ID

44899

Description

Sponsor: OSI Pharmaceuticals Information provided by : 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: Baseline Local Laboratory Data

Link

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

Keywords

Versions (4)
  1. 8/1/16 8/1/16 -
  2. 9/27/16 9/27/16 -
  3. 4/1/22 4/1/22 - Martin Dugas
  4. 4/1/22 4/1/22 - Martin Dugas
Copyright Holder

Astellas Pharma Inc

Uploaded on

April 1, 2022

DOI

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License

Creative Commons BY-NC 4.0
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Baseline Local Laboratory Data, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425

English

Baseline Local Laboratory Data, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 forms  
  1. StudyEvent: Baseline Local Laboratory Data, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425
    1. Baseline Local Laboratory Data, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425
Hematology
Description

Hematology

Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0011008
Lab Name
Description

For each different lab, provide normal ranges.

Data type

text

Alias
UMLS CUI [1]
C1882331
Hemoglobin
Description

Hemoglobin

Data type

float

Measurement units
  • g/dl
Alias
UMLS CUI [1]
C0518015
g/dl
WBC
Description

WBC

Data type

float

Alias
UMLS CUI [1]
C0023508
ANC
Description

Neutrophil count

Data type

float

Alias
UMLS CUI [1]
C0200633
Platelet Count
Description

Platelet Count

Data type

float

Alias
UMLS CUI [1]
C0032181
Biochemistry
Description

Biochemistry

Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0011008
Lab Name
Description

For each different lab, provide normal ranges.

Data type

text

Alias
UMLS CUI [1]
C1882331
Creatinine
Description

Creatinine

Data type

float

Measurement units
  • mg/dl
Alias
UMLS CUI [1]
C0201976
mg/dl
Total Bilirubin
Description

Total Bilirubin

Data type

float

Alias
UMLS CUI [1]
C0201913
ALT (SGPT)
Description

ALT

Data type

float

Alias
UMLS CUI [1]
C0201836
Sodium
Description

Sodium

Data type

float

Measurement units
  • mmol/l
Alias
UMLS CUI [1]
C0337443
mmol/l
Potassium
Description

Potassium

Data type

float

Measurement units
  • mmol/l
Alias
UMLS CUI [1]
C0202194
mmol/l
Magnesium
Description

Magnesium

Data type

float

Alias
UMLS CUI [1]
C0373675
Pregnancy Tests
Description

Pregnancy Tests

Pregnancy Test: Not Applicable
Description

Pregnancy Test

Data type

boolean

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

Pregnancy Tests

Data type

boolean

Alias
UMLS CUI [1]
C0032976
If Yes, date test performed:
Description

Pregnancy test date

Data type

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Pregnancy test result
Description

If positive, complete an Initial Pregnancy Report form.

Data type

integer

Alias
UMLS CUI [1]
C0427777
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Similar models

Baseline Local Laboratory Data, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 forms
  1. StudyEvent: Baseline Local Laboratory Data, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425
    1. Baseline Local Laboratory Data, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Hematology
Date
Item
Date
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory Name
Item
Lab Name
text
C1882331 (UMLS CUI [1])
Hemoglobin
Item
Hemoglobin
float
C0518015 (UMLS CUI [1])
WBC
Item
WBC
float
C0023508 (UMLS CUI [1])
Neutrophil count
Item
ANC
float
C0200633 (UMLS CUI [1])
Platelet Count
Item
Platelet Count
float
C0032181 (UMLS CUI [1])
Item Group
Biochemistry
Date
Item
Date
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory Name
Item
Lab Name
text
C1882331 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Total Bilirubin
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1])
ALT
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Magnesium
Item
Magnesium
float
C0373675 (UMLS CUI [1])
Item Group
Pregnancy Tests
Pregnancy Test
Item
Pregnancy Test: Not Applicable
boolean
C0032976 (UMLS CUI [1])
Pregnancy Tests
Item
Was a serum pregnancy test performed?
boolean
C0032976 (UMLS CUI [1])
Pregnancy test date
Item
If Yes, date test performed:
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pregnancy test result
integer
C0427777 (UMLS CUI [1])
Pregnancy test method
Code List
Pregnancy test result
CL Item
Positive (1)
CL Item
Negative (2)
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