ID

6353

Beschreibung

S0205 Toxicity and Dosage Form S0205 Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A1204548-9EF3-3AA5-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A1204548-9EF3-3AA5-E034-080020C9C0E0

Stichworte

Versionen (3)
  1. 18.12.14 18.12.14 - Martin Dugas
  2. 18.12.14 18.12.14 - Martin Dugas
  3. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

18. Dezember 2014

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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Pancreatic Cancer NCT00075686 Toxicity - S0205 Toxicity and Dosage Form - 2035853v3.0

Englisch

Instructions: Please complete every 4 weeks while on treatment. All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in a Comments section. Place an X in appropriate boxes. Circle AMENDED items

1 Formulare  
Unnamed1
Beschreibung

Unnamed1

SWOG Patient ID
Beschreibung

SWOGPatientID

Datentyp

text

SWOG Study No.
Beschreibung

SWOGStudyNo.

Datentyp

text

Registration Step
Beschreibung

RegistrationStep

Datentyp

text

Patient Initials (L, F M)
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
Beschreibung

InstitutionName

Datentyp

text

Affiliate
Beschreibung

AffiliateName

Datentyp

text

Physician
Beschreibung

RegisteredInvestigator

Datentyp

text

Disease Status
Beschreibung

Disease Status

Date of Last Contact or Death
Beschreibung

DeathDate/LastContactDate

Datentyp

date

Vital Status
Beschreibung

Patient'sVitalStatus

Datentyp

text

Treatment
Beschreibung

Treatment

Is patient still on protocol treatment?
Beschreibung

Ispatientstillonprotocoltreatment?

Datentyp

text

Reporting interval start date (Reporting interval start date should be the day after the last full toxicity assessment date.)
Beschreibung

IntervalReportFromDate

Datentyp

date

Reporting interval stop date (First Day of Reporting Interval)
Beschreibung

IntervalReportToDate

Datentyp

date

Weight (kg)
Beschreibung

PatientWeight

Datentyp

double

BSA (m?)
Beschreibung

BodySurfaceArea

Datentyp

double

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25157
UMLS 2011AA Property
C0005902
Performance Status
Beschreibung

PerformanceStatus

Datentyp

text

Were there any additions, adjustments or omissions to protocol treatment based on previous cycle toxicities?
Beschreibung

DoseModification(Change)

Datentyp

text

If Yes, unplanned, Specify therapy, amount and reason on line below
Beschreibung

DoseModificationReason

Datentyp

text

Number of weeks treatment given in reports interval
Beschreibung

Numberofweekstreatmentgiveninreportsinterval

Datentyp

text

Total dose gemcitabine given this reporting interval (mg)
Beschreibung

AgentTotalDose(percourse)

Datentyp

double

Total dose gemcitabine given this reporting interval (mg)
Beschreibung

AgentTotalDose(percourse)

Datentyp

double

Comments
Beschreibung

Comments

Comments
Beschreibung

Comments

Datentyp

text

Unnamed2
Beschreibung

Unnamed2

SWOG Patient ID
Beschreibung

SWOGPatientID

Datentyp

text

SWOG Study No.
Beschreibung

SWOGStudyNo.

Datentyp

text

Registration Step
Beschreibung

RegistrationStep

Datentyp

text

Patient Initials (L, F M)
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
Toxicity
Beschreibung

Toxicity

Were toxicities assessed for this reporting interval?
Beschreibung

Weretoxicitiesassessedforthisreportinginterval?

Datentyp

text

Date of most recent toxicity assessment
Beschreibung

SymptomAssessmentDate

Datentyp

date

Unnamed3
Beschreibung

Unnamed3

Datentyp

text

For Stat Center Use
Beschreibung

ForStatCenterUse

Datentyp

text

Toxicity
Beschreibung

CTCAdverseEventTerm

Datentyp

text

Grade (0-5)
Beschreibung

CTCAdverseEventGrade

Datentyp

text

Pain - other, specify below
Beschreibung

Pain-other,specifybelow

Datentyp

text

Other Toxicities (specify)
Beschreibung

CTCAdverseEventTerm,Other

Datentyp

text

Comments
Beschreibung

Comments

Comments
Beschreibung

Comments

Datentyp

text

Ccrr Module For S0205 Toxicity And Dosage Form
Beschreibung

Ccrr Module For S0205 Toxicity And Dosage Form

Was patient hospitalized during this reporting interval?
Beschreibung

HospitalizationReportPeriodInd-2

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ObjectClass
C25179
UMLS 2011AA ObjectClass
C0019993
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Ähnliche Modelle

Instructions: Please complete every 4 weeks while on treatment. All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in a Comments section. Place an X in appropriate boxes. Circle AMENDED items

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Unnamed1
SWOGPatientID
Item
SWOG Patient ID
text
SWOGStudyNo.
Item
SWOG Study No.
text
RegistrationStep
Item
Registration Step
text
PatientInitialsName
Item
Patient Initials (L, F M)
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)
InstitutionName
Item
Institution
text
AffiliateName
Item
Affiliate
text
RegisteredInvestigator
Item
Physician
text
Item Group
Disease Status
DeathDate/LastContactDate
Item
Date of Last Contact or Death
date
Item
Vital Status
text
CL.1
Code List
Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Item Group
Treatment
Item
Is patient still on protocol treatment?
text
CL.2
Code List
Is patient still on protocol treatment?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
IntervalReportFromDate
Item
Reporting interval start date (Reporting interval start date should be the day after the last full toxicity assessment date.)
date
IntervalReportToDate
Item
Reporting interval stop date (First Day of Reporting Interval)
date
PatientWeight
Item
Weight (kg)
double
BodySurfaceArea
Item
BSA (m?)
double
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)
PerformanceStatus
Item
Performance Status
text
Item
Were there any additions, adjustments or omissions to protocol treatment based on previous cycle toxicities?
text
CL.3
Code List
Were there any additions, adjustments or omissions to protocol treatment based on previous cycle toxicities?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
(i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned (per protocol guidelines))
CL Item
(i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned (not per protocol guidelines))
DoseModificationReason
Item
If Yes, unplanned, Specify therapy, amount and reason on line below
text
Numberofweekstreatmentgiveninreportsinterval
Item
Number of weeks treatment given in reports interval
text
AgentTotalDose(percourse)
Item
Total dose gemcitabine given this reporting interval (mg)
double
AgentTotalDose(percourse)
Item
Total dose gemcitabine given this reporting interval (mg)
double
Item Group
Comments
Comments
Item
Comments
text
Item Group
Unnamed2
SWOGPatientID
Item
SWOG Patient ID
text
SWOGStudyNo.
Item
SWOG Study No.
text
RegistrationStep
Item
Registration Step
text
PatientInitialsName
Item
Patient Initials (L, F M)
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)
Item Group
Toxicity
Item
Were toxicities assessed for this reporting interval?
text
CL.4
Code List
Were toxicities assessed for this reporting interval?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
SymptomAssessmentDate
Item
Date of most recent toxicity assessment
date
Item
Unnamed3
text
CL.5
Code List
Unnamed3
CL Item
Mark Box If Toxicities Were Assessed But None Were Seen. (Mark box if toxicities were assessed but none were seen.)
Item
For Stat Center Use
text
CL.6
Code List
For Stat Center Use
CL Item
Ca02 (CA02)
CL Item
Ca20 (CA20)
CL Item
Ca30 (CA30)
CL Item
Ca53 (CA53)
CL Item
Ey01 (EY01)
CL Item
Ey02 (EY02)
CL Item
Ey99 (EY99)
CL Item
Fl01 (FL01)
CL Item
Fl10 (FL10)
CL Item
Fl40 (FL40)
CL Item
Gi00 (GI00)
CL Item
Gi01 (GI01)
CL Item
