ID

43443

Description

ODM derived from http://clinicaltrials.gov/show/NCT00761280

Link

http://clinicaltrials.gov/show/NCT00761280

Keywords

Versions (3)
  1. 12/6/13 12/6/13 - 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 DRKS00003686 NCT00761280 Anaplastic Astrocytoma

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 70 Years
Description

age 18 Years to 70 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
The patient has provided written informed consent prior to any study-related procedure.
Description

The patient has provided written informed consent prior to any study-related procedure.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
The patient has a present diagnosis of AA or secondary GBM.
Description

The patient has a present diagnosis of AA or secondary GBM.

Data type

boolean

Alias
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0334579
SNOMED CT 2011_0131
55353007
MedDRA 14.1
10002224
UMLS CUI 2011AA
C1519214
The patient has a measurable lesion (> 1 ccm in volume, central MRI review).
Description

The patient has a measurable lesion (> 1 ccm in volume, central MRI review).

Data type

boolean

Alias
UMLS CUI 2011AA
C1513040
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C2700258
UMLS CUI 2011AA
C0205099
SNOMED CT 2011_0131
26216008
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
UMLS CUI 2011AA
C1552617
HL7 V3 2006_05
REV
The lesion (or sum of lesions) does not exceed 50 ccm in volume (central MRI review).
Description

The lesion (or sum of lesions) does not exceed 50 ccm in volume (central MRI review).

Data type

boolean

Alias
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0439090
SNOMED CT 2011_0131
276137008
HL7 V3 2006_05
LE
UMLS CUI 2011AA
C2700258
UMLS CUI 2011AA
C0205099
SNOMED CT 2011_0131
26216008
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
UMLS CUI 2011AA
C1552617
HL7 V3 2006_05
REV
The tumor is localized supratentorially (central MRI review).
Description

The tumor is localized supratentorially (central MRI review).

Data type

boolean

Alias
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
C0392752
SNOMED CT 2011_0131
255471002
UMLS CUI 2011AA
C0441938
SNOMED CT 2011_0131
258329003
All patients have recurrent or refractory disease, i.e. disease has progressed after prior surgery and radiotherapy at any time of the disease course or stage. Secondary GBM patients have progressed after a previous diagnosis of A and/or AA.
Description

All patients have recurrent or refractory disease, i.e. disease has progressed after prior surgery and radiotherapy at any time of the disease course or stage. Secondary GBM patients have progressed after a previous diagnosis of A and/or AA.

Data type

boolean

Alias
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C1514815
UMLS CUI 2011AA
C0455610
SNOMED CT 2011_0131
161615003
UMLS CUI 2011AA
CL414551
UMLS CUI 2011AA
C1519214
UMLS CUI 2011AA
C0332132
SNOMED CT 2011_0131
48318009
UMLS CUI 2011AA
C0004114
SNOMED CT 2011_0131
38713004
MedDRA 14.1
10003571
UMLS CUI 2011AA
C0334579
SNOMED CT 2011_0131
55353007
MedDRA 14.1
10002224
The patient has not received more than one chemotherapy regimen. Radiation with concomitant chemotherapy, followed by adjuvant chemotherapy, is considered as one chemotherapy regimen.
Description

The patient has not received more than one chemotherapy regimen. Radiation with concomitant chemotherapy, followed by adjuvant chemotherapy, is considered as one chemotherapy regimen.

Data type

boolean

Alias
UMLS CUI 2011AA
C0439090
SNOMED CT 2011_0131
276137008
HL7 V3 2006_05
LE
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
The patient is eligible for chemotherapy.
Description

The patient is eligible for chemotherapy.

