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)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial