ID

11079

Description

E2603 Treatment Form NCT00110019 Carboplatin and Paclitaxel With or Without Sorafenib in Treating Patients With Unresectable Stage III or Stage IV Melanoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E79ADF68-8651-1E39-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E79ADF68-8651-1E39-E034-0003BA3F9857

Keywords

Versions (5)
  1. 9/19/12 9/19/12 -
  2. 8/8/14 8/8/14 - Martin Dugas
  3. 1/8/15 1/8/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
  5. 6/18/15 6/18/15 -
Uploaded on

June 18, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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E2603 Treatment Form NCT00110019

English

INSTRUCTIONS: Complete this form at the end of each cycle (1 cycle =3 weeks). Submit original to the ECOG Coordinating Center. Keep a copy for your files. Refer to forms packet for submission schedule

1 forms  
Header
Description

Header

ECOG Protocol Number
Description

Protocol Number ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Description

Patient ID ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
DCI Name
Description

Generic drug form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
Registration Step
Description

Registration Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Patient demographics
Description

Patient demographics

Patient Initials
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
ECOG Protocol Number
Description

Protocol Number ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Description

Patient ID ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
Participating Group Protocol Number
Description

Study Number Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Institution/Affiliate
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Participating Group Patient ID
Description

Trial subject ID Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
On Treatment Report Period (Choose one)
Description

Cycle number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25214
NCI Thesaurus Property-2
C25616
NCI Thesaurus ObjectClass
C15368
cycle (specify)
Description

Chemotherapy cycle

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25214
UMLS CUI-1
C1302181
NCI Thesaurus Property-2
C25616
NCI Thesaurus ValueDomain
C25685
NCI Thesaurus ValueDomain-2
C25472
NCI Thesaurus ValueDomain-3
C25275
Data amendment
Description

Data amendment

Please mark an 'X' if data have been amended.
Description

Data amended

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended
Description

Data amended date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25367
Vital Status
Description

Vital Status

Patient Vital Status
Description

Patient Status

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C3846084
NCI Thesaurus ValueDomain
C18003
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25717
Date of last contact or death
Description

Date last contact

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C0805839
NCI Thesaurus Property
C25461
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Primary Cause of Death (if applicable)
Description

Primary Cause of Death

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C28554
NCI Thesaurus ValueDomain-2
C25251
Describe cause of death
Description

Cause of Death, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1521902
NCI Thesaurus Property
C28554
Cycle Information
Description

Cycle Information

Cycle Start Date
Description

Chemotherapy Cycle Start Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1302181
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C3173309
NCI Thesaurus Property
C25379
Cycle End Date
Description

Chemotherapy Cycle End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1302181
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS CUI-2
C0806020
ECOG Performance status (Day 1 of this cycle)
Description

PerformanceStatusScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C25361
UMLS 2011AA ObjectClass
C0597198
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Blood Pressure, Systolic
Description

Systolic blood pressure

Data type

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0871470
NCI Thesaurus Property
C25214
NCI Thesaurus ObjectClass
C25298
Blood Pressure, Diastolic (systolic/diastolic)
Description

Diastolic blood pressure

Data type

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0428883
NCI Thesaurus Property
C25214
NCI Thesaurus ObjectClass
C25299
Mark an 'X' if not done
Description

Laboratory Procedure Not Performed

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25594
UMLS CUI-2
C0445106
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Therapy Administered
Description

Therapy Administered

Mark here if carboplatin has previously been discontinued on a previous cycle
Description

CarboplatinAgentPriorCourseDiscontinuedAdministrationText

Data type

text

Alias
NCI Thesaurus ObjectClass
C1282
UMLS 2011AA ObjectClass
C0079083
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C25379
UMLS 2011AA Property-2
C0750729
NCI Thesaurus Property-3
C25484
UMLS 2011AA Property-3
C1444662
NCI Thesaurus Property-4
C25409
UMLS 2011AA Property-4
C1533734
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Were there any dose modifications or additions/omissions to protocol treatment (Paxlitaxel)
Description

Dose Modification

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25256
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain-2
C25572
other, specify
Description

Dose Modification Reason, other

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C3840932
NCI Thesaurus Property
C25572
Date agent administered
Description

Agent Administered Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0450442
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1521801
NCI Thesaurus Property
C25382
UMLS CUI-3
C0011008
Dose Modified Reason
Description

