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

  1. 7/27/16 7/27/16 -
  2. 8/1/16 8/1/16 -
  3. 9/27/16 9/27/16 -
Uploaded on

September 27, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

Significant Medical and Surgical History
Description

Significant Medical and Surgical History

Significant Medical and Surgical History?
Description

Significant Medical and Surgical History

Data type

boolean

Alias
UMLS CUI [1]
C0262926
Significant Medical and Surgical History
Description

Significant Medical and Surgical History

List Specific Diagnosis/Procedure
Description

Diagnosis/Procedure

Data type

text

Alias
UMLS CUI [1]
C0011900
UMLS CUI [2]
C0087111
Date of Onset if Known
Description

Date of Onset

Data type

date

Alias
UMLS CUI [1]
C0574845
Active
Description

Active disease

Data type

boolean

Alias
UMLS CUI [1]
C2707252
NSCLC Diagnosis
Description

NSCLC Diagnosis

Date of Initial Pathological Diagnosis
Description

Date of Diagnosis

Data type

date

Alias
UMLS CUI [1]
C2316983
Pathological Stage
Description

Tumor Stage

Data type

integer

Alias
UMLS CUI [1]
C1300072
Tumor size
Description

Tumor Size

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C0475440
mm
Histology
Description

Histologic Type

Data type

integer

Alias
UMLS CUI [1]
C0449574
If Adenocarcinoma: Bronchoalveolar Carcinoma Features?
Description

Bronchoalveolar Carcinoma Features

Data type

integer

Alias
UMLS CUI [1]
C0007120
If mixed histology: Adenocarcinoma?
Description

Adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0001418
If mixed histology: Squamous cell carcinoma?
Description

Squamous cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007137
If mixed histology: Undifferentiated?
Description

Undifferentiated carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0205698
If mixed histology: Other? (specify)
Description

Mixed histology

Data type

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0205430
If mixed histology: other, please specify
Description

Mixed histology

Data type

text

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0205430
If other histologic type, please specify
Description

Histologic Type

Data type

text

Alias
UMLS CUI [1]
C0449574
NSCLC-related Surgery
Description

NSCLC-related Surgery

Date of Surgery
Description

Surgery Date

Data type

date

Alias
UMLS CUI [1]
C1628561
Primary surgical procedure
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
If other, specify:
Description

Primary Surgical Procedure

Data type

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205225
Were any other surgical procedures performed?
Description

Other surgical procedures

Data type

boolean

Alias
UMLS CUI [1]
C0543467
If Yes, specify:
Description

Other surgical procedure

Data type

text

Alias
UMLS CUI [1]
C0543467
How were mediastinal nodes assessed?
Description

lymph node assessment

Data type

integer

Alias
UMLS CUI [1]
C0193842
Number of nodes sampled
Description

Number of Nodes Sampled

Data type

integer

Alias
UMLS CUI [1,1]
C0444261
UMLS CUI [1,2]
C0750480
Tobacco/Nicotine Smoking History at Randomization
Description

Tobacco/Nicotine Smoking History at Randomization

Date of evaluation:
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Cigarette Smoking History (Please indicate one of the following:)
Description

Cigarette Smoking

Data type

integer

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0677453
If patient has stopped smoking, please indicate when stopped:
Description

Time since stopped smoking

Data type

integer

Alias
UMLS CUI [1]
C0453997
If patient has smoked ≥ 100 cigarettes in a lifetime and stopped or is currently smoking cigarettes, please indicate average number of cigarettes smoked per day:
Description

Number of cigarettes smoked per day

Data type

integer

Alias
UMLS CUI [1]
C3694146
If patient has smoked ≥ 100 cigarettes in a lifetime and stopped or is currently smoking cigarettes, please indicate number of years smoked:
Description

Number of years smoked

Data type

integer

Alias
UMLS CUI [1]
C3694955
Other Tobacco/Nicotine History at Randomization
Description

