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title | Information for Reviewers |
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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. |
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Title | Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) Library Version 1.0 (PRO-CTCAE V1.0) |
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CDISC Reference | QuestionnaireSupplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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QRS Short Name | |
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QRS Permission Status | Approved |
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Team | CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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Title | Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Item Library Version 1.0 (PRO-CTCAE® V1.0) |
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CDISC Reference | QuestionnaireSupplement to the Study Data Tabulation Model Implementation Guide for Human Clinical TrialsQRS Short Name | |
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QRS Permission Status | Approved |
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Team | Pancreatic Cancer Therapeutic Area Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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Supplement Version | 1.0 |
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Status | DRAFT |
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Date | 20222023-0312-2108 |
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Notes | This supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials. |
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Revision History
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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.
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Revision History
Date | Version |
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2023-12-08 | 1.0 Draft |
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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.
- 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.
- 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 responses. The responses for the PRO-CTCAE V1.0 are as follows:
- 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 1 = “Yes”);
- 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”).
- 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”).
- 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”).
- 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”). - QSTESTCD = "PT01066A " to "PT01071A" sexual symptoms have specific responses.
- 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 QSTESTCD=PT01066A, PT01068A, and PT01071A assessing sexual symptom severity are rated on a 5-point scale
and are rated from 0-4 (e.g., 0 = “None”, 1 = “Mild”, 2 = “Moderate”, 3 = “Severe”, and 4 = “Very severe”,
“Not applicable”, "Not sexually
active", and “Prefer not to answer”).
Items assessing symptom interference are - QSTESTCD = "PT01067A" assessing sexual symptom frequency is rated on a 5-point scale
and are - rated from 0-4 (e.g., 0 =
“Not at all”- “Never”, 1 =
“A little bit”- “Rarely”, 2 =
“Somewhat”- “Occasionally”, 3 =
“Quite a bit”- “Frequently”,
and 4 = “Very much”).
- 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").
- 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.).
- 4 = “Almost constantly”, "Not sexually active", and “Prefer not to answer”).
- 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,
- 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.)
- 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").
- 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).
- 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.
- 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.
- 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".
- 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.
- 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:
QSSTAT = "NOT DONE".
QSREASND = "LOGICALLY SKIPPED ITEM".
QSORRES, is set to null (missing).
- 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.
.- When a paper version is administered, conditional branching does not apply.
- 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:
QNAM = “QSCBRFL”, QLABEL = “Conditionally Branched Item Flag “, QVAL = “Y” (this is a QS supplemental qualifier variable)
QSORRES
For severity items, QSORRES = "None"
- For interference items, QSORRES = "Not at all"
- QSSTRESC = 0 and QSSTRESN = 0
- 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.
- For items not done due to conditional branching, refer to assumption 8.
- In the unexpected situation where the reason is unknown, then QSORRES, QSSTRESC, and QSSTRESN are all missing; QSSTAT = "NOT DONE"; and QSREASND is missing.
- 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.
- Terminology
QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.
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.
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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. |
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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.
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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". | |
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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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| Y | 1 | 2015-05-15 | -P7D | 7 | STUDYX | QS | 23-P0001 | 7 | PT01006A | PT01-Hoarseness Severity | PRO-CTCAE V1.0 | ORAL | Mild | 1 | 1 |
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| 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 |
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| 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 |
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| 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 |
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| Y | 1 | 2015-05-15 | -P7D | 11 | STUDYX | QS | 23-P0001 | 11 | PT01009A | PT01-Nausea Frequency | PRO-CTCAE V1.0 | GASTROINTESTINAL | Occasionally | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | 12 | STUDYX | QS | 23-P0001 | 12 | PT01009B | PT01-Nausea Severity | PRO-CTCAE V1.0 | GASTROINTESTINAL | Mild | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | 13 | STUDYX | QS | 23-P0001 | 13 | PT01010A | PT01-Vomiting Frequency | PRO-CTCAE V1.0 | GASTROINTESTINAL | Occasionally | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | 14 | STUDYX | QS | 23-P0001 | 14 | PT01010B | PT01-Vomiting Severity | PRO-CTCAE V1.0 | GASTROINTESTINAL | Mild | 1 | 1 |
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| 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 | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 63 | STUDYX | QS | 23-P0001 | 63 | PT01044B | PT01-Watery Eyes Interference | PRO-CTCAE V1.0 | VISUAL/PERCEPTUAL | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 64 | STUDYX | QS | 23-P0001 | 64 | PT01045A | PT01-Ringing in Ears Severity | PRO-CTCAE V1.0 | VISUAL/PERCEPTUAL | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 65 | STUDYX | QS | 23-P0001 | 65 | PT01046A | PT01-Concentration Problems Severity | PRO-CTCAE V1.0 | ATTENTION/MEMORY | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 66 | STUDYX | QS | 23-P0001 | 66 | PT01046B | PT01-Concentration Problems Interference | PRO-CTCAE V1.0 | ATTENTION/MEMORY | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 67 | STUDYX | QS | 23-P0001 | 67 | PT01047A | PT01-Memory Problems Severity | PRO-CTCAE V1.0 | ATTENTION/MEMORY | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 68 | STUDYX | QS | 23-P0001 | 68 | PT01047B | PT01-Memory Problems Interference | PRO-CTCAE V1.0 | ATTENTION/MEMORY | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 69 | STUDYX | QS | 23-P0001 | 69 | PT01048A | PT01-General