ID

42009

Beschreibung

Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Stichworte

Versionen (4)
  1. 08.05.19 08.05.19 -
  2. 14.08.19 14.08.19 -
  3. 14.08.19 14.08.19 -
  4. 15.03.21 15.03.21 - Dr. rer. medic Philipp Neuhaus
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

15. März 2021

DOI

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Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328

Englisch

Screening - Subject Identification; Demography; Disease Characteristics; Status at Screening; Anti-Cancer Therapy; Anti-Cancer Radiotherapy; Medical Conditions

1 Formulare  
Inform Screening
Beschreibung

Inform Screening

Alias
UMLS CUI-1
C1710477
Subject initials
Beschreibung

Subject initials

Datentyp

integer

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Date of birth
Beschreibung

Date of birth

Datentyp

date

What is the primary method that prompted the subject's interest in the study?
Beschreibung

What is the primary method that prompted the subject's interest in the study?

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0543488
UMLS CUI [1,3]
C0392360
If other Internet provider paid by GSK. (e.g., harrisinteractive.com), specify
Beschreibung

If other Internet provider paid by GSK. (e.g., harrisinteractive.com), specify

Datentyp

text

Alias
UMLS CUI [1,1]
C1138603
UMLS CUI [1,2]
C0205394
If other primary method that prompted the subject's interest in the study, please specify.
Beschreibung

If other primary method that prompted the subject's interest in the study, please specify.

Datentyp

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0543488
UMLS CUI [1,3]
C0392360
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Was this subject a screen failure?
Beschreibung

Was this subject a screen failure?

Datentyp

integer

Alias
UMLS CUI [1]
C1710476
Subject number
Beschreibung

Subject number

Alias
UMLS CUI-1
C2348585
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit/ Assessment
Beschreibung

Date of Visit/ Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of Visit/ Assessment
Beschreibung

Date of Visit/ Assessment

Datentyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Local Laboratories
Beschreibung

Local Laboratories

Alias
UMLS CUI-1
C0022877
UMLS CUI-2
C0205276
Select the number of local laboratories used by the subject during the study.
Beschreibung

If another local laboratory is used after you have already selected a response and submitted fjjjl Th the form, change your response and an additional local laboratory form will be created.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0237753
Laboratory Name
Beschreibung

Laboratory Name

Datentyp

text

Alias
UMLS CUI [1]
C3258037
Laboratory Address
Beschreibung

Laboratory Address

Datentyp

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0022877
Laboratory ID
Beschreibung

Laboratory ID

Datentyp

text

Alias
UMLS CUI [1]
C2986056
Subject identification
Beschreibung

Subject identification

Alias
UMLS CUI-1
C2348585
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beschreibung

Ethnicity

Datentyp

integer

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry
Beschreibung

Check all that apply

Datentyp

integer

Alias
UMLS CUI [1]
C3841890
Disease Characteristics
Beschreibung

Disease Characteristics

Alias
UMLS CUI-1
C1705348
Primary Tumour Type at Initial Diagnosis
Beschreibung

Primary Tumour Type at Initial Diagnosis

Datentyp

integer

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C4071762
Date of Initial Diagnosis
Beschreibung

Date of Initial Diagnosis

Datentyp

date

Alias
UMLS CUI [1]
C2316983
Stage at Initial Diagnosis
Beschreibung

Stage at Initial Diagnosis

Datentyp

integer

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0205265
Histology at Initial Diagnosis
Beschreibung

Histology at Initial Diagnosis

Datentyp

integer

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0205265
Date of Last Progression
Beschreibung

Date of Last Progression

Datentyp

date

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
Date of Staging at Screening
Beschreibung

Date of Staging at Screening

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0027646
UMLS CUI [2]
C1710477
Stage at Screening
Beschreibung

Stage at Screening

Datentyp

integer

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C0220908
Lines of Therapy Completed at Screening
Beschreibung

