Revision History

...

Revision History

© 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

© 2021 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 Version Date 4/26/2020 (PRO-CTCAE V1.0 VERSION DATE 4/26/2020) instrument.

CDISC does not modify QRS instruments 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 web site at: https://www.cdisc.org/standards/aboutfoundational/bylawssdtmig.

...

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 nor or how to conduct clinical assessments or protocols. CDISC disclaims any liability for your use of this material.

Although FDA has 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 at the NATIONAL INSTITUTES OF HEALTH (NCI) owns the copyright for the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 instrument and has made the it exempt from copyright restrictions. Use of the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 is subject to NCI terms of use (See https://healthcaredelivery.cancer.gov/pro-ctcae/terms_of_use.html). 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 instrument measurement system. 

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 National Cancer Institute (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 the 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 VERSION DATE 4/26/2020 in the CDISC data standards.

Reference for the PRO-CTCAE V1.0 VERSION DATE 4/26/2020:

• These materials discuss and/or include the PRO-CTCAE® Item Library Version 1.0 (PRO-CTCAE V1.0). The PRO-CTCAE® Measurement System is owned exclusively by the National Cancer Institute. No part of 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, Bethesda, Maryland, USA. Use of the PRO-CTCAE is subject to NCI’s Terms of Use. PRO-CTCAE Measurement 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 Bethesda, Maryland, U.S.A. Use of the PRO-CTCAE is subject to 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/).

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, (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 Sep 29;106(9)).

3 The QS Domain Model

...

• 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 VERSION DATE 4/26/2020 are listed below.

The PRO-CTCAE V1.0 VERSION DATE 4/26/2020 a measurement system is a patient-reported outcome (PRO) instrument developed to capture symptomatic adverse events of patients in patients on cancer clinical trials. The PRO-CTCAE V1.0 VERSION DATE 4/26/2020 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 at: https://healthcaredelivery.cancer.gov/pro-ctcae/instrument.html and as described on the PRO-CTCAE website to build CRFs with instructions provided by NCI to select the items to implement it in your a clinical study. The PRO-CTCAE V1.0 VERSION DATE 4/26/2020 includes multiple choice questions includes multiple-choice questions on the frequency. , severity, interference, presence/absence, and amount of specific adverse events.The items are rated on a 5-point scale ("0-4"). Total scoring instructions have not yet been developed.

[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

...

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 VERSION DATE 4/26/2020 is an item library rather than a static/fixed instrument. You should use the form builder at: https://healthcaredelivery.cancer.gov/pro-ctcae/instrument.html and instructions provided by NCI to select the items to implement in your clinical study. As a CDISC QRS standard, the instrument supplement name is PRO-CTCAE V1.0 VERSION DATE 4/26/2020, 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 Controlled Terminology as appropriate for the condiction condition being studied. It is the users user's responsibility to identify the subset of items used from the ovearll overall PRO-CTCAE V1.0 Quick Guide to the Item Library (Version 1.0) for this use case. The subsetted PROsubsetted PRO-CTCAE V1.0 VERSION DATE 4/26/2020 user's instrument can be named measurement system should be titled "PRO-CTCAE sponsor-specified symptoms..." based on the usersponsor's descretion discretion when they identify the specifc specific items being used.
2. 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 = "QSSYMTRM". This will match the term identified in the PRO-CTCAE V1.0 Item Library (Version 1.0).
3. This will distinctly describe the subsetted 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. 
4. For the Administration of PRO-CTCAE V1.0 VERSION DATE 4/26/2020 may be conducted via different modes, including screen-based, interactive voice response, and paper, offers flexibility for patients and for study operations personnel.The language in which , QSORRES is represented with the text description; the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN. Please see the PRO-CTCAE website FAQs for more details on the numeric responses. The responses for the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 was administered (e.g., English, Spanish, Japanese) is collected with the Form Builder application and may be represented as a supplemental qualifier with QNAM = "QSLANG". Reference the PRO-CTCAE V1.0 website for a list of available translations at: https://healthcaredelivery.cancer.gov/pro-ctcae/.are as follows:
   1. Depending on the symptomatic adverse event (AE) being measured, items assessing symptom presence/absence are rated on a binary response scale (i.e., 0 = “No” and 1 = “Yes”)
   2. Items assessing symptom frequency are rated from 0-4 (i.e., 0 = “Never”, 1 = “Rarely”, 2 = “Occasionally”, 3 = “Frequently”, and 4 = “Almost constantly”).
   3. Items assessing symptom severity are rated on a 5-point scale rated from 0-4 (e.g., 0 = “None”, 1 = “Mild”, 2 = “Moderate”, 3 = “Severe”, and 4 = “Very severe”).
   4. Items assessing symptom interference are 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 amount are rated from 0-4 (e.g., 0 = “Not at all”, 1 = “A little bit”, 2 = “Somewhat”, 3 = “Quite a bit”, and 4 = “Very much”).
   6. QSTESTCD = "PT01066A " to "PT01071A" sexual symptoms have specific responses.

      The PRO-CTCAE V1.0 VERSION DATE 4/26/2020, QSORRES is populated with the text description and the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN. Please reference the PRO-CTCAE website for more details on the scoring criteria at: https://healthcaredelivery.cancer.gov/pro-ctcae/faqs.html. The responses for the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 are as follows:

      1. Depending on the symptomatic AE being measured, items assessing symptom presence/absence are rated as follows:
         1. Items rated on a binary response scale and scored from "0-1" (e.g., "0 = “No” and "1" = “Yes”);
         2. Items rated on a polytomous response scale and scored from "0-1" (e.g., "0" = “No”, "1 " =“Yes”, and “Not applicable”); or
         3. 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”
         4. Items rated on a polytomous response scale and scored from "0-1" (e.g., "0" = “No”, "1" = “Yes”, “Not sexually active”, and “Prefer not to answer”).
         Items assessing symptom amount

         1. QSTESTCD=PT01066A, PT01068A, and PT01071A assessing sexual symptom severity are rated on a 5-point

         Likert

         1. scale

         and scored

         1. rated from

         "

         1. 0-4

         "

         1. (e.g.,

          "

         1. 0

         "

         1. =

         “Not at all”

         1. “None”,

         "

         1. 1

         "

         1. =

         “A little bit”

         1. “Mild”,

         "

         1. 2

         "

         1. =

         “Somewhat”

         1. “Moderate”,

         "

         1. 3

         "

         1. =

         “Quite a bit”

         1. “Severe”, and

         '

         1. 4

         '

         1. = “Very

         much”

