ID

9375

Beskrivning

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

Länk

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

Nyckelord

Versioner (3)
  1. 2014-12-18 2014-12-18 - Martin Dugas
  2. 2014-12-18 2014-12-18 - Martin Dugas
  3. 2015-01-09 2015-01-09 - Martin Dugas
Uppladdad den

9 januari 2015

DOI

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Licens

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

Engelsk

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 Formulär  
Header
Beskrivning

Header

Alias
UMLS CUI-1
C1320722
SWOG Patient ID
Beskrivning

SWOGPatientID

Datatyp

text

SWOG Study No.
Beskrivning

SWOGStudyNo.

Datatyp

text

Registration Step
Beskrivning

RegistrationStep

Datatyp

text

Patient Initials (L, F M)
Beskrivning

Patient Initials

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
UMLS CUI-1
C2986440
Institution
Beskrivning

Institution Name

Datatyp

text

Alias
UMLS CUI-1
C0565990
Affiliate
Beskrivning

Affiliate

Datatyp

text

Alias
UMLS CUI-1
C1510825
Physician
Beskrivning

Registered Investigator

Datatyp

text

Alias
UMLS CUI-1
C2826892
Was patient hospitalized during this reporting interval?
Beskrivning

HospitalizationReportPeriodInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C25616
NCI Thesaurus Property-2
C25375
NCI Thesaurus ObjectClass
C25179
UMLS CUI-1
C1512698
UMLS CUI-2
C1948053
UMLS CUI-3
C0684224
UMLS CUI-4
C0019993
Disease Status
Beskrivning

Disease Status

Date of Last Contact or Death
Beskrivning

DeathDate/LastContactDate

Datatyp

date

Vital Status
Beskrivning

Patient'sVitalStatus

Datatyp

text

Treatment
Beskrivning

Treatment

Is patient still on protocol treatment?
Beskrivning

Ispatientstillonprotocoltreatment?

Datatyp

boolean

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

IntervalReportFromDate

Datatyp

date

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

IntervalReportToDate

Datatyp

date

Weight
Beskrivning

Patient Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI-1
C1305866
kg
BSA (m?)
Beskrivning

Body Surface Area

Datatyp

float

Måttenheter
  • m^2
Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
UMLS CUI-1
C0005902
m^2
Performance Status
Beskrivning

PerformanceStatus

Datatyp

text

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

DoseModification(Change)

Datatyp

text

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

DoseModificationReason

Datatyp

text

Number of weeks treatment given in reports interval
Beskrivning

Numberofweekstreatmentgiveninreportsinterval

Datatyp

text

Total dose gemcitabine given this reporting interval (mg)
Beskrivning

AgentTotalDose(percourse)

Datatyp

float

Total dose gemcitabine given this reporting interval (mg)
Beskrivning

AgentTotalDose(percourse)

Datatyp

float

Comments
Beskrivning

Comments

Comments
Beskrivning

Comments

Datatyp

text

Toxicity
Beskrivning

Toxicity

Were toxicities assessed for this reporting interval?
Beskrivning

Weretoxicitiesassessedforthisreportinginterval?

Datatyp

boolean

Date of most recent toxicity assessment
Beskrivning

SymptomAssessmentDate

Datatyp

date

Toxicity assessed but none were seen
Beskrivning

Toxicity assessed but none were seen

Datatyp

boolean

For Stat Center Use
Beskrivning

ForStatCenterUse

Datatyp

text

Toxicity
Beskrivning

CTCAdverseEventTerm

Datatyp

text

CTC Adverse Event Grade (0-5)
Beskrivning

CTC Adverse Event Grade

Datatyp

integer

Alias
UMLS CUI-1
C2985911
Pain - other, specify below
Beskrivning

Pain-other,specifybelow

Datatyp

text

Other Toxicities (specify)
Beskrivning

CTCAdverseEventTerm,Other

Datatyp

text

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Similar models

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
SWOGPatientID
Item
SWOG Patient ID
text
SWOGStudyNo.
Item
SWOG Study No.
text
RegistrationStep
Item
Registration Step
text
Patient Initials
Item
Patient Initials (L, F M)
text
C25191 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
C2986440 (UMLS CUI-1)
Institution Name
Item
Institution
text
C0565990 (UMLS CUI-1)
Affiliate
Item
Affiliate
text
C1510825 (UMLS CUI-1)
Registered Investigator
Item
Physician
text
C2826892 (UMLS CUI-1)
HospitalizationReportPeriodInd-2
Item
Was patient hospitalized during this reporting interval?
boolean
C38147 (NCI Thesaurus ValueDomain)
C25616 (NCI Thesaurus Property)
C25375 (NCI Thesaurus Property-2)
C25179 (NCI Thesaurus ObjectClass)
C1512698 (UMLS CUI-1)
C1948053 (UMLS CUI-2)
C0684224 (UMLS CUI-3)
C0019993 (UMLS CUI-4)
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
Patient still on protocol treatment
Item
Is patient still on protocol treatment?
boolean
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
Patient Weight
Item
Weight
float
C1305866 (UMLS CUI-1)
Body Surface Area
Item
BSA (m?)
float
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS CUI-1)
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)
float
AgentTotalDose(percourse)
Item
Total dose gemcitabine given this reporting interval (mg)
float
Item Group
Comments
Comments
Item
Comments
text
Item Group
Toxicity
Toxicity assessment
Item
Were toxicities assessed for this reporting interval?
boolean
SymptomAssessmentDate
Item
Date of most recent toxicity assessment
date
Toxicity assessed but none were seen
Item
Toxicity assessed but none were seen
boolean
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
CTC Adverse Event Grade (0-5)
integer
C2985911 (UMLS CUI-1)
CL.8
Code List
CTC Adverse Event 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
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