Pain Frequency | PRO-CTCAE V1.0 | PAIN | Occasionally | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 70 | STUDYX | QS | 23-P0001 | 70 | PT01048B | PT01-General Pain Severity | PRO-CTCAE V1.0 | PAIN | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 71 | STUDYX | QS | 23-P0001 | 71 | PT01048C | PT01-General Pain Interference | PRO-CTCAE V1.0 | PAIN | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 72 | STUDYX | QS | 23-P0001 | 72 | PT01049A | PT01-Headache Frequency | PRO-CTCAE V1.0 | PAIN | Occasionally | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 73 | STUDYX | QS | 23-P0001 | 73 | PT01049B | PT01-Headache Severity | PRO-CTCAE V1.0 | PAIN | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 74 | STUDYX | QS | 23-P0001 | 74 | PT01049C | PT01-Headache Interference | PRO-CTCAE V1.0 | PAIN | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 75 | STUDYX | QS | 23-P0001 | 75 | PT01050A | PT01-Muscle Pain Frequency | PRO-CTCAE V1.0 | PAIN | Occasionally | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 76 | STUDYX | QS | 23-P0001 | 76 | PT01050B | PT01-Muscle Pain Severity | PRO-CTCAE V1.0 | PAIN | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 77 | STUDYX | QS | 23-P0001 | 77 | PT01050C | PT01-Muscle Pain Interference | PRO-CTCAE V1.0 | PAIN | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 78 | STUDYX | QS | 23-P0001 | 78 | PT01051A | PT01-Joint Pain Frequency | PRO-CTCAE V1.0 | PAIN | Occasionally | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 79 | STUDYX | QS | 23-P0001 | 79 | PT01051B | PT01-Joint Pain Severity | PRO-CTCAE V1.0 | PAIN | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 80 | STUDYX | QS | 23-P0001 | 80 | PT01051C | PT01-Joint Pain Interference | PRO-CTCAE V1.0 | PAIN | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 81 | STUDYX | QS | 23-P0001 | 81 | PT01052A | PT01-Insomnia Severity | PRO-CTCAE V1.0 | SLEEP/WAKE | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 82 | STUDYX | QS | 23-P0001 | 82 | PT01052B | PT01-Insomnia Interference | PRO-CTCAE V1.0 | SLEEP/WAKE | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 83 | STUDYX | QS | 23-P0001 | 83 | PT01053A | PT01-Fatigue Severity | PRO-CTCAE V1.0 | SLEEP/WAKE | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 84 | STUDYX | QS | 23-P0001 | 84 | PT01053B | PT01-Fatigue Interference | PRO-CTCAE V1.0 | SLEEP/WAKE | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 85 | STUDYX | QS | 23-P0001 | 85 | PT01054A | PT01-Anxious Frequency | PRO-CTCAE V1.0 | MOOD | Occasionally | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 86 | STUDYX | QS | 23-P0001 | 86 | PT01054B | PT01-Anxious Severity | PRO-CTCAE V1.0 | MOOD | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 87 | STUDYX | QS | 23-P0001 | 87 | PT01054C | PT01-Anxious Interference | PRO-CTCAE V1.0 | MOOD | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 88 | STUDYX | QS | 23-P0001 | 88 | PT01055A | PT01-Discouraged Frequency | PRO-CTCAE V1.0 | MOOD | Occasionally | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 89 | STUDYX | QS | 23-P0001 | 89 | PT01055B | PT01-Discouraged Severity | PRO-CTCAE V1.0 | MOOD | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 90 | STUDYX | QS | 23-P0001 | 90 | PT01055C | PT01-Discouraged Interference | PRO-CTCAE V1.0 | MOOD | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 91 | STUDYX | QS | 23-P0001 | 91 | PT01056A | PT01-Sad Frequency | PRO-CTCAE V1.0 | MOOD | Occasionally | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 92 | STUDYX | QS | 23-P0001 | 92 | PT01056B | PT01-Sad Severity | PRO-CTCAE V1.0 | MOOD | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 93 | STUDYX | QS | 23-P0001 | 93 | PT01056C | PT01-Sad Interference | PRO-CTCAE V1.0 | MOOD | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 94 | STUDYX | QS | 23-P0001 | 94 | PT01057A | PT01-Irregular Menstrual Period Presence | PRO-CTCAE V1.0 | GYNECOLOGIC/URINARY | No | 0 | 0 |
|
| Y | 1 | 2015-05-15 | -P7D | 95 | STUDYX | QS | 23-P0001 | 95 | PT01058A | PT01-Missed Menstrual Period Presence | PRO-CTCAE V1.0 | GYNECOLOGIC/URINARY | No | 0 | 0 |
|
| Y | 1 | 2015-05-15 | -P7D | 96 | STUDYX | QS | 23-P0001 | 96 | PT01059A | PT01-Vaginal Discharge Amount | PRO-CTCAE V1.0 | GYNECOLOGIC/URINARY | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 97 | STUDYX | QS | 23-P0001 | 97 | PT01060A | PT01-Vaginal Dryness Severity | PRO-CTCAE V1.0 | GYNECOLOGIC/URINARY | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 98 | STUDYX | QS | 23-P0001 | 98 | PT01061A | PT01-Painful Urination Severity | PRO-CTCAE V1.0 | GYNECOLOGIC/URINARY | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 99 | STUDYX | QS | 23-P0001 | 99 | PT01062A | PT01-Urinary Urgency Frequency | PRO-CTCAE V1.0 | GYNECOLOGIC/URINARY | Occasionally | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 100 | STUDYX | QS | 23-P0001 | 100 | PT01062B | PT01-Urinary Urgency Interference | PRO-CTCAE V1.0 | GYNECOLOGIC/URINARY | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 191 | STUDYX | QS | 23-P0001 | 191 | PT01063A | PT01-Urinary Frequency Frequency | PRO-CTCAE V1.0 | GYNECOLOGIC/URINARY | Occasionally | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 102 | STUDYX | QS | 23-P0001 | 102 | PT01063B | PT01-Urinary Frequency Interference | PRO-CTCAE V1.0 | GYNECOLOGIC/URINARY | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 103 | STUDYX | QS | 23-P0001 | 103 | PT01064A | PT01-Urine Color Change Presence | PRO-CTCAE V1.0 | GYNECOLOGIC/URINARY | No | 0 | 0 |
|
| Y | 1 | 2015-05-15 | -P7D | 104 | STUDYX | QS | 23-P0001 | 104 | PT01065A | PT01-Urinary Incontinence Frequency | PRO-CTCAE V1.0 | GYNECOLOGIC/URINARY | Occasionally | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 105 | STUDYX | QS | 23-P0001 | 105 | PT01065B | PT01-Urinary Incontinence Interference | PRO-CTCAE V1.0 | GYNECOLOGIC/URINARY | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 106 | STUDYX | QS | 23-P0001 | 106 | PT01066A | PT01-Achieve&Maintain Erection Severity | PRO-CTCAE V1.0 | SEXUAL | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 107 | STUDYX | QS | 23-P0001 | 107 | PT01067A | PT01-Ejaculation Frequency | PRO-CTCAE V1.0 | SEXUAL | Occasionally | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 108 | STUDYX | QS | 23-P0001 | 108 | PT01068A | PT01-Decreased Libido Severity | PRO-CTCAE V1.0 | SEXUAL | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 109 | STUDYX | QS | 23-P0001 | 109 | PT01069A | PT01-Delayed Orgasm Presence | PRO-CTCAE V1.0 | SEXUAL | No | 0 | 0 |
|
| Y | 1 | 2015-05-15 | -P7D | 110 | STUDYX | QS | 23-P0001 | 110 | PT01070A | PT01-Unable to Have Orgasm Presence | PRO-CTCAE V1.0 | SEXUAL | No | 0 | 0 |
|
| Y | 1 | 2015-05-15 | -P7D | 111 | STUDYX | QS | 23-P0001 | 111 | PT01071A | PT01-Pain w/Sexual Intercourse Severity | PRO-CTCAE V1.0 | SEXUAL | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 112 | STUDYX | QS | 23-P0001 | 112 | PT01072A | PT01-Breast Swelling&Tenderness Severity | PRO-CTCAE V1.0 | MISCELLANEOUS | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 113 | STUDYX | QS | 23-P0001 | 113 | PT01073A | PT01-Bruising Presence | PRO-CTCAE V1.0 | MISCELLANEOUS | No | 0 | 0 |
|
| Y | 1 | 2015-05-15 | -P7D | 114 | STUDYX | QS | 23-P0001 | 114 | PT01074A | PT01-Chills Frequency | PRO-CTCAE V1.0 | MISCELLANEOUS | Occasionally | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 115 | STUDYX | QS | 23-P0001 | 115 | PT01074B | PT01-Chills Severity | PRO-CTCAE V1.0 | MISCELLANEOUS | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 116 | STUDYX | QS | 23-P0001 | 116 | PT01075A | PT01-Increased Sweating Frequency | PRO-CTCAE V1.0 | MISCELLANEOUS | Occasionally | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 117 | STUDYX | QS | 23-P0001 | 117 | PT01075B | PT01-Increased Sweating Severity | PRO-CTCAE V1.0 | MISCELLANEOUS | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 118 | STUDYX | QS | 23-P0001 | 118 | PT01076A | PT01-Decreased Sweating Presence | PRO-CTCAE V1.0 | MISCELLANEOUS | No | 0 | 0 |
