ID

10571

Description

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

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 5/28/15 5/28/15 -
  3. 6/3/15 6/3/15 -
Uploaded on

June 3, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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S0023 ZD1839 DOSE AND TOXICITY REPORTING FORM NCT00020709

English

No Instruction available.

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

SWOG clinical trial administrative data

SWOG Patient ID
Description

SWOGPatientID

Data type

text

SWOG Study No.
Description

SWOGStudyNo.

Data type

text

Registration Step
Description

RegistrationStep

Data type

text

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

SubmissionTime:

Data type

text

Patient Initials (L, F,M)
Description

PatientInitials

Data type

text

Institution / Affiliate
Description

Institution/Affiliate

Data type

text

Physician
Description

Physician

Data type

text

Group Name (Groups other than SWOG )
Description

GroupName

Data type

text

Study No. (Groups other than SWOG )
Description

StudyNo.

Data type

double

Pt. ID (Groups other than SWOG )
Description

Pt.ID

Data type

text

Treatment
Description

Treatment

Reporting Begin Date (4 week period)
Description

ReportingBeginDate:

Data type

text

Reporting End Date
Description

ReportingEndDate:

Data type

text

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

Werethereanydosemodificationsoradditions/deletionstoprotocoltreatment?

Data type

text

Delay
Description

Delay:

Data type

text

Dose reduction
Description

Dosereduction:

Data type

text

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

Totaldoseforthisreportingperiod:

Data type

text

Toxicity
Description

Toxicity

Were toxicities assessed during this time period?
Description

Weretoxicitiesassessedduringthistimeperiod?

Data type

text

Date of most recent toxicity assessment
Description

Dateofmostrecenttoxicityassessment:

Data type

text

CTC 2.0 Code
Description

CTC2.0Code

Data type

text

Toxicity
Description

Toxicity

Data type

text

Grade (1 - 5)
Description

Grade

Data type

double

Treatment Relation
Description

TreatmentRelation

Data type

text

Other Toxicities (specify:)
Description

OtherToxicities

Data type

text

Notes
Description

Notes

Notes
Description

Notes

Data type

text

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Similar models

No Instruction available.

1 forms
  1. StudyEvent: S0023 ZD1839 DOSE AND TOXICITY REPORTING FORM
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
CL.1
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
CL.2
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
CL.3
Code List
Delay
CL Item
Yes (Yes)
CL Item
No (No)
Item
Dose reduction
text
CL.4
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
CL.5
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
CL.6
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
CL.7
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
CL.8
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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