Age, Histologically confirmed prostate cancer, indication of androgen deprivation therapy | Concomitant treatment with gonadotropin releasing hormone (gnrh) analogue possible | Status post bilateral orchiectomy
Item
subject is a male aged 18 years old or older (at screening) with histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant setting). subjects may be on ongoing androgen deprivation therapy with a gonadotropin releasing hormone (gnrh) analogue or have undergone prior bilateral orchiectomy at screening.
boolean
C0001779 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
C0521093 (UMLS CUI [1,4])
C0205462 (UMLS CUI [1,5])
C0279492 (UMLS CUI [1,6])
C3146298 (UMLS CUI [1,7])
C0332300 (UMLS CUI [1,8])
C1298675 (UMLS CUI [1,9])
C1298676 (UMLS CUI [1,10])
C2267073 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
C0007347 (UMLS CUI [3])
Progressive disease by prostate-specific antigen (psa) or imaging
Item
subject has progressive disease by prostate-specific antigen (psa) or imaging.
boolean
C1335499 (UMLS CUI [1,1])
C0201544 (UMLS CUI [1,2])
C1335499 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
Chemotherapy regimens quantity
Item
subject has received no more than 2 prior chemotherapy regimens.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Eastern cooperative oncology group (ecog) performance status
Item
subject has an eastern cooperative oncology group (ecog) performance status of 0-2.
boolean
C1520224 (UMLS CUI [1])
Gender, use of condoms if having sex with a pregnant woman
Item
male subject must use a condom if having sex with a pregnant woman.
boolean
C0079399 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0677582 (UMLS CUI [1,3])
C0009253 (UMLS CUI [1,4])
C0347984 (UMLS CUI [1,5])
C0032961 (UMLS CUI [1,6])
Use of 2 acceptable methods of birth control when there is a childbearing potential
Item
male subject and their female spouse/partners who are of childbearing potential must use 2 acceptable methods of birth control starting at screening and continuing throughout the study period and for 3 months after final study drug administration.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Estimated life expectancy, minimum
Item
subject has an estimated life expectancy of at least 6 months.
boolean
C0023671 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
CYP2D6 poor metaboliser status | CYP2D6 ultrarapid metaboliser status based on genotyping analysis.
Item
subject has confirmed cyp2d6 poor metabolizer, or cyp2d6 ultrarapid metabolizer status based on genotyping analysis.
boolean
C3888904 (UMLS CUI [1,1])
C0679560 (UMLS CUI [1,2])
C3203681 (UMLS CUI [2,1])
C0679560 (UMLS CUI [2,2])
Known metastases in the liver | Hepatic disorder that could affect drug metabolism
Item
subject has known metastases in the liver or any hepatic disorder that could affect drug metabolism deemed clinically significant by the investigator after discussion with the sponsor.
boolean
C0494165 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0031328 (UMLS CUI [2,3])
Recent major surgery
Item
subject has undergone major surgery within 4 weeks prior to day 1.
boolean
C0679637 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Recent chemotherapy | Chemotherapy planned during the study
Item
subject received treatment with chemotherapy within 4 weeks prior to enrollment (day 1 visit) or plans to initiate treatment with chemotherapy during the study.
boolean
C0392920 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1301732 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
Inducers and/or inhibitors of cyp1a2, cyp2c8, cyp2d6, or cyp3a4.
Item
subject uses concomitant medications that are potent inducers and/or inhibitors of cyp1a2, cyp2c8, cyp2d6, or cyp3a4.
boolean
C2347852 (UMLS CUI [1,1])
C3850050 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2,1])
C3850068 (UMLS CUI [2,2])
C2347852 (UMLS CUI [3,1])
C3850048 (UMLS CUI [3,2])
C2347852 (UMLS CUI [4,1])
C3850061 (UMLS CUI [4,2])
C2347852 (UMLS CUI [5,1])
C3850058 (UMLS CUI [5,2])
C2347852 (UMLS CUI [6,1])
C3850045 (UMLS CUI [6,2])
C2347852 (UMLS CUI [7,1])
C3830624 (UMLS CUI [7,2])
C2347852 (UMLS CUI [8,1])
C3830625 (UMLS CUI [8,2])