ID

9577

Beschreibung

S1007 Adverse Event Summary Form Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=90DA93B9-537E-5D33-E040-BB89AD434FA6

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=90DA93B9-537E-5D33-E040-BB89AD434FA6

Stichworte

  1. 27.08.12 27.08.12 -
  2. 08.01.15 08.01.15 - Martin Dugas
  3. 09.01.15 09.01.15 - Martin Dugas
  4. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

9. Januar 2015

DOI

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Breast Cancer NCT01272037 Toxicity - S1007 Adverse Event Summary Form - 3140849v1.0

Instructions: Please complete this form at 6 months, 1 year, 2 years, and 3 years after randomization. Report Grades 3-5 adverse events only. Document the worst Grade seen during the reporting period. Do not code a condition existing prior to registration as an adverse event unless it worsens. Category lists may not include all adverse events from that category. Record any observed adverse events not listed on the blank lines at the end. 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 and write AMENDED across top of form

Header
Beschreibung

Header

SWOG Patient ID
Beschreibung

Trial subject ID SWOG

Datentyp

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.
Beschreibung

Protocol ID SWOG

Datentyp

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
Beschreibung

Registration Number

Datentyp

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)
Beschreibung

Patient Initials

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Reporting Period
Beschreibung

Clinical Trial Period

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
Institution/Affiliate
Beschreibung

Institution Name

Datentyp

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
Beschreibung

Investigator Name

Datentyp

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
Beschreibung

Participating Group

Datentyp

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.
Beschreibung

Study Number Participating Group

Datentyp

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
Beschreibung

Trial subject ID Participating Group

Datentyp

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
Beschreibung

Adverse Events

Reporting Period Start Date (MM DD YYYY Day 1 of this reporting period)
Beschreibung

Reporting Period Start Date

Datentyp

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 (MM DD YYYY Day one of next reporting period. If final reporting period, date of first visit or contact after resolution of acute adverse events.)
Beschreibung

Reporting Period End Date

Datentyp

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?
Beschreibung

AdverseEventCurrentAssessmentInd

Datentyp

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
Beschreibung

CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C49704
UMLS 2011AA Property
C1516728
NCI Thesaurus Property-2
C45559
UMLS 2011AA Property-2
C1705313
NCI Thesaurus ValueDomain
C45255
UMLS 2011AA ValueDomain
C1708523
NCI Thesaurus ValueDomain-2
C49704
UMLS 2011AA ValueDomain-2
C1516728
NCI Thesaurus ValueDomain-3
C42614
UMLS 2011AA ValueDomain-3
C0027365
NCI Thesaurus ValueDomain-4
C45559
UMLS 2011AA ValueDomain-4
C1705313
NCI Thesaurus ValueDomain-5
C25714
UMLS 2011AA ValueDomain-5
C0333052
CTC Adverse Event Term Other (specify using CTCAE 4.0 terminology)
Beschreibung

CTC Adverse Event Term

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
CTC AE Grade (4.0 3-5)
Beschreibung

AdverseEventSeverityGrade

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C48309
UMLS 2011AA Property
C0441800
NCI Thesaurus Property-2
C49705
UMLS 2011AA Property-2
C1710065
NCI Thesaurus Property-3
C25676
UMLS 2011AA Property-3
C0439793
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
NCI Thesaurus ValueDomain-2
C48309
UMLS 2011AA ValueDomain-2
C0441800
NCI Thesaurus ValueDomain-3
C25676
UMLS 2011AA ValueDomain-3
C0439793
CTC Adverse Event Attribution Code
Beschreibung

CTC Adverse Event Attribution Category

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Comments
Beschreibung

Comments

Comments
Beschreibung

Research Comments

Datentyp

text

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

Ähnliche Modelle

Instructions: Please complete this form at 6 months, 1 year, 2 years, and 3 years after randomization. Report Grades 3-5 adverse events only. Document the worst Grade seen during the reporting period. Do not code a condition existing prior to registration as an adverse event unless it worsens. Category lists may not include all adverse events from that category. Record any observed adverse events not listed on the blank lines at the end. 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 and write AMENDED across top of form

