Informazione:
Errore:
ID
17646
Descrizione
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: Baseline Assessments
collegamento
https://clinicaltrials.gov/ct2/show/NCT00373425
Keywords
versioni (3)
- 27/07/16 27/07/16 -
- 01/08/16 01/08/16 -
- 27/09/16 27/09/16 -
Caricato su
27 settembre 2016
DOI
Per favore, per richiedere un accesso.
Licenza
Creative Commons BY 4.0
Commenti del modello :
Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.
Commenti del gruppo di articoli per :
Commenti dell'articolo per :
Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.
Baseline Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425
Baseline Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425
Similar models
Baseline Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Significant Medical and Surgical History
Item
Significant Medical and Surgical History?
boolean
C0262926 (UMLS CUI [1])
Diagnosis/Procedure
Item
List Specific Diagnosis/Procedure
text
C0011900 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0087111 (UMLS CUI [2])
Date of Onset
Item
Date of Onset if Known
date
C0574845 (UMLS CUI [1])
Active disease
Item
Active
boolean
C2707252 (UMLS CUI [1])
Date of Diagnosis
Item
Date of Initial Pathological Diagnosis
date
C2316983 (UMLS CUI [1])
CL Item
IB (1)
CL Item
IIB (2)
CL Item
IIA (3)
CL Item
IIIA (4)
Tumor Size
Item
Tumor size
float
C0475440 (UMLS CUI [1])
CL Item
Adenocarcinoma (1)
CL Item
Squamous cell carcinoma (2)
CL Item
Undifferentiated large cell carcinoma (3)
CL Item
Mixed histology (specify) (4)
CL Item
Other (specify) (5)
Item
If Adenocarcinoma: Bronchoalveolar Carcinoma Features?
integer
C0007120 (UMLS CUI [1])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Adenocarcinoma
Item
If mixed histology: Adenocarcinoma?
boolean
C0001418 (UMLS CUI [1])
Squamous cell carcinoma
Item
If mixed histology: Squamous cell carcinoma?
boolean
C0007137 (UMLS CUI [1])
Undifferentiated carcinoma
Item
If mixed histology: Undifferentiated?
boolean
C0205698 (UMLS CUI [1])
Mixed histology
Item
If mixed histology: Other? (specify)
boolean
C0019638 (UMLS CUI [1,1])
C0205430 (UMLS CUI [1,2])
C0205430 (UMLS CUI [1,2])
Mixed histology
Item
If mixed histology: other, please specify
text
C0019638 (UMLS CUI [1,1])
C0205430 (UMLS CUI [1,2])
C0205430 (UMLS CUI [1,2])
Histologic Type
Item
If other histologic type, please specify
text
C0449574 (UMLS CUI [1])
Surgery Date
Item
Date of Surgery
date
C1628561 (UMLS CUI [1])
Item
Primary surgical procedure
integer
C0543467 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,2])
CL Item
Pneumonectomy (1)
CL Item
Lobectomy (2)
CL Item
Bilobectomy (3)
CL Item
Sleeve Lobectomy (4)
CL Item
Other (5)
Primary Surgical Procedure
Item
If other, specify:
text
C0543467 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,2])
Other surgical procedures
Item
Were any other surgical procedures performed?
