Childbearing Potential Contraceptive methods | Contraceptives, Oral | Contraceptive injection | Intrauterine Devices | Barrier Contraception Double | Contraceptive patch
Item
childbearing potential women who consent to the use of the consistently permissible contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0009905 (UMLS CUI [2])
C1656586 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0004764 (UMLS CUI [5,1])
C0205173 (UMLS CUI [5,2])
C2985284 (UMLS CUI [6])
Compliance behavior Self Medication | Ability Receive Support
Item
participants who are compliant with self-medication or can receive consistent help or support
boolean
C1321605 (UMLS CUI [1,1])
C0036600 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C1521721 (UMLS CUI [2,3])
Antipsychotic Agents | Patient need for Change Antipsychotic Agent | Etiology aspects | Lack of Efficacy | Intolerance to substance | Safety Lacking | Medication Compliance Lacking
Item
participants who need to change the antipsychotic drug to another one for the following reasons among the participants treated with an antipsychotic drug for more than two weeks before the screening (1) group of lack of efficacy: the antipsychotic drug is clinically required to be changed because there is no or little therapeutic response despite the appropriately dosed antipsychotic therapy (2) group of lack of tolerance: the antipsychotic drug is required to be changed due to lack of tolerance to the existing antipsychotic drug or the safety issue (3) group of lack of compliance: the antipsychotic drug is required to be changed due to lack of medication compliance or the participant wants to change the antipsychotic drug)
boolean
C0040615 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0040615 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3])
C0235828 (UMLS CUI [4])
C1744706 (UMLS CUI [5])
C0036043 (UMLS CUI [6,1])
C0332268 (UMLS CUI [6,2])
C3489773 (UMLS CUI [7,1])
C0332268 (UMLS CUI [7,2])
Neuroleptic Malignant Syndrome
Item
participants with the past history of neuroleptic malignant syndrome (nms)
boolean
C0027849 (UMLS CUI [1])
Risk Clinical Significance | At risk for suicide | At risk Aggressive behavior | Completion of clinical trial Unable
Item
participants who are suspicious of having clinically significant risk including suicide or aggressive behavior and are expected to unable to complete the study (based on the investigator's judgment)
boolean
C0035647 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0563664 (UMLS CUI [2])
C1444641 (UMLS CUI [3,1])
C0001807 (UMLS CUI [3,2])
C2732579 (UMLS CUI [4,1])
C1299582 (UMLS CUI [4,2])
Gastrointestinal stenosis Pre-existing Severe | Gastrointestinal stenosis Pre-existing Severe Iatrogenic | Lacking Able to swallow Investigational New Drugs
Item
participants with severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or participants who cannot swallow the drug whole (the study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile
boolean
C0521587 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0521587 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0439669 (UMLS CUI [2,4])
C0332268 (UMLS CUI [3,1])
C2712086 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
female participants who are pregnant or are breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
participants who have participated in any investigational drug trial within 1 month prior to the screening visit
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])