ID

6478

Beschreibung

E1A05 Treatment Form - Form 2860 Bortezomib and Dexamethasone With or Without Lenalidomide in Treating Patients With Multiple Myeloma Previously Treated With Dexamethasone NCT00522392 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=32B65860-B480-5012-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=32B65860-B480-5012-E044-0003BA3F9857

Stichworte

Klinische Studie [Dokumenttyp]

Treatment Form

Multiples Myelom

19.09.12 19.09.12 -
01.01.15 01.01.15 - Martin Dugas

Hochgeladen am

1. Januar 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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Treatment Form Multiple Myeloma (Form 2860)

Modell
Details

No Instruction available.

1 Formulare

StudyEvent: E1A05 Treatment Form - Form 2860
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Header section

Item Group

Header section

C1320722 (UMLS CUI-1)

Patient Initials

Item

Patient Initials (Last, First)

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)

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)

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)

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)

Form name

Item

DCI Name

text

C25191 (NCI Thesaurus ValueDomain)
C3242370 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)

ReportingEvaluationPeriodType

Item

Reporting Period

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus ObjectClass)
C0220825 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus ObjectClass-2)
C0700287 (UMLS 2011AA ObjectClass-2)

CL.1

Code List

Reporting Period

CL Item

Cycle 1 (Cycle 1)

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)

Data amended

Item

Please mark an 'X' if data have been amended. (Please circle amended items in red)

text

C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Data amended date

Item

Date data amended (s - mm/dd/yyyy)

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)

Reporting Period Start Date

Item

Reporting Period Start Date (mm/dd/yyyy)

date

C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)

Reporting Period End Date

Item

Reporting Period End Date (mm/dd/yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)

Vital Status

Item Group

Vital Status

C1148433 (UMLS CUI-1)

Patient Status

Item

Patient's 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's Vital Status

CL Item

Alive (Alive)

CL Item

Dead (Dead)

Date last contact

Item

Date of last contact or death (mm/dd/yyyy)

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)

Primary Cause of Death

Item

Primary Cause of Death

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

CL Item

Due To Other Cause (Due to other cause)

CL Item

Due To Protocol Treatment (Due to protocol treatment)

CL Item

Due To This Disease (Due to this disease)

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)

Patient Characteristics

Item Group

Patient Characteristics

C0815172 (UMLS CUI-1)

Patient Weight

Item

Weight (Day 1 of this reporting period cycle)

float

C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)

Body Surface Area

Item

Body Surface Area (BSA Day 1 of this reporting period cycle)

float

C25190 (NCI Thesaurus ObjectClass)
C0005902 (UMLS CUI-1)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)

Therapy Administered - Section I

Item Group

Therapy Administered - Section I

Agent

Item

Agent Name (Complete base on completed Patient Pill Diary)

text

C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)

Agent administered during reporting period

Item

Was the agent administered during this reporting period? (Bortezomib)

boolean

C38147 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (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)

Agent Total Dose

Item

Total Dose of Agents/Drugs for this Cycle

float

C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)

Dose Modification

Item

Were there any dose modifications or additions/omissions to protocol treatment? (Bortezomib this report period)

text

C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)

CL.10

Code List

Were there any dose modifications or additions/omissions to protocol treatment? (Bortezomib this report period)

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)

Dose Modification Status

Item

Dose modification

text

C25488 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25688 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)

CL.17

Code List

Dose modification

CL Item

Dose Delayed (Dose delayed)

CL Item

Dose Held (Dose held)

CL Item

Dose Missed (Dose missed)

CL Item

Dose Escalated (Dose escalated)

CL Item

Dose Reduced (Dose reduced)

C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus-3)
C1707814 (UMLS 2011AA-4)

CL Item

Drug Discontinued (Drug discontinued)

CL Item

No Dose Modification (No dose modification)

Dose Modification Reason

Item

Dose Modification Reason

text

C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)

