ID

3258

Description

Concomitant Medication Form A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A6277C4D-6BBD-3D79-E034-0003BA0B1A09

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A6277C4D-6BBD-3D79-E034-0003BA0B1A09

Mots-clés

  1. 19/09/2012 19/09/2012 - Philipp Bruland
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 03/07/2015 03/07/2015 -
Téléchargé le

19 septembre 2012

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0 Legacy

Modèle Commentaires :

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Pancreatic Cancer NCT00058149 Treatment - Concomitant Medication Form - 2047658v3.0

No Instruction available.

  1. StudyEvent: Concomitant Medication Form
    1. No Instruction available.
Unnamed1
Description

Unnamed1

Registration Step
Description

RegistrationStep

Type de données

text

Patient?s Name
Description

Patient'sName

Type de données

text

ECOG Prot. No.
Description

ECOGProtocolNo.

Type de données

text

ECOG Prot. No.
Description

ECOGProtocolNo.

Type de données

text

ECOG Patient Seq. No.
Description

ECOGPatientID

Type de données

text

ECOG Patient Seq. No.
Description

ECOGPatientID

Type de données

text

Participating Group Prot. No.
Description

ParticipatingGroupProtocolNo.

Type de données

text

Participating Group Patient ID No.
Description

ParticipatingGroupPatientID

Type de données

text

Step No.
Description

StepNo.

Type de données

text

Group
Description

ParticipatingGroupName

Type de données

text

Institution
Description

InstitutionName

Type de données

text

Network
Description

Network

Type de données

text

Affiliate
Description

AffiliateName

Type de données

text

Unnamed2
Description

Unnamed2

Are data amended? (If yes, please circle amended items in red)
Description

AmendedDataInd

Type de données

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Reporting period Start Date: (M D Y)
Description

IntervalReportFromDate

Type de données

date

Reporting period End Date: (M D Y)
Description

IntervalReportToDate

Type de données

date

Unnamed3
Description

Unnamed3

Generic Name (Use brand or trade if generic name unknown)
Description

AgentName

Type de données

text

Dose
Description

Dose

Type de données

double

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
Units
Description

Units

Type de données

text

other, specify
Description

other,specify

Type de données

text

Alias
NCI Thesaurus ObjectClass
C25179
UMLS 2011AA ObjectClass
C0019993
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
other, specify
Description

other,specify

Type de données

text

Alias
NCI Thesaurus ObjectClass
C25179
UMLS 2011AA ObjectClass
C0019993
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
other, specify
Description

other,specify

Type de données

text

Alias
NCI Thesaurus ObjectClass
C25179
UMLS 2011AA ObjectClass
C0019993
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Frequency
Description

Frequency

Type de données

text

Alias
NCI Thesaurus ObjectClass
C25515
UMLS 2011AA ObjectClass
C0439603
Route
Description

AgentAdminRoute

Type de données

text

Start Date (Leave blank if continuing from a prior report period)
Description

AgentBeginDate

Type de données

date

Is this medication continuing?
Description

Isthismedicationcontinuing?

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Stop Date (Leave blank if continuing)
Description

AgentEndDate

Type de données

date

Unnamed4
Description

Unnamed4

Comments
Description

Comments

Type de données

text

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

InvestigatorSignatureDate

Type de données

date

Ccrr Module For Concomitant Medication Form
Description

Ccrr Module For Concomitant Medication Form

Institution/Affiliate
Description

MainMemberInstitution/Affiliate

Type de données

text

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
DCI Name
Description

DCIName

Type de données

text

Similar models

No Instruction available.

