ID

807

Description

Chemotherapy Form (Form 25/26-CT) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BD161F67-0591-4F92-E034-0003BA12F5E7

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BD161F67-0591-4F92-E034-0003BA12F5E7

Mots-clés

Versions (3)
  1. 26/08/2012 26/08/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 09/01/2015 09/01/2015 - Martin Dugas
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26 août 2012

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Breast Cancer NCT00066703 Treatment - Chemotherapy Form (Form 25/26-CT) - 2167893v3.0

Anglais

No Instruction available.

1 Formulaires  
  1. StudyEvent: Chemotherapy Form (Form 25/26-CT)
    1. No Instruction available.
Ccrr Module For Chemotherapy Form (form 25/26-ct)
Description

Ccrr Module For Chemotherapy Form (form 25/26-ct)

IBCSG Patient ID
Description

PatientInternationalBreastCancerStudyGroupIdentifierNumber

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25530
UMLS 2011AA Property
C1512890
Patient Initials
Description

PatientInitialsName

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Patient's Date of Birth
Description

PatientBirthDate

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C25155
UMLS 2011AA Property
C0005615
Participating Center/Affiliate
Description

ParticipatingCenter/Affiliate

Type de données

text

Center Code
Description

CenterCode

Type de données

text

Did the patient complete chemotherapy?
Description

Didthepatientcompletechemotherapy?

Type de données

text

Reason code, specify (reason treatment ended)
Description

Reasoncode,specify(reasontreatmentended)

Type de données

text

adverse event, specify
Description

Adverseevent,specify

Type de données

text

medical decision, specify
Description

Medicaldecision,specify

Type de données

text

other, specify
Description

OffTreatmentReason,Other

Type de données

text

Reasons chemotherapy was delayed or modified
Description

Reasonschemotherapywasdelayedormodified

Type de données

text

other toxicity, specify
Description

othertoxicity,specify

Type de données

text

reason other than toxicity, specify
Description

reasonotherthantoxicity,specify

Type de données

text

Date of first dose of chemotherapy
Description

PriorChemotherapyBeginDate

Type de données

date

Date of last dose of chemotherapy
Description

Dateoflastdoseofchemotherapy

Type de données

text

Total number of cycles of the regimen of chemotherapy given
Description

TotalCourseNumber

Type de données

double

Investigator Signature
Description

InvestigatorSignature

Type de données

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Date
Description

Date

Type de données

text

Agent Name
Description

AgentName

Type de données

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Agent Dose
Description

AgentDoseLevelValue

Type de données

text

Alias
NCI Thesaurus Property
C25488
UMLS 2011AA Property
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property
C25554
UMLS 2011AA Property
C0441889
Route of Administration
Description

AgentAdminRoute

Type de données

text

Schedule & Frequency
Description

Schedule&Frequency

Type de données

text

Leukocytes CTCAE Grade
Description

CTCAdverseEventWBCGrade

Type de données

double

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Platelets CTCAE Grade
Description

CTCAdverseEventPlateletGrade

Type de données

double

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Hemoglobin CTCAE Grade
Description

CTCAdverseEventHemoglobinGrade

Type de données

double

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Mucositis/Stomatis CTCAE Grade
Description

CTCAdverseEventStomatitisGrade

Type de données

double

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Fatigue CTCAE Grade
Description

CTCAdverseEventFatigueGrade

Type de données

double

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Dizziness/lightheadedness CTCAE Grade
Description

CTCAdverseEventDizzinessGrade

Type de données

double

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Somnolence/Depressed level of consciousness CTCAE Grade
Description

CTCAdverseEventConsciousnessGrade

Type de données

double

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Memory impairment CTCAE Grade
Description

CTCAdverseEventMemoryGrade

Type de données

double

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Mood alternation-depression CTCAE Grade
Description

CTCAdverseEventDepressionGrade

Type de données

double

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Neuropathy-sensory CTCAE Grade
Description

CommonToxicityCriteriaAdverseEventPeripheralSensoryNeuropathyGrade

Type de données

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Metathesaurus Property
C0151313
Did the patient have other Grade 3 or higher adverse event(s)?
Description

DidthepatienthaveotherGrade3orhigheradverseevent(s)?

Type de données

text

If yes, specify other CTCAE terms not listed
Description

CTCAdverseEventTermSpecify

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25703
UMLS 2011AA Property
C1515273
CTCAE Grade
Description

CTCAdverseEventGrade

Type de données

double

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
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No Instruction available.