CL.18

Code List

Dose Modification Reason

CL Item

Adverse Event (Adverse event)

C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)

CL Item

Alternative Therapy For Other Reason (Alternative therapy for other reason)

CL Item

Dosing Error (Dosing error)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Patient Refusal/noncompliance (Patient refusal/noncompliance)

CL Item

Scheduling (Scheduling)

CL Item

Second Primary Cancer (Second primary)

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)

Therapy Administered - Section II

Item Group

Therapy Administered - Section I

Agent

Item

Agent Name (Complete base on completed Patient Pill Diary)

text

C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)

Patient Diary complete

Item

Did the patient complete the Patient Pill Calendar this cycle (Diary)

boolean

C38147 (NCI Thesaurus ValueDomain)
C3259162 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25394 (NCI Thesaurus ObjectClass)
C19459 (NCI Thesaurus Property-2)

Agent administered during reporting period

Item

Was the agent administered during this reporting period? (Bortezomib)

boolean

C38147 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)

Agent Administered Date

Item

Date Agent Administered

date

Agent Total Dose

Item

Total Dose of Agents/Drugs for this Cycle

float

C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)

Dose Modification

Item

Were there any dose modifications or additions/omissions to protocol treatment? (Bortezomib this report period)

text

C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)

CL.10

Code List

Were there any dose modifications or additions/omissions to protocol treatment? (Bortezomib this report period)

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)

Dose Modification Status

Item

Dose modification

text

C25488 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25688 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)

CL.17

Code List

Dose modification

CL Item

Dose Delayed (Dose delayed)

CL Item

Dose Held (Dose held)

CL Item

Dose Missed (Dose missed)

CL Item

Dose Escalated (Dose escalated)

CL Item

Dose Reduced (Dose reduced)

C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus-3)
C1707814 (UMLS 2011AA-4)

CL Item

Drug Discontinued (Drug discontinued)

CL Item

No Dose Modification (No dose modification)

Dose Modification Reason

Item

Dose Modification Reason

text

C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)

CL.18

Code List

Dose Modification Reason

CL Item

Adverse Event (Adverse event)

C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)

CL Item

Alternative Therapy For Other Reason (Alternative therapy for other reason)

CL Item

Dosing Error (Dosing error)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Patient Refusal/noncompliance (Patient refusal/noncompliance)

CL Item

Scheduling (Scheduling)

CL Item

Second Primary Cancer (Second primary)

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)

Therapy Administered - Section III

Item Group

Therapy Administered - Section I

Agent

Item

Agent Name (Complete base on completed Patient Pill Diary)

text

C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)

Patient Diary complete

Item

Did the patient complete the Patient Pill Calendar this cycle (Diary)

boolean

C38147 (NCI Thesaurus ValueDomain)
C3259162 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25394 (NCI Thesaurus ObjectClass)
C19459 (NCI Thesaurus Property-2)

Agent administered during reporting period

Item

Was the agent administered during this reporting period? (Bortezomib)

boolean

C38147 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)

Agent day count

Item

Number of days agent was taken

float

C25301 (NCI Thesaurus ValueDomain)
C25639 (NCI Thesaurus Property)
C25463 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS CUI-1)
C0439228 (UMLS CUI-2)
C0750480 (UMLS CUI-3)

Agent Total Dose

Item

Total Dose of Agents/Drugs for this Cycle

float

C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)

Dose modification Lenalidomide

Item

Were there any dose modifications or additions/omissions to Lenalidomide protocol treatment

boolean

C38147 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C2668 (NCI Thesaurus ObjectClass)
C1144149 (UMLS CUI-2)
C25488 (NCI Thesaurus ObjectClass-2)
C25572 (NCI Thesaurus Property)

Dose modification Lenalidomide per protocol

Item

Was treatment modification to Lenalidomide planned (per protocol)? (If yes,)

boolean

C2668 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass-2)
C1144149 (UMLS CUI-2)
C25320 (NCI Thesaurus Property)
C1698058 (UMLS CUI-3)
C25572 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)

