age 18 Years to 50 Years
Item
Alter 18 bis 50 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Be a pre-menopausal woman between 18 and 50 years inclusive.
Item
Be a pre-menopausal woman between 18 and 50 years inclusive.
boolean
C0279752 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
Have excessive uterine bleeding due to myoma
Item
Have excessive uterine bleeding due to myoma
boolean
C0442802 (UMLS CUI 2011AA)
260378005 (SNOMED CT 2011_0131)
C0042134 (UMLS CUI 2011AA)
38280009 (SNOMED CT 2011_0131)
10046765 (MedDRA 14.1)
E13237 (CTCAE 1105E)
CL420107 (UMLS CUI 2011AA)
C0027086 (UMLS CUI 2011AA)
66357004, 92237006 (SNOMED CT 2011_0131)
10061692 (MedDRA 14.1)
D21 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Have a myomatous uterus with at least one myoma of >= 3 cm diameter in size
Item
Have a myomatous uterus with at least one myoma of >= 3 cm diameter in size
boolean
C0282606 (UMLS CUI 2011AA)
115228006 (SNOMED CT 2011_0131)
10070956 (MedDRA 14.1)
C0042149 (UMLS CUI 2011AA)
35039007 (SNOMED CT 2011_0131)
MTHU002943 (LOINC Version 232)
C0027086 (UMLS CUI 2011AA)
66357004, 92237006 (SNOMED CT 2011_0131)
10061692 (MedDRA 14.1)
D21 (ICD-10-CM Version 2010)
C1301886 (UMLS CUI 2011AA)
81827009 (SNOMED CT 2011_0131)
MTHU002654 (LOINC Version 232)
C0456389 (UMLS CUI 2011AA)
246115007 (SNOMED CT 2011_0131)
MTHU010347 (LOINC Version 232)
Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
Item
Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
boolean
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0020699 (UMLS CUI 2011AA)
236886002 (SNOMED CT 2011_0131)
10021151 (MedDRA 14.1)
C0195309 (UMLS CUI 2011AA)
42010004 (SNOMED CT 2011_0131)
10028634 (MedDRA 14.1)
If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
Item
If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
boolean
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0458083 (UMLS CUI 2011AA)
278994005 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Have a Body Mass Index (BMI) >= 18 and <= 40.
Item
BMI >= 18 und <= 40
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
Has a history of or current uterine, cervical, ovarian or breast cancer.
Item
Has a history of or current uterine, cervical, ovarian or breast cancer.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0153567 (UMLS CUI 2011AA)
371973000 (SNOMED CT 2011_0131)
10046766 (MedDRA 14.1)
C55 (ICD-10-CM Version 2010)
179 (ICD-9-CM Version 2011)
C0302592 (UMLS CUI 2011AA)
285432005 (SNOMED CT 2011_0131)
10008342 (MedDRA 14.1)
C0919267 (UMLS CUI 2011AA)
123843001 (SNOMED CT 2011_0131)
10061535 (MedDRA 14.1)
C0678222 (UMLS CUI 2011AA)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
Item
Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0349579 (UMLS CUI 2011AA)
277158007 (SNOMED CT 2011_0131)
10063353 (MedDRA 14.1)
N85.02 (ICD-10-CM Version 2010)
621.33 (ICD-9-CM Version 2011)
C0001418 (UMLS CUI 2011AA)
35917007 (SNOMED CT 2011_0131)
10001141 (MedDRA 14.1)
Has a known severe coagulation disorder.
Item
Has a known severe coagulation disorder.
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0005779 (UMLS CUI 2011AA)
64779008 (SNOMED CT 2011_0131)
10009802 (MedDRA 14.1)
D68.9 (ICD-10-CM Version 2010)
Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.
Item
Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0027086 (UMLS CUI 2011AA)
66357004, 92237006 (SNOMED CT 2011_0131)
10061692 (MedDRA 14.1)
D21 (ICD-10-CM Version 2010)
C0034833 (UMLS CUI 2011AA)
61078009 (SNOMED CT 2011_0131)
MTHU002145 (LOINC Version 232)
C1268855 (UMLS CUI 2011AA)
395962005 (SNOMED CT 2011_0131)
Has a history of or known current osteoporosis.
Item
Has a history of or known current osteoporosis.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0029456 (UMLS CUI 2011AA)
64859006 (SNOMED CT 2011_0131)
10031282 (MedDRA 14.1)
MTHU020796 (LOINC Version 232)
M81.0 (ICD-10-CM Version 2010)
733.00 (ICD-9-CM Version 2011)
E12508 (CTCAE 1105E)
Has abnormal hepatic function at study entry.
Item
Has abnormal hepatic function at study entry.
boolean
C0086565 (UMLS CUI 2011AA)
75183008 (SNOMED CT 2011_0131)
10019670 (MedDRA 14.1)
C2348558 (UMLS CUI 2011AA)
Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.
Item
Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.
boolean
C0240802 (UMLS CUI 2011AA)
250423000 (SNOMED CT 2011_0131)
10036575 (MedDRA 14.1)
C1442488 (UMLS CUI 2011AA)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
Has a current (within twelve months) problem with alcohol or drug abuse.
Item
Has a current (within twelve months) problem with alcohol or drug abuse.
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0085762 (UMLS CUI 2011AA)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
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)
Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
Item
Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
C2346570 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)