|
| Y | 1 | 2015-05-15 | -P7D | 118 | STUDYX | QS | 23-P0001 | 118 | PT01077A | PT01-Hot Flashes Frequency | PRO-CTCAE V1.0 | MISCELLANEOUS | Occasionally | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 120 | STUDYX | QS | 23-P0001 | 120 | PT01077B | PT01-Hot Flashes Severity | PRO-CTCAE V1.0 | MISCELLANEOUS | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 121 | STUDYX | QS | 23-P0001 | 121 | PT01078A | PT01-Nosebleed Frequency | PRO-CTCAE V1.0 | MISCELLANEOUS | Occasionally | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 122 | STUDYX | QS | 23-P0001 | 122 | PT01078B | PT01-Nosebleed Severity | PRO-CTCAE V1.0 | MISCELLANEOUS | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 123 | STUDYX | QS | 23-P0001 | 123 | PT01079A | PT01-Pain&Swelling at Inj Site Presence | PRO-CTCAE V1.0 | MISCELLANEOUS | No | 0 | 0 |
|
| Y | 1 | 2015-05-15 | -P7D | 124 | STUDYX | QS | 23-P0001 | 124 | PT01080A | PT01-Body Odor Severity | PRO-CTCAE V1.0 | MISCELLANEOUS | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 125 | STUDYX | QS | 23-P0001 | 125 | PT01081 | PT01-Any Other Symptoms Reported | PRO-CTCAE V1.0 | OTHER SYMPTOMS | Yes | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 126 | STUDYX | QS | 23-P0001 | 126 | PT01082A | PT01-Other Symptom 1 | PRO-CTCAE V1.0 | OTHER SYMPTOMS | Another symptom 1 | Another symptom 1 |
|
|
| Y | 1 | 2015-05-15 | -P7D | 127 | STUDYX | QS | 23-P0001 | 127 | PT01082B | PT01-Other Symptom 1 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 128 | STUDYX | QS | 23-P0001 | 128 | PT01083A | PT01-Other Symptom 2 | PRO-CTCAE V1.0 | OTHER SYMPTOMS | Another symptom 2 | Another symptom 2 |
|
|
| Y | 1 | 2015-05-15 | -P7D | 129 | STUDYX | QS | 23-P0001 | 129 | PT01083B | PT01-Other Symptom 2 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 130 | STUDYX | QS | 23-P0001 | 130 | PT01084A | PT01-Other Symptom 3 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
| Y | 1 | 2015-05-15 | -P7D | 131 | STUDYX | QS | 23-P0001 | 131 | PT01084B | PT01-Other Symptom 3 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
| Y | 1 | 2015-05-15 | -P7D | 132 | STUDYX | QS | 23-P0001 | 132 | PT01085A | PT01-Other Symptom 4 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
| Y | 1 | 2015-05-15 | -P7D | 133 | STUDYX | QS | 23-P0001 | 133 | PT01085B | PT01-Other Symptom 4 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
| Y | 1 | 2015-05-15 | -P7D | 134 | STUDYX | QS | 23-P0001 | 134 | PT01086A | PT01-Other Symptom 5 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
| Y | 1 | 2015-05-15 | -P7D | 135 | STUDYX | QS | 23-P0001 | 135 | PT01086B | PT01-Other Symptom 5 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
| Y | 1 | 2015-05-15 | -P7D | 136 | STUDYX | QS | 23-P0001 | 136 | PT01087A | PT01-Other Symptom 6 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
| Y | 1 | 2015-05-15 | -P7D | 137 | STUDYX | QS | 23-P0001 | 137 | PT01087B | PT01-Other Symptom 6 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
| Y | 1 | 2015-05-15 | -P7D | 138 | STUDYX | QS | 23-P0001 | 138 | PT01088A | PT01-Other Symptom 7 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
| Y | 1 | 2015-05-15 | -P7D | 139 | STUDYX | QS | 23-P0001 | 139 | PT01088B | PT01-Other Symptom 7 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
| Y | 1 | 2015-05-15 | -P7D | 140 | STUDYX | QS | 23-P0001 | 140 | PT01089A | PT01-Other Symptom 8 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
| Y | 1 | 2015-05-15 | -P7D | 141 | STUDYX | QS | 23-P0001 | 141 | PT01089B | PT01-Other Symptom 8 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
| Y | 1 | 2015-05-15 | -P7D | 142 | STUDYX | QS | 23-P0001 | 142 | PT01090A | PT01-Other Symptom 9 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
| Y | 1 | 2015-05-15 | -P7D | 143 | STUDYX | QS | 23-P0001 | 143 | PT01090B | PT01-Other Symptom 9 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
| Y | 1 | 2015-05-15 | -P7D | 144 | STUDYX | QS | 23-P0001 | 144 | PT01091A | PT01-Other Symptom 10 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
| Y | 1 | 2015-05-15 | -P7D | 145 | STUDYX | QS | 23-P0001 | 145 | PT01091B | PT01-Other Symptom 10 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
| Y | 1 | 2015-05-15 | -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 |
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Dataset2 |
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| STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | STUDYX | QS | 23-P0001 | QSSEQ | 21 | QSCBRFL | Conditionally Branched Item Flag | Y | ASSIGNED | STUDYX | QS | 23-P0001 | QSSEQ | 25 | QSCBRFL | Conditionally Branched Item Flag | Y | ASSIGNED | STUDYX | QS | 23-P0001 | QSSEQ | 26 | QSCBRFL | Conditionally Branched Item Flag | Y | ASSIGNED | STUDYX | QS | 23-P0001 | QSTESTCD | PT01001A | QSSYMPTM | Symptom Term | DRY MOUTH | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01002A | QSSYMPTM | Symptom Term | DIFFICULTY SWALLOWING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01003A | QSSYMPTM | Symptom Term | MOUTH/THROAT SORES | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01003B | QSSYMPTM | Symptom Term | MOUTH/THROAT SORES | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01004A | QSSYMPTM | Symptom Term | CRACKING AT THE CORNERS OF THE MOUTH (CHEILOSIS/CHEILITIS) | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01005A | QSSYMPTM | Symptom Term | VOICE QUALITY CHANGES | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01006A | QSSYMPTM | Symptom Term | HOARSENESS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01007A | QSSYMPTM | Symptom Term | TASTE CHANGES | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01008A | QSSYMPTM | Symptom Term | DECREASED APPETITE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01008B | QSSYMPTM | Symptom Term | DECREASED APPETITE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01009A | QSSYMPTM | Symptom Term | NAUSEA | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01009B | QSSYMPTM | Symptom Term | NAUSEA | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01010A | QSSYMPTM | Symptom Term | VOMITING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01010B | QSSYMPTM | Symptom Term | VOMITING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01011A | QSSYMPTM | Symptom Term | HEARTBURN | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01011B | QSSYMPTM | Symptom Term | HEARTBURN | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01012A | QSSYMPTM | Symptom Term | GAS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01013A | QSSYMPTM | Symptom Term | BLOATING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01013B | QSSYMPTM | Symptom Term | BLOATING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01014A | QSSYMPTM | Symptom Term | HICCUPS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01014B | QSSYMPTM | Symptom Term | HICCUPS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01015A | QSSYMPTM | Symptom Term | CONSTIPATION | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01016A | QSSYMPTM | Symptom Term | DIARRHEA | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01017A | QSSYMPTM | Symptom Term | ABDOMINAL PAIN | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01017B | QSSYMPTM | Symptom Term | ABDOMINAL PAIN | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01017C | QSSYMPTM | Symptom Term | ABDOMINAL PAIN | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01018A | QSSYMPTM | Symptom Term | FECAL INCONTINENCE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01018B | QSSYMPTM | Symptom Term | FECAL INCONTINENCE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01019A | QSSYMPTM | Symptom Term | SHORTNESS OF BREATH | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01019B | QSSYMPTM | Symptom Term | SHORTNESS OF BREATH | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01020A | QSSYMPTM | Symptom Term | COUGH | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01020B | QSSYMPTM | Symptom Term | COUGH | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01021A | QSSYMPTM | Symptom Term | WHEEZING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01022A | QSSYMPTM | Symptom Term | SWELLING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01022B | QSSYMPTM | Symptom Term | SWELLING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01022C | QSSYMPTM | Symptom Term | SWELLING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01023A | QSSYMPTM | Symptom Term | HEART PALPITATIONS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01023B | QSSYMPTM | Symptom Term | HEART PALPITATIONS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01024A | QSSYMPTM | Symptom Term | RASH | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01025A | QSSYMPTM | Symptom Term | SKIN DRYNESS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01026A | QSSYMPTM | Symptom Term | ACNE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01027A | QSSYMPTM | Symptom Term | HAIR LOSS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01028A | QSSYMPTM | Symptom Term | ITCHING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01029A | QSSYMPTM | Symptom Term | HIVES | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01030A | QSSYMPTM | Symptom Term | HAND-FOOT SYNDROME | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01031A | QSSYMPTM | Symptom Term | NAIL LOSS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01032A | QSSYMPTM | Symptom Term | NAIL RIDGING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01033A | QSSYMPTM | Symptom Term | NAIL DISCOLORATION | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01034A | QSSYMPTM | Symptom Term | SENSITIVITY TO SUNLIGHT | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01035A | QSSYMPTM | Symptom Term | BED/PRESSURE SORES | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01036A | QSSYMPTM | Symptom Term | RADIATION SKIN REACTION | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01037A | QSSYMPTM | Symptom Term | SKIN DARKENING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01038A | QSSYMPTM | Symptom Term | STRETCH MARKS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01039A | QSSYMPTM | Symptom Term | NUMBNESS & TINGLING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01039B | QSSYMPTM | Symptom Term | NUMBNESS & TINGLING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01040A | QSSYMPTM | Symptom Term | DIZZINESS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01040B | QSSYMPTM | Symptom Term | DIZZINESS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01041A | QSSYMPTM | Symptom Term | BLURRED VISION | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01041B | QSSYMPTM | Symptom Term | BLURRED VISION | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01042A | QSSYMPTM | Symptom Term | FLASHING LIGHTS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01043A | QSSYMPTM | Symptom Term | VISUAL FLOATERS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01044A | QSSYMPTM | Symptom Term | WATERY EYES | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01044B | QSSYMPTM | Symptom Term | WATERY EYES | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01045A | QSSYMPTM | Symptom Term | RINGING IN EARS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01046A | QSSYMPTM | Symptom Term | CONCENTRATION | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01046B | QSSYMPTM | Symptom Term | CONCENTRATION | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01047A | QSSYMPTM | Symptom Term | MEMORY | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01047B | QSSYMPTM | Symptom Term | MEMORY | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01048A | QSSYMPTM | Symptom Term | GENERAL PAIN | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01048B | QSSYMPTM | Symptom Term | GENERAL PAIN | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01048C | QSSYMPTM | Symptom Term | GENERAL PAIN | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01049A | QSSYMPTM | Symptom Term | HEADACHE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01049B | QSSYMPTM | Symptom Term | HEADACHE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01049C | QSSYMPTM | Symptom Term | HEADACHE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01050A | QSSYMPTM | Symptom Term | MUSCLE PAIN | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01050B | QSSYMPTM | Symptom Term | MUSCLE PAIN | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01050C | QSSYMPTM | Symptom Term | MUSCLE PAIN | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01051A | QSSYMPTM | Symptom Term | JOINT PAIN | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01051B | QSSYMPTM | Symptom Term | JOINT PAIN | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01051C | QSSYMPTM | Symptom Term | JOINT PAIN | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01052A | QSSYMPTM | Symptom Term | INSOMNIA | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01052B | QSSYMPTM | Symptom Term | INSOMNIA | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01053A | QSSYMPTM | Symptom Term | FATIGUE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01053B | QSSYMPTM | Symptom Term | FATIGUE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01054A | QSSYMPTM | Symptom Term | ANXIOUS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01054B | QSSYMPTM | Symptom Term | ANXIOUS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01054C | QSSYMPTM | Symptom Term | ANXIOUS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01055A | QSSYMPTM | Symptom Term | DISCOURAGED | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01055B | QSSYMPTM | Symptom Term | DISCOURAGED | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01055C | QSSYMPTM | Symptom Term | DISCOURAGED | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01056A | QSSYMPTM | Symptom Term | SAD | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01056B | QSSYMPTM | Symptom Term | SAD | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01056C | QSSYMPTM | Symptom Term | SAD | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01057A | QSSYMPTM | Symptom Term | IRREGULAR PERIODS/VAGINAL BLEEDING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01058A | QSSYMPTM | Symptom Term | MISSED EXPECTED MENSTRUAL PERIOD | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01059A | QSSYMPTM | Symptom Term | VAGINAL DISCHARGE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01060A | QSSYMPTM | Symptom Term | VAGINAL DRYNESS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01061A | QSSYMPTM | Symptom Term | PAINFUL URINATION | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01062A | QSSYMPTM | Symptom Term | URINARY URGENCY | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01062B | QSSYMPTM | Symptom Term | URINARY URGENCY | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01063A | QSSYMPTM | Symptom Term | URINARY FREQUENCY | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01063B | QSSYMPTM | Symptom Term | URINARY FREQUENCY | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01064A | QSSYMPTM | Symptom Term | CHANGE IN USUAL URINE COLOR | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01065A | QSSYMPTM | Symptom Term | URINARY INCONTINENCE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01065B | QSSYMPTM | Symptom Term | URINARY INCONTINENCE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01066A | QSSYMPTM | Symptom Term | ACHIEVE AND MAINTAIN ERECTION | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01067A | QSSYMPTM | Symptom Term | EJACULATION | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01068A | QSSYMPTM | Symptom Term | DECREASED LIBIDO | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01069A | QSSYMPTM | Symptom Term | DELAYED ORGASM | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01070A | QSSYMPTM | Symptom Term | UNABLE TO HAVE ORGASM | CRF |
|
|
...
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 |
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Dataset2 |
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| STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL | STUDYX | QS | 23-P0001 | QSTESTCD | PT01001APT01071A | QSSYMTRMQSSYMPTM | Symptom TermDRY MOUTH | PAIN W/SEXUAL INTERCOURSE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01002APT01072A | QSSYMTRMQSSYMPTM | Symptom TermDIFFICULTY SWALLOWING | BREAST SWELLING AND TENDERNESS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01003APT01073A | QSSYMTRMQSSYMPTM | Symptom Term | MOUTH/THROAT SORESBRUISING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01003BPT01074A | QSSYMTRMQSSYMPTM | Symptom Term | MOUTH/THROAT SORESCHILLS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01004APT01074B | QSSYMTRMQSSYMPTM | Symptom Term | CRACKING AT THE CORNERS OF THE MOUTH (CHEILOSIS/CHEILITIS)CHILLS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01005APT01075A | QSSYMTRMQSSYMPTM | Symptom Term | VOICE QUALITY CHANGESINCREASED SWEATING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01006APT01075B | QSSYMTRMQSSYMPTM | Symptom Term | HOARSENESSINCREASED SWEATING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01007APT01076A | QSSYMTRMQSSYMPTM | Symptom Term | TASTE CHANGESDECREASED SWEATING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01008APT01077A | QSSYMTRMQSSYMPTM | Symptom Term | DECREASED APPETITEHOT FLASHES | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01008BPT01077B | QSSYMTRMQSSYMPTM | Symptom Term | DECREASED APPETITEHOT FLASHES | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01009APT01078A | QSSYMTRMQSSYMPTM | Symptom Term | NAUSEANOSEBLEED | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01009BPT01078B | QSSYMTRMQSSYMPTM | Symptom Term | NAUSEANOSEBLEED | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01010APT01079A | QSSYMTRMQSSYMPTM | Symptom TermVOMITING | PAIN AND SWELLING AT INJECTION SITE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01010BPT01080A | QSSYMTRMQSSYMPTM | Symptom Term | VOMITINGBODY ODOR | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01011APT01081 | QSSYMTRMQSSYMPTM | Symptom TermHEARTBURN | ANY OTHER SYMPTOMS REPORTED | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01011BPT01082A | QSSYMTRMQSSYMPTM | Symptom TermHEARTBURN | OTHER SYMPTOM 1 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01012APT01082B | QSSYMTRMQSSYMPTM | Symptom TermGAS | OTHER SYMPTOM 1 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01013APT01083A | QSSYMTRMQSSYMPTM | Symptom TermBLOATING | OTHER SYMPTOM 2 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01013BPT01083B | QSSYMTRMQSSYMPTM | Symptom TermBLOATING | OTHER SYMPTOM 2 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01014APT01084A | QSSYMTRMQSSYMPTM | Symptom TermHICCUPS | OTHER SYMPTOM 3 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01014BPT01084B | QSSYMTRMQSSYMPTM | Symptom TermHICCUPS | OTHER SYMPTOM 3 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01015APT01085A | QSSYMTRMQSSYMPTM | Symptom TermCONSTIPATION | OTHER SYMPTOM 4 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01016APT01085B | QSSYMTRMQSSYMPTM | Symptom TermDIARRHEA | OTHER SYMPTOM 4 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01017APT01086A | QSSYMTRMQSSYMPTM | Symptom TermABDOMINAL | PAINOTHER SYMPTOM 5 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01017BPT01086B | QSSYMTRMQSSYMPTM | Symptom TermABDOMINAL | PAINOTHER SYMPTOM 5 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01017CPT01087A | QSSYMTRMQSSYMPTM | Symptom TermABDOMINAL | PAINOTHER SYMPTOM 6 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01018APT01087B | QSSYMTRMQSSYMPTM | Symptom TermFECAL | INCONTINENCEOTHER SYMPTOM 6 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01018BPT01088A | QSSYMTRMQSSYMPTM | Symptom TermFECAL | INCONTINENCEOTHER SYMPTOM 7 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01019APT01088B | QSSYMTRMQSSYMPTM | Symptom TermSHORTNESS | OF BREATHOTHER SYMPTOM 7 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01019BPT01089A | QSSYMTRMQSSYMPTM | Symptom TermSHORTNESS | OF BREATHOTHER SYMPTOM 8 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01020APT01089B | QSSYMTRMQSSYMPTM | Symptom TermCOUGH | OTHER SYMPTOM 8 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01020BPT01090A | QSSYMTRMQSSYMPTM | Symptom TermCOUGH | OTHER SYMPTOM 9 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01021APT01090B | QSSYMTRMQSSYMPTM | Symptom TermWHEEZING | OTHER SYMPTOM 9 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01022APT01091A | QSSYMTRMQSSYMPTM | Symptom TermSWELLING | OTHER SYMPTOM 10 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01022B | QSSYMTRM | Symptom Term | SWELLING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01022C | QSSYMTRM | Symptom Term | SWELLING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01023A | QSSYMTRM | Symptom Term | HEART PALPITATIONS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01023B | QSSYMTRM | Symptom Term | HEART PALPITATIONS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01024A | QSSYMTRM | Symptom Term | RASH | | PT01091B | QSSYMPTM | Symptom Term | OTHER SYMPTOM 10 | CRF |
|
|
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 |
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Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT | 1CRF | STUDYX | QS | 23-P0001 | QSTESTCD1 | PT01025A | QSSYMTRM | Symptom Term | SKIN DRYNESS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01026A | QSSYMTRM | Symptom Term | ACNE | CRF | PT01019A | PT01-Shortness of Breath Severity | PRO-CTCAE V1.0 | RESPIRATORY | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 2 | STUDYX | QS | 23-P0001 | QSTESTCD2 | PT01027A | QSSYMTRM | Symptom Term | HAIR LOSS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01028A | QSSYMTRM | Symptom Term | ITCHING | PT01019B | PT01-Shortness of Breath Interference | PRO-CTCAE V1.0 | RESPIRATORY | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 3CRF | STUDYX | QS | 23-P0001 | QSTESTCD3 | PT01029A | QSSYMTRM | Symptom Term | HIVES | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01030A | QSSYMTRM | Symptom Term | HAND-FOOT SYNDROME | PT01020A | PT01-Cough Severity | PRO-CTCAE V1.0 | RESPIRATORY | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 4CRF | STUDYX | QS | 23-P0001 | QSTESTCD4 | PT01031A | QSSYMTRM | Symptom Term | NAIL LOSS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01032A | QSSYMTRM | Symptom Term | NAIL RIDGING | PT01020B | PT01-Cough Interference | PRO-CTCAE V1.0 | RESPIRATORY | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 5CRF | STUDYX | QS | 23-P0001 | QSTESTCD5 | PT01033A | QSSYMTRM | Symptom Term | NAIL DISCOLORATION | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01034A | QSSYMTRM | Symptom Term | SENSITIVITY TO SUNLIGHT | PT01021A | PT01-Wheezing Severity | PRO-CTCAE V1.0 | RESPIRATORY | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 6CRF | STUDYX | QS | 23-P0001 | QSTESTCD6 | PT01035A | QSSYMTRM | Symptom Term | BED/PRESSURE SORES | PT01022A | PT01-Swelling Frequency | PRO-CTCAE V1.0 | CARDIO/CIRCULATORY | Occasionally | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 7CRF | STUDYX | QS | 23-P0001 | QSTESTCD7 | PT01036A | QSSYMTRM | Symptom Term | RADIATION SKIN REACTION | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01037A | QSSYMTRM | Symptom Term | SKIN DARKENING | PT01022B | PT01-Swelling Severity | PRO-CTCAE V1.0 | CARDIO/CIRCULATORY | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 8CRF | STUDYX | QS | 23-P0001 | QSTESTCD8 | PT01038A | QSSYMTRM | Symptom Term | STRETCH MARKS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01039A | QSSYMTRM | Symptom Term | NUMBNESS & TINGLING | CRF | PT01022C | PT01-Swelling Interference | PRO-CTCAE V1.0 | CARDIO/CIRCULATORY | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 9 | STUDYX | QS | 23-P0001 | QSTESTCD9 | PT01039B | QSSYMTRM | Symptom Term | NUMBNESS & TINGLING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01040A | QSSYMTRM | Symptom Term | DIZZINESS | PT01023A | PT01-Heart Palpitations Frequency | PRO-CTCAE V1.0 | CARDIO/CIRCULATORY | Occasionally | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 10CRF | STUDYX | QS | 23-P0001 | QSTESTCD10 | PT01040B | QSSYMTRM | Symptom Term | DIZZINESS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01041A | QSSYMTRM | Symptom Term | BLURRED VISION | PT01023B | PT01-Heart Palpitations Severity | PRO-CTCAE V1.0 | CARDIO/CIRCULATORY | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 11CRF | STUDYX | QS | 23-P0001 | QSTESTCD11 | PT01041B | QSSYMTRM | Symptom Term | BLURRED VISION | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01042A | QSSYMTRM | Symptom Term | FLASHING LIGHTS | PT01039A | PT01-Numbness & Tingling Severity | PRO-CTCAE V1.0 | NEUROLOGICAL | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 12CRF | STUDYX | QS | 23-P0001 | QSTESTCD12 | PT01043A | QSSYMTRM | Symptom Term | VISUAL FLOATERS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01044A | QSSYMTRM | Symptom Term | WATERY EYES | CRF | PT01039B | PT01-Numbness & Tingling Interference | PRO-CTCAE V1.0 | NEUROLOGICAL | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 13 | STUDYX | QS | 23-P0001 | QSTESTCD13 | PT01044B | QSSYMTRM | Symptom Term | WATERY EYES | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01045A | QSSYMTRM | Symptom Term | RINGING IN EARS | PT01040A | PT01-Dizziness Severity | PRO-CTCAE V1.0 | NEUROLOGICAL | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 14CRF | STUDYX | QS | 23-P0001 | QSTESTCD14 | PT01046A | QSSYMTRM | Symptom Term | CONCENTRATION | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01046B | QSSYMTRM | Symptom Term | CONCENTRATION | PT01040B | PT01-Dizziness Interference | PRO-CTCAE V1.0 | NEUROLOGICAL | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 15CRF | STUDYX | QS | 23-P0001 | QSTESTCD15 | PT01047A | QSSYMTRM | Symptom Term | MEMORY | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01047B | QSSYMTRM | Symptom Term | MEMORY | CRF | PT01046A | PT01-Concentration Problems Severity | PRO-CTCAE V1.0 | ATTENTION/MEMORY | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 16 | STUDYX | QS | 23-P0001 | QSTESTCD16 | PT01048A | QSSYMTRM | Symptom Term | GENERAL PAIN | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01048B | QSSYMTRM | Symptom Term | GENERAL PAIN | PT01046B | PT01-Concentration Problems Interference | PRO-CTCAE V1.0 | ATTENTION/MEMORY | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 17CRF | STUDYX | QS | 23-P0001 | QSTESTCD17 | PT01048C | QSSYMTRM | Symptom Term | GENERAL PAIN | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01049A | QSSYMTRM | Symptom Term | HEADACHE | CRF | PT01047A | PT01-Memory Problems Severity | PRO-CTCAE V1.0 | ATTENTION/MEMORY | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 18 | STUDYX | QS | 23-P0001 | QSTESTCD18 | PT01049B | QSSYMTRM | Symptom Term | HEADACHE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01049C | QSSYMTRM | Symptom Term | HEADACHE | PT01047B | PT01-Memory Problems Interference | PRO-CTCAE V1.0 | ATTENTION/MEMORY | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | 19CRF | STUDYX | QS | 23-P0001 | QSTESTCD19 | PT01050A | QSSYMTRM | Symptom Term | MUSCLE PAIN | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01050B | QSSYMTRM | Symptom Term | MUSCLE PAIN | CRF | PT01081 | PT01-Any Other Symptoms Reported | PRO-CTCAE V1.0 | OTHER SYMPTOMS | Yes | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 20 | STUDYX | QS | 23-P0001 | QSTESTCD20 | PT01050C | QSSYMTRM | Symptom Term | MUSCLE PAIN | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01051A | QSSYMTRM | Symptom Term | JOINT PAIN | PT01082A | PT01-Other Symptom 1 | PRO-CTCAE V1.0 | OTHER SYMPTOMS | Another symptom 1 | Another symptom 1 |
|
|
| Y | 1 | 2015-05-15 | -P7D | 21CRF | STUDYX | QS | 23-P0001 | QSTESTCD21 | PT01051B | QSSYMTRM | Symptom Term | JOINT PAIN | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01051C | QSSYMTRM | Symptom Term | JOINT PAIN | PT01082B | PT01-Other Symptom 1 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 22CRF | STUDYX | QS | 23-P0001 | QSTESTCD22 | PT01052A | QSSYMTRM | Symptom Term | INSOMNIA | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01052B | QSSYMTRM | Symptom Term | INSOMNIA | PT01083A | PT01-Other Symptom 2 | PRO-CTCAE V1.0 | OTHER SYMPTOMS | Another symptom 2 | Another symptom 2 |
|
|
| Y | 1 | 2015-05-15 | -P7D | 23CRF | STUDYX | QS | 23-P0001 | QSTESTCD23 | PT01053A | QSSYMTRM | Symptom Term | FATIGUE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01053B | QSSYMTRM | Symptom Term | FATIGUE | CRF | PT01083B | PT01-Other Symptom 2 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS | Mild | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | 24 | STUDYX | QS | 23-P0001 | QSTESTCD24 | PT01054A | QSSYMTRM | Symptom Term | ANXIOUS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01054B | QSSYMTRM | Symptom Term | ANXIOUS | CRF | PT01084A | PT01-Other Symptom 3 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
|
| 1 | 2015-05-15 | -P7D | 25 | STUDYX | QS | 23-P0001 | QSTESTCD25 | PT01054C | QSSYMTRM | Symptom Term | ANXIOUS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01055A | QSSYMTRM | Symptom Term | DISCOURAGED | PT01084B | PT01-Other Symptom 3 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
|
| 1 | 2015-05-15 | -P7D | 26CRF | STUDYX | QS | 23-P0001 | QSTESTCD26 | PT01055B | QSSYMTRM | Symptom Term | DISCOURAGED | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01055C | QSSYMTRM | Symptom Term | DISCOURAGED | CRF | PT01085A | PT01-Other Symptom 4 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
|
| 1 | 2015-05-15 | -P7D | 27 | STUDYX | QS | 23-P0001 | QSTESTCD27 | PT01056A | QSSYMTRM | Symptom Term | SAD | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01056B | QSSYMTRM | Symptom Term | SAD | PT01085B | PT01-Other Symptom 4 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
|
| 1 | 2015-05-15 | -P7D | 28CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01056C | QSSYMTRM | Symptom Term | SAD | 28 | PT01086A | PT01-Other Symptom 5 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
|
| 1 | 2015-05-15 | -P7D | 29CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01057A | QSSYMTRM | Symptom Term | IRREGULAR PERIODS/VAGINAL BLEEDING | | 29 | PT01086B | PT01-Other Symptom 5 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
|
| 1 | 2015-05-15 | -P7D | 30CRF | STUDYX | QS | 23-P0001 | QSTESTCD30 | PT01058A | QSSYMTRM | Symptom Term | MISSED EXPECTED MENSTRUAL PERIOD | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01059A | QSSYMTRM | Symptom Term | VAGINAL DISCHARGE | PT01087A | PT01-Other Symptom 6 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
|
