ID

12112

Beskrivning

Evaluation Of The Impact Of A Call Center In Management Of Metastatic And/Or Advanced Renal Cell Carcinoma Patients Treated With Sunitinib (Sutent) In First Line; ODM derived from: https://clinicaltrials.gov/show/NCT02187042

Länk

https://clinicaltrials.gov/show/NCT02187042

Nyckelord

Versioner (1)
  1. 2015-09-24 2015-09-24 - Julian Varghese
Uppladdad den

24 september 2015

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Metastatic/Advanced Renal Cell Carcinoma NCT02187042

Engelsk

Eligibility Metastatic/Advanced Renal Cell Carcinoma NCT02187042

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
metastatic and/or advanced renal cell carcinoma patients treated with sunitinib in first line according to the summary of product characteristics
Beskrivning

Renal Cell Carcinoma; Metastatic to | Renal Cell Carcinoma; Advanced phase | sunitinib

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007134
UMLS CUI [1,2]
C0036525
UMLS CUI [2,1]
C0007134
UMLS CUI [2,2]
C0205179
UMLS CUI [3]
C1176020
resolution of all adverse event (grade ≤ 1 according to the common terminology criteria for adverse events v 4.3 of june 2010) from a prior treatment by radiotherapy and/or surgery
Beskrivning

Recovery of Function radiotherapy; surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0599766
patient who can be followed for 6 months
Beskrivning

compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
patient who has signed a consent form
Beskrivning

consent; form

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0805443
UMLS CUI [1,2]
C0514044
UMLS CUI [2,1]
C0348078
UMLS CUI [2,2]
C0221198
patient affiliated to a national health service
Beskrivning

Organizational Affiliation patient affiliated to a national health service

Datatyp

boolean

Alias
UMLS CUI [1]
C0029239
sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception during the course of the study and for 28 days after the last dose of study treatment
Beskrivning

Contraceptive methods | Childbearing Potential

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C3831118
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient who is participating in another clinical study
Beskrivning

participation in another clinical study

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
patient taken in charge by a home help service
Beskrivning

Home help needed

Datatyp

boolean

Alias
UMLS CUI [1]
C0578841
patient with brain metastases not treated or symptomatic
Beskrivning

brain metastases; symptomatic; not treated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0231220
patient with an eastern cooperative oncology group at inclusion > 2
Beskrivning

eastern cooperative oncology group

Datatyp

boolean

Alias
UMLS CUI [1]
C1512162
patient with a rate of serum creatinine > 1.5 times the upper limit normal
Beskrivning

serum creatinine > 1.5 mg/dl

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
patient with a rate of bilirubin > 2 mg/dl
Beskrivning

bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C1557209
patient with a rate of aspartate transaminase (asat) or alanine transaminase (alat) > 2.5 times the upper limit normal or > 5 times the upper limit normal for patients with hepatic metastases
Beskrivning

aspartate transaminase; alanine transaminase;

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
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Similar models

Eligibility Metastatic/Advanced Renal Cell Carcinoma NCT02187042

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Renal Cell Carcinoma; Metastatic to | Renal Cell Carcinoma; Advanced phase | sunitinib
Item
metastatic and/or advanced renal cell carcinoma patients treated with sunitinib in first line according to the summary of product characteristics
boolean
C0007134 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C0007134 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C1176020 (UMLS CUI [3])
Recovery of Function radiotherapy; surgery
Item
resolution of all adverse event (grade ≤ 1 according to the common terminology criteria for adverse events v 4.3 of june 2010) from a prior treatment by radiotherapy and/or surgery
boolean
C0599766 (UMLS CUI [1])
compliance
Item
patient who can be followed for 6 months
boolean
C1321605 (UMLS CUI [1])
consent; form
Item
patient who has signed a consent form
boolean
C0805443 (UMLS CUI [1,1])
C0514044 (UMLS CUI [1,2])
C0348078 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
Organizational Affiliation patient affiliated to a national health service
Item
patient affiliated to a national health service
boolean
C0029239 (UMLS CUI [1])
Contraceptive methods | Childbearing Potential
Item
sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception during the course of the study and for 28 days after the last dose of study treatment
boolean
C0700589 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
participation in another clinical study
Item
patient who is participating in another clinical study
boolean
C2348568 (UMLS CUI [1])
Home help needed
Item
patient taken in charge by a home help service
boolean
C0578841 (UMLS CUI [1])
brain metastases; symptomatic; not treated
Item
patient with brain metastases not treated or symptomatic
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
eastern cooperative oncology group
Item
patient with an eastern cooperative oncology group at inclusion > 2
boolean
C1512162 (UMLS CUI [1])
serum creatinine > 1.5 mg/dl
Item
patient with a rate of serum creatinine > 1.5 times the upper limit normal
boolean
C0201976 (UMLS CUI [1])
bilirubin
Item
patient with a rate of bilirubin > 2 mg/dl
boolean
C1557209 (UMLS CUI [1])
aspartate transaminase; alanine transaminase;
Item
patient with a rate of aspartate transaminase (asat) or alanine transaminase (alat) > 2.5 times the upper limit normal or > 5 times the upper limit normal for patients with hepatic metastases
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
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