ID
17646
Beschrijving
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
Trefwoorden
Versies (3)
- 27-07-16 27-07-16 -
- 01-08-16 01-08-16 -
- 27-09-16 27-09-16 -
Geüploaded op
27 september 2016
DOI
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Licentie
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
Beschrijving
Significant Medical and Surgical History
Beschrijving
Diagnosis/Procedure
Datatype
text
Alias
- UMLS CUI [1]
- C0011900
- UMLS CUI [2]
- C0087111
Beschrijving
Date of Onset
Datatype
date
Alias
- UMLS CUI [1]
- C0574845
Beschrijving
Active disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C2707252
Beschrijving
NSCLC Diagnosis
Beschrijving
Date of Diagnosis
Datatype
date
Alias
- UMLS CUI [1]
- C2316983
Beschrijving
Tumor Stage
Datatype
integer
Alias
- UMLS CUI [1]
- C1300072
Beschrijving
Tumor Size
Datatype
float
Maateenheden
- mm
Alias
- UMLS CUI [1]
- C0475440
Beschrijving
Histologic Type
Datatype
integer
Alias
- UMLS CUI [1]
- C0449574
Beschrijving
Bronchoalveolar Carcinoma Features
Datatype
integer
Alias
- UMLS CUI [1]
- C0007120
Beschrijving
Adenocarcinoma
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001418
Beschrijving
Squamous cell carcinoma
Datatype
boolean
Alias
- UMLS CUI [1]
- C0007137
Beschrijving
Undifferentiated carcinoma
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205698
Beschrijving
Mixed histology
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0019638
- UMLS CUI [1,2]
- C0205430
Beschrijving
Mixed histology
Datatype
text
Alias
- UMLS CUI [1,1]
- C0019638
- UMLS CUI [1,2]
- C0205430
Beschrijving
Histologic Type
Datatype
text
Alias
- UMLS CUI [1]
- C0449574
Beschrijving
NSCLC-related Surgery
Beschrijving
Surgery Date
Datatype
date
Alias
- UMLS CUI [1]
- C1628561
Beschrijving
A copy of the surgical report must be collected and submitted with the Case Report Form.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0543467
- UMLS CUI [1,2]
- C0205225
Beschrijving
Primary Surgical Procedure
Datatype
text
Alias
- UMLS CUI [1,1]
- C0543467
- UMLS CUI [1,2]
- C0205225
Beschrijving
Other surgical procedures
Datatype
boolean
Alias
- UMLS CUI [1]
- C0543467
Beschrijving
Other surgical procedure
Datatype
text
Alias
- UMLS CUI [1]
- C0543467
Beschrijving
lymph node assessment
Datatype
integer
Alias
- UMLS CUI [1]
- C0193842
Beschrijving
Number of Nodes Sampled
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0444261
- UMLS CUI [1,2]
- C0750480
Beschrijving
Tobacco/Nicotine Smoking History at Randomization
Beschrijving
Assessment Date
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Cigarette Smoking
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0677453
Beschrijving
Time since stopped smoking
Datatype
integer
Alias
- UMLS CUI [1]
- C0453997
Beschrijving
Number of cigarettes smoked per day
Datatype
integer
Alias
- UMLS CUI [1]
- C3694146
Beschrijving
Number of years smoked
Datatype
integer
Alias
- UMLS CUI [1]
- C3694955
Beschrijving
Other Tobacco/Nicotine History
Datatype
integer
Alias
- UMLS CUI [1]
- C0543414
Beschrijving
Cigar and Pipe Smoking
Datatype
boolean
Alias
- UMLS CUI [1]
- C0337666
- UMLS CUI [2]
- C0240766
Beschrijving
Cigar and Pipe Smoking
Datatype
integer
Alias
- UMLS CUI [1]
- C0337666
- UMLS CUI [2]
- C0240766
Beschrijving
Cigars and Pipe Frequency used
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0337666
- UMLS CUI [1,2]
- C0439603
- UMLS CUI [2,1]
- C0240766
- UMLS CUI [2,2]
- C0439603
Beschrijving
Cigar and Pipe Smoking Status
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0337666
- UMLS CUI [1,2]
- C0449438
- UMLS CUI [2,1]
- C0240766
- UMLS CUI [2,2]
- C0449438
Beschrijving
Oral Tobacco Products
Datatype
boolean
Alias
- UMLS CUI [1]
- C0008038
Beschrijving
Oral Tobacco Products
Datatype
integer
Alias
- UMLS CUI [1]
- C0008038
Beschrijving
Oral Tobacco Products Frequency used
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0008038
- UMLS CUI [1,2]
- C0439603
Beschrijving
Oral Tobacco Products Status
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0008038
- UMLS CUI [1,2]
- C0449438
Beschrijving
Nicotine Replacement Therapy
Datatype
integer
Alias
- UMLS CUI [1]
- C1278444
Beschrijving
Nicotine Replacement Therapy
Datatype
integer
Alias
- UMLS CUI [1]
- C1278444
Beschrijving
Nicotine Replacement Therapy Frequency used
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1278444
- UMLS CUI [1,2]
- C0439603
Beschrijving
Nicotine Replacement Therapy Status
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1278444
- UMLS CUI [1,2]
- C0449438
Beschrijving
Other tobacco/nicotine products
Datatype
text
Alias
- UMLS CUI [1]
- C0543414
Beschrijving
Other tobacco/nicotine products
Datatype
text
Alias
- UMLS CUI [1]
- C0543414
Beschrijving
Other tobacco/nicotine products
Datatype
integer
Alias
- UMLS CUI [1]
- C0543414
Beschrijving
Other tobacco/nicotine products frequency used
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0439603
Beschrijving
Other tobacco/nicotine products status
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0449438
