ID

9622

Beschrijving

E2603 Adverse Event Form - (CTCAE v3) Carboplatin and Paclitaxel With or Without Sorafenib in Treating Patients With Unresectable Stage III or Stage IV Melanoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E75AC780-DB8D-20A4-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E75AC780-DB8D-20A4-E034-0003BA3F9857

Trefwoorden

Klinische Studie [Dokumenttyp]

Melanom

Adverse event

Geüploaded op

9 januari 2015

DOI

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Creative Commons BY-NC 3.0 Legacy

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Melanoma (Skin) NCT00110019 Toxicity - E2603 Adverse Event Form - (CTCAE v3) - 2296800v3.0

model
Details

INSTRUCTIONS: Complete this form at the end of each cycle (1 cycle = 3 weeks), and at required follow-ups if specified by the Long-Term Follow-Up Form (to report late adverse events).

1 Formulieren

StudyEvent: E2603 Adverse Event Form - (CTCAE v3)
1. INSTRUCTIONS: Complete this form at the end of each cycle (1 cycle = 3 weeks), and at required follow-ups if specified by the Long-Term Follow-Up Form (to report late adverse events).

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Header

Item Group

Header

Protocol Number ECOG

Item

ECOG Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Patient ID ECOG

Item

ECOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Generic drug form

Item

DCI Name

text

C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-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)

Unnamed2

Item Group

Unnamed2

Protocol Number ECOG

Item

ECOG Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Patient Initials

Item

Patient Initials

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Patient ID ECOG

Item

ECOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Study Number Participating Group

Item

Participating Group Protocol Number

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)

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)

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)

Unnamed3

Item Group

Unnamed3

Data amended

Item

Please mark an 'X' if data have been amended.

text

C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Data amended date

Item

Date data amended

date

C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)

ON TREATMENT

Item Group

On Treatment

Cycle number

Item

On Treatment Report Period (Choose one)

text

C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)

CL.1

Code List

On Treatment Report Period (Choose one)

CL Item

Cycle 1 (Cycle 1)

CL Item

Cycle 2 (Cycle 2)

CL Item

Cycle 3 (Cycle 3)

CL Item

Cycle 4 (Cycle 4)

CL Item

Cycle 5 (Cycle 5)

CL Item

Cycle 6 (Cycle 6)

CL Item

Cycle 7 (Cycle 7)

CL Item

Cycle 8 (Cycle 8)

CL Item

Cycle 9 (Cycle 9)

CL Item

Cycle 10 (Cycle 10)

CL Item

> Cycle 10 (> Cycle 10)

Chemotherapy cycle

Item

cycle (specify)

text

C15368 (NCI Thesaurus ObjectClass)
C25214 (NCI Thesaurus Property)
C1302181 (UMLS CUI-1)
C25616 (NCI Thesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)
C25472 (NCI Thesaurus ValueDomain-2)
C25275 (NCI Thesaurus ValueDomain-3)

OFF TREATMENT

Item Group

Off Treatment

PersonOff-TreatmentTimePeriodType

Item

Off Treatment Report Period (since registration)

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25601 (NCI Thesaurus Property-2)
C1518544 (UMLS 2011AA Property-2)
C25207 (NCI Thesaurus Property-3)
C0040223 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.2

Code List

Off Treatment Report Period (since registration)

CL Item

3 Months (3 Months Post Registration)

CL Item

6 Months (6 Months Post Registration)

CL Item

9 Months (9 Months Post Registration)

CL Item

12 Months (12 Months Post Registration)

CL Item

15 Months (15 Months Post Registration)

CL Item

18 Months (18 Months Post Registration)

CL Item

21 Months Post Registration (21 Months Post Registration)

CL Item

2 Years (24 Months Post Registration)

CL Item

30 Months (30 Months Post Registration)

CL Item

3 Years (36 Months Post Registration)

CL Item

42 Months (42 Months Post Registration)

CL Item

4 Years (48 Months Post Registration)

CL Item

54 Months (54 Months Post Registration)

CL Item

5 Years (60 Months Post Registration)

Unnamed4

Item Group

Unnamed4

AdverseEventCurrentAssessmentInd

Item

Were adverse events assessed during this report period (cycle)

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.3

Code List

Were adverse events assessed during this report period (cycle)

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)

Adverse Event Start Date

Item

CTC Adverse Event Report Begin Date

date

C25164 (NCI Thesaurus ValueDomain)
C2697888 (UMLS CUI-1)
C25375 (NCI Thesaurus Property)
C25431 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)