Other Tobacco/Nicotine History

Data type

integer

Alias
UMLS CUI [1]
C0543414
Cigars and/or Pipes: Not Applicable
Description

Cigar and Pipe Smoking

Data type

boolean

Alias
UMLS CUI [1]
C0337666
UMLS CUI [2]
C0240766
Cigars and/or Pipes: Number of years used
Description

Cigar and Pipe Smoking

Data type

integer

Alias
UMLS CUI [1]
C0337666
UMLS CUI [2]
C0240766
Cigars and/or Pipes: Frequency used
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
Cigars and/or Pipes: Product stopped
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
Oral Tobacco Products: Not Applicable
Description

Oral Tobacco Products

Data type

boolean

Alias
UMLS CUI [1]
C0008038
Oral Tobacco Products: Number of years used
Description

Oral Tobacco Products

Data type

integer

Alias
UMLS CUI [1]
C0008038
Oral Tobacco Products: Frequency used
Description

Oral Tobacco Products Frequency used

Data type

integer

Alias
UMLS CUI [1,1]
C0008038
UMLS CUI [1,2]
C0439603
Oral Tobacco Products: Product stopped
Description

Oral Tobacco Products Status

Data type

integer

Alias
UMLS CUI [1,1]
C0008038
UMLS CUI [1,2]
C0449438
Nicotine replacement therapy: Not Applicable
Description

Nicotine Replacement Therapy

Data type

integer

Alias
UMLS CUI [1]
C1278444
Nicotine replacement therapy: Number of years used
Description

Nicotine Replacement Therapy

Data type

integer

Alias
UMLS CUI [1]
C1278444
Nicotine replacement therapy: Frequency used
Description

Nicotine Replacement Therapy Frequency used

Data type

integer

Alias
UMLS CUI [1,1]
C1278444
UMLS CUI [1,2]
C0439603
Nicotine replacement therapy: Product stopped
Description

Nicotine Replacement Therapy Status

Data type

integer

Alias
UMLS CUI [1,1]
C1278444
UMLS CUI [1,2]
C0449438
Other: Not Applicable
Description

Other tobacco/nicotine products

Data type

text

Alias
UMLS CUI [1]
C0543414
Other, please specify:
Description

Other tobacco/nicotine products

Data type

text

Alias
UMLS CUI [1]
C0543414
Other: Number of years used
Description

Other tobacco/nicotine products

Data type

integer

Alias
UMLS CUI [1]
C0543414
Other: Frequency used
Description

Other tobacco/nicotine products frequency used

Data type

integer

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0439603
Other: Product stopped
Description

Other tobacco/nicotine products status

Data type

integer

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0449438
Prior Adjuvant Chemotherapy
Description

Prior Adjuvant Chemotherapy

Prior Adjuvant Chemotherapy for NSCLC?
Description

Adjuvant Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0007131
Prior Adjuvant Chemotherapy for NSCLC
Description

Prior Adjuvant Chemotherapy for NSCLC

Cycle Number
Description

Cycle Number

Data type

integer

Alias
UMLS CUI [1]
C2045829
Adjuvant Chemotherapy Regimen
Description

Adjuvant Chemotherapy

Data type

text

Alias
UMLS CUI [1]
C0085533
Dose Administered: Amount
Description

Dosage

Data type

float

Alias
UMLS CUI [1]
C0178602
Dose Administered: Unit
Description

Dosage Unit

Data type

text

Alias
UMLS CUI [1]
C2348328
Cycle Start Date
Description

Chemotherapy Cycle Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C3173309
Optional Research Blood Sample
Description

Optional Research Blood Sample

Was consent for optional research signed?
Description

Consent for optional research

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0005834
Date optional research consent was signed:
Description

Date optional research consent was signed

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
Was a 3-5mL whole blood sample collected?
Description

Blood Sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
If Yes, date sample was collected:
Description

Collection Date

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Radiology
Description

Radiology

Date chest X-ray performed:
Description

Chest x-ray

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0039985
Date chest/upper abdomen CT scan performed:
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
Vital Assessment
Description

Vital Assessment

Date
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Description

Height

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
ECOG performance status:
Description

ECOG

Data type

integer

Alias
UMLS CUI [1]
C1520224
Physical Examination
Description

Physical Examination

Date
Description

Physical Examination Date

Data type

date

Alias
UMLS CUI [1]
C2826643
General Appearance
Description

General Appearance

Data type

integer

Alias
UMLS CUI [1]
C1148438
General appearance: If abnormal, please specify
Description

General Appearance

Data type

text

Alias
UMLS CUI [1]
C1148438
Head/Neck
Description

Head/Neck examination

Data type

integer

Alias
UMLS CUI [1,1]
C0460004
UMLS CUI [1,2]
C0031809
Head/Neck: If abnormal, please specify
Description

Head and neck examination

Data type

text

Alias
UMLS CUI [1]
C0460004
Eyes
Description

Eyes

Data type

integer

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0031809
Eyes: If abnormal, please specify
Description

Eyes

Data type

text

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0031809
Ears, Nose, Throat
Description

Ears, Nose, Throat

Data type

integer

Alias
UMLS CUI [1]
C0278350
Ears, Nose, Throat: If abnormal, please specify
Description

Ears, Nose, Throat

Data type

text

Alias
UMLS CUI [1]
C0278350
Lungs
Description

Lungs

Data type

integer

Alias
UMLS CUI [1]
C2228454
Lungs, if abnormal, please specify
Description

Lungs

Data type

text

Alias
UMLS CUI [1]
C2228454
Cardiovascular
Description

Cardiovascular

Data type

integer

Alias
UMLS CUI [1]
C3854344
Cardiovascular: If abnormal, please specify
Description

Cardiovascular Examination

Data type

text

Alias
UMLS CUI [1]
C3854344
Abdomen
Description

Abdomen

Data type

integer

Alias
UMLS CUI [1]
C0562238
Abdomen: If abnormal, please specify
Description

Abdomen Examination

Data type

text

Alias
UMLS CUI [1]
C0562238
Musculoskeletal
Description

Musculoskeletal System Examination

Data type

integer

Alias
UMLS CUI [1]
C0475091
Musculoskeletal: If abnormal, please specify
Description

Musculoskeletal System Examination

Data type

text

Alias
UMLS CUI [1]
C0475091
Neurologic (include reflexes)
Description

Neurologic Examination

Data type

integer

Alias
UMLS CUI [1]
C0027853
Neurologic: If abnormal, please specify
Description

Neurologic Examination

Data type

text

Alias
UMLS CUI [1]
C0027853
Genitourinary
Description

Genitourinary System Examination

Data type

integer

Alias
UMLS CUI [1]
C0555350
Genitourinary: If abnormal, please specify
Description

Genitourinary System Examination

Data type

text

Alias
UMLS CUI [1]
C0555350
Breast
Description

Breast Examination

Data type

integer

Alias
UMLS CUI [1]
C0199850
Breast: If abnormal, please specify
Description

Breast Examination

Data type

text

Alias
UMLS CUI [1]
C0199850
Rectum
Description

Rectal Examination

Data type

integer

Alias
UMLS CUI [1]
C0199900
Rectal: If abnormal, please specify
Description

Rectal Examination

Data type

text

Alias
UMLS CUI [1]
C0199900
Lymph Node
Description

Lymph Nodes

Data type

integer

Alias
UMLS CUI [1]
C0024204
Lymph Node: If abnormal, please specify
Description

Lymph Nodes

Data type

text

Alias
UMLS CUI [1]
C0024204
Skin
Description

Skin Examination

Data type

integer

Alias
UMLS CUI [1]
C0437750
Skin: If abnormal, please specify
Description

Skin Examination

Data type

text

Alias
UMLS CUI [1]
C0437750
Extremities
Description

Extremities Examination

Data type

integer

Alias
UMLS CUI [1]
C0436150
Extremities: If abnormal, please specify
Description

Extremities Examination

Data type

text

Alias
UMLS CUI [1]
C0436150
Pregnancy Test
Description

Pregnancy Test

Pregnancy Test: Not Applicable
Description

Pregnancy Test

Data type

boolean

Alias
UMLS CUI [1]
C0032976
Was pregnancy test performed?
Description

If applicable: Was pregnancy test performed?