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

         Items assessing
         1. QSTESTCD = "PT01067A" assessing sexual symptom frequency
         are
         1. is rated on a 5-point
         Likert
         1. scale
         and are scored
         1. rated from
         "
         1. 0-4
         "
         1. (e.g.,
          "
         1. 0
         "
         1. = “Never”,
         "
         1. 1
         "
         1. = “Rarely”,
         "
         1. 2
         "
         1. = “Occasionally”,
         "
         1. 3
         "
         1. = “Frequently”,
         and "
         1. 4
         "
         1. = “Almost constantly”
         ).
      2. Items assessing symptom severity are rated on a 5-point Likert scale and are scored from "0-4" (e.g., "0" = “None”, "1" = “Mild”, "2" = “Moderate”, "3" = “Severe”, and "4" = “Very severe”).
      3. 1. , "Not sexually active", and “Prefer not to answer”).
      4. 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
         Items assessing symptom interference are rated on a 5-point Likert scale and are scored from "0-4"
         1. (e.g.,
          "
         1. 0
         "
         1. =
         “Not at all”
         1. “None”,
         "
         1. 1
         "
         1. =
         “A little bit”
         1. “Mild”,
         "
         1. 2
         "
         1. =
         “Somewhat”
         1. “Moderate”,
          "
         1. 3
         '
         1. =
         “Quite a bit”
         1. “Severe”, and
         "
         1. 4
         "
         1. = “Very
         much”). Item-level
         1. severe”. The response "Not applicable" is also given and could be provided a value of -99.)
   7. 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").
   8. PRO-CTCAE V1.0 total scoring instructions have not yet been developed. Item-level scores are not combined (i.e.g., no total score nor symptom-specific scores are calculated).Conditional branching is used in the conduct
   9. of The time period of evaluation for the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 for symptom terms that have two 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>none, you pose the interference question. Please reference 0 is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the PRO-CTCAE V1.0 is the past 7 days (QSEVLINT = "-P7D"). Please see the PRO-CTCAE website for more details on the conditional branching approach at: https://healthcaredelivery.cancer.gov/pro-ctcae/faqs.html.These branching items on the evaluation interval.
   10. Items are divided into 15 subcategories represented in the QSSCAT variable. These categorizations represent how the symptom terms are categorized in the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 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". 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. RSSTAT = "NOT DONE".

       2. RSREASND = "LOGICALLY SKIPPED ITEM".
          

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

       4. RSSTRESC and RSSTRESN 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.

   11. The time period of evaluation for the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 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 VERSION DATE 4/26/2020 is the past 7 days. Please reference the PRO-CTCAE website for more details on the evaluation interval at: https://healthcaredelivery.cancer.gov/pro-ctcae/faqs.html.

   12. 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 VERSION DATE 4/26/2020 QS Domain Model

   The PRO-CTCAE V1.0 VERSION DATE 4/26/2020 example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at the baseline visit for a PRO-CTCAE V1.0 VERSION DATE 4/26/2020 instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results are represented with preferred terminology in QSORRES. This result is then transformed into the standard numeric score in QSSTRESN and a character representation of the standard numeric score 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.

   ...

   1. 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 = "QSSYMPTM". This matches the symptom term identified in the PRO-CTCAE V1.0 Quick guide to the Item Library. The exception to this is the solicited verbatim symptom terms QSTESTCD = "PT01081 to PT01091B"with QNAM = "OTHER SYMPTOMS".
   2. Conditional branching is recommended by NCI/NIH in the conduct of the electronic version of the PRO-CTCAE V1.0 for symptom terms that have 2 or more items. The logic branches from frequency, then to severity, then to interference. For example, if frequency is > (greater than) never, next pose the severity question, and if severity > none, pose the interference question. Please see the PRO-CTCAE website for more details on the electronic conditional branching approach.
      1. When a paper version is administered, conditional branching does not apply.
   3. 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
   4. 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.
   5. 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 = "QSLANGDC". See the PRO-CTCAE V1.0 website for a list of available language translations.
   6. Terminology

      1. QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.

      2. A full list of value sets for the qualifier, 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 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. 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.

   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.