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
Item
Reporting Period
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
Code List
Reporting Period
CL Item
0-6 Months (0-6 months)
CL Item
6 Mo-1 Yr (6 mo-1 yr)
CL Item
24 Months (24 months)
CL Item
36 Months (36 months)
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 (MM DD YYYY Day 1 of this reporting period)
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 (MM DD YYYY Day one of next reporting period. If final reporting period, 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)
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
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)
Code List
CTC Adverse Event Term
CL Item
Abdominal Pain (Abdominal pain)
E10460 (CTCAE)
CL Item
Allergic Reaction (Allergic reaction)
E11248 (CTCAE)
CL Item
Anemia (Anemia)
E10010 (CTCAE)
CL Item
Anorexia (Anorexia)
E12252 (CTCAE)
CL Item
Arthralgia (Arthralgia)
E12374 (CTCAE)
CL Item
Aspartate Aminotransferase Increased (Aspartate aminotransferase increased)
E12087 (CTCAE)
CL Item
Ataxia (Ataxia)
E12597 (CTCAE)
CL Item
Atrial Fibrillation (Atrial fibrillation)
E10081 (CTCAE)
CL Item
Blood Bilirubin Increased (Blood bilirubin increased)
E12096 (CTCAE)
CL Item
Blurred Vision (Blurred vision)
E10346 (CTCAE)
CL Item
Bone Pain (Bone pain)
E12392 (CTCAE)
CL Item
Cardiac Troponin T Increased (Cardiac troponin T increased)
E12119 (CTCAE)
CL Item
Chills (Chills)
E11074 (CTCAE)
CL Item
Constipation (Constipation)
E10562 (CTCAE)
CL Item
Diarrhea (Diarrhea)
E10572 (CTCAE)
CL Item
Dry Mouth (Dry mouth)
E10578 (CTCAE)
CL Item
Dysgeusia (Dysgeusia)
E12643 (CTCAE)
CL Item
Dyspareunia (Dyspareunia)
E13081 (CTCAE)
CL Item
Dysphagia (Dysphagia)
E10621 (CTCAE)
CL Item
Dyspnea (Dyspnea)
E13368 (CTCAE)
CL Item
Esophagitis (Esophagitis)
E10687 (CTCAE)
CL Item
Fatigue (Fatigue)
E11098 (CTCAE)
CL Item
Febrile Neutropenia (Febrile neutropenia)
E10033 (CTCAE)
CL Item
Fever (Fever)
E11102 (CTCAE)
CL Item
Fracture (Fracture)
E11703 (CTCAE)
CL Item
General Disorders And Administration Site Conditions - Other, Specify (General disorders and administration site conditions - Other, Specify)
E11116 (CTCAE)
CL Item
Heart Failure (Heart failure)
E10124 (CTCAE)
CL Item
Hot Flashes (Hot flashes)
E13781 (CTCAE)
CL Item
Hyperhidrosis (Hyperhidrosis)
E13645 (CTCAE)
CL Item
Hypertension (Hypertension)
E13785 (CTCAE)
CL Item
Injection Site Reaction (Injection site reaction)
E11138 (CTCAE)
CL Item
Insomnia (Insomnia)
E12925 (CTCAE)
CL Item
Left Ventricular Systolic Dysfunction (Left ventricular systolic dysfunction)
E10130 (CTCAE)
CL Item
Lung Infection (Lung infection)
E11444 (CTCAE)
CL Item
Mucositis Oral (Mucositis oral)
E10872 (CTCAE)
CL Item
Myalgia (Myalgia)
E12485 (CTCAE)
CL Item
Nausea (Nausea)
E10878 (CTCAE)
CL Item
Neutrophil Count Decreased (Neutrophil count decreased)
E12198 (CTCAE)
CL Item
Palmar-plantar Erythrodysesthesia Syndrome (Palmar-plantar erythrodysesthesia syndrome)
E13672 (CTCAE)
CL Item
Peripheral Sensory Neuropathy (Peripheral sensory neuropathy)
E12768 (CTCAE)
CL Item
Pharyngeal Mucositis (Pharyngeal mucositis)
E13466 (CTCAE)
CL Item
Platelet Count Decreased (Platelet count decreased)
E12207 (CTCAE)
CL Item
Pneumonitis (Pneumonitis)
E13502 (CTCAE)
CL Item
Pruritus (Pruritus)
E13686 (CTCAE)
CL Item
Rash Maculo-papular (Rash maculo-papular)
E13700 (CTCAE)
CL Item
Seizure (Seizure)
E12804 (CTCAE)
CL Item
Thromboembolic Event (Thromboembolic event)
E13825 (CTCAE)
CL Item
Typhlitis (Typhlitis)
E11058 (CTCAE)
CL Item
Urinary Tract Infection (Urinary tract infection)
E11614 (CTCAE)
CL Item
Vaginal Hemorrhage (Vaginal hemorrhage)
E13264 (CTCAE)
CL Item
Vascular Access Complication (Vascular access complication)
E12046 (CTCAE)
CL Item
Ventricular Tachycardia (Ventricular tachycardia)
E10239 (CTCAE)
CL Item
Vomiting (Vomiting)
E11068 (CTCAE)
CL Item
Weight Gain (Weight gain)
E12224 (CTCAE)
CL Item
White Blood Cell Decreased (White blood cell decreased)
E12232 (CTCAE)
CTC Adverse Event Term
Item
CTC Adverse Event Term Other (specify using CTCAE 4.0 terminology)
text
C25685 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
Item
CTC AE Grade (4.0 3-5)
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property-2)
C1710065 (UMLS 2011AA Property-2)
C25676 (NCI Thesaurus Property-3)
C0439793 (UMLS 2011AA Property-3)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)
Code List
CTC AE Grade (4.0 3-5)
CL Item
Severe Adverse Event (3)
C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)
CL Item
Life Threatening Adverse Event (4)
C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
Item
CTC Adverse Event Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
Code List
CTC Adverse Event Attribution Code
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 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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