ID

16625

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 Post-Treatment Assessments

Link

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

Keywords

Versions (3)
  1. 7/27/16 7/27/16 -
  2. 8/1/16 8/1/16 -
  3. 9/27/16 9/27/16 -
Uploaded on

July 27, 2016

DOI

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License

Creative Commons BY-NC 3.0
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TEST A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors (RADIANT) NCT00373425

English

Post-Treatment Assessment TEST A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors (RADIANT) 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
Vital Assessment
Description

Vital Assessment

Alias
UMLS CUI-1
C0031809
Date
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
ECOG performance status
Description

ECOG

Data type

integer

Alias
UMLS CUI [1]
C1520224
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Date Physical Examination performed: (Record any new physical findings or changes in severity from previous examination on the Adverse Events page. If a new physical finding represents NSCLC relapse, per protocol, it must be confirmed by radiological examination and/or biopsy. lf confirmed, complete Relapse Report and New Lesion Specification page.)
Description

Examination Date

Data type

date

Alias
UMLS CUI [1]
C2826643
Pregnancy Test
Description

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Was pregnancy test performed?
Description

Pregnancy Test

Data type

boolean

Alias
UMLS CUI [1]
C0032976
Date of Collection
Description

Date of Collection

Data type

text

Alias
UMLS CUI [1,1]
C1516698
UMLS CUI [1,2]
C0011008
Accession Number
Description

Accession Number

Data type

text

Alias
UMLS CUI [1]
C2826726
Biochemistry/Proteomics
Description

Biochemistry/Proteomics

Date of Collection
Description

Date of collection

Data type

date

Alias
UMLS CUI [1,1]
C1516698
UMLS CUI [1,2]
C0011008
Accession Number
Description

Accession Number

Data type

integer

Alias
UMLS CUI [1]
C2826726
Reason Off Treatment
Description

Reason Off Treatment

Reason Off Treatment
Description

Reason Off Treatment

Data type

integer

Alias
UMLS CUI [1,1]
C1518544
UMLS CUI [1,2]
C0566251
Specify event(s) or reason(s)
Description

Off Treatment Reason

Data type

text

Alias
UMLS CUI [1,1]
C1518544
UMLS CUI [1,2]
C0566251
Death
Description

Death

Alias
UMLS CUI-1
C0011065
Did the patient die before the Post-treatment visit? (If Yes, complete section below as well as Adverse Events page and Serious Adverse Event Report Form)
Description

Death

Data type

boolean

Alias
UMLS CUI [1]
C0011065
Primary Cause of Death
Description

Primary Cause of Death

Data type

integer

Alias
UMLS CUI [1]
C0007465
If applicable, please specify primary cause of death
Description

Cause of death

Data type

text

Alias
UMLS CUI [1]
C0007465
Was an autopsy performed?
Description

Autopsy

Data type

integer

Alias
UMLS CUI [1]
C0004398
Investigator Signature
Description

Investigator Signature

I have reviewed the data recorded in this Case Report Form. To the best of my knowledge, it is a complete and accurate representation of the patient's status during the study. Investigator's Signature
Description

Investigator Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
UMLS CUI [1]
C2346576
Date
Description

Investigator Signature Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C19464
NCI Thesaurus Property
C25250
NCI Thesaurus Property-2
C25604
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Post-Treatment Assessment TEST A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors (RADIANT) 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])
Item Group
Vital Assessment
C0031809 (UMLS CUI-1)
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
C0031809 (UMLS CUI-1)
Examination Date
Item
Date Physical Examination performed: (Record any new physical findings or changes in severity from previous examination on the Adverse Events page. If a new physical finding represents NSCLC relapse, per protocol, it must be confirmed by radiological examination and/or biopsy. lf confirmed, complete Relapse Report and New Lesion Specification page.)
date
C2826643 (UMLS CUI [1])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Pregnancy Test
Item
Was pregnancy test performed?
boolean
C0032976 (UMLS CUI [1])
Date of Collection
Item
Date of Collection
text
C1516698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Accession Number
Item
Accession Number
text
C2826726 (UMLS CUI [1])
Item Group
Biochemistry/Proteomics
Date of collection
Item
Date of Collection
date
C1516698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Accession Number
Item
Accession Number
integer
C2826726 (UMLS CUI [1])
Item Group
Reason Off Treatment
Item
Reason Off Treatment
integer
C1518544 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reason Off Treatment
Code List
Reason Off Treatment
CL Item
Completion of 2 years of study drug therapy (1)
CL Item
Relapse of NSCLC (Complete Relapse Report page and New Anticancer Treatment page, if applicable) (2)
CL Item
Adverse event, specify event(s) (3)
CL Item
Medical or ethical reasons, or noncompliance, following discussion between the lnvestigator and the OSI medical team (for reasons other than Adverse Event), specify reason(s) (4)
CL Item
Patient request (for reasons other than Adverse Event), specify reason(s) (5)
CL Item
Patient death (6)
Off Treatment Reason
Item
Specify event(s) or reason(s)
text
C1518544 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Item Group
Death
C0011065 (UMLS CUI-1)
Death
Item
Did the patient die before the Post-treatment visit? (If Yes, complete section below as well as Adverse Events page and Serious Adverse Event Report Form)
boolean
C0011065 (UMLS CUI [1])
Item
Primary Cause of Death
integer
C0007465 (UMLS CUI [1])
Primary Cause of Death
Code List
Primary Cause of Death
CL Item
NSCLC Relapse (1)
CL Item
Protocol-related toxicity, specify (2)
CL Item
Intercurrent illness, specify (3)
CL Item
Other, specify (4)
CL Item
Unknown (5)
Cause of death
Item
If applicable, please specify primary cause of death
text
C0007465 (UMLS CUI [1])
Item
Was an autopsy performed?
integer
C0004398 (UMLS CUI [1])
Autopsy
Code List
Was an autopsy performed?
CL Item
Yes (if Yes, append a copy of the autopsy report) (1)
CL Item
No (2)
Item Group
Investigator Signature
Investigator Signature
Item
I have reviewed the data recorded in this Case Report Form. To the best of my knowledge, it is a complete and accurate representation of the patient's status during the study. Investigator's Signature
text
C25704 (NCI Thesaurus ValueDomain)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Date
date
C19464 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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