ID

9582

Description

Southwest Oncology Group S0600 Adverse Event Form 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=5DA30D89-6264-0FC6-E040-BB89A643170F

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5DA30D89-6264-0FC6-E040-BB89A643170F

Keywords

Versions (4)
  1. 8/27/12 8/27/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
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January 9, 2015

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Creative Commons BY-NC 3.0 Legacy
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    Colorectal Cancer NCT00499369 Toxicity - Southwest Oncology Group S0600 Adverse Event Form - 2813352v1.0

    English

    No Instruction available.

    1 forms  
    1. StudyEvent: Southwest Oncology Group S0600 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
    Patient Initials (L, F M)
    Description

    Patient Initials

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    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
    Current Cycle Number
    Description

    Cycle Number Chemotherapeutics

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2045829
    NCI Thesaurus Property
    C25471
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property-2
    C25379
    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
    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
    Adverse Events
    Description

    Adverse Events

    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 one 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
    CTC Adverse Event Term
    Description

    CTC Adverse Event Term

    Data type

    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 1-5)
    Description

    CTC Adverse Event Grade

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    CTC Adverse Event Attribution Code (* Attribution codes: 1-unrelated 2-unlikely 3-possible 4-probably 5-definite)
    Description

    CTC Adverse Event Attribution Category

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    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)
    Description

    AdverseEventCourseAssessmentStatus

    Data type

    text

    Alias
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property-2
    C25379
    UMLS 2011AA Property-2
    C0750729
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    CTC Adverse Event Term Other (specify using CTCAE 3.0 terminology)
    Description

    CTC Adverse Event Term

    Data type

    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

    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 S0600 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)
    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)
    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)
    Cycle Number Chemotherapeutics
    Item
    Current Cycle Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2045829 (UMLS CUI-1)
    C25471 (NCI Thesaurus Property)
    C15368 (NCI Thesaurus ObjectClass)
    C25379 (NCI Thesaurus Property-2)
    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)
    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 Events
    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 one 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.1
    Code List
    Were adverse events assessed during this time period?
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    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)
    Item
    CTC Adverse Event Term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus Property)
    CL.2
    Code List
    CTC Adverse Event Term
    CL Item
    Hypersensitivity Nos (Allergic reaction/hypersensitivity (including drug fever))
    CL Item
    Rhinitis Allergic Nos (Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip))
    C0002103 (NCI Metathesaurus)
    CL Item
    Haemoglobin Decreased (Hemoglobin)
    C0162119 (NCI Metathesaurus)
    CL Item
    Leucopenia Nos (Leukocytes (total WBC))
    CL Item
    Neutropenia (Neutrophils/granulocytes (ANC/AGC))
    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 (asthenia, lethargy, malaise))
    C3036 (NCI Thesaurus)
    C0015672 (UMLS 2011AA)
    CL Item
    Pyrexia (Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L))
    CL Item
    Rigors (Rigors/chills)
    C0424790 (NCI Metathesaurus)
    CL Item
    Weight Decreased (Weight loss)
    CL Item
    Alopecia (Hair loss/Alopecia (scalp or body))
    C2865 (NCI Thesaurus)
    CL Item
    Skin Discolouration (Hyperpigmentation)
    CL Item
    Nail Abnormality Nos (Nail changes)
    CL038732 (NCI Metathesaurus)
    CL Item
    Pruritus Nos (Pruritus/itching)
    CL Item
    Dermatitis Exfoliative Nos (Rash/desquamation)
    CL Item
    Urticaria Nos (Urticaria (hives, welts, wheals))
    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
    Fistula, Gi (Fistula, GI - Abdomen NOS)
    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
    Mucositis/stomatitis (clinical Exam) (Mucositis/stomatitis (clinical exam) - Large bowel)
    CL Item
    Mucositis/stomatitis (clinical Exam) (Mucositis/stomatitis (clinical exam) - Small bowel)
    CL Item
    Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Large bowel)
    CL Item
    Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Oral cavity)
    CL Item
    Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Small bowel)
    CL Item
    Nausea (Nausea)
    C3258 (NCI Thesaurus)
    C0027497 (UMLS 2011AA)
    CL Item
    Necrosis, Gi (Necrosis, GI - Rectum)
    CL Item
    Obstruction, Gi (Obstruction, GI - Colon)
    CL Item
    Obstruction, Gi (Obstruction, GI - Small bowel NOS)
    CL Item
    Perforation, Gi (Perforation, GI - Colon)
    CL Item
    Perforation, Gi (Perforation, GI - Stomach)
    CL Item
    Perforation, Gi (Perforation, GI - Small bowel NOS)
    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
    Blood Magnesium Decreased (Magnesium, serum-low (hypomagnesemia))
    CL039365 (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 (shortness of breath))
    CL Item
    Hypoxia (Hypoxia)
    C3890 (NCI Thesaurus)
    C0242184 (UMLS 2011AA)
    CL Item
    Nasal Cavity/paranasal Sinus Reactions (Nasal cavity/paranasal sinus reactions)
    CL Item
    Pneumonitis Nos (Pneumonitis/pulmonary infiltrates)
    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 1-5)
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    Item
    CTC Adverse Event Attribution Code (* Attribution codes: 1-unrelated 2-unlikely 3-possible 4-probably 5-definite)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus 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)
    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-2)
    C0750729 (UMLS 2011AA Property-2)
    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)
    CTC Adverse Event Term
    Item
    CTC Adverse Event Term Other (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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