Dose modification begin date

Item

Start Date of Dose Modification

date

C25164 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C0808070 (UMLS CUI-2)
C25488 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)

Dose modification end date

Item

End Date of Dose Modification

date

C25164 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)

Total Modified Dose

Item

Total Modified Dose

float

C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25488 (NCI Thesaurus ValueDomain-2)
C0392747 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)

Dose Modification Status

Item

Dose modification

text

C25488 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25688 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)

CL.17

Code List

Dose modification

CL Item

Dose Delayed (Dose delayed)

CL Item

Dose Held (Dose held)

CL Item

Dose Missed (Dose missed)

CL Item

Dose Escalated (Dose escalated)

CL Item

Dose Reduced (Dose reduced)

C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus-3)
C1707814 (UMLS 2011AA-4)

CL Item

Drug Discontinued (Drug discontinued)

CL Item

No Dose Modification (No dose modification)

Dose Modification Reason

Item

Dose Modification Reason

text

C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)

CL.18

Code List

Dose Modification Reason

CL Item

Adverse Event (Adverse event)

C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)

CL Item

Alternative Therapy For Other Reason (Alternative therapy for other reason)

CL Item

Dosing Error (Dosing error)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Patient Refusal/noncompliance (Patient refusal/noncompliance)

CL Item

Scheduling (Scheduling)

CL Item

Second Primary Cancer (Second primary)

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)

Other Therapy Administered

Item Group

Other Therapy Administered - Section IV

Bisphosphonates

Item

Has the patient received bisphosphonates (this report period)

boolean

C38148 (NCI Thesaurus ValueDomain)
C0012544 (UMLS CUI-1)
C443 (NCI Thesaurus ObjectClass)
C37902 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)

Bisphosphonates type

Item

Bisphosphonate type(s) received

text

C25284 (NCI Thesaurus ValueDomain)
C0012544 (UMLS CUI-1)
C443 (NCI Thesaurus ObjectClass)
C0683312 (UMLS CUI-2)
C37902 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)

CL.20

Code List

Bisphosphonate type(s) received

CL Item

Both Pamidronate And Zoledronic Acid (both pamidronate and zoledronic acid)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Pamidronate (pamidronate)

CL Item

Zoledronic Acid (zoledronic acid)

Bisphosphonates, specify

Item

Bisphosphonates, specify

text

C25685 (NCI Thesaurus ValueDomain)
C0012544 (UMLS CUI-1)
C443 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C37902 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)

Anticoagulation therapy daily

Item

Was patient on anti-coagulation therapy daily (this report period)

boolean

C263 (NCI Thesaurus ObjectClass)
C0003280 (UMLS CUI-1)
C25473 (NCI Thesaurus Property)
C0332173 (UMLS CUI-2)
C25629 (NCI Thesaurus Property-2)
C25409 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)

Anticoagulation Drugs

Item

Anti-Coagulant Drugs (Specify)

text

C25284 (NCI Thesaurus ValueDomain)
C0003280 (UMLS CUI-1)
C263 (NCI Thesaurus ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)

CL.22

Code List

Anti-Coagulant Drugs (Specify)

CL Item

Aspirin 325mg (Aspirin 325mg)

CL Item

Aspirin, Other (Aspirin, other)

CL Item

Coumadin (Coumadin)

CL Item

Low Molecular Weight Heparin (Low Molecular Weight Heparin)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Anticoagulation Drug, specify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C0003280 (UMLS CUI-1)
C263 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C25730 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)

INR

Item

International Normalization Ratio (INR) (Specify at the end of report period)

float

C20200 (NCI Thesaurus Property)
C0525032 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25352 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)

Non-Protocol Therapy

Item Group

Section E: 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)

Comments

Item Group

Comments

C0947611 (UMLS CUI-1)

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

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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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Treatment Form Multiple Myeloma (Form 2860)

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