Data type

boolean

Alias
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
The patient is on a maximum dose of 4 mg/day dexamethasone or equivalent doses for other corticosteroids, which has been stable or decreasing for at least 3 weeks prior to Screening.
Description

The patient is on a maximum dose of 4 mg/day dexamethasone or equivalent doses for other corticosteroids, which has been stable or decreasing for at least 3 weeks prior to Screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0806909
SNOMED CT 2011_0131
398303009
LOINC Version 232
MTHU008917
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0011777
SNOMED CT 2011_0131
372584003
LOINC Version 232
MTHU004621
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0547047
SNOMED CT 2011_0131
260370003
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
The patient is male or a non-pregnant, non-lactating female.
Description

The patient is male or a 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
Females of childbearing potential must have a negative beta-HCG pregnancy test at Screening.
Description

Females of childbearing potential must have a negative beta-HCG pregnancy test at Screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0430061
SNOMED CT 2011_0131
166435006
UMLS CUI 2011AA
C0106132
SNOMED CT 2011_0131
40940006
UMLS CUI 2011AA
C1409616
Females of childbearing potential and males must practice strict birth control.
Description

Females of childbearing potential and males must practice strict birth control.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
The patient must have recovered from acute toxicity caused by any previous therapy.
Description

The patient must have recovered 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
The patient has a life expectancy of at least 3 months.
Description

The patient has a life expectancy of at least 3 months.

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
Karnofsky performance status (assessment scale)
Description

The patient has a Karnofsky Performance Status of at least 70%.

Data type

boolean

Alias
UMLS CUI 2011AA
C0206065
SNOMED CT 2011_0131
273546003
The patient shows adequate organ functions as assessed by the following screening laboratory values:
Description

The patient shows adequate organ functions as assessed by the following screening 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
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
C1522609
Adequate renal function determined by serum creatinine and urea < 2 times the upper limit of normal
Description

Adequate renal function determined by serum creatinine and urea < 2 times the upper limit of normal

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C0455273
SNOMED CT 2011_0131
273967009
Adequate liver function with ALT, AST and AP < 3 times the upper limit of normal, and bilirubin < 2.5 mg/dL
Description

Adequate liver function with ALT, AST and AP < 3 times the upper limit of normal, and bilirubin < 2.5 mg/dL

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
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
C0011221
SNOMED CT 2011_0131
79706000
LOINC Version 232
1975-2
INR < 1.5 and aPTT < 1.5 x ULN
Description

INR < 1.5 and aPTT < 1.5 x ULN

Data type

boolean

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

Hemoglobin > 9 g/dL

Data type

boolean

Alias
UMLS CUI 2011AA
C0518015
Platelet count - finding
Description

Platelet count > 100 x 10E9/L

Data type

boolean

Alias
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
White Blood Cell Count procedure (WBC)
Description

WBC > 3 x 10E9/L

Data type

boolean

Alias
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
ANC > 1.5 x 10E9/L (or WBC > 3.0 x 10E9/L)
Description

ANC > 1.5 x 10E9/L (or WBC > 3.0 x 10E9/L)

Data type

boolean

Alias
UMLS CUI 2011AA
C0948762
MedDRA 14.1
10052033
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Patient unable or not willing to comply with the protocol regulations.
Description

Patient unable or not willing to comply with the protocol regulations.

Data type

boolean

Alias
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0525058
The investigator deems it necessary to surgically (re-)resect the present tumor (NOTE: the patient might still be eligible for randomization at a later timepoint).
Description

The investigator deems it necessary to surgically (re-)resect the present tumor (NOTE: the patient might still be eligible for randomization at a later timepoint).

Data type

boolean

Alias
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
C1555447
HL7 V3 2006_05
MEDNEC
UMLS CUI 2011AA
C0728940
SNOMED CT 2011_0131
65801008
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Tumor surgery, tumor debulking, or other neurosurgery within 3 months prior to randomization. If a <=48-hour routine post-surgery MRI (in accordance with study specifications) qualifies the patient for study participation, the patient can be randomized 30 ± 7 days post-surgery.
Description

Tumor surgery, tumor debulking, or other neurosurgery within 3 months prior to randomization. If a <=48-hour routine post-surgery MRI (in accordance with study specifications) qualifies the patient for study participation, the patient can be randomized 30 ± 7 days post-surgery.

