ID
16621
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 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 juli 2016
DOI
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Licens
Creative Commons BY-NC 3.0
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A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors (RADIANT) NCT00373425
Baseline Assessments A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors (RADIANT) 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
Histologic Type
Datatyp
text
Alias
- UMLS CUI [1]
- C0449574
Beskrivning
NSCLC-related Surgery (biopsy information should not be reported.)
Beskrivning
Surgery Date
Datatyp
date
Alias
- UMLS CUI [1]
- C1628561
Beskrivning
Primary Surgical Procedure
Datatyp
integer
Alias
- UMLS CUI [1]
- C0543467
Beskrivning
Primary Surgical Procedure
Datatyp
text
Alias
- UMLS CUI [1]
- C0543467
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 History
Datatyp
integer
Alias
- UMLS CUI [1]
- C0700219
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
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
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 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
integer
Alias
- UMLS CUI [1]
- C0040329
Beskrivning
Other tobacco/nicotine products frequency used
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0040329
- UMLS CUI [1,2]
- C0439603
Beskrivning
Other tobacco/nicotine products status
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0040329
- UMLS CUI [1,2]
- C0449438
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]
- C1317250
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
Date of Collection
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beskrivning
Accession Number
Datatyp
text
Alias
- UMLS CUI [1]
- C2826726
Beskrivning
Hematology
Beskrivning
Biochemistry/Proteomics
Beskrivning
Study Drug Dispensed for Month 1
Beskrivning
Investigator's Signature
Beskrivning
Signature Investigator
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 A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors (RADIANT) NCT00373425
C0600091 (UMLS CUI [1,2])
C1948041 (UMLS CUI [2])
C0750480 (UMLS CUI [1,2])
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])
C3173309 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
C0021430 (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])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1880359 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])