011_0131)
MTHU010347 (LOINC Version 232)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C1562297 (UMLS CUI 2011AA)
415990002 (SNOMED CT 2011_0131)
C0206655 (UMLS CUI 2011AA)
404053004 (SNOMED CT 2011_0131)
10065867 (MedDRA 14.1)
Rhabdomyosarcoma of the Very High Risk Group, i.e.:
Item
Rhabdomyosarcoma of the Very High Risk Group, i.e.:
boolean
C0035412 (UMLS CUI 2011AA)
302847003 (SNOMED CT 2011_0131)
10039022 (MedDRA 14.1)
C0442824 (UMLS CUI 2011AA)
260358002 (SNOMED CT 2011_0131)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
CL415249 (UMLS CUI 2011AA)
RGRP (HL7 V3 2006_05)
RMA, N1, MO, IRS II&III, any size or age or
Item
RMA, N1, MO, IRS II&III, any size or age or
boolean
C0206655 (UMLS CUI 2011AA)
404053004 (SNOMED CT 2011_0131)
10065867 (MedDRA 14.1)
C0441962 (UMLS CUI 2011AA)
53623008 (SNOMED CT 2011_0131)
C0445034 (UMLS CUI 2011AA)
30893008 (SNOMED CT 2011_0131)
C1320617 (UMLS CUI 2011AA)
405916000 (SNOMED CT 2011_0131)
C0439069 (UMLS CUI 2011AA)
257470002 (SNOMED CT 2011_0131)
C0439070 (UMLS CUI 2011AA)
257471003 (SNOMED CT 2011_0131)
CL407060 (UMLS CUI 2011AA)
C0456389 (UMLS CUI 2011AA)
246115007 (SNOMED CT 2011_0131)
MTHU010347 (LOINC Version 232)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
localised high-risk RMS-like Soft Tissue Sarcoma, i.e.:
Item
localised high-risk RMS-like Soft Tissue Sarcoma, i.e.:
boolean
C0392752 (UMLS CUI 2011AA)
255471002 (SNOMED CT 2011_0131)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C0035412 (UMLS CUI 2011AA)
302847003 (SNOMED CT 2011_0131)
10039022 (MedDRA 14.1)
C2348205 (UMLS CUI 2011AA)
CL353068 (UMLS CUI 2011AA)
2424003 (SNOMED CT 2011_0131)
EES, pPNET, UDS: any N, M0, any IRS-group, any size or age
Item
EES, pPNET, UDS: any N, M0, any IRS-group, any size or age
boolean
C0852530 (UMLS CUI 2011AA)
10015759 (MedDRA 14.1)
C0206663 (UMLS CUI 2011AA)
39781001 (SNOMED CT 2011_0131)
10057846 (MedDRA 14.1)
CL364379 (UMLS CUI 2011AA)
SySa, any N, M0, any size or age (exception: SySa IRSI&II, not T2b, N0, M0 are not eligible)
Item
Synovioma, malignant
boolean
C0039101 (UMLS CUI 2011AA)
63211008 (SNOMED CT 2011_0131)
10042863 (MedDRA 14.1)
no pre-existing illness preventing treatment (esp. those listed in the medicinal product information, e.g. cardiac, hepatic, metabolic, or renal dysfunction, hypersensitivity)
Item
no pre-existing illness preventing treatment (esp. those listed in the medicinal product information, e.g. cardiac, hepatic, metabolic, or renal dysfunction, hypersensitivity)
boolean
C1518422 (UMLS CUI 2011AA)
C2347662 (UMLS CUI 2011AA)
C0221423 (UMLS CUI 2011AA)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
CL414898 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C1522601 (UMLS CUI 2011AA)
C0311400 (UMLS CUI 2011AA)
C0277785 (UMLS CUI 2011AA)
386585008 (SNOMED CT 2011_0131)
C0086565 (UMLS CUI 2011AA)
75183008 (SNOMED CT 2011_0131)
10019670 (MedDRA 14.1)
C1848822 (UMLS CUI 2011AA)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
no previous malignant tumours
Item
no previous malignant tumours
boolean
C1518422 (UMLS CUI 2011AA)
C0205156 (UMLS CUI 2011AA)
9130008 (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)
available for long term follow up through the treating centre
Item
available for long term follow up through the treating centre
boolean
C0470187 (UMLS CUI 2011AA)
103328004 (SNOMED CT 2011_0131)
C1517942 (UMLS CUI 2011AA)
in remission (according to the CWS-2007-HR definition (see X7.1.8X)) at the time of randomisation after standard multimodal therapy e.g. according to the CWS-guidance
Item
in remission (according to the CWS-2007-HR definition (see X7.1.8X)) at the time of randomisation after standard multimodal therapy e.g. according to the CWS-guidance
boolean
C0544452 (UMLS CUI 2011AA)
277022003 (SNOMED CT 2011_0131)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C2828392 (UMLS CUI 2011AA)
C0009429 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
pregnant or lactating women
Item
pregnant or lactating women
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
other medical condition precluding treatment with protocol therapy (e.g. HIV, psychiatric disorder, etc.)
Item
other medical condition precluding treatment with protocol therapy (e.g. HIV, psychiatric disorder, etc.)
boolean
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
CL411789 (UMLS CUI 2011AA)
C2348563 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0019682 (UMLS CUI 2011AA)
19030005 (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)
for sexually active females and males in Arm B (O-TIE treatment): refusal to use effective contraception (e.g. oral, IUD)
Item
for sexually active females and males in Arm B (O-TIE treatment): refusal to use effective contraception (e.g. oral, IUD)
boolean
C0241028 (UMLS CUI 2011AA)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0077375 (UMLS CUI 2011AA)
C0020789 (UMLS CUI 2011AA)
372539000 (SNOMED CT 2011_0131)
C0015133 (UMLS CUI 2011AA)
56928005 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C2733540 (UMLS CUI 2011AA)
443390004 (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)
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