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16715
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: Open-label Baseline Assessments
Link
https://clinicaltrials.gov/ct2/show/NCT00373425
Stichworte
Versionen (2)
- 02.08.16 02.08.16 -
- 27.09.16 27.09.16 -
Hochgeladen am
2. August 2016
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Open-label Baseline Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425
Open-label Baseline Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425
Ähnliche Modelle
Open-label Baseline Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
Date of Examination
Item
Date Physical Examination performed:
date
C2826643 (UMLS CUI [1])
Pregnancy Test
Item
Pregnancy Test: 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])
C0032976 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Accession Number
Item
Accession Number
text
C2826726 (UMLS CUI [1])
Date of Collection
Item
Date of Collection
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Accession Number
Item
Accession Number
text
C2826726 (UMLS CUI [1])
Date of collection
Item
Date of Collection
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Accession Number
Item
Accession Number
text
C2826726 (UMLS CUI [1])
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])
C0677453 (UMLS CUI [1,2])
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])
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: Applicable?
boolean
C0337666 (UMLS CUI [1])
C0240766 (UMLS CUI [2])
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])
C0439603 (UMLS CUI [1,2])
C0240766 (UMLS CUI [2,1])
C0439603 (UMLS CUI [2,2])
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: 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])
C0439603 (UMLS CUI [1,2])
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: 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])
C0439603 (UMLS CUI [1,2])
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: 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])
C0439603 (UMLS CUI [1,2])
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)
Open-label Tarceva: Date dispensed
Item
Date dispensed
date
C0011008 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
C1135136 (UMLS CUI [1,3])
C0947323 (UMLS CUI [1,2])
C1135136 (UMLS CUI [1,3])
Bottle number
Item
Bottle number
integer
C1300638 (UMLS CUI [1])