Successful completion of phase 1,2 or 3 tolvaptan adpkd or renal impairment trial, with a confirmed diagnosis of adpkd
Item
subjects who have successfully completed a phase 1, 2, or 3 tolvaptan adpkd or renal impairment trial, with a confirmed diagnosis of adpkd
boolean
C0750484 (UMLS CUI [1,1])
C0085413 (UMLS CUI [1,2])
C0805732 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1176308 (UMLS CUI [2,3])
C0805732 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1565489 (UMLS CUI [3,3])
Absence of informed consent
Item
subjects unable to provide written informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Lack of proper contraception
Item
subjects (men or women) who will not adhere to the reproductive precautions as outlined in the informed consent form
boolean
C0700589 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Women with a positive pregnancy test
Item
subjects (women only) with a positive urine pregnancy test
boolean
C0240802 (UMLS CUI [1])
Pregnancy or breast feeding
Item
subjects who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Inability to take oral medications
Item
subjects unable to take oral medications
boolean
C0175795 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Hypersensitivity to tolvaptan or chemically related structures such as benzazepines
Item
subjects who have allergic reactions to tolvaptan or chemically related structures such as benzazepines (benzazepril, conivaptan, fenoldopam mesylate or mirtazapine)
boolean
C0020517 (UMLS CUI [1,1])
C1176308 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0220807 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
C1176308 (UMLS CUI [2,4])
C0020517 (UMLS CUI [3,1])
C0005034 (UMLS CUI [3,2])
Disorders in thirst recognition or inability to access fluids
Item
subjects who have disorders in thirst recognition or an inability to access fluids
boolean
C0599535 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1299582 (UMLS CUI [2,1])
C2013463 (UMLS CUI [2,2])
Critical electrolyte imbalances
Item
subjects with critical electrolyte imbalances, as determined by the investigator
boolean
C0342579 (UMLS CUI [1,1])
C1511545 (UMLS CUI [1,2])
Having or being at risk of significant hypovolemia
Item
subjects with or at risk of significant hypovolemia, as determined by investigator
boolean
C0205420 (UMLS CUI [1,1])
C0546884 (UMLS CUI [1,2])
C0332190 (UMLS CUI [2,1])
C0546884 (UMLS CUI [2,2])
Anemia
Item
subjects with anemia, as determined by investigator
boolean
C0002871 (UMLS CUI [1])
History of substance abuse
Item
subjects with a history of substance abuse (within the last 3 years)
boolean
C1299544 (UMLS CUI [1])
Other experimental therapies or current participation in another clinical drug or device trial
Item
subjects taking other experimental (ie, non-marketed) therapies or current participation in another clinical drug or device trial; current participation in the off-drug follow-up period of another adpkd trial with tolvaptan is permitted
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Inability to complete mri assessments, e.g. due to ferro-magnetic prostheses, aneurysm clips, severe claustrophobia
Item
subjects unable to complete mri assessments (eg, subjects with ferro-magnetic prostheses, aneurysm clips, severe claustrophobia)
boolean
C1299582 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0008909 (UMLS CUI [2])
C0175649 (UMLS CUI [3,1])
C2986473 (UMLS CUI [3,2])
C0179977 (UMLS CUI [4])
Former treatment with a vasopressin antagonist
Item
subjects who have taken a vasopressin antagonist (outside of previous participation in a tolvaptan trial)
boolean
C1514463 (UMLS CUI [1,1])
C3537128 (UMLS CUI [1,2])
C0332300 (UMLS CUI [1,3])
C1176308 (UMLS CUI [1,4])
Incompliance with important medical therapy such as anti-hypertensive therapy
Item
subjects unable to comply with anti-hypertensive or other important medical therapy
boolean
C0457432 (UMLS CUI [1,1])
C3898777 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0457432 (UMLS CUI [2,1])
C0585941 (UMLS CUI [2,2])
Advanced diabetes
Item
subjects with advanced diabetes
boolean
C0011849 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Confounding medication or comorbiditiy (including taking approved therapies for the purpose of affecting pkd cysts)
Item
subjects taking medications or having an illness that could confound endpoint assessments (including taking approved therapies for the purpose of affecting pkd cysts)
boolean
C2347852 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2603343 (UMLS CUI [2,3])