Informatie:
Fout:
ID
44798
Beschrijving
Japanese Study of BMS-901608 (Elotuzumab) in Combination With Lenalidomide and Low Dose Dexamethasone; ODM derived from: https://clinicaltrials.gov/show/NCT01241292
Link
https://clinicaltrials.gov/show/NCT01241292
Trefwoorden
Versies (1)
- 30-11-21 30-11-21 - Tabea Kampen
Houder van rechten
Bristol-Myers Squibb
Geüploaded op
30 november 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Eligibility Multiple Myeloma NCT01241292
Eligibility Multiple Myeloma NCT01241292
- StudyEvent: Eligibility
Similar models
Eligibility Multiple Myeloma NCT01241292
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Pre-treatment
Item
received between 1 to 4 prior lines of therapy
boolean
C1514463 (UMLS CUI [1])
Diagnosis
Item
measureable disease
boolean
C1513041 (UMLS CUI [1])
Kontraception
Item
men and women of childbearing potential (women) must be using two acceptable methods of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,2])
Reproduction
Item
men must agree to use a latex condom and a second form of birth control during sexual contact with women and must agree to not donate semen during study drug therapy
boolean
C0004764 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0871414 (UMLS CUI [3,1])
C1518422 (UMLS CUI [3,2])
C0700589 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0871414 (UMLS CUI [3,1])
C1518422 (UMLS CUI [3,2])
Blood donation
Item
subjects must be willing to refrain from blood donations during study drug therapy
boolean
C0005794 (UMLS CUI [1,1])
C3640974 (UMLS CUI [1,2])
C3640974 (UMLS CUI [1,2])
Excluded diagnoses
Item
subjects with non-secretory or oligo-secretory or light-chain only myeloma or active/prior plasma cell leukemia or known /suspect poems syndrome
boolean
C0456845 (UMLS CUI [1])
C0205251 (UMLS CUI [2,1])
C0036536 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0026764 (UMLS CUI [2,4])
C0456844 (UMLS CUI [3])
C0023484 (UMLS CUI [4])
C0085404 (UMLS CUI [5])
C0205251 (UMLS CUI [2,1])
C0036536 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0026764 (UMLS CUI [2,4])
C0456844 (UMLS CUI [3])
C0023484 (UMLS CUI [4])
C0085404 (UMLS CUI [5])
Manifestations
Item
solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dysplasia
boolean
C0032112 (UMLS CUI [1,1])
C0334044 (UMLS CUI [1,2])
C1868812 (UMLS CUI [1,3])
C0032112 (UMLS CUI [2,1])
C0334044 (UMLS CUI [2,2])
C1512957 (UMLS CUI [2,3])
C0334044 (UMLS CUI [1,2])
C1868812 (UMLS CUI [1,3])
C0032112 (UMLS CUI [2,1])
C0334044 (UMLS CUI [2,2])
C1512957 (UMLS CUI [2,3])
Tolerability of other medication
Item
unable to take aspirin daily as prophylactic anticoagulation therapy. prior history of inability to tolerate weekly 40 mg dexamethasone
boolean
C0004057 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0003281 (UMLS CUI [1,3])
C0199176 (UMLS CUI [1,4])
C0011777 (UMLS CUI [2,1])
C1744706 (UMLS CUI [2,2])
C0456683 (UMLS CUI [1,2])
C0003281 (UMLS CUI [1,3])
C0199176 (UMLS CUI [1,4])
C0011777 (UMLS CUI [2,1])
C1744706 (UMLS CUI [2,2])
Renal function
Item
history of renal failure
boolean
C0035078 (UMLS CUI [1])
Thrombosis
Item
history of clinical significant thrombosis, such as treatment for thrombosis was required
boolean
C0262926 (UMLS CUI [1,1])
C0040053 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0039798 (UMLS CUI [1,4])
C0040053 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0039798 (UMLS CUI [1,4])