ID

6766

Description

SOUTHWEST ONCOLOGY GROUP S0023 ADVERSE EVENT FORM 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=E1C4BD05-F022-4833-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E1C4BD05-F022-4833-E034-0003BA12F5E7

Keywords

Versions (2)
  1. 9/19/12 9/19/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
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January 8, 2015

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Creative Commons BY-NC 3.0 Legacy
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Lung Cancer NCT00020709 Toxicity - SOUTHWEST ONCOLOGY GROUP S0023 ADVERSE EVENT FORM - 2291195v3.0

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No Instruction available.

1 forms  
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0023 ADVERSE EVENT FORM
    1. No Instruction available.
Header
Description

Header

SWOG Patient ID
Description

Trial subject ID SWOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
SWOG Study No.
Description

Protocol ID SWOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
Registration Step
Description

Registration Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Patient Initials
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Institution/Affiliate
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Physician
Description

Investigator Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2826892
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C17089
NCI Thesaurus ObjectClass-2
C25644
Treatment Segment
Description

SegmentalTreatmentAdministeredType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ObjectClass-2
C25238
UMLS 2011AA ObjectClass
C0205122
Participating Group Name
Description

Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No.
Description

Study Number Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Description

Trial subject ID Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Toxicity
Description

Toxicity

Reporting period start date (Day 1 of this Cycle)
Description

Reporting Period Start Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS CUI-1
C2361257
NCI Thesaurus Property-2
C25651
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Reporting period end date (Day 1 of next cycle. If final cycle, date of first visit or contact after resolution of acute adverse events.)
Description

Reporting Period End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Were adverse events assessed during this time period?
Description

AdverseEventCurrentAssessmentInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Select box if adverse events were assessed but none were seen. (Otherwise complete information below.)
Description

Unnamed3

Data type

text

CTC Code 2.0
Description

CTCAdverseEventSWOGCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Toxicity
Description

AdverseEventToxicityType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C27990
UMLS 2011AA Property
C0600688
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Other toxicities (specify)
Description

OtherToxicities

Data type

text

Grade (1 - 5)
Description

Grade

Data type

text

Treatment relation (*)
Description

TreatmentRelation

Data type

text

Comments
Description

Comments

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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1 forms
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0023 ADVERSE EVENT FORM
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Trial subject ID SWOG
Item
SWOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Protocol ID SWOG
Item
SWOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Investigator Name
Item
Physician
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
Item
Treatment Segment
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25238 (NCI Thesaurus ObjectClass-2)
C0205122 (UMLS 2011AA ObjectClass)
CL.1
Code List
Treatment Segment
CL Item
Induction Chemo/rt (Induction Chemo/RT)
CL Item
Consolidation Chemo (Consolidation Chemo)
CL Item
Zd1839/placebo Week 4 (ZD1839/Placebo week 4)
CL Item
Zd1839/placebo Week 8 (ZD1839/Placebo week 8)
CL Item
Zd1839/placebo Week 12 (ZD1839/Placebo week 12)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Participating Group
Item
Participating Group Name
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Toxicity
Reporting Period Start Date
Item
Reporting period start date (Day 1 of this Cycle)
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting period end date (Day 1 of next cycle. If final cycle, date of first visit or contact after resolution of acute adverse events.)
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Item
Were adverse events assessed during this time period?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL.2
Code List
Were adverse events assessed during this time period?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
CL Item
Yes, But No Reportable Adverse Events Occurred (Yes, but no reportable adverse events occurred)
CL Item
Yes, And Reportable Adverse Events Occurred (Yes, and reportable adverse events occurred)
Unnamed3
Item
Select box if adverse events were assessed but none were seen. (Otherwise complete information below.)
text
Item
CTC Code 2.0
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL.3
Code List
CTC Code 2.0
CL Item
Ca51 (CA51)
CL Item
Ca52 (CA52)
CL Item
Ca53 (CA53)
CL Item
Ea20 (EA20)
CL Item
Ey02_2005347 (EY02)
CL Item
Ey30_2005348 (EY30)
CL Item
Ey42 (EY42)
CL Item
Ey992005350 (EY99)
CL Item
Fl01 (FL01)
CL Item
Fl10 (FL10)
CL Item
Fl40_2005351 (FL40)
CL Item
Fl51 (FL51)
CL Item
Gi00_2005354 (GI00)
CL Item
Gi10_2005356 (GI10)
CL Item
Gi20_2005357 (GI20)
CL Item
Gi23 (GI23)
CL Item
Gi30 (GI30)
CL Item
Gi43 (GI43)
CL Item
Gi51 (GI51)
CL Item
Gi60 (GI60)
CL Item
Gi61 (GI61)
CL Item
Gir60 (GIR60)
CL Item
Gir69 (GIR69)
CL Item
Gu50_2005358 (GU50)
CL Item
He002005359 (HE00)
CL Item
He102005360 (HE10)
CL Item
He202005361 (HE20)
CL Item
He21 (HE21)
CL Item
He302005362 (HE30)
CL Item
Im00_2005363 (IM00)
CL Item
In002005364 (IN00)
CL Item
In01 (IN01)
CL Item
In05_2005365 (IN05)
CL Item
In06 (IN06)
CL Item
In30_2005366 (IN30)
CL Item
Li00_2005352 (LI00)
CL Item
Li11 (LI11)
CL Item
Li12_2005353 (LI12)
CL Item
Li20 (LI20)
CL Item
Lu50 (LU50)
CL Item
Nr50 (NR50)
CL Item
Nr60 (NR60)
CL Item
Pa21 (PA21)
CL Item
Pa22 (PA22)
CL Item
Pa30 (PA30)
CL Item
Sk00 (SK00)
CL Item
Sk16 (SK16)
CL Item
Skr72 (SKR72)
Item
Toxicity
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C27990 (NCI Thesaurus Property)
C0600688 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL.4
Code List
Toxicity
CL Item
Hypotension (Hypotension)
C3128 (NCI Thesaurus)
C0020649 (UMLS 2011AA)
CL Item
Thrombosis/embolism (Thrombosis/embolism)
CL Item
Edema (Edema)
C3002 (NCI Thesaurus)
C0013604 (UMLS 2011AA)
CL Item
Phlebitis (Phlebitis)
C38003 (NCI Thesaurus)
C0031542 (UMLS 2011AA)
CL Item
Hearing Loss (Hearing loss)
CL Item
Keratitis_2005370 (Keratitis)
CL Item
Tearing_2005371 (Tearing)
CL Item
Blurred Vision (Blurred vision)
CL Item
Eye_other2005373 (eye - other)
CL Item
Fever Without Neutropenia (Fever without neutropenia)
CL Item
Rigors/chills (Rigors/chills)
CL Item
Fatigue_2005374 (Fatigue/malaise/lethargy)
CL Item
Weight Loss (Weight loss)
CL Item
Nausea_2005377 (Nausea)
CL Item
Vomiting_2005379 (Vomiting)
CL Item
Diarrhea_2005380 (Diarrhea)
CL Item
Dehydration (Dehydration)
C26740 (NCI Thesaurus)
C0011175 (UMLS 2011AA)
CL Item
Constipation (Constipation)
C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)
CL Item
Taste Disturbance (Taste disturbance)
CL Item
Gastritis (Gastritis)
CL Item
Stomatitis/pharyngitis (Stomatitis/pharyngitis)
CL Item
Esophagitis (Esophagitis)
C9224 (NCI Thesaurus)
C0014868 (UMLS 2011AA)
CL Item
Rt-dysphasia (RT-dysphasia)
CL Item
Rt-esophagitis (RT-esophagitis)
CL Item
Rt-mucositis (RT-mucositis)
CL Item
Creatinine_increase_2005381 (Creatinine increase)
CL Item
Leukopenia2005382 (Leukopenia)
CL Item
Thrombocytopenia_2005383 (Thrombocytopenia)
CL Item
Anemia_2005384 (Anemia)
CL Item
Prbc Transfusion (pRBC transfusion)
CL Item
Neutropeniagranulocytop2005385 (Neutropenia/granulocytopenia)
CL Item
Allergyhypersensitivity2005386 (Allergy/hypertension)
CL Item
Infection Without 3-4 Neutropenia (Infection without 3-4 neutropenia)
CL Item
Febrile_neutropenia_2005389 (Febrile neutropenia)
CL Item
Bilirubin_increase_2005375 (Bilirubin increase)
CL Item
Sgot Increase (SGOT increase)
CL Item
Sgpt_increase_2005376 (SGPT increase)
CL Item
Alkaline Phosphatase Increase (Alkaline phosphatase increase)
CL Item
Pneumonitis (Pneumonitis)
CL Item
Motor Neuropathy (Motor neuropathy)
CL Item
Paresthesia (Paresthesia)
CL Item
Myalgia (Myalgia)
C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)
CL Item
Abdominal Pain (Abdominal pain)
CL Item
Local/injection Site Reaction (Local/injection site reaction)
CL Item
Rashdesquamation2005368 (Rash/desquamation)
CL Item
Pruritis (Pruritis)
CL Item
Radiation Dermatitis (Radiation dermatitis)
CL Item
Arthralgia (Arthralgia)
C0003862 (NCI Metathesaurus)
CL Item
Respiratory Infection With Neutropenia (Respiratory infection with neutropenia)
OtherToxicities
Item
Other toxicities (specify)
text
Item
Grade (1 - 5)
text
CL.5
Code List
Grade (1 - 5)
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
Item
Treatment relation (*)
text
CL.6
Code List
Treatment relation (*)
CL Item
Unrelated_2005393 (unrelated)
CL Item
Unlikely_2005394 (unlikely)
CL Item
Possible_2005395 (possible)
CL Item
Probable_2005396 (probable)
CL Item
Definite_2005397 (definite)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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