Adverse Event End Date

Item

CTC Adverse Event Report End Date

date

C25164 (NCI Thesaurus ValueDomain)
C2697886 (UMLS CUI-1)
C25375 (NCI Thesaurus Property)
C49704 (NCI Thesaurus ObjectClass)

Unnamed5

Item Group

Unnamed5

CTC Adverse Event Term

Item

CTC Adverse Event Term Type

text

C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)

CL.4

Code List

CTC Adverse Event Term Type

CL Item

Anorexia (Anorexia)

C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)

CL Item

Diarrhoea Nos (Diarrhea)

CL Item

Fatigue (Fatigue)

C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)

CL Item

Hypertension Nos (Hypertension)

CL Item

Mucositis/stomatitis (functional/symptomatic) (Mucositis/Stomatitis, Stomach)

CL Item

Nausea (Nausea)

C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)

CL Item

Peripheral Sensory Neuropathy (Neuropathy: sensory)

C3501 (NCI Thesaurus)
C0151313 (UMLS 2011AA)

CL Item

Arthralgia (Pain, Joint)

C0003862 (NCI Metathesaurus)

CL Item

Myalgia (Pain, Muscle)

C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)

CL Item

Pruritus Nos (Pruritus/itching)

CL Item

Dermatitis Exfoliative Nos (Rash/desquamation)

CL Item

Localised Exfoliation (Rash: hand-foot skin reaction)

CL Item

Rigors (Rigors/chills)

C0424790 (NCI Metathesaurus)

CL Item

Vomiting Nos (Vomiting)

InvestigatorTermName

Item

Investigator Term

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)

CTC Adverse Event Grade

Item

CTC Adverse Event Grade (v3.0)

float

C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)

CTC Adverse Event Attribution Category

Item

CTC Adverse Event Attribution Scale

text

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

CL.15

Code List

CTC Adverse Event Attribution Scale

CL Item

Unrelated (unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)

CL Item

Unlikely (unlikely)

CL Item

Possible (possible)

C0332149 (NCI Metathesaurus)

CL Item

Probable (probable)

C0332148 (NCI Metathesaurus)

CL Item

Definite (definite)

CL209464 (NCI Metathesaurus)

AdverseEventActionType

Item

Action Taken at Time of Adverse Event

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25404 (NCI Thesaurus Property)
C0441472 (UMLS 2011AA Property)

CL.16

Code List

Action Taken at Time of Adverse Event

CL Item

There Was No Action Taken Based On The Adverse Event (none)

CL Item

Study Dose Was Reduced As A Result Of The Adverse Event (study dose reduced)

CL Item

Protocol Treatment Was Delayed As A Result Of The Adverse Event (protocol treatment delayed)

CL Item

Protocol Treatment Was Discontinued As A Result Of The Adverse Event (protocol treatment discontinued)

CL Item

Other Treatment Was Required As A Result Of The Adverse Event (other treatment required)

AdverseEventOutcomeType

Item

Outcome of Adverse Event

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)

CL.17

Code List

Outcome of Adverse Event

CL Item

Adverse Event Is Resolved (resolved)

CL Item

Adverse Event Has Improved (improved)

CL Item

Adverse Event Is Unchanged (unchanged)

CL Item

Adverse Event Is Worse (worsened)

CL Item

Adverse Event Was Fatal (death/fatal)

CL Item

Adverse Event Is Ongoing (ongoing)

PriorAdverseEventContinuedText

Item

Mark an 'X' if continuing from prior cycle.

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C0750536 (NCI Metathesaurus Property)

Adverse Event Onset Date

Item

CTC Adverse Event Start Date (Enter Day 1 of this report period if continuing from previous report period)

date

C25164 (NCI Thesaurus ValueDomain)
C2985916 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C25279 (NCI Thesaurus Property)

Adverse Event Resolution Date

Item

CTC Adverse Event End Date (Leave blank if not resolved by end of report period)

date

C25164 (NCI Thesaurus ValueDomain)
C2985918 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C25655 (NCI Thesaurus Property)

II. INFECTIONS

Item Group

Ii. Infections

CommonToxicityCriteriaAdverseEventShortNameType

Item

Unnamed question1 (Specify site for each event)

text

C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0332307 (NCI Metathesaurus ValueDomain)
C25249 (NCI Thesaurus Property-2)
C1806781 (UMLS 2011AA Property-2)

CL.9

Code List

Unnamed question1 (Specify site for each event)

CL Item

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically) - select)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC - select)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - select)

