Study Subject Completed Clinical Trial Preceding
Item
subject completed the preceding trial 243-07-001 (nct00537485)
boolean
C0681850 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
Patient withdrawn from Clinical Trial Preceding
Item
subject discontinued from the preceding trial 243-07-001.
boolean
C0422727 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Serious Adverse Event | Relationship Investigational New Drugs
Item
subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-07-001.
boolean
C1519255 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Serious Adverse Event Persistent | Relationship Investigational New Drugs Excluded
Item
subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-07-001.
boolean
C1519255 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0439849 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Hallucinations Persistent | Delusions Persistent
Item
subject had persistent hallucination or delusion during trial 243-07-001.
boolean
C0018524 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0011253 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
Mental condition | Confusion | Excitement | Delirium | Abnormal behavior
Item
subject has psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline.
boolean
C3840291 (UMLS CUI [1])
C0009676 (UMLS CUI [2])
C0233571 (UMLS CUI [3])
C0011206 (UMLS CUI [4])
C0233514 (UMLS CUI [5])
Hypotension, Orthostatic | Systolic Pressure | Decreased systolic arterial pressure Supine Position Standing position
Item
subject has orthostatic hypotension or a systolic blood pressure (sbp) <= 100 mmhg and has a decrease of sbp from spine to standing position >= 30 mmhg at baseline.
boolean
C0020651 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0277885 (UMLS CUI [3,1])
C0038846 (UMLS CUI [3,2])
C0231472 (UMLS CUI [3,3])
Epilepsy | Convulsions
Item
subject has a history of epilepsy, convulsion etc. during trial 243-07-001.
boolean
C0014544 (UMLS CUI [1])
C4048158 (UMLS CUI [2])
ECG abnormality Serious
Item
subject develops serious ecg abnormality at the baseline.
boolean
C1832603 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Prolonged QTc interval | Gender
Item
subject has qtc-interval >= 500 msec at the baseline or subject has an increase of qtc-interval >= 60 msec from the baseline in the trial 243-07-001 and has a qtc-interval > 470 msec in female or > 450 msec in male at the baseline.
boolean
C1560305 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Serum potassium measurement
Item
subject has a serum potassium level < 3.5 meq/l at the end of the taper period in trial 243-07-001.
boolean
C0302353 (UMLS CUI [1])
Serum total bilirubin measurement | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
subject has a total bilirubin >= 3.0 mg/dl or ast(got) or alt(gpt) greater than 2.5 times of the upper limit of the reference range (or >= 100 iu/l) at the end of the period in trial 243-07-001.
boolean
C1278039 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Blood urea nitrogen measurement | Creatinine measurement, serum
Item
subject has bun >= 30 mg/dl or serum creatinine >= 2.0 mg/dl at the end of the taper period in trial 243-07-001.
boolean
C0005845 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Pregnancy, Planned
Item
subject who plans pregnancy during the trial.
boolean
C0032992 (UMLS CUI [1])
Dementia
Item
subject has dementia.
boolean
C0497327 (UMLS CUI [1])
Informed Consent Unable
Item
subject is unable to give consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Study Subject Participation Status Inappropriate
Item
subject is judged to be inappropriate for this trial by the investigator for the reasons other than above.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])