ID

11467

Description

Southwest Oncology Group S0600 Baseline Abnormalities Form NCT00499369 Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer That Progressed During First-Line Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=15416480-968A-679D-E044-0003BA3F9857

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=15416480-968A-679D-E044-0003BA3F9857

Mots-clés

  1. 27/08/2012 27/08/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 09/01/2015 09/01/2015 - Martin Dugas
  4. 05/07/2015 05/07/2015 -
Téléchargé le

5 juillet 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy

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Southwest Oncology Group S0600 Baseline Abnormalities Form NCT00499369

No Instruction available.

  1. StudyEvent: Southwest Oncology Group S0600 Baseline Abnormalities Form
    1. No Instruction available.
Header
Description

Header

SWOG Patient ID
Description

Trial subject ID SWOG

Type de données

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

Type de données

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

Type de données

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 (L, F M)
Description

Patient Initials

Type de données

text

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

Institution Name

Type de données

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 (Participating Group)
Description

Investigator Name

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2826892
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C17089
NCI Thesaurus ObjectClass-2
C25644
Participating Group Name
Description

Participating Group

Type de données

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

Type de données

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

Type de données

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
Adverse event assessment
Description

Adverse event assessment

CTC Adverse Event Term (Pre-treatment)
Description

CTC Adverse Event Term

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
CTC AE Grade (3.0 1-4)
Description

CTC Adverse Event Grade

Type de données

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
CTC Adverse Event Term, Other (pre-treatment specify using CTCAE 3.0 terminology)
Description

CTC Adverse Event Term

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
Comments
Description

Comments

Comments
Description

Research Comments

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393

Similar models

No Instruction available.

