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 thru 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. Since 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.
Title
Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) Library Version1.0 (PRO-CTCAE V1.0)
CDISC Reference
QuestionnaireSupplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name
PRO-CTCAE V1.0
QRS Permission Status
Approved
Team
CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version
1.0
Status
DRAFT
Date
2022-07-06
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.
Known Issue
The concept of “conditional branching” in QRS instruments is when the instrument directs the subject to another item of the instrument based onthe 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 “Conditional Branched Item Indicator” has been requested to be released in the SDTMIG V4.0. This new variable will streamline the data representation of conditional branched items.
Revision History
Date
Version
2022-07-06
1.0 Draft
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.
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.
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 thePRO-CTCAE V1.0measurement systemand has made it exempt from copyright restrictions.Use of the PRO-CTCAE V1.0 is subject to NCI terms of use policy listed on the website. CDISC has included this supplement in the CDISC inventory of QRS data standards supplements.Hence, CDISC developedQSTESTCD and QSTESTfor each item based on the actual text on the measurement system.
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.
CDISC has developed this documentation at no cost to copyright holder or any additional cost to users of the measurement system 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 (PRO-CTCAE V1.0) which is owned exclusively by the Division of Cancer Control and Population Sciences in the National Cancer Institute (NCI) at the National Institutes of Health (NIH). 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. All rights reserved.
Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item Library Version 1.0 (PRO-CTCAE V1.0) (The PRO-CTCAE trademark items and information herein were developed by the Division of Cancer Control and Population Sciences in the National Cancer Institute at the National Institutes of Health, in Bethesda, Maryland, U.S.A. Use of the PRO-CTCAE is subject to NCI’s "Terms of Use". PRO-CTCAE Measurement System content should be downloaded using the "Instrument & Form Builder". https://healthcaredelivery.cancer.gov/pro-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 Sep 29;106(9)).
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 conjunction with the Common Terminology Criteria for Adverse Events (CTCAE).[1] It consists of an item library rather than a static/fixed item type of instrument. 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 with instructions provided by NCI to select the items to implement it in a clinical study. The PRO-CTCAE V1.0 includes multiple choice questions on the frequency, severity, interference, presence/absence and/or amount of specificadverse 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 supplement name is PRO-CTCAE V1.0, as provided in this document. As an item library, 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 responsibility to identify the subset of items used from the overall PRO-CTCAE V1.0 Item Library (Version 1.0). The subsetted PRO-CTCAE V1.0 user's 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 measurement system from the overall PRO-CTCAE V1.0.
For thePRO-CTCAE V1.0, QSORRES is represented with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN. Please reference 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 AE being measured, items assessing symptom presence/absence are rated as follows:
Items assessing symptom presence/absence are rated on a binary response scale and rated from 1-0 (e.g., 1 = “Yes” and 0 = “No”);
Items assessing symptom presence/absence rated on a multiple (more than two) response scale and rated from 1-0 (e.g., 1 = “Yes” and 0 = “No”, and “Not applicable”);
Items assessing symptom frequency are rated on a 5-point scale and are rated from 0-4 (e.g., 0 = “Never”, 1 = “Rarely”, 2 = “Occasionally”, 3 = “Frequently”, and 4 = “Almost constantly”).
Items assessing symptom severity are rated on a 5-point scale rated from 0-4 (e.g., 0 = “None”, 1 = “Mild”, 2 = “Moderate”, 3 = “Severe”, and 4 = “Very severe”).
QSTESTCD=PT01036A assessing symptom severity is rated on a 5-point scale rated from 0-4 (e.g., 0 = “None”, 1 = “Mild”, 2 = “Moderate”, 3 = “Severe”, and 4 = “Very severe”, "Not applicable")
Items assessing symptom interference are rated on a 5-point scale and are rated from 0-4 (e.g., 0 = “Not at all”, 1 = “A little bit”, 2 = “Somewhat”, 3 = “Quite a bit”, and 4 = “Very much”).
Items assessing symptom amount 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”).