   1

   Dataset wrap
   Name qs
   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 Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSSTRESN QSSTAT QSREASND QSLOBXFL VISITNUM QSDTC QSEVLINT 1 STUDYX QS 23-P0001 1 PT01001A PT01-Dry Mouth Severity PRO-CTCAE V1.0 ORAL Mild 1 1 Y 1 2015-05-15 -P7D 2 STUDYX QS 23-P0001 2 PT01002A PT01-Difficulty Swallowing Severity PRO-CTCAE V1.0 ORAL Mild 1 1 Y 1 2015-05-15 -P7D 3 STUDYX QS 23-P0001 3 PT01003A PT01-Mouth/Throat Sores Severity PRO-CTCAE V1.0 ORAL Mild 1 1 Y 1 2015-05-15 -P7D 4 STUDYX QS 23-P0001 4 PT01003B PT01-Mouth/Throat Sores Interference PRO-CTCAE V1.0 ORAL A little bit 1 1 Y 1 2015-05-15 -P7D 5 STUDYX QS 23-P0001 5 PT01004A PT01-Cracking Corners of Mouth Severity PRO-CTCAE V1.0 ORAL Mild 1 1 Y 1 2015-05-15 -P7D 6 STUDYX QS 23-P0001 6 PT01005A PT01-Voice Quality Changes Presence PRO-CTCAE V1.0 ORAL No 0 0 Y 1 2015-05-15 -P7D 7 STUDYX QS 23-P0001 7 PT01006A PT01-Hoarseness Severity PRO-CTCAE V1.0 ORAL Mild 1 1 Y 1 2015-05-15 -P7D 8 STUDYX QS 23-P0001 8 PT01007A PT01-Taste Changes Severity PRO-CTCAE V1.0 GASTROINTESTINAL Mild 1 1 Y 1 2015-05-15 -P7D 9 STUDYX QS 23-P0001 9 PT01008A PT01-Decreased Appetite Severity PRO-CTCAE V1.0 GASTROINTESTINAL Mild 1 1 Y 1 2015-05-15 -P7D 10 STUDYX QS 23-P0001 10 PT01008B PT01-Decreased Appetite Interference PRO-CTCAE V1.0 GASTROINTESTINAL Somewhat 2 2 Y 1 2015-05-15 -P7D 11 STUDYX QS 23-P0001 11 PT01009A PT01-Nausea Frequency PRO-CTCAE V1.0 GASTROINTESTINAL Occasionally 2 2 Y 1 2015-05-15 -P7D 12 STUDYX QS 23-P0001 12 PT01009B PT01-Nausea Severity PRO-CTCAE V1.0 GASTROINTESTINAL Mild 1 1 Y 1 2015-05-15 -P7D 13 STUDYX QS 23-P0001 13 PT01010A PT01-Vomiting Frequency PRO-CTCAE V1.0 GASTROINTESTINAL Occasionally 2 2 Y 1 2015-05-15 -P7D 14 STUDYX QS 23-P0001 14 PT01010B PT01-Vomiting Severity PRO-CTCAE V1.0 GASTROINTESTINAL Mild 1 1 Y 1 2015-05-15 -P7D 15 STUDYX QS 23-P0001 15 PT01011A PT01-Heartburn Frequency PRO-CTCAE V1.0 GASTROINTESTINAL Occasionally 2 2 Y 1 2015-05-15 -P7D 16 STUDYX QS 23-P0001 16 PT01011B PT01-Heartburn Severity PRO-CTCAE V1.0 GASTROINTESTINAL Mild 1 1 Y 1 2015-05-15 -P7D 17 STUDYX QS 23-P0001 17 PT01012A PT01-Gas Presence PRO-CTCAE V1.0 GASTROINTESTINAL No 0 0 Y 1 2015-05-15 -P7D 18 STUDYX QS 23-P0001 18 PT01013A PT01-Bloating Frequency PRO-CTCAE V1.0 GASTROINTESTINAL Occasionally 2 2 Y 1 2015-05-15 -P7D 19 STUDYX QS 23-P0001 19 PT01013B PT01-Bloating Severity PRO-CTCAE V1.0 GASTROINTESTINAL Mild 1 1 Y 1 2015-05-15 -P7D 20 STUDYX QS 23-P0001 20 PT01014A PT01-Hiccups Frequency PRO-CTCAE V1.0 GASTROINTESTINAL Never 0 0 Y 1 2015-05-15 -P7D 21 STUDYX QS 23-P0001 21 PT01014B PT01-Hiccups Severity PRO-CTCAE V1.0 GASTROINTESTINAL None 0 0 Y 1 2015-05-15 -P7D 22 STUDYX QS 23-P0001 22 PT01015A PT01-Constipation Severity PRO-CTCAE V1.0 GASTROINTESTINAL Mild 1 1 Y 1 2015-05-15 -P7D 23 STUDYX QS 23-P0001 23 PT01016A PT01-Diarrhea Frequency PRO-CTCAE V1.0 GASTROINTESTINAL Rarely 1 1 Y 1 2015-05-15 -P7D 24 STUDYX QS 23-P0001 24 PT01017A PT01-Abdominal Pain Frequency PRO-CTCAE V1.0 GASTROINTESTINAL Never 0 0 Y 1 2015-05-15 -P7D 25 STUDYX QS 23-P0001 25 PT01017B PT01-Abdominal Pain Severity PRO-CTCAE V1.0 GASTROINTESTINAL None 0 0 Y 1 2015-05-15 -P7D 26 STUDYX QS 23-P0001 26 PT01017C PT01-Abdominal Pain Interference PRO-CTCAE V1.0 GASTROINTESTINAL Not at all 0 0 Y 1 2015-05-15 -P7D 27 STUDYX QS 23-P0001 27 PT01018A PT01-Fecal Incontinence Frequency PRO-CTCAE V1.0 GASTROINTESTINAL Occasionally 2 2 Y 1 2015-05-15 -P7D 28 STUDYX QS 23-P0001 28 PT01018B PT01-Fecal Incontinence Interference PRO-CTCAE V1.0 GASTROINTESTINAL Somewhat 2 2 Y 1 2015-05-15 -P7D 29 STUDYX QS 23-P0001 29 PT01019A PT01-Shortness of Breath Severity PRO-CTCAE V1.0 RESPIRATORY Mild 1 1 Y 1 2015-05-15 -P7D 30 STUDYX QS 23-P0001 30 PT01019B PT01-Shortness of Breath Interference PRO-CTCAE V1.0 RESPIRATORY Somewhat 2 2 Y 1 2015-05-15 -P7D 31 STUDYX QS 23-P0001 31 PT01020A PT01-Cough Severity PRO-CTCAE V1.0 RESPIRATORY Mild 1 1 Y 1 2015-05-15 -P7D 32 STUDYX QS 23-P0001 32 PT01020B PT01-Cough Interference PRO-CTCAE V1.0 RESPIRATORY Somewhat 2 2 Y 1 2015-05-15 -P7D 33 STUDYX QS 23-P0001 33 PT01021A PT01-Wheezing Severity PRO-CTCAE V1.0 RESPIRATORY Mild 1 1 Y 1 2015-05-15 -P7D 34 STUDYX QS 23-P0001 34 PT01022A PT01-Swelling Frequency PRO-CTCAE V1.0 CARDIO/CIRCULATORY Occasionally 2 2 Y 1 2015-05-15 -P7D 35 STUDYX