| 1 | 2015-05-15 | -P7D | 31CRF | STUDYX | QS | 23-P0001 | QSTESTCD31 | PT01060A | QSSYMTRM | Symptom Term | VAGINAL DRYNESS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01061A | QSSYMTRM | Symptom Term | PAINFUL URINATION | CRF | PT01087B | PT01-Other Symptom 6 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
|
| 1 | 2015-05-15 | -P7D | 32 | STUDYX | QS | 23-P0001 | QSTESTCD32 | PT01062A | QSSYMTRM | Symptom Term | URINARY URGENCY | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01062B | QSSYMTRM | Symptom Term | URINARY URGENCY | PT01088A | PT01-Other Symptom 7 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
|
| 1 | 2015-05-15 | -P7D | 33CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01063A | QSSYMTRM | Symptom Term | 33 | PT01088B | PT01-Other Symptom 7 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
|
| 1 | 2015-05-15 | -P7D | 34 | URINARY FREQUENCY | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01063B | QSSYMTRM | Symptom Term | URINARY FREQUENCY | | 34 | PT01089A | PT01-Other Symptom 8 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
|
| 1 | 2015-05-15 | -P7D | 35CRF | STUDYX | QS | 23-P0001 | QSTESTCD35 | PT01064A | QSSYMTRM | Symptom Term | CHANGE IN USUAL URINE COLOR | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01065A | QSSYMTRM | PT01089B | PT01-Other Symptom 8 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
|
| 1 | 2015-05-15 | -P7D | 36 | Symptom Term | URINARY INCONTINENCE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD36 | PT01065B | QSSYMTRM | Symptom Term | URINARY INCONTINENCE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01066A | QSSYMTRM | Symptom Term | ACHIEVE AND MAINTAIN ERECTION | CRF | PT01090A | PT01-Other Symptom 9 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
|
| 1 | 2015-05-15 | -P7D | 37 | STUDYX | QS | 23-P0001 | QSTESTCD37 | PT01067A | QSSYMTRM | Symptom Term | EJACULATION | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01068A | QSSYMTRM | Symptom Term | DECREASED LIBIDO | PT01090B | PT01-Other Symptom 9 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
|
| 1 | 2015-05-15 | -P7D | 38CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01069A | QSSYMTRM | Symptom Term | DELAYED ORGASM | | 38 | PT01091A | PT01-Other Symptom 10 | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
|
| 1 | 2015-05-15 | -P7D | 39CRF | STUDYX | QS | 23-P0001 | QSTESTCD39 | PT01091B | PT01-Other Symptom 10 Severity | PRO-CTCAE V1.0 | OTHER SYMPTOMS |
|
|
| NOT DONE |
|
| 1 | 2015-05-15 | -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.
Dataset wrap |
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Dataset2 |
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| STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | PT01070A | QSSYMTRM | Symptom Term | UNABLE TO HAVE ORGASM | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01071A | QSSYMTRM | Symptom Term | PAIN W/SEXUAL INTERCOURSE | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01072A | QSSYMTRM | Symptom Term | BREAST SWELLING AND TENDERNESS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01073A | QSSYMTRM | Symptom Term | BRUISING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01074APT01019A | QSSYMTRMQSSYMPTM | Symptom TermCHILLS | SHORTNESS OF BREATH | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01074BPT01019B | QSSYMTRMQSSYMPTM | Symptom TermCHILLS | SHORTNESS OF BREATH | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01075APT01020A | QSSYMTRMQSSYMPTM | Symptom Term | INCREASED SWEATINGCOUGH | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01075BPT01020B | QSSYMTRMQSSYMPTM | Symptom Term | INCREASED SWEATINGCOUGH | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01076APT01021A | QSSYMTRMQSSYMPTM | Symptom Term | DECREASED SWEATINGWHEEZING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01077APT01022A | QSSYMTRMQSSYMPTM | Symptom Term | HOT FLASHESSWELLING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01077BPT01022B | QSSYMTRMQSSYMPTM | Symptom Term | HOT FLASHESSWELLING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01078APT01022C | QSSYMTRMQSSYMPTM | Symptom Term | NOSEBLEEDSWELLING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01078BPT01023A | QSSYMTRMQSSYMPTM | Symptom Term | NOSEBLEEDHEART PALPITATIONS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01079APT01023B | QSSYMTRMQSSYMPTM | Symptom Term | PAIN AND SWELLING AT INJECTION SITEHEART PALPITATIONS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01080APT01039A | QSSYMTRMQSSYMPTM | Symptom TermBODY | ODORNUMBNESS & TINGLING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01081PT01039B | QSSYMTRMQSSYMPTM | Symptom TermANY | OTHER SYMPTOMS REPORTEDNUMBNESS & TINGLING | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01082APT01040A | QSSYMTRMQSSYMPTM | Symptom Term | OTHER SYMPTOM 1DIZZINESS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01082BPT01040B | QSSYMTRMQSSYMPTM | Symptom Term | OTHER SYMPTOM 1DIZZINESS | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01083APT01046A | QSSYMTRMQSSYMPTM | Symptom Term | OTHER SYMPTOM 2CONCENTRATION | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01083BPT01046B | QSSYMTRMQSSYMPTM | Symptom Term | OTHER SYMPTOM 2CONCENTRATION | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01084APT01047A | QSSYMTRMQSSYMPTM | Symptom Term | OTHER SYMPTOM 3MEMORY | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01084BPT01047B | QSSYMTRMQSSYMPTM | Symptom Term | OTHER SYMPTOM 3MEMORY | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01085APT01081 | QSSYMTRMQSSYMPTM | Symptom Term | ANY OTHER SYMPTOM 4SYMPTOMS REPORTED | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01085BPT01082A | QSSYMTRMQSSYMPTM | Symptom Term | OTHER SYMPTOM 41 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01086APT01082B | QSSYMTRMQSSYMPTM | Symptom Term | OTHER SYMPTOM 51 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01086BPT01083A | QSSYMTRMQSSYMPTM | Symptom Term | OTHER SYMPTOM 52 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01087APT01083B | QSSYMTRMQSSYMPTM | Symptom Term | OTHER SYMPTOM 62 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01087BPT01084A | QSSYMTRMQSSYMPTM | Symptom Term | OTHER SYMPTOM 63 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01088APT01084B | QSSYMTRMQSSYMPTM | Symptom Term | OTHER SYMPTOM 73 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01088BPT01085A | QSSYMTRMQSSYMPTM | Symptom Term | OTHER SYMPTOM 74 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01089APT01085B | QSSYMTRMQSSYMPTM | Symptom Term | OTHER SYMPTOM 84 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01089BPT01086A | QSSYMTRMQSSYMPTM | Symptom Term | OTHER SYMPTOM 85 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01090APT01086B | QSSYMTRMQSSYMPTM | Symptom Term | OTHER SYMPTOM 95 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01090BPT01087A | QSSYMTRMQSSYMPTM | Symptom Term | OTHER SYMPTOM 96 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01091APT01087B | QSSYMTRMQSSYMPTM | Symptom Term | OTHER SYMPTOM 106 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01091BPT01088A | QSSYMTRMQSSYMPTM | Symptom Term | OTHER SYMPTOM 107 | CRF |
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Info |
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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 |
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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.
