ID

17649

Description

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: Unscheduled Visit

Link

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

Keywords

Versions (2)
  1. 8/1/16 8/1/16 -
  2. 9/27/16 9/27/16 -
Uploaded on

September 27, 2016

DOI

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License

Creative Commons BY 4.0
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Unscheduled Visit, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425

English

Unscheduled Visit, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 forms  
Header
Description

Header

Visit Number
Description

Visit Number

Data type

text

Alias
UMLS CUI [1]
C1549755
Vital Assessment
Description

Vital Assessment

Date
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
ECOG performance status:
Description

ECOG

Data type

integer

Alias
UMLS CUI [1]
C1520224
Physical Examination
Description

Physical Examination

Date Physical Examination performed:
Description

Date of Examination

Data type

date

Alias
UMLS CUI [1]
C2826643
Pregnancy Test
Description

Pregnancy Test

Pregnancy Test: Not Applicable
Description

Pregnancy Test

Data type

boolean

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

If applicable: Was pregnancy test performed?

Data type

boolean

Alias
UMLS CUI [1]
C0032976
Date of Collection
Description

Date of Collection

Data type

date

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

Accession Number

Data type

float

Alias
UMLS CUI [1]
C2826726
Hematology
Description

Hematology

Date of Collection
Description

Date of Collection

Data type

date

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

Accession Number

Data type

float

Alias
UMLS CUI [1]
C2826726
Biochemistry/Proteomics
Description

Biochemistry/Proteomics

Date of Collection
Description

Date of collection

Data type

date

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

Accession Number

Data type

float

Alias
UMLS CUI [1]
C2826726
Cigarette Smoking Status
Description

Cigarette Smoking Status

Cigarette Smoking Status: Done?
Description

Cigarette Smoking Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0677453
Date of evaluation:
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Cigarette Smoking Status
Description

Cigarette Smoking Status

Data type

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:
Description

Number of cigarettes smoked per day

Data type

integer

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

Other Tobacco/Nicotine Use Status

Other Tobacco/Nicotine Use
Description

Other Tobacco/Nicotine Use

Data type

integer

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

Cigars and Pipes

Data type

boolean

Alias
UMLS CUI [1]
C0337666
UMLS CUI [2]
C0240766
Cigars and/or Pipes: Frequency used
Description

Cigars and Pipes Frequency used

Data type

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
Description

Oral Tobacco Products

Data type

boolean

Alias
UMLS CUI [1]
C0008038
Oral Tobacco Products: Frequency used
Description

Oral Tobacco Products Frequency used

Data type

integer

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

Nicotine Replacement Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1278444
Nicotine replacement therapy: Frequency used
Description

Nicotine Replacement Therapy Frequency used

Data type

integer

Alias
UMLS CUI [1,1]
C1278444
UMLS CUI [1,2]
C0439603
Other tobacco/nicotine products: Not Applicable
Description

Other tobacco/nicotine products

Data type

boolean

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

Other tobacco/nicotine products

Data type

text

Alias
UMLS CUI [1]
C0543414
Other: Frequency used
Description

Other tobacco/nicotine products frequency used

Data type

integer

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

Radiology

Was a chest X-ray performed?
Description

Chest X-Ray

Data type

integer

Alias
UMLS CUI [1]
C0039985
Date
Description

Chest x-ray date

Data type

date

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

Chest/upper abdomen CT scan

Data type

integer

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

Date chest/upper abdomen CT scan

Data type

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?
Description

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

Data type

boolean

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

Radiologic Examination

Data type

boolean

Alias
UMLS CUI [1]
C0043299
Date of assessment
Description

Date of assessment

Data type

date

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

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

Data type

boolean

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

Evaluation Method

Data type

text

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

Chest X-ray

Data type

boolean

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

Chest CT

Data type

boolean

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

CT of the chest/upper abdomen

Data type

boolean

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

Study Drug Dispensed

Study Drug Dispensed: Not Applicable
Description

Study Drug Dispensed

Data type

text

Alias
UMLS CUI [1]
C0947323
Study Drug Dispensed
Description

Study Drug Dispensed

Date dispensed
Description

Date dispensed

Data type

date

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

Bottle number

Data type

integer

Alias
UMLS CUI [1]
C1300638
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Similar models

Unscheduled Visit, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Visit Number
Item
Visit Number
text
C1549755 (UMLS CUI [1])
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
float
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
float
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
float
C2826726 (UMLS CUI [1])
Item Group
Cigarette Smoking Status
Cigarette Smoking Status
Item
Cigarette Smoking Status: Done?
boolean
C0543414 (UMLS CUI [1,1])
C0677453 (UMLS CUI [1,2])
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
Cigars and/or Pipes: 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
Cigars and/or Pipes: 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
Oral Tobacco Products: Frequency used
integer
C0008038 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Oral Tobacco Products Frequency used
Code List
Oral Tobacco Products: 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
Nicotine replacement therapy: Frequency used
integer
C1278444 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Oral Tobacco Products Frequency used
Code List
Nicotine replacement therapy: 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 tobacco/nicotine products: Not Applicable
boolean
C0543414 (UMLS CUI [1])
Other tobacco/nicotine products
Item
Other, please specify:
text
C0543414 (UMLS CUI [1])
Item
Other: Frequency used
integer
C0543414 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Oral Tobacco Products Frequency used
Code List
Other: 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/upper abdomen CT scan
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
Study Drug Dispensed
Item
Study Drug Dispensed: Not Applicable
text
C0947323 (UMLS CUI [1])
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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