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Comment: working on updating assumption 2 per Sandy's comments
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titleInformation for Reviewers

Text in black is part of the template used to create this document and is not under review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

Please especially note assumptions 7 through 9, which discuss the concept of "conditional branching," and Example 1, which shows an example of data not done due to conditional branching in the electronic version of the PRO-CTCAE. Conditional branching replaces the concept of logically skipped items as it allows for situations (such as in the electronic version of the PRO-CTCAE) where items can be not done due to conditional branching. In this case NIH provides scoring for those items not done due to conditional branching. Because it is known that the items were not done due to the symptom not occurring (e.g., when the frequency item response is "Never"), any remaining items for the symptom are provided a standardized score of "None" or "Not at all", with a numeric value of 0.

Page properties
Title

Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) Library Version 1.0 (PRO-CTCAE V1.0)

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

PRO-CTCAE V1.0

QRS Permission StatusApproved
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Page properties
QuestionnaireSupplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
Title

Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Item Library Version 1.0 (PRO-CTCAE® V1.0)

CDISC Reference
QRS Short Name

PRO-CTCAE® V1.0

QRS Permission StatusApproved
TeamPancreatic Cancer Therapeutic Area Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date20222023-0312-2108
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.

Revision History

...

Known Issue
  • The concept of “conditional branching” in QRS instruments is when the instrument directs the subject to another item of the instrument based on the result of a response compare for a given condition. This concept was reviewed with the CDISC standards teams and it was agreed to use this term instead of “logically skipped item” moving forward for this QRS instrument use case. A new QRS variable named “QSCBRFL” with the description of “Conditionally Branched Item Flag” has been approved for SDTMIG v4.0. This new variable will streamline the data representation of conditionally branched items.


Revision History

DateVersion
2023-12-081.0 Draft
Info

The CDISC PRO-CTCAE V1.0 supplement Version 1.0 was developed based on the NCI/NIH PRO-CTCAE® website. The website’s PRO-CTCAE Version 1.0 release notes indicate the revisions made by NCI/NIH on the PRO-CTCAE 1.0 measurement system. The measurement system version is 1.0 based on the website's release notes (specific correction of typographical errors in the different CRF translations). NCI/NIH will notify CDISC of any major changes in the future that would require a change control to the CDISC PRO-CTCAE V1.0 supplement version.

© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) Item Library Version 1.0 (PRO-CTCAE V1.0).

CDISC did not modify this questionnaires, ratings, and scales (QRS) measurement to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

The representation of data collected for this measurement is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, which can be found at the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this measurement are meant to be used in conjunction with the SDTMIG. All QRS documentation can be found on the CDISC web site at: https://www.cdisc.org/standards/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols. CDISC disclaims any liability for your use of this material.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument. 

2 Copyright Status

The PRO-CTCAE® Measurement System is owned exclusively by National Cancer Institute (NCI). Use of the PRO-CTCAE V1.0 is subject to NCI terms of use policy listed on the website. Based on these terms of use, CDISC considers this instrument exempt from copyright restrictions. CDISC has included this supplement in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the measurement system

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

1 Introduction

This document describes the CDISC implementation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Item Library Version 1.0 (PRO-CTCAE V1.0) instrument.

CDISC did not modify this questionnaires, ratings, and scales (QRS) instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, which can be found at the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All instrument documentation can be found on the CDISC web site at: https://www.cdisc.org/standards/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols. CDISC disclaims any liability for your use of this material.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument. 

2 Copyright Status

The NATIONAL CANCER INSTITUTE (NCI) at the NATIONAL INSTITUTES OF HEALTH (NIH) owns the copyright for the PRO-CTCAE V1.0 instrument and has made it exempt from copyright restrictions. Use of the PRO-CTCAE V1.0 is subject to NCI terms of use (See https://healthcaredelivery.cancer.gov/pro-ctcae/terms_of_use.html). CDISC has included this supplement in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument. 

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values.

Note: CDISC Controlled Terminology is maintained by NCI Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

CDISC has developed this documentation at no cost to copyright holder or any additional cost to users of the instrument beyond the normal licenses fees charged by the copyright holder.

CDISC acknowledges Sandra Mitchell, PhD, CRNP, Research Scientist and Program Director Scientific Lead, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Outcomes Research Branch; Healthcare Delivery Research Program Division of Cancer Control and Population Sciences, National Cancer Institute, for the approval to include the PRO-CTCAE V1.0 in the CDISC data standards.

Reference for the PRO-CTCAE V1.0:

  • These materials discuss and/or include the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events PRO-CTCAE® Item Library Version 1.0 Version Date 4/26/2020 (PRO-CTCAE V1.0) which . The PRO-CTCAE® Measurement System is owned exclusively by the Division of Cancer Control and Population Sciences in the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH (NCI)National Cancer Institute. No part of the PRO-CTCAE V1.0 may be reproduced, distributed, or transmitted in any form or by any means, including photocopying recording, or other electronic or mechanical methods, without the prior written permission of NCI and payment of any applicable fees. PRO-CTCAE V1.0 copyright, NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH (NCI). All rights reserved.the PRO-CTCAE® Measurement System may be adapted, altered, amended, abridged, modified, condensed, made into derivative works, or translated without prior written permission from the US National Cancer Institute. PRO-CTCAE is a registered trademark of the US Department of Health & Human Services. All rights reserved. For additional terms of use and to access PRO-CTCAE® Measurement System content, visit https://healthcaredelivery.cancer.gov/pro-ctcae/.
  • The PRO-CTCAE trademark items and information herein were developed by the Division of Cancer Control and Population Sciences in the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, in National Cancer Institute at the National Institutes of Health, Bethesda, Maryland, U.S.AUSA. Use of the PRO-CTCAE is subject to NCI's "NCI’s Terms of Use". PRO-CTCAE Measurement System content should be downloaded using the "Instrument Instruments & Form Builder ". link (https://healthcaredelivery.cancer.gov/protpro-ctcae/. (Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, Mendoza TR, Hay J, Atkinson TM, Abernethy AP, Bruner DW, Cleeland CS, Sloan JA, Chilukuri R, Baumgartner P, Denicoff A, St Germain D, O'Mara AM, Chen A, Kelaghan J, Bennett AV, Sit L, Rogak L, Barz A, Paul DB, Schrag D. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst 2014 Sept 29;106(9)).
  • [1] National Institutes of Health – National Cancer Institute, Division of Cancer Control & Population Sciences. (2017, July 2) https://healthcaredelivery.cancer.gov/pro-ctcae/overview.html

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the PRO-CTCAE V1.0 are listed below.

  • ).

The CDISC documentation of this measurement system consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values (referred to hereafter as annotated Item Library v1.0 form).

Note: CDISC Controlled Terminology is maintained by NCI Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

CDISC has developed this documentation at no cost to the owner, trademark holder, or users of the measurement system.

CDISC acknowledges Sandra Mitchell, PhD, CRNP, Research Scientist and Program Director Scientific Lead, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Outcomes Research Branch, Healthcare Delivery Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, for the approval to include the PRO-CTCAE V1.0 in the CDISC data standards.

References for the PRO-CTCAE V1.0:

  • Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, Mendoza TR, Hay J, Atkinson TM, Abernethy AP, Bruner DW, Cleeland CS, Sloan JA, Chilukuri R, Baumgartner P, Denicoff A, St Germain D, O'Mara AM, Chen A, Kelaghan J, Bennett AV, Sit L, Rogak L, Barz A, Paul DB, Schrag D. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).J Natl Cancer Inst 2014 Sep 29;106(9)).
  • National Institutes of Health – National Cancer Institute, Division of Cancer Control & Population Sciences. (2017, July 2) https://healthcaredelivery.cancer.gov/pro-ctcae/overview.html

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the PRO-CTCAE V1.0 are listed below.

The PRO-CTCAE measurement system is a patient-reported outcome (PRO) developed to capture symptomatic adverse events of patients in cancer clinical trials. The PRO-CTCAE V1.0 was designed to be used in The PRO-CTCAE V1.0 is a patient-reported outcome (PRO) instrument developed to capture symptomatic adverse events of patients in cancer clinical trials. The PRO-CTCAE V1.0 was designed to be used in conjunction with the Common Terminology Criteria for Adverse Events (CTCAE).[1] It consists of an item library rather than a static/fixed question item type of instrument. You should . This item library concept is different than other CDISC public domain and copyrighted specific QRS instruments. Users are directed to use the form builder as described on the PRO-CTCAE website to build CRFs and with instructions provided by NCI to select the items to implement it in your a clinical study. The PRO-CTCAE V1.0 includes multiple-choice questions on the frequency, severity, interference, presence/absence, and /or amount of specific adverse events.

Administration of PRO-CTCAE V1.0 may be conducted via different modes, including screen-based, interactive voice response, and paper. Electronic implementation of the PRO-CTCAE V1.0 measurement system is recommended by NCI/NIH.

  1. As a CDISC QRS standard, the instrument supplement name is PRO-CTCAE V1.0, as provided in this supplementdocument. As an item library, sponsors sponsors may select items from the overall library as a subset of items with the same CDISC Controlled Terminology as appropriate for the condition being studied. It is the users user's responsibility to identify the subset of items used from the overall PRO-CTCAE V1.0 Quick Guide to the Item Library (Version 1.0). The . The subsetted PRO-CTCAE V1.0 user's instrument measurement system should be titled "PRO-CTCAE sponsor-specified symptoms..." based on the sponsor's discretion when they identify the specific items being used. This will distinctly describe the subsetted instrument measurement system from the overall PRO-CTCAE V1.0. The form builder does not represent the Quick Guide to the Item Library symptom term when creating forms with selected symptoms. Users need to reference the annotated Item Library v1.0 form to obtain the related symptom term for forms based on selected symptoms. 
  2. For the PRO-CTCAE V1.0, QSORRES is populated represented with the text description while ; the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN. Please reference see the PRO-CTCAE website FAQs for more details on the numeric responsesThe responses for the PRO-CTCAE V1.0 are as follows:
    1. Depending on the symptomatic adverse event (AE) being measured, items assessing symptom presence/absence are rated as follows:Items rated on a binary response scale and rated from 0-1 ((i.e.g., 0 = “No” and 1 = “Yes”);
    2. Items rated on multiple (more than two) response scale and assessing symptom frequency are rated from 0-1 4 (i.e.g., 0 = “No”“Never”, 1 = “Yes”, and “Not applicable” or "Not Applicable"); orItems rated on multiple (more than two) response scale and “Rarely”, 2 = “Occasionally”, 3 = “Frequently”, and 4 = “Almost constantly”).
    3. Items assessing symptom severity are rated on a 5-point scale rated from 0-1 4 (e.g., 0 = “No”“None”, 1 = “Mild”, 2 = “Yes”, “Not sexually active”, and “Prefer not to answer”“Moderate”, 3 = “Severe”, and 4 = “Very severe”).
    4. Items assessing symptom amount interference are rated on a 5-point scale and rated from 0-4 (e.g., 0 = “Not at all”, 1 = “A little bit”, 2 = “Somewhat”, 3 = “Quite a bit”, and 4 = “Very much”).
    5. Items assessing symptom frequency are rated on a 5-point scale and amount are rated from 0-4 (e.g., 0 = “Never”“Not at all”, 1 = “Rarely”“A little bit”, 2 = “Occasionally”“Somewhat”, 3 = “Frequently”“Quite a bit”, and 4 = “Almost constantly”, "Not sexually
      active", = “Very much”).
    6. QSTESTCD = "PT01066A " to "PT01071A" sexual symptoms have specific responses.
      1. QSTESTCD=PT01069A and QSTESTCD=PT01070A assessing sexual symptom presence/absence are rated on multiple (more than 2) response scale and rated from 1-0 (e.g., 1 = “Yes” and 0 = “No”, “Not sexually active”, and “Prefer not to answer”).
      Items assessing
      1. QSTESTCD=PT01066A, PT01068A, and PT01071A assessing sexual symptom severity are rated on a 5-point scale

      and are
      1. rated from 0-4 (e.g., 0 = “None”, 1 = “Mild”, 2 = “Moderate”, 3 = “Severe”, and 4 = “Very severe”,

      “Not applicable”,
      1. "Not sexually


      1. active", and “Prefer not to answer”).

