ID

44900

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

  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

To request one please log in.

License

Creative Commons BY-NC 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :


No comments

In order to download data models you must be logged in. Please log in or register for free.

Baseline Local Laboratory Data, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425

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

  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

Similar models

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

  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])
Code List
Pregnancy test result
CL Item
Positive (1)
CL Item
Negative (2)

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial