ID

15596

Descrição

Docetaxel and Gemcitabine With Filgrastim-SD/01 Support in Patients With Advanced Non-Small Cell Lung Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00050674

Link

https://clinicaltrials.gov/show/NCT00050674

Palavras-chave

  1. 04/06/2016 04/06/2016 -
Transferido a

4 de junho de 2016

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Non-small Cell Lung Cancer NCT00050674

Eligibility Non-small Cell Lung Cancer NCT00050674

Criteria
Descrição

Criteria

subjects must have stage iv or iiib nsclc
Descrição

nsclc

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007131
0-1 prior treatment regimens of chemotherapy
Descrição

regimens of chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0449788
subjects must have bi-dimensionally measurable disease or evaluable disease by physical exam or radiological studies
Descrição

measurable disease or evaluable disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
age > 18 years
Descrição

age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
1st line - ecog 0-2
Descrição

ecog

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
2nd line - ecog 0-1
Descrição

ecog 2nd line

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
absolute neutrophil count > or = 1.5 x 10 to the 9th power/l
Descrição

absolute neutrophil count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948762
platelet count > or = 100 x 10 to the 9th power/l
Descrição

platelet count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005821
adequate renal function with screening serum creatinine < or = 2.0 mg/dl
Descrição

renal function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
adequate ast and alt no more than 1.5 x the upper limit of normal and serum bilirubin < or = upper limit of normal
Descrição

adequate ast and alt

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C1278039
subjects must be at least two weeks from prior major thoracic or abdominal surgery and at least two weeks from completion of radiation therapy, and recovered from all toxicities associated with these treatments
Descrição

time between major surgery

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0872291
UMLS CUI [1,2]
C0087111
negative hcg by urine or blood test in subject of child-bearing potential
Descrição

negative hcg

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1141639
UMLS CUI [1,2]
C0205160
life expectancy > 2 months
Descrição

life expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
ethical - before any study specific procedure is done or before study medication is administered, the subject or legally acceptable representative must give informed consent for participation in the study
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430

Similar models

Eligibility Non-small Cell Lung Cancer NCT00050674

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
nsclc
Item
subjects must have stage iv or iiib nsclc
boolean
C0007131 (UMLS CUI [1])
regimens of chemotherapy
Item
0-1 prior treatment regimens of chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
measurable disease or evaluable disease
Item
subjects must have bi-dimensionally measurable disease or evaluable disease by physical exam or radiological studies
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
ecog
Item
1st line - ecog 0-2
boolean
C1520224 (UMLS CUI [1])
ecog 2nd line
Item
2nd line - ecog 0-1
boolean
C1520224 (UMLS CUI [1])
absolute neutrophil count
Item
absolute neutrophil count > or = 1.5 x 10 to the 9th power/l
boolean
C0948762 (UMLS CUI [1])
platelet count
Item
platelet count > or = 100 x 10 to the 9th power/l
boolean
C0005821 (UMLS CUI [1])
renal function
Item
adequate renal function with screening serum creatinine < or = 2.0 mg/dl
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
adequate ast and alt
Item
adequate ast and alt no more than 1.5 x the upper limit of normal and serum bilirubin < or = upper limit of normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
time between major surgery
Item
subjects must be at least two weeks from prior major thoracic or abdominal surgery and at least two weeks from completion of radiation therapy, and recovered from all toxicities associated with these treatments
boolean
C0872291 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
negative hcg
Item
negative hcg by urine or blood test in subject of child-bearing potential
boolean
C1141639 (UMLS CUI [1,1])
C0205160 (UMLS CUI [1,2])
life expectancy
Item
life expectancy > 2 months
boolean
C0023671 (UMLS CUI [1])
informed consent
Item
ethical - before any study specific procedure is done or before study medication is administered, the subject or legally acceptable representative must give informed consent for participation in the study
boolean
C0021430 (UMLS CUI [1])

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