Dose Modification Reason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C0392360
NCI Thesaurus Property
C25572
Agent Dose
Description

Medication Dose

Data type

float

Alias
NCI Thesaurus ValueDomain
C25488
UMLS CUI-1
C3174092
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain-2
C1708
NCI Thesaurus Property
C25382
Agent Name: Paclitaxel
Description

Agent Name: Paclitaxel

Mark here if paclitaxel has previously been discontinued on a previous cycle
Description

PaclitaxelAgentPriorCourseDiscontinuedAdministrationText

Data type

text

Alias
NCI Thesaurus ObjectClass
C1411
UMLS 2011AA ObjectClass
C0144576
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C25379
UMLS 2011AA Property-2
C0750729
NCI Thesaurus Property-3
C25484
UMLS 2011AA Property-3
C1444662
NCI Thesaurus Property-4
C25409
UMLS 2011AA Property-4
C1533734
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Were there any dose modifications or additions/omissions to protocol treatment (Paxlitaxel)
Description

Dose Modification

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25256
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain-2
C25572
other, specify
Description

Dose Modification Reason, other

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C3840932
NCI Thesaurus Property
C25572
Date agent administered
Description

Agent Administered Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0450442
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1521801
NCI Thesaurus Property
C25382
UMLS CUI-3
C0011008
Agent Dose
Description

Medication Dose

Data type

float

Alias
NCI Thesaurus ValueDomain
C25488
UMLS CUI-1
C3174092
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain-2
C1708
NCI Thesaurus Property
C25382
Dose Modified Reason
Description

Dose Modification Reason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C0392360
NCI Thesaurus Property
C25572
Agent Name: Bay 43-9006 Or Placebo
Description

Agent Name: Bay 43-9006 Or Placebo

Number of pills per dose
Description

PillsQuantityDose

Data type

float

Alias
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C25394
UMLS 2011AA ObjectClass
C0994475
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
Date of dose modifications
Description

DoseModificationDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C25572
New dose
Description

PillsChangeAdministrationDose

Data type

float

Alias
NCI Thesaurus ObjectClass
C25394
UMLS 2011AA ObjectClass
C0994475
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
NCI Thesaurus Property-2
C25409
UMLS 2011AA Property-2
C1533734
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ValueDomain-2
C1708
UMLS 2011AA ValueDomain-2
C0450442
Frequency
Description

Medication frequency

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C3476109
NCI Thesaurus ValueDomain
C25515
NCI Thesaurus Property
C25382
Frequency
Description

Medication frequency

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C3476109
NCI Thesaurus ValueDomain
C25515
NCI Thesaurus Property
C25382
Dose Modified Reason
Description

Dose Modification Reason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C0392360
NCI Thesaurus Property
C25572
Did the patient complete the Patient Pill Calendar this cycle
Description

Patient Diary complete

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C3259162
NCI Thesaurus Property
C25250
NCI Thesaurus ObjectClass
C25394
NCI Thesaurus Property-2
C19459
Total Number of Pills Taken (this cycle, based on the Patient Pill Calendar)
Description

PillsTakenTotalCount

Data type

text

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
NCI Thesaurus ObjectClass
C25394
UMLS 2011AA ObjectClass
C0994475
NCI Thesaurus Property
C25701
UMLS 2011AA Property
C1883727
Non-protocol Therapy
Description

Non-protocol Therapy

Was any non-protocol therapy given during protocol treatment (not previously reported)
Description

Non-protocol therapy

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25590
UMLS CUI-1
C1518384
NCI Thesaurus ObjectClass-2
C16212
UMLS CUI-2
C0087111
NCI Thesaurus Property
C25320
NCI Thesaurus Property-2
C49236
NCI Thesaurus Property-3
C25456
NCI Thesaurus Property-4
C25382
NCI Thesaurus ValueDomain
C38148
Related Forms
Description

Related Forms

Comments
Description

Comments

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Investigator Signature
Description

Investigator Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature Date
Description

Investigator Signature Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
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INSTRUCTIONS: Complete this form at the end of each cycle (1 cycle =3 weeks). Submit original to the ECOG Coordinating Center. Keep a copy for your files. Refer to forms packet for submission schedule

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Item Group
Patient demographics
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Study Number Participating Group
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item
On Treatment Report Period (Choose one)
text
C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
CL.1
Code List
On Treatment Report Period (Choose one)
CL Item
Cycle 2 (Cycle 2)
CL Item
Cycle 3 (Cycle 3)
CL Item
Cycle 4 (Cycle 4)
CL Item
Cycle 5 (Cycle 5)
CL Item
Cycle 6 (Cycle 6)
CL Item
Cycle 7 (Cycle 7)
CL Item
Cycle 8 (Cycle 8)
CL Item
Cycle 9 (Cycle 9)
CL Item
Cycle 10 (Cycle 10)
CL Item
> Cycle 10 (> Cycle 10)
Chemotherapy cycle
Item
cycle (specify)
text
C15368 (NCI Thesaurus ObjectClass)
C25214 (NCI Thesaurus Property)
C1302181 (UMLS CUI-1)
C25616 (NCI Thesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)
C25472 (NCI Thesaurus ValueDomain-2)
C25275 (NCI Thesaurus ValueDomain-3)
Item Group
Data amendment
Data amended
Item
Please mark an 'X' if data have been amended.
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended
date
C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Vital Status
Item
Patient Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)
CL.2
Code List
Patient Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Date last contact
Item
Date of last contact or death
date
C16960 (NCI Thesaurus ObjectClass)
C0805839 (UMLS CUI-1)
C25461 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Primary Cause of Death (if applicable)
text
C25638 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ValueDomain-2)
CL.3
Code List
Primary Cause of Death (if applicable)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Other Cause (Due to other cause)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Cause of Death, specify
Item
Describe cause of death
text
C25685 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C28554 (NCI Thesaurus Property)
Item Group
Cycle Information
Chemotherapy Cycle Start Date
Item
Cycle Start Date
date
C25164 (NCI Thesaurus ValueDomain)
C1302181 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C3173309 (UMLS CUI-2)
C25379 (NCI Thesaurus Property)
Chemotherapy Cycle End Date
Item
Cycle End Date
date
C25164 (NCI Thesaurus ValueDomain)
C1302181 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0806020 (UMLS CUI-2)
Item
ECOG Performance status (Day 1 of this cycle)
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25361 (NCI Thesaurus ObjectClass)
C0597198 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.4
Code List
ECOG Performance status (Day 1 of this cycle)
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction (karnofsky 90 - 100) (ecog - 0 Asymptomatic) (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory (k70 - 80) (ecog - 1 Symptomatic - Fully Ambulatory) (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities (k 50 - 60) (ecog - 2 Symptomatic; In Bed , 50% Of The Day) (2)
CL Item
Capable Of Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (k 30 - 40) (ecog - 3 Symptomatic; In Bed > 50% Of The Day But Not Bedridden) (3)
CL Item
Completely Disabled (k10 - 20) (ecog - 4 Bedridden) (4)
Systolic blood pressure
Item
Blood Pressure, Systolic
float
C25209 (NCI Thesaurus ValueDomain)
C0871470 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25298 (NCI Thesaurus ObjectClass)
Diastolic blood pressure
Item
Blood Pressure, Diastolic (systolic/diastolic)
float
C25209 (NCI Thesaurus ValueDomain)
C0428883 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25299 (NCI Thesaurus ObjectClass)
Laboratory Procedure Not Performed
Item
Mark an 'X' if not done
text
C25704 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25594 (NCI Thesaurus Property)
C0445106 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Item Group
Therapy Administered
CarboplatinAgentPriorCourseDiscontinuedAdministrationText
Item
Mark here if carboplatin has previously been discontinued on a previous cycle
text
C1282 (NCI Thesaurus ObjectClass)
C0079083 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25379 (NCI Thesaurus Property-2)
C0750729 (UMLS 2011AA Property-2)
C25484 (NCI Thesaurus Property-3)
C1444662 (UMLS 2011AA Property-3)
C25409 (NCI Thesaurus Property-4)
C1533734 (UMLS 2011AA Property-4)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Item
Were there any dose modifications or additions/omissions to protocol treatment (Paxlitaxel)
text
C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)
CL.7
Code List
Were there any dose modifications or additions/omissions to protocol treatment (Paxlitaxel)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (yes, planned)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (yes, unplanned)