      Items assessing symptom interference are
      1. QSTESTCD = "PT01067A" assessing sexual symptom frequency is rated on a 5-point scale
      and are
      1. rated from 0-4 (e.g., 0 =
      “Not at all”
      1. “Never”, 1 =
      “A little bit”
      1. “Rarely”, 2 =
      “Somewhat”
      1. “Occasionally”, 3 =
      “Quite a bit”
      1. “Frequently”,
      and 4 = “Very much”).
  3. The CRF represents up to 5 "other symptoms" to be recorded. In discusions with NIH, it was agreed to provide up to 10 "other symptoms" to be recorded if they existed. QSTESTCDs (QSTESTCDs "PT01082A" thru "PT0191A") and severity of the symptom at its worst (QSTESTCDs "PT01082B" thru "PT0191B").
  4. Total scoring instructions have not yet been developed. Item-level scores are not combined (i.e., No total score nor symptom-specific scores are calculated.).
      1. 4 = “Almost constantly”, "Not sexually active", and “Prefer not to answer”).
    1. Selected items include additional response options such as "Not applicable", "Not sexually active", and "Prefer not to answer". Users will need to apply a customized value to each of these (e.g., -99 = "Not applicable", 999 = "Not sexually active", and 9999 = "Prefer not to answer"). For example,
      1. QSTESTCD=PT01036A assessing symptom severity is rated from 0-4 (e.g., 0 = “None”, 1 = “Mild”, 2 = “Moderate”, 3 = “Severe”, and 4 = “Very severe”. The response "Not applicable" is also given and could be provided a value of -99.)
  5. The CRF represents up to 5 "other symptoms" to be recorded. In discussions with NIH, it was agreed to provide up to 10 "other symptoms" to be recorded if they existed. QSTESTCDs (QSTESTCDs "PT01082A" through "PT01091A") and severity of the symptom at its worst (QSTESTCDs "PT01082B" through "PT01091B").
  6. PRO-CTCAE V1.0 total scoring instructions have not yet been developed. Item-level scores are not combined (i.e., no total score nor symptom-specific scores are calculated).
  7. The time period of evaluation for the PRO-CTCAE V1.0 is The time period of evaluation for the PRO-CTCAE V1.0 is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. The recommended evaluation interval for the PRO-CTCAE V1.0 is the past 7 days (QSEVLINT = "-P7D"). Please reference see the PRO-CTCAE website for more details on the evaluation interval at: https://healthcaredelivery.cancer.gov/pro-ctcae/faqs.html.evaluation interval.
  8. Items are divided into 14 15 subcategories represented in the QSSCAT variable. These categorizations represent how the symptom terms are categorized in the PRO-CTCAE V1.0 Item Library (Version 1.0). See Section 4, SDTM Mapping Strategy, for a list of these subcategory values. 
    1. The symptomatic AE being measured by a given item (e.g., the Symptom Term represented on the CRF corresponding to a given item) is stored in the SUPPQS dataset with the QNAM = "QSSYMTRMQSSYMPTM". This matches the symptom term identified in the PRO-CTCAE V1.0 Quick guide to the Item Library (Version 1.0). The exception to this is the solicited verbatim symptom terms QSTESTCD = "PT01081 to PT01091B"with QNAM = "OTHER SYMPTOMS".
  9. Conditional branching is used recommended by NCI/NIH in the conduct of the electronic version of the PRO-CTCAE V1.0 for symptom terms that have two 2 or more items. The logic branches from frequency, then to severity, then to interference. For example, if frequency is > (greater than) never, you next pose the severity question, and if severity>noneseverity > none, you pose the interference question. Please reference  Please see the PRO-CTCAE website for more details on the electronic conditional branching approach at: https://healthcaredelivery.cancer.gov/pro-ctcae/faqs.html.
    1. These branching items on the PRO-CTCAE V1.0 may be logically skipped per the instrument instructions. For example, if the item "In the last 7 days, how OFTEN did you have PAIN IN THE ABDOMEN (BELLY AREA)?" (QSTESTCD = "PT01017A") is answered as "Never", then the related symptom items for severity and interference are logically skipped (QSTESTCD = "PT01017B" and "PT01017C"), since the symptom did not occur. A record is created in qs.xpt for all items. When an item is considered a logically skipped item, it is represented as follows:
      1. QSSTAT = "NOT DONE".

      2. QSREASND = "LOGICALLY SKIPPED ITEM".

      3. QSORRES, is set to null (missing).

      4. QSSTRESC and QSSTRESN are represented with the numeric value 0 as specified in the scoring criteria. Please reference the FAQ "How is the PRO-CTCAE scored" on the website at: https://healthcaredelivery.cancer.gov/pro-ctcae/faqs.html.
    .
    1. When a paper version is administered, conditional branching does not apply.
  10. Some items on the PRO-CTCAE may be not done due to conditional branching per the electronic instrument instructions as described in assumption 7. A record is created with the assigned responses based on the PRO-CTCAE V1.0 website FAQ and a QS supplemental qualifier variable is used to indicate an item was conditionally branched. Per NIH, these items are assigned values as follows: severity items are assigned responses of "None" and 0; interference items are assigned "Not at all" and 0. When an item is not done due to conditional branching, it is represented as follows:
    1. QNAM = “QSCBRFL”, QLABEL = “Conditionally Branched Item Flag “, QVAL = “Y” (this is a QS supplemental qualifier variable) 

    2. QSORRES

      1. For severity items, QSORRES = "None"

      2. For interference items, QSORRES = "Not at all"
    3. QSSTRESC = 0 and QSSTRESN = 0
  11. Records are created in qs.xpt for every item on the sponsor's version of the instrument. In the conduct of the PRO-CTCAE V1.0 NIH expects responses for each item and there should be no missing responses. 
    1. For items not done due to conditional branching, refer to assumption 8.
    2. In the unexpected situation where the reason is unknown, then QSORRES, QSSTRESC, and QSSTRESN are all missing; QSSTAT = "NOT DONE"; and QSREASND is missing.
  12. The language in which the PRO-CTCAE V1.0 was administered (e.g., English, Spanish, Japanese) is collected with the Form Builder application and may be The language in which the PRO-CTCAE V1.0 was administered (e.g., English, Spanish, Japanese) is collected with the Form Builder application and may be represented as a supplemental qualifier with QNAM = "QSLANGQSLANGDC". Reference See the PRO-CTCAE V1.0 website for a list of available translations at: https://healthcaredelivery.cancer.gov/pro-ctcae/language translations.
  13. Terminology
    1. QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the qualifier, timing, and result fields is provided in Section 4, SDTM Mapping Strategy.

3.2 Example for the PRO-CTCAE V1.0 QS Domain Model

The PRO-CTCAE V1.0 example below shows the terminology used to implement the instrument in measurement system in the QS domain. This example shows the data for 1 subject collected at the baseline visit for a PRO-CTCAE V1.0 instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results, matching the CRF item response text, are represented in QSORRES.This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC.

Info

We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.

...

Nameqs

...

the example below.

Example 1: PRO-CTCAE V1.0 measuring the full set of symptoms
The table represents the items from the PRO-CTCAE V1.0 measurement system.

Dataset wrap
Nameqs
Rowcaps
Rows 20-21:

Represent the electronic conditional branching on data entry for the symptom hiccups did not occur and then the symptom of hiccups severity was assigned 0 = “None”.

Rows 24-26:Represent the electronic conditional branching on data entry for the symptom abdominal pain frequency did not occur. The symptom of abdominal pain severity is assigned 0 = “None” and abdominal pain interference is assigned 0 = “Not at all” for the standardized result values.
Rows 126-129:Represent two additional symptoms that existed for the subject.
Rows 130-145:Represent the symptoms "Other Symptom 3 and Other Symptom 3 Severity" through "Other Symptom 10 and Other Symptom 10 Severity" that did not exist for the subject. These symptoms are represented as "NOT DONE".
Dataset2
RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSSCATQSORRESQSSTRESCQSSTRESNQSSTATQSREASNDQSLOBXFLVISITNUMQSDTCQSEVLINT
1STUDYXQS23-P00011PT01001APT01-Dry Mouth SeverityPRO-CTCAE V1.0ORALMild11

Y12015-05-15-P7D
2STUDYXQS23-P00012PT01002APT01-Difficulty Swallowing SeverityPRO-CTCAE V1.0ORALMild11

Y12015-05-15-P7D
3STUDYXQS23-P00013PT01003APT01-Mouth/Throat Sores SeverityPRO-CTCAE V1.0ORALMild11

Y12015-05-15-P7D
4STUDYXQS23-P00014PT01003BPT01-Mouth/Throat Sores InterferencePRO-CTCAE V1.0ORALA little bit11

Y12015-05-15-P7D
5STUDYXQS23-P00015PT01004APT01-Cracking Corners of Mouth SeverityPRO-CTCAE V1.0ORALMild11

Y12015-05-15-P7D
6STUDYXQS23-P00016PT01005APT01-Voice Quality Changes PresencePRO-CTCAE V1.0ORALNo00

Y12015-05-15-P7D
7STUDYXQS23-P00017PT01006APT01-Hoarseness SeverityPRO-CTCAE V1.0ORALMild11

Y12015-05-15-P7D
8STUDYXQS23-P00018PT01007APT01-Taste Changes SeverityPRO-CTCAE V1.0GASTROINTESTINALMild11

Y12015-05-15-P7D
9STUDYXQS23-P00019PT01008APT01-Decreased Appetite SeverityPRO-CTCAE V1.0GASTROINTESTINALMild11

Y12015-05-15-P7D
10STUDYXQS23-P000110PT01008BPT01-Decreased Appetite InterferencePRO-CTCAE V1.0GASTROINTESTINALSomewhat22

Y12015-05-15-P7D
11STUDYXQS23-P000111PT01009APT01-Nausea FrequencyPRO-CTCAE V1.0GASTROINTESTINALOccasionally22

Y12015-05-15-P7D
12STUDYXQS23-P000112PT01009BPT01-Nausea SeverityPRO-CTCAE V1.0GASTROINTESTINALMild11

Y12015-05-15-P7D
13STUDYXQS23-P000113PT01010APT01-Vomiting FrequencyPRO-CTCAE V1.0GASTROINTESTINALOccasionally22

Y12015-05-15-P7D
14STUDYXQS23-P000114PT01010BPT01-Vomiting SeverityPRO-CTCAE V1.0GASTROINTESTINALMild11

Y12015-05-15-P7D
15STUDYXQS23-P000115PT01011APT01-Heartburn FrequencyPRO-CTCAE V1.0GASTROINTESTINALOccasionally22

Y12015-05-15-P7D
16STUDYXQS23-P000116PT01011BPT01-Heartburn SeverityPRO-CTCAE V1.0GASTROINTESTINALMild11

Y12015-05-15-P7D
17STUDYXQS23-P000117PT01012APT01-Gas PresencePRO-CTCAE V1.0GASTROINTESTINALNo00

Y12015-05-15-P7D
18STUDYXQS23-P000118PT01013APT01-Bloating FrequencyPRO-CTCAE V1.0GASTROINTESTINALOccasionally22

Y12015-05-15-P7D
19STUDYXQS23-P000119PT01013BPT01-Bloating SeverityPRO-CTCAE V1.0GASTROINTESTINALMild11

Y12015-05-15-P7D
20STUDYXQS23-P000120PT01014APT01-Hiccups FrequencyPRO-CTCAE V1.0GASTROINTESTINALNever00

Y12015-05-15-P7D
21STUDYXQS23-P000121PT01014BPT01-Hiccups SeverityPRO-CTCAE V1.0GASTROINTESTINALNone00

Y12015-05-15-P7D
22STUDYXQS23-P000122PT01015APT01-Constipation SeverityPRO-CTCAE V1.0GASTROINTESTINALMild11

Y12015-05-15-P7D
23STUDYXQS23-P000123PT01016APT01-Diarrhea FrequencyPRO-CTCAE V1.0GASTROINTESTINALRarely11

Y12015-05-15-P7D
24STUDYXQS23-P000124PT01017APT01-Abdominal Pain FrequencyPRO-CTCAE V1.0GASTROINTESTINALNever00

Y12015-05-15-P7D
25STUDYXQS23-P000125PT01017BPT01-Abdominal Pain SeverityPRO-CTCAE V1.0GASTROINTESTINALNone00

Y12015-05-15-P7D
26STUDYXQS23-P000126PT01017CPT01-Abdominal Pain InterferencePRO-CTCAE V1.0GASTROINTESTINALNot at all00

Y12015-05-15-P7D
27STUDYXQS23-P000127PT01018APT01-Fecal Incontinence FrequencyPRO-CTCAE V1.0GASTROINTESTINALOccasionally22

Y12015-05-15-P7D
28STUDYXQS23-P000128PT01018BPT01-Fecal Incontinence InterferencePRO-CTCAE V1.0GASTROINTESTINALSomewhat22

Y12015-05-15-P7D
29STUDYXQS23-P000129PT01019APT01-Shortness of Breath SeverityPRO-CTCAE V1.0RESPIRATORYMild11

Y12015-05-15-P7D
30STUDYXQS23-P000130PT01019BPT01-Shortness of Breath InterferencePRO-CTCAE V1.0RESPIRATORYSomewhat22

Y12015-05-15-P7D
31STUDYXQS23-P000131PT01020APT01-Cough SeverityPRO-CTCAE V1.0RESPIRATORYMild11

Y12015-05-15-P7D
32STUDYXQS23-P000132PT01020BPT01-Cough InterferencePRO-CTCAE V1.0RESPIRATORYSomewhat22

Y12015-05-15-P7D
33STUDYXQS23-P000133PT01021APT01-Wheezing SeverityPRO-CTCAE V1.0RESPIRATORYMild11

Y12015-05-15-P7D
34STUDYXQS23-P000134PT01022APT01-Swelling FrequencyPRO-CTCAE V1.0CARDIO/CIRCULATORYOccasionally22

Y12015-05-15-P7D
35STUDYXQS23-P000135PT01022BPT01-Swelling SeverityPRO-CTCAE V1.0CARDIO/CIRCULATORYMild11

Y12015-05-15-P7D
36STUDYXQS23-P000136PT01022CPT01-Swelling InterferencePRO-CTCAE V1.0CARDIO/CIRCULATORYSomewhat22

Y12015-05-15-P7D
37STUDYXQS23-P000137PT01023APT01-Heart Palpitations FrequencyPRO-CTCAE V1.0CARDIO/CIRCULATORYOccasionally22

Y12015-05-15-P7D
38STUDYXQS23-P000138PT01023BPT01-Heart Palpitations SeverityPRO-CTCAE V1.0CARDIO/CIRCULATORYMild11

Y12015-05-15-P7D
39STUDYXQS23-P000139PT01024APT01-Rash PresencePRO-CTCAE V1.0CUTANEOUSNo00

Y12015-05-15-P7D
40STUDYXQS23-P000140PT01025APT01-Skin Dryness SeverityPRO-CTCAE V1.0CUTANEOUSMild11

Y12015-05-15-P7D
41STUDYXQS23-P000141PT01026APT01-Acne SeverityPRO-CTCAE V1.0CUTANEOUSMild11

Y12015-05-15-P7D
42STUDYXQS23-P000142PT01027APT01-Hair Loss AmountPRO-CTCAE V1.0CUTANEOUSQuite a bit33

Y12015-05-15-P7D
43STUDYXQS23-P000143PT01028APT01-Itching SeverityPRO-CTCAE V1.0CUTANEOUSMild11

Y12015-05-15-P7D
44STUDYXQS23-P000144PT01029APT01-Hives PresencePRO-CTCAE V1.0CUTANEOUSNo00

Y12015-05-15-P7D
45STUDYXQS23-P000145PT01030APT01-Hand-Foot Syndrome SeverityPRO-CTCAE V1.0CUTANEOUSMild11

Y12015-05-15-P7D
46STUDYXQS23-P000146PT01031APT01-Nail Loss PresencePRO-CTCAE V1.0CUTANEOUSNo00

Y12015-05-15-P7D
47STUDYXQS23-P000147PT01032APT01-Nail Ridging PresencePRO-CTCAE V1.0CUTANEOUSNo00

Y12015-05-15-P7D
48STUDYXQS23-P000148PT01033APT01-Nail Discoloration PresencePRO-CTCAE V1.0CUTANEOUSNo00

Y12015-05-15-P7D
49STUDYXQS23-P000149PT01034APT01-Sensitivity to Sunlight PresencePRO-CTCAE V1.0CUTANEOUSNo00

Y12015-05-15-P7D
50STUDYXQS23-P000150PT01035APT01-Bed/Pressure Sores PresencePRO-CTCAE V1.0CUTANEOUSNo00

Y12015-05-15-P7D
51STUDYXQS23-P000151PT01036APT01-Radiation Skin Reaction SeverityPRO-CTCAE V1.0CUTANEOUSMild11

Y12015-05-15-P7D
52STUDYXQS23-P000152PT01037APT01-Skin Darkening PresencePRO-CTCAE V1.0CUTANEOUSNo00

Y12015-05-15-P7D
53STUDYXQS23-P000153PT01038APT01-Stretch Marks PresencePRO-CTCAE V1.0CUTANEOUSNo00

Y12015-05-15-P7D
54STUDYXQS23-P000154PT01039APT01-Numbness & Tingling SeverityPRO-CTCAE V1.0NEUROLOGICALMild11

Y12015-05-15-P7D
55STUDYXQS23-P000155PT01039BPT01-Numbness & Tingling InterferencePRO-CTCAE V1.0NEUROLOGICALSomewhat22

Y12015-05-15-P7D
56STUDYXQS23-P000156PT01040APT01-Dizziness SeverityPRO-CTCAE V1.0NEUROLOGICALMild11

Y12015-05-15-P7D
57STUDYXQS23-P000157PT01040BPT01-Dizziness InterferencePRO-CTCAE V1.0NEUROLOGICALSomewhat22

Y12015-05-15-P7D
58STUDYXQS23-P000158PT01041APT01-Blurred Vision SeverityPRO-CTCAE V1.0VISUAL/PERCEPTUALMild11

Y12015-05-15-P7D
59STUDYXQS23-P000159PT01041BPT01-Blurred Vision InterferencePRO-CTCAE V1.0VISUAL/PERCEPTUALSomewhat22

Y12015-05-15-P7D
60STUDYXQS23-P000160PT01042APT01-Flashing Lights in Eyes PresencePRO-CTCAE V1.0VISUAL/PERCEPTUALNo00

Y12015-05-15-P7D
61STUDYXQS23-P000161PT01043APT01-Visual Floaters PresencePRO-CTCAE V1.0VISUAL/PERCEPTUALNo00

Y12015-05-15-P7D
62STUDYXQS23-P000162PT01044APT01-Watery Eyes SeverityPRO-CTCAE V1.0VISUAL/PERCEPTUALMild11

Y12015-05-15-P7D
63STUDYXQS23-P000163PT01044BPT01-Watery Eyes InterferencePRO-CTCAE V1.0VISUAL/PERCEPTUALSomewhat22

Y12015-05-15-P7D
64STUDYXQS23-P000164PT01045APT01-Ringing in Ears SeverityPRO-CTCAE V1.0VISUAL/PERCEPTUALMild11

Y12015-05-15-P7D
65STUDYXQS23-P000165PT01046APT01-Concentration Problems SeverityPRO-CTCAE V1.0ATTENTION/MEMORYMild11

Y12015-05-15-P7D
66STUDYXQS23-P000166PT01046BPT01-Concentration Problems InterferencePRO-CTCAE V1.0ATTENTION/MEMORYSomewhat22

Y12015-05-15-P7D
67STUDYXQS23-P000167PT01047APT01-Memory Problems SeverityPRO-CTCAE V1.0ATTENTION/MEMORYMild11

Y12015-05-15-P7D
68STUDYXQS23-P000168PT01047BPT01-Memory Problems InterferencePRO-CTCAE V1.0ATTENTION/MEMORYSomewhat22

Y12015-05-15-P7D
69STUDYXQS23-P000169PT01048APT01-General Pain FrequencyPRO-CTCAE V1.0PAINOccasionally22

Y12015-05-15-P7D
70STUDYXQS23-P000170PT01048BPT01-General Pain SeverityPRO-CTCAE V1.0PAINMild11

Y12015-05-15-P7D
71STUDYXQS23-P000171PT01048CPT01-General Pain InterferencePRO-CTCAE V1.0PAINSomewhat22

Y12015-05-15-P7D
72STUDYXQS23-P000172PT01049APT01-Headache FrequencyPRO-CTCAE V1.0PAINOccasionally22

Y12015-05-15-P7D
73STUDYXQS23-P000173PT01049BPT01-Headache SeverityPRO-CTCAE V1.0PAINMild11

Y12015-05-15-P7D
74STUDYXQS23-P000174PT01049CPT01-Headache InterferencePRO-CTCAE V1.0PAINSomewhat22

Y12015-05-15-P7D
75STUDYXQS23-P000175PT01050APT01-Muscle Pain FrequencyPRO-CTCAE V1.0PAINOccasionally22

Y12015-05-15-P7D
76STUDYXQS23-P000176PT01050BPT01-Muscle Pain SeverityPRO-CTCAE V1.0PAINMild11

Y12015-05-15-P7D
77STUDYXQS23-P000177PT01050CPT01-Muscle Pain InterferencePRO-CTCAE V1.0PAINSomewhat22

Y12015-05-15-P7D
78STUDYXQS23-P000178PT01051APT01-Joint Pain FrequencyPRO-CTCAE V1.0PAINOccasionally22

Y12015-05-15-P7D
79STUDYXQS23-P000179PT01051BPT01-Joint Pain SeverityPRO-CTCAE V1.0PAINMild11

Y12015-05-15-P7D
80STUDYXQS23-P000180PT01051CPT01-Joint Pain InterferencePRO-CTCAE V1.0PAINSomewhat22

Y12015-05-15-P7D
81STUDYXQS23-P000181PT01052APT01-Insomnia SeverityPRO-CTCAE V1.0SLEEP/WAKEMild11

Y12015-05-15-P7D
82STUDYXQS23-P000182PT01052BPT01-Insomnia InterferencePRO-CTCAE V1.0SLEEP/WAKESomewhat22

Y12015-05-15-P7D
83STUDYXQS23-P000183PT01053APT01-Fatigue SeverityPRO-CTCAE V1.0SLEEP/WAKEMild11

Y12015-05-15-P7D
84STUDYXQS23-P000184PT01053BPT01-Fatigue InterferencePRO-CTCAE V1.0SLEEP/WAKESomewhat22

Y12015-05-15-P7D
85STUDYXQS23-P000185PT01054APT01-Anxious FrequencyPRO-CTCAE V1.0MOODOccasionally22

Y12015-05-15-P7D
86STUDYXQS23-P000186PT01054BPT01-Anxious SeverityPRO-CTCAE V1.0MOODMild11

Y12015-05-15-P7D
87STUDYXQS23-P000187PT01054CPT01-Anxious InterferencePRO-CTCAE V1.0MOODSomewhat22

Y12015-05-15-P7D
88STUDYXQS23-P000188PT01055APT01-Discouraged FrequencyPRO-CTCAE V1.0MOODOccasionally22

Y12015-05-15-P7D
89STUDYXQS23-P000189PT01055BPT01-Discouraged SeverityPRO-CTCAE V1.0MOODMild11

Y12015-05-15-P7D
90STUDYXQS23-P000190PT01055CPT01-Discouraged InterferencePRO-CTCAE V1.0MOODSomewhat22

Y12015-05-15-P7D
91STUDYXQS23-P000191PT01056APT01-Sad FrequencyPRO-CTCAE V1.0MOODOccasionally22

