ID

17647

Descripción

Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc (OSI Pharmaceuticals) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of study: On-Treatment Assessments

Link

https://clinicaltrials.gov/ct2/show/NCT00373425

Palabras clave

Versiones (4)
  1. 27/7/16 27/7/16 -
  2. 1/8/16 1/8/16 -
  3. 1/8/16 1/8/16 -
  4. 27/9/16 27/9/16 -
Subido en

27 de septiembre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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On-Treatment Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425

Inglés

On-Treatment Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 formularios  
Header
Descripción

Header

Month Number
Descripción

Month Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0439231
UMLS CUI [1,2]
C0750480
Vital Assessment
Descripción

Vital Assessment

Date
Descripción

Assessment Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2985720
Weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
ECOG performance status:
Descripción

ECOG

Tipo de datos

integer

Alias
UMLS CUI [1]
C1520224
Physical Examination
Descripción

Physical Examination

Date Physical Examination performed:
Descripción

Date of Examination

Tipo de datos

date

Alias
UMLS CUI [1]
C2826643
Pregnancy Test
Descripción

Pregnancy Test

Pregnancy Test: Not Applicable
Descripción

Pregnancy Test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032976
Was pregnancy test performed?
Descripción

If applicable: Was pregnancy test performed?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032976
Date of Collection
Descripción

Date of Collection

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1516698
UMLS CUI [1,2]
C0032976
UMLS CUI [1,3]
C0011008
Accession Number
Descripción

Accession Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2826726
Hematology
Descripción

Hematology

Date of Collection
Descripción

Date of Collection

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Accession Number
Descripción

Accession Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2826726
Biochemistry/Proteomics
Descripción

Biochemistry/Proteomics

Date of Collection
Descripción

Date of collection

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Accession Number
Descripción

Accession Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2826726
Cigarette Smoking Status
Descripción

Cigarette Smoking Status

Date of evaluation:
Descripción

Assessment Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2985720
Cigarette Smoking Status
Descripción

Cigarette Smoking Status

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0677453
If patient is currently smoking cigarettes, indicate average number of cigarettes smoked per day:
Descripción

Number of cigarettes smoked per day

Tipo de datos

integer

Alias
UMLS CUI [1]
C3694146
Other Tobacco/Nicotine Use Status
Descripción

Other Tobacco/Nicotine Use Status

Other Tobacco/Nicotine Use
Descripción

Other Tobacco/Nicotine Use

Tipo de datos

integer

Alias
UMLS CUI [1]
C0543414
Cigars and/or Pipes: Not Applicable
Descripción

Cigars and Pipes

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0337666
UMLS CUI [2]
C0240766
If a current user of cigars and/or pipes, indicate frequency used:
Descripción

Cigars and Pipes Frequency used

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0337666
UMLS CUI [1,2]
C0439603
UMLS CUI [2,1]
C0240766
UMLS CUI [2,2]
C0439603
Oral Tobacco Products: Not Applicable
Descripción

Oral Tobacco Products

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0008038
If a current user of oral tobacco products, indicate frequency used:
Descripción

Oral Tobacco Products Frequency used

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0008038
UMLS CUI [1,2]
C0439603
Nicotine replacement therapy: Not Applicable
Descripción

Nicotine Replacement Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278444
If a current user of nicotine replacement therapy, indicate frequency used:
Descripción

Nicotine Replacement Therapy Frequency used

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1278444
UMLS CUI [1,2]
C0439603
Other: Not Applicable
Descripción

Other tobacco/nicotine products

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0543414
Other, please specify:
Descripción

Other tobacco/nicotine products

Tipo de datos

text

Alias
UMLS CUI [1]
C0543414
If a current user of other tobacco/nicotine products, indicate frequency used:
Descripción

Other tobacco/nicotine products frequency used

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0439603
Radiology
Descripción

