ID

16691

Beskrivning

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

Länk

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

Nyckelord

Versioner (2)
  1. 2016-07-27 2016-07-27 -
  2. 2016-08-01 2016-08-01 -
Uppladdad den

1 augusti 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

Inga kommentarer

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Screening Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425

Engelsk

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

1 Formulär  
Header
Beskrivning

Header

Site Number
Beskrivning

Site number

Datatyp

integer

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

Patient Number

Datatyp

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beskrivning

Patient Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Demographics
Beskrivning

Demographics

Date of birth
Beskrivning

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beskrivning

Gender

Datatyp

integer

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beskrivning

Ethnicity

Datatyp

integer

Alias
UMLS CUI [1]
C0015031
Race
Beskrivning

Race

Datatyp

integer

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

Race

Datatyp

text

Alias
UMLS CUI [1]
C0034510
Screening Eligibility Criteria
Beskrivning

Screening Eligibility Criteria

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

Inclusion Criteria

Datatyp

boolean

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

Inclusion Criteria

Datatyp

text

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

Exclusion Criteria

Datatyp

boolean

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

Exclusion Criteria

Datatyp

text

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

Eligibility Criteria

Datatyp

integer

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

Date screening consent was signed

Datatyp

date

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

IVRS Screening Number

Datatyp

text

Alias
UMLS CUI [1]
C1710477
Treatment Eligibility Criteria
Beskrivning

Treatment Eligibility Criteria

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

Inclusion Criteria

Datatyp

boolean

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

Inclusion Criteria

Datatyp

text

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

Exclusion Criteria

Datatyp

boolean

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

Exclusion Criteria

Datatyp

text

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

Eligibility Criteria

Datatyp

integer

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

Date main study consent was signed

Datatyp

date

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

IVRS Randomization

Date randomized through IVRS:
Beskrivning

Study drug therapy must start within 5 days of randomization.

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0034656
Tillbaka till toppen

Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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