ID

44798

Beschreibung

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

Stichworte

  1. 30.11.21 30.11.21 - Tabea Kampen
Rechteinhaber

Bristol-Myers Squibb

Hochgeladen am

30. November 2021

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT01241292

Eligibility Multiple Myeloma NCT01241292

Criteria
Beschreibung

Criteria

Inclusion criteria
Beschreibung

Inclusion criteria

Alias
UMLS CUI [1]
C1512693
received between 1 to 4 prior lines of therapy
Beschreibung

Pre-treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C1514463
measureable disease
Beschreibung

Diagnosis

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
men and women of childbearing potential (women) must be using two acceptable methods of contraception
Beschreibung

Kontraception

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
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
Beschreibung

Reproduction

Datentyp

boolean

Alias
UMLS CUI [1]
C0004764
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0205394
UMLS CUI [3,1]
C0871414
UMLS CUI [3,2]
C1518422
subjects must be willing to refrain from blood donations during study drug therapy
Beschreibung

Blood donation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C3640974
Exclusion criteria
Beschreibung

Exclusion criteria

Alias
UMLS CUI [1]
C0680251
subjects with non-secretory or oligo-secretory or light-chain only myeloma or active/prior plasma cell leukemia or known /suspect poems syndrome
Beschreibung

Excluded diagnoses

Datentyp

boolean

Alias
UMLS CUI [1]
C0456845
UMLS CUI [2,1]
C0205251
UMLS CUI [2,2]
C0036536
UMLS CUI [2,3]
C0332296
UMLS CUI [2,4]
C0026764
UMLS CUI [3]
C0456844
UMLS CUI [4]
C0023484
UMLS CUI [5]
C0085404
solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dysplasia
Beschreibung

Manifestations

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032112
UMLS CUI [1,2]
C0334044
UMLS CUI [1,3]
C1868812
UMLS CUI [2,1]
C0032112
UMLS CUI [2,2]
C0334044
UMLS CUI [2,3]
C1512957
unable to take aspirin daily as prophylactic anticoagulation therapy. prior history of inability to tolerate weekly 40 mg dexamethasone
Beschreibung

Tolerability of other medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0456683
UMLS CUI [1,3]
C0003281
UMLS CUI [1,4]
C0199176
UMLS CUI [2,1]
C0011777
UMLS CUI [2,2]
C1744706
history of renal failure
Beschreibung

Renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0035078
history of clinical significant thrombosis, such as treatment for thrombosis was required
Beschreibung

Thrombosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0040053
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0039798

Ähnliche Modelle

Eligibility Multiple Myeloma NCT01241292

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Item Group
Inclusion criteria
C1512693 (UMLS CUI [1])
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])
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])
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])
Item Group
Exclusion criteria
C0680251 (UMLS CUI [1])
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])
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])
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])
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])

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