Gi10 (GI10)
CL Item
Gi20 (GI20)
CL Item
Gi30 (GI30)
CL Item
Gi41 (GI41)
CL Item
Gi60 (GI60)
CL Item
Gu50 (GU50)
CL Item
He00 (HE00)
CL Item
He10 (HE10)
CL Item
He20 (HE20)
CL Item
He30 (HE30)
CL Item
Hm40 (HM40)
CL Item
Im00 (IM00)
CL Item
Li00 (LI00)
CL Item
Li11 (LI11)
CL Item
Li12 (LI12)
CL Item
Li20 (LI20)
CL Item
Li30 (LI30)
CL Item
Lu00 (LU00)
CL Item
Lu50 (LU50)
CL Item
Lu51 (LU51)
CL Item
Ms00 (MS00)
CL Item
Nr30 (NR30)
CL Item
Nr60 (NR60)
CL Item
Nr92 (NR92)
CL Item
Pa00 (PA00)
CL Item
Pa21 (PA21)
CL Item
Pa22 (PA22)
CL Item
Pa40 (PA40)
CL Item
Pa70 (PA70)
CL Item
Pa80 (PA80)
CL Item
Pa99 (PA99)
CL Item
Sk11 (SK11)
CL Item
Sk16 (SK16)
CL Item
Sk20 (SK20)
CL Item
Sk80 (SK80)
CL Item
Sk90 (SK90)
Item
Toxicity
text
CL.7
Code List
Toxicity
CL Item
Nodal / junctional dysrhythmia (Nodal / junctional dysrhythmia)
CL Item
Cardiac ischemia/infarction (Cardiac ischemia/infarction)
CL Item
Pericardial effusion/pericarditis (Pericardial effusion/pericarditis)
CL Item
Edema (Edema)
CL Item
Conjunctivitis (Conjunctivitis)
CL Item
Keratitis (Keratitis)
CL Item
Eye - other (Eye - other)
CL Item
Fever without neutropenia (Fever without neutropenia)
CL Item
Rigors/chills (Rigors/chills)
CL Item
Fatigue (Fatigue)
CL Item
Nausea (Nausea)
CL Item
Anorexia (Anorexia)
CL Item
Vomiting (Vomiting)
CL Item
Diarrhea (Diarrhea)
CL Item
Constipation (Constipation)
CL Item
Mouth dryness (Mouth dryness)
CL Item
Stomatitis/pharyngitis (Stomatitis/pharyngitis)
CL Item
Creatinine (Creatinine)
CL Item
Leukopenia (Leukopenia)
CL Item
Thrombocytopenia (Thrombocytopenia)
CL Item
Anemia (Anemia)
CL Item
Neutropenia (ANC) (Neutropenia (ANC))
CL Item
Hematuria (Hematuria)
CL Item
Allergy/hypersensitivity (Allergy/hypersensitivity)
CL Item
Bilirubin (Bilirubin)
CL Item
SGOT (AST) (SGOT (AST))
CL Item
SGPT (ALT) (SGPT (ALT))
CL Item
Alkaline phosphatase (Alkaline phosphatase)
CL Item
Liver - clinical (Liver - clinical)
CL Item
Dyspnea (Dyspnea)
CL Item
Pneumonitis/infiltrates (Pneumonitis/infiltrates)
CL Item
Plural effusion (Plural effusion)
CL Item
Muscle weakness (Muscle weakness)
CL Item
Seizure(s) (Seizure(s))
CL Item
Neuropathy - sensory (Neuropathy - sensory)
CL Item
Insomnia (Insomnia)
CL Item
Headache (Headache)
CL Item
Myalgia (Myalgia)
CL Item
Arthralgia (Arthralgia)
CL Item
Chest pain (Chest pain)
CL Item
Neuropathic pain (Neuropathic pain)
CL Item
Tumor pain (Tumor pain)
CL Item
Pain - other, specify below (Pain - other, specify below)
CL Item
Rash/desquamation (Rash/desquamation)
CL Item
Pruritus (Pruritus)
CL Item
Erythema multiforme (Erythema multiforme)
CL Item
Dry skin (Dry skin)
CL Item
Alopecia (Alopecia)
Item
Grade (0-5)
text
CL.8
Code List
Grade (0-5)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
Pain-other,specifybelow
Item
Pain - other, specify below
text
CTCAdverseEventTerm,Other
Item
Other Toxicities (specify)
text
Item Group
Comments
Comments
Item
Comments
text
Item Group
Ccrr Module For S0205 Toxicity And Dosage Form
Item
Was patient hospitalized during this reporting interval?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25179 (NCI Thesaurus ObjectClass)
C0019993 (UMLS 2011AA ObjectClass)
CL.9
Code List
Was patient hospitalized during this reporting interval?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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