Y12015-05-15-P7D
92STUDYXQS23-P000192PT01056BPT01-Sad SeverityPRO-CTCAE V1.0MOODMild11

Y12015-05-15-P7D
93STUDYXQS23-P000193PT01056CPT01-Sad InterferencePRO-CTCAE V1.0MOODSomewhat22

Y12015-05-15-P7D
94STUDYXQS23-P000194PT01057APT01-Irregular Menstrual Period PresencePRO-CTCAE V1.0GYNECOLOGIC/URINARYNo00

Y12015-05-15-P7D
95STUDYXQS23-P000195PT01058APT01-Missed Menstrual Period PresencePRO-CTCAE V1.0GYNECOLOGIC/URINARYNo00

Y12015-05-15-P7D
96STUDYXQS23-P000196PT01059APT01-Vaginal Discharge AmountPRO-CTCAE V1.0GYNECOLOGIC/URINARYSomewhat22

Y12015-05-15-P7D
97STUDYXQS23-P000197PT01060APT01-Vaginal Dryness SeverityPRO-CTCAE V1.0GYNECOLOGIC/URINARYMild11

Y12015-05-15-P7D
98STUDYXQS23-P000198PT01061APT01-Painful Urination SeverityPRO-CTCAE V1.0GYNECOLOGIC/URINARYMild11

Y12015-05-15-P7D
99STUDYXQS23-P000199PT01062APT01-Urinary Urgency FrequencyPRO-CTCAE V1.0GYNECOLOGIC/URINARYOccasionally22

Y12015-05-15-P7D
100STUDYXQS23-P0001100PT01062BPT01-Urinary Urgency InterferencePRO-CTCAE V1.0GYNECOLOGIC/URINARYSomewhat22

Y12015-05-15-P7D
191STUDYXQS23-P0001191PT01063APT01-Urinary Frequency FrequencyPRO-CTCAE V1.0GYNECOLOGIC/URINARYOccasionally22

Y12015-05-15-P7D
102STUDYXQS23-P0001102PT01063BPT01-Urinary Frequency InterferencePRO-CTCAE V1.0GYNECOLOGIC/URINARYSomewhat22

Y12015-05-15-P7D
103STUDYXQS23-P0001103PT01064APT01-Urine Color Change PresencePRO-CTCAE V1.0GYNECOLOGIC/URINARYNo00

Y12015-05-15-P7D
104STUDYXQS23-P0001104PT01065APT01-Urinary Incontinence FrequencyPRO-CTCAE V1.0GYNECOLOGIC/URINARYOccasionally22

Y12015-05-15-P7D
105STUDYXQS23-P0001105PT01065BPT01-Urinary Incontinence InterferencePRO-CTCAE V1.0GYNECOLOGIC/URINARYSomewhat22

Y12015-05-15-P7D
106STUDYXQS23-P0001106PT01066APT01-Achieve&Maintain Erection SeverityPRO-CTCAE V1.0SEXUALMild11

Y12015-05-15-P7D
107STUDYXQS23-P0001107PT01067APT01-Ejaculation FrequencyPRO-CTCAE V1.0SEXUALOccasionally22

Y12015-05-15-P7D
108STUDYXQS23-P0001108PT01068APT01-Decreased Libido SeverityPRO-CTCAE V1.0SEXUALMild11

Y12015-05-15-P7D
109STUDYXQS23-P0001109PT01069APT01-Delayed Orgasm PresencePRO-CTCAE V1.0SEXUALNo00

Y12015-05-15-P7D
110STUDYXQS23-P0001110PT01070APT01-Unable to Have Orgasm PresencePRO-CTCAE V1.0SEXUALNo00

Y12015-05-15-P7D
111STUDYXQS23-P0001111PT01071APT01-Pain w/Sexual Intercourse SeverityPRO-CTCAE V1.0SEXUALMild11

Y12015-05-15-P7D
112STUDYXQS23-P0001112PT01072APT01-Breast Swelling&Tenderness SeverityPRO-CTCAE V1.0MISCELLANEOUSMild11

Y12015-05-15-P7D
113STUDYXQS23-P0001113PT01073APT01-Bruising PresencePRO-CTCAE V1.0MISCELLANEOUSNo00

Y12015-05-15-P7D
114STUDYXQS23-P0001114PT01074APT01-Chills FrequencyPRO-CTCAE V1.0MISCELLANEOUSOccasionally22

Y12015-05-15-P7D
115STUDYXQS23-P0001115PT01074BPT01-Chills SeverityPRO-CTCAE V1.0MISCELLANEOUSMild11

Y12015-05-15-P7D
116STUDYXQS23-P0001116PT01075APT01-Increased Sweating FrequencyPRO-CTCAE V1.0MISCELLANEOUSOccasionally22

Y12015-05-15-P7D
117STUDYXQS23-P0001117PT01075BPT01-Increased Sweating SeverityPRO-CTCAE V1.0MISCELLANEOUSMild11

Y12015-05-15-P7D
118STUDYXQS23-P0001118PT01076APT01-Decreased Sweating PresencePRO-CTCAE V1.0MISCELLANEOUSNo00

Y12015-05-15-P7D
118STUDYXQS23-P0001118PT01077APT01-Hot Flashes FrequencyPRO-CTCAE V1.0MISCELLANEOUSOccasionally22

Y12015-05-15-P7D
120STUDYXQS23-P0001120PT01077BPT01-Hot Flashes SeverityPRO-CTCAE V1.0MISCELLANEOUSMild11

Y12015-05-15-P7D
121STUDYXQS23-P0001121PT01078APT01-Nosebleed FrequencyPRO-CTCAE V1.0MISCELLANEOUSOccasionally22

Y12015-05-15-P7D
122STUDYXQS23-P0001122PT01078BPT01-Nosebleed SeverityPRO-CTCAE V1.0MISCELLANEOUSMild11

Y12015-05-15-P7D
123STUDYXQS23-P0001123PT01079APT01-Pain&Swelling at Inj Site PresencePRO-CTCAE V1.0MISCELLANEOUSNo00

Y12015-05-15-P7D
124STUDYXQS23-P0001124PT01080APT01-Body Odor SeverityPRO-CTCAE V1.0MISCELLANEOUSMild11

Y12015-05-15-P7D
125STUDYXQS23-P0001125PT01081PT01-Any Other Symptoms ReportedPRO-CTCAE V1.0OTHER SYMPTOMSYes11

Y12015-05-15-P7D
126STUDYXQS23-P0001126PT01082APT01-Other Symptom 1PRO-CTCAE V1.0OTHER SYMPTOMSAnother symptom 1Another symptom 1


Y12015-05-15-P7D
127STUDYXQS23-P0001127PT01082BPT01-Other Symptom 1 SeverityPRO-CTCAE V1.0OTHER SYMPTOMSMild11

Y12015-05-15-P7D
128STUDYXQS23-P0001128PT01083APT01-Other Symptom 2PRO-CTCAE V1.0OTHER SYMPTOMSAnother symptom 2Another symptom 2


Y12015-05-15-P7D
129STUDYXQS23-P0001129PT01083BPT01-Other Symptom 2 SeverityPRO-CTCAE V1.0OTHER SYMPTOMSMild11

Y12015-05-15-P7D
130STUDYXQS23-P0001130PT01084APT01-Other Symptom 3PRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE
Y12015-05-15-P7D
131STUDYXQS23-P0001131PT01084BPT01-Other Symptom 3 SeverityPRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE
Y12015-05-15-P7D
132STUDYXQS23-P0001132PT01085APT01-Other Symptom 4PRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE
Y12015-05-15-P7D
133STUDYXQS23-P0001133PT01085BPT01-Other Symptom 4 SeverityPRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE
Y12015-05-15-P7D
134STUDYXQS23-P0001134PT01086APT01-Other Symptom 5PRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE
Y12015-05-15-P7D
135STUDYXQS23-P0001135PT01086BPT01-Other Symptom 5 SeverityPRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE
Y12015-05-15-P7D
136STUDYXQS23-P0001136PT01087APT01-Other Symptom 6PRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE
Y12015-05-15-P7D
137STUDYXQS23-P0001137PT01087BPT01-Other Symptom 6 SeverityPRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE
Y12015-05-15-P7D
138STUDYXQS23-P0001138PT01088APT01-Other Symptom 7PRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE
Y12015-05-15-P7D
139STUDYXQS23-P0001139PT01088BPT01-Other Symptom 7 SeverityPRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE
Y12015-05-15-P7D
140STUDYXQS23-P0001140PT01089APT01-Other Symptom 8PRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE
Y12015-05-15-P7D
141STUDYXQS23-P0001141PT01089BPT01-Other Symptom 8 SeverityPRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE
Y12015-05-15-P7D
142STUDYXQS23-P0001142PT01090APT01-Other Symptom 9PRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE
Y12015-05-15-P7D
143STUDYXQS23-P0001143PT01090BPT01-Other Symptom 9 SeverityPRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE
Y12015-05-15-P7D
144STUDYXQS23-P0001144PT01091APT01-Other Symptom 10PRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE
Y12015-05-15-P7D
145STUDYXQS23-P0001145PT01091BPT01-Other Symptom 10 SeverityPRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE
Y12015-05-15-P7D


The SUPPQS dataset shows the items in the QS dataset which have assigned responses (QSCBRFL = "Y") due to electronic conditional branching and also relates the symptom terms from the annotated Item Library v1.0 form to each symptom item represented in the QS dataset.