CTC Adverse Event Term

Item

Specify site

text

C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C38024 (NCI Thesaurus Property)
C45559 (NCI Thesaurus Property-2)

InvestigatorTermName

Item

Investigator Term

text

CTC Adverse Event Grade

Item

CTC Adverse Event Grade (v3.0)

float

C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)

CTC Adverse Event Attribution Category

Item

CTC Adverse Event Attribution Scale

text

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

CL.15

Code List

CTC Adverse Event Attribution Scale

CL Item

Unrelated (unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)

CL Item

Unlikely (unlikely)

CL Item

Possible (possible)

C0332149 (NCI Metathesaurus)

CL Item

Probable (probable)

C0332148 (NCI Metathesaurus)

CL Item

Definite (definite)

CL209464 (NCI Metathesaurus)

AdverseEventActionType

Item

Action Taken at Time of Adverse Event

text

CL.16

Code List

Action Taken at Time of Adverse Event

CL Item

There Was No Action Taken Based On The Adverse Event (none)

CL Item

Study Dose Was Reduced As A Result Of The Adverse Event (study dose reduced)

CL Item

Protocol Treatment Was Delayed As A Result Of The Adverse Event (protocol treatment delayed)

CL Item

Protocol Treatment Was Discontinued As A Result Of The Adverse Event (protocol treatment discontinued)

CL Item

Other Treatment Was Required As A Result Of The Adverse Event (other treatment required)

AdverseEventOutcomeType

Item

Outcome of Adverse Event

text

CL.17

Code List

Outcome of Adverse Event

CL Item

Adverse Event Is Resolved (resolved)

CL Item

Adverse Event Has Improved (improved)

CL Item

Adverse Event Is Unchanged (unchanged)

CL Item

Adverse Event Is Worse (worsened)

CL Item

Adverse Event Was Fatal (death/fatal)

CL Item

Adverse Event Is Ongoing (ongoing)

Other Adverse Events

Item Group

Other Adverse Events

CTC Adverse Event Term

Item

Other CTC Adverse Event Term not listed

text

C25685 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)

CTC Adverse Event Reported Term

Item

Other, Specify (site/sub-term)

text

C25685 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2699044 (UMLS CUI-2)
C25161 (NCI Thesaurus Property)

InvestigatorTermName

Item

Investigator Term

text

CTC Adverse Event Grade

Item

CTC Adverse Event Grade (v3.0)

float

C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)

CTC Adverse Event Attribution Category

Item

CTC Adverse Event Attribution Scale

text

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

CL.15

Code List

CTC Adverse Event Attribution Scale

CL Item

Unrelated (unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)

CL Item

Unlikely (unlikely)

CL Item

Possible (possible)

C0332149 (NCI Metathesaurus)

CL Item

Probable (probable)

C0332148 (NCI Metathesaurus)

CL Item

Definite (definite)

CL209464 (NCI Metathesaurus)

AdverseEventActionType

Item

Action Taken at Time of Adverse Event

text

CL.16

Code List

Action Taken at Time of Adverse Event

CL Item

There Was No Action Taken Based On The Adverse Event (none)

CL Item

Study Dose Was Reduced As A Result Of The Adverse Event (study dose reduced)

CL Item

Protocol Treatment Was Delayed As A Result Of The Adverse Event (protocol treatment delayed)

CL Item

Protocol Treatment Was Discontinued As A Result Of The Adverse Event (protocol treatment discontinued)

CL Item

Other Treatment Was Required As A Result Of The Adverse Event (other treatment required)

AdverseEventOutcomeType

Item

Outcome of Adverse Event

text

CL.17

Code List

Outcome of Adverse Event

CL Item

Adverse Event Is Resolved (resolved)

CL Item

Adverse Event Has Improved (improved)

CL Item

Adverse Event Is Unchanged (unchanged)

CL Item

Adverse Event Is Worse (worsened)

CL Item

Adverse Event Was Fatal (death/fatal)

CL Item

Adverse Event Is Ongoing (ongoing)

Comments

Item Group

Comments

Research Comments

Item

Comments

text

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

Investigator Signature

Item

Investigator Signature

text

C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)

Investigator Signature Date

Item

Investigator Signature Date

date

C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)

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Melanoma (Skin) NCT00110019 Toxicity - E2603 Adverse Event Form - (CTCAE v3) - 2296800v3.0

INSTRUCTIONS: Complete this form at the end of each cycle (1 cycle = 3 weeks), and at required follow-ups if specified by the Long-Term Follow-Up Form (to report late adverse events).

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