Informatie:
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ID
13222
Beschrijving
Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I; ODM derived from: https://clinicaltrials.gov/show/NCT00171925
Link
https://clinicaltrials.gov/show/NCT00171925
Trefwoorden
Versies (1)
- 24-01-16 24-01-16 -
Geüploaded op
24 januari 2016
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Multiple Myeloma Stage I NCT00171925
Eligibility Multiple Myeloma Stage I NCT00171925
- StudyEvent: Eligibility
Similar models
Eligibility Multiple Myeloma Stage I NCT00171925
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
mm
Item
evidence of myeloma according to the criteria of the british columbia cancer agency (for the diagnosis, 2 of the 3 criteria must be met):
boolean
C0026764 (UMLS CUI [1])
paraprotein
Item
evidence of paraprotein in the serum or urine
boolean
C0030490 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
C0030490 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
C0229671 (UMLS CUI [1,2])
C0030490 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
bone marrow
Item
bone marrow infiltration with plasma cells which represent more than 10% of the nucleated cells
boolean
C0005953 (UMLS CUI [1])
osteolytic lesion
Item
radiologically, at least one osteolytic lesion
boolean
C0302313 (UMLS CUI [1])
tumor stage
Item
asymptomatic patients with stage i (durie and salmon) multiple myeloma
boolean
C1300072 (UMLS CUI [1])
osteolytic lesion
Item
patients with more than one osteolytic lesion on conventional skeletal radiography
boolean
C0302313 (UMLS CUI [1])
bisphosphonates
Item
previous treatment with bisphosphonates
boolean
C0012544 (UMLS CUI [1])
bilirubin
Item
bilirubin > 2.5 mg/dl
boolean
C1278039 (UMLS CUI [1])
creatinine clearance
Item
abnormal renal function as evidenced by: a calculated creatinine clearance < 30 ml/minute. creatinine clearance (crcl) is calculated using the cockcroft-gault formula: crcl= [140-age(years)] x weight(kg)/[72xserumcreatinine(mg/dl)] x {0.85 for female patients}
boolean
C0373595 (UMLS CUI [1])
malignancy, comorbidity
Item
patients with other malignant diseases or severe concomitant diseases
boolean
C0006826 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
C0009488 (UMLS CUI [2])
contraception
Item
potentially fertile patients who are not using a reliable and appropriate method of contraception
boolean
C0700589 (UMLS CUI [1])
pregnancy or breastfeeding
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
study subject participation status
Item
participation in another clinical study with an investigational drug within 12 weeks of study entry
boolean
C2348568 (UMLS CUI [1])
dental disease
Item
current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures.
boolean
C1704330 (UMLS CUI [1])
dental or jaw surgery
Item
recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)
boolean
C0204324 (UMLS CUI [1])
C0407713 (UMLS CUI [2])
C0407713 (UMLS CUI [2])
others
Item
other protocol-defined inclusion and exclusion criteria may apply.
text