ID

15596

Descripción

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

Palabras clave

Versiones (1)
  1. 4/6/16 4/6/16 -
Subido en

4 de junio de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT00050674

Inglés

Eligibility Non-small Cell Lung Cancer NCT00050674

1 formularios  
Criteria
Descripción

Criteria

subjects must have stage iv or iiib nsclc
Descripción

nsclc

Tipo de datos

boolean

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

regimens of chemotherapy

Tipo de datos

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
Descripción

measurable disease or evaluable disease

Tipo de datos

boolean

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

age

Tipo de datos

boolean

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

ecog

Tipo de datos

boolean

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

ecog 2nd line

Tipo de datos

boolean

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

absolute neutrophil count

Tipo de datos

boolean

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

platelet count

Tipo de datos

boolean

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

renal function

Tipo de datos

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
Descripción

adequate ast and alt

Tipo de datos

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
Descripción

time between major surgery

Tipo de datos

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
Descripción

negative hcg

Tipo de datos

boolean

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

life expectancy

Tipo de datos

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
Descripción

informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility Non-small Cell Lung Cancer NCT00050674

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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