  1. StudyEvent: Southwest Oncology Group S0600 Baseline Abnormalities Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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 (L, F M)
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 (Participating Group)
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
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
Adverse event assessment
Item
CTC Adverse Event Term (Pre-treatment)
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
Code List
CTC Adverse Event Term (Pre-treatment)
CL Item
Haemoglobin Decreased (Hemoglobin)
C0162119 (NCI Metathesaurus)
CL Item
Leucopenia Nos (Leukocytes (total WBC))
CL Item
Neutropenia (Neutrophils/granulocytes)
C3277 (NCI Thesaurus)
CL Item
Supraventricular Arrhythmia Nos (Supraventricular and nodal arrhythmia - Supraventricular arrhythmia NOS)
CL Item
Ventricular Arrhythmia (Ventricular arrhythmia - Ventricular fibrillation)
C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)
C26924 (NCI Thesaurus-3)
C0085612 (UMLS 2011AA-4)
C26924 (NCI Thesaurus-5)
C0085612 (UMLS 2011AA-6)
C26924 (NCI Thesaurus-7)
C0085612 (UMLS 2011AA-8)
C26924 (NCI Thesaurus-9)
C0085612 (UMLS 2011AA-10)
C26924 (NCI Thesaurus-11)
C0085612 (UMLS 2011AA-12)
C26924 (NCI Thesaurus-13)
C0085612 (UMLS 2011AA-14)
C26924 (NCI Thesaurus-15)
C0085612 (UMLS 2011AA-16)
CL Item
Cardiac Troponin I Increased (Cardiac troponin I (cTnI))
CL038402 (NCI Metathesaurus)
CL Item
Myocardial Ischaemia (Cardiac ischemia/infarction)
C0151744 (NCI Metathesaurus)
CL Item
Hypertension Nos (Hypertension)
CL Item
Hypotension Nos (Hypotension)
CL Item
Left Ventricular Diastolic Dysfunction (Left ventricular diastolic dysfunction)
CL Item
Left Ventricular Failure (Left ventricular systolic dysfunction)
C0023212 (NCI Metathesaurus)
CL Item
Fatigue (Fatigue)
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Pyrexia (Fever)
CL Item
Rigors (Rigors/chills)
C0424790 (NCI Metathesaurus)
CL Item
Weight Decreased (Weight loss)
CL Item
Anorexia (Anorexia)
C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)
CL Item
Colitis Nos (Colitis)
CL Item
Constipation (Constipation)
C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)
CL Item
Dehydration (Dehydration)
C26740 (NCI Thesaurus)
C0011175 (UMLS 2011AA)
CL Item
Diarrhoea Nos (Diarrhea)
CL Item
Dyspepsia (Heartburn/dyspepsia)
C26756 (NCI Thesaurus)
C0013395 (UMLS 2011AA)
CL Item
Leak (including Anastomotic), Gi (Leak (including anastomotic), GI - Large bowel)
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Vomiting Nos (Vomiting)
CL Item
Haemorrhagic Stroke (Hemorrhage, CNS)
CL036983 (NCI Metathesaurus)
CL Item
Melaena (Hemorrhage, GI - Abdomen NOS)
C0025222 (NCI Metathesaurus)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Colon)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Lower GI NOS)
CL Item
Rectal Bleeding (Hemorrhage, GI - Rectum)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Upper GI NOS)
CL Item
Hemorrhage, Pulmonary/upper Respiratory (Hemorrhage, pulmonary/upper respiratory - Lung)
CL Item
Epistaxis (Hemorrhage, pulmonary/upper respiratory - Nose)
C26766 (NCI Thesaurus)
C0014591 (UMLS 2011AA)
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 - Colon)
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 - Pleura (empyema))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Rectum)
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
Alanine Aminotransferase Increased (ALT, SGPT (serum glutamic pyruvic transaminase))
C26948 (NCI Thesaurus)
C0151905 (UMLS 2011AA)
CL Item
Aspartate Aminotransferase Increased (AST, SGOT (serum glutamic oxaloacetic transaminase))
C26947 (NCI Thesaurus)
C0151904 (UMLS 2011AA)
CL Item
Blood Alkaline Phosphatase Nos Increased (Alkaline phosphatase)
CL Item
Blood Bilirubin Increased (Bilirubin (hyperbilirubinemia))
CL039714 (NCI Metathesaurus)
