ID

17654

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: Open-label Tarceva Consent and Eligibility

Link

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

Keywords

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

September 27, 2016

DOI

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License

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

English

Open-label Tarceva Consent and Eligibility, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 forms  
Open Label Tarceva Consent
Description

Open Label Tarceva Consent

Date addendum to main study consent was signed:
Description

Consent date

Data type

date

Alias
UMLS CUI [1]
C2985782
Open-label Tarceva: please check one
Description

Open-label Tarceva

Data type

integer

Alias
UMLS CUI [1,1]
C1709323
UMLS CUI [1,2]
C1135136
Open-label Tarceva Eligibility
Description

Open-label Tarceva Eligibility

Open-label Tarceva Eligibility: Not Applicable
Description

Open-label Tarceva Eligibility

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Did the patient meet all of the eligibility criteria to receive open-label Tarceva?
Description

Eligibility Criteria: OSI-774-302 Protocol Version 2, 21 November 2007, Appendix 12.9

Data type

boolean

Alias
UMLS CUI [1]
C1302261
If No, which of the 4 criteria was/were not met? Criteria 1 met?
Description

Eligibility Criteria

Data type

boolean

Alias
UMLS CUI [1]
C1516637
If No, which of the 4 criteria was/were not met? Criteria 2 met?
Description

Eligibility Criteria

Data type

boolean

Alias
UMLS CUI [1]
C1516637
If No, which of the 4 criteria was/were not met? Criteria 3 met?
Description

Eligibility Criteria

Data type

boolean

Alias
UMLS CUI [1]
C1516637
If No, which of the 4 criteria was/were not met? Criteria 4 met?
Description

Eligibility Criteria

Data type

boolean

Alias
UMLS CUI [1]
C1516637
lf any eligibility criteria were not met, was an exemption granted by OSI?
Description

Exemption

Data type

integer

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348482
Investigator Signature
Description

Investigator Signature

Investigator's Signature:
Description

I have reviewed all data for this patient's eligibility and confirm that consent has been obtained in accordance with the GCP Directive (2005/28/EC) or EU Directive (2001/20/EC) and other applicable GCP requirements.

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Investigator Signature Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Open-label Tarceva Consent and Eligibility, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Open Label Tarceva Consent
Consent date
Item
Date addendum to main study consent was signed:
date
C2985782 (UMLS CUI [1])
Item
Open-label Tarceva: please check one
integer
C1709323 (UMLS CUI [1,1])
C1135136 (UMLS CUI [1,2])
Open-label Tarceva
Code List
Open-label Tarceva: please check one
CL Item
Patient to receive open-label Tarceva for up to two years and will be followed for all On-treatment, Post-treatment and Long-term Follow-up Assessments according to the protocol. (Complete Open-label Baseline Assessments.) (1)
CL Item
Patient not to receive open-label Tarceva but will remain in the study and continue to be followed for all Post-treatment and Long-term Follow-up Assessments. (Complete Post-treatment Assessments and Long-term Follow-up Assessments.) (2)
Item Group
Open-label Tarceva Eligibility
Open-label Tarceva Eligibility
Item
Open-label Tarceva Eligibility: Not Applicable
boolean
C1516637 (UMLS CUI [1])
Eligibility
Item
Did the patient meet all of the eligibility criteria to receive open-label Tarceva?
boolean
C1302261 (UMLS CUI [1])
Eligibility Criteria
Item
If No, which of the 4 criteria was/were not met? Criteria 1 met?
boolean
C1516637 (UMLS CUI [1])
Eligibility Criteria
Item
If No, which of the 4 criteria was/were not met? Criteria 2 met?
boolean
C1516637 (UMLS CUI [1])
Eligibility Criteria
Item
If No, which of the 4 criteria was/were not met? Criteria 3 met?
boolean
C1516637 (UMLS CUI [1])
Eligibility Criteria
Item
If No, which of the 4 criteria was/were not met? Criteria 4 met?
boolean
C1516637 (UMLS CUI [1])
Item
lf any eligibility criteria were not met, was an exemption granted by OSI?
integer
C1516637 (UMLS CUI [1,1])
C2348482 (UMLS CUI [1,2])
Exemption
Code List
lf any eligibility criteria were not met, was an exemption granted by OSI?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Item Group
Investigator Signature
Investigator Signature
Item
Investigator's Signature:
text
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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