Data type

boolean

Alias
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
C0038895
UMLS CUI 2011AA
C0439805
MedDRA 14.1
10067616
UMLS CUI 2011AA
C0027926
SNOMED CT 2011_0131
394610002
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
Radiotherapy or stereotactic (gamma knife) radiosurgery within 3 months prior to randomization.
Description

Radiotherapy or stereotactic (gamma knife) radiosurgery within 3 months prior to randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C0729296
SNOMED CT 2011_0131
313226005
UMLS CUI 2011AA
C0086330
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
Prior interstitial brachytherapy of the brain with permanent implants. Prior interstitial brachytherapy of the brain with removable implants within 3 months prior to randomization.
Description

Prior interstitial brachytherapy of the brain with permanent implants. Prior interstitial brachytherapy of the brain with removable implants within 3 months prior to randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1881237
SNOMED CT 2011_0131
113120007
UMLS CUI 2011AA
C0205355
SNOMED CT 2011_0131
6934004
UMLS CUI 2011AA
C0021102
SNOMED CT 2011_0131
40388003
Chemotherapy, hormone therapy, or any other therapy with established or suggested anti-tumor effects within 4 weeks (nitrosoureas: 6 weeks) prior to randomization.
Description

Chemotherapy, hormone therapy, or any other therapy with established or suggested anti-tumor effects within 4 weeks (nitrosoureas: 6 weeks) prior to randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0279025
SNOMED CT 2011_0131
309542002, 169413002
MedDRA 14.1
10065646
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1280500
SNOMED CT 2011_0131
253861007
UMLS CUI 2011AA
C0521124
SNOMED CT 2011_0131
65897001
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
C0028210
SNOMED CT 2011_0131
372610009
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
Prior anti-TGF-beta 2 targeted therapy.
Description

Prior anti-TGF-beta 2 targeted therapy.

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0521124
SNOMED CT 2011_0131
65897001
UMLS CUI 2011AA
C0079441
Screening MRI shows a mass effect caused by the tumor defined as significant compression of the ventricular system and/or a midline shift (>= 3 mm, central MRI review). Compression of the ventricular system and/or a midline shift >= 3 mm only due to the presence of (a) cyst(s) or scarring processes does not exclude an individual from the study.
Description

Screening MRI shows a mass effect caused by the tumor defined as significant compression of the ventricular system and/or a midline shift (>= 3 mm, central MRI review). Compression of the ventricular system and/or a midline shift >= 3 mm only due to the presence of (a) cyst(s) or scarring processes does not exclude an individual from the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C1314792
SNOMED CT 2011_0131
134198009
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
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0332459
SNOMED CT 2011_0131
71173004
UMLS CUI 2011AA
C2333438
UMLS CUI 2011AA
C0576481
SNOMED CT 2011_0131
299728009
MedDRA 14.1
10069551
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
Participation in another clinical study with another investigational medicinal product within 30 days prior to randomization.
Description

Participation in another clinical study with another investigational medicinal product within 30 days prior to randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C2348568
History of a second independent malignant disorder within 5 years, except for carcinoma in situ of the cervix and basal cell carcinoma.
Description

History of a second independent malignant disorder within 5 years, except for carcinoma in situ of the cervix and basal cell carcinoma.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205436
SNOMED CT 2011_0131
81170007
UMLS CUI 2011AA
C0085862
LOINC Version 232
MTHU013536
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
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
C0007117
SNOMED CT 2011_0131
1338007
MedDRA 14.1
10004146
Seizures, poorly controlled
Description

Presence of poorly controlled seizures.

Data type

boolean

Alias
UMLS CUI 2011AA
C1853624
Clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure, unstable angina, or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomization.
Description

Clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure, unstable angina, or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C0243050
SNOMED CT 2011_0131
9904008
MedDRA 14.1
10061054
UMLS CUI 2011AA
C1868885
MedDRA 14.1
10066860
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
Known HIV, HBV or HCV infection.
Description

Known HIV, HBV or HCV infection.