CL Item
Blood Creatinine Increased (Creatinine)
C0235431 (NCI Metathesaurus)
CL Item
Proteinuria Present (Proteinuria)
CL Item
Ataxia Nec (Ataxia (incoordination))
CL Item
Cerebral Ischaemia (CNS cerebrovascular ischemia)
C0917798 (NCI Metathesaurus)
CL Item
Dizziness (exc Vertigo) (Dizziness)
CL Item
Peripheral Sensory Neuropathy (Neuropathy - sensory)
C3501 (NCI Thesaurus)
C0151313 (UMLS 2011AA)
CL Item
Speech Disorder Nec (Speech impairment (e.g., dysphasia or aphasia))
CL Item
Vision Blurred (Vision-blurred vision)
CL Item
Abdominal Pain Nos (Pain - Abdomen NOS)
CL Item
Pain (Pain - Back)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus-3)
C0030193 (UMLS 2011AA-4)
C3303 (NCI Thesaurus-5)
C0030193 (UMLS 2011AA-6)
C3303 (NCI Thesaurus-7)
C0030193 (UMLS 2011AA-8)
C3303 (NCI Thesaurus-9)
C0030193 (UMLS 2011AA-10)
C3303 (NCI Thesaurus-11)
C0030193 (UMLS 2011AA-12)
C3303 (NCI Thesaurus-13)
C0030193 (UMLS 2011AA-14)
C3303 (NCI Thesaurus-15)
C0030193 (UMLS 2011AA-16)
C3303 (NCI Thesaurus-17)
C0030193 (UMLS 2011AA-18)
C3303 (NCI Thesaurus-19)
C0030193 (UMLS 2011AA-20)
C3303 (NCI Thesaurus-21)
C0030193 (UMLS 2011AA-22)
C3303 (NCI Thesaurus-23)
C0030193 (UMLS 2011AA-24)
C3303 (NCI Thesaurus-25)
C0030193 (UMLS 2011AA-26)
C3303 (NCI Thesaurus-27)
C0030193 (UMLS 2011AA-28)
C3303 (NCI Thesaurus-29)
C0030193 (UMLS 2011AA-30)
C3303 (NCI Thesaurus-31)
C0030193 (UMLS 2011AA-32)
C3303 (NCI Thesaurus-33)
C0030193 (UMLS 2011AA-34)
C3303 (NCI Thesaurus-35)
C0030193 (UMLS 2011AA-36)
C3303 (NCI Thesaurus-37)
C0030193 (UMLS 2011AA-38)
C3303 (NCI Thesaurus-39)
C0030193 (UMLS 2011AA-40)
C3303 (NCI Thesaurus-41)
C0030193 (UMLS 2011AA-42)
C3303 (NCI Thesaurus-43)
C0030193 (UMLS 2011AA-44)
C3303 (NCI Thesaurus-45)
C0030193 (UMLS 2011AA-46)
C3303 (NCI Thesaurus-47)
C0030193 (UMLS 2011AA-48)
C3303 (NCI Thesaurus-49)
C0030193 (UMLS 2011AA-50)
C3303 (NCI Thesaurus-51)
C0030193 (UMLS 2011AA-52)
C3303 (NCI Thesaurus-53)
C0030193 (UMLS 2011AA-54)
C3303 (NCI Thesaurus-55)
C0030193 (UMLS 2011AA-56)
C3303 (NCI Thesaurus-57)
C0030193 (UMLS 2011AA-58)
C3303 (NCI Thesaurus-59)
C0030193 (UMLS 2011AA-60)
C3303 (NCI Thesaurus-61)
C0030193 (UMLS 2011AA-62)
C3303 (NCI Thesaurus-63)
C0030193 (UMLS 2011AA-64)
C3303 (NCI Thesaurus-65)
C0030193 (UMLS 2011AA-66)
C3303 (NCI Thesaurus-67)
C0030193 (UMLS 2011AA-68)
C3303 (NCI Thesaurus-69)
C0030193 (UMLS 2011AA-70)
C3303 (NCI Thesaurus-71)
C0030193 (UMLS 2011AA-72)
C3303 (NCI Thesaurus-73)
C0030193 (UMLS 2011AA-74)
C3303 (NCI Thesaurus-75)
C0030193 (UMLS 2011AA-76)
CL Item
Chest Pain (Pain - Chest/thorax NOS)
C38665 (NCI Thesaurus)
C0008031 (UMLS 2011AA)
CL Item
Headache Nos (Pain - Head/headache)
CL Item
Arthralgia (Pain - Joint)
C0003862 (NCI Metathesaurus)
CL Item
Myalgia (Pain - Muscle)
C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)
CL Item
Bronchospasm, Wheezing (Bronchospasm, wheezing)
CL Item
Cough (Cough)
C37935 (NCI Thesaurus)
C0010200 (UMLS 2011AA)
CL Item
Dyspnoea Nos (Dyspnea)
CL Item
Nasal Cavity/paranasal Sinus Reactions (Nasal cavity/paranasal sinus reactions)
CL Item
Dysphonia (Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis))
C0935979 (NCI Metathesaurus)
CL Item
Renal Failure Nos (Renal failure)
CL Item
Cytokine Release Syndrome/acute Infusion Reaction (Cytokine release syndrome/acute infusion reaction)
CL Item
Thrombosis Nos (Thrombosis/thrombus/embolism)
CL Item
Visceral Arterial Ischaemia (Visceral arterial ischemia (non-myocardial))
CL039426 (NCI Metathesaurus)
CTC Adverse Event Grade
Item
CTC AE Grade (3.0 1-4)
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
CTC Adverse Event Term
Item
CTC Adverse Event Term, Other (pre-treatment specify using CTCAE 3.0 terminology)
text
C25685 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
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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