Beschrijving
Prior Adjuvant Chemotherapy
Beschrijving
Prior Adjuvant Chemotherapy for NSCLC
Beschrijving
Cycle Number
Datatype
integer
Alias
- UMLS CUI [1]
- C2045829
Beschrijving
Adjuvant Chemotherapy
Datatype
text
Alias
- UMLS CUI [1]
- C0085533
Beschrijving
Dosage
Datatype
float
Alias
- UMLS CUI [1]
- C0178602
Beschrijving
Dosage Unit
Datatype
text
Alias
- UMLS CUI [1]
- C2348328
Beschrijving
Chemotherapy Cycle Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1302181
- UMLS CUI [1,2]
- C3173309
Beschrijving
Optional Research Blood Sample
Beschrijving
Consent for optional research
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0005834
Beschrijving
Date optional research consent was signed
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0021430
Beschrijving
Blood Sample
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005834
Beschrijving
Collection Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beschrijving
Radiology
Beschrijving
Chest x-ray
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0039985
Beschrijving
Date chest/upper abdomen CT scan performed
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0202823
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1627748
Beschrijving
Vital Assessment
Beschrijving
Assessment Date
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Height
Datatype
float
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
ECOG
Datatype
integer
Alias
- UMLS CUI [1]
- C1520224
Beschrijving
Physical Examination
Beschrijving
Physical Examination Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826643
Beschrijving
General Appearance
Datatype
integer
Alias
- UMLS CUI [1]
- C1148438
Beschrijving
General Appearance
Datatype
text
Alias
- UMLS CUI [1]
- C1148438
Beschrijving
Head/Neck examination
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0460004
- UMLS CUI [1,2]
- C0031809
Beschrijving
Head and neck examination
Datatype
text
Alias
- UMLS CUI [1]
- C0460004
Beschrijving
Eyes
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0031809
Beschrijving
Eyes
Datatype
text
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0031809
Beschrijving
Ears, Nose, Throat
Datatype
integer
Alias
- UMLS CUI [1]
- C0278350
Beschrijving
Ears, Nose, Throat
Datatype
text
Alias
- UMLS CUI [1]
- C0278350
Beschrijving
Lungs
Datatype
integer
Alias
- UMLS CUI [1]
- C2228454
Beschrijving
Lungs
Datatype
text
Alias
- UMLS CUI [1]
- C2228454
Beschrijving
Cardiovascular
Datatype
integer
Alias
- UMLS CUI [1]
- C3854344
Beschrijving
Cardiovascular Examination
Datatype
text
Alias
- UMLS CUI [1]
- C3854344
Beschrijving
Abdomen
Datatype
integer
Alias
- UMLS CUI [1]
- C0562238
Beschrijving
Abdomen Examination
Datatype
text
Alias
- UMLS CUI [1]
- C0562238
Beschrijving
Musculoskeletal System Examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0475091
Beschrijving
Musculoskeletal System Examination
Datatype
text
Alias
- UMLS CUI [1]
- C0475091
Beschrijving
Neurologic Examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0027853
Beschrijving
Neurologic Examination
Datatype
text
Alias
- UMLS CUI [1]
- C0027853
Beschrijving
Genitourinary System Examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0555350
Beschrijving
Genitourinary System Examination
Datatype
text
Alias
- UMLS CUI [1]
- C0555350
Beschrijving
Breast Examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0199850
Beschrijving
Breast Examination
Datatype
text
Alias
- UMLS CUI [1]
- C0199850
Beschrijving
Rectal Examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0199900
Beschrijving
Rectal Examination
Datatype
text
Alias
- UMLS CUI [1]
- C0199900
Beschrijving
Lymph Nodes
Datatype
integer
Alias
- UMLS CUI [1]
- C0024204
Beschrijving
Lymph Nodes
Datatype
text
Alias
- UMLS CUI [1]
- C0024204
Beschrijving
Skin Examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0437750
Beschrijving
Skin Examination
Datatype
text
Alias
- UMLS CUI [1]
- C0437750
Beschrijving
Extremities Examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0436150
Beschrijving
Extremities Examination
Datatype
text
Alias
- UMLS CUI [1]
- C0436150
Beschrijving
Pregnancy Test
Beschrijving
Pregnancy Test
Datatype
boolean
Alias
- UMLS CUI [1]
- C0032976
Beschrijving
If applicable: Was pregnancy test performed?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0032976
Beschrijving
Date of Collection
Datatype
date
Alias
- UMLS CUI [1,1]
- C1516698
- UMLS CUI [1,2]
- C0032976
- UMLS CUI [1,3]
- C0011008
Beschrijving
Accession Number
Datatype
float
Alias
- UMLS CUI [1]
- C2826726
Beschrijving
Hematology
Beschrijving
Biochemistry/Proteomics
Beschrijving
Study Drug Dispensed for Month 1
Beschrijving
Investigator's Signature
Beschrijving
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:
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator Signature Date
Datatype
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
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])
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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])