STUDYX | QS | 23-P0001 | QSTESTCD | PT01088B | QSSYMPTM | Symptom Term | OTHER SYMPTOM 7 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01089A | QSSYMPTM | Symptom Term | OTHER SYMPTOM 8 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01089B | QSSYMPTM | Symptom Term | OTHER SYMPTOM 8 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01090A | QSSYMPTM | Symptom Term | OTHER SYMPTOM 9 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01090B | QSSYMPTM | Symptom Term | OTHER SYMPTOM 9 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01091A | QSSYMPTM | Symptom Term | OTHER SYMPTOM 10 | CRF | STUDYX | QS | 23-P0001 | QSTESTCD | PT01091B | QSSYMPTM | Symptom Term | OTHER SYMPTOM 10 | CRF |
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|
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 |
---|
None | 0 | 0 |
Mild | 1 | 1 |
Moderate | 2 | 2 |
Severe | 3 | 3 |
Very severe | 4 | 4 |
All PRO-CTCAE V1.0 Interference Questions
QSORRES | QSSTRESC | QSSTRESN |
---|
Not at all | 0 | 0 |
A little bit | 1 | 1 |
Somewhat | 2 | 2 |
Quite a bit | 3 | 3 |
Very much | 4 | 4 |
All PRO-CTCAE V1.0 Frequency Questions
QSORRES | QSSTRESC | QSSTRESN |
---|
Never | 0 | 0 |
Rarely | 1 | 1 |
Occasionally | 2 | 2 |
Frequently | 3 | 3 |
Almost constantly | 4 | 4 |
All PRO-CTCAE V1.0 Presence/Absence Questions
QSORRES | QSSTRESC | QSSTRESN |
---|
YesYes | 1 | 1 |
NoNo | 0 | 0 |
All PRO-CTCAE V1.0 Amount Questions
QSORRES | QSSTRESC | QSSTRESN |
---|
Not at all | 0 | 0 |
A little bit | 1 | 1 |
Somewhat | 2 | 2 |
Quite a bit | 3 | 3 |
Very much | 4 | 4 |
--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 |
---|
None | 0 | 0 |
Mild | 1 | 1 |
Moderate | 2 | 2 |
Severe | 3 | 3 |
Very severe | 4 | 4 |
Not sexually active | Not sexually active |
|
Prefer not to answer | Prefer not to answer |
|
--TESTCD QSTESTCD = "PT01067A" --TEST QSTEST = "PT01-Ejaculation Frequency"
QSORRES | QSSTRESC | QSSTRESN |
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Never | 0 | 0 |
Rarely | 1 | 1 |
Occasionally | 2 | 2 |
Frequently | 3 | 3 |
Almost constantly | 4 | 4 |
Not sexually active | Not sexually active |
|
Prefer not to Answer | Prefer 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 |
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Yes | 1 | 1 |
No | 0 | 0 |
Not sexually active | Not sexually active |
|
Prefer not to answer | Prefer not to answer |
|
--TESTCD QSTESTCD = "PT01036A" --TEST QSTEST = "PT01-Radiation Skin Reaction Severity"
QSORRES | QSSTRESC | QSSTRESN |
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None | 0 | 0 |
Mild | 1 | 1 |
Moderate | 2 | 2 |
Severe | 3 | 3 |
Very severe | 4 | 4 |
Not applicable | Not 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 |
Yes | 1 | 1 |
No | 0 | 0 |
Not Applicableapplicable | Not Applicable applicable |
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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
QNAM | QLABEL | QVAL |
QSCBRFL | Conditionally Branched Item Flag | |
PRO-CTCAE V1.0 supported languages
QNAM | QLABEL | QVAL |
QSLANGQSLANGDC | Questionnaire Data Collection Language | CHINESE |
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| CZECH |
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| DANISH |
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| DUTCH |
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| ENGLISH |
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| FRENCH |
|
| GERMAN |
|
| GREEK |
|
| HUNGARIAN |
|
| ITALIAN |
|
| JAPANESE |
|
| KOREAN |
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| POLISH |
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| PORTUGUESE |
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| RUSSIAN |
|
| SPANISH |
PRO-CTCAE ITEM LIBRARY (Version 1V1.0 ) symptom terms
QNAM | QLABEL | QVAL |
QSSYMTRMQSSYMPTM | Symptom Term | ABDOMINAL PAIN |
|
| ACHIEVE AND MAINTAIN ERECTION |
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| 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 |
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| DIZZINESS |
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| DRY MOUTH |
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| EJACULATION |
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| FATIGUE |
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| FECAL INCONTINENCE |
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| FLASHING LIGHTS |
|
| GAS |
|
| GENERAL PAIN |
|
| HAIR LOSS |
|
| HAND-FOOT SYNDROME |
|
| HEADACHE |
|
| HEARTBURN |
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| HEART PALPITATIONS |
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| HICCUPS |
|
| HIVES |
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| HOARSENESS |
|
| HOT FLASHES/FLUSHES |
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| INCREASED SWEATING |
|
| INSOMNIA |
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| IRREGULAR PERIODS/VAGINAL BLEEDING |
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| ITCHING |
|
| JOINT PAIN |
|
| MEMORY |
|
| MISSED EXPECTED MENSTRUAL PERIOD |
|
| MOUTH/THROAT SORES |
|
| MUSCLE PAIN |
|
| NAIL DISCOLORATION |
|
| NAIL LOSS |
|
| NAIL RIDGING |
|
| NAUSEA |
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| 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