ID

10571

Descripción

S0023 ZD1839 DOSE AND TOXICITY REPORTING FORM NCT00020709 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=9CA62D43-50BE-361C-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9CA62D43-50BE-361C-E034-080020C9C0E0

Palabras clave

  1. 19/9/12 19/9/12 -
  2. 28/5/15 28/5/15 -
  3. 3/6/15 3/6/15 -
Subido en

3 de junio de 2015

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy

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S0023 ZD1839 DOSE AND TOXICITY REPORTING FORM NCT00020709

No Instruction available.

  1. StudyEvent: S0023 ZD1839 DOSE AND TOXICITY REPORTING FORM
    1. No Instruction available.
SWOG clinical trial administrative data
Descripción

SWOG clinical trial administrative data

SWOG Patient ID
Descripción

SWOGPatientID

Tipo de datos

text

SWOG Study No.
Descripción

SWOGStudyNo.

Tipo de datos

text

Registration Step
Descripción

RegistrationStep

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ValueDomain
C16154
UMLS 2011AA ValueDomain
C1704379
Submission Time
Descripción

SubmissionTime:

Tipo de datos

text

Patient Initials (L, F,M)
Descripción

PatientInitials

Tipo de datos

text

Institution / Affiliate
Descripción

Institution/Affiliate

Tipo de datos

text

Physician
Descripción

Physician

Tipo de datos

text

Group Name (Groups other than SWOG )
Descripción

GroupName

Tipo de datos

text

Study No. (Groups other than SWOG )
Descripción

StudyNo.

Tipo de datos

double

Pt. ID (Groups other than SWOG )
Descripción

Pt.ID

Tipo de datos

text

Treatment
Descripción

Treatment

Reporting Begin Date (4 week period)
Descripción

ReportingBeginDate:

Tipo de datos

text

Reporting End Date
Descripción

ReportingEndDate:

Tipo de datos

text

Were there any dose modifications or additions/deletions to protocol treatment?
Descripción

Werethereanydosemodificationsoradditions/deletionstoprotocoltreatment?

Tipo de datos

text

Delay
Descripción

Delay:

Tipo de datos

text

Dose reduction
Descripción

Dosereduction:

Tipo de datos

text

Total dose for this reporting period (mg ZD1839 1 Tablet = 250 mg)
Descripción

Totaldoseforthisreportingperiod:

Tipo de datos

text

Toxicity
Descripción

Toxicity

Were toxicities assessed during this time period?
Descripción

Weretoxicitiesassessedduringthistimeperiod?

Tipo de datos

text

Date of most recent toxicity assessment
Descripción

Dateofmostrecenttoxicityassessment:

Tipo de datos

text

CTC 2.0 Code
Descripción

CTC2.0Code

Tipo de datos

text

Toxicity
Descripción

Toxicity

Tipo de datos

text

Grade (1 - 5)
Descripción

Grade

Tipo de datos

double

Treatment Relation
Descripción

TreatmentRelation

Tipo de datos

text

Other Toxicities (specify:)
Descripción

OtherToxicities

Tipo de datos

text

Notes
Descripción

Notes

Notes
Descripción

Notes

Tipo de datos

text

Similar models

No Instruction available.

