ID

16691

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: Screening Assessments

Link

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

Keywords

Versions (2)
  1. 7/27/16 7/27/16 -
  2. 8/1/16 8/1/16 -
Uploaded on

August 1, 2016

DOI

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License

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

English

Screening Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 forms  
Header
Description

Header

Site Number
Description

Site number

Data type

integer

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Patient Number
Description

Patient Number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Demographics
Description

Demographics

Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510
If other, specify
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
Screening Eligibility Criteria
Description

Screening Eligibility Criteria

Did the patient meet all of the screening inclusion criteria?
Description

Inclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
lf No, which was/were not met? Inclusion Letter(s):
Description

Inclusion Criteria

Data type

text

Alias
UMLS CUI [1]
C1512693
Did the patient meet any of the screening exclusion criteria?
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
If Yes, which was/were met? Exclusion Letter(s):
Description

Exclusion Criteria

Data type

text

Alias
UMLS CUI [1]
C0680251
lf any screening eligibility criteria were not met, was an exemption granted by OSI?
Description

Eligibility Criteria

Data type

integer

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348482
Date screening consent was signed:
Description

Date screening consent was signed

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
IVRS Screening Number
Description

IVRS Screening Number

Data type

text

Alias
UMLS CUI [1]
C1710477
Treatment Eligibility Criteria
Description

Treatment Eligibility Criteria

Did the patient meet all of the treatment inclusion criteria?
Description

Inclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
lf No, which was/were not met? Inclusion Number(s):
Description

Inclusion Criteria

Data type

text

Alias
UMLS CUI [1]
C1512693
Did the patient meet any of the treatment exclusion criteria?
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
If Yes, which was/were met? Exclusion Number(s):
Description

Exclusion Criteria

Data type

text

Alias
UMLS CUI [1]
C0680251
lf any treatment eligibility criteria were not met, was an exemption granted by OSI?
Description

Eligibility Criteria

Data type

integer

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348482
Date main study consent was signed:
Description

Date main study consent was signed

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
IVRS Randomization
Description

IVRS Randomization

Date randomized through IVRS:
Description

Study drug therapy must start within 5 days of randomization.

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0034656
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Similar models

Screening Assessments, 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
Site number
Item
Site Number
integer
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Demographics
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic/Latino (1)
CL Item
Not Hispanic/Latino (2)
Item
Race
integer
C0034510 (UMLS CUI [1])
Ethnicity
Code List
Race
CL Item
American Indian/Alaska Native (1)
CL Item
Asian: Far East (2)
CL Item
Asian: Southeast Asia (3)
CL Item
Asian: Indian Subcontinent (4)
CL Item
Black (5)
CL Item
Native Hawaiian/Pacific Islander (6)
CL Item
White (7)
CL Item
Other (8)
Race
Item
If other, specify
text
C0034510 (UMLS CUI [1])
Item Group
Screening Eligibility Criteria
Inclusion Criteria
Item
Did the patient meet all of the screening inclusion criteria?
boolean
C1512693 (UMLS CUI [1])
Inclusion Criteria
Item
lf No, which was/were not met? Inclusion Letter(s):
text
C1512693 (UMLS CUI [1])
Exclusion Criteria
Item
Did the patient meet any of the screening exclusion criteria?
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
If Yes, which was/were met? Exclusion Letter(s):
text
C0680251 (UMLS CUI [1])
Item
lf any screening eligibility criteria were not met, was an exemption granted by OSI?
integer
C1516637 (UMLS CUI [1,1])
C2348482 (UMLS CUI [1,2])
Eligibility Criteria
Code List
lf any screening eligibility criteria were not met, was an exemption granted by OSI?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Date screening consent was signed
Item
Date screening consent was signed:
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
IVRS Screening Number
Item
IVRS Screening Number
text
C1710477 (UMLS CUI [1])
Item Group
Treatment Eligibility Criteria
Inclusion Criteria
Item
Did the patient meet all of the treatment inclusion criteria?
boolean
C1512693 (UMLS CUI [1])
Inclusion Criteria
Item
lf No, which was/were not met? Inclusion Number(s):
text
C1512693 (UMLS CUI [1])
Exclusion Criteria
Item
Did the patient meet any of the treatment exclusion criteria?
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
If Yes, which was/were met? Exclusion Number(s):
text
C0680251 (UMLS CUI [1])
Item
lf any treatment eligibility criteria were not met, was an exemption granted by OSI?
integer
C1516637 (UMLS CUI [1,1])
C2348482 (UMLS CUI [1,2])
Eligibility Criteria
Code List
lf any treatment eligibility criteria were not met, was an exemption granted by OSI?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Date main study consent was signed
Item
Date main study consent was signed:
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Item Group
IVRS Randomization
Randomization Date
Item
Date randomized through IVRS:
date
C0011008 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
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