ID

17649

Beschreibung

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

Stichworte

Versionen (2)
  1. 01.08.16 01.08.16 -
  2. 27.09.16 27.09.16 -
Hochgeladen am

27. September 2016

DOI

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Lizenz

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

Englisch

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

1 Formulare  
Header
Beschreibung

Header

Visit Number
Beschreibung

Visit Number

Datentyp

text

Alias
UMLS CUI [1]
C1549755
Vital Assessment
Beschreibung

Vital Assessment

Date
Beschreibung

Assessment Date

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
ECOG performance status:
Beschreibung

ECOG

Datentyp

integer

Alias
UMLS CUI [1]
C1520224
Physical Examination
Beschreibung

Physical Examination

Date Physical Examination performed:
Beschreibung

Date of Examination

Datentyp

date

Alias
UMLS CUI [1]
C2826643
Pregnancy Test
Beschreibung

Pregnancy Test

Pregnancy Test: Not Applicable
Beschreibung

Pregnancy Test

Datentyp

boolean

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

If applicable: Was pregnancy test performed?

Datentyp

boolean

Alias
UMLS CUI [1]
C0032976
Date of Collection
Beschreibung

Date of Collection

Datentyp

date

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

Accession Number

Datentyp

float

Alias
UMLS CUI [1]
C2826726
Hematology
Beschreibung

Hematology

Date of Collection
Beschreibung

Date of Collection

Datentyp

date

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

Accession Number

Datentyp

float

Alias
UMLS CUI [1]
C2826726
Biochemistry/Proteomics
Beschreibung

Biochemistry/Proteomics

Date of Collection
Beschreibung

Date of collection

Datentyp

date

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

Accession Number

Datentyp

float

Alias
UMLS CUI [1]
C2826726
Cigarette Smoking Status
Beschreibung

Cigarette Smoking Status

Cigarette Smoking Status: Done?
Beschreibung

Cigarette Smoking Status

Datentyp

boolean

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

Assessment Date

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Cigarette Smoking Status
Beschreibung

Cigarette Smoking Status

Datentyp

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:
Beschreibung

Number of cigarettes smoked per day

Datentyp

integer

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

Other Tobacco/Nicotine Use Status

Other Tobacco/Nicotine Use
Beschreibung

Other Tobacco/Nicotine Use

Datentyp

integer

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

Cigars and Pipes

Datentyp

boolean

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

Cigars and Pipes Frequency used

Datentyp

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
Beschreibung

Oral Tobacco Products

Datentyp

boolean

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

Oral Tobacco Products Frequency used

Datentyp

integer

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

Nicotine Replacement Therapy

Datentyp

boolean

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

Nicotine Replacement Therapy Frequency used

Datentyp

integer

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

Other tobacco/nicotine products

Datentyp

boolean

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

Other tobacco/nicotine products

Datentyp

text

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

Other tobacco/nicotine products frequency used

Datentyp

integer

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

Radiology

Was a chest X-ray performed?
Beschreibung

Chest X-Ray

Datentyp

integer

Alias
UMLS CUI [1]
C0039985
Date
Beschreibung

Chest x-ray date

Datentyp

date

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

Chest/upper abdomen CT scan

Datentyp

integer

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

Date chest/upper abdomen CT scan

Datentyp

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?
Beschreibung

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

Datentyp

boolean

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

Radiologic Examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0043299
Date of assessment
Beschreibung

Date of assessment

Datentyp

date

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

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

Datentyp

boolean

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

Evaluation Method

Datentyp

text

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

Chest X-ray

Datentyp

boolean

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

Chest CT

Datentyp

boolean

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

CT of the chest/upper abdomen

Datentyp

boolean

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

Study Drug Dispensed

Study Drug Dispensed: Not Applicable
Beschreibung

Study Drug Dispensed

Datentyp

text

Alias
UMLS CUI [1]
C0947323
Study Drug Dispensed
Beschreibung

Study Drug Dispensed

Date dispensed
Beschreibung

Date dispensed

Datentyp

date

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

Bottle number

Datentyp

integer

Alias
UMLS CUI [1]
C1300638
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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