ID

16327

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00540800

Trefwoorden

  1. 11-07-16 11-07-16 -
Geüploaded op

11 juli 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Breast Cancer NCT00540800

Eligibility Breast Cancer NCT00540800

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological diagnosis of breast cancer
Beschrijving

diagnosis of breast cancer

Datatype

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
Beschrijving

inoperable locally advanced or metastatic disease

Datatype

boolean

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

Age

Datatype

boolean

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

ecog performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
written informed consent
Beschrijving

written informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

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)
Beschrijving

previous or concomitant malignant neoplasm

Datatype

boolean

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

docetaxel

Datatype

boolean

Alias
UMLS CUI [1]
C0246415
symptomatic brain metastases
Beschrijving

symptomatic brain metastases

Datatype

boolean

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

Neutrophil, platelets, haemoglobin

Datatype

boolean

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

creatinine

Datatype

boolean

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

transaminases

Datatype

boolean

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

transaminases in presence of hepatic metastases

Datatype

boolean

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

bilirubin

Datatype

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
Beschrijving

Comorbidity

Datatype

boolean

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

Unable Informed Consent

Datatype

boolean

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

inability to comply with follow-up

Datatype

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)
Datatype
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])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial