ID

16327

Description

BREAST-10: Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00540800

Lien

https://clinicaltrials.gov/show/NCT00540800

Mots-clés

  1. 11/07/2016 11/07/2016 -
Téléchargé le

11 juillet 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00540800

Eligibility Breast Cancer NCT00540800

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological diagnosis of breast cancer
Description

diagnosis of breast cancer

Type de données

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0678222
inoperable locally advanced or metastatic disease not yet treated with first-line chemotherapy
Description

inoperable locally advanced or metastatic disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C0205187
UMLS CUI [2]
C0278488
age < 70 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status < 2
Description

ecog performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
written informed consent
Description

written informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix)
Description

previous or concomitant malignant neoplasm

Type de données

boolean

Alias
UMLS CUI [1]
C0006826
previous treatment with docetaxel
Description

docetaxel

Type de données

boolean

Alias
UMLS CUI [1]
C0246415
symptomatic brain metastases
Description

symptomatic brain metastases

Type de données

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
neutrophil < 2000/mm3, platelets < 100,000/mm3, haemoglobin < 10 g/dl
Description

Neutrophil, platelets, haemoglobin

Type de données

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
creatinine > 1.25 x the upper normal limits
Description

creatinine

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
got and/or gpt > 1.25 x the upper normal limits in absence of hepatic metastases
Description

transaminases

Type de données

boolean

Alias
UMLS CUI [1]
C0002594
got and/or gpt > 2.5 x the upper normal limits in presence of hepatic metastases
Description

transaminases in presence of hepatic metastases

Type de données

boolean

Alias
UMLS CUI [1]
C0002594
UMLS CUI [2]
C0494165
bilirubin > 1.5 x the upper normal limit
Description

bilirubin

Type de données

boolean

Alias
UMLS CUI [1]
C1278039
any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
Description

Comorbidity

Type de données

boolean

Alias
UMLS CUI [1]
C0009488
inability to provide informed consent
Description

Unable Informed Consent

Type de données

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0021430
inability to comply with follow-up
Description

inability to comply with follow-up

Type de données

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1299582

Similar models

Eligibility Breast Cancer NCT00540800

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
diagnosis of breast cancer
Item
histological diagnosis of breast cancer
boolean
C0019638 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
inoperable locally advanced or metastatic disease
Item
inoperable locally advanced or metastatic disease not yet treated with first-line chemotherapy
boolean
C3495949 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C0278488 (UMLS CUI [2])
Age
Item
age < 70 years
boolean
C0001779 (UMLS CUI [1])
ecog performance status
Item
ecog performance status < 2
boolean
C1520224 (UMLS CUI [1])
written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
previous or concomitant malignant neoplasm
Item
previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix)
boolean
C0006826 (UMLS CUI [1])
docetaxel
Item
previous treatment with docetaxel
boolean
C0246415 (UMLS CUI [1])
symptomatic brain metastases
Item
symptomatic brain metastases
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Neutrophil, platelets, haemoglobin
Item
neutrophil < 2000/mm3, platelets < 100,000/mm3, haemoglobin < 10 g/dl
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
creatinine
Item
creatinine > 1.25 x the upper normal limits
boolean
C0201976 (UMLS CUI [1])
transaminases
Item
got and/or gpt > 1.25 x the upper normal limits in absence of hepatic metastases
boolean
C0002594 (UMLS CUI [1])
transaminases in presence of hepatic metastases
Item
got and/or gpt > 2.5 x the upper normal limits in presence of hepatic metastases
boolean
C0002594 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
bilirubin
Item
bilirubin > 1.5 x the upper normal limit
boolean
C1278039 (UMLS CUI [1])
Comorbidity
Item
any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
boolean
C0009488 (UMLS CUI [1])
Unable Informed Consent
Item
inability to provide informed consent
boolean
C1299582 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
inability to comply with follow-up
Item
inability to comply with follow-up
boolean
C3274571 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])

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