QS 23-P0001 35 PT01022B PT01-Swelling Severity PRO-CTCAE V1.0 CARDIO/CIRCULATORY Mild 1 1 Y 1 2015-05-15 -P7D 36 STUDYX QS 23-P0001 36 PT01022C PT01-Swelling Interference PRO-CTCAE V1.0 CARDIO/CIRCULATORY Somewhat 2 2 Y 1 2015-05-15 -P7D 37 STUDYX QS 23-P0001 37 PT01023A PT01-Heart Palpitations Frequency PRO-CTCAE V1.0 CARDIO/CIRCULATORY Occasionally 2 2 Y 1 2015-05-15 -P7D 38 STUDYX QS 23-P0001 38 PT01023B PT01-Heart Palpitations Severity PRO-CTCAE V1.0 CARDIO/CIRCULATORY Mild 1 1 Y 1 2015-05-15 -P7D 39 STUDYX QS 23-P0001 39 PT01024A PT01-Rash Presence PRO-CTCAE V1.0 CUTANEOUS No 0 0 Y 1 2015-05-15 -P7D 40 STUDYX QS 23-P0001 40 PT01025A PT01-Skin Dryness Severity PRO-CTCAE V1.0 CUTANEOUS Mild 1 1 Y 1 2015-05-15 -P7D 41 STUDYX QS 23-P0001 41 PT01026A PT01-Acne Severity PRO-CTCAE V1.0 CUTANEOUS Mild 1 1 Y 1 2015-05-15 -P7D 42 STUDYX QS 23-P0001 42 PT01027A PT01-Hair Loss Amount PRO-CTCAE V1.0 CUTANEOUS Quite a bit 3 3 Y 1 2015-05-15 -P7D 43 STUDYX QS 23-P0001 43 PT01028A PT01-Itching Severity PRO-CTCAE V1.0 CUTANEOUS Mild 1 1 Y 1 2015-05-15 -P7D 44 STUDYX QS 23-P0001 44 PT01029A PT01-Hives Presence PRO-CTCAE V1.0 CUTANEOUS No 0 0 Y 1 2015-05-15 -P7D 45 STUDYX QS 23-P0001 45 PT01030A PT01-Hand-Foot Syndrome Severity PRO-CTCAE V1.0 CUTANEOUS Mild 1 1 Y 1 2015-05-15 -P7D 46 STUDYX QS 23-P0001 46 PT01031A PT01-Nail Loss Presence PRO-CTCAE V1.0 CUTANEOUS No 0 0 Y 1 2015-05-15 -P7D 47 STUDYX QS 23-P0001 47 PT01032A PT01-Nail Ridging Presence PRO-CTCAE V1.0 CUTANEOUS No 0 0 Y 1 2015-05-15 -P7D 48 STUDYX QS 23-P0001 48 PT01033A PT01-Nail Discoloration Presence PRO-CTCAE V1.0 CUTANEOUS No 0 0 Y 1 2015-05-15 -P7D 49 STUDYX QS 23-P0001 49 PT01034A PT01-Sensitivity to Sunlight Presence PRO-CTCAE V1.0 CUTANEOUS No 0 0 Y 1 2015-05-15 -P7D 50 STUDYX QS 23-P0001 50 PT01035A PT01-Bed/Pressure Sores Presence PRO-CTCAE V1.0 CUTANEOUS No 0 0 Y 1 2015-05-15 -P7D 51 STUDYX QS 23-P0001 51 PT01036A PT01-Radiation Skin Reaction Severity PRO-CTCAE V1.0 CUTANEOUS Mild 1 1 Y 1 2015-05-15 -P7D 52 STUDYX QS 23-P0001 52 PT01037A PT01-Skin Darkening Presence PRO-CTCAE V1.0 CUTANEOUS No 0 0 Y 1 2015-05-15 -P7D 53 STUDYX QS 23-P0001 53 PT01038A PT01-Stretch Marks Presence PRO-CTCAE V1.0 CUTANEOUS No 0 0 Y 1 2015-05-15 -P7D 54 STUDYX QS 23-P0001 54 PT01039A PT01-Numbness & Tingling Severity PRO-CTCAE V1.0 NEUROLOGICAL Mild 1 1 Y 1 2015-05-15 -P7D 55 STUDYX QS 23-P0001 55 PT01039B PT01-Numbness & Tingling Interference PRO-CTCAE V1.0 NEUROLOGICAL Somewhat 2 2 Y 1 2015-05-15 -P7D 56 STUDYX QS 23-P0001 56 PT01040A PT01-Dizziness Severity PRO-CTCAE V1.0 NEUROLOGICAL Mild 1 1 Y 1 2015-05-15 -P7D 57 STUDYX QS 23-P0001 57 PT01040B PT01-Dizziness Interference PRO-CTCAE V1.0 NEUROLOGICAL Somewhat 2 2 Y 1 2015-05-15 -P7D 58 STUDYX QS 23-P0001 58 PT01041A PT01-Blurred Vision Severity PRO-CTCAE V1.0 VISUAL/PERCEPTUAL Mild 1 1 Y 1 2015-05-15 -P7D 59 STUDYX QS 23-P0001 59 PT01041B PT01-Blurred Vision Interference PRO-CTCAE V1.0 VISUAL/PERCEPTUAL Somewhat 2 2 Y 1 2015-05-15 -P7D 60 STUDYX QS 23-P0001 60 PT01042A PT01-Flashing Lights in Eyes Presence PRO-CTCAE V1.0 VISUAL/PERCEPTUAL No 0 0 Y 1 2015-05-15 -P7D 61 STUDYX QS 23-P0001 61 PT01043A PT01-Visual Floaters Presence PRO-CTCAE V1.0 VISUAL/PERCEPTUAL No 0 0 Y 1 2015-05-15 -P7D 62 STUDYX QS 23-P0001 62 PT01044A PT01-Watery Eyes Severity PRO-CTCAE V1.0 VISUAL/PERCEPTUAL
   Dataset wrap
   Name qs
   ORAL Rowcaps Rows 20-21 Represent the symptom hiccups did not occur and then the symptom  hiccups severity was logically skipped. Rows 24-26 Represent the symptom abdominal pain frequency did not occur and then the symptoms abdominal pain severity and abdominal pain interference were logically skipped. Rows 126-129 Represent two additonal symptoms that existed for the subject. Rows 130-145 Represent the symptoms "Other Sympton 3 and Other Symptom 3 Severity" through "Other Sympton 10 and Other Symptom 10 Severity" did not exist for the subject. Dataset2 Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSSTRESN QSSTAT QSREASND QSLOBXFL VISITNUM QSDTC QSEVLINT 1 STUDYX QS 23-P0001 1 PT01001A PT01-Dry Mouth Severity PRO-CTCAE V1.0 VERSION DATE 4/26/2020 Mild 1 1 Y 1 2015-05-15 -P7D 2 63 STUDYX QS 23-P0001 2 63 PT01002A PT01044B PT01- Difficulty Swallowing Severity Watery Eyes Interference PRO-CTCAE V1.0 VERSION DATE 4/26/2020 VISUAL/PERCEPTUAL Somewhat 2 2	ORAL	Mild	1

   Y

   1

   2015-05-15

   -P7D

   3

   64

   STUDYX

   QS

   23-P0001

   3

   64

   PT01003A

   PT01045A

   PT01-

   Mouth/Throat Sores

   Ringing in Ears Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   VISUAL/PERCEPTUAL

   ORAL

   Mild

   1

   1

   Y

   1

   2015-05-15

   -P7D

   4

   65

   STUDYX

   QS

   23-P0001

   4

   65

   PT01003B

   PT01046A

   PT01-

   Mouth/Throat Sores Interference

   Concentration Problems Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020ORALA little bit

   ATTENTION/MEMORY

   Mild

   1

   1

   Y

   1

   2015-05-15

   -P7D

   5

   66

   STUDYX

   QS

   23-P0001

   5

   66

   PT01004A

   PT01046B

   PT01-

   Cracking Corners of Mouth Severity

   Concentration Problems Interference

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   ATTENTION/MEMORY

   Somewhat

   2

   2

   ORALMild11

   Y

   1

   2015-05-15

   -P7D

   6

   67

   STUDYX

   QS

   23-P0001

   6

   67

   PT01005A

   PT01047A

   PT01-

   Voice Quality Changes Presence

   Memory Problems Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   ATTENTION/MEMORY

   Mild

   1

   1

   ORALNo0

   Y

   1

   2015-05-15

   -P7D

   7

   68

   STUDYX

   QS

   23-P0001

   7

   68

   PT01006A

   PT01047B

   PT01-

   Hoarseness SeverityORALMild11

   Memory Problems Interference

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   ATTENTION/MEMORY

   Somewhat

   2

   2

   Y

   1

   2015-05-15

   -P7D

   8

   69

   STUDYX

   QS

   23-P0001

   8

   69

   PT01007A

   PT01048A

   PT01-

   Taste Changes Severity

   General Pain Frequency

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   PAIN

   Occasionally

   2

   2

   GASTROINTESTINALMild11

   Y

   1

   2015-05-15

   -P7D

   9

   70

   STUDYX

   QS

   23-P0001

   9

   70

   PT01008A

   PT01048B

   PT01-

   Decreased Appetite

   General Pain Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   PAIN

   GASTROINTESTINAL

   Mild

   1

   1

   Y

   1

   2015-05-15

   -P7D

   10

   71

   STUDYX

   QS

   23-P0001

   10

   71

   PT01008B

   PT01048C

   PT01-

   Decreased Appetite

   General Pain Interference

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   PAIN

   GASTROINTESTINAL

   Somewhat

   2

   2

   Y

   1

   2015-05-15

   -P7D

   11

   72

   STUDYX

   QS

   23-P0001

   11

   72

   PT01009A

   PT01049A

   PT01-

   Nausea

   Headache Frequency

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   PAIN

   GASTROINTESTINAL

   Occasionally

   2

   2

   Y

   1

   2015-05-15

   -P7D

   12

   73

   STUDYX

   QS

   23-P0001

   12

   73

   PT01009B

   PT01049B

   PT01-

   Nausea

   Headache Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   PAIN

   GASTROINTESTINAL

   Mild

   1

   1

   Y

   1

   2015-05-15

   -P7D

   13

   74

   STUDYX

   QS

   23-P0001

   13

   74

   PT01010A

   PT01049C

   PT01-

   Vomiting Frequency

   Headache Interference

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   PAIN

   Somewhat

   GASTROINTESTINALOccasionally

   2

   2

   Y

   1

   2015-05-15

   -P7D

   14

   75

   STUDYX

   QS

   23-P0001

   14

   75

   PT01010B

   PT01050A

   PT01-

   Vomiting Severity

   Muscle Pain Frequency

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   PAIN

   Occasionally

   2

   2

   GASTROINTESTINALMild11

   Y

   1

   2015-05-15

   -P7D

   15

   76

   STUDYX

   QS

   23-P0001

   15

   76

   PT01011A

   PT01050B

   PT01-

   Heartburn Frequency

   Muscle Pain Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   PAIN

   Mild

   1

   1

   GASTROINTESTINALOccasionally22

   Y

   1

   2015-05-15

   -P7D

   16

   77

   STUDYX

   QS

   23-P0001

   16

   77

   PT01011B

   PT01050C

   PT01-

   Heartburn Severity

   Muscle Pain Interference

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   PAIN

   Somewhat

   2

   2

   GASTROINTESTINALMild11

   Y

   1

   2015-05-15

   -P7D

   17

   78

   STUDYX

   QS

   23-P0001

   17

   78

   PT01012A

   PT01051A

   PT01-

   Gas Presence

   Joint Pain Frequency

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   PAIN

   Occasionally

   2

   2

   GASTROINTESTINALNo00

   Y

   1

   2015-05-15

   -P7D

   18

   79

   STUDYX

   QS

   23-P0001

   18

   79

   PT01013A

   PT01051B

   PT01-

   Bloating Frequency

   Joint Pain Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   PAIN

   Mild

   1

   1

   GASTROINTESTINALOccasionally22

   Y

   1

   2015-05-15

   -P7D

   19

   80

   STUDYX

   QS

   23-P0001

   19

   80

   PT01013B

   PT01051C

   PT01-

   Bloating Severity

   Joint Pain Interference

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   PAIN

   Somewhat

   2

   2

   GASTROINTESTINALMild11

   Y

   1

   2015-05-15

   -P7D

   20

   81

   STUDYX

   QS

   23-P0001

   20

   81

   PT01014A

   PT01052A

   PT01-

   Hiccups Frequency

   Insomnia Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   SLEEP/WAKE

   Mild

   1

   1

   GASTROINTESTINALNever00

   Y

   1

   2015-05-15

   -P7D

   21

   82

   STUDYX

   QS

   23-P0001

   21

   82

   PT01014B

   PT01052B

   PT01-

   Hiccups Severity

   Insomnia Interference

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020GASTROINTESTINAL00NOT DONELOGICALLY SKIPPED ITEM

   SLEEP/WAKE

   Somewhat

   2

   2

   Y

   1

   2015-05-15

   -P7D

   22

   83

   STUDYX

   QS

   23-P0001

   22

   83

   PT01015A

   PT01053A

   PT01-

   Constipation

   Fatigue Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   SLEEP/WAKE

   GASTROINTESTINAL

   Mild

   1

   1

   Y

   1

   2015-05-15

   -P7D

   23

   84

   STUDYX

   QS

   23-P0001

   23

   84

   PT01016A

   PT01053B

   PT01-

   Diarrhea Frequency

   Fatigue Interference

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   SLEEP/WAKE

   Somewhat

   2

   2

   GASTROINTESTINALRarely11

   Y

   1

   2015-05-15

   -P7D

   24

   85

   STUDYX

   QS

   23-P0001

   24

   85

   PT01017A

   PT01054A

   PT01-

   Abdominal Pain

   Anxious Frequency

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   MOOD

   Occasionally

   2

   2

   GASTROINTESTINALNever00

   Y

   1

   2015-05-15

   -P7D

   25

   86

   STUDYX

   QS

   23-P0001

   25

   86

   PT01017B

   PT01054B

   PT01-

   Abdominal Pain

   Anxious Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   MOOD

   Mild

   1

   1

   GASTROINTESTINAL00NOT DONELOGICALLY SKIPPED ITEM

   Y

   1

   2015-05-15

   -P7D

   26

   87

   STUDYX

   QS

   23-P0001

   26

   87

   PT01017C

   PT01054C

   PT01-

   Abdominal Pain

   Anxious Interference

   PRO-CTCAE V1.