boolean
C0543467 (UMLS CUI [1])
Other surgical procedure
Item
If Yes, specify:
text
C0543467 (UMLS CUI [1])
CL Item
Node Dissection (1)
CL Item
Node Sampling Only (2)
CL Item
Unknown (3)
Number of Nodes Sampled
Item
Number of nodes sampled
integer
C0444261 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
Item Group
Tobacco/Nicotine Smoking History at Randomization
Assessment Date
Item
Date of evaluation:
date
C2985720 (UMLS CUI [1])
Item
Cigarette Smoking History (Please indicate one of the following:)
integer
C0543414 (UMLS CUI [1,1])
C0677453 (UMLS CUI [1,2])
C0677453 (UMLS CUI [1,2])
Code List
Cigarette Smoking History (Please indicate one of the following:)
CL Item
Patient never smoked cigarettes. (1)
CL Item
Patient has smoked ≤ 100 cigarettes in a lifetime and stopped. (2)
CL Item
Patient has smoked ≥ 100 cigarettes in a lifetime and stopped. (3)
CL Item
Patient is currently smoking cigarettes. (4)
Item
If patient has stopped smoking, please indicate when stopped:
integer
C0453997 (UMLS CUI [1])
CL Item
< 1 month (1)
CL Item
1 month-1 year (2)
CL Item
> 1 year (3)
Item
If patient has smoked ≥ 100 cigarettes in a lifetime and stopped or is currently smoking cigarettes, please indicate average number of cigarettes smoked per day:
integer
C3694146 (UMLS CUI [1])
Code List
If patient has smoked ≥ 100 cigarettes in a lifetime and stopped or is currently smoking cigarettes, please indicate average number of cigarettes smoked per day:
Number of years smoked
Item
If patient has smoked ≥ 100 cigarettes in a lifetime and stopped or is currently smoking cigarettes, please indicate number of years smoked:
integer
C3694955 (UMLS CUI [1])
Item
Other Tobacco/Nicotine History at Randomization
integer
C0543414 (UMLS CUI [1])
CL Item
Patient never used other tobacco or nicotine products. Do not complete next questions. (1)
CL Item
Patient currently or in the past has used other tobacco or nicotine products. Complete next questions. (2)
Cigar and Pipe Smoking
Item
Cigars and/or Pipes: Not Applicable
boolean
C0337666 (UMLS CUI [1])
C0240766 (UMLS CUI [2])
C0240766 (UMLS CUI [2])
Cigar and Pipe Smoking
Item
Cigars and/or Pipes: Number of years used
integer
C0337666 (UMLS CUI [1])
C0240766 (UMLS CUI [2])
C0240766 (UMLS CUI [2])
Item
Cigars and/or Pipes: Frequency used
integer
C0337666 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0240766 (UMLS CUI [2,1])
C0439603 (UMLS CUI [2,2])
C0439603 (UMLS CUI [1,2])
C0240766 (UMLS CUI [2,1])
C0439603 (UMLS CUI [2,2])
CL Item
at least once daily (1)
CL Item
at least once weekly (2)
CL Item
at least once monthly (3)
CL Item
< once monthly (4)
Item
Cigars and/or Pipes: Product stopped
integer
C0337666 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0240766 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C0449438 (UMLS CUI [1,2])
C0240766 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
CL Item
no, current user (1)
CL Item
< 1 month (2)
CL Item
1 month-1 year (3)
CL Item
> 1 year (4)
Oral Tobacco Products
Item
Oral Tobacco Products: Not Applicable
boolean
C0008038 (UMLS CUI [1])
Oral Tobacco Products
Item
Oral Tobacco Products: Number of years used
integer
C0008038 (UMLS CUI [1])
Item
Oral Tobacco Products: Frequency used
integer
C0008038 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
CL Item
at least once daily (1)
CL Item
at least once weekly (2)
CL Item
at least once monthly (3)
CL Item
< once monthly (4)
Item
Oral Tobacco Products: Product stopped
integer
C0008038 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
CL Item
no, current user (1)
CL Item
< 1 month (2)
CL Item
1 month-1 year (3)
CL Item
> 1 year (4)
Nicotine Replacement Therapy
Item
Nicotine replacement therapy: Not Applicable
integer
C1278444 (UMLS CUI [1])
Nicotine Replacement Therapy
Item
Nicotine replacement therapy: Number of years used
integer
C1278444 (UMLS CUI [1])
Item
Nicotine replacement therapy: Frequency used
integer
C1278444 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
CL Item
at least once daily (1)
CL Item
at least once weekly (2)
CL Item
at least once monthly (3)
CL Item
< once monthly (4)
Item
Nicotine replacement therapy: Product stopped
integer
C1278444 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
CL Item
no, current user (1)
CL Item
< 1 month (2)
CL Item
1 month-1 year (3)
CL Item
> 1 year (4)
Other tobacco/nicotine products
Item
Other: Not Applicable
text
C0543414 (UMLS CUI [1])
Other tobacco/nicotine products
Item
Other, please specify:
text
C0543414 (UMLS CUI [1])
Other tobacco/nicotine products
Item
Other: Number of years used
integer
C0543414 (UMLS CUI [1])
Item
Other: Frequency used
integer
C0543414 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
CL Item
at least once daily (1)
CL Item
at least once weekly (2)
CL Item
at least once monthly (3)
CL Item
< once monthly (4)
Item
Other: Product stopped
integer
C0543414 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
CL Item
no, current user (1)
CL Item
< 1 month (2)
CL Item
1 month-1 year (3)
CL Item
> 1 year (4)
Adjuvant Chemotherapy
Item
Prior Adjuvant Chemotherapy for NSCLC?