Data type

boolean

Alias
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
UMLS CUI 2011AA
C0019169
SNOMED CT 2011_0131
81665004
UMLS CUI 2011AA
C0220847
SNOMED CT 2011_0131
62944002
MedDRA 14.1
10019752
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
Acute viral, bacterial, or fungal infection.
Description

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, which might be contraindications for starting study treatment.
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
C1715372
LOINC Version 232
44100-6
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
MedDRA 14.1
10010833
Presence of high risk for pulmonary toxicities, defined as:
Description

Presence of high risk for pulmonary toxicities, defined as:

Data type

boolean

Alias
UMLS CUI 2011AA
C0332167
SNOMED CT 2011_0131
15508007
UMLS CUI 2011AA
C0919924
MedDRA 14.1
10061924
UMLS CUI 2011AA
C1704788
Lung function: vital capacity ≤ 70%
Description

Lung function: vital capacity ≤ 70%

Data type

boolean

Alias
UMLS CUI 2011AA
C0024119
SNOMED CT 2011_0131
23426006
MedDRA 14.1
10025099
LOINC Version 232
MTHU029811
UMLS CUI 2011AA
C0042834
SNOMED CT 2011_0131
50834005
LOINC Version 232
MTHU008908
Status following sequential or concomitant thoracic irradiation
Description

Status following sequential or concomitant thoracic irradiation

Data type

boolean

Alias
UMLS CUI 2011AA
C0449438
SNOMED CT 2011_0131
263490005
LOINC Version 232
MTHU015827
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C1705294
UMLS CUI 2011AA
CL415222
UMLS CUI 2011AA
CL318009
SNOMED CT 2011_0131
261179002
UMLS CUI 2011AA
C1522449
SNOMED CT 2011_0131
108290001
MedDRA 14.1
10037794
Increased risk for a pulmonary toxicity induced by BCNU (Carmustine) or CCNU (Lomustine). Risk factors include smoking, presence of a respiratory condition, pre-existing radiographic pulmonary abnormalities, exposure to agents that cause lung damage.
Description

Increased risk for a pulmonary toxicity induced by BCNU (Carmustine) or CCNU (Lomustine). Risk factors include smoking, presence of a respiratory condition, pre-existing radiographic pulmonary abnormalities, exposure to agents that cause lung damage.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332167
SNOMED CT 2011_0131
15508007
UMLS CUI 2011AA
C0919924
MedDRA 14.1
10061924
UMLS CUI 2011AA
C0007257
SNOMED CT 2011_0131
387281007
UMLS CUI 2011AA
C0699181
SNOMED CT 2011_0131
387227009
UMLS CUI 2011AA
C0035648
SNOMED CT 2011_0131
80943009
LOINC Version 232
MTHU028018
UMLS CUI 2011AA
C0037369
UMLS CUI 2011AA
C0155905
MedDRA 14.1
10038676
ICD-10-CM Version 2010
J70.9
ICD-9-CM Version 2011
508.9
UMLS CUI 2011AA
C0444708
SNOMED CT 2011_0131
258106000
UMLS CUI 2011AA
C0476405
SNOMED CT 2011_0131
165019004
MedDRA 14.1
10061602
ICD-10-CM Version 2010
R94.2
ICD-9-CM Version 2011
794.2
UMLS CUI 2011AA
C1254351
UMLS CUI 2011AA
C0678227
SNOMED CT 2011_0131
23981006
UMLS CUI 2011AA
C0273115
SNOMED CT 2011_0131
316358009
MedDRA 14.1
10061230
ICD-10-CM Version 2010
S27.30
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
Clinically relevant psychiatric disorders / legal incapacity or a limited legal capacity.
Description

Clinically relevant psychiatric disorders / legal incapacity or a 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
C1518422
UMLS CUI 2011AA
C0683673
UMLS CUI 2011AA
C0439801
SNOMED CT 2011_0131
255469002
Concomitant treatment with yellow fever vaccine.
Description

Concomitant treatment with yellow fever vaccine.