  1. StudyEvent: Concomitant Medication Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Unnamed1
RegistrationStep
Item
Registration Step
text
Patient'sName
Item
Patient?s Name
text
ECOGProtocolNo.
Item
ECOG Prot. No.
text
ECOGProtocolNo.
Item
ECOG Prot. No.
text
ECOGPatientID
Item
ECOG Patient Seq. No.
text
ECOGPatientID
Item
ECOG Patient Seq. No.
text
ParticipatingGroupProtocolNo.
Item
Participating Group Prot. No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID No.
text
StepNo.
Item
Step No.
text
ParticipatingGroupName
Item
Group
text
InstitutionName
Item
Institution
text
Network
Item
Network
text
AffiliateName
Item
Affiliate
text
Item Group
Unnamed2
Item
Are data amended? (If yes, please circle amended items in red)
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Code List
Are data amended? (If yes, please circle amended items in red)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
IntervalReportFromDate
Item
Reporting period Start Date: (M D Y)
date
IntervalReportToDate
Item
Reporting period End Date: (M D Y)
date
Item Group
Unnamed3
AgentName
Item
Generic Name (Use brand or trade if generic name unknown)
text
Dose
Item
Dose
double
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
Item
Units
text
Code List
Units
CL Item
capsules (caps) (capsules (caps))
CL Item
gram (gm) (gram (gm))
CL Item
drops (gtts) (drops (gtts))
CL Item
inch (inch) (inch (inch))
CL Item
kilogram (kg) (kilogram (kg))
CL Item
liter (l) (liter (l))
CL Item
microgram (mcg) (microgram (mcg))
CL Item
milliequivalent (mEq) (milliequivalent (mEq))
CL Item
milligram (mg) (milligram (mg))
CL Item
milliliter (ml) (milliliter (ml))
CL Item
ounce (oz) (ounce (oz))
CL Item
tablets (tabs) (tablets (tabs))
CL Item
tablespoon (tbsp) (tablespoon (tbsp))
CL Item
teaspoon (tsp) (teaspoon (tsp))
CL Item
unit (u) (unit (u))
CL Item
other, specify (other, specify)
other,specify
Item
other, specify
text
C25179 (NCI Thesaurus ObjectClass)
C0019993 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
other,specify
Item
other, specify
text
C25179 (NCI Thesaurus ObjectClass)
C0019993 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
other,specify
Item
other, specify
text
C25179 (NCI Thesaurus ObjectClass)
C0019993 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
Frequency
text
C25515 (NCI Thesaurus ObjectClass)
C0439603 (UMLS 2011AA ObjectClass)
Code List
Frequency
CL Item
Immediately (stat) (immediately (Stat))
CL Item
As Needed (p.r.n) (as needed (P.R.N))
CL Item
Every Day (q.d.) (every day (Q.D.))
CL Item
Every Other Day (q.o.d.) (every other day (Q.O.D.))
CL Item
Twice A Day (b.i.d) (twice a day (B.I.D))
CL Item
Three Times A Day (t.i.d) (three times a day (T.I.D))
CL Item
Four Times A Day (q.i.d) (four times a day (Q.I.D))
CL Item
Twice A Week (b.i.w) (twice a week (B.I.W))
CL Item
Three Times A Week (t.i.w) (three times a week (T.I.W))
CL Item
Before Meals (a.c.) (before meals (A.C.))
CL Item
After Meals (p.c.) (after meals (P.C.))
CL Item
At Bedtime Or Hour Of Sleep (h.s.) (at bedtime or hour of sleep (H.S.))
CL Item
Every 4 Hours (q4hr) (every 4 hours (Q4hr))
CL Item
Every 6 Hours (q6hr) (every 6 hours (Q6hr))
CL Item
Every 8 Hours (q8hr) (every 8 hours (Q8hr))
CL Item
Every 12 Hours (q12hr) (every 12 hours (Q12hr))
CL Item
Other, Specify (other, specify)
Item
Route
text
Code List
Route
CL Item
Oral Administration Of Drug (oral (p.o.))
CL Item
subcutaneous (s.c.) (subcutaneous (s.c.))
CL Item
Intramuscular Administration Of Drug (intramuscular (i.m.))
CL Item
Intravenous Administration Of Drug (intravenous (i.v.))
CL Item
rectal (rectal)
CL Item
topical (topical)
CL Item
nasal (nasal)
CL Item
inhaled (inhaled)
CL Item
transdermal (transdermal)
CL Item
sublingual (sublingual)
CL Item
intradermal (intradermal)
CL Item
other, specify (other, specify)
AgentBeginDate
Item
Start Date (Leave blank if continuing from a prior report period)
date
Item
Is this medication continuing?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Code List
Is this medication continuing?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
AgentEndDate
Item
Stop Date (Leave blank if continuing)
date
Item Group
Unnamed4
Comments
Item
Comments
text
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date
date
Item Group
Ccrr Module For Concomitant Medication Form
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
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)
DCIName
Item
DCI Name
text

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