boolean
C0085533 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0007131 (UMLS CUI [1,2])
Cycle Number
Item
Cycle Number
integer
C2045829 (UMLS CUI [1])
Adjuvant Chemotherapy
Item
Adjuvant Chemotherapy Regimen
text
C0085533 (UMLS CUI [1])
Dosage
Item
Dose Administered: Amount
float
C0178602 (UMLS CUI [1])
Dosage Unit
Item
Dose Administered: Unit
text
C2348328 (UMLS CUI [1])
Chemotherapy Cycle Start Date
Item
Cycle Start Date
date
C1302181 (UMLS CUI [1,1])
C3173309 (UMLS CUI [1,2])
C3173309 (UMLS CUI [1,2])
Consent for optional research
Item
Was consent for optional research signed?
boolean
C0021430 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
Date optional research consent was signed
Item
Date optional research consent was signed:
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
Blood Sample
Item
Was a 3-5mL whole blood sample collected?
boolean
C0005834 (UMLS CUI [1])
Collection Date
Item
If Yes, date sample was collected:
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Chest x-ray
Item
Date chest X-ray performed:
date
C0011008 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
C0039985 (UMLS CUI [1,2])
Date chest/upper abdomen CT scan performed
Item
Date chest/upper abdomen CT scan performed:
date
C0011008 (UMLS CUI [1,1])
C0202823 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1627748 (UMLS CUI [2,2])
C0202823 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1627748 (UMLS CUI [2,2])
Assessment Date
Item
Date
date
C2985720 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
float
C0005890 (UMLS CUI [1])
ECOG
Item
ECOG performance status:
integer
C1520224 (UMLS CUI [1])
Physical Examination Date
Item
Date
date
C2826643 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
General Appearance
Item
General appearance: If abnormal, please specify
text
C1148438 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Head and neck examination
Item
Head/Neck: If abnormal, please specify
text
C0460004 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Eyes
Item
Eyes: If abnormal, please specify
text
C0015392 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Ears, Nose, Throat
Item
Ears, Nose, Throat: If abnormal, please specify
text
C0278350 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Lungs
Item
Lungs, if abnormal, please specify
text
C2228454 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Cardiovascular Examination
Item
Cardiovascular: If abnormal, please specify
text
C3854344 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Abdomen Examination
Item
Abdomen: If abnormal, please specify
text
C0562238 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Musculoskeletal System Examination
Item
Musculoskeletal: If abnormal, please specify
text
C0475091 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Neurologic Examination
Item
Neurologic: If abnormal, please specify
text
C0027853 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Genitourinary System Examination
Item
Genitourinary: If abnormal, please specify
text
C0555350 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Breast Examination
Item
Breast: If abnormal, please specify
text
C0199850 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Rectal Examination
Item
Rectal: If abnormal, please specify
text
C0199900 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Lymph Nodes
Item
Lymph Node: If abnormal, please specify
text
C0024204 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Skin Examination
Item
Skin: If abnormal, please specify
text
C0437750 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Extremities Examination
Item
Extremities: If abnormal, please specify
text
C0436150 (UMLS CUI [1])
Pregnancy Test
Item
Pregnancy Test: Not Applicable
boolean
C0032976 (UMLS CUI [1])
Pregnancy test
Item
Was pregnancy test performed?
boolean
C0032976 (UMLS CUI [1])
Date of Collection
Item
Date of Collection
date
C1516698 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0032976 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Accession Number
Item
Accession Number
float
C2826726 (UMLS CUI [1])
Date of Collection
Item
Date of Collection
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Accession Number
Item
Accession Number
float
C2826726 (UMLS CUI [1])
Date of collection
Item
Date of Collection
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Accession Number
Item
Accession Number
float
C2826726 (UMLS CUI [1])
Date dispensed
Item
Date dispensed
date
C0011008 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
C0947323 (UMLS CUI [1,2])
Bottle number
Item
Bottle number
float
C1300638 (UMLS CUI [1])
Signature Investigator
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])
C0011008 (UMLS CUI [1,2])