ID
17646
Beschreibung
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
Stichworte
Versionen (3)
- 27.07.16 27.07.16 -
- 01.08.16 01.08.16 -
- 27.09.16 27.09.16 -
Hochgeladen am
27. September 2016
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY 4.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
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
Beschreibung
Significant Medical and Surgical History
Beschreibung
Diagnosis/Procedure
Datentyp
text
Alias
- UMLS CUI [1]
- C0011900
- UMLS CUI [2]
- C0087111
Beschreibung
Date of Onset
Datentyp
date
Alias
- UMLS CUI [1]
- C0574845
Beschreibung
Active disease
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2707252
Beschreibung
NSCLC Diagnosis
Beschreibung
Date of Diagnosis
Datentyp
date
Alias
- UMLS CUI [1]
- C2316983
Beschreibung
Tumor Stage
Datentyp
integer
Alias
- UMLS CUI [1]
- C1300072
Beschreibung
Tumor Size
Datentyp
float
Maßeinheiten
- mm
Alias
- UMLS CUI [1]
- C0475440
Beschreibung
Histologic Type
Datentyp
integer
Alias
- UMLS CUI [1]
- C0449574
Beschreibung
Bronchoalveolar Carcinoma Features
Datentyp
integer
Alias
- UMLS CUI [1]
- C0007120
Beschreibung
Adenocarcinoma
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001418
Beschreibung
Squamous cell carcinoma
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0007137
Beschreibung
Undifferentiated carcinoma
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0205698
Beschreibung
Mixed histology
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0019638
- UMLS CUI [1,2]
- C0205430
Beschreibung
Mixed histology
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0019638
- UMLS CUI [1,2]
- C0205430
Beschreibung
Histologic Type
Datentyp
text
Alias
- UMLS CUI [1]
- C0449574
Beschreibung
NSCLC-related Surgery
Beschreibung
Surgery Date
Datentyp
date
Alias
- UMLS CUI [1]
- C1628561
Beschreibung
A copy of the surgical report must be collected and submitted with the Case Report Form.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0543467
- UMLS CUI [1,2]
- C0205225
Beschreibung
Primary Surgical Procedure
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0543467
- UMLS CUI [1,2]
- C0205225
Beschreibung
Other surgical procedures
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0543467
Beschreibung
Other surgical procedure
Datentyp
text
Alias
- UMLS CUI [1]
- C0543467
Beschreibung
lymph node assessment
Datentyp
integer
Alias
- UMLS CUI [1]
- C0193842
Beschreibung
Number of Nodes Sampled
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0444261
- UMLS CUI [1,2]
- C0750480
Beschreibung
Tobacco/Nicotine Smoking History at Randomization
Beschreibung
Assessment Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
Cigarette Smoking
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0677453
Beschreibung
Time since stopped smoking
Datentyp
integer
Alias
- UMLS CUI [1]
- C0453997
Beschreibung
Number of cigarettes smoked per day
Datentyp
integer
Alias
- UMLS CUI [1]
- C3694146
Beschreibung
Number of years smoked
Datentyp
integer
Alias
- UMLS CUI [1]
- C3694955
Beschreibung
Other Tobacco/Nicotine History
Datentyp
integer
Alias
- UMLS CUI [1]
- C0543414
Beschreibung
Cigar and Pipe Smoking
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0337666
- UMLS CUI [2]
- C0240766
Beschreibung
Cigar and Pipe Smoking
Datentyp
integer
Alias
- UMLS CUI [1]
- C0337666
- UMLS CUI [2]
- C0240766
Beschreibung
Cigars and Pipe Frequency used
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0337666
- UMLS CUI [1,2]
- C0439603
- UMLS CUI [2,1]
- C0240766
- UMLS CUI [2,2]
- C0439603
Beschreibung
Cigar and Pipe Smoking Status
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0337666
- UMLS CUI [1,2]
- C0449438
- UMLS CUI [2,1]
- C0240766
- UMLS CUI [2,2]
- C0449438
Beschreibung
Oral Tobacco Products
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0008038
Beschreibung
Oral Tobacco Products
Datentyp
integer
Alias
- UMLS CUI [1]
- C0008038
Beschreibung
Oral Tobacco Products Frequency used
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0008038
- UMLS CUI [1,2]
- C0439603
Beschreibung
Oral Tobacco Products Status
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0008038
- UMLS CUI [1,2]
- C0449438
Beschreibung
Nicotine Replacement Therapy
Datentyp
integer
Alias
- UMLS CUI [1]
- C1278444
Beschreibung
Nicotine Replacement Therapy
Datentyp
integer
Alias
- UMLS CUI [1]
- C1278444
Beschreibung
Nicotine Replacement Therapy Frequency used
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1278444
- UMLS CUI [1,2]
- C0439603
Beschreibung
Nicotine Replacement Therapy Status
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1278444
- UMLS CUI [1,2]
- C0449438
Beschreibung
Other tobacco/nicotine products
Datentyp
text
Alias
- UMLS CUI [1]
- C0543414
Beschreibung
Other tobacco/nicotine products
Datentyp
text
Alias
- UMLS CUI [1]
- C0543414
Beschreibung
Other tobacco/nicotine products
Datentyp
integer
Alias
- UMLS CUI [1]
- C0543414
Beschreibung
Other tobacco/nicotine products frequency used
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0439603
Beschreibung