Dataset wrap
Namesuppqs
Dataset2
tableidsuppqs
STUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
STUDYXQS23-P0001QSSEQ21QSCBRFLConditionally Branched Item FlagYASSIGNED
STUDYXQS23-P0001QSSEQ25QSCBRFLConditionally Branched Item FlagYASSIGNED
STUDYXQS23-P0001QSSEQ26QSCBRFLConditionally Branched Item FlagYASSIGNED
STUDYXQS23-P0001QSTESTCDPT01001AQSSYMPTMSymptom TermDRY MOUTHCRF
STUDYXQS23-P0001QSTESTCDPT01002AQSSYMPTMSymptom TermDIFFICULTY SWALLOWINGCRF
STUDYXQS23-P0001QSTESTCDPT01003AQSSYMPTMSymptom TermMOUTH/THROAT SORESCRF
STUDYXQS23-P0001QSTESTCDPT01003BQSSYMPTMSymptom TermMOUTH/THROAT SORESCRF
STUDYXQS23-P0001QSTESTCDPT01004AQSSYMPTMSymptom TermCRACKING AT THE CORNERS OF THE MOUTH (CHEILOSIS/CHEILITIS)CRF
STUDYXQS23-P0001QSTESTCDPT01005AQSSYMPTMSymptom TermVOICE QUALITY CHANGESCRF
STUDYXQS23-P0001QSTESTCDPT01006AQSSYMPTMSymptom TermHOARSENESSCRF
STUDYXQS23-P0001QSTESTCDPT01007AQSSYMPTMSymptom TermTASTE CHANGESCRF
STUDYXQS23-P0001QSTESTCDPT01008AQSSYMPTMSymptom TermDECREASED APPETITECRF
STUDYXQS23-P0001QSTESTCDPT01008BQSSYMPTMSymptom TermDECREASED APPETITECRF
STUDYXQS23-P0001QSTESTCDPT01009AQSSYMPTMSymptom TermNAUSEACRF
STUDYXQS23-P0001QSTESTCDPT01009BQSSYMPTMSymptom TermNAUSEACRF
STUDYXQS23-P0001QSTESTCDPT01010AQSSYMPTMSymptom TermVOMITINGCRF
STUDYXQS23-P0001QSTESTCDPT01010BQSSYMPTMSymptom TermVOMITINGCRF
STUDYXQS23-P0001QSTESTCDPT01011AQSSYMPTMSymptom TermHEARTBURNCRF
STUDYXQS23-P0001QSTESTCDPT01011BQSSYMPTMSymptom TermHEARTBURNCRF
STUDYXQS23-P0001QSTESTCDPT01012AQSSYMPTMSymptom TermGASCRF
STUDYXQS23-P0001QSTESTCDPT01013AQSSYMPTMSymptom TermBLOATINGCRF
STUDYXQS23-P0001QSTESTCDPT01013BQSSYMPTMSymptom TermBLOATINGCRF
STUDYXQS23-P0001QSTESTCDPT01014AQSSYMPTMSymptom TermHICCUPSCRF
STUDYXQS23-P0001QSTESTCDPT01014BQSSYMPTMSymptom TermHICCUPSCRF
STUDYXQS23-P0001QSTESTCDPT01015AQSSYMPTMSymptom TermCONSTIPATIONCRF
STUDYXQS23-P0001QSTESTCDPT01016AQSSYMPTMSymptom TermDIARRHEACRF
STUDYXQS23-P0001QSTESTCDPT01017AQSSYMPTMSymptom TermABDOMINAL PAINCRF
STUDYXQS23-P0001QSTESTCDPT01017BQSSYMPTMSymptom TermABDOMINAL PAINCRF
STUDYXQS23-P0001QSTESTCDPT01017CQSSYMPTMSymptom TermABDOMINAL PAINCRF
STUDYXQS23-P0001QSTESTCDPT01018AQSSYMPTMSymptom TermFECAL INCONTINENCECRF
STUDYXQS23-P0001QSTESTCDPT01018BQSSYMPTMSymptom TermFECAL INCONTINENCECRF
STUDYXQS23-P0001QSTESTCDPT01019AQSSYMPTMSymptom TermSHORTNESS OF BREATHCRF
STUDYXQS23-P0001QSTESTCDPT01019BQSSYMPTMSymptom TermSHORTNESS OF BREATHCRF
STUDYXQS23-P0001QSTESTCDPT01020AQSSYMPTMSymptom TermCOUGHCRF
STUDYXQS23-P0001QSTESTCDPT01020BQSSYMPTMSymptom TermCOUGHCRF
STUDYXQS23-P0001QSTESTCDPT01021AQSSYMPTMSymptom TermWHEEZINGCRF
STUDYXQS23-P0001QSTESTCDPT01022AQSSYMPTMSymptom TermSWELLINGCRF
STUDYXQS23-P0001QSTESTCDPT01022BQSSYMPTMSymptom TermSWELLINGCRF
STUDYXQS23-P0001QSTESTCDPT01022CQSSYMPTMSymptom TermSWELLINGCRF
STUDYXQS23-P0001QSTESTCDPT01023AQSSYMPTMSymptom TermHEART PALPITATIONSCRF
STUDYXQS23-P0001QSTESTCDPT01023BQSSYMPTMSymptom TermHEART PALPITATIONSCRF
STUDYXQS23-P0001QSTESTCDPT01024AQSSYMPTMSymptom TermRASHCRF
STUDYXQS23-P0001QSTESTCDPT01025AQSSYMPTMSymptom TermSKIN DRYNESSCRF
STUDYXQS23-P0001QSTESTCDPT01026AQSSYMPTMSymptom TermACNECRF
STUDYXQS23-P0001QSTESTCDPT01027AQSSYMPTMSymptom TermHAIR LOSSCRF
STUDYXQS23-P0001QSTESTCDPT01028AQSSYMPTMSymptom TermITCHINGCRF
STUDYXQS23-P0001QSTESTCDPT01029AQSSYMPTMSymptom TermHIVESCRF
STUDYXQS23-P0001QSTESTCDPT01030AQSSYMPTMSymptom TermHAND-FOOT SYNDROMECRF
STUDYXQS23-P0001QSTESTCDPT01031AQSSYMPTMSymptom TermNAIL LOSSCRF
STUDYXQS23-P0001QSTESTCDPT01032AQSSYMPTMSymptom TermNAIL RIDGINGCRF
STUDYXQS23-P0001QSTESTCDPT01033AQSSYMPTMSymptom TermNAIL DISCOLORATIONCRF
STUDYXQS23-P0001QSTESTCDPT01034AQSSYMPTMSymptom TermSENSITIVITY TO SUNLIGHTCRF
STUDYXQS23-P0001QSTESTCDPT01035AQSSYMPTMSymptom TermBED/PRESSURE SORESCRF
STUDYXQS23-P0001QSTESTCDPT01036AQSSYMPTMSymptom TermRADIATION SKIN REACTIONCRF
STUDYXQS23-P0001QSTESTCDPT01037AQSSYMPTMSymptom TermSKIN DARKENINGCRF
STUDYXQS23-P0001QSTESTCDPT01038AQSSYMPTMSymptom TermSTRETCH MARKSCRF
STUDYXQS23-P0001QSTESTCDPT01039AQSSYMPTMSymptom TermNUMBNESS & TINGLINGCRF
STUDYXQS23-P0001QSTESTCDPT01039BQSSYMPTMSymptom TermNUMBNESS & TINGLINGCRF
STUDYXQS23-P0001QSTESTCDPT01040AQSSYMPTMSymptom TermDIZZINESSCRF
STUDYXQS23-P0001QSTESTCDPT01040BQSSYMPTMSymptom TermDIZZINESSCRF
STUDYXQS23-P0001QSTESTCDPT01041AQSSYMPTMSymptom TermBLURRED VISIONCRF
STUDYXQS23-P0001QSTESTCDPT01041BQSSYMPTMSymptom TermBLURRED VISIONCRF
STUDYXQS23-P0001QSTESTCDPT01042AQSSYMPTMSymptom TermFLASHING LIGHTSCRF
STUDYXQS23-P0001QSTESTCDPT01043AQSSYMPTMSymptom TermVISUAL FLOATERSCRF
STUDYXQS23-P0001QSTESTCDPT01044AQSSYMPTMSymptom TermWATERY EYESCRF
STUDYXQS23-P0001QSTESTCDPT01044BQSSYMPTMSymptom TermWATERY EYESCRF
STUDYXQS23-P0001QSTESTCDPT01045AQSSYMPTMSymptom TermRINGING IN EARSCRF
STUDYXQS23-P0001QSTESTCDPT01046AQSSYMPTMSymptom TermCONCENTRATIONCRF
STUDYXQS23-P0001QSTESTCDPT01046BQSSYMPTMSymptom TermCONCENTRATIONCRF
STUDYXQS23-P0001QSTESTCDPT01047AQSSYMPTMSymptom TermMEMORYCRF
STUDYXQS23-P0001QSTESTCDPT01047BQSSYMPTMSymptom TermMEMORYCRF
STUDYXQS23-P0001QSTESTCDPT01048AQSSYMPTMSymptom TermGENERAL PAINCRF
STUDYXQS23-P0001QSTESTCDPT01048BQSSYMPTMSymptom TermGENERAL PAINCRF
STUDYXQS23-P0001QSTESTCDPT01048CQSSYMPTMSymptom TermGENERAL PAINCRF
STUDYXQS23-P0001QSTESTCDPT01049AQSSYMPTMSymptom TermHEADACHECRF
STUDYXQS23-P0001QSTESTCDPT01049BQSSYMPTMSymptom TermHEADACHECRF
STUDYXQS23-P0001QSTESTCDPT01049CQSSYMPTMSymptom TermHEADACHECRF
STUDYXQS23-P0001QSTESTCDPT01050AQSSYMPTMSymptom TermMUSCLE PAINCRF
STUDYXQS23-P0001QSTESTCDPT01050BQSSYMPTMSymptom TermMUSCLE PAINCRF
STUDYXQS23-P0001QSTESTCDPT01050CQSSYMPTMSymptom TermMUSCLE PAINCRF
STUDYXQS23-P0001QSTESTCDPT01051AQSSYMPTMSymptom TermJOINT PAINCRF
STUDYXQS23-P0001QSTESTCDPT01051BQSSYMPTMSymptom TermJOINT PAINCRF
STUDYXQS23-P0001QSTESTCDPT01051CQSSYMPTMSymptom TermJOINT PAINCRF
STUDYXQS23-P0001QSTESTCDPT01052AQSSYMPTMSymptom TermINSOMNIACRF
STUDYXQS23-P0001QSTESTCDPT01052BQSSYMPTMSymptom TermINSOMNIACRF
STUDYXQS23-P0001QSTESTCDPT01053AQSSYMPTMSymptom TermFATIGUECRF
STUDYXQS23-P0001QSTESTCDPT01053BQSSYMPTMSymptom TermFATIGUECRF
STUDYXQS23-P0001QSTESTCDPT01054AQSSYMPTMSymptom TermANXIOUSCRF
STUDYXQS23-P0001QSTESTCDPT01054BQSSYMPTMSymptom TermANXIOUSCRF
STUDYXQS23-P0001QSTESTCDPT01054CQSSYMPTMSymptom TermANXIOUSCRF
STUDYXQS23-P0001QSTESTCDPT01055AQSSYMPTMSymptom TermDISCOURAGEDCRF
STUDYXQS23-P0001QSTESTCDPT01055BQSSYMPTMSymptom TermDISCOURAGEDCRF
STUDYXQS23-P0001QSTESTCDPT01055CQSSYMPTMSymptom TermDISCOURAGEDCRF
STUDYXQS23-P0001QSTESTCDPT01056AQSSYMPTMSymptom TermSADCRF
STUDYXQS23-P0001QSTESTCDPT01056BQSSYMPTMSymptom TermSADCRF
STUDYXQS23-P0001QSTESTCDPT01056CQSSYMPTMSymptom TermSADCRF
STUDYXQS23-P0001QSTESTCDPT01057AQSSYMPTMSymptom TermIRREGULAR PERIODS/VAGINAL BLEEDINGCRF
STUDYXQS23-P0001QSTESTCDPT01058AQSSYMPTMSymptom TermMISSED EXPECTED MENSTRUAL PERIODCRF
STUDYXQS23-P0001QSTESTCDPT01059AQSSYMPTMSymptom TermVAGINAL DISCHARGECRF
STUDYXQS23-P0001QSTESTCDPT01060AQSSYMPTMSymptom TermVAGINAL DRYNESSCRF
STUDYXQS23-P0001QSTESTCDPT01061AQSSYMPTMSymptom TermPAINFUL URINATIONCRF
STUDYXQS23-P0001QSTESTCDPT01062AQSSYMPTMSymptom TermURINARY URGENCYCRF
STUDYXQS23-P0001QSTESTCDPT01062BQSSYMPTMSymptom TermURINARY URGENCYCRF
STUDYXQS23-P0001QSTESTCDPT01063AQSSYMPTMSymptom TermURINARY FREQUENCYCRF
STUDYXQS23-P0001QSTESTCDPT01063BQSSYMPTMSymptom TermURINARY FREQUENCYCRF
STUDYXQS23-P0001QSTESTCDPT01064AQSSYMPTMSymptom TermCHANGE IN USUAL URINE COLORCRF
STUDYXQS23-P0001QSTESTCDPT01065AQSSYMPTMSymptom TermURINARY INCONTINENCECRF
STUDYXQS23-P0001QSTESTCDPT01065BQSSYMPTMSymptom TermURINARY INCONTINENCECRF
STUDYXQS23-P0001QSTESTCDPT01066AQSSYMPTMSymptom TermACHIEVE AND MAINTAIN ERECTIONCRF
STUDYXQS23-P0001QSTESTCDPT01067AQSSYMPTMSymptom TermEJACULATIONCRF
STUDYXQS23-P0001QSTESTCDPT01068AQSSYMPTMSymptom TermDECREASED LIBIDOCRF
STUDYXQS23-P0001QSTESTCDPT01069AQSSYMPTMSymptom TermDELAYED ORGASMCRF
STUDYXQS23-P0001QSTESTCDPT01070AQSSYMPTMSymptom TermUNABLE TO HAVE ORGASMCRF

...

The suppqs dataset relates the symptom term from the PRO-CTCAE ITEM LIBRARY (Version 1.0) to each symptom item represented in the qs dataset.