Data type

boolean

Alias
UMLS CUI 2011AA
C1707479
UMLS CUI 2011AA
C0301508
SNOMED CT 2011_0131
56844000
HL7 V3 2006_05
37
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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 70 Years
Item
age 18 Years to 70 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
The patient has provided written informed consent prior to any study-related procedure.
Item
The patient has provided written informed consent prior to any study-related procedure.
boolean
C0021430 (UMLS CUI 2011AA)
The patient has a present diagnosis of AA or secondary GBM.
Item
The patient has a present diagnosis of AA or secondary GBM.
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0334579 (UMLS CUI 2011AA)
55353007 (SNOMED CT 2011_0131)
10002224 (MedDRA 14.1)
C1519214 (UMLS CUI 2011AA)
The patient has a measurable lesion (> 1 ccm in volume, central MRI review).
Item
The patient has a measurable lesion (> 1 ccm in volume, central MRI review).
boolean
C1513040 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C2700258 (UMLS CUI 2011AA)
C0205099 (UMLS CUI 2011AA)
26216008 (SNOMED CT 2011_0131)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C1552617 (UMLS CUI 2011AA)
REV (HL7 V3 2006_05)
The lesion (or sum of lesions) does not exceed 50 ccm in volume (central MRI review).
Item
The lesion (or sum of lesions) does not exceed 50 ccm in volume (central MRI review).
boolean
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0439090 (UMLS CUI 2011AA)
276137008 (SNOMED CT 2011_0131)
LE (HL7 V3 2006_05)
C2700258 (UMLS CUI 2011AA)
C0205099 (UMLS CUI 2011AA)
26216008 (SNOMED CT 2011_0131)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C1552617 (UMLS CUI 2011AA)
REV (HL7 V3 2006_05)
The tumor is localized supratentorially (central MRI review).
Item
The tumor is localized supratentorially (central MRI review).
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0392752 (UMLS CUI 2011AA)
255471002 (SNOMED CT 2011_0131)
C0441938 (UMLS CUI 2011AA)
258329003 (SNOMED CT 2011_0131)
All patients have recurrent or refractory disease, i.e. disease has progressed after prior surgery and radiotherapy at any time of the disease course or stage. Secondary GBM patients have progressed after a previous diagnosis of A and/or AA.
Item
All patients have recurrent or refractory disease, i.e. disease has progressed after prior surgery and radiotherapy at any time of the disease course or stage. Secondary GBM patients have progressed after a previous diagnosis of A and/or AA.
boolean
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C1514815 (UMLS CUI 2011AA)
C0455610 (UMLS CUI 2011AA)
161615003 (SNOMED CT 2011_0131)
CL414551 (UMLS CUI 2011AA)
C1519214 (UMLS CUI 2011AA)
C0332132 (UMLS CUI 2011AA)
48318009 (SNOMED CT 2011_0131)
C0004114 (UMLS CUI 2011AA)
38713004 (SNOMED CT 2011_0131)
10003571 (MedDRA 14.1)
C0334579 (UMLS CUI 2011AA)
55353007 (SNOMED CT 2011_0131)
10002224 (MedDRA 14.1)
The patient has not received more than one chemotherapy regimen. Radiation with concomitant chemotherapy, followed by adjuvant chemotherapy, is considered as one chemotherapy regimen.
Item
The patient has not received more than one chemotherapy regimen. Radiation with concomitant chemotherapy, followed by adjuvant chemotherapy, is considered as one chemotherapy regimen.
boolean
C0439090 (UMLS CUI 2011AA)
276137008 (SNOMED CT 2011_0131)
LE (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
The patient is eligible for chemotherapy.
Item
The patient is eligible for chemotherapy.
boolean
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
The patient is on a maximum dose of 4 mg/day dexamethasone or equivalent doses for other corticosteroids, which has been stable or decreasing for at least 3 weeks prior to Screening.
Item
The patient is on a maximum dose of 4 mg/day dexamethasone or equivalent doses for other corticosteroids, which has been stable or decreasing for at least 3 weeks prior to Screening.
boolean
C0806909 (UMLS CUI 2011AA)
398303009 (SNOMED CT 2011_0131)
MTHU008917 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0011777 (UMLS CUI 2011AA)
372584003 (SNOMED CT 2011_0131)
MTHU004621 (LOINC Version 232)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0547047 (UMLS CUI 2011AA)
260370003 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