Lines of Therapy Completed at Screening

Datentyp

integer

Alias
UMLS CUI [1]
C1514463
Metastatic Disease
Beschreibung

Metastatic Disease

Alias
UMLS CUI-1
C0027627
Did the subject have metastatic disease at screening?
Beschreibung

Did the subject have metastatic disease at screening?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0220908
If subject had metastatic disease at screening, complete date metastatic disease was first diagnosed
Beschreibung

If subject had metastatic disease at screening, complete date metastatic disease was first diagnosed

Datentyp

date

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0220908
UMLS CUI [1,3]
C0011008
Status at Screening
Beschreibung

Status at Screening

Alias
UMLS CUI-1
C0220908
UMLS CUI-2
C0449438
Did the subject receive prior chemo, immuno, hormonal or biologic therapies for the cancer under study?
Beschreibung

Did the subject receive prior chemo, immuno, hormonal or biologic therapies for the cancer under study?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C0332152
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0920425
UMLS CUI [2,3]
C0332152
UMLS CUI [3,1]
C1531518
UMLS CUI [3,2]
C0920425
UMLS CUI [3,3]
C0332152
UMLS CUI [4,1]
C0021083
UMLS CUI [4,2]
C0920425
UMLS CUI [4,3]
C0332152
Did the subject receive prior radiotherapy for the cancer under study?
Beschreibung

Did the subject receive prior radiotherapy for the cancer under study?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C0332152
Has subject had prior surgery/ procedure?
Beschreibung

Has subject had prior surgery/ procedure?

Datentyp

boolean

Alias
UMLS CUI [1]
C0744961
Were any concomitant medications taken by the subject prior to screening?
Beschreibung

Were any concomitant medications taken by the subject prior to screening?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0220908
Anti-Cancer Therapy
Beschreibung

Anti-Cancer Therapy

Alias
UMLS CUI-1
C0920425
Sequence Number
Beschreibung

Sequence Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348184
Drug Name
Beschreibung

(Trade Name preferred)

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Modified reported term
Beschreibung

Modified reported term

Datentyp

text

Alias
UMLS CUI [1]
C2826302
GSK Drug synonym
Beschreibung

GSK Drug synonym

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0871468
GSR Drug Collection code
Beschreibung

GSR Drug Collection code

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1516698
UMLS CUI [1,3]
C0805701
Failed coding
Beschreibung

Failed coding

Datentyp

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Regimen Sequence
Beschreibung

Regimen Sequence

Datentyp

integer

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C2348184
Therapy Type
Beschreibung

Therapy Type

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0087111
Number of Cycles/Doses
Beschreibung

Number of Cycles/Doses

Datentyp

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0750480
Units
Beschreibung

Units

Datentyp

integer

Alias
UMLS CUI [1]
C1519795
Intent
Beschreibung

Intent

Datentyp

integer

Alias
UMLS CUI [1]
C1283828
Therapy Start Date
Beschreibung

Therapy Start Date

Datentyp

date

Alias
UMLS CUI [1]
C3173309
Therapy Stop Date
Beschreibung

Therapy Stop Date

Datentyp

date

Alias
UMLS CUI [1]
C1531784
Best Response
Beschreibung

Best Response

Datentyp

integer

Alias
UMLS CUI [1]
C2986560
Duration of Response
Beschreibung

Duration of Response

Datentyp

durationDatetime

Maßeinheiten
  • Weeks
Alias
UMLS CUI [1]
C0237585
Weeks
Anti-Cancer Therapy
Beschreibung

Anti-Cancer Therapy

Alias
UMLS CUI-1
C0920425
Sequence Number
Beschreibung

Sequence Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348184
Site
Beschreibung

Site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Cumulative Dose
Beschreibung

