ID
17646
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: Baseline Assessments
Lien
https://clinicaltrials.gov/ct2/show/NCT00373425
Mots-clés
Versions (3)
- 27/07/2016 27/07/2016 -
- 01/08/2016 01/08/2016 -
- 27/09/2016 27/09/2016 -
Téléchargé le
27 septembre 2016
DOI
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Licence
Creative Commons BY 4.0
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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
Description
Significant Medical and Surgical History
Description
Diagnosis/Procedure
Type de données
text
Alias
- UMLS CUI [1]
- C0011900
- UMLS CUI [2]
- C0087111
Description
Date of Onset
Type de données
date
Alias
- UMLS CUI [1]
- C0574845
Description
Active disease
Type de données
boolean
Alias
- UMLS CUI [1]
- C2707252
Description
NSCLC Diagnosis
Description
Date of Diagnosis
Type de données
date
Alias
- UMLS CUI [1]
- C2316983
Description
Tumor Stage
Type de données
integer
Alias
- UMLS CUI [1]
- C1300072
Description
Tumor Size
Type de données
float
Unités de mesure
- mm
Alias
- UMLS CUI [1]
- C0475440
Description
Histologic Type
Type de données
integer
Alias
- UMLS CUI [1]
- C0449574
Description
Bronchoalveolar Carcinoma Features
Type de données
integer
Alias
- UMLS CUI [1]
- C0007120
Description
Adenocarcinoma
Type de données
boolean
Alias
- UMLS CUI [1]
- C0001418
Description
Squamous cell carcinoma
Type de données
boolean
Alias
- UMLS CUI [1]
- C0007137
Description
Undifferentiated carcinoma
Type de données
boolean
Alias
- UMLS CUI [1]
- C0205698
Description
Mixed histology
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0019638
- UMLS CUI [1,2]
- C0205430
Description
Mixed histology
Type de données
text
Alias
- UMLS CUI [1,1]
- C0019638
- UMLS CUI [1,2]
- C0205430
Description
Histologic Type
Type de données
text
Alias
- UMLS CUI [1]
- C0449574
Description
NSCLC-related Surgery
Description
Surgery Date
Type de données
date
Alias
- UMLS CUI [1]
- C1628561
Description
A copy of the surgical report must be collected and submitted with the Case Report Form.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0543467
- UMLS CUI [1,2]
- C0205225
Description
Primary Surgical Procedure
Type de données
text
Alias
- UMLS CUI [1,1]
- C0543467
- UMLS CUI [1,2]
- C0205225
Description
Other surgical procedures
Type de données
boolean
Alias
- UMLS CUI [1]
- C0543467
Description
Other surgical procedure
Type de données
text
Alias
- UMLS CUI [1]
- C0543467
Description
lymph node assessment
Type de données
integer
Alias
- UMLS CUI [1]
- C0193842
Description
Number of Nodes Sampled
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0444261
- UMLS CUI [1,2]
- C0750480
Description
Tobacco/Nicotine Smoking History at Randomization
Description
Assessment Date
Type de données
date
Alias
- UMLS CUI [1]
- C2985720
Description
Cigarette Smoking
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0677453
Description
Time since stopped smoking
Type de données
integer
Alias
- UMLS CUI [1]
- C0453997
Description
Number of cigarettes smoked per day
Type de données
integer
Alias
- UMLS CUI [1]
- C3694146
Description
Number of years smoked
Type de données
integer
Alias
- UMLS CUI [1]
- C3694955
Description
Other Tobacco/Nicotine History
Type de données
integer
Alias
- UMLS CUI [1]
- C0543414
Description
Cigar and Pipe Smoking
Type de données
boolean
Alias
- UMLS CUI [1]
- C0337666
- UMLS CUI [2]
- C0240766
Description
Cigar and Pipe Smoking
Type de données
integer
Alias
- UMLS CUI [1]
- C0337666
- UMLS CUI [2]
- C0240766
Description
Cigars and Pipe Frequency used
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0337666
- UMLS CUI [1,2]
- C0439603
- UMLS CUI [2,1]
- C0240766
- UMLS CUI [2,2]
- C0439603
Description
Cigar and Pipe Smoking Status
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0337666
- UMLS CUI [1,2]
- C0449438
- UMLS CUI [2,1]
- C0240766
- UMLS CUI [2,2]
- C0449438
Description
Oral Tobacco Products
Type de données
boolean
Alias
- UMLS CUI [1]
- C0008038
Description
Oral Tobacco Products
Type de données
integer
Alias
- UMLS CUI [1]
- C0008038
Description
Oral Tobacco Products Frequency used
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0008038
- UMLS CUI [1,2]
- C0439603
Description
Oral Tobacco Products Status
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0008038
- UMLS CUI [1,2]
- C0449438
Description
Nicotine Replacement Therapy
Type de données
integer
Alias
- UMLS CUI [1]
- C1278444
Description
Nicotine Replacement Therapy
Type de données
integer
Alias
- UMLS CUI [1]
- C1278444
Description
Nicotine Replacement Therapy Frequency used
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1278444
- UMLS CUI [1,2]
- C0439603
Description
Nicotine Replacement Therapy Status
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1278444
- UMLS CUI [1,2]
- C0449438
Description
Other tobacco/nicotine products
Type de données
text
Alias
- UMLS CUI [1]
- C0543414
Description
Other tobacco/nicotine products
Type de données
text
Alias
- UMLS CUI [1]
- C0543414
Description
Other tobacco/nicotine products
Type de données
integer
Alias
- UMLS CUI [1]
- C0543414
Description
Other tobacco/nicotine products frequency used
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0439603
Description
Other tobacco/nicotine products status
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0449438
Description
Prior Adjuvant Chemotherapy
Description
Prior Adjuvant Chemotherapy for NSCLC
Description
Cycle Number
Type de données
integer
Alias
- UMLS CUI [1]
- C2045829
Description
Adjuvant Chemotherapy
Type de données
text
Alias
- UMLS CUI [1]
- C0085533
Description
Dosage
Type de données
float
Alias
- UMLS CUI [1]
- C0178602
Description
Dosage Unit
Type de données
text
Alias
- UMLS CUI [1]
- C2348328
Description
Chemotherapy Cycle Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1302181
- UMLS CUI [1,2]
- C3173309
Description
Optional Research Blood Sample
Description
Consent for optional research
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0005834
Description
Date optional research consent was signed
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0021430
Description
Blood Sample
Type de données
boolean
Alias
- UMLS CUI [1]
- C0005834
Description
Collection Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Description
Radiology
Description
Chest x-ray
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0039985
Description
Date chest/upper abdomen CT scan performed
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0202823
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1627748
Description
Vital Assessment
Description
Assessment Date
Type de données
date
Alias
- UMLS CUI [1]
- C2985720
Description
Weight
Type de données
float
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Height
Type de données
float
Unités de mesure
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
ECOG
Type de données
integer
Alias
- UMLS CUI [1]
- C1520224
Description
Physical Examination
Description
Physical Examination Date
Type de données
date
Alias
- UMLS CUI [1]
- C2826643
Description
General Appearance
Type de données
integer
Alias
- UMLS CUI [1]
- C1148438
Description
General Appearance
Type de données
text
Alias
- UMLS CUI [1]
- C1148438
Description
Head/Neck examination
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0460004
- UMLS CUI [1,2]
- C0031809
Description
Head and neck examination
Type de données
text
Alias
- UMLS CUI [1]
- C0460004
Description
Eyes
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0031809
Description
Eyes
Type de données
text
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0031809
Description
Ears, Nose, Throat
Type de données
integer
Alias
- UMLS CUI [1]
- C0278350
Description
Ears, Nose, Throat
Type de données
text
Alias
- UMLS CUI [1]
- C0278350
Description
Lungs
Type de données
integer
Alias
- UMLS CUI [1]
- C2228454
Description
Lungs
Type de données
text
Alias
- UMLS CUI [1]
- C2228454
Description
Cardiovascular
Type de données
integer
Alias
- UMLS CUI [1]
- C3854344
Description
Cardiovascular Examination
Type de données
text
Alias
- UMLS CUI [1]
- C3854344
Description
Abdomen
Type de données
integer
Alias
- UMLS CUI [1]
- C0562238
Description
Abdomen Examination
Type de données
text
Alias
- UMLS CUI [1]
- C0562238
Description
Musculoskeletal System Examination
Type de données
integer
Alias
- UMLS CUI [1]
- C0475091
Description
Musculoskeletal System Examination
Type de données
text
Alias
- UMLS CUI [1]
- C0475091
Description
Neurologic Examination
Type de données
integer
Alias
- UMLS CUI [1]
- C0027853
Description
Neurologic Examination
Type de données
text
Alias
- UMLS CUI [1]
- C0027853
Description
Genitourinary System Examination
Type de données
integer
Alias
- UMLS CUI [1]
- C0555350
Description
Genitourinary System Examination
Type de données
text
Alias
- UMLS CUI [1]
- C0555350
Description
Breast Examination
Type de données
integer
Alias
- UMLS CUI [1]
- C0199850
Description
Breast Examination
Type de données
text
Alias
- UMLS CUI [1]
- C0199850
Description
Rectal Examination
Type de données
integer
Alias
- UMLS CUI [1]
- C0199900
Description
Rectal Examination
Type de données
text
Alias
- UMLS CUI [1]
- C0199900
Description
Lymph Nodes
Type de données
integer
Alias
- UMLS CUI [1]
- C0024204
Description
Lymph Nodes
Type de données
text
Alias
- UMLS CUI [1]
- C0024204
Description
Skin Examination
Type de données
integer
Alias
- UMLS CUI [1]
- C0437750
Description
Skin Examination
Type de données
text
Alias
- UMLS CUI [1]
- C0437750
Description
Extremities Examination
Type de données
integer
Alias
- UMLS CUI [1]
- C0436150
Description
Extremities Examination
Type de données
text
Alias
- UMLS CUI [1]
- C0436150
Description
Pregnancy Test
Description
Pregnancy Test
Type de données
boolean
Alias
- UMLS CUI [1]
- C0032976
Description
If applicable: Was pregnancy test performed?
Type de données
boolean
Alias
- UMLS CUI [1]
- C0032976
Description
Date of Collection
Type de données
date
Alias
- UMLS CUI [1,1]
- C1516698
- UMLS CUI [1,2]
- C0032976
- UMLS CUI [1,3]
- C0011008
Description
Accession Number
Type de données
float
Alias
- UMLS CUI [1]
- C2826726
Description
Hematology
Description
Biochemistry/Proteomics
Description
Study Drug Dispensed for Month 1
Description
Investigator's Signature
Description
I have reviewed all data for enrollment 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:
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator Signature Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Baseline Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425
C0087111 (UMLS CUI [2])
C0205430 (UMLS CUI [1,2])
C0205430 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
C0677453 (UMLS CUI [1,2])
C0240766 (UMLS CUI [2])
C0240766 (UMLS CUI [2])
C0439603 (UMLS CUI [1,2])
C0240766 (UMLS CUI [2,1])
C0439603 (UMLS CUI [2,2])
C0449438 (UMLS CUI [1,2])
C0240766 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C0439603 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
C0007131 (UMLS CUI [1,2])
C3173309 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0039985 (UMLS CUI [1,2])
C0202823 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1627748 (UMLS CUI [2,2])
C0031809 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0947323 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])