ID

2221

Beschreibung

SOUTHWEST ONCOLOGY GROUP S0023 ADVERSE EVENT FORM S0023: Combination Chemo Plus RT With or Without Gefitinib in Treating Patients With Unresectable Stage III NSCLC Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E1C4BD05-F022-4833-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E1C4BD05-F022-4833-E034-0003BA12F5E7

Stichworte

Versionen (2)
  1. 19.09.12 19.09.12 -
  2. 08.01.15 08.01.15 - Martin Dugas
Hochgeladen am

19. September 2012

DOI

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Lung Cancer NCT00020709 Toxicity - SOUTHWEST ONCOLOGY GROUP S0023 ADVERSE EVENT FORM - 2291195v3.0

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0023 ADVERSE EVENT FORM
    1. No Instruction available.
Unnamed1
Beschreibung

Unnamed1

SWOG Patient ID
Beschreibung

PatientSouthwestOncologyGroupIdentifierNumber

Datentyp

double

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
C25699
UMLS 2011AA Property
C1519429
SWOG Study No.
Beschreibung

ProtocolSWOGIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25699
UMLS 2011AA Property
C1519429
Registration Step
Beschreibung

RegistrationStepNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25646
UMLS 2011AA ObjectClass
C1514821
NCI Thesaurus Property
C16154
UMLS 2011AA Property
C1704379
NCI Thesaurus ValueDomain
C16154
UMLS 2011AA ValueDomain
C1704379
Patient Initials
Beschreibung

PatientInitialsName

Datentyp

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
Institution/Affiliate
Beschreibung

CombinedInstitutionName

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS 2011AA ObjectClass
C0205195
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
Physician
Beschreibung

RegisteredInvestigatorName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
NCI Thesaurus ObjectClass
C25644
Treatment Segment
Beschreibung

SegmentalTreatmentAdministeredType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ObjectClass
C25238
UMLS 2011AA ObjectClass
C0205122
Participating Group Name
Beschreibung

ParticipatingGroupName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25608
UMLS 2011AA ObjectClass
C0679823
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participating Group Study No.
Beschreibung

ProtocolParticipatingIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participating Group Patient ID
Beschreibung

PatientParticipatingIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Toxicity
Beschreibung

Toxicity

Reporting period start date (Day 1 of this Cycle)
Beschreibung

TreatmentReportingPeriodBeginDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Reporting period end date (Day 1 of next cycle. If final cycle, date of first visit or contact after resolution of acute adverse events.)
Beschreibung

TreatmentReportingPeriodEndDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
Were adverse events assessed during this time period?
Beschreibung

AdverseEventCurrentAssessmentInd

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Select box if adverse events were assessed but none were seen. (Otherwise complete information below.)
Beschreibung

Unnamed3

Datentyp

text

CTC Code 2.0
Beschreibung

CTCAdverseEventSWOGCode

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Toxicity
Beschreibung

AdverseEventToxicityType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C27990
UMLS 2011AA Property
C0600688
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Other toxicities (specify)
Beschreibung

OtherToxicities

Datentyp

text

Grade (1 - 5)
Beschreibung

Grade

Datentyp

text

Treatment relation (*)
Beschreibung

TreatmentRelation

Datentyp

text

Comments
Beschreibung

Comments

Comments
Beschreibung

ResearchCommentsText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
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Ähnliche Modelle

No Instruction available.