Data type

boolean

Alias
UMLS CUI [1]
C0032976
Date of Collection
Description

Date of Collection

Data type

date

Alias
UMLS CUI [1,1]
C1516698
UMLS CUI [1,2]
C0032976
UMLS CUI [1,3]
C0011008
Accession Number
Description

Accession Number

Data type

float

Alias
UMLS CUI [1]
C2826726
Hematology
Description

Hematology

Date of Collection
Description

Date of Collection

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Accession Number
Description

Accession Number

Data type

float

Alias
UMLS CUI [1]
C2826726
Biochemistry/Proteomics
Description

Biochemistry/Proteomics

Date of Collection
Description

Date of collection

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Accession Number
Description

Accession Number

Data type

float

Alias
UMLS CUI [1]
C2826726
Study Drug Dispensed for Month 1
Description

Study Drug Dispensed for Month 1

Date dispensed
Description

Date dispensed

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0947323
Bottle number
Description

Bottle number

Data type

float

Alias
UMLS CUI [1]
C1300638
Investigator's Signature
Description

Investigator's Signature

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
Date
Description

Investigator Signature Date

Data type

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

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Significant Medical and Surgical History
Significant Medical and Surgical History
Item
Significant Medical and Surgical History?
boolean
C0262926 (UMLS CUI [1])
Item Group
Significant Medical and Surgical History
Diagnosis/Procedure
Item
List Specific Diagnosis/Procedure
text
C0011900 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
Date of Onset
Item
Date of Onset if Known
date
C0574845 (UMLS CUI [1])
Active disease
Item
Active
boolean
C2707252 (UMLS CUI [1])
Item Group
NSCLC Diagnosis
Date of Diagnosis
Item
Date of Initial Pathological Diagnosis
date
C2316983 (UMLS CUI [1])
Item
Pathological Stage
integer
C1300072 (UMLS CUI [1])
Code List
Pathological Stage
CL Item
IB (1)
CL Item
IIB (2)
CL Item
IIA (3)
CL Item
IIIA (4)
Tumor Size
Item
Tumor size
float
C0475440 (UMLS CUI [1])
Item
Histology
integer
C0449574 (UMLS CUI [1])
Code List
Histology
CL Item
Adenocarcinoma (1)
CL Item
Squamous cell carcinoma (2)
CL Item
Undifferentiated large cell carcinoma (3)
CL Item
Mixed histology (specify) (4)
CL Item
Other (specify) (5)
Item
If Adenocarcinoma: Bronchoalveolar Carcinoma Features?
integer
C0007120 (UMLS CUI [1])
Code List
If Adenocarcinoma: Bronchoalveolar Carcinoma Features?
CL Item
Yes (1)
CL Item
No  (2)
CL Item
Unknown (3)
Adenocarcinoma
Item
If mixed histology: Adenocarcinoma?
boolean
C0001418 (UMLS CUI [1])
Squamous cell carcinoma
Item
If mixed histology: Squamous cell carcinoma?
boolean
C0007137 (UMLS CUI [1])
Undifferentiated carcinoma
Item
If mixed histology: Undifferentiated?
boolean
C0205698 (UMLS CUI [1])
Mixed histology
Item
If mixed histology: Other? (specify)
boolean
C0019638 (UMLS CUI [1,1])
C0205430 (UMLS CUI [1,2])
Mixed histology
Item
If mixed histology: other, please specify
text
C0019638 (UMLS CUI [1,1])
C0205430 (UMLS CUI [1,2])
Histologic Type
Item
If other histologic type, please specify
text
C0449574 (UMLS CUI [1])
Item Group
NSCLC-related Surgery
Surgery Date
Item
Date of Surgery
date
C1628561 (UMLS CUI [1])
Item
Primary surgical procedure
integer
C0543467 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Code List
Primary surgical procedure
CL Item
Pneumonectomy (1)
CL Item
Lobectomy (2)
CL Item
Bilobectomy (3)
CL Item
Sleeve Lobectomy (4)
CL Item
Other (5)
Primary Surgical Procedure
Item
If other, specify:
text
C0543467 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Other surgical procedures
Item
Were any other surgical procedures performed?
boolean
C0543467 (UMLS CUI [1])
Other surgical procedure
Item
If Yes, specify:
text
C0543467 (UMLS CUI [1])