The patient is male or a non-pregnant, non-lactating female.
Item
The patient is male or a 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)
Females of childbearing potential must have a negative beta-HCG pregnancy test at Screening.
Item
Females of childbearing potential must have a negative beta-HCG pregnancy test at Screening.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0430061 (UMLS CUI 2011AA)
166435006 (SNOMED CT 2011_0131)
C0106132 (UMLS CUI 2011AA)
40940006 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Females of childbearing potential and males must practice strict birth control.
Item
Females of childbearing potential and males must practice strict birth control.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
The patient must have recovered from acute toxicity caused by any previous therapy.
Item
The patient must have recovered 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)
The patient has a life expectancy of at least 3 months.
Item
The patient has a life expectancy of at least 3 months.
boolean
C0023671 (UMLS CUI 2011AA)
The patient has a Karnofsky Performance Status of at least 70%.
Item
Karnofsky performance status (assessment scale)
boolean
C0206065 (UMLS CUI 2011AA)
273546003 (SNOMED CT 2011_0131)
The patient shows adequate organ functions as assessed by the following screening laboratory values:
Item
The patient shows adequate organ functions as assessed by the following screening 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)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1522609 (UMLS CUI 2011AA)
Adequate renal function determined by serum creatinine and urea < 2 times the upper limit of normal
Item
Adequate renal function determined by serum creatinine and urea < 2 times the upper limit of normal
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0455273 (UMLS CUI 2011AA)
273967009 (SNOMED CT 2011_0131)
Adequate liver function with ALT, AST and AP < 3 times the upper limit of normal, and bilirubin < 2.5 mg/dL
Item
Adequate liver function with ALT, AST and AP < 3 times the upper limit of normal, and bilirubin < 2.5 mg/dL
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
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)
C0011221 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
INR < 1.5 and aPTT < 1.5 x ULN
Item
INR < 1.5 and aPTT < 1.5 x ULN
boolean
CL415281 (UMLS CUI 2011AA)
C0030605 (UMLS CUI 2011AA)
42525009 (SNOMED CT 2011_0131)
10000630 (MedDRA 14.1)
Hemoglobin > 9 g/dL
Item
Hemoglobin
boolean
C0518015 (UMLS CUI 2011AA)
Platelet count > 100 x 10E9/L
Item
Platelet count - finding
boolean
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
WBC > 3 x 10E9/L
Item
White Blood Cell Count procedure (WBC)
boolean
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
ANC > 1.5 x 10E9/L (or WBC > 3.0 x 10E9/L)
Item
ANC > 1.5 x 10E9/L (or WBC > 3.0 x 10E9/L)
boolean
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Patient unable or not willing to comply with the protocol regulations.
Item
Patient unable or not willing to comply with the protocol regulations.
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
The investigator deems it necessary to surgically (re-)resect the present tumor (NOTE: the patient might still be eligible for randomization at a later timepoint).
Item
The investigator deems it necessary to surgically (re-)resect the present tumor (NOTE: the patient might still be eligible for randomization at a later timepoint).
boolean
CL102947 (UMLS CUI 2011AA)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
C1555447 (UMLS CUI 2011AA)
MEDNEC (HL7 V3 2006_05)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C0150312 (UMLS CUI 2011AA)
52101004 (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)
Tumor surgery, tumor debulking, or other neurosurgery within 3 months prior to randomization. If a <=48-hour routine post-surgery MRI (in accordance with study specifications) qualifies the patient for study participation, the patient can be randomized 30 ± 7 days post-surgery.
Item
Tumor surgery, tumor debulking, or other neurosurgery within 3 months prior to randomization. If a <=48-hour routine post-surgery MRI (in accordance with study specifications) qualifies the patient for study participation, the patient can be randomized 30 ± 7 days post-surgery.