   0 VERSION DATE 4/26/2020

   0

   MOOD

   Somewhat

   2

   2

   GASTROINTESTINAL00NOT DONELOGICALLY SKIPPED ITEM

   Y

   1

   2015-05-15

   -P7D

   27

   88

   STUDYX

   QS

   23-P0001

   27

   88

   PT01018A

   PT01055A

   PT01-

   Fecal Incontinence

   Discouraged Frequency

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   MOOD

   GASTROINTESTINAL

   Occasionally

   2

   2

   Y

   1

   2015-05-15

   -P7D

   28

   89

   STUDYX

   QS

   23-P0001

   28

   89

   PT01018B

   PT01055B

   PT01-

   Fecal Incontinence Interference

   Discouraged Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   MOOD

   Mild

   1

   1

   GASTROINTESTINALSomewhat22

   Y

   1

   2015-05-15

   -P7D

   29

   90

   STUDYX

   QS

   23-P0001

   29

   90

   PT01019A

   PT01055C

   PT01-

   Shortness of Breath Severity

   Discouraged Interference

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   MOOD

   Somewhat

   2

   2

   RESPIRATORYMild11

   Y

   1

   2015-05-15

   -P7D

   30

   91

   STUDYX

   QS

   23-P0001

   30

   91

   PT01019B

   PT01056A

   PT01-

   Shortness of Breath Interference

   Sad Frequency

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   MOOD

   Occasionally

   RESPIRATORYSomewhat

   2

   2

   Y

   1

   2015-05-15

   -P7D

   31

   92

   STUDYX

   QS

   23-P0001

   31

   92

   PT01020A

   PT01056B

   PT01-

   Cough

   Sad Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   MOOD

   RESPIRATORY

   Mild

   1

   1

   Y

   1

   2015-05-15

   -P7D

   32

   93

   STUDYX

   QS

   23-P0001

   32

   93

   PT01020B

   PT01056C

   PT01-

   Cough

   Sad Interference

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   MOOD

   RESPIRATORY

   Somewhat

   2

   2

   Y

   1

   2015-05-15

   -P7D

   33

   94

   STUDYX

   QS

   23-P0001

   33

   94

   PT01021A

   PT01057A

   PT01-

   Wheezing Severity

   Irregular Menstrual Period Presence

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   GYNECOLOGIC/URINARY

   No

   0

   0

   RESPIRATORYMild11

   Y

   1

   2015-05-15

   -P7D

   34

   95

   STUDYX

   QS

   23-P0001

   34

   95

   PT01022A

   PT01058A

   PT01-

   Swelling Frequency

   Missed Menstrual Period Presence

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   GYNECOLOGIC/URINARY

   No

   0

   0

   CARDIO/CIRCULATORYOccasionally22

   Y

   1

   2015-05-15

   -P7D

   35

   96

   STUDYX

   QS

   23-P0001

   35

   96

   PT01022B

   PT01059A

   PT01-

   Swelling Severity

   Vaginal Discharge Amount

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   GYNECOLOGIC/URINARY

   Somewhat

   2

   2

   CARDIO/CIRCULATORYMild11

   Y

   1

   2015-05-15

   -P7D

   36

   97

   STUDYX

   QS

   23-P0001

   36

   97

   PT01022C

   PT01060A

   PT01-

   Swelling Interference

   Vaginal Dryness Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   GYNECOLOGIC/URINARY

   Mild

   1

   1

   CARDIO/CIRCULATORYSomewhat22

   Y

   1

   2015-05-15

   -P7D

   37

   98

   STUDYX

   QS

   23-P0001

   37

   98

   PT01023A

   PT01061A

   PT01-

   Heart Palpitations Frequency

   Painful Urination Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   GYNECOLOGIC/URINARY

   Mild

   1

   1

   CARDIO/CIRCULATORYOccasionally22

   Y

   1

   2015-05-15

   -P7D

   38

   99

   STUDYX

   QS

   23-P0001

   38

   99

   PT01023B

   PT01062A

   PT01-

   Heart Palpitations Severity

   Urinary Urgency Frequency

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   GYNECOLOGIC/URINARY

   Occasionally

   2

   2

   CARDIO/CIRCULATORYMild11

   Y

   1

   2015-05-15

   -P7D

   39

   100

   STUDYX

   QS

   23-P0001

   39

   100

   PT01024A

   PT01062B

   PT01-

   Rash Presence

   Urinary Urgency Interference

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   GYNECOLOGIC/URINARY

   Somewhat

   2

   2

   CUTANEOUSNo00

   Y

   1

   2015-05-15

   -P7D

   40

   191

   STUDYX

   QS

   23-P0001

   40

   191

   PT01025A

   PT01063A

   PT01-

   Skin Dryness Severity

   Urinary Frequency Frequency

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   GYNECOLOGIC/URINARY

   Occasionally

   2

   2

   CUTANEOUSMild11

   Y

   1

   2015-05-15

   -P7D

   41

   102

   STUDYX

   QS

   23-P0001

   41

   102

   PT01026A

   PT01063B

   PT01-

   Acne Severity

   Urinary Frequency Interference

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   GYNECOLOGIC/URINARY

   Somewhat

   2

   2

   CUTANEOUSMild11

   Y

   1

   2015-05-15

   -P7D

   42

   103

   STUDYX

   QS

   23-P0001

   42

   103

   PT01027A

   PT01064A

   PT01-

   Hair Loss Amount

   Urine Color Change Presence

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   GYNECOLOGIC/URINARY

   No

   0

   0

   CUTANEOUSQuite a bit33

   Y

   1

   2015-05-15

   -P7D

   43

   104

   STUDYX

   QS

   23-P0001

   43

   104

   PT01028A

   PT01065A

   PT01-

   Itching SeverityCUTANEOUSMild11

   Urinary Incontinence Frequency

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   GYNECOLOGIC/URINARY

   Occasionally

   2

   2

   Y

   1

   2015-05-15

   -P7D

   44

   105

   STUDYX

   QS

   23-P0001

   44

   105

   PT01029A

   PT01065B

   PT01-

   Hives Presence

   Urinary Incontinence Interference

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   GYNECOLOGIC/URINARY

   Somewhat

   2

   2

   CUTANEOUSNo00

   Y

   1

   2015-05-15

   -P7D

   45

   106

   STUDYX

   QS

   23-P0001

   45

   106

   PT01030A

   PT01066A

   PT01-

   Hand-Foot Syndrome

   Achieve&Maintain Erection Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   SEXUAL