Item
How were mediastinal nodes assessed?
integer
C0193842 (UMLS CUI [1])
Code List
How were mediastinal nodes assessed?
CL Item
Node Dissection (1)
CL Item
Node Sampling Only (2)
CL Item
Unknown (3)
Number of Nodes Sampled
Item
Number of nodes sampled
integer
C0444261 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Item Group
Tobacco/Nicotine Smoking History at Randomization
Assessment Date
Item
Date of evaluation:
date
C2985720 (UMLS CUI [1])
Item
Cigarette Smoking History (Please indicate one of the following:)
integer
C0543414 (UMLS CUI [1,1])
C0677453 (UMLS CUI [1,2])
Code List
Cigarette Smoking History (Please indicate one of the following:)
CL Item
Patient never smoked cigarettes. (1)
CL Item
Patient has smoked ≤ 100 cigarettes in a lifetime and stopped. (2)
CL Item
Patient has smoked ≥ 100 cigarettes in a lifetime and stopped. (3)
CL Item
Patient is currently smoking cigarettes. (4)
Item
If patient has stopped smoking, please indicate when stopped:
integer
C0453997 (UMLS CUI [1])
Code List
If patient has stopped smoking, please indicate when stopped:
CL Item
< 1 month  (1)
CL Item
1 month-1 year (2)
CL Item
> 1 year (3)
Item
If patient has smoked ≥ 100 cigarettes in a lifetime and stopped or is currently smoking cigarettes, please indicate average number of cigarettes smoked per day:
integer
C3694146 (UMLS CUI [1])
Code List
If patient has smoked ≥ 100 cigarettes in a lifetime and stopped or is currently smoking cigarettes, please indicate average number of cigarettes smoked per day:
Number of years smoked
Item
If patient has smoked ≥ 100 cigarettes in a lifetime and stopped or is currently smoking cigarettes, please indicate number of years smoked:
integer
C3694955 (UMLS CUI [1])
Item
Other Tobacco/Nicotine History at Randomization
integer
C0543414 (UMLS CUI [1])
Code List
Other Tobacco/Nicotine History at Randomization
CL Item
Patient never used other tobacco or nicotine products. Do not complete next questions. (1)
CL Item
Patient currently or in the past has used other tobacco or nicotine products. Complete next questions. (2)
Cigar and Pipe Smoking
Item
Cigars and/or Pipes: Not Applicable
boolean
C0337666 (UMLS CUI [1])
C0240766 (UMLS CUI [2])
Cigar and Pipe Smoking
Item
Cigars and/or Pipes: Number of years used
integer
C0337666 (UMLS CUI [1])
C0240766 (UMLS CUI [2])
Item
Cigars and/or Pipes: Frequency used
integer
C0337666 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0240766 (UMLS CUI [2,1])
C0439603 (UMLS CUI [2,2])
Code List
Cigars and/or Pipes: Frequency used
CL Item
at least once daily (1)
CL Item
at least once weekly (2)
CL Item
at least once monthly (3)
CL Item
< once monthly (4)
Item
Cigars and/or Pipes: Product stopped
integer
C0337666 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0240766 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
Code List
Cigars and/or Pipes: Product stopped
CL Item
no, current user (1)
CL Item
< 1 month (2)
CL Item
1 month-1 year (3)
CL Item
> 1 year (4)
Oral Tobacco Products
Item
Oral Tobacco Products: Not Applicable
boolean
C0008038 (UMLS CUI [1])
Oral Tobacco Products
Item
Oral Tobacco Products: Number of years used
integer
C0008038 (UMLS CUI [1])
Item
Oral Tobacco Products: Frequency used
integer
C0008038 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Code List
Oral Tobacco Products: Frequency used
CL Item
at least once daily (1)
CL Item
at least once weekly (2)
CL Item
at least once monthly (3)
CL Item
< once monthly (4)
Item
Oral Tobacco Products: Product stopped
integer
C0008038 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Code List
Oral Tobacco Products: Product stopped
CL Item
no, current user (1)
CL Item
< 1 month (2)
CL Item
1 month-1 year (3)
CL Item
> 1 year (4)
Nicotine Replacement Therapy
Item
Nicotine replacement therapy: Not Applicable
integer
C1278444 (UMLS CUI [1])
Nicotine Replacement Therapy
