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

DOI

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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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