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