Item
Nicotine replacement therapy: Number of years used
integer
C1278444 (UMLS CUI [1])
Item
Nicotine replacement therapy: Frequency used
integer
C1278444 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Code List
Nicotine replacement therapy: Frequency used
CL Item
at least once daily (1)
CL Item
at least once weekly (2)
CL Item
at least once monthly (3)
CL Item
< once monthly (4)
Item
Nicotine replacement therapy: Product stopped
integer
C1278444 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Code List
Nicotine replacement therapy: Product stopped
CL Item
no, current user (1)
CL Item
< 1 month (2)
CL Item
1 month-1 year (3)
CL Item
> 1 year (4)
Other tobacco/nicotine products
Item
Other: Not Applicable
text
C0543414 (UMLS CUI [1])
Other tobacco/nicotine products
Item
Other, please specify:
text
C0543414 (UMLS CUI [1])
Other tobacco/nicotine products
Item
Other: Number of years used
integer
C0543414 (UMLS CUI [1])
Item
Other: Frequency used
integer
C0543414 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Code List
Other: Frequency used
CL Item
at least once daily (1)
CL Item
at least once weekly (2)
CL Item
at least once monthly (3)
CL Item
< once monthly (4)
Item
Other: Product stopped
integer
C0543414 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Code List
Other: Product stopped
CL Item
no, current user (1)
CL Item
< 1 month (2)
CL Item
1 month-1 year (3)
CL Item
> 1 year (4)
Item Group
Prior Adjuvant Chemotherapy
Adjuvant Chemotherapy
Item
Prior Adjuvant Chemotherapy for NSCLC?
boolean
C0085533 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
Item Group
Prior Adjuvant Chemotherapy for NSCLC
Cycle Number
Item
Cycle Number
integer
C2045829 (UMLS CUI [1])
Adjuvant Chemotherapy
Item
Adjuvant Chemotherapy Regimen
text
C0085533 (UMLS CUI [1])
Dosage
Item
Dose Administered: Amount
float
C0178602 (UMLS CUI [1])
Dosage Unit
Item
Dose Administered: Unit
text
C2348328 (UMLS CUI [1])
Chemotherapy Cycle Start Date
Item
Cycle Start Date
date
C1302181 (UMLS CUI [1,1])
C3173309 (UMLS CUI [1,2])
Item Group
Optional Research Blood Sample
Consent for optional research
Item
Was consent for optional research signed?
boolean
C0021430 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Date optional research consent was signed
Item
Date optional research consent was signed:
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Blood Sample
Item
Was a 3-5mL whole blood sample collected?
boolean
C0005834 (UMLS CUI [1])
Collection Date
Item
If Yes, date sample was collected:
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Radiology
Chest x-ray
Item
Date chest X-ray performed:
date
C0011008 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
Date chest/upper abdomen CT scan performed
Item
Date chest/upper abdomen CT scan performed:
date
C0011008 (UMLS CUI [1,1])
C0202823 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1627748 (UMLS CUI [2,2])
Item Group
Vital Assessment
Assessment Date
Item
Date
date
C2985720 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
float
C0005890 (UMLS CUI [1])
ECOG
Item
ECOG performance status:
integer
C1520224 (UMLS CUI [1])
Item Group
Physical Examination
Physical Examination Date
Item
Date
date
C2826643 (UMLS CUI [1])
Item
General Appearance
integer
C1148438 (UMLS CUI [1])
Code List
General Appearance
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
General Appearance
Item
General appearance: If abnormal, please specify
text
C1148438 (UMLS CUI [1])
Item
Head/Neck
integer
C0460004 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Code List
Head/Neck
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Head and neck examination
Item
Head/Neck: If abnormal, please specify
text
C0460004 (UMLS CUI [1])
Item
Eyes
integer
C0015392 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Code List
Eyes
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Eyes
