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
Link
https://clinicaltrials.gov/ct2/show/NCT00373425
Keywords
Versions (3)
- 7/27/16 7/27/16 -
- 8/1/16 8/1/16 -
- 9/27/16 9/27/16 -
Uploaded on
September 27, 2016
DOI
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License
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
Data type
text
Alias
- UMLS CUI [1]
- C0011900
- UMLS CUI [2]
- C0087111
Description
Date of Onset
Data type
date
Alias
- UMLS CUI [1]
- C0574845
Description
Active disease
Data type
boolean
Alias
- UMLS CUI [1]
- C2707252
Description
NSCLC Diagnosis
Description
Date of Diagnosis
Data type
date
Alias
- UMLS CUI [1]
- C2316983
Description
Tumor Stage
Data type
integer
Alias
- UMLS CUI [1]
- C1300072
Description
Tumor Size
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0475440
Description
Histologic Type
Data type
integer
Alias
- UMLS CUI [1]
- C0449574
Description
Bronchoalveolar Carcinoma Features
Data type
integer
Alias
- UMLS CUI [1]
- C0007120
Description
Adenocarcinoma
Data type
boolean
Alias
- UMLS CUI [1]
- C0001418
Description
Squamous cell carcinoma
Data type
boolean
Alias
- UMLS CUI [1]
- C0007137
Description
Undifferentiated carcinoma
Data type
boolean
Alias
- UMLS CUI [1]
- C0205698
Description
Mixed histology
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019638
- UMLS CUI [1,2]
- C0205430
Description
Mixed histology
Data type
text
Alias
- UMLS CUI [1,1]
- C0019638
- UMLS CUI [1,2]
- C0205430
Description
Histologic Type
Data type
text
Alias
- UMLS CUI [1]
- C0449574
Description
NSCLC-related Surgery
Description
Surgery Date
Data type
date
Alias
- UMLS CUI [1]
- C1628561
Description
A copy of the surgical report must be collected and submitted with the Case Report Form.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0543467
- UMLS CUI [1,2]
- C0205225
Description
Primary Surgical Procedure
Data type
text
Alias
- UMLS CUI [1,1]
- C0543467
- UMLS CUI [1,2]
- C0205225
Description
Other surgical procedures
Data type
boolean
Alias
- UMLS CUI [1]
- C0543467
Description
Other surgical procedure
Data type
text
Alias
- UMLS CUI [1]
- C0543467
Description
lymph node assessment
Data type
integer
Alias
- UMLS CUI [1]
- C0193842
Description
Number of Nodes Sampled
Data type
integer
Alias
- UMLS CUI [1,1]
- C0444261
- UMLS CUI [1,2]
- C0750480
Description
Tobacco/Nicotine Smoking History at Randomization
Description
Assessment Date
Data type
date
Alias
- UMLS CUI [1]
- C2985720
Description
Cigarette Smoking
Data type
integer
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0677453
Description
Time since stopped smoking
Data type
integer
Alias
- UMLS CUI [1]
- C0453997
Description
Number of cigarettes smoked per day
Data type
integer
Alias
- UMLS CUI [1]
- C3694146
Description
Number of years smoked
Data type
integer
Alias
- UMLS CUI [1]
- C3694955
Description
Other Tobacco/Nicotine History
Data type
integer
Alias
- UMLS CUI [1]
- C0543414
Description
Cigar and Pipe Smoking
Data type
boolean
Alias
- UMLS CUI [1]
- C0337666
- UMLS CUI [2]
- C0240766
Description
Cigar and Pipe Smoking
Data type
integer
Alias
- UMLS CUI [1]
- C0337666
- UMLS CUI [2]
- C0240766
Description
Cigars and Pipe Frequency used
Data type
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
Data type
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
Data type
boolean
Alias
- UMLS CUI [1]
- C0008038
Description
Oral Tobacco Products
Data type
integer
Alias
- UMLS CUI [1]
- C0008038
Description
Oral Tobacco Products Frequency used
Data type
integer
Alias
- UMLS CUI [1,1]
- C0008038
- UMLS CUI [1,2]
- C0439603
Description
Oral Tobacco Products Status
Data type
integer
Alias
- UMLS CUI [1,1]
- C0008038
- UMLS CUI [1,2]
- C0449438
Description
Nicotine Replacement Therapy
Data type
integer
Alias
- UMLS CUI [1]
- C1278444
Description
Nicotine Replacement Therapy
Data type
integer
Alias
- UMLS CUI [1]
- C1278444
Description
Nicotine Replacement Therapy Frequency used
Data type
integer
Alias
- UMLS CUI [1,1]
- C1278444
- UMLS CUI [1,2]
- C0439603
Description
Nicotine Replacement Therapy Status
Data type
integer
Alias
- UMLS CUI [1,1]
- C1278444
- UMLS CUI [1,2]
- C0449438
Description
Other tobacco/nicotine products
Data type
text
Alias
- UMLS CUI [1]
- C0543414
Description
Other tobacco/nicotine products
Data type
text
Alias
- UMLS CUI [1]
- C0543414
Description
Other tobacco/nicotine products
Data type
integer
Alias
- UMLS CUI [1]
- C0543414
Description
Other tobacco/nicotine products frequency used
Data type
integer
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0439603
Description
Other tobacco/nicotine products status
Data type
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
Data type
integer
Alias
- UMLS CUI [1]
- C2045829
Description
Adjuvant Chemotherapy
Data type
text
Alias
- UMLS CUI [1]
- C0085533
Description
Dosage
Data type
float
Alias
- UMLS CUI [1]
- C0178602
Description
Dosage Unit
Data type
text
Alias
- UMLS CUI [1]
- C2348328
Description
Chemotherapy Cycle Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1302181
- UMLS CUI [1,2]
- C3173309
Description
Optional Research Blood Sample
Description
Consent for optional research
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0005834
Description
Date optional research consent was signed
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0021430
Description
Blood Sample
Data type
boolean
Alias
- UMLS CUI [1]
- C0005834
Description
Collection Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Description
Radiology
Description
Chest x-ray
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0039985
Description
Date chest/upper abdomen CT scan performed
Data type
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
Data type
date
Alias
- UMLS CUI [1]
- C2985720
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Height
Data type
float
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
ECOG
Data type
integer
Alias
- UMLS CUI [1]
- C1520224
Description
Physical Examination
Description
Physical Examination Date
Data type
date
Alias
- UMLS CUI [1]
- C2826643
Description
General Appearance
Data type
integer
Alias
- UMLS CUI [1]
- C1148438
Description
General Appearance
Data type
text
Alias
- UMLS CUI [1]
- C1148438
Description
Head/Neck examination
Data type
integer
Alias
- UMLS CUI [1,1]
- C0460004
- UMLS CUI [1,2]
- C0031809
Description
Head and neck examination
Data type
text
Alias
- UMLS CUI [1]
- C0460004
Description
Eyes
Data type
integer
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0031809
Description
Eyes
Data type
text
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0031809
Description
Ears, Nose, Throat
Data type
integer
Alias
- UMLS CUI [1]
- C0278350
Description
Ears, Nose, Throat
Data type
text
Alias
- UMLS CUI [1]
- C0278350
Description
Lungs
Data type
integer
Alias
- UMLS CUI [1]
- C2228454
Description
Lungs
Data type
text
Alias
- UMLS CUI [1]
- C2228454
Description
Cardiovascular
Data type
integer
Alias
- UMLS CUI [1]
- C3854344
Description
Cardiovascular Examination
Data type
text
Alias
- UMLS CUI [1]
- C3854344
Description
Abdomen
Data type
integer
Alias
- UMLS CUI [1]
- C0562238
Description
Abdomen Examination
Data type
text
Alias
- UMLS CUI [1]
- C0562238
Description
Musculoskeletal System Examination
Data type
integer
Alias
- UMLS CUI [1]
- C0475091
Description
Musculoskeletal System Examination
Data type
text
Alias
- UMLS CUI [1]
- C0475091
Description
Neurologic Examination
Data type
integer
Alias
- UMLS CUI [1]
- C0027853
Description
Neurologic Examination
Data type
text
Alias
- UMLS CUI [1]
- C0027853
Description
Genitourinary System Examination
Data type
integer
Alias
- UMLS CUI [1]
- C0555350
Description
Genitourinary System Examination
Data type
text
Alias
- UMLS CUI [1]
- C0555350
Description
Breast Examination
Data type
integer
Alias
- UMLS CUI [1]
- C0199850
Description
Breast Examination
Data type
text
Alias
- UMLS CUI [1]
- C0199850
Description
Rectal Examination
Data type
integer
Alias
- UMLS CUI [1]
- C0199900
Description
Rectal Examination
Data type
text
Alias
- UMLS CUI [1]
- C0199900
Description
Lymph Nodes
Data type
integer
Alias
- UMLS CUI [1]
- C0024204
Description
Lymph Nodes
Data type
text
Alias
- UMLS CUI [1]
- C0024204
Description
Skin Examination
Data type
integer
Alias
- UMLS CUI [1]
- C0437750
Description
Skin Examination
Data type
text
Alias
- UMLS CUI [1]
- C0437750
Description
Extremities Examination
Data type
integer
Alias
- UMLS CUI [1]
- C0436150
Description
Extremities Examination
Data type
text
Alias
- UMLS CUI [1]
- C0436150
Description
Pregnancy Test
Description
Pregnancy Test
Data type
boolean
Alias
- UMLS CUI [1]
- C0032976
Description
If applicable: Was pregnancy test performed?
Data type
boolean
Alias
- UMLS CUI [1]
- C0032976
Description
Date of Collection
Data type
date
Alias
- UMLS CUI [1,1]
- C1516698
- UMLS CUI [1,2]
- C0032976
- UMLS CUI [1,3]
- C0011008
Description
Accession Number
Data type
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:
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator Signature Date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
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Baseline Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425
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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])