ID

11196

Descrição

SOUTHWEST ONCOLOGY GROUP S0226 ADVERSE EVENT FORM NCT00075764 S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=C3226D1D-8263-26E7-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=C3226D1D-8263-26E7-E034-0003BA12F5E7

Palavras-chave

Versões (4)
  1. 26/08/2012 26/08/2012 -
  2. 08/01/2015 08/01/2015 - Martin Dugas
  3. 09/01/2015 09/01/2015 - Martin Dugas
  4. 21/06/2015 21/06/2015 -
Transferido a

21 de junho de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy
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SOUTHWEST ONCOLOGY GROUP S0226 ADVERSE EVENT FORM NCT00075764

Inglês

No Instruction available.

1 Formulários  
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0226 ADVERSE EVENT FORM
    1. No Instruction available.
Header
Descrição

Header

SWOG Patient ID
Descrição

Trial subject ID SWOG

Tipo de dados

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.
Descrição

Protocol ID SWOG

Tipo de dados

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
Descrição

Registration Number

Tipo de dados

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)
Descrição

Patient Initials

Tipo de dados

text

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

Institution Name

Tipo de dados

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
Descrição

Investigator Name

Tipo de dados

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
Descrição

Participating Group

Tipo de dados

text

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

Study Number Participating Group

Tipo de dados

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 Patient ID (Instructions: Please complete this form after each cycle one cycle = 3 weeks. Report adverse events occuring up until the next cycle of treatment begins. Document the worst Grade seen during the reporting interval. Do not code a pre-existing condition as an adverse event unless it worsens due to treatment. All dates are MONTH, DAY, YEAR. Explain any blank dates or fields in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red.)
Descrição

Trial subject ID Participating Group

Tipo de dados

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
Descrição

Toxicity

Reporting period start date
Descrição

Reporting Period Start Date

Tipo de dados

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
Descrição

Reporting Period End Date

Tipo de dados

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
Descrição

AdverseEventCurrentAssessmentInd

Tipo de dados

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
Adverse event assessment
Descrição

Adverse event assessment

CTC Adverse Event Term
Descrição

CTC Adverse Event Term

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
CTC Adverse Event Grade
Descrição

CTC Adverse Event Grade

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
Adverse Event Status Code (Status codes)
Descrição

CTC Adverse Event Attribution Category

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Adverse Event Status Code (Status codes)
Descrição

CTC Adverse Event Attribution Category

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
CTC Adverse Event Term, Other
Descrição

CTCAdverseEventTerm,Other

Tipo de dados

text

Comments
Descrição

Comments

Comments
Descrição

Research Comments

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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1 Formulários
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0226 ADVERSE EVENT FORM
    1. No Instruction available.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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
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 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 Patient ID (Instructions: Please complete this form after each cycle one cycle = 3 weeks. Report adverse events occuring up until the next cycle of treatment begins. Document the worst Grade seen during the reporting interval. Do not code a pre-existing condition as an adverse event unless it worsens due to treatment. All dates are MONTH, DAY, YEAR. Explain any blank dates or fields in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red.)
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
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
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, 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)
Item Group
Adverse event assessment
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
Hypotension Nos (Hypotension)
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
Insomnia Nec (Insomnia)
CL Item
Rigors (Rigors/chills)
C0424790 (NCI Metathesaurus)
CL Item
Weight Increased (Weight gain)
C0043094 (NCI Metathesaurus)
CL Item
Constitutional Symptoms Other (Constitutional Symptoms-Other (Specify))
CL Item
Injection Site Reaction Nos (Injection site reaction/extravasation changes)
CL Item
Pruritus Nos (Pruritus/itching)
CL Item
Dermatitis Exfoliative Nos (Rash/desquamation)
CL Item
Menopausal Symptoms (Hot flashes/flushes)
CL Item
Anorexia (Anorexia)
C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)
CL Item
Constipation (Constipation)
C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)
CL Item
Diarrhoea Nos (Diarrhea)
CL Item
Dry Mouth (Dry mouth/salivary gland (xerostomia))
C26917 (NCI Thesaurus)
C0043352 (UMLS 2011AA)
CL Item
Mucositis/stomatitis (clinical Exam) (Mucositis/stomatitis (clinical exam) - Oral cavity)
CL Item
Stomatitis (Mucositis/stomatitis (clinical exam) - Pharynx)
C26887 (NCI Thesaurus)
C0038362 (UMLS 2011AA)
CL Item
Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Oral cavity)
CL Item
Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Pharynx)
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Vomiting Nos (Vomiting)
CL Item
Vaginal Haemorrhage (Hemorrhage, GU - Vagina)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Urinary tract NOS)
CL Item
Infection Nos (Infection-Other (Specify))
CL Item
Oedema Nos (Edema: limb)
CL Item
Confusion (Confusion)
C37928 (NCI Thesaurus)
C0009676 (UMLS 2011AA)
CL Item
Dizziness (exc Vertigo) (Dizziness)
CL Item
Mood Alteration - Agitation (Mood alteration - agitation)
CL Item
Anxiety Nec (Mood alteration - anxiety)
CL Item
Depression Nec (Mood alteration - depression)
CL Item
Peripheral Motor Neuropathy (Neuropathy: motor)
C3500 (NCI Thesaurus)
C0018995 (UMLS 2011AA)
CL Item
Peripheral Sensory Neuropathy (Neuropathy: sensory)
C3501 (NCI Thesaurus)
C0151313 (UMLS 2011AA)
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
Bone Pain (Pain - Bone)
C38644 (NCI Thesaurus)
C0151825 (UMLS 2011AA)
CL Item
Arthralgia (Pain - Joint)
C0003862 (NCI Metathesaurus)
CL Item
Myalgia (Pain - Muscle)
C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)
CL Item
Headache Nos (Pain - Head/headache)
CL Item
Chest Pain (Pain - Chest/thorax NOS)
C38665 (NCI Thesaurus)
C0008031 (UMLS 2011AA)
CL Item
Pelvic Pain Nos (Pain - Pelvis)
C0030794 (NCI Metathesaurus)
CL Item
Pain Other (Pain-Other (Specify))
CL Item
Cough (Cough)
C37935 (NCI Thesaurus)
C0010200 (UMLS 2011AA)
CL Item
Dyspnoea Nos (Dyspnea (shortness of breath))
CL Item
Vulvovaginal Dryness (Vaginal dryness)
CL036720 (NCI Metathesaurus)
CL Item
Vaginitis (Vaginitis (not due to infection))
C26911 (NCI Thesaurus)
C0042267 (UMLS 2011AA)
CL Item
Tumour Flare (Tumor flare)
CL039490 (NCI Metathesaurus)
CL Item
Thrombosis/embolism (vascular Access-related) (Thrombosis/embolism (vascular access-related))
CL Item
Thrombosis Nos (Thrombosis/thrombus/embolism)
CTC Adverse Event Grade
Item
CTC Adverse Event Grade
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Item
Adverse Event Status Code (Status codes)
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
CL.5
Code List
Adverse Event Status Code (Status codes)
CL Item
new (new)
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)
Item
Adverse Event Status Code (Status codes)
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
CL.5
Code List
Adverse Event Status Code (Status codes)
CL Item
new (new)
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)
CTCAdverseEventTerm,Other
Item
CTC Adverse Event Term, Other
text
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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