Cumulative Dose

Datentyp

float

Alias
UMLS CUI [1]
C2986497
Units
Beschreibung

Units

Datentyp

integer

Alias
UMLS CUI [1]
C1519795
Intent
Beschreibung

Intent

Datentyp

integer

Alias
UMLS CUI [1]
C1283828
Radiotherapy Start Date
Beschreibung

Radiotherapy Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0436382
Radiotherapy Stop Date
Beschreibung

Radiotherapy Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0806020
Best Response
Beschreibung

Best Response

Datentyp

integer

Alias
UMLS CUI [1]
C2986560
Duration of Response
Beschreibung

Duration of Response

Datentyp

durationDatetime

Maßeinheiten
  • Weeks
Alias
UMLS CUI [1]
C0237585
Weeks
Medical Conditions
Beschreibung

Medical Conditions

Alias
UMLS CUI-1
C0012634
Sequence Number
Beschreibung

Sequence Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348184
Specific Condition
Beschreibung

Specific Condition

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Modified Term
Beschreibung

Modified Term

Datentyp

text

Alias
UMLS CUI [1]
C2826302
MedDRA Synonym
Beschreibung

MedDRA Synonym

Datentyp

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Beschreibung

MedDRA lower level term code

Datentyp

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Beschreibung

Failed coding

Datentyp

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
NCI CTCAE v.3 Grade
Beschreibung

NCI CTCAE v.3 Grade

Datentyp

integer

Alias
UMLS CUI [1]
C3887242
Status
Beschreibung

Status

Datentyp

integer

Alias
UMLS CUI [1]
C0449438
Classification
Beschreibung

Classification

Datentyp

integer

Alias
UMLS CUI [1]
C0008902
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Ähnliche Modelle

Screening - Subject Identification; Demography; Disease Characteristics; Status at Screening; Anti-Cancer Therapy; Anti-Cancer Radiotherapy; Medical Conditions

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inform Screening
C1710477 (UMLS CUI-1)
Subject initials
Item
Subject initials
integer
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
Item
What is the primary method that prompted the subject's interest in the study?
integer
C0008976 (UMLS CUI [1,1])
C0543488 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
What is the primary method that prompted the subject's interest in the study?
Code List
What is the primary method that prompted the subject's interest in the study?
CL Item
Clinic patient (site actively reviews patient charts and/or databases and initiates contact with patient). (1)
CL Item
Physician referral (e.g., lunch-n—learn, letter to colleagues, etc.) (2)
CL Item
Referred by family member (3)
CL Item
Referred by study participant (4)
CL Item
Subject-initiated internet search (e.g. discovered findclinicalstudy.com) (5)
CL Item
Other Internet provider paid by GSK. (e.g., harrisinteractive.com), specify (6)
CL Item
Information in clinic (e.g., posters, brochure, etc.) (7)
CL Item
Community outreach (e.g., healthfair, advocacy groups, support groups, etc.) (8)
CL Item
Local newspaper advertisement (9)
CL Item
Local radio advertisement (10)
CL Item
Other local paid advertisement (e.g., local television, local direct mail, etc.) (11)
CL Item
Other, specify (12)
If other Internet provider paid by GSK. (e.g., harrisinteractive.com), specify
Item
If other Internet provider paid by GSK. (e.g., harrisinteractive.com), specify
text
C1138603 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
If other primary method that prompted the subject's interest in the study, please specify.
Item
If other primary method that prompted the subject's interest in the study, please specify.
text
C0008976 (UMLS CUI [1,1])
C0543488 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item
Was this subject a screen failure?
integer
C1710476 (UMLS CUI [1])
Was this subject a screen failure?
Code List
Was this subject a screen failure?
CL Item
No (1)
Item Group
Subject number
C2348585 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Date of Visit/ Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Local Laboratories
C0022877 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
Item
Select the number of local laboratories used by the subject during the study.
integer
C0022877 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Select the number of local laboratories used by the subject during the study.
Code List
Select the number of local laboratories used by the subject during the study.
CL Item
One (1)
CL Item
Two (2)
CL Item
Three (3)
CL Item
Four (4)
CL Item
Five (5)
CL Item
Six (6)
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
Laboratory Address
Item
Laboratory Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Laboratory ID
Item
Laboratory ID
text
C2986056 (UMLS CUI [1])
Item Group
Subject identification
C2348585 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (1)
CL Item
Female: Record chi|d—bearing potential (2)
CL Item
Female: Post-menopausal (3)
CL Item
Female: Sterile (of child—bearing age) (4)
CL Item
Female: Potentially able to bear children (5)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Geographic Ancestry
integer
C3841890 (UMLS CUI [1])
Geographic Ancestry
Code List
Geographic Ancestry
CL Item
African American/African Heritage (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian — Central/South Asian Heritage (3)
CL Item
Asian — East Asian Heritage (4)
CL Item
Asian — Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic/ North African Heritage (8)
CL Item
White - White/Caucasian/European Heritage (9)
Item Group
Disease Characteristics
C1705348 (UMLS CUI-1)
Item
Primary Tumour Type at Initial Diagnosis
integer
C0677930 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
Primary Tumour Type at Initial Diagnosis
Code List
Primary Tumour Type at Initial Diagnosis
CL Item
Non-Small Cell Lung (1)
Date of Initial Diagnosis
Item
Date of Initial Diagnosis
date
C2316983 (UMLS CUI [1])
Item
Stage at Initial Diagnosis
integer
C1300072 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
Stage at Initial Diagnosis
Code List
Stage at Initial Diagnosis
CL Item
I (1)
CL Item
II (2)
CL Item
IIIa (3)
CL Item
IIIb (4)
CL Item
IV (5)
Item
Histology at Initial Diagnosis
integer
C0019638 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
Histology at Initial Diagnosis
Code List
Histology at Initial Diagnosis
CL Item
Adenocarcinoma (1)
CL Item
Bronchioloalveolar (2)
CL Item
Large cell carcinoma (3)
CL Item
Squamous (4)
CL Item
Unknown (5)
CL Item
Other, Specify (6)
Date of Last Progression
Item
Date of Last Progression
date
C0242656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
Date of Staging at Screening
Item
Date of Staging at Screening
date
C0011008 (UMLS CUI [1,1])
C0027646 (UMLS CUI [1,2])
C1710477 (UMLS CUI [2])
Item
Stage at Screening
integer
C1300072 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Stage at Screening
Code List
Stage at Screening
CL Item
IIIb (1)
CL Item
IV (2)
Lines of Therapy Completed at Screening
Item
Lines of Therapy Completed at Screening
integer
C1514463 (UMLS CUI [1])
Item Group
Metastatic Disease
C0027627 (UMLS CUI-1)
Did the subject have metastatic disease at screening?
Item
Did the subject have metastatic disease at screening?
boolean
C0027627 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
If subject had metastatic disease at screening, complete date metastatic disease was first diagnosed
Item
If subject had metastatic disease at screening, complete date metastatic disease was first diagnosed
date
C0027627 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Status at Screening
C0220908 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Did the subject receive prior chemo, immuno, hormonal or biologic therapies for the cancer under study?
Item
Did the subject receive prior chemo, immuno, hormonal or biologic therapies for the cancer under study?
boolean
C0392920 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0279025 (UMLS CUI [2,1])
C0920425 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C1531518 (UMLS CUI [3,1])
C0920425 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
C0021083 (UMLS CUI [4,1])
C0920425 (UMLS CUI [4,2])
C0332152 (UMLS CUI [4,3])
Did the subject receive prior radiotherapy for the cancer under study?
Item
Did the subject receive prior radiotherapy for the cancer under study?
boolean
C1522449 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Has subject had prior surgery/ procedure?
Item
Has subject had prior surgery/ procedure?
boolean
C0744961 (UMLS CUI [1])
Were any concomitant medications taken by the subject prior to screening?
Item
Were any concomitant medications taken by the subject prior to screening?
boolean
C2347852 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
Item Group
Anti-Cancer Therapy
C0920425 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Modified reported term
Item
Modified reported term
text
C2826302 (UMLS CUI [1])
GSK Drug synonym
Item
GSK Drug synonym
text
C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
GSR Drug Collection code
Item
GSR Drug Collection code
text
C0013227 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Regimen Sequence
Item
Regimen Sequence
integer
C1276413 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item
Therapy Type
integer
C0332307 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Therapy Type
Code List
Therapy Type
CL Item
Biologic Therapy (antibodies, cytokines) (1)
CL Item
Chemotherapy (cytotoxics, non-cytotoxics) (2)
CL Item
Hormonal Therapy (3)
CL Item
Immunotherapy (4)
Number of Cycles/Doses
Item
Number of Cycles/Doses
integer
C0178602 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Item
Units
integer
C1519795 (UMLS CUI [1])
Units
Code List
Units
CL Item
Cycles (1)
CL Item
Doses (2)
Item
Intent
integer
C1283828 (UMLS CUI [1])
Intent
Code List
Intent
CL Item
Neo-adjuvant (1)
CL Item
Adjuva nt (2)
CL Item
Advanced or Metastatic (3)
Therapy Start Date
Item
Therapy Start Date
date
C3173309 (UMLS CUI [1])
Therapy Stop Date
Item
Therapy Stop Date
date
C1531784 (UMLS CUI [1])
Item
Best Response
integer
C2986560 (UMLS CUI [1])
Best Response
Code List
Best Response
CL Item
Complete Response (1)
CL Item
Partial Response (2)
CL Item
Stable Disease (3)
CL Item
Prog ressive Disease (4)
CL Item
Unknown (5)
Duration of Response
Item
Duration of Response
durationDatetime
C0237585 (UMLS CUI [1])
Item Group
Anti-Cancer Therapy
C0920425 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Cumulative Dose
Item
Cumulative Dose
float
C2986497 (UMLS CUI [1])
Item
Units
integer
C1519795 (UMLS CUI [1])
Units
Code List
Units
CL Item
Grays (1)
CL Item
Centigrays (2)
CL Item
x100 Rads (3)
Item
Intent
integer
C1283828 (UMLS CUI [1])
Intent
Code List
Intent
CL Item
Neo-adjuvant (1)
CL Item
Adjuvant (2)
CL Item
Advanced or Metastatic (3)
CL Item
Local/ Regional (4)
CL Item
Other (5)
Radiotherapy Start Date
Item
Radiotherapy Start Date
date
C0436382 (UMLS CUI [1])
Radiotherapy Stop Date
Item
Radiotherapy Stop Date
date
C1522449 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Best Response
integer
C2986560 (UMLS CUI [1])
Best Response
Code List
Best Response
CL Item
Complete Response (1)
CL Item
Partial Response (2)
CL Item
Stable Disease (3)
CL Item
Progressive Disease (4)
CL Item
Not Evaluable (5)
Duration of Response
Item
Duration of Response
durationDatetime
C0237585 (UMLS CUI [1])
Item Group
Medical Conditions
C0012634 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Specific Condition
Item
Specific Condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Modified Term
Item
Modified Term
text
C2826302 (UMLS CUI [1])
MedDRA Synonym
Item
MedDRA Synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Item
NCI CTCAE v.3 Grade
integer
C3887242 (UMLS CUI [1])
NCI CTCAE v.3 Grade
Code List
NCI CTCAE v.3 Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Not Applicable (5)
Item
Status
integer
C0449438 (UMLS CUI [1])
Status
Code List
Status
CL Item
Current (1)
CL Item
Past (2)
Item
Classification
integer
C0008902 (UMLS CUI [1])
Classification
Code List
Classification
CL Item
Cancer related (1)
CL Item
Other (general) (2)
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