Dataset wrap
Namesuppqs
Dataset2
tableidsuppqs.xpt
QEVAL
STUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
STUDYXQS23-P0001QSTESTCDPT01001APT01071AQSSYMTRMQSSYMPTMSymptom TermDRY MOUTHPAIN W/SEXUAL INTERCOURSECRF
STUDYXQS23-P0001QSTESTCDPT01002APT01072AQSSYMTRMQSSYMPTMSymptom TermDIFFICULTY SWALLOWINGBREAST SWELLING AND TENDERNESSCRF
STUDYXQS23-P0001QSTESTCDPT01003APT01073AQSSYMTRMQSSYMPTMSymptom TermMOUTH/THROAT SORESBRUISINGCRF
STUDYXQS23-P0001QSTESTCDPT01003BPT01074AQSSYMTRMQSSYMPTMSymptom TermMOUTH/THROAT SORESCHILLSCRF
STUDYXQS23-P0001QSTESTCDPT01004APT01074BQSSYMTRMQSSYMPTMSymptom TermCRACKING AT THE CORNERS OF THE MOUTH (CHEILOSIS/CHEILITIS)CHILLSCRF
STUDYXQS23-P0001QSTESTCDPT01005APT01075AQSSYMTRMQSSYMPTMSymptom TermVOICE QUALITY CHANGESINCREASED SWEATINGCRF
STUDYXQS23-P0001QSTESTCDPT01006APT01075BQSSYMTRMQSSYMPTMSymptom TermHOARSENESSINCREASED SWEATINGCRF
STUDYXQS23-P0001QSTESTCDPT01007APT01076AQSSYMTRMQSSYMPTMSymptom TermTASTE CHANGESDECREASED SWEATINGCRF
STUDYXQS23-P0001QSTESTCDPT01008APT01077AQSSYMTRMQSSYMPTMSymptom TermDECREASED APPETITEHOT FLASHESCRF
STUDYXQS23-P0001QSTESTCDPT01008BPT01077BQSSYMTRMQSSYMPTMSymptom TermDECREASED APPETITEHOT FLASHESCRF
STUDYXQS23-P0001QSTESTCDPT01009APT01078AQSSYMTRMQSSYMPTMSymptom TermNAUSEANOSEBLEEDCRF
STUDYXQS23-P0001QSTESTCDPT01009BPT01078BQSSYMTRMQSSYMPTMSymptom TermNAUSEANOSEBLEEDCRF
STUDYXQS23-P0001QSTESTCDPT01010APT01079AQSSYMTRMQSSYMPTMSymptom TermVOMITINGPAIN AND SWELLING AT INJECTION SITECRF
STUDYXQS23-P0001QSTESTCDPT01010BPT01080AQSSYMTRMQSSYMPTMSymptom TermVOMITINGBODY ODORCRF
STUDYXQS23-P0001QSTESTCDPT01011APT01081QSSYMTRMQSSYMPTMSymptom TermHEARTBURNANY OTHER SYMPTOMS REPORTEDCRF
STUDYXQS23-P0001QSTESTCDPT01011BPT01082AQSSYMTRMQSSYMPTMSymptom TermHEARTBURNOTHER SYMPTOM 1CRF
STUDYXQS23-P0001QSTESTCDPT01012APT01082BQSSYMTRMQSSYMPTMSymptom TermGASOTHER SYMPTOM 1CRF
STUDYXQS23-P0001QSTESTCDPT01013APT01083AQSSYMTRMQSSYMPTMSymptom TermBLOATINGOTHER SYMPTOM 2CRF
STUDYXQS23-P0001QSTESTCDPT01013BPT01083BQSSYMTRMQSSYMPTMSymptom TermBLOATINGOTHER SYMPTOM 2CRF
STUDYXQS23-P0001QSTESTCDPT01014APT01084AQSSYMTRMQSSYMPTMSymptom TermHICCUPSOTHER SYMPTOM 3CRF
STUDYXQS23-P0001QSTESTCDPT01014BPT01084BQSSYMTRMQSSYMPTMSymptom TermHICCUPSOTHER SYMPTOM 3CRF
STUDYXQS23-P0001QSTESTCDPT01015APT01085AQSSYMTRMQSSYMPTMSymptom TermCONSTIPATIONOTHER SYMPTOM 4CRF
STUDYXQS23-P0001QSTESTCDPT01016APT01085BQSSYMTRMQSSYMPTMSymptom TermDIARRHEAOTHER SYMPTOM 4CRF
STUDYXQS23-P0001QSTESTCDPT01017APT01086AQSSYMTRMQSSYMPTMSymptom TermABDOMINAL PAINOTHER SYMPTOM 5CRF
STUDYXQS23-P0001QSTESTCDPT01017BPT01086BQSSYMTRMQSSYMPTMSymptom TermABDOMINAL PAINOTHER SYMPTOM 5CRF
STUDYXQS23-P0001QSTESTCDPT01017CPT01087AQSSYMTRMQSSYMPTMSymptom TermABDOMINAL PAINOTHER SYMPTOM 6CRF
STUDYXQS23-P0001QSTESTCDPT01018APT01087BQSSYMTRMQSSYMPTMSymptom TermFECAL INCONTINENCEOTHER SYMPTOM 6CRF
STUDYXQS23-P0001QSTESTCDPT01018BPT01088AQSSYMTRMQSSYMPTMSymptom TermFECAL INCONTINENCEOTHER SYMPTOM 7CRF
STUDYXQS23-P0001QSTESTCDPT01019APT01088BQSSYMTRMQSSYMPTMSymptom TermSHORTNESS OF BREATHOTHER SYMPTOM 7CRF
STUDYXQS23-P0001QSTESTCDPT01019BPT01089AQSSYMTRMQSSYMPTMSymptom TermSHORTNESS OF BREATHOTHER SYMPTOM 8CRF
STUDYXQS23-P0001QSTESTCDPT01020APT01089BQSSYMTRMQSSYMPTMSymptom TermCOUGHOTHER SYMPTOM 8CRF
STUDYXQS23-P0001QSTESTCDPT01020BPT01090AQSSYMTRMQSSYMPTMSymptom TermCOUGHOTHER SYMPTOM 9CRF
STUDYXQS23-P0001QSTESTCDPT01021APT01090BQSSYMTRMQSSYMPTMSymptom TermWHEEZINGOTHER SYMPTOM 9CRF
STUDYXQS23-P0001QSTESTCDPT01022APT01091AQSSYMTRMQSSYMPTMSymptom TermSWELLINGOTHER SYMPTOM 10CRF
STUDYXQS23-P0001QSTESTCDPT01022BQSSYMTRMSymptom TermSWELLINGCRFSTUDYXQS23-P0001QSTESTCDPT01022CQSSYMTRMSymptom TermSWELLINGCRFSTUDYXQS23-P0001QSTESTCDPT01023AQSSYMTRMSymptom TermHEART PALPITATIONSCRFSTUDYXQS23-P0001QSTESTCDPT01023BQSSYMTRMSymptom TermHEART PALPITATIONSCRFSTUDYXQS23-P0001QSTESTCDPT01024AQSSYMTRMSymptom TermRASHPT01091BQSSYMPTMSymptom TermOTHER SYMPTOM 10CRF

Example 2: PRO-CTCAE V1.0 measuring the subset of symptoms from the following subcategories as represented in the Quick Guide to the Item Library:

  • RESPIRATORY
  • CARDIO/CIRCULATORY
  • NEUROLOGICAL
  • ATTENTION/MEMORY

The table represents the subset of items from the PRO-CTCAE V1.0 measurement system. The subject did not have any symptoms represented with "Other Symptom 3 and Other Symptom 3 Severity" through "Other Symptom 10 and Other Symptom 10 Severity". These records are represented as "NOT DONE".

Dataset wrap
Nameqsxx
Dataset2
tableidqsxx
RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSSCATQSORRESQSSTRESCQSSTRESNQSSTATQSREASNDQSLOBXFLVISITNUMQSDTCQSEVLINT
1CRFSTUDYXQS23-P0001QSTESTCD1PT01025AQSSYMTRMSymptom TermSKIN DRYNESSCRFSTUDYXQS23-P0001QSTESTCDPT01026AQSSYMTRMSymptom TermACNECRFPT01019APT01-Shortness of Breath SeverityPRO-CTCAE V1.0RESPIRATORYMild11

Y12015-05-15-P7D
2STUDYXQS23-P0001QSTESTCD2PT01027AQSSYMTRMSymptom TermHAIR LOSSCRFSTUDYXQS23-P0001QSTESTCDPT01028AQSSYMTRMSymptom TermITCHINGPT01019BPT01-Shortness of Breath InterferencePRO-CTCAE V1.0RESPIRATORYSomewhat22

Y12015-05-15-P7D
3CRFSTUDYXQS23-P0001QSTESTCD3PT01029AQSSYMTRMSymptom TermHIVESCRFSTUDYXQS23-P0001QSTESTCDPT01030AQSSYMTRMSymptom TermHAND-FOOT SYNDROMEPT01020APT01-Cough SeverityPRO-CTCAE V1.0RESPIRATORYMild11

Y12015-05-15-P7D
4CRFSTUDYXQS23-P0001QSTESTCD4PT01031AQSSYMTRMSymptom TermNAIL LOSSCRFSTUDYXQS23-P0001QSTESTCDPT01032AQSSYMTRMSymptom TermNAIL RIDGINGPT01020BPT01-Cough InterferencePRO-CTCAE V1.0RESPIRATORYSomewhat22

Y12015-05-15-P7D
5CRFSTUDYXQS23-P0001QSTESTCD5PT01033AQSSYMTRMSymptom TermNAIL DISCOLORATIONCRFSTUDYXQS23-P0001QSTESTCDPT01034AQSSYMTRMSymptom TermSENSITIVITY TO SUNLIGHTPT01021APT01-Wheezing SeverityPRO-CTCAE V1.0RESPIRATORYMild11

Y12015-05-15-P7D
6CRFSTUDYXQS23-P0001QSTESTCD6PT01035AQSSYMTRMSymptom TermBED/PRESSURE SORESPT01022APT01-Swelling FrequencyPRO-CTCAE V1.0CARDIO/CIRCULATORYOccasionally22

Y12015-05-15-P7D
7CRFSTUDYXQS23-P0001QSTESTCD7PT01036AQSSYMTRMSymptom TermRADIATION SKIN REACTIONCRFSTUDYXQS23-P0001QSTESTCDPT01037AQSSYMTRMSymptom TermSKIN DARKENINGPT01022BPT01-Swelling SeverityPRO-CTCAE V1.0CARDIO/CIRCULATORYMild11

Y12015-05-15-P7D
8CRFSTUDYXQS23-P0001QSTESTCD8PT01038AQSSYMTRMSymptom TermSTRETCH MARKSCRFSTUDYXQS23-P0001QSTESTCDPT01039AQSSYMTRMSymptom TermNUMBNESS & TINGLINGCRFPT01022CPT01-Swelling InterferencePRO-CTCAE V1.0CARDIO/CIRCULATORYSomewhat22

Y12015-05-15-P7D
9STUDYXQS23-P0001QSTESTCD9PT01039BQSSYMTRMSymptom TermNUMBNESS & TINGLINGCRFSTUDYXQS23-P0001QSTESTCDPT01040AQSSYMTRMSymptom TermDIZZINESSPT01023APT01-Heart Palpitations FrequencyPRO-CTCAE V1.0CARDIO/CIRCULATORYOccasionally22

Y12015-05-15-P7D
10CRFSTUDYXQS23-P0001QSTESTCD10PT01040BQSSYMTRMSymptom TermDIZZINESSCRFSTUDYXQS23-P0001QSTESTCDPT01041AQSSYMTRMSymptom TermBLURRED VISIONPT01023BPT01-Heart Palpitations SeverityPRO-CTCAE V1.0CARDIO/CIRCULATORYMild11

Y12015-05-15-P7D
11CRFSTUDYXQS23-P0001QSTESTCD11PT01041BQSSYMTRMSymptom TermBLURRED VISIONCRFSTUDYXQS23-P0001QSTESTCDPT01042AQSSYMTRMSymptom TermFLASHING LIGHTSPT01039APT01-Numbness & Tingling SeverityPRO-CTCAE V1.0NEUROLOGICALMild11