Radiology

Was a chest X-ray performed?
Descripción

Chest X-Ray

Tipo de datos

integer

Alias
UMLS CUI [1]
C0039985
Date
Descripción

Chest x-ray date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0039985
Was a chest/upper abdomen CT scan performed?
Descripción

Chest/upper abdomen CT scan

Tipo de datos

integer

Alias
UMLS CUI [1]
C0202823
UMLS CUI [2]
C1627748
Date chest/upper abdomen CT scan performed:
Descripción

Date chest/upper abdomen CT scan

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0202823
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C1627748
If yes, was relapse documented?
Descripción

If relapse was documented, complete Relapse Report and New Lesion Specification page.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0277556
Was any other radiological disease assessment performed?
Descripción

Radiologic Examination

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0043299
Date of assessment
Descripción

Date of assessment

Tipo de datos

date

Alias
UMLS CUI [1]
C2985720
If Yes, was relapse documented?
Descripción

If relapse was documented, complete Relapse Report and New Lesion Specification page.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0277556
Specify type of assessment:
Descripción

Evaluation Method

Tipo de datos

text

Alias
UMLS CUI [1]
C2911685
Did the ''Other'' radiological assessment performed include X-Ray imaging of the chest?
Descripción

Chest X-ray

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0039985
Did the ''Other'' radiological assessment performed include CT imaging of the chest?
Descripción

Chest CT

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202823
Did the ''Other'' radiological assessment performed include CT imaging of the chest/upper abdomen?
Descripción

CT of the chest/upper abdomen

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202823
UMLS CUI [2]
C1627748
Study Drug Dispensed
Descripción

Study Drug Dispensed

Date dispensed
Descripción

Date dispensed

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0947323
Bottle number
Descripción

Bottle number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1300638
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Similar models

