ID

41484

Beskrivning

Clarithromycin Plus CTd Regimen for Patients With Newly Diagnosed Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02248428

Länk

https://clinicaltrials.gov/show/NCT02248428

Nyckelord

Versioner (1)
  1. 2020-10-26 2020-10-26 -
Rättsinnehavare

see on clinicaltrials.gov

Uppladdad den

26 oktober 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT02248428

Engelsk

Eligibility Multiple Myeloma NCT02248428

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent form
Beskrivning

Signed informed consent form

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
adhere to the study visit schedule and other protocol requirements
Beskrivning

Ability to meet study requirements

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
diagnosed with active multiple myeloma
Beskrivning

active multiple myeloma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205177
UMLS CUI [1,2]
C0026764
myeloma previously untreated
Beskrivning

previously untreated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332155
UMLS CUI [1,2]
C0026764
karnofsky performance status(kps) ≥50
Beskrivning

karnofsky performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
karnofsky performance status (kps) <50 related to bony disease
Beskrivning

karnofsky performance status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0206065
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0005940
new york heart association (nyha) functional ≤ class iii
Beskrivning

new york heart association

Datatyp

boolean

Alias
UMLS CUI [1]
C1275491
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypersensitivity to clarithromycin or any of its excipients, erythromycin, or any of the macrolide antibiotics;
Beskrivning

hypersensitivity to clarithromycin or any of its excipients, erythromycin, or any of the macrolide antibiotics

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0055856
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0055856
UMLS CUI [2,3]
C0015237
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0014806
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0003240
concomitant administration of cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine, simvastatin, lovastatin, and atorvastatin;
Beskrivning

concomitant administration of cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine, simvastatin, lovastatin, and atorvastatin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0072916
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C0031935
UMLS CUI [3,1]
C2347852
UMLS CUI [3,2]
C0085170
UMLS CUI [4,1]
C2347852
UMLS CUI [4,2]
C0085173
UMLS CUI [5,1]
C2347852
UMLS CUI [5,2]
C0014710
UMLS CUI [6,1]
C2347852
UMLS CUI [6,2]
C0012291
UMLS CUI [7,1]
C2347852
UMLS CUI [7,2]
C0074554
UMLS CUI [8,1]
C2347852
UMLS CUI [8,2]
C0024027
UMLS CUI [9,1]
C2347852
UMLS CUI [9,2]
C0286651
a history of cholestatic jaundice/hepatic dysfunction associated with prior use of clarithromycin
Beskrivning

previous cholestatic jaundice/hepatic dysfunction linked to use of clarithromycin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0008370
UMLS CUI [1,3]
C0022346
UMLS CUI [1,4]
C0332281
UMLS CUI [1,5]
C0055856
UMLS CUI [2,1]
C0205156
UMLS CUI [2,2]
C0086565
UMLS CUI [2,3]
C0332281
UMLS CUI [2,4]
C0055856
impaired renal function,creatinine ≥221umol/l；
Beskrivning

abnormal renal function, creatinine

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0151746
pregnant or breast feeding females
Beskrivning

pregnant or breast feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any condition which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Beskrivning

condition placing the subject at unacceptable risk in case of study participation or confounds the study's data interpretation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1883420
UMLS CUI [1,4]
C0035647
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0681873
UMLS CUI [2,4]
C0459471
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Similar models

Eligibility Multiple Myeloma NCT02248428

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Signed informed consent form
Item
signed informed consent form
boolean
C0021430 (UMLS CUI [1])
Ability to meet study requirements
Item
adhere to the study visit schedule and other protocol requirements
boolean
C0525058 (UMLS CUI [1])
active multiple myeloma
Item
diagnosed with active multiple myeloma
boolean
C0205177 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
previously untreated
Item
myeloma previously untreated
boolean
C0332155 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
karnofsky performance status
Item
karnofsky performance status(kps) ≥50
boolean
C0206065 (UMLS CUI [1])
karnofsky performance status
Item
karnofsky performance status (kps) <50 related to bony disease
boolean
C0206065 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0005940 (UMLS CUI [1,3])
new york heart association
Item
new york heart association (nyha) functional ≤ class iii
boolean
C1275491 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
hypersensitivity to clarithromycin or any of its excipients, erythromycin, or any of the macrolide antibiotics
Item
hypersensitivity to clarithromycin or any of its excipients, erythromycin, or any of the macrolide antibiotics;
boolean
C0020517 (UMLS CUI [1,1])
C0055856 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0055856 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0014806 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0003240 (UMLS CUI [4,2])
concomitant administration of cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine, simvastatin, lovastatin, and atorvastatin
Item
concomitant administration of cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine, simvastatin, lovastatin, and atorvastatin;
boolean
C2347852 (UMLS CUI [1,1])
C0072916 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2,1])
C0031935 (UMLS CUI [2,2])
C2347852 (UMLS CUI [3,1])
C0085170 (UMLS CUI [3,2])
C2347852 (UMLS CUI [4,1])
C0085173 (UMLS CUI [4,2])
C2347852 (UMLS CUI [5,1])
C0014710 (UMLS CUI [5,2])
C2347852 (UMLS CUI [6,1])
C0012291 (UMLS CUI [6,2])
C2347852 (UMLS CUI [7,1])
C0074554 (UMLS CUI [7,2])
C2347852 (UMLS CUI [8,1])
C0024027 (UMLS CUI [8,2])
C2347852 (UMLS CUI [9,1])
C0286651 (UMLS CUI [9,2])
previous cholestatic jaundice/hepatic dysfunction linked to use of clarithromycin
Item
a history of cholestatic jaundice/hepatic dysfunction associated with prior use of clarithromycin
boolean
C0205156 (UMLS CUI [1,1])
C0008370 (UMLS CUI [1,2])
C0022346 (UMLS CUI [1,3])
C0332281 (UMLS CUI [1,4])
C0055856 (UMLS CUI [1,5])
C0205156 (UMLS CUI [2,1])
C0086565 (UMLS CUI [2,2])
C0332281 (UMLS CUI [2,3])
C0055856 (UMLS CUI [2,4])
abnormal renal function, creatinine
Item
impaired renal function,creatinine ≥221umol/l；
boolean
C0201976 (UMLS CUI [1])
C0151746 (UMLS CUI [2])
pregnant or breast feeding
Item
pregnant or breast feeding females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
condition placing the subject at unacceptable risk in case of study participation or confounds the study's data interpretation
Item
any condition which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1883420 (UMLS CUI [1,3])
C0035647 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0681873 (UMLS CUI [2,3])
C0459471 (UMLS CUI [2,4])
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