Other tobacco/nicotine products status
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0449438
Beschreibung
Prior Adjuvant Chemotherapy
Beschreibung
Prior Adjuvant Chemotherapy for NSCLC
Beschreibung
Cycle Number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2045829
Beschreibung
Adjuvant Chemotherapy
Datentyp
text
Alias
- UMLS CUI [1]
- C0085533
Beschreibung
Dosage
Datentyp
float
Alias
- UMLS CUI [1]
- C0178602
Beschreibung
Dosage Unit
Datentyp
text
Alias
- UMLS CUI [1]
- C2348328
Beschreibung
Chemotherapy Cycle Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1302181
- UMLS CUI [1,2]
- C3173309
Beschreibung
Optional Research Blood Sample
Beschreibung
Consent for optional research
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0005834
Beschreibung
Date optional research consent was signed
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0021430
Beschreibung
Blood Sample
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005834
Beschreibung
Collection Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beschreibung
Radiology
Beschreibung
Chest x-ray
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0039985
Beschreibung
Date chest/upper abdomen CT scan performed
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0202823
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1627748
Beschreibung
Vital Assessment
Beschreibung
Assessment Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Height
Datentyp
float
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
ECOG
Datentyp
integer
Alias
- UMLS CUI [1]
- C1520224
Beschreibung
Physical Examination
Beschreibung
Physical Examination Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826643
Beschreibung
General Appearance
Datentyp
integer
Alias
- UMLS CUI [1]
- C1148438
Beschreibung
General Appearance
Datentyp
text
Alias
- UMLS CUI [1]
- C1148438
Beschreibung
Head/Neck examination
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0460004
- UMLS CUI [1,2]
- C0031809
Beschreibung
Head and neck examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0460004
Beschreibung
Eyes
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0031809
Beschreibung
Eyes
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0031809
Beschreibung
Ears, Nose, Throat
Datentyp
integer
Alias
- UMLS CUI [1]
- C0278350
Beschreibung
Ears, Nose, Throat
Datentyp
text
Alias
- UMLS CUI [1]
- C0278350
Beschreibung
Lungs
Datentyp
integer
Alias
- UMLS CUI [1]
- C2228454
Beschreibung
Lungs
Datentyp
text
Alias
- UMLS CUI [1]
- C2228454
Beschreibung
Cardiovascular
Datentyp
integer
Alias
- UMLS CUI [1]
- C3854344
Beschreibung
Cardiovascular Examination
Datentyp
text
Alias
- UMLS CUI [1]
- C3854344
Beschreibung
Abdomen
Datentyp
integer
Alias
- UMLS CUI [1]
- C0562238
Beschreibung
Abdomen Examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0562238
Beschreibung
Musculoskeletal System Examination
Datentyp
integer
Alias
- UMLS CUI [1]
- C0475091
Beschreibung
Musculoskeletal System Examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0475091
Beschreibung
Neurologic Examination
Datentyp
integer
Alias
- UMLS CUI [1]
- C0027853
Beschreibung
Neurologic Examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0027853
Beschreibung
Genitourinary System Examination
Datentyp
integer
Alias
- UMLS CUI [1]
- C0555350
Beschreibung
Genitourinary System Examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0555350
Beschreibung
Breast Examination
Datentyp
integer
Alias
- UMLS CUI [1]
- C0199850
Beschreibung
Breast Examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0199850
Beschreibung
Rectal Examination
Datentyp
integer
Alias
- UMLS CUI [1]
- C0199900
Beschreibung
Rectal Examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0199900
Beschreibung
Lymph Nodes
Datentyp
integer
Alias
- UMLS CUI [1]
- C0024204
Beschreibung
Lymph Nodes
Datentyp
text
Alias
- UMLS CUI [1]
- C0024204
Beschreibung
Skin Examination
Datentyp
integer
Alias
- UMLS CUI [1]
- C0437750
Beschreibung
Skin Examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0437750
Beschreibung
Extremities Examination
Datentyp
integer
Alias
- UMLS CUI [1]
- C0436150
Beschreibung
Extremities Examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0436150
Beschreibung
Pregnancy Test
Beschreibung
Pregnancy Test
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0032976
Beschreibung
If applicable: Was pregnancy test performed?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0032976
Beschreibung
Date of Collection
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1516698
- UMLS CUI [1,2]
- C0032976
- UMLS CUI [1,3]
- C0011008
Beschreibung
Accession Number
Datentyp
float
Alias
- UMLS CUI [1]
- C2826726
Beschreibung
Hematology
Beschreibung
Biochemistry/Proteomics
Beschreibung
Study Drug Dispensed for Month 1
Beschreibung
Investigator's Signature
Beschreibung
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:
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator Signature Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Ähnliche Modelle
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])