  1. StudyEvent: S0023 ZD1839 DOSE AND TOXICITY REPORTING FORM
    1. No Instruction available.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
SWOG clinical trial administrative data
SWOGPatientID
Item
SWOG Patient ID
text
SWOGStudyNo.
Item
SWOG Study No.
text
RegistrationStep
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)
Item
Submission Time
text
Code List
Submission Time
CL Item
4 week (First) Submission (4 week (First) Submission)
CL Item
8 week (Second) Submission (8 week (Second) Submission)
CL Item
Other (Other)
PatientInitials
Item
Patient Initials (L, F,M)
text
Institution/Affiliate
Item
Institution / Affiliate
text
Physician
Item
Physician
text
GroupName
Item
Group Name (Groups other than SWOG )
text
StudyNo.
Item
Study No. (Groups other than SWOG )
double
Pt.ID
Item
Pt. ID (Groups other than SWOG )
text
Item Group
Treatment
ReportingBeginDate:
Item
Reporting Begin Date (4 week period)
text
ReportingEndDate:
Item
Reporting End Date
text
Item
Were there any dose modifications or additions/deletions to protocol treatment?
text
Code List
Were there any dose modifications or additions/deletions to protocol treatment?
CL Item
No (No)
CL Item
Yes, planned (per protocol guidelines) (Yes, planned (per protocol guidelines))
CL Item
Yes, unplanned (not per protocol guidelines) (Yes, unplanned (not per protocol guidelines))
Item
Delay
text
Code List
Delay
CL Item
Yes (Yes)
CL Item
No (No)
Item
Dose reduction
text
Code List
Dose reduction
CL Item
Yes (Yes)
CL Item
No (No)
Totaldoseforthisreportingperiod:
Item
Total dose for this reporting period (mg ZD1839 1 Tablet = 250 mg)
text
Item Group
Toxicity
Item
Were toxicities assessed during this time period?
text
Code List
Were toxicities assessed during this time period?
CL Item
No (No)
CL Item
Yes (Yes)
Dateofmostrecenttoxicityassessment:
Item
Date of most recent toxicity assessment
text
Item
CTC 2.0 Code
text
Code List
CTC 2.0 Code
CL Item
SK11 (SK11)
CL Item
EY01 (EY01)
CL Item
EY02 (EY02)
CL Item
EY30 (EY30)
CL Item
EY40 (EY40)
CL Item
EY99 (EY99)
CL Item
FL40 (FL40)
CL Item
LI00 (LI00)
CL Item
LI12 (LI12)
CL Item
GI00 (GI00)
CL Item
GI01 (GI01)
CL Item
GI10 (GI10)
CL Item
GI20 (GI20)
CL Item
GU50 (GU50)
CL Item
HE00 (HE00)
CL Item
HE10 (HE10)
CL Item
HE20 (HE20)
CL Item
HE30 (HE30)
CL Item
IM00 (IM00)
CL Item
IN00 (IN00)
CL Item
IN05 (IN05)
CL Item
IN30 (IN30)
Item
Toxicity
text
Code List
Toxicity
CL Item
Rash/Desquamation (Rash/Desquamation)
CL Item
Conjunctivitis (Conjunctivitis)
CL Item
Keratitis (Keratitis)
CL Item
Tearing (Tearing)
CL Item
Vision, NOS (Vision, NOS)
CL Item
Eye, Other (Eye, Other)
CL Item
Fatigue (Fatigue)
CL Item
Bilirubin increase (Bilirubin increase)
CL Item
SGPT increase (SGPT increase)
CL Item
Nausea (Nausea)
CL Item
Anorexia (Anorexia)
CL Item
Vomiting (Vomiting)
CL Item
Diarrhea (Diarrhea)
CL Item
Creatinine increase (Creatinine increase)
CL Item
Leukopenia (Leukopenia)
CL Item
Thrombocytopenia (Thrombocytopenia)
CL Item
Anemia (Anemia)
CL Item
Neutropenia/granulocytopenia (Neutropenia/granulocytopenia)
CL Item
Allergy/hypersensitivity (Allergy/hypersensitivity)
CL Item
Infection w/o 3-4 neutropenia (Infection w/o 3-4 neutropenia)
CL Item
Infection with 3-4 neutropenia (Infection with 3-4 neutropenia)
CL Item
Febrile neutropenia (Febrile neutropenia)
Grade
Item
Grade (1 - 5)
double
Item
Treatment Relation
text
Code List
Treatment Relation
CL Item
unrelated (unrelated)
CL Item
unlikely (unlikely)
CL Item
possible (possible)
CL Item
probable (probable)
CL Item
definite (definite)
OtherToxicities
Item
Other Toxicities (specify:)
text
Item Group
Notes
Notes
Item
Notes
text

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