Y12015-05-15-P7D
12CRFSTUDYXQS23-P0001QSTESTCD12PT01043AQSSYMTRMSymptom TermVISUAL FLOATERSCRFSTUDYXQS23-P0001QSTESTCDPT01044AQSSYMTRMSymptom TermWATERY EYESCRFPT01039BPT01-Numbness & Tingling InterferencePRO-CTCAE V1.0NEUROLOGICALSomewhat22

Y12015-05-15-P7D
13STUDYXQS23-P0001QSTESTCD13PT01044BQSSYMTRMSymptom TermWATERY EYESCRFSTUDYXQS23-P0001QSTESTCDPT01045AQSSYMTRMSymptom TermRINGING IN EARSPT01040APT01-Dizziness SeverityPRO-CTCAE V1.0NEUROLOGICALMild11

Y12015-05-15-P7D
14CRFSTUDYXQS23-P0001QSTESTCD14PT01046AQSSYMTRMSymptom TermCONCENTRATIONCRFSTUDYXQS23-P0001QSTESTCDPT01046BQSSYMTRMSymptom TermCONCENTRATIONPT01040BPT01-Dizziness InterferencePRO-CTCAE V1.0NEUROLOGICALSomewhat22

Y12015-05-15-P7D
15CRFSTUDYXQS23-P0001QSTESTCD15PT01047AQSSYMTRMSymptom TermMEMORYCRFSTUDYXQS23-P0001QSTESTCDPT01047BQSSYMTRMSymptom TermMEMORYCRFPT01046APT01-Concentration Problems SeverityPRO-CTCAE V1.0ATTENTION/MEMORYMild11

Y12015-05-15-P7D
16STUDYXQS23-P0001QSTESTCD16PT01048AQSSYMTRMSymptom TermGENERAL PAINCRFSTUDYXQS23-P0001QSTESTCDPT01048BQSSYMTRMSymptom TermGENERAL PAINPT01046BPT01-Concentration Problems InterferencePRO-CTCAE V1.0ATTENTION/MEMORYSomewhat22

Y12015-05-15-P7D
17CRFSTUDYXQS23-P0001QSTESTCD17PT01048CQSSYMTRMSymptom TermGENERAL PAINCRFSTUDYXQS23-P0001QSTESTCDPT01049AQSSYMTRMSymptom TermHEADACHECRFPT01047APT01-Memory Problems SeverityPRO-CTCAE V1.0ATTENTION/MEMORYMild11

Y12015-05-15-P7D
18STUDYXQS23-P0001QSTESTCD18PT01049BQSSYMTRMSymptom TermHEADACHECRFSTUDYXQS23-P0001QSTESTCDPT01049CQSSYMTRMSymptom TermHEADACHEPT01047BPT01-Memory Problems InterferencePRO-CTCAE V1.0ATTENTION/MEMORYSomewhat22

Y12015-05-15-P7D
19CRFSTUDYXQS23-P0001QSTESTCD19PT01050AQSSYMTRMSymptom TermMUSCLE PAINCRFSTUDYXQS23-P0001QSTESTCDPT01050BQSSYMTRMSymptom TermMUSCLE PAINCRFPT01081PT01-Any Other Symptoms ReportedPRO-CTCAE V1.0OTHER SYMPTOMSYes11

Y12015-05-15-P7D
20STUDYXQS23-P0001QSTESTCD20PT01050CQSSYMTRMSymptom TermMUSCLE PAINCRFSTUDYXQS23-P0001QSTESTCDPT01051AQSSYMTRMSymptom TermJOINT PAINPT01082APT01-Other Symptom 1PRO-CTCAE V1.0OTHER SYMPTOMSAnother symptom 1Another symptom 1


Y12015-05-15-P7D
21CRFSTUDYXQS23-P0001QSTESTCD21PT01051BQSSYMTRMSymptom TermJOINT PAINCRFSTUDYXQS23-P0001QSTESTCDPT01051CQSSYMTRMSymptom TermJOINT PAINPT01082BPT01-Other Symptom 1 SeverityPRO-CTCAE V1.0OTHER SYMPTOMSMild11

Y12015-05-15-P7D
22CRFSTUDYXQS23-P0001QSTESTCD22PT01052AQSSYMTRMSymptom TermINSOMNIACRFSTUDYXQS23-P0001QSTESTCDPT01052BQSSYMTRMSymptom TermINSOMNIAPT01083APT01-Other Symptom 2PRO-CTCAE V1.0OTHER SYMPTOMSAnother symptom 2Another symptom 2


Y12015-05-15-P7D
23CRFSTUDYXQS23-P0001QSTESTCD23PT01053AQSSYMTRMSymptom TermFATIGUECRFSTUDYXQS23-P0001QSTESTCDPT01053BQSSYMTRMSymptom TermFATIGUECRFPT01083BPT01-Other Symptom 2 SeverityPRO-CTCAE V1.0OTHER SYMPTOMSMild11

Y12015-05-15-P7D
24STUDYXQS23-P0001QSTESTCD24PT01054AQSSYMTRMSymptom TermANXIOUSCRFSTUDYXQS23-P0001QSTESTCDPT01054BQSSYMTRMSymptom TermANXIOUSCRFPT01084APT01-Other Symptom 3PRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE

12015-05-15-P7D
25STUDYXQS23-P0001QSTESTCD25PT01054CQSSYMTRMSymptom TermANXIOUSCRFSTUDYXQS23-P0001QSTESTCDPT01055AQSSYMTRMSymptom TermDISCOURAGEDPT01084BPT01-Other Symptom 3 SeverityPRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE

12015-05-15-P7D
26CRFSTUDYXQS23-P0001QSTESTCD26PT01055BQSSYMTRMSymptom TermDISCOURAGEDCRFSTUDYXQS23-P0001QSTESTCDPT01055CQSSYMTRMSymptom TermDISCOURAGEDCRFPT01085APT01-Other Symptom 4PRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE

12015-05-15-P7D
27STUDYXQS23-P0001QSTESTCD27PT01056AQSSYMTRMSymptom TermSADCRFSTUDYXQS23-P0001QSTESTCDPT01056BQSSYMTRMSymptom TermSADPT01085BPT01-Other Symptom 4 SeverityPRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE

12015-05-15-P7D
28CRFSTUDYXQS23-P0001QSTESTCDPT01056CQSSYMTRMSymptom TermSAD28PT01086APT01-Other Symptom 5PRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE

12015-05-15-P7D
29CRFSTUDYXQS23-P0001QSTESTCDPT01057AQSSYMTRMSymptom TermIRREGULAR PERIODS/VAGINAL BLEEDING29PT01086BPT01-Other Symptom 5 SeverityPRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE

12015-05-15-P7D
30CRFSTUDYXQS23-P0001QSTESTCD30PT01058AQSSYMTRMSymptom TermMISSED EXPECTED MENSTRUAL PERIODCRFSTUDYXQS23-P0001QSTESTCDPT01059AQSSYMTRMSymptom TermVAGINAL DISCHARGEPT01087APT01-Other Symptom 6PRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE

12015-05-15-P7D
31CRFSTUDYXQS23-P0001QSTESTCD31PT01060AQSSYMTRMSymptom TermVAGINAL DRYNESSCRFSTUDYXQS23-P0001QSTESTCDPT01061AQSSYMTRMSymptom TermPAINFUL URINATIONCRFPT01087BPT01-Other Symptom 6 SeverityPRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE

12015-05-15-P7D
32STUDYXQS23-P0001QSTESTCD32PT01062AQSSYMTRMSymptom TermURINARY URGENCYCRFSTUDYXQS23-P0001QSTESTCDPT01062BQSSYMTRMSymptom TermURINARY URGENCYPT01088APT01-Other Symptom 7PRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE

12015-05-15-P7D
33CRFSTUDYXQS23-P0001QSTESTCDPT01063AQSSYMTRMSymptom Term33PT01088BPT01-Other Symptom 7 SeverityPRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE

12015-05-15-P7D
34URINARY FREQUENCYCRFSTUDYXQS23-P0001QSTESTCDPT01063BQSSYMTRMSymptom TermURINARY FREQUENCY34PT01089APT01-Other Symptom 8PRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE

12015-05-15-P7D
35CRFSTUDYXQS23-P0001QSTESTCD35PT01064AQSSYMTRMSymptom TermCHANGE IN USUAL URINE COLORCRFSTUDYXQS23-P0001QSTESTCDPT01065AQSSYMTRMPT01089BPT01-Other Symptom 8 SeverityPRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE

12015-05-15-P7D
36Symptom TermURINARY INCONTINENCECRFSTUDYXQS23-P0001QSTESTCD36PT01065BQSSYMTRMSymptom TermURINARY INCONTINENCECRFSTUDYXQS23-P0001QSTESTCDPT01066AQSSYMTRMSymptom TermACHIEVE AND MAINTAIN ERECTIONCRFPT01090APT01-Other Symptom 9PRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE

12015-05-15-P7D
37STUDYXQS23-P0001QSTESTCD37PT01067AQSSYMTRMSymptom TermEJACULATIONCRFSTUDYXQS23-P0001QSTESTCDPT01068AQSSYMTRMSymptom TermDECREASED LIBIDOPT01090BPT01-Other Symptom 9 SeverityPRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE

12015-05-15-P7D
38CRFSTUDYXQS23-P0001QSTESTCDPT01069AQSSYMTRMSymptom TermDELAYED ORGASM38PT01091APT01-Other Symptom 10PRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE

12015-05-15-P7D
39CRFSTUDYXQS23-P0001QSTESTCD39PT01091BPT01-Other Symptom 10 SeverityPRO-CTCAE V1.0OTHER SYMPTOMS


NOT DONE

12015-05-15-P7D

The SUPPQS dataset relates the symptom terms from the annotated Item Library v1.0 form to each symptom item represented in the subset of symptoms in the QS dataset.

The evaluation interval text value for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.