CL Item
Unknown (yes, both planned and unplanned)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Dose Modification Reason, other
Item
other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C3840932 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
Agent Administered Date
Item
Date agent administered
date
C25164 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
C0011008 (UMLS CUI-3)
Item
Dose Modified Reason
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
CL.12
Code List
Dose Modified Reason
CL Item
Not Per Protocol (not per protocol)
CL Item
Per Protocol (per protocol)
Medication Dose
Item
Agent Dose
float
C25488 (NCI Thesaurus ValueDomain)
C3174092 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
Item Group
Agent Name: Paclitaxel
PaclitaxelAgentPriorCourseDiscontinuedAdministrationText
Item
Mark here if paclitaxel has previously been discontinued on a previous cycle
text
C1411 (NCI Thesaurus ObjectClass)
C0144576 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25379 (NCI Thesaurus Property-2)
C0750729 (UMLS 2011AA Property-2)
C25484 (NCI Thesaurus Property-3)
C1444662 (UMLS 2011AA Property-3)
C25409 (NCI Thesaurus Property-4)
C1533734 (UMLS 2011AA Property-4)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Item
Were there any dose modifications or additions/omissions to protocol treatment (Paxlitaxel)
text
C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)
CL.7
Code List
Were there any dose modifications or additions/omissions to protocol treatment (Paxlitaxel)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (yes, planned)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (yes, unplanned)
CL Item
Unknown (yes, both planned and unplanned)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Dose Modification Reason, other
Item
other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C3840932 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
Agent Administered Date
Item
Date agent administered
date
C25164 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
C0011008 (UMLS CUI-3)
Medication Dose
Item
Agent Dose
float
C25488 (NCI Thesaurus ValueDomain)
C3174092 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
Item
Dose Modified Reason
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
CL.12
Code List
Dose Modified Reason
CL Item
Not Per Protocol (not per protocol)
CL Item
Per Protocol (per protocol)
Item Group
Agent Name: Bay 43-9006 Or Placebo
PillsQuantityDose
Item
Number of pills per dose
float
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
DoseModificationDate
Item
Date of dose modifications
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
PillsChangeAdministrationDose
Item
New dose
float
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ValueDomain-2)
C0450442 (UMLS 2011AA ValueDomain-2)
Item
Frequency
text
C1708 (NCI Thesaurus ObjectClass)
C3476109 (UMLS CUI-1)
C25515 (NCI Thesaurus ValueDomain)
C25382 (NCI Thesaurus Property)
CL.11
Code List
Frequency
CL Item
Twice A Day (b.i.d) (twice a day (B.I.D))
CL Item
Once A Day (q.d.) (Once a day (Q.D.))
CL Item
Dose Held (Dose held)
Item
Frequency
text
C1708 (NCI Thesaurus ObjectClass)
C3476109 (UMLS CUI-1)
C25515 (NCI Thesaurus ValueDomain)
C25382 (NCI Thesaurus Property)
CL.11
Code List
Frequency
CL Item
Twice A Day (b.i.d) (twice a day (B.I.D))
CL Item
Once A Day (q.d.) (Once a day (Q.D.))
CL Item
Dose Held (Dose held)
Item
Dose Modified Reason
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
CL.12
Code List
Dose Modified Reason
CL Item
Not Per Protocol (not per protocol)
CL Item
Per Protocol (per protocol)
Patient Diary complete
Item
Did the patient complete the Patient Pill Calendar this cycle
boolean
C38147 (NCI Thesaurus ValueDomain)
C3259162 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25394 (NCI Thesaurus ObjectClass)
C19459 (NCI Thesaurus Property-2)
PillsTakenTotalCount
Item
Total Number of Pills Taken (this cycle, based on the Patient Pill Calendar)
text
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)
C25701 (NCI Thesaurus Property)
C1883727 (UMLS 2011AA Property)
Item Group
Non-protocol Therapy
Non-protocol therapy
Item
Was any non-protocol therapy given during protocol treatment (not previously reported)
boolean
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS CUI-1)
C16212 (NCI Thesaurus ObjectClass-2)
C0087111 (UMLS CUI-2)
C25320 (NCI Thesaurus Property)
C49236 (NCI Thesaurus Property-2)
C25456 (NCI Thesaurus Property-3)
C25382 (NCI Thesaurus Property-4)
C38148 (NCI Thesaurus ValueDomain)
Item Group
Related Forms
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
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