On-Treatment Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Header
Month Number
Item
Month Number
integer
C0439231 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Item Group
Vital Assessment
Assessment Date
Item
Date
date
C2985720 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
ECOG
Item
ECOG performance status:
integer
C1520224 (UMLS CUI [1])
Item Group
Physical Examination
Date of Examination
Item
Date Physical Examination performed:
date
C2826643 (UMLS CUI [1])
Item Group
Pregnancy Test
Pregnancy Test
Item
Pregnancy Test: Not Applicable
boolean
C0032976 (UMLS CUI [1])
Pregnancy test
Item
Was pregnancy test performed?
boolean
C0032976 (UMLS CUI [1])
Date of Collection
Item
Date of Collection
date
C1516698 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Accession Number
Item
Accession Number
text
C2826726 (UMLS CUI [1])
Item Group
Hematology
Date of Collection
Item
Date of Collection
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Accession Number
Item
Accession Number
text
C2826726 (UMLS CUI [1])
Item Group
Biochemistry/Proteomics
Date of collection
Item
Date of Collection
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Accession Number
Item
Accession Number
text
C2826726 (UMLS CUI [1])
Item Group
Cigarette Smoking Status
Assessment Date
Item
Date of evaluation:
date
C2985720 (UMLS CUI [1])
Item
Cigarette Smoking Status
integer
C0543414 (UMLS CUI [1,1])
C0677453 (UMLS CUI [1,2])
Cigarette Smoking History
Code List
Cigarette Smoking Status
CL Item
Patient not currently smoking cigarettes. (1)
CL Item
Patient is currently smoking cigarettes. (2)
Number of cigarettes smoked per day
Item
If patient is currently smoking cigarettes, indicate average number of cigarettes smoked per day:
integer
C3694146 (UMLS CUI [1])
Item Group
Other Tobacco/Nicotine Use Status
Item
Other Tobacco/Nicotine Use
integer
C0543414 (UMLS CUI [1])
Other Tobacco/Nicotine History
Code List
Other Tobacco/Nicotine Use
CL Item
Patient not currently using other tobacco or nicotine products. Do not complete next questions. (1)
CL Item
Patient currently using other tobacco or nicotine products. Complete next questions. (2)
Cigars and Pipes
Item
Cigars and/or Pipes: Not Applicable
boolean
C0337666 (UMLS CUI [1])
C0240766 (UMLS CUI [2])
Item
If a current user of cigars and/or pipes, indicate frequency used:
integer
C0337666 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0240766 (UMLS CUI [2,1])
C0439603 (UMLS CUI [2,2])
Cigar and Pipe Smoking
Code List
If a current user of cigars and/or pipes, indicate frequency used:
CL Item
at least once daily (1)
CL Item
at least once weekly (2)
CL Item
at least once monthly (3)
CL Item
< once monthly (4)
Oral Tobacco Products
Item
Oral Tobacco Products: Not Applicable
boolean
C0008038 (UMLS CUI [1])
Item
If a current user of oral tobacco products, indicate frequency used:
integer
C0008038 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Cigar and Pipe Smoking
Code List
If a current user of oral tobacco products, indicate frequency used:
CL Item
at least once daily (1)
CL Item
at least once weekly (2)
CL Item
at least once monthly (3)
CL Item
< once monthly (4)
Nicotine Replacement Therapy
Item
Nicotine replacement therapy: Not Applicable
boolean
C1278444 (UMLS CUI [1])
Item
If a current user of nicotine replacement therapy, indicate frequency used:
integer
C1278444 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Cigar and Pipe Smoking
Code List
If a current user of nicotine replacement therapy, indicate frequency used:
CL Item
at least once daily (1)
CL Item
at least once weekly (2)
CL Item
at least once monthly (3)
CL Item
< once monthly (4)
Other tobacco/nicotine products
Item
Other: Not Applicable
boolean
C0543414 (UMLS CUI [1])
Other tobacco/nicotine products
Item
Other, please specify:
text
C0543414 (UMLS CUI [1])
Item
If a current user of other tobacco/nicotine products, indicate frequency used:
integer
C0543414 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Cigar and Pipe Smoking
Code List
If a current user of other tobacco/nicotine products, indicate frequency used:
CL Item
at least once daily (1)
CL Item
at least once weekly (2)
CL Item
at least once monthly (3)
CL Item
< once monthly (4)
Item Group
Radiology
Item
Was a chest X-ray performed?
integer
C0039985 (UMLS CUI [1])
Chest X-Ray
Code List
Was a chest X-ray performed?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Chest x-ray date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
Item
Was a chest/upper abdomen CT scan performed?
integer
C0202823 (UMLS CUI [1])
C1627748 (UMLS CUI [2])
Chest X-Ray
Code List
Was a chest/upper abdomen CT scan performed?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Date chest/upper abdomen CT scan
Item
Date chest/upper abdomen CT scan performed:
date
C0011008 (UMLS CUI [1,1])
C0202823 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1627748 (UMLS CUI [2,2])
Relapse
Item
If yes, was relapse documented?
boolean
C0277556 (UMLS CUI [1])
Radiologic Examination
Item
Was any other radiological disease assessment performed?
boolean
C0043299 (UMLS CUI [1])
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Relapse
Item
If Yes, was relapse documented?
boolean
C0277556 (UMLS CUI [1])
Evaluation Method
Item
Specify type of assessment:
text
C2911685 (UMLS CUI [1])
Chest X-ray
Item
Did the ''Other'' radiological assessment performed include X-Ray imaging of the chest?
boolean
C0039985 (UMLS CUI [1])
Chest CT
Item
Did the ''Other'' radiological assessment performed include CT imaging of the chest?
boolean
C0202823 (UMLS CUI [1])
CT of the chest/upper abdomen
Item
Did the ''Other'' radiological assessment performed include CT imaging of the chest/upper abdomen?
boolean
C0202823 (UMLS CUI [1])
C1627748 (UMLS CUI [2])
Item Group
Study Drug Dispensed
Date dispensed
Item
Date dispensed
date
C0011008 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
Bottle number
Item
Bottle number
integer
C1300638 (UMLS CUI [1])
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