ID

36281

Beschrijving

A Single Arm, Tolerability and Safety Phase IV Study of Fulvestrant(Faslodex® ) as 2nd Line and Later Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02447328

Link

https://clinicaltrials.gov/show/NCT02447328

Trefwoorden

Versies (1)
  1. 29-04-19 29-04-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

29 april 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Locally Advanced or NCT02447328

Engels

Eligibility Locally Advanced or NCT02447328

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal women
Beschrijving

Postmenopausal state

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
postmenopausal: amenorrhea over 12 months prior to the visit 1 or history of hysterectomy ２) outpatient or inpatient with locally advanced or metastatic breast cancer who have failed with prior anti-estrogen therapy.
Beschrijving

Postmenopausal state | Amenorrhea Duration | Hysterectomy | Outpatients | Inpatient | Locally advanced breast cancer | Secondary malignant neoplasm of female breast | Prior antiestrogen therapy failed

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
UMLS CUI [3]
C0020699
UMLS CUI [4]
C0029921
UMLS CUI [5]
C0021562
UMLS CUI [6]
C3495949
UMLS CUI [7]
C0346993
UMLS CUI [8,1]
C0279797
UMLS CUI [8,2]
C0231175
estrogen receptor positive ４)radiographic progression of disease after the prior therapy ５) patients who agree to participate in this study and sign the informed consent
Beschrijving

Patients Estrogen receptor positive | Disease Progression Radiography | Status post Prior Therapy | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0279754
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0034571
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1514463
UMLS CUI [4]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are treated with fulvestrant
Beschrijving

fulvestrant

Datatype

boolean

Alias
UMLS CUI [1]
C0935916
patients who are being treated with the other antitumor agents
Beschrijving

Antineoplastic Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0003392
pregnancy or lactating women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of hypersensitivity to any of included ingredients (eg. castor oil) ５) patients who are considered not fit for the study by investigators
Beschrijving

Hypersensitivity Ingredient | Castor oil allergy | Patients Medically unfit

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1550600
UMLS CUI [2]
C0571232
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C3841806
patients who have severe dysfunction of liver or kidney
Beschrijving

Liver Dysfunction Severe | Renal dysfunction Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C3279454
UMLS CUI [2,2]
C0205082
total bilirubin > 5 x uln
Beschrijving

Elevated total bilirubin

Datatype

boolean

Alias
UMLS CUI [1]
C0741494
ast/alt > 5 x uln
Beschrijving

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
creatinine > 2 x uln
Beschrijving

Creatinine increased

Datatype

boolean

Alias
UMLS CUI [1]
C0151578
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Similar models

Eligibility Locally Advanced or NCT02447328

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state
Item
postmenopausal women
boolean
C0232970 (UMLS CUI [1])
Postmenopausal state | Amenorrhea Duration | Hysterectomy | Outpatients | Inpatient | Locally advanced breast cancer | Secondary malignant neoplasm of female breast | Prior antiestrogen therapy failed
Item
postmenopausal: amenorrhea over 12 months prior to the visit 1 or history of hysterectomy ２) outpatient or inpatient with locally advanced or metastatic breast cancer who have failed with prior anti-estrogen therapy.
boolean
C0232970 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0020699 (UMLS CUI [3])
C0029921 (UMLS CUI [4])
C0021562 (UMLS CUI [5])
C3495949 (UMLS CUI [6])
C0346993 (UMLS CUI [7])
C0279797 (UMLS CUI [8,1])
C0231175 (UMLS CUI [8,2])
Patients Estrogen receptor positive | Disease Progression Radiography | Status post Prior Therapy | Informed Consent
Item
estrogen receptor positive ４)radiographic progression of disease after the prior therapy ５) patients who agree to participate in this study and sign the informed consent
boolean
C0030705 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2,1])
C0034571 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C1514463 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
fulvestrant
Item
patients who are treated with fulvestrant
boolean
C0935916 (UMLS CUI [1])
Antineoplastic Agents
Item
patients who are being treated with the other antitumor agents
boolean
C0003392 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Ingredient | Castor oil allergy | Patients Medically unfit
Item
history of hypersensitivity to any of included ingredients (eg. castor oil) ５) patients who are considered not fit for the study by investigators
boolean
C0020517 (UMLS CUI [1,1])
C1550600 (UMLS CUI [1,2])
C0571232 (UMLS CUI [2])
C0030705 (UMLS CUI [3,1])
C3841806 (UMLS CUI [3,2])
Liver Dysfunction Severe | Renal dysfunction Severe
Item
patients who have severe dysfunction of liver or kidney
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3279454 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Elevated total bilirubin
Item
total bilirubin > 5 x uln
boolean
C0741494 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
ast/alt > 5 x uln
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Creatinine increased
Item
creatinine > 2 x uln
boolean
C0151578 (UMLS CUI [1])
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