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Title

Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Item Library Version 1.0 Version Date 4/26/2020 (PRO-CTCAE V1.0 VERSION DATE 4/26/2020)

CDISC ReferenceQuestionnaireSupplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

QRS Permission StatusApproved
TeamPancreatic Cancer Therapeutic Area Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date20212022-1202-2109
NotesThis supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.


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Revision History


DateVersion
20212022-1202-21091.0 Draft

© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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QSORRES

QSSTRESC

QSSTRESN

None0None0
Mild1Mild1
Moderate2Moderate2
Severe3Severe3
Very severe4Very severe4

All PRO-CTCAE V1.0 VERSION DATE 4/26/2020 Interference Questions

Not at allA little bitSomewhatQuite a bitVery much

QSORRES

QSSTRESC

QSSTRESN

Not at all00
A little bit11
Somewhat22
Quite a bit33
Very much44

All PRO-CTCAE V1.0 VERSION DATE 4/26/2020 Frequency Questions

NeverRarelyOccasionallyFrequentlyAlmost constantly

QSORRES

QSSTRESC

QSSTRESN

Never00
Rarely11
Occasionally22
Frequently33
Almost constantly44

All PRO-CTCAE V1.0 VERSION DATE 4/26/2020 Presence Questions

QSORRES

QSSTRESC

QSSTRESN

YesYes1
NoNo0

All PRO-CTCAE V1.0 VERSION DATE 4/26/2020 Amount Questions

Not at allA little bitSomewhatQuite a bitVery much

QSORRES

QSSTRESC

QSSTRESN

Not at all00
A little bit11
Somewhat22
Quite a bit33
Very much44

--TESTCD = "PT01066A" --TEST = "PT01-Achieve/Maintain Erection Severity"

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QSORRES

QSSTRESC

QSSTRESN

None0None0
Mild1Mild1
Moderate2Moderate2
Severe3Severe3
Very severe4Very severe4
Not sexually activeNot sexually active
Prefer not to answerPrefer not to answer

...

QSORRES

QSSTRESC

QSSTRESN

Never0Never0
Rarely1Rarely1
Occasionally2Occasionally2
Frequently3Frequently3
Almost constantly4Almost constantly4
Not sexually activeNot sexually active
Prefer not to AnswerPrefer not to Answer

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QSORRES

QSSTRESC

QSSTRESN

Yes1Y1
No0N0
Not sexually activeNot sexually active
Prefer not to answerPrefer not to answer

...

QSORRES

QSSTRESC

QSSTRESN

None0None0
MildMild11
Moderate2Moderate2
Severe3Severe3
Very severeVery severe44
Not applicableNot applicable

...

QSORRES

QSSTRESC

QSSTRESN

Yes1Y1
No00N
Not ApplicableNot Applicable

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