ID

1765

Descrição

S0502 Adverse Event Form S0502 Imatinib Mesylate With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FCBF7FD7-A1A5-7312-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FCBF7FD7-A1A5-7312-E034-0003BA3F9857

Palavras-chave

Transferido a

19 de setembro de 2012

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy

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Gastrointestinal Stromal Tumor NCT00324987 Toxicity - S0502 Adverse Event Form - 2320351v1.0

model
Detalhes

Intergroup Coalition Against Sarcomas (ICAS)

1 Formulários

StudyEvent: S0502 Adverse Event Form
1. Intergroup Coalition Against Sarcomas (ICAS)

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Unnamed1

Item Group

Unnamed1

PatientSouthwestOncologyGroupIdentifierNumber

Item

SWOG Patient ID

double

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property)
C1519429 (UMLS 2011AA Property)

ProtocolSWOGIdentifierNumber

Item

SWOG Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property)
C1519429 (UMLS 2011AA Property)

RegistrationStepNumber

Item

Registration Step

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)

PatientInitialsName

Item

Patient Initials (L, F M)

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)

TreatmentCurrentCourseNumber

Item

Current Cycle Number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)

CombinedInstitutionName

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)

RegisteredInvestigatorName

Item

Physician

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C25644 (NCI Thesaurus ObjectClass)

ParticipatingGroupName

Item

Participating Group Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

ProtocolParticipatingIdentifierNumber

Item

Participating Group Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientParticipatingIdentifierNumber

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

Adverse Events

Item Group

Adverse Events

TreatmentReportingPeriodBeginDate

Item

Reporting Period Start Date (Day 1 of this cycle)

date

C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

TreatmentReportingPeriodEndDate

Item

Reporting Period End Date (Day one of next cycle. If final cycle, date of first visit or contact after resolution of acute adverse events.)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)

AdverseEventCurrentAssessmentInd

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)
C0521116 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)

CL.1

Code List

Were adverse events assessed during this time period?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes, And Reportable Adverse Events Occurred (Yes, and reportable adverse events occurred)

CL Item

Yes, But No Reportable Adverse Events Occurred (Yes, but no reportable adverse events occurred)

CommonToxicityCriteriaAdverseEventTermType

Item

CTC Adverse Event Term

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)

CL.2

Code List

CTC Adverse Event Term

CL Item

Blood Alkaline Phosphatase Nos Increased (Alkaline phosphatase)

CL Item

Alanine Aminotransferase Increased (ALT, SGPT (serum glutamic pyruvic transaminase))

C26948 (NCI Thesaurus)
C0151905 (UMLS 2011AA)

CL Item

Anorexia (Anorexia)

C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)

CL Item

Aspartate Aminotransferase Increased (AST, SGOT (serum glutamic oxaloacetic transaminase))

C26947 (NCI Thesaurus)
C0151904 (UMLS 2011AA)

CL Item

Blood Bilirubin Increased (Bilirubin (hyperbilirubinemia))

CL039714 (NCI Metathesaurus)

CL Item

Blood Creatinine Increased (Creatinine)

C0235431 (NCI Metathesaurus)

CL Item

Diarrhoea Nos (Diarrhea)

CL Item

Fatigue (Fatigue (asthenia, lethargy, malaise))

C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)

CL Item

Febrile Neutropenia (fever Of Unknown Origin Without Clinically Or Microbiologically Documented Infection) (anc <1.0 X 10^9/l, Fever >=38.5 Degrees C) (Febrile neutropenia)

CL Item

Pyrexia (Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L))

CL Item

Flatulence (Flatulence)

C37954 (NCI Thesaurus)
C0016204 (UMLS 2011AA)

CL Item

Dyspepsia (Heartburn/dyspepsia)

C26756 (NCI Thesaurus)
C0013395 (UMLS 2011AA)

CL Item

Haemoglobin Decreased (Hemoglobin)

C0162119 (NCI Metathesaurus)

CL Item

Haemorrhagic Stroke (Hemorrhage, CNS)

CL036983 (NCI Metathesaurus)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Liver)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Lower GI NOS)

CL Item

Haematemesis (Hemorrhage, GI - Stomach)

C0018926 (NCI Metathesaurus)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Upper GI NOS)

CL Item

Haemoptysis (Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS)

CL Item

Hemorrhage, Pulmonary/upper Respiratory (Hemorrhage, pulmonary/upper respiratory - Trachea)

CL Item

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Bladder (urinary))

CL Item

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Colon)

CL Item

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Sinus)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Abdomen NOS)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Anal/perianal)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary))

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Cecum)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Colon)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Duodenum)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Esophagus)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Ileum)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Jejunum)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Kidney)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Larynx)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Liver)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia))

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Mediastinum NOS)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Mucosa)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Oral cavity-gums (gingivitis))

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Peritoneal cavity)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Small bowel NOS)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Soft tissue NOS)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Stomach)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Trachea)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Upper aerodigestive NOS)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Bladder (urinary))

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Bronchus)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Colon)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Esophagus)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Lung (pneumonia))

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Oral cavity-gums (gingivitis))

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Sinus)

CL Item

Leucopenia Nos (Leukocytes (total WBC))

CL Item

Lymphopenia (Lymphopenia)

C26823 (NCI Thesaurus)
C0024312 (UMLS 2011AA)

CL Item

Mucositis/stomatitis (clinical Exam) (Mucositis/stomatitis (clinical exam) - Oral cavity)

CL Item

Nausea (Nausea)

C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)

CL Item

Neutropenia (Neutrophils/granulocytes (ANC/AGC))

C3277 (NCI Thesaurus)

CL Item

Headache Nos (Pain - Head/headache)

CL Item

Myalgia (Pain - Muscle)

C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)

CL Item

Platelet Count Decreased (Platelets)

C0392386 (NCI Metathesaurus)

CL Item

Proteinuria Present (Proteinuria)

CL Item

Dermatitis Exfoliative Nos (Rash/desquamation)

CL Item

Rigors (Rigors/chills)

C0424790 (NCI Metathesaurus)

CL Item

Thrombosis Nos (Thrombosis/thrombus/embolism)

CL Item

Vomiting Nos (Vomiting)

CL Item

Weight Increased (Weight gain)

C0043094 (NCI Metathesaurus)

CommonToxicityCriteriaAdverseEventGrade

Item

CTC AE Grade (3.0 1-5)

double

C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.3

Code List

CTC AE Grade (3.0 1-5)

CL Item

Severe Adverse Event (3)

C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)

CL Item

Life-threatening Or Disabling Adverse Event (4)

CL Item

Death Related To Adverse Event (5)

C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)

CTCAdverseEventAttributionScale

Item

CTC Adverse Event Attribution Code (* Attribution codes: 1-unrelated 2-unlikely 3-possible 4-probably 5-definite)

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)

CL.4

Code List

CTC Adverse Event Attribution Code (* Attribution codes: 1-unrelated 2-unlikely 3-possible 4-probably 5-definite)

CL Item

Definite (Definite)

CL209464 (NCI Metathesaurus)

CL Item

Possible (Possible)

C0332149 (NCI Metathesaurus)

CL Item

Probable (Probable)

C0332148 (NCI Metathesaurus)

CL Item

Unlikely (Unlikely)

CL Item

Unrelated (Unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)

AdverseEventCourseAssessmentStatus

Item

Adverse event status code (** Status codes since baseline or last cycle: 1-new 2-continues at same or lower grade 3-increased grade OR improved then worsened)

text

C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.5

Code List

Adverse event status code (** Status codes since baseline or last cycle: 1-new 2-continues at same or lower grade 3-increased grade OR improved then worsened)

CL Item

Continues At Same Or Lower Grade (Continues at same or lower grade)

CL Item

Increased Grade Or Improved Then Worsened (Increased grade or improved then worsened)

CL Item

New (New)

C25586 (NCI Thesaurus)
C0205314 (UMLS 2011AA)

CTCAdverseEventTermSpecify

Item

CTC Adverse Event Term Other (specify using CTCAE 3.0 terminology)

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)

Comments

Item Group

Comments

ResearchCommentsText

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

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Gastrointestinal Stromal Tumor NCT00324987 Toxicity - S0502 Adverse Event Form - 2320351v1.0

Intergroup Coalition Against Sarcomas (ICAS)

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Intergroup Coalition Against Sarcomas (ICAS)

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