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 two) response scale and rated from 1-0 (e.g., 1 = “Yes” and 0 = “No”,“Not sexually active”, and “Prefer not to answer”).
QSTESTCD=PT01066A, PT01068A, and PT01071A assessing sexual symptom severity are rated on a 5-point scale rated from 0-4 (e.g., 0 = “None”, 1 = “Mild”, 2 = “Moderate”, 3 = “Severe”, and 4 = “Very severe”, "Not sexually active", and “Prefer not to answer”).
QSTESTCD = "PT01067A" assessing sexual symptom frequency is rated on a 5-point scale rated from 0-4 (e.g., 0 = “Never”, 1 = “Rarely”, 2 = “Occasionally”, 3 = “Frequently”, 4 = “Almost constantly”, "Not sexually active", and “Prefer not to answer”).
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" thru "PT01091A") and severity of the symptom at its worst (QSTESTCDs "PT01082B" thru "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 populated in the QSEVLINTfield in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the PRO-CTCAE V1.0 is the past 7 days (QSEVLINT = "-P7D". Please reference the PRO-CTCAE website for more details on the evaluation interval.
Items are divided into 15 subcategories represented in the QSSCAT variable. These categorizations represent how the symptom terms are categorized in the PRO-CTCAE V1.0 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 = "QSSYMPTM". This matches the symptom term identified in the PRO-CTCAE V1.0 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 recommended by NCI/NIH in the conduct of the electronic version of the PRO-CTCAE V1.0 for symptom terms that have two or more items. The logic branches from frequency, then to severity, then to interference. For example, if frequency is > (greater than) never, you next pose the severity question, and if severity>none, you pose the interference question. Please reference the PRO-CTCAE website for more details on the electronic conditional branching approach.
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 derived 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:
QSDRVFL = "Y".
QNAM = “QSCBRFL”, QLABEL = “Conditional Branched Item Indicator “, QVAL = “Y”. (This is a QS supplemental qualifier variable.)
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 represented as a supplemental qualifier with QNAM = "QSLANGDC". Reference the PRO-CTCAE V1.0 website for a list of available language translations.
Terminology
QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.
A full list of value sets for the qualifier, and result fields is provided in Section 4, SDTM Mapping Strategy.
3.2 Example for the PRO-CTCAE V1.0 QS Domain Model
The PRO-CTCAE V1.0example below shows the terminology used to implement the measurement system in the QS domain. This example shows the data for 1 subject collected at the baseline visit for a PRO-CTCAE V1.0. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results, matching the CRF item response text, are represented inQSORRES.This result is then represented as a standard numeric score inQSSTRESNand as a standard character representation inQSSTRESC.
We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.
Example 1: PRO-CTCAE V1.0 measuring the full set of symptoms The table represents the items from the PRO-CTCAE V1.0measurement system.
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".
qs.xpt
qs.xpt
Row
STUDYID
DOMAIN
USUBJID
QSSEQ
QSTESTCD
QSTEST
QSCAT
QSSCAT
QSORRES
QSSTRESC
QSSTRESN
QSSTAT
QSREASND
QSLOBXFL
QSDRVFL
VISITNUM
QSDTC
QSEVLINT
1
STUDYX
QS
23-P0001
1
PT01001A
PT01-Dry Mouth Severity
PRO-CTCAE V1.0
ORAL
Mild
1
1
Y
1
2015-05-15
-P7D
2
STUDYX
QS
23-P0001
2
PT01002A
PT01-Difficulty Swallowing Severity
PRO-CTCAE V1.0
ORAL
Mild
1
1
Y
1
2015-05-15
-P7D
3
STUDYX
QS
23-P0001
3
PT01003A
PT01-Mouth/Throat Sores Severity
PRO-CTCAE V1.0
ORAL
Mild
1
1
Y
1
2015-05-15
-P7D
4
STUDYX
QS
23-P0001
4
PT01003B
PT01-Mouth/Throat Sores Interference
PRO-CTCAE V1.0
ORAL
A little bit
1
1
Y