Dataset wrap
Namesuppqsxx
Dataset2
tableidsuppqsxx
STUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGPT01070AQSSYMTRMSymptom TermUNABLE TO HAVE ORGASMCRFSTUDYXQS23-P0001QSTESTCDPT01071AQSSYMTRMSymptom TermPAIN W/SEXUAL INTERCOURSECRFSTUDYXQS23-P0001QSTESTCDPT01072AQSSYMTRMSymptom TermBREAST SWELLING AND TENDERNESSCRFSTUDYXQS23-P0001QSTESTCDPT01073AQSSYMTRMSymptom TermBRUISINGCRF
STUDYXQS23-P0001QSTESTCDPT01074APT01019AQSSYMTRMQSSYMPTMSymptom TermCHILLSSHORTNESS OF BREATHCRF
STUDYXQS23-P0001QSTESTCDPT01074BPT01019BQSSYMTRMQSSYMPTMSymptom TermCHILLSSHORTNESS OF BREATHCRF
STUDYXQS23-P0001QSTESTCDPT01075APT01020AQSSYMTRMQSSYMPTMSymptom TermINCREASED SWEATINGCOUGHCRF
STUDYXQS23-P0001QSTESTCDPT01075BPT01020BQSSYMTRMQSSYMPTMSymptom TermINCREASED SWEATINGCOUGHCRF
STUDYXQS23-P0001QSTESTCDPT01076APT01021AQSSYMTRMQSSYMPTMSymptom TermDECREASED SWEATINGWHEEZINGCRF
STUDYXQS23-P0001QSTESTCDPT01077APT01022AQSSYMTRMQSSYMPTMSymptom TermHOT FLASHESSWELLINGCRF
STUDYXQS23-P0001QSTESTCDPT01077BPT01022BQSSYMTRMQSSYMPTMSymptom TermHOT FLASHESSWELLINGCRF
STUDYXQS23-P0001QSTESTCDPT01078APT01022CQSSYMTRMQSSYMPTMSymptom TermNOSEBLEEDSWELLINGCRF
STUDYXQS23-P0001QSTESTCDPT01078BPT01023AQSSYMTRMQSSYMPTMSymptom TermNOSEBLEEDHEART PALPITATIONSCRF
STUDYXQS23-P0001QSTESTCDPT01079APT01023BQSSYMTRMQSSYMPTMSymptom TermPAIN AND SWELLING AT INJECTION SITEHEART PALPITATIONSCRF
STUDYXQS23-P0001QSTESTCDPT01080APT01039AQSSYMTRMQSSYMPTMSymptom TermBODY ODORNUMBNESS & TINGLINGCRF
STUDYXQS23-P0001QSTESTCDPT01081PT01039BQSSYMTRMQSSYMPTMSymptom TermANY OTHER SYMPTOMS REPORTEDNUMBNESS & TINGLINGCRF
STUDYXQS23-P0001QSTESTCDPT01082APT01040AQSSYMTRMQSSYMPTMSymptom TermOTHER SYMPTOM 1DIZZINESSCRF
STUDYXQS23-P0001QSTESTCDPT01082BPT01040BQSSYMTRMQSSYMPTMSymptom TermOTHER SYMPTOM 1DIZZINESSCRF
STUDYXQS23-P0001QSTESTCDPT01083APT01046AQSSYMTRMQSSYMPTMSymptom TermOTHER SYMPTOM 2CONCENTRATIONCRF
STUDYXQS23-P0001QSTESTCDPT01083BPT01046BQSSYMTRMQSSYMPTMSymptom TermOTHER SYMPTOM 2CONCENTRATIONCRF
STUDYXQS23-P0001QSTESTCDPT01084APT01047AQSSYMTRMQSSYMPTMSymptom TermOTHER SYMPTOM 3MEMORYCRF
STUDYXQS23-P0001QSTESTCDPT01084BPT01047BQSSYMTRMQSSYMPTMSymptom TermOTHER SYMPTOM 3MEMORYCRF
STUDYXQS23-P0001QSTESTCDPT01085APT01081QSSYMTRMQSSYMPTMSymptom TermANY OTHER SYMPTOM 4SYMPTOMS REPORTEDCRF
STUDYXQS23-P0001QSTESTCDPT01085BPT01082AQSSYMTRMQSSYMPTMSymptom TermOTHER SYMPTOM 41CRF
STUDYXQS23-P0001QSTESTCDPT01086APT01082BQSSYMTRMQSSYMPTMSymptom TermOTHER SYMPTOM 51CRF
STUDYXQS23-P0001QSTESTCDPT01086BPT01083AQSSYMTRMQSSYMPTMSymptom TermOTHER SYMPTOM 52CRF
STUDYXQS23-P0001QSTESTCDPT01087APT01083BQSSYMTRMQSSYMPTMSymptom TermOTHER SYMPTOM 62CRF
STUDYXQS23-P0001QSTESTCDPT01087BPT01084AQSSYMTRMQSSYMPTMSymptom TermOTHER SYMPTOM 63CRF
STUDYXQS23-P0001QSTESTCDPT01088APT01084BQSSYMTRMQSSYMPTMSymptom TermOTHER SYMPTOM 73CRF
STUDYXQS23-P0001QSTESTCDPT01088BPT01085AQSSYMTRMQSSYMPTMSymptom TermOTHER SYMPTOM 74CRF
STUDYXQS23-P0001QSTESTCDPT01089APT01085BQSSYMTRMQSSYMPTMSymptom TermOTHER SYMPTOM 84CRF
STUDYXQS23-P0001QSTESTCDPT01089BPT01086AQSSYMTRMQSSYMPTMSymptom TermOTHER SYMPTOM 85CRF
STUDYXQS23-P0001QSTESTCDPT01090APT01086BQSSYMTRMQSSYMPTMSymptom TermOTHER SYMPTOM 95CRF
STUDYXQS23-P0001QSTESTCDPT01090BPT01087AQSSYMTRMQSSYMPTMSymptom TermOTHER SYMPTOM 96CRF
STUDYXQS23-P0001QSTESTCDPT01091APT01087BQSSYMTRMQSSYMPTMSymptom TermOTHER SYMPTOM 106CRF
STUDYXQS23-P0001QSTESTCDPT01091BPT01088AQSSYMTRMQSSYMPTMSymptom TermOTHER SYMPTOM 107CRF
Info
Dataset wrap
Namesuppqs

4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

...

QSSCAT alignment with QSTESTCD

As stated in Section 3.1 assumptions, the PRO-CTCAE V1.0 is grouped into subcategories. The table below includes the subcategory names along with the applicable question numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.

STUDYXQS23-P0001QSTESTCDPT01088BQSSYMPTMSymptom TermOTHER SYMPTOM 7CRF
STUDYXQS23-P0001QSTESTCDPT01089AQSSYMPTMSymptom TermOTHER SYMPTOM 8CRF
STUDYXQS23-P0001QSTESTCDPT01089BQSSYMPTMSymptom TermOTHER SYMPTOM 8CRF
STUDYXQS23-P0001QSTESTCDPT01090AQSSYMPTMSymptom TermOTHER SYMPTOM 9CRF
STUDYXQS23-P0001QSTESTCDPT01090BQSSYMPTMSymptom TermOTHER SYMPTOM 9CRF
STUDYXQS23-P0001QSTESTCDPT01091AQSSYMPTMSymptom TermOTHER SYMPTOM 10CRF
STUDYXQS23-P0001QSTESTCDPT01091BQSSYMPTMSymptom TermOTHER SYMPTOM 10CRF


4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the measurement system to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

...

QSSCAT alignment with QSTESTCD

As stated in Section 3.1 assumptions, Assumptions, the PRO-CTCAE V1.0 symptom terms are grouped into subcategories as represented in the PRO-CTCAE ITEM LIBRARY (Version 1.0)Quick Guide to the Item Library. The table below includes the subcategory names along with the applicable question numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.

...

QSORRES

QSSTRESC

QSSTRESN

None00
Mild11
Moderate22
Severe33
Very severe44

All PRO-CTCAE V1.0 Interference Questions

QSORRES

QSSTRESC

QSSTRESN

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

All PRO-CTCAE V1.0 Frequency Questions

QSORRES

QSSTRESC

QSSTRESN

Never00
Rarely11
Occasionally22
Frequently33
Almost constantly44

All PRO-CTCAE V1.0 Presence/Absence Questions

QSORRES

QSSTRESC

QSSTRESN

YesYes11
NoNo00

All PRO-CTCAE V1.0 Amount Questions

QSORRES

QSSTRESC

QSSTRESN

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

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

--TESTCD QSTESTCD = "PT01068A" --TEST  QSTEST = "PT01-Decreased Libido Severity"

--TESTCD QSTESTCD = "PT01071A" --TEST  QSTEST = "PT01-Pain w/Sexual Intercourse Severity"

QSORRES

QSSTRESC

QSSTRESN

None00
Mild11
Moderate22
Severe33
Very severe44
Not sexually activeNot sexually active
Prefer not to answerPrefer not to answer

--TESTCD QSTESTCD = "PT01067A" --TEST  QSTEST = "PT01-Ejaculation Frequency"

QSORRES

QSSTRESC

QSSTRESN

Never00
Rarely11
Occasionally22
Frequently33
Almost constantly44
Not sexually activeNot sexually active
Prefer not to AnswerPrefer not to Answer

--TESTCD QSTESTCD = "PT01069A" --TEST  QSTEST = "PT01-Delayed Orgasm Presence"

--TESTCD QSTESTCD = "PT01070A" --TEST  QSTEST = "PT01-Unable to Have Orgasm Presence"

QSORRES

QSSTRESC

QSSTRESN

Yes11
No00
Not sexually activeNot sexually active
Prefer not to answerPrefer not to answer

--TESTCD QSTESTCD = "PT01036A" --TEST  QSTEST = "PT01-Radiation Skin Reaction Severity"

QSORRES

QSSTRESC

QSSTRESN

None00
Mild11
Moderate22
Severe33
Very severe44
Not applicableNot applicable

--TESTCD QSTESTCD = "PT01057A" --TEST  QSTEST = "PT01-Irregular Menstrual Period Presence"

--TESTCD QSTESTCD = "PT01058A"  --TEST QSTEST = "PT01-Missed Menstrual Period Presence"

--TESTCD QSTESTCD = "PT01079A"  --TEST QSTEST = "PT01-Pain&Swelling at Inj Site Presence"

QSORRES

QSSTRESC

QSSTRESN

Yes11
No00
Not ApplicableapplicableNot Applicable applicable

5 Supplemental Qualifier Name Codes

The following table contains additional standard name codes for use in the Supplement Qualifiers for Questionnaires (SUPPQS) special purpose dataset.purpose dataset.

PRO-CTCAE V1.0 conditional branching items

QNAMQLABELQVAL
QSCBRFLConditionally Branched Item Flag

Y

PRO-CTCAE V1.0 supported languages

QNAMQLABELQVAL
QSLANGQSLANGDCQuestionnaire Data Collection LanguageCHINESE


CZECH


DANISH


DUTCH


ENGLISH


FRENCH


GERMAN


GREEK


HUNGARIAN


ITALIAN


JAPANESE


KOREAN


POLISH


PORTUGUESE


RUSSIAN


SPANISH

PRO-CTCAE ITEM LIBRARY (Version 1V1.0 ) symptom terms

QNAMQLABELQVAL
QSSYMTRMQSSYMPTMSymptom TermABDOMINAL PAIN


ACHIEVE AND MAINTAIN ERECTION


ACNE


ANXIOUS


ANY OTHER SYMPTOMS REPORTED


BED/PRESSURE SORES


BLOATING


BLURRED VISION


BODY ODOR


BREAST SWELLING AND TENDERNESS


BRUISING


CHANGE IN USUAL URINE COLOR


CHILLS


CONCENTRATION


CONSTIPATION


COUGH


CRACKING AT THE CORNERS OF THE MOUTH (CHEILOSIS/CHEILITIS)


DECREASED APPETITE


DECREASED LIBIDO


DECREASED SWEATING


DELAYED ORGASM


DIARRHEA


DIFFICULTY SWALLOWING


DISCOURAGED


DIZZINESS


DRY MOUTH


EJACULATION


FATIGUE


FECAL INCONTINENCE


FLASHING LIGHTS


GAS


GENERAL PAIN


HAIR LOSS


HAND-FOOT SYNDROME


HEADACHE


HEARTBURN


HEART PALPITATIONS


HICCUPS


HIVES


HOARSENESS


HOT FLASHES/FLUSHES


INCREASED SWEATING


INSOMNIA


IRREGULAR PERIODS/VAGINAL BLEEDING


ITCHING


JOINT PAIN


MEMORY


MISSED EXPECTED MENSTRUAL PERIOD


MOUTH/THROAT SORES


MUSCLE PAIN


NAIL DISCOLORATION


NAIL LOSS


NAIL RIDGING


NAUSEA


NOSEBLEED


NUMBNESS & TINGLING


OTHER SYMPTOM


PAIN AND SWELLING AT INJECTION SITE


PAIN W/SEXUAL INTERCOURSE


PAINFUL URINATION


RADIATION SKIN REACTION


RASH


RINGING IN EARS


SAD


SENSITIVITY TO SUNLIGHT


SHORTNESS OF BREATH


SKIN DARKENING


SKIN DRYNESS


STRETCH MARKS


SWELLING


TASTE CHANGES


UNABLE TO HAVE ORGASM


URINARY FREQUENCY


URINARY INCONTINENCE


URINARY URGENCY


VAGINAL DISCHARGE


VAGINAL DRYNESS


VISUAL FLOATERS


VOICE QUALITY CHANGES


VOMITING


WATERY EYES


WHEEZING


OTHER SYMPTOM 1


OTHER SYMPTOM 2


OTHER SYMPTOM 3


OTHER SYMPTOM 4


OTHER SYMPTOM 5


OTHER SYMPTOM 6


OTHER SYMPTOM 7


OTHER SYMPTOM 8


OTHER SYMPTOM 9


OTHER SYMPTOM 10


End of Document