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0038895 (UMLS CUI 2011AA)
C0439805 (UMLS CUI 2011AA)
10067616 (MedDRA 14.1)
C0027926 (UMLS CUI 2011AA)
394610002 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Radiotherapy or stereotactic (gamma knife) radiosurgery within 3 months prior to randomization.
Item
Radiotherapy or stereotactic (gamma knife) radiosurgery within 3 months prior to randomization.
boolean
C0034619 (UMLS CUI 2011AA)
C0729296 (UMLS CUI 2011AA)
313226005 (SNOMED CT 2011_0131)
C0086330 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Prior interstitial brachytherapy of the brain with permanent implants. Prior interstitial brachytherapy of the brain with removable implants within 3 months prior to randomization.
Item
Prior interstitial brachytherapy of the brain with permanent implants. Prior interstitial brachytherapy of the brain with removable implants within 3 months prior to randomization.
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1881237 (UMLS CUI 2011AA)
113120007 (SNOMED CT 2011_0131)
C0205355 (UMLS CUI 2011AA)
6934004 (SNOMED CT 2011_0131)
C0021102 (UMLS CUI 2011AA)
40388003 (SNOMED CT 2011_0131)
Chemotherapy, hormone therapy, or any other therapy with established or suggested anti-tumor effects within 4 weeks (nitrosoureas: 6 weeks) prior to randomization.
Item
Chemotherapy, hormone therapy, or any other therapy with established or suggested anti-tumor effects within 4 weeks (nitrosoureas: 6 weeks) prior to randomization.
boolean
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0279025 (UMLS CUI 2011AA)
309542002, 169413002 (SNOMED CT 2011_0131)
10065646 (MedDRA 14.1)
C0039798 (UMLS CUI 2011AA)
C1280500 (UMLS CUI 2011AA)
253861007 (SNOMED CT 2011_0131)
C0521124 (UMLS CUI 2011AA)
65897001 (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)
C0028210 (UMLS CUI 2011AA)
372610009 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Prior anti-TGF-beta 2 targeted therapy.
Item
Prior anti-TGF-beta 2 targeted therapy.
boolean
C1514463 (UMLS CUI 2011AA)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C0079441 (UMLS CUI 2011AA)
Screening MRI shows a mass effect caused by the tumor defined as significant compression of the ventricular system and/or a midline shift (>= 3 mm, central MRI review). Compression of the ventricular system and/or a midline shift >= 3 mm only due to the presence of (a) cyst(s) or scarring processes does not exclude an individual from the study.
Item
Screening MRI shows a mass effect caused by the tumor defined as significant compression of the ventricular system and/or a midline shift (>= 3 mm, central MRI review). Compression of the ventricular system and/or a midline shift >= 3 mm only due to the presence of (a) cyst(s) or scarring processes does not exclude an individual from the study.
boolean
C1314792 (UMLS CUI 2011AA)
134198009 (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)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0332459 (UMLS CUI 2011AA)
71173004 (SNOMED CT 2011_0131)
C2333438 (UMLS CUI 2011AA)
C0576481 (UMLS CUI 2011AA)
299728009 (SNOMED CT 2011_0131)
10069551 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
Participation in another clinical study with another investigational medicinal product within 30 days prior to randomization.
Item
Participation in another clinical study with another investigational medicinal product within 30 days prior to randomization.
boolean
C2348568 (UMLS CUI 2011AA)
History of a second independent malignant disorder within 5 years, except for carcinoma in situ of the cervix and basal cell carcinoma.
Item
History of a second independent malignant disorder within 5 years, except for carcinoma in situ of the cervix and basal cell carcinoma.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205436 (UMLS CUI 2011AA)
81170007 (SNOMED CT 2011_0131)
C0085862 (UMLS CUI 2011AA)
MTHU013536 (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)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
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)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
Presence of poorly controlled seizures.
Item
Seizures, poorly controlled
boolean
C1853624 (UMLS CUI 2011AA)
Clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure, unstable angina, or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomization.
Item
Clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure, unstable angina, or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomization.
boolean
C0243050 (UMLS CUI 2011AA)
9904008 (SNOMED CT 2011_0131)
10061054 (MedDRA 14.1)
C1868885 (UMLS CUI 2011AA)
10066860 (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)
Known HIV, HBV or HCV infection.
Item
Known HIV, HBV or HCV infection.
boolean
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)
C0019169 (UMLS CUI 2011AA)
81665004 (SNOMED CT 2011_0131)
C0220847 (UMLS CUI 2011AA)
62944002 (SNOMED CT 2011_0131)
10019752 (MedDRA 14.1)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
Acute viral, bacterial, or fungal infection.
Item
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, which might be contraindications for starting study treatment.
Item
Acute medical problems that may be considered to become an unacceptable risk, or any conditions, which might be contraindications for starting study treatment.
boolean
C1715372 (UMLS CUI 2011AA)
44100-6 (LOINC Version 232)
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)
10010833 (MedDRA 14.1)
Presence of high risk for pulmonary toxicities, defined as:
Item
Presence of high risk for pulmonary toxicities, defined as:
boolean
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C0919924 (UMLS CUI 2011AA)
10061924 (MedDRA 14.1)
C1704788 (UMLS CUI 2011AA)
Lung function: vital capacity ≤ 70%
Item
Lung function: vital capacity ≤ 70%
boolean
C0024119 (UMLS CUI 2011AA)
23426006 (SNOMED CT 2011_0131)
10025099 (MedDRA 14.1)
MTHU029811 (LOINC Version 232)
C0042834 (UMLS CUI 2011AA)
50834005 (SNOMED CT 2011_0131)
MTHU008908 (LOINC Version 232)
Status following sequential or concomitant thoracic irradiation
Item
Status following sequential or concomitant thoracic irradiation
boolean
C0449438 (UMLS CUI 2011AA)
263490005 (SNOMED CT 2011_0131)
MTHU015827 (LOINC Version 232)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C1705294 (UMLS CUI 2011AA)
CL415222 (UMLS CUI 2011AA)
CL318009 (UMLS CUI 2011AA)
261179002 (SNOMED CT 2011_0131)
C1522449 (UMLS CUI 2011AA)
108290001 (SNOMED CT 2011_0131)
10037794 (MedDRA 14.1)
Increased risk for a pulmonary toxicity induced by BCNU (Carmustine) or CCNU (Lomustine). Risk factors include smoking, presence of a respiratory condition, pre-existing radiographic pulmonary abnormalities, exposure to agents that cause lung damage.
Item
Increased risk for a pulmonary toxicity induced by BCNU (Carmustine) or CCNU (Lomustine). Risk factors include smoking, presence of a respiratory condition, pre-existing radiographic pulmonary abnormalities, exposure to agents that cause lung damage.
boolean
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C0919924 (UMLS CUI 2011AA)
10061924 (MedDRA 14.1)
C0007257 (UMLS CUI 2011AA)
387281007 (SNOMED CT 2011_0131)
C0699181 (UMLS CUI 2011AA)
387227009 (SNOMED CT 2011_0131)
C0035648 (UMLS CUI 2011AA)
80943009 (SNOMED CT 2011_0131)
MTHU028018 (LOINC Version 232)
C0037369 (UMLS CUI 2011AA)
C0155905 (UMLS CUI 2011AA)
10038676 (MedDRA 14.1)
J70.9 (ICD-10-CM Version 2010)
508.9 (ICD-9-CM Version 2011)
C0444708 (UMLS CUI 2011AA)
258106000 (SNOMED CT 2011_0131)
C0476405 (UMLS CUI 2011AA)
165019004 (SNOMED CT 2011_0131)
10061602 (MedDRA 14.1)
R94.2 (ICD-10-CM Version 2010)
794.2 (ICD-9-CM Version 2011)
C1254351 (UMLS CUI 2011AA)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C0273115 (UMLS CUI 2011AA)
316358009 (SNOMED CT 2011_0131)
10061230 (MedDRA 14.1)
S27.30 (ICD-10-CM Version 2010)
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)
Clinically relevant psychiatric disorders / legal incapacity or a limited legal capacity.
Item
Clinically relevant psychiatric disorders / legal incapacity or a 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)
C1518422 (UMLS CUI 2011AA)
C0683673 (UMLS CUI 2011AA)
C0439801 (UMLS CUI 2011AA)
255469002 (SNOMED CT 2011_0131)
Concomitant treatment with yellow fever vaccine.
Item
Concomitant treatment with yellow fever vaccine.
boolean
C1707479 (UMLS CUI 2011AA)
C0301508 (UMLS CUI 2011AA)
56844000 (SNOMED CT 2011_0131)
37 (HL7 V3 2006_05)
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