1 Formulaires
  1. StudyEvent: Chemotherapy Form (Form 25/26-CT)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Ccrr Module For Chemotherapy Form (form 25/26-ct)
PatientInternationalBreastCancerStudyGroupIdentifierNumber
Item
IBCSG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25530 (NCI Thesaurus Property)
C1512890 (UMLS 2011AA Property)
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientBirthDate
Item
Patient's Date of Birth
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)
ParticipatingCenter/Affiliate
Item
Participating Center/Affiliate
text
CenterCode
Item
Center Code
text
Item
Did the patient complete chemotherapy?
text
CL.1
Code List
Did the patient complete chemotherapy?
CL Item
No, Will Never Start (no, will never start)
CL Item
No, Started But Stopped Early (no, started but stopped early)
CL Item
Yes, Completed With Modifications Or Delays Of One Week Or More (yes, completed with modifications or delays of one week or more)
CL Item
Yes, Completed As Planned (yes, completed as planned)
Item
Reason code, specify (reason treatment ended)
text
CL.2
Code List
Reason code, specify (reason treatment ended)
CL Item
Patient Refused (patient refused)
CL Item
Adverse Event (adverse event)
C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)
CL Item
Medical Decision (medical decision)
CL Item
Recurrence (recurrence)
C3352 (NCI Thesaurus)
C0034897 (UMLS 2011AA)
CL Item
Death On Study (death on study)
CL Item
Error (error)
C0743559 (NCI Metathesaurus)
CL Item
Other, Specify (other, specify)
Adverseevent,specify
Item
adverse event, specify
text
Medicaldecision,specify
Item
medical decision, specify
text
OffTreatmentReason,Other
Item
other, specify
text
Item
Reasons chemotherapy was delayed or modified
text
CL.3
Code List
Reasons chemotherapy was delayed or modified
CL Item
Hematologic Toxicity (hematologic toxicity)
CL Item
Other Toxicity, Specify (other toxicity, specify)
CL Item
Reason Other Than Toxicity, Specify (reason other than toxicity, specify)
othertoxicity,specify
Item
other toxicity, specify
text
reasonotherthantoxicity,specify
Item
reason other than toxicity, specify
text
PriorChemotherapyBeginDate
Item
Date of first dose of chemotherapy
date
Dateoflastdoseofchemotherapy
Item
Date of last dose of chemotherapy
text
TotalCourseNumber
Item
Total number of cycles of the regimen of chemotherapy given
double
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
Date
Item
Date
text
AgentName
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
AgentDoseLevelValue
Item
Agent Dose
text
C25488 (NCI Thesaurus Property)
C0178602 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)
AgentAdminRoute
Item
Route of Administration
text
Schedule&Frequency
Item
Schedule & Frequency
text
Item
Leukocytes CTCAE Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.4
Code List
Leukocytes CTCAE Grade
CL Item
>= 1.0 - <2.0 X 10e9/l; >= 1000 - <2000/mm(3) (Grade 3)
CL Item
<1.0 X 10e9/l; <1000/mm(3) (Grade 4)
CL Item
Death Related To Toxicity (Grade 5)
Item
Platelets CTCAE Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.5
Code List
Platelets CTCAE Grade
CL Item
>=10.0 - <50.0 X 10e9/l; >=10,000 - <50,000/mm(3) (Grade 3)
CL Item
<10.0 X 10e9/l; <10,000/mm(3) (Grade 4)
CL Item
Death Related To Toxicity (Grade 5)
Item
Hemoglobin CTCAE Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.6
Code List
Hemoglobin CTCAE Grade
CL Item
6.5 - <8.0 G/dl; 65 - <80 G/l; 4.0 - <4.9 Mmol/l (Grade 3)
CL Item
Grade 4 (Grade 4)
CL Item
Death Related To Toxicity (Grade 5)
Item
Mucositis/Stomatis CTCAE Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.7
Code List
Mucositis/Stomatis CTCAE Grade
CL Item
Painful Erythema, Edema, Or Ulcers Requiring Iv Hydration (Grade 3)
CL Item
Severe Ulceration Or Requires Parenteral Or Enteral Nutritional Support Or Prophylactic Intubation (Grade 4)
CL Item
Death Related To Toxicity (Grade 5)
Item
Fatigue CTCAE Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.8
Code List
Fatigue CTCAE Grade
CL Item
Severe (e.g., Decrease In Performance Status By >= 2 Ecog Levels Or 40% Karnofsky Or Lansky) Or Loss Of Ability To Perform Some Activities (Grade 3)
CL Item
Bedridden Or Disabling (Grade 4)
Item
Dizziness/lightheadedness CTCAE Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.9
Code List
Dizziness/lightheadedness CTCAE Grade
CL Item
Interfering With Activities Of Daily Living (Grade 3)
CL Item
Bedridden Or Disabling (Grade 4)
CL Item
Death Related To Toxicity (Grade 5)
Item
Somnolence/Depressed level of consciousness CTCAE Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.10
Code List
Somnolence/Depressed level of consciousness CTCAE Grade
CL Item
Obtundation Or Stupor; Difficult To Arouse; Interfering With Activities Of Daily Living (Grade 3)
CL Item
Coma (Grade 4)
C34497 (NCI Thesaurus)
C0009421 (UMLS 2011AA)
CL Item
Death Related To Toxicity (Grade 5)
Item
Memory impairment CTCAE Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.11
Code List
Memory impairment CTCAE Grade
CL Item
Memory Loss Interfering With Activities Of Daily Living (Grade 3)
CL Item
Amnesia (Grade 4)
C2867 (NCI Thesaurus)
C0002622 (UMLS 2011AA)
Item
Mood alternation-depression CTCAE Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.12
Code List
Mood alternation-depression CTCAE Grade
CL Item
Severe Mood Alteration Interfering With Activities Of Daily Living (Grade 3)
CL Item
Suicidal Ideation Or Danger To Self (Grade 4)
CL Item
Death Related To Toxicity (Grade 5)
Item
Neuropathy-sensory CTCAE Grade
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C0151313 (NCI Metathesaurus Property)
CL.13
Code List
Neuropathy-sensory CTCAE Grade
CL Item
Sensory Loss Or Paresthesia Interfering With Activities Of Daily Living (Grade 3)
CL Item
Permanent Sensory Loss That Interferes With Function (Grade 4)
CL Item
Death Related To Toxicity (Grade 5)
Item
Did the patient have other Grade 3 or higher adverse event(s)?
text
CL.14
Code List
Did the patient have other Grade 3 or higher adverse event(s)?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CTCAdverseEventTermSpecify
Item
If yes, specify other CTCAE terms not listed
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25703 (NCI Thesaurus Property)
C1515273 (UMLS 2011AA Property)
Item
CTCAE Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.15
Code List
CTCAE Grade
CL Item
Severe And Undesirable Adverse Event (Grade 3)
CL Item
Life-threatening Or Disabling Adverse Event (Grade 4)
CL Item
Death Related To Adverse Event (Grade 5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
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