   CUTANEOUS

   Mild

   1

   1

   Y

   1

   2015-05-15

   -P7D

   46

   107

   STUDYX

   QS

   23-P0001

   46

   107

   PT01031A

   PT01067A

   PT01-

   Nail Loss Presence

   Ejaculation Frequency

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   SEXUAL

   Occasionally

   2

   2

   CUTANEOUSNo00

   Y

   1

   2015-05-15

   -P7D

   47

   108

   STUDYX

   QS

   23-P0001

   47

   108

   PT01032A

   PT01068A

   PT01-

   Nail Ridging Presence

   Decreased Libido Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   SEXUAL

   Mild

   1

   1

   CUTANEOUSNo00

   Y

   1

   2015-05-15

   -P7D

   48

   109

   STUDYX

   QS

   23-P0001

   48

   109

   PT01033A

   PT01069A

   PT01-

   Nail Discoloration

   Delayed Orgasm Presence

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   SEXUAL

   CUTANEOUS

   No

   0

   0

   Y

   1

   2015-05-15

   -P7D

   49

   110

   STUDYX

   QS

   23-P0001

   49

   110

   PT01034A

   PT01070A

   PT01-

   Sensitivity

   Unable to

   Sunlight

   Have Orgasm Presence

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   SEXUAL

   CUTANEOUS

   No

   0

   0

   Y

   1

   2015-05-15

   -P7D

   50

   111

   STUDYX

   QS

   23-P0001

   50

   111

   PT01035A

   PT01071A

   PT01-

   Bed/Pressure Sores Presence

   Pain w/Sexual Intercourse Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   SEXUAL

   Mild

   1

   1

   CUTANEOUSNo00

   Y

   1

   2015-05-15

   -P7D

   51

   112

   STUDYX

   QS

   23-P0001

   51

   112

   PT01036A

   PT01072A

   PT01-

   Radiation Skin Reaction

   Breast Swelling&Tenderness Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   MISCELLANEOUS

   CUTANEOUS

   Mild

   1

   1

   Y

   1

   2015-05-15

   -P7D

   52

   113

   STUDYX

   QS

   23-P0001

   52

   113

   PT01037A

   PT01073A

   PT01-

   Skin Darkening

   Bruising Presence

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   MISCELLANEOUS

   CUTANEOUS

   No

   0

   0

   Y

   1

   2015-05-15

   -P7D

   53

   114

   STUDYX

   QS

   23-P0001

   53

   114

   PT01038A

   PT01074A

   PT01-

   Stretch Marks Presence

   Chills Frequency

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   MISCELLANEOUS

   Occasionally

   2

   2

   CUTANEOUSNo00

   Y

   1

   2015-05-15

   -P7D

   54

   115

   STUDYX

   QS

   23-P0001

   54

   115

   PT01039A

   PT01074B

   PT01-

   Numbness & Tingling

   Chills Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020NEUROLOGICAL

   MISCELLANEOUS

   Mild

   1

   1

   Y

   1

   2015-05-15

   -P7D

   55

   116

   STUDYX

   QS

   23-P0001

   55

   116

   PT01039B

   PT01075A

   PT01-

   Numbness & Tingling Interference

   Increased Sweating Frequency

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   MISCELLANEOUS

   Occasionally

   NEUROLOGICALSomewhat

   2

   2

   Y

   1

   2015-05-15

   -P7D

   56

   117

   STUDYX

   QS

   23-P0001

   56

   117

   PT01040A

   PT01075B

   PT01-

   Dizziness

   Increased Sweating Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   MISCELLANEOUS