1 Formulare
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0023 ADVERSE EVENT FORM
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Unnamed1
PatientSouthwestOncologyGroupIdentifierNumber
Item
SWOG Patient ID
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property)
C1519429 (UMLS 2011AA Property)
ProtocolSWOGIdentifierNumber
Item
SWOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property)
C1519429 (UMLS 2011AA Property)
RegistrationStepNumber
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)
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)
CombinedInstitutionName
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
RegisteredInvestigatorName
Item
Physician
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C25644 (NCI Thesaurus ObjectClass)
Item
Treatment Segment
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25238 (NCI Thesaurus ObjectClass)
C0205122 (UMLS 2011AA ObjectClass)
CL.1
Code List
Treatment Segment
CL Item
Induction Chemo/rt (Induction Chemo/RT)
CL Item
Consolidation Chemo (Consolidation Chemo)
CL Item
Zd1839/placebo Week 4 (ZD1839/Placebo week 4)
CL Item
Zd1839/placebo Week 8 (ZD1839/Placebo week 8)
CL Item
Zd1839/placebo Week 12 (ZD1839/Placebo week 12)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
ParticipatingGroupName
Item
Participating Group Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientParticipatingIdentifierNumber
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item Group
Toxicity
TreatmentReportingPeriodBeginDate
Item
Reporting period start date (Day 1 of this Cycle)
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
TreatmentReportingPeriodEndDate
Item
Reporting period end date (Day 1 of next cycle. If final cycle, date of first visit or contact after resolution of acute adverse events.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
Item
Were adverse events assessed during this time period?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL.2
Code List
Were adverse events assessed during this time period?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
CL Item
Yes, But No Reportable Adverse Events Occurred (Yes, but no reportable adverse events occurred)
CL Item
Yes, And Reportable Adverse Events Occurred (Yes, and reportable adverse events occurred)
Unnamed3
Item
Select box if adverse events were assessed but none were seen. (Otherwise complete information below.)
text
Item
CTC Code 2.0
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL.3
Code List
CTC Code 2.0
CL Item
Ca51 (CA51)
CL Item
Ca52 (CA52)
CL Item
Ca53 (CA53)
CL Item
Ea20 (EA20)
CL Item
Ey02_2005347 (EY02)
CL Item
Ey30_2005348 (EY30)
CL Item
Ey42 (EY42)
CL Item
Ey992005350 (EY99)
CL Item
Fl01 (FL01)
CL Item
Fl10 (FL10)
CL Item
Fl40_2005351 (FL40)
CL Item
Fl51 (FL51)
CL Item
Gi00_2005354 (GI00)
CL Item
Gi10_2005356 (GI10)
CL Item
Gi20_2005357 (GI20)
CL Item
Gi23 (GI23)
CL Item
Gi30 (GI30)
CL Item
Gi43 (GI43)
CL Item
Gi51 (GI51)
CL Item
Gi60 (GI60)
CL Item
Gi61 (GI61)
CL Item
Gir60 (GIR60)
CL Item
Gir69 (GIR69)
CL Item
Gu50_2005358 (GU50)
CL Item
He002005359 (HE00)
CL Item
He102005360 (HE10)
CL Item
He202005361 (HE20)
CL Item
He21 (HE21)
CL Item
He302005362 (HE30)
CL Item
Im00_2005363 (IM00)
CL Item
In002005364 (IN00)
CL Item
In01 (IN01)
CL Item
In05_2005365 (IN05)
CL Item
In06 (IN06)
CL Item
In30_2005366 (IN30)
CL Item
Li00_2005352 (LI00)
CL Item
Li11 (LI11)
CL Item
Li12_2005353 (LI12)
CL Item
Li20 (LI20)
CL Item
Lu50 (LU50)
CL Item
Nr50 (NR50)
CL Item
Nr60 (NR60)
CL Item
Pa21 (PA21)
CL Item
Pa22 (PA22)
CL Item
Pa30 (PA30)
CL Item
Sk00 (SK00)
CL Item
Sk16 (SK16)
CL Item
Skr72 (SKR72)
Item
Toxicity
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C27990 (NCI Thesaurus Property)
C0600688 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL.4
Code List
Toxicity
CL Item
Hypotension (Hypotension)
C3128 (NCI Thesaurus)
C0020649 (UMLS 2011AA)
CL Item
Thrombosis/embolism (Thrombosis/embolism)
CL Item
Edema (Edema)
C3002 (NCI Thesaurus)
C0013604 (UMLS 2011AA)
CL Item
Phlebitis (Phlebitis)
C38003 (NCI Thesaurus)
C0031542 (UMLS 2011AA)
CL Item
Hearing Loss (Hearing loss)
CL Item
Keratitis_2005370 (Keratitis)
CL Item
Tearing_2005371 (Tearing)
CL Item
Blurred Vision (Blurred vision)
CL Item
Eye_other2005373 (eye - other)
CL Item
Fever Without Neutropenia (Fever without neutropenia)
CL Item
Rigors/chills (Rigors/chills)
CL Item
Fatigue_2005374 (Fatigue/malaise/lethargy)
CL Item
Weight Loss (Weight loss)
CL Item
Nausea_2005377 (Nausea)
CL Item
Vomiting_2005379 (Vomiting)
CL Item
Diarrhea_2005380 (Diarrhea)
CL Item
Dehydration (Dehydration)
C26740 (NCI Thesaurus)
C0011175 (UMLS 2011AA)
CL Item
Constipation (Constipation)
C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)
CL Item
Taste Disturbance (Taste disturbance)
CL Item
Gastritis (Gastritis)
CL Item
Stomatitis/pharyngitis (Stomatitis/pharyngitis)
CL Item
Esophagitis (Esophagitis)
C9224 (NCI Thesaurus)
C0014868 (UMLS 2011AA)
CL Item
Rt-dysphasia (RT-dysphasia)
CL Item
Rt-esophagitis (RT-esophagitis)
CL Item
Rt-mucositis (RT-mucositis)
CL Item
Creatinine_increase_2005381 (Creatinine increase)
CL Item
Leukopenia2005382 (Leukopenia)
CL Item
Thrombocytopenia_2005383 (Thrombocytopenia)
CL Item
Anemia_2005384 (Anemia)
CL Item
Prbc Transfusion (pRBC transfusion)
CL Item
Neutropeniagranulocytop2005385 (Neutropenia/granulocytopenia)
CL Item
Allergyhypersensitivity2005386 (Allergy/hypertension)
CL Item
Infection Without 3-4 Neutropenia (Infection without 3-4 neutropenia)
CL Item
Febrile_neutropenia_2005389 (Febrile neutropenia)
CL Item
Bilirubin_increase_2005375 (Bilirubin increase)
CL Item
Sgot Increase (SGOT increase)
CL Item
Sgpt_increase_2005376 (SGPT increase)
CL Item
Alkaline Phosphatase Increase (Alkaline phosphatase increase)
CL Item
Pneumonitis (Pneumonitis)
CL Item
Motor Neuropathy (Motor neuropathy)
CL Item
Paresthesia (Paresthesia)
CL Item
Myalgia (Myalgia)
C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)
CL Item
Abdominal Pain (Abdominal pain)
CL Item
Local/injection Site Reaction (Local/injection site reaction)
CL Item
Rashdesquamation2005368 (Rash/desquamation)
CL Item
Pruritis (Pruritis)
CL Item
Radiation Dermatitis (Radiation dermatitis)
CL Item
Arthralgia (Arthralgia)
C0003862 (NCI Metathesaurus)
CL Item
Respiratory Infection With Neutropenia (Respiratory infection with neutropenia)
OtherToxicities
Item
Other toxicities (specify)
text
Item
Grade (1 - 5)
text
CL.5
Code List
Grade (1 - 5)
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
Item
Treatment relation (*)
text
CL.6
Code List
Treatment relation (*)
CL Item
Unrelated_2005393 (unrelated)
CL Item
Unlikely_2005394 (unlikely)
CL Item
Possible_2005395 (possible)
CL Item
Probable_2005396 (probable)
CL Item
Definite_2005397 (definite)
Item Group
Comments
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
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