Adult | Scleroderma
Item
1. adults with scleroderma and:
boolean
C0001675 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
Chronic Kidney Diseases
Item
2. ckd 2/3 (zebra 1)
boolean
C1561643 (UMLS CUI [1])
Kidney crisis | Dialysis Absent
Item
3. renal crisis not on dialysis (zebra 2a)
boolean
C1408261 (UMLS CUI [1])
C0011946 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Kidney crisis | Dialysis
Item
4. renal crisis on dialysis (zebra 2b)
boolean
C1408261 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
Endothelin receptor antagonist
Item
1. previous use of an endothelin receptor antagonist within 3 months of the study start
boolean
C1134681 (UMLS CUI [1])
Liver Function Tests Abnormality | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin
Item
2. significant abnormalities in liver function testing (alt, alp, bilirubin) more than three times upper limit of normal)
boolean
C0023901 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0741494 (UMLS CUI [4])
Body Weight
Item
3. patients with body weight <40kg.
boolean
C0005910 (UMLS CUI [1])
Patient condition Preventing Protocol Compliance | Patient condition Treatment Compliance failed
Item
4. patients with conditions which prevent compliance with the protocol or failure to adhere to therapy.
boolean
C0683521 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0683521 (UMLS CUI [2,1])
C4319828 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
Condition Life Threatening
Item
5. patients with any other life threatening condition.
boolean
C0348080 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
Hypersensitivity Zibotentan | Hypersensitivity Zibotentan Excipient
Item
6. patients with known hypersensitivity to zibotentan or its excipients
boolean
C0020517 (UMLS CUI [1,1])
C2713006 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2713006 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Epilepsy | Central Nervous System Adverse events | Neurologic Symptoms Consistent with Compression of spinal cord | Neurologic Signs Consistent with Compression of spinal cord | CNS metastases
Item
7. previous history of epilepsy or other cns aes, neurologic symptoms or signs consistent with acute or evolving spinal cord compression, and cns metastases
boolean
C0014544 (UMLS CUI [1])
C3714787 (UMLS CUI [2,1])
C0877248 (UMLS CUI [2,2])
C0235031 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C0037926 (UMLS CUI [3,3])
C0751378 (UMLS CUI [4,1])
C0332290 (UMLS CUI [4,2])
C0037926 (UMLS CUI [4,3])
C0686377 (UMLS CUI [5])
Left ventricular ejection fraction | Status pre- Scleroderma renal crisis | Myocardial Infarction | Patients At risk Cardiac complication
Item
8. patients with a baseline left ventricular ejection fraction < 40% (prior to any scleroderma renal crisis), patients with acute myocardial infarction within six months or patients who are judged by the trial clinician to be at unacceptable risk from cardiac complications.
boolean
C0428772 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C1262147 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0030705 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0161816 (UMLS CUI [4,3])
Substance Use Disorders chronic | Condition Associated with Poor compliance
Item
9. history of chronic alcohol or drug abuse or any condition associated with poor compliance as judged by the investigator
boolean
C0038586 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0032646 (UMLS CUI [2,3])
Cyclosporine A | Cyclosporine A Expected
Item
10. patients receiving cyclosporin a within 1 week of screening or expecting to receive this agent during the study.
boolean
C0010592 (UMLS CUI [1])
C0010592 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
Investigational New Drugs
Item
11. patients who have received an investigational agent in the month prior to screening. these patients may be eligible if after a month of washout period, they are still within 112 months of the onset of the scleroderma renal crisis.
boolean
C0013230 (UMLS CUI [1])
Malignant Neoplasms | Neoplastic disease
Item
12. active malignancy or neoplastic disease in the previous 12 months
boolean
C0006826 (UMLS CUI [1])
C1882062 (UMLS CUI [2])
Gender | Estrogen Contraceptive Agents
Item
13. women who rely on oestrogencontaining contraceptives (due to potential drug interaction with zibotentan).
boolean
C0079399 (UMLS CUI [1])
C0009907 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
14. females who are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])