   NEUROLOGICAL

   Mild

   1

   1

   Y

   1

   2015-05-15

   -P7D

   57

   118

   STUDYX

   QS

   23-P0001

   57

   118

   PT01040B

   PT01076A

   PT01-

   Dizziness Interference

   Decreased Sweating Presence

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   MISCELLANEOUS

   No

   0

   0

   NEUROLOGICALSomewhat22

   Y

   1

   2015-05-15

   -P7D

   58

   118

   STUDYX

   QS

   23-P0001

   58

   118

   PT01041A

   PT01077A

   PT01-

   Blurred Vision Severity

   Hot Flashes Frequency

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   MISCELLANEOUS

   Occasionally

   2

   2

   VISUAL/PERCEPTUALMild11

   Y

   1

   2015-05-15

   -P7D

   59

   120

   STUDYX

   QS

   23-P0001

   59

   120

   PT01041B

   PT01077B

   PT01-

   Blurred Vision Interference

   Hot Flashes Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   MISCELLANEOUS

   Mild

   1

   1

   VISUAL/PERCEPTUALSomewhat22

   Y

   1

   2015-05-15

   -P7D

   60

   121

   STUDYX

   QS

   23-P0001

   60

   121

   PT01042A

   PT01078A

   PT01-

   Flashing Lights in Eyes Presence

   Nosebleed Frequency

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   MISCELLANEOUS

   Occasionally

   2

   2

   VISUAL/PERCEPTUALNo00

   Y

   1

   2015-05-15

   -P7D

   61

   122

   STUDYX

   QS

   23-P0001

   61

   122

   PT01043A

   PT01078B

   PT01-

   Visual Floaters Presence

   Nosebleed Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   MISCELLANEOUS

   Mild

   1

   1

   VISUAL/PERCEPTUALNo00

   Y

   1

   2015-05-15

   -P7D

   62

   123

   STUDYX

   QS

   23-P0001

   62

   123

   PT01044A

   PT01079A

   PT01-

   Watery Eyes Severity

   Pain&Swelling at Inj Site Presence

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   MISCELLANEOUS

   No

   0

   0

   VISUAL/PERCEPTUALMild11

   Y

   1

   2015-05-15

   -P7D

   63

   124

   STUDYX

   QS

   23-P0001

   63

   124

   PT01044B

   PT01080A

   PT01-

   Watery Eyes Interference

   Body Odor Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   MISCELLANEOUS

   Mild

   1

   1

   VISUAL/PERCEPTUALSomewhat22

   Y

   1

   2015-05-15

   -P7D

   64

   125

   STUDYX

   QS

   23-P0001

   64

   125

   PT01045A

   PT01081

   PT01-

   Ringing in Ears Severity

   Any Other Symptoms Reported

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   OTHER SYMPTOMS

   Yes

   VISUAL/PERCEPTUALMild

   1

   1

   Y

   1

   2015-05-15

   -P7D

   65

   126

   STUDYX

   QS

   23-P0001

   65

   126

   PT01046A

   PT01082A

   PT01-

   Concentration Problems Severity

   Other Symptom 1

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   OTHER SYMPTOMS

   Another symptom 1

   Another symptom

   ATTENTION/MEMORYMild1

   1

   Y

   1

   2015-05-15

   -P7D

   66

   127

   STUDYX

   QS

   23-P0001

   66

   127

   PT01046B

   PT01082B

   PT01-

   Concentration Problems Interference

   Other Symptom 1 Severity

   PRO-CTCAE V1

   .0 VERSION DATE 4/26/2020

   .0

   OTHER SYMPTOMS

   Mild

   1

   1

   ATTENTION/MEMORYSomewhat22

   Y

   1

   2015-05-15

   -P7D

   67

   128

   STUDYX

   QS

   23-P0001

   67

   128

   PT01047A

   PT01083A

   PT01-

   Memory Problems Severity

   Other Symptom 2

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   OTHER SYMPTOMS

   Another symptom 2

   Another symptom 2

   ATTENTION/MEMORYMild11

   Y

   1

   2015-05-15

   -P7D

   68

   129

   STUDYX

   QS

   23-P0001

   68

   129

   PT01047B

   PT01083B

   PT01-

   Memory Problems Interference

   Other Symptom 2 Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   OTHER SYMPTOMS

   Mild

   1

   1

   ATTENTION/MEMORYSomewhat22

   Y

   1

   2015-05-15

   -P7D

   69

   130

   STUDYX

   QS

   23-P0001

   69

   130

   PT01048A

   PT01084A

   PT01-

   General Pain Frequency

   Other Symptom 3

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   OTHER SYMPTOMS

   NOT DONE

   PAINOccasionally22

   Y

   1

   2015-05-15

   -P7D

   70

   131

   STUDYX

   QS

   23-P0001

   70

   131

   PT01048B

   PT01084B

   PT01-

   General Pain

   Other Symptom 3 Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   OTHER SYMPTOMS

   NOT DONE

   PAINMild11

   Y

   1

   2015-05-15

   -P7D

   71

   132

   STUDYX

   QS

   23-P0001

   71

   132

   PT01048C

   PT01085A

   PT01-

   General Pain InterferencePAINSomewhat22

   Other Symptom 4

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   OTHER SYMPTOMS

   NOT DONE

   Y

   1

   2015-05-15

   -P7D

   72

   133

   STUDYX

   QS

   23-P0001

   72

   133

   PT01049A

   PT01085B

   PT01-

   Headache Frequency

   Other Symptom 4 Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   OTHER SYMPTOMS

   NOT DONE

   PAINOccasionally22

   Y

   1

   2015-05-15

   -P7D

   73

   134

   STUDYX

   QS

   23-P0001

   73

   134

   PT01049B

   PT01086A

   PT01-

   Headache Severity

   Other Symptom 5

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   OTHER SYMPTOMS

   NOT DONE

   PAINMild11

   Y

   1

   2015-05-15

   -P7D

   74

   135

   STUDYX

   QS

   23-P0001

   74

   135

   PT01049C

   PT01086B

   PT01-

   Headache Interference

   Other Symptom 5 Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   OTHER SYMPTOMS

   NOT DONE

   PAINSomewhat22

   Y

   1

   2015-05-15

   -P7D

   75

   136

   STUDYX

   QS

   23-P0001

   75

   136

   PT01050A

   PT01087A

   PT01-

   Muscle Pain FrequencyPAINOccasionally22

   Other Symptom 6

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   OTHER SYMPTOMS

   NOT DONE

   Y

   1

   2015-05-15

   -P7D

   76

   137

   STUDYX

   QS

   23-P0001

   76

   137

   PT01050B

   PT01087B

   PT01-

   Muscle Pain

   Other Symptom 6 Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   OTHER SYMPTOMS

   NOT DONE

   PAINMild11

   Y

   1

   2015-05-15

   -P7D

   77

   138

   STUDYX

   QS

   23-P0001

   77

   138

   PT01050C

   PT01088A

   PT01-

   Muscle Pain InterferencePAINSomewhat22

   Other Symptom 7

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   OTHER SYMPTOMS

   NOT DONE

   Y

   1

   2015-05-15

   -P7D

   78

   139

   STUDYX

   QS

   23-P0001

   78

   139

   PT01051A

   PT01088B

   PT01-

   Joint Pain Frequency

   Other Symptom 7 Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   OTHER SYMPTOMS

   NOT DONE

   PAINOccasionally22

   Y

   1

   2015-05-15

   -P7D

   79

   140

   STUDYX

   QS

   23-P0001

   79

   140

   PT01051B

   PT01089A

   PT01-

   Joint Pain Severity

   Other Symptom 8

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   OTHER SYMPTOMS

   NOT DONE

   PAINMild11

   Y

   1

   2015-05-15

   -P7D

   80

   141

   STUDYX

   QS

   23-P0001

   80

   141

   PT01051C

   PT01089B

   PT01-

   Joint Pain InterferencePAINSomewhat22

   Other Symptom 8 Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   OTHER SYMPTOMS

   NOT DONE

   Y

   1

   2015-05-15

   -P7D

   81

   142

   STUDYX

   QS

   23-P0001

   81

   142

   PT01052A

   PT01090A

   PT01-

   Insomnia Severity

   Other Symptom 9

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   OTHER SYMPTOMS

   NOT DONE

   SLEEP/WAKEMild11

   Y

   1

   2015-05-15

   -P7D

   82

   143

   STUDYX

   QS

   23-P0001

   82

   143

   PT01052B

   PT01090B

   PT01-

   Insomnia Interference

   Other Symptom 9 Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   OTHER SYMPTOMS

   NOT DONE

   SLEEP/WAKESomewhat22

   Y

   1

   2015-05-15

   -P7D

   83

   144

   STUDYX

   QS

   23-P0001

   83

   144

   PT01053A

   PT01091A

   PT01-

   Fatigue Severity

   Other Symptom 10

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   OTHER SYMPTOMS

   NOT DONE

   SLEEP/WAKEMild11

   Y

   1

   2015-05-15

   -P7D

   84

   145

   STUDYX

   QS

   23-P0001

   84

   145

   PT01053B

   PT01091B

   PT01-

   Fatigue Interference

   Other Symptom 10 Severity

   PRO-CTCAE V1.0

   VERSION DATE 4/26/2020

   OTHER SYMPTOMS

   NOT DONE

   SLEEP/WAKESomewhat22

   Y

   1

   2015-05-15

   -P7D

   85STUDYXQS23-P000185PT01054APT01-Anxious FrequencyPRO-CTCAE V1.0 VERSION DATE 4/26/2020MOODOccasionally22Y12015-05-15-P7D86