Informações:
Falhas:
ID
16326
Descrição
Gemcitabine + Carboplatin in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00450762
Link
https://clinicaltrials.gov/show/NCT00450762
Palavras-chave
Versões (1)
- 11/07/2016 11/07/2016 -
Transferido a
11 de julho de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00450762
Eligibility Breast Cancer NCT00450762
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT00450762
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
metastatic breast cancer
Item
histologically confirmed metastatic breast cancer
boolean
C0278488 (UMLS CUI [1])
informed consent
Item
all patients were required to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Previous treatment
Item
prior treatment with chemotherapy, hormonal therapy, immunotherapy or local radiotherapy was allowed (except gemcitabine or platinum agents).
boolean
C2114510 (UMLS CUI [1])
Measurable lesion outside a previous radiation port
Item
patients were required to have at least one bidimensionally measurable lesion outside a previous radiation port.
boolean
C1513041 (UMLS CUI [1,1])
C1282506 (UMLS CUI [1,2])
C1282506 (UMLS CUI [1,2])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
karnofsky performance status
Item
karnofsky performance status ≥ 70 %
boolean
C0206065 (UMLS CUI [1])
Life expectancy
Item
minimal life expectancy of 12 weeks
boolean
C0023671 (UMLS CUI [1])
Organ function
Item
adequate haematological, renal, cardiac and hepatic function:
boolean
C0678852 (UMLS CUI [1])
leukocyte count
Item
1. leukocyte count ≥ 3.0 x 109/l
boolean
C0023508 (UMLS CUI [1])
absolute neutrophil count
Item
2. absolute neutrophil count ≥ 2.0 x 109/l
boolean
C0948762 (UMLS CUI [1])
platelet count
Item
3. platelet count ≥ 100 x 109/l
boolean
C0005821 (UMLS CUI [1])
haemoglobin
Item
4. haemoglobin ≥ 8 g/dl
boolean
C0518015 (UMLS CUI [1])
total serum bilirubin
Item
5. total serum bilirubin ≤ 1.25 x upper limit of normal (uln) in presence of liver metastasis ≤ 3 x uln
boolean
C1278039 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
C0494165 (UMLS CUI [2])
transaminases
Item
6. transaminase (alt,ast) level ≤ 3 x uln in presence of liver metastasis ≤ 5 x uln
boolean
C0002594 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
C0494165 (UMLS CUI [2])
alkaline phosphatase level
Item
7. alkaline phosphatase level ≤ 2.5 x uln
boolean
C1272113 (UMLS CUI [1])
creatinine clearance
Item
8. creatinine clearance was required to exceed 60 ml/min.
boolean
C0373595 (UMLS CUI [1])
Gemcitabine or platinum agents
Item
prior treatment with gemcitabine or platinum agents
boolean
C0045093 (UMLS CUI [1])
C2266918 (UMLS CUI [2])
C2266918 (UMLS CUI [2])
creatinine clearance
Item
inadequate creatinine clearance (< 60 ml/min)
boolean
C0373595 (UMLS CUI [1])
bone metastases
Item
only bone metastases
boolean
C0153690 (UMLS CUI [1])
brain metastases
Item
symptomatic brain metastases
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,2])
women who are pregnant, lactating or refuse effective contraception
Item
women who are pregnant, lactating or refuse effective contraception
boolean
C0425965 (UMLS CUI [1])
C0549206 (UMLS CUI [2])
C2828358 (UMLS CUI [3])
C0549206 (UMLS CUI [2])
C2828358 (UMLS CUI [3])
secondary malignancy
Item
secondary malignancy
boolean
C3266877 (UMLS CUI [1])
another primary malignant disease
Item
history of another primary malignant disease other than in situ carcinoma of the uterine cervix or adequately treated basal cell skin cancer
boolean
C0751623 (UMLS CUI [1])
active infection
Item
active infection
boolean
C0009450 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
comorbidity
Item
any other concomitant severe clinical condition making implementation of the protocol including pre-hydration difficult.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,2])