Item
Eyes: If abnormal, please specify
text
C0015392 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Item
Ears, Nose, Throat
integer
C0278350 (UMLS CUI [1])
Code List
Ears, Nose, Throat
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Ears, Nose, Throat
Item
Ears, Nose, Throat: If abnormal, please specify
text
C0278350 (UMLS CUI [1])
Item
Lungs
integer
C2228454 (UMLS CUI [1])
Code List
Lungs
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Lungs
Item
Lungs, if abnormal, please specify
text
C2228454 (UMLS CUI [1])
Item
Cardiovascular
integer
C3854344 (UMLS CUI [1])
Code List
Cardiovascular
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Cardiovascular Examination
Item
Cardiovascular: If abnormal, please specify
text
C3854344 (UMLS CUI [1])
Item
Abdomen
integer
C0562238 (UMLS CUI [1])
Code List
Abdomen
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Abdomen Examination
Item
Abdomen: If abnormal, please specify
text
C0562238 (UMLS CUI [1])
Item
Musculoskeletal
integer
C0475091 (UMLS CUI [1])
Code List
Musculoskeletal
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Musculoskeletal System Examination
Item
Musculoskeletal: If abnormal, please specify
text
C0475091 (UMLS CUI [1])
Item
Neurologic (include reflexes)
integer
C0027853 (UMLS CUI [1])
Code List
Neurologic (include reflexes)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Neurologic Examination
Item
Neurologic: If abnormal, please specify
text
C0027853 (UMLS CUI [1])
Item
Genitourinary
integer
C0555350 (UMLS CUI [1])
Code List
Genitourinary
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Genitourinary System Examination
Item
Genitourinary: If abnormal, please specify
text
C0555350 (UMLS CUI [1])
Item
Breast
integer
C0199850 (UMLS CUI [1])
Code List
Breast
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Breast Examination
Item
Breast: If abnormal, please specify
text
C0199850 (UMLS CUI [1])
Item
Rectum
integer
C0199900 (UMLS CUI [1])
Code List
Rectum
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Rectal Examination
Item
Rectal: If abnormal, please specify
text
C0199900 (UMLS CUI [1])
Item
Lymph Node
integer
C0024204 (UMLS CUI [1])
Code List
Lymph Node
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Lymph Nodes
Item
Lymph Node: If abnormal, please specify
text
C0024204 (UMLS CUI [1])
Item
Skin
integer
C0437750 (UMLS CUI [1])
Code List
Skin
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Skin Examination
Item
Skin: If abnormal, please specify
text
C0437750 (UMLS CUI [1])
Item
Extremities
integer
C0436150 (UMLS CUI [1])
Code List
Extremities
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not done (3)
Extremities Examination
Item
Extremities: If abnormal, please specify
text
C0436150 (UMLS CUI [1])
Item Group
Pregnancy Test
Pregnancy Test
Item
Pregnancy Test: Not Applicable
boolean
C0032976 (UMLS CUI [1])
Pregnancy test
Item
Was pregnancy test performed?
boolean
C0032976 (UMLS CUI [1])
Date of Collection
Item
Date of Collection
date
C1516698 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Accession Number
Item
Accession Number
float
C2826726 (UMLS CUI [1])
Item Group
Hematology
Date of Collection
Item
Date of Collection
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Accession Number
Item
Accession Number
float
C2826726 (UMLS CUI [1])
Item Group
Biochemistry/Proteomics
Date of collection
Item
Date of Collection
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Accession Number
Item
Accession Number
float
C2826726 (UMLS CUI [1])
Item Group
Study Drug Dispensed for Month 1
Date dispensed
Item
Date dispensed
date
C0011008 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
Bottle number
Item
Bottle number
float
C1300638 (UMLS CUI [1])
Item Group
Investigator's Signature
Signature Investigator
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial