ID

36663

Beschrijving

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 Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Trefwoorden

Versies (1)
  1. 29-05-19 29-05-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

29 mei 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328

Engels

Cancer and Non-Cancer related surgical Procedures; Investigational Product; Blood Products and Blood Supportive Care Products; Date of Visit/ Assessment; Unscheduled Lesion Assessment; Follow-Up; Follow-Up Anti-Cancer Therapy; Follow-Up Radiotherapy

1 Formulieren  
Prior Cancer and Non-Cancer related surgical procedures
Beschrijving

Prior Cancer and Non-Cancer related surgical procedures

Alias
UMLS CUI-1
C0543467
UMLS CUI-2
C2826292
Prior Cancer and Non-Cancer related surgical procedures - Sequence Number
Beschrijving

Prior Cancer and Non-Cancer related surgical procedures - Sequence Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C2826292
UMLS CUI [2]
C2348184
Prior Cancer and Non-Cancer related surgical procedures - Specific Procedure
Beschrijving

Prior Cancer and Non-Cancer related surgical procedures - Specific Procedure

Datatype

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C2826292
UMLS CUI [2]
C2348235
Prior Cancer and Non-Cancer related surgical procedures - Modified Term
Beschrijving

Prior Cancer and Non-Cancer related surgical procedures - Modified Term

Datatype

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C2826292
UMLS CUI [2]
C2826302
Prior Cancer and Non-Cancer related surgical procedures - MedDRA Synonym
Beschrijving

Prior Cancer and Non-Cancer related surgical procedures - MedDRA Synonym

Datatype

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C2826292
UMLS CUI [2]
C1140263
Prior Cancer and Non-Cancer related surgical procedures - MedDRA lower level term code
Beschrijving

Prior Cancer and Non-Cancer related surgical procedures - MedDRA lower level term code

Datatype

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C2826292
UMLS CUI [2]
C3898442
Prior Cancer and Non-Cancer related surgical procedures - Failed coding
Beschrijving

Prior Cancer and Non-Cancer related surgical procedures - Failed coding

Datatype

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C2826292
UMLS CUI [2,1]
C0805701
UMLS CUI [2,2]
C0231175
Prior Cancer and Non-Cancer related surgical procedures - Date of Procedure
Beschrijving

Prior Cancer and Non-Cancer related surgical procedures - Date of Procedure

Datatype

date

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C2826292
UMLS CUI [2]
C2584899
Prior Cancer and Non-Cancer related surgical procedures - Classification
Beschrijving

Prior Cancer and Non-Cancer related surgical procedures - Classification

Datatype

integer

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C2826292
UMLS CUI [2]
C0008902
Investigational Product
Beschrijving

Investigational Product

Alias
UMLS CUI-1
C0304229
Investigational Product - Sequence Number
Beschrijving

Investigational Product - Sequence Number

Datatype

text

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2]
C2348184
Investigational Product - Dose start date
Beschrijving

Investigational Product - Dose start date

Datatype

date

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2]
C0808070
Investigational Product - Dose stop date
Beschrijving

Investigational Product - Dose stop date

Datatype

date

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2]
C0806020
Investigational Product - Actual Dose
Beschrijving

Investigational Product - Actual Dose

Datatype

integer

Maateenheden
  • mg
Alias
UMLS CUI [1]
C0304229
UMLS CUI [2]
C3174092
mg
Investigational Product - Dose Modifications
Beschrijving

Investigational Product - Dose Modifications

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1707811
Investigational Product - Was dose delayed?
Beschrijving

Investigational Product - Was dose delayed?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1299700
Investigational Product - If dose was delayed, record the primary reason
Beschrijving

Investigational Product - If dose was delayed, record the primary reason

Datatype

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1299700
UMLS CUI [1,3]
C1549995
Investigational Product - If other reason for dose was delayed, please specify
Beschrijving

Investigational Product - If other primary reason for dose was delayed, please specify

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1299700
UMLS CUI [2,1]
C1549995
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C2348235
Investigational Product - Was dose reduced?
Beschrijving

Investigational Product - Was dose reduced?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1707814
Investigational Product - If dose was reduced, record the primary reason
Beschrijving

Investigational Product - If dose was reduced, record the primary reason

Datatype

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C1549995
Investigational Product - If other reason for dose was reduced, please specify
Beschrijving

Investigational Product - If other reason for dose was reduced, please specify

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1707814
UMLS CUI [2,1]
C1549995
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C2348235
Investigational Product - Was dose escalated?
Beschrijving

Investigational Product - Was dose escalated?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C3816728
Investigational Product - If dose was escalated, record the primary reason
Beschrijving

Investigational Product - If dose was escalated, record the primary reason

Datatype

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C3816728
UMLS CUI [1,3]
C1549995
Investigational Product - If other reason for dose escalated, please specify
Beschrijving

Investigational Product - If other reason for dose escalated, please specify

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C3816728
UMLS CUI [2,1]
C1549995
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C2348235
Investigational Product - Was an anti-hypertension medication added or adjusted?
Beschrijving

Investigational Product - Was an anti-hypertension medication added or adjusted?

Datatype

boolean

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C1524062
UMLS CUI [2,3]
C0456081
Investigational Product - If an anti-hypertension medication was added or adjusted, record the primary reason
Beschrijving

Investigational Product - If an anti-hypertension medication was added or adjusted, record the primary reason

Datatype

integer

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C1524062
UMLS CUI [2,3]
C0456081
UMLS CUI [2,4]
C1549995
Investigational Product - If other reason for anti-hypertension medication was added or adjusted, please specify
Beschrijving

undefined item

Datatype

text

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C1524062
UMLS CUI [2,3]
C0456081
UMLS CUI [2,4]
C1549995
UMLS CUI [3,1]
C0205394
UMLS CUI [3,2]
C2348235
Blood Products and Blood Supportive Care Products
Beschrijving

Blood Products and Blood Supportive Care Products

Alias
UMLS CUI-1
C0456388
UMLS CUI-2
C0344211
Blood Products and Blood Supportive Care Products - Sequence Number
Beschrijving

Blood Products and Blood Supportive Care Products - Sequence Number

Datatype

integer

Alias
UMLS CUI [1]
C0456388
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0344211
UMLS CUI [3]
C2348184
Blood Products and Blood Supportive Care Products
Beschrijving

Blood Products and Blood Supportive Care Products

Datatype

integer

Alias
UMLS CUI [1]
C0456388
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0344211
If other Blood Products and Blood Supportive Care Products, please specify
Beschrijving

If other Blood Products and Blood Supportive Care Products, please specify

Datatype

text

Alias
UMLS CUI [1]
C0456388
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0344211
UMLS CUI [3,1]
C0205394
UMLS CUI [3,2]
C2348235
Blood Products and Blood Supportive Care Products - Cumulative Quantitiy or Dose
Beschrijving

Blood Products and Blood Supportive Care Products - Cumulative Quantitiy or Dose

Datatype

integer

Alias
UMLS CUI [1]
C0456388
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0344211
UMLS CUI [3]
C2986497
Cumulative Quantitiy or Dose Units
Beschrijving

Cumulative Quantitiy or Dose Units

Datatype

text

Alias
UMLS CUI [1]
C0456388
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0344211
UMLS CUI [3,1]
C2986497
UMLS CUI [3,2]
C1519795
Blood Products and Blood Supportive Care Products Start Date
Beschrijving

Blood Products and Blood Supportive Care Products Start Date

Datatype

date

Alias
UMLS CUI [1]
C0456388
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0344211
UMLS CUI [3]
C0808070
Blood Products and Blood Supportive Care Products Stop Date
Beschrijving

Blood Products and Blood Supportive Care Products Stop Date

Datatype

date

Alias
UMLS CUI [1]
C0456388
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0344211
UMLS CUI [3]
C0806020
Date of visit/ Assessment
Beschrijving

Date of visit/ Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/ Assessment
Beschrijving

Date of visit/ Assessment

Datatype

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
100% Random Sample SDV Performed on this Subject visit
Beschrijving

100% Random Sample SDV Performed on this Subject visit

Datatype

integer

Alias
UMLS CUI [1]
C0034656
List unscheduled assessment(s) performed at this visit by clicking on the appropriate box(es) to enter the details
Beschrijving

List unscheduled assessment(s) performed at this visit by clicking on the appropriate box(es) to enter the details

Datatype

integer

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C0545082
UMLS CUI [2]
C3854240
Unscheduled Lesion Assessment
Beschrijving

Unscheduled Lesion Assessment

Alias
UMLS CUI-1
C0221198
UMLS CUI-2
C3854240
UMLS CUI-3
C0220825
Did the subject have any lesion assessments performed at this visit?
Beschrijving

Did the subject have any lesion assessments performed at this visit?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0220825
Follow-Up
Beschrijving

Follow-Up

Alias
UMLS CUI-1
C1522577
Is the subject alive?
Beschrijving

Is the subject alive?

Datatype

boolean

Alias
UMLS CUI [1]
C2584946
If subject is alive, complete Date of Contact
Beschrijving

If No, complete Death form and Study Conclusion form

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
Has the subject started any new anti-cancer therapy since the last contact?
Beschrijving

Has the subject started any new anti-cancer therapy since the last contact?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205314
UMLS CUI [2,1]
C1705415
UMLS CUI [2,2]
C1517741
Has the subject started any new radiation therapy since the last contact?
Beschrijving

Has the subject started any new radiation therapy since the last contact?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205314
UMLS CUI [2,1]
C1705415
UMLS CUI [2,2]
C1517741
Follow-Up Anti-Cancer Therapy
Beschrijving

Follow-Up Anti-Cancer Therapy

Alias
UMLS CUI-1
C1522577
UMLS CUI-2
C0920425
Follow-Up Anti-Cancer Therapy Sequence Number
Beschrijving

Follow-Up Anti-Cancer Therapy Sequence Number

Datatype

integer

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C2348184
Follow-Up Anti-Cancer Therapy - Drug Name
Beschrijving

(Trade Name preferred)

Datatype

text

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0920425
UMLS CUI [2]
C0013227
Follow-Up Anti-Cancer Therapy - Modified reported term
Beschrijving

Follow-Up Anti-Cancer Therapy - Modified reported term

Datatype

text

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0920425
UMLS CUI [2]
C2826302
Follow-Up Anti-Cancer Therapy - GSK Drug synonym
Beschrijving

Follow-Up Anti-Cancer Therapy - GSK Drug synonym

Datatype

text

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0920425
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0871468
Follow-Up Anti-Cancer Therapy - GSK Drug Collection code
Beschrijving

Follow-Up Anti-Cancer Therapy - GSK Drug Collection code

Datatype

text

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0920425
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1516698
UMLS CUI [2,3]
C0805701
Follow-Up Anti-Cancer Therapy - Failed coding
Beschrijving

Follow-Up Anti-Cancer Therapy - Failed coding

Datatype

text

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0920425
UMLS CUI [2,1]
C0805701
UMLS CUI [2,2]
C0231175
Follow-Up Anti-Cancer Therapy - Therapy Type
Beschrijving

Follow-Up Anti-Cancer Therapy - Therapy Type

Datatype

integer

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0920425
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0332307
Follow-Up Anti-Cancer Therapy - Start Date
Beschrijving

Follow-Up Anti-Cancer Therapy - Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0920425
UMLS CUI [2]
C0808070
Follow-Up Anti-Cancer Therapy - Best Response
Beschrijving

Follow-Up Anti-Cancer Therapy - Best Response

Datatype

integer

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0920425
UMLS CUI [2]
C2986560
Follow-Up Anti-Cancer Therapy - Duration of Response
Beschrijving

Follow-Up Anti-Cancer Therapy - Duration of Response

Datatype

durationDatetime

Maateenheden
  • Weeks
Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0920425
UMLS CUI [2]
C0237585
Weeks
Follow-Up Anti-Cancer Radiotherapy
Beschrijving

Follow-Up Anti-Cancer Radiotherapy

Alias
UMLS CUI-1
C1522449
UMLS CUI-2
C0920425
UMLS CUI-3
C1522577
Follow-Up Anti-Cancer Radiotherapy - Sequence Number
Beschrijving

Follow-Up Anti-Cancer Radiotherapy - Sequence Number

Datatype

integer

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C1522577
UMLS CUI [2]
C2348184
Follow-Up Anti-Cancer Radiotherapy - Site
Beschrijving

Follow-Up Anti-Cancer Radiotherapy - Site

Datatype

text

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C1522577
UMLS CUI [2]
C1515974
Follow-Up Anti-Cancer Radiotherapy - Start Date
Beschrijving

Follow-Up Anti-Cancer Radiotherapy - Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C1522577
UMLS CUI [2]
C0808070
Follow-Up Anti-Cancer Radiotherapy - Best Response
Beschrijving

Follow-Up Anti-Cancer Radiotherapy - Best Response

Datatype

integer

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C1522577
UMLS CUI [2]
C2986560
Follow-Up Anti-Cancer Radiotherapy - Duration of Response
Beschrijving

Follow-Up Anti-Cancer Radiotherapy - Duration of Response

Datatype

durationDatetime

Maateenheden
  • Weeks
Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C1522577
UMLS CUI [2]
C0237585
Weeks
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Similar models

Cancer and Non-Cancer related surgical Procedures; Investigational Product; Blood Products and Blood Supportive Care Products; Date of Visit/ Assessment; Unscheduled Lesion Assessment; Follow-Up; Follow-Up Anti-Cancer Therapy; Follow-Up Radiotherapy

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Prior Cancer and Non-Cancer related surgical procedures
C0543467 (UMLS CUI-1)
C2826292 (UMLS CUI-2)
Prior Cancer and Non-Cancer related surgical procedures - Sequence Number
Item
Prior Cancer and Non-Cancer related surgical procedures - Sequence Number
integer
C0543467 (UMLS CUI [1,1])
C2826292 (UMLS CUI [1,2])
C2348184 (UMLS CUI [2])
Prior Cancer and Non-Cancer related surgical procedures - Specific Procedure
Item
Prior Cancer and Non-Cancer related surgical procedures - Specific Procedure
text
C0543467 (UMLS CUI [1,1])
C2826292 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Prior Cancer and Non-Cancer related surgical procedures - Modified Term
Item
Prior Cancer and Non-Cancer related surgical procedures - Modified Term
text
C0543467 (UMLS CUI [1,1])
C2826292 (UMLS CUI [1,2])
C2826302 (UMLS CUI [2])
Prior Cancer and Non-Cancer related surgical procedures - MedDRA Synonym
Item
Prior Cancer and Non-Cancer related surgical procedures - MedDRA Synonym
text
C0543467 (UMLS CUI [1,1])
C2826292 (UMLS CUI [1,2])
C1140263 (UMLS CUI [2])
Prior Cancer and Non-Cancer related surgical procedures - MedDRA lower level term code
Item
Prior Cancer and Non-Cancer related surgical procedures - MedDRA lower level term code
text
C0543467 (UMLS CUI [1,1])
C2826292 (UMLS CUI [1,2])
C3898442 (UMLS CUI [2])
Prior Cancer and Non-Cancer related surgical procedures - Failed coding
Item
Prior Cancer and Non-Cancer related surgical procedures - Failed coding
text
C0543467 (UMLS CUI [1,1])
C2826292 (UMLS CUI [1,2])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Prior Cancer and Non-Cancer related surgical procedures - Date of Procedure
Item
Prior Cancer and Non-Cancer related surgical procedures - Date of Procedure
date
C0543467 (UMLS CUI [1,1])
C2826292 (UMLS CUI [1,2])
C2584899 (UMLS CUI [2])
Item
Prior Cancer and Non-Cancer related surgical procedures - Classification
integer
C0543467 (UMLS CUI [1,1])
C2826292 (UMLS CUI [1,2])
C0008902 (UMLS CUI [2])
Prior Cancer and Non-Cancer related surgical procedures - Classification
Code List
Prior Cancer and Non-Cancer related surgical procedures - Classification
CL Item
Cancer related (1)
CL Item
Other (general) (2)
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Investigational Product - Sequence Number
Item
Investigational Product - Sequence Number
text
C0304229 (UMLS CUI [1])
C2348184 (UMLS CUI [2])
Investigational Product - Dose start date
Item
Investigational Product - Dose start date
date
C0304229 (UMLS CUI [1])
C0808070 (UMLS CUI [2])
Investigational Product - Dose stop date
Item
Investigational Product - Dose stop date
date
C0304229 (UMLS CUI [1])
C0806020 (UMLS CUI [2])
Investigational Product - Actual Dose
Item
Investigational Product - Actual Dose
integer
C0304229 (UMLS CUI [1])
C3174092 (UMLS CUI [2])
Item Group
Investigational Product - Dose Modifications
C0304229 (UMLS CUI-1)
C1707811 (UMLS CUI-2)
Investigational Product - Was dose delayed?
Item
Investigational Product - Was dose delayed?
boolean
C0304229 (UMLS CUI [1,1])
C1299700 (UMLS CUI [1,2])
Item
Investigational Product - If dose was delayed, record the primary reason
integer
C0304229 (UMLS CUI [1,1])
C1299700 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,3])
Investigational Product - If dose was delayed, record the primary reason
Code List
Investigational Product - If dose was delayed, record the primary reason
CL Item
Neutropenia (1)
CL Item
Thrombocytopenia (2)
CL Item
Hypertension (3)
CL Item
Thrombosis/ embolism (4)
CL Item
Haemorrhage (5)
CL Item
Proteinuria (6)
CL Item
Liver dysfunction (7)
CL Item
Fatigue (8)
CL Item
Rash (9)
CL Item
Diarrhea (10)
CL Item
Antithrombotic medication (11)
CL Item
Other, specify (12)
Investigational Product - If other primary reason for dose was delayed, please specify
Item
Investigational Product - If other reason for dose was delayed, please specify
text
C0304229 (UMLS CUI [1,1])
C1299700 (UMLS CUI [1,2])
C1549995 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
Investigational Product - Was dose reduced?
Item
Investigational Product - Was dose reduced?
boolean
C0304229 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
Item
Investigational Product - If dose was reduced, record the primary reason
integer
C0304229 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,3])
Investigational Product - If dose was reduced, record the primary reason
Code List
Investigational Product - If dose was reduced, record the primary reason
CL Item
Neutropenia (1)
CL Item
Thrombocytopenia (2)
CL Item
Hypertension (3)
CL Item
Thrombosis/ embolism (4)
CL Item
Haemorrhage (5)
CL Item
Proteinuria (6)
CL Item
Live r d ysfu nction (7)
CL Item
Fatigue (8)
CL Item
Rash (9)
CL Item
Diarrhea (10)
CL Item
Other, specify (11)
Investigational Product - If other reason for dose was reduced, please specify
Item
Investigational Product - If other reason for dose was reduced, please specify
text
C0304229 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C1549995 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
Investigational Product - Was dose escalated?
Item
Investigational Product - Was dose escalated?
boolean
C0304229 (UMLS CUI [1,1])
C3816728 (UMLS CUI [1,2])
Item
Investigational Product - If dose was escalated, record the primary reason
integer
C0304229 (UMLS CUI [1,1])
C3816728 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,3])
Investigational Product - If dose was escalated, record the primary reason
Code List
Investigational Product - If dose was escalated, record the primary reason
CL Item
Toxicity resolved (1)
CL Item
Dosing error (2)
CL Item
Other, specify (3)
Investigational Product - If other reason for dose escalated, please specify
Item
Investigational Product - If other reason for dose escalated, please specify
text
C0304229 (UMLS CUI [1,1])
C3816728 (UMLS CUI [1,2])
C1549995 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
Investigational Product - Was an anti-hypertension medication added or adjusted?
Item
Investigational Product - Was an anti-hypertension medication added or adjusted?
boolean
C0304229 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0456081 (UMLS CUI [2,3])
Item
Investigational Product - If an anti-hypertension medication was added or adjusted, record the primary reason
integer
C0304229 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0456081 (UMLS CUI [2,3])
C1549995 (UMLS CUI [2,4])
Investigational Product - If an anti-hypertension medication was added or adjusted, record the primary reason
Code List
Investigational Product - If an anti-hypertension medication was added or adjusted, record the primary reason
CL Item
Hypertension (1)
CL Item
Other, specify (2)
undefined item
Item
Investigational Product - If other reason for anti-hypertension medication was added or adjusted, please specify
text
C0304229 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0456081 (UMLS CUI [2,3])
C1549995 (UMLS CUI [2,4])
C0205394 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
Item Group
Blood Products and Blood Supportive Care Products
C0456388 (UMLS CUI-1)
C0344211 (UMLS CUI-2)
Blood Products and Blood Supportive Care Products - Sequence Number
Item
Blood Products and Blood Supportive Care Products - Sequence Number
integer
C0456388 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
C2348184 (UMLS CUI [3])
Item
Blood Products and Blood Supportive Care Products
integer
C0456388 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
Blood Products and Blood Supportive Care Products
Code List
Blood Products and Blood Supportive Care Products
CL Item
Red Blood Cells (1)
CL Item
Platelets (2)
CL Item
Whole Blood (3)
CL Item
Plasma - FFP (4)
CL Item
Factor VIII (5)
CL Item
Cryoprecipitate (6)
CL Item
White Blood Cells (7)
CL Item
Other Blood Product, specify (8)
CL Item
G-CSF (9)
CL Item
Prophylactic G-CSF (10)
CL Item
Treatment G-CSF (11)
CL Item
G(M)CSF (12)
CL Item
Erythropoietin (13)
CL Item
Pegfilgrastim (Conjugated G-CSF/ Neulasta) (14)
CL Item
Oprelvecin (IL-11) (15)
If other Blood Products and Blood Supportive Care Products, please specify
Item
If other Blood Products and Blood Supportive Care Products, please specify
text
C0456388 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
C0205394 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
Blood Products and Blood Supportive Care Products - Cumulative Quantitiy or Dose
Item
Blood Products and Blood Supportive Care Products - Cumulative Quantitiy or Dose
integer
C0456388 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
C2986497 (UMLS CUI [3])
Cumulative Quantitiy or Dose Units
Item
Cumulative Quantitiy or Dose Units
text
C0456388 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
C2986497 (UMLS CUI [3,1])
C1519795 (UMLS CUI [3,2])
Blood Products and Blood Supportive Care Products Start Date
Item
Blood Products and Blood Supportive Care Products Start Date
date
C0456388 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
C0808070 (UMLS CUI [3])
Blood Products and Blood Supportive Care Products Stop Date
Item
Blood Products and Blood Supportive Care Products Stop Date
date
C0456388 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
C0806020 (UMLS CUI [3])
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
100% Random Sample SDV Performed on this Subject visit
integer
C0034656 (UMLS CUI [1])
100% Random Sample SDV Performed on this Subject visit
Code List
100% Random Sample SDV Performed on this Subject visit
CL Item
Yes (1)
Item
List unscheduled assessment(s) performed at this visit by clicking on the appropriate box(es) to enter the details
integer
C0220825 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C3854240 (UMLS CUI [2])
List unscheduled assessment(s) performed at this visit by clicking on the appropriate box(es) to enter the details
Code List
List unscheduled assessment(s) performed at this visit by clicking on the appropriate box(es) to enter the details
CL Item
VS (1)
CL Item
ECG (2)
CL Item
ECOG (3)
CL Item
HEM (4)
CL Item
CHEM (5)
CL Item
URIN (6)
CL Item
COAG (7)
CL Item
TFT (8)
CL Item
IP_COMP_PAZ (9)
CL Item
UNS LESION ASMT (10)
CL Item
TARGET LS (11)
CL Item
NONTARGET LS (12)
CL Item
NEW LS/OVR RESP (13)
CL Item
LIVER ASMT (14)
CL Item
BIOM_SAMPLE (15)
Item Group
Unscheduled Lesion Assessment
C0221198 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Did the subject have any lesion assessments performed at this visit?
Item
Did the subject have any lesion assessments performed at this visit?
boolean
C0221198 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Item Group
Follow-Up
C1522577 (UMLS CUI-1)
Is the subject alive?
Item
Is the subject alive?
boolean
C2584946 (UMLS CUI [1])
If subject is alive, complete Date of Contact
Item
If subject is alive, complete Date of Contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
Has the subject started any new anti-cancer therapy since the last contact?
Item
Has the subject started any new anti-cancer therapy since the last contact?
boolean
C0920425 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C1705415 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
Has the subject started any new radiation therapy since the last contact?
Item
Has the subject started any new radiation therapy since the last contact?
boolean
C1522449 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C1705415 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
Item Group
Follow-Up Anti-Cancer Therapy
C1522577 (UMLS CUI-1)
C0920425 (UMLS CUI-2)
Follow-Up Anti-Cancer Therapy Sequence Number
Item
Follow-Up Anti-Cancer Therapy Sequence Number
integer
C1522577 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Follow-Up Anti-Cancer Therapy - Drug Name
Item
Follow-Up Anti-Cancer Therapy - Drug Name
text
C1522577 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2])
Follow-Up Anti-Cancer Therapy - Modified reported term
Item
Follow-Up Anti-Cancer Therapy - Modified reported term
text
C1522577 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C2826302 (UMLS CUI [2])
Follow-Up Anti-Cancer Therapy - GSK Drug synonym
Item
Follow-Up Anti-Cancer Therapy - GSK Drug synonym
text
C1522577 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0871468 (UMLS CUI [2,2])
Follow-Up Anti-Cancer Therapy - GSK Drug Collection code
Item
Follow-Up Anti-Cancer Therapy - GSK Drug Collection code
text
C1522577 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C1516698 (UMLS CUI [2,2])
C0805701 (UMLS CUI [2,3])
Follow-Up Anti-Cancer Therapy - Failed coding
Item
Follow-Up Anti-Cancer Therapy - Failed coding
text
C1522577 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Item
Follow-Up Anti-Cancer Therapy - Therapy Type
integer
C1522577 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0332307 (UMLS CUI [2,2])
Follow-Up Anti-Cancer Therapy - Therapy Type
Code List
Follow-Up Anti-Cancer Therapy - 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)
Follow-Up Anti-Cancer Therapy - Start Date
Item
Follow-Up Anti-Cancer Therapy - Start Date
date
C1522577 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0808070 (UMLS CUI [2])
Item
Follow-Up Anti-Cancer Therapy - Best Response
integer
C1522577 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C2986560 (UMLS CUI [2])
Follow-Up Anti-Cancer Therapy - Best Response
Code List
Follow-Up Anti-Cancer Therapy - Best Response
CL Item
Complete Response (1)
CL Item
Partial Response (2)
CL Item
Stable Disease (3)
CL Item
Progressive Disease (4)
CL Item
Unknown (5)
Follow-Up Anti-Cancer Therapy - Duration of Response
Item
Follow-Up Anti-Cancer Therapy - Duration of Response
durationDatetime
C1522577 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0237585 (UMLS CUI [2])
Item Group
Follow-Up Anti-Cancer Radiotherapy
C1522449 (UMLS CUI-1)
C0920425 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
Follow-Up Anti-Cancer Radiotherapy - Sequence Number
Item
Follow-Up Anti-Cancer Radiotherapy - Sequence Number
integer
C1522449 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
C2348184 (UMLS CUI [2])
Follow-Up Anti-Cancer Radiotherapy - Site
Item
Follow-Up Anti-Cancer Radiotherapy - Site
text
C1522449 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
C1515974 (UMLS CUI [2])
Follow-Up Anti-Cancer Radiotherapy - Start Date
Item
Follow-Up Anti-Cancer Radiotherapy - Start Date
date
C1522449 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
C0808070 (UMLS CUI [2])
Item
Follow-Up Anti-Cancer Radiotherapy - Best Response
integer
C1522449 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
C2986560 (UMLS CUI [2])
Follow-Up Anti-Cancer Radiotherapy - Best Response
Code List
Follow-Up Anti-Cancer Radiotherapy - 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)
Follow-Up Anti-Cancer Radiotherapy - Duration of Response
Item
Follow-Up Anti-Cancer Radiotherapy - Duration of Response
durationDatetime
C1522449 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
C0237585 (UMLS CUI [2])
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