Body mass index
Item
has a body-mass index (bmi) >/=18.0 and </=32.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Use of Contraceptive methods
Item
agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration
boolean
C1524063 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Inclusion criteria Additional
Item
additional criteria may apply
boolean
C1512693 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
is currently pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hot flushes Lifetime
Item
has a lifetime history of menopausal hot flashes
boolean
C0600142 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
Medical condition Clinical Significance
Item
has a clinically significant medical condition
boolean
C3843040 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Illness Clinical Significance Recent
Item
has had a clinically significant illness in the 30 days prior to first study drug administration
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Communicable Disease Serious | Pneumonia | Septicemia
Item
has had a serious infection (eg, pneumonia or septicemia) within the 3 months prior to study drug administration
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0032285 (UMLS CUI [2])
C0036690 (UMLS CUI [3])
Vaccination | Status pre- Inpatient Admission
Item
has had any vaccinations in the 4 weeks prior to inpatient admission
boolean
C0042196 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0021562 (UMLS CUI [2,2])
C0809949 (UMLS CUI [2,3])
Diabetes Mellitus Lifetime
Item
has a lifetime history of diabetes
boolean
C0011849 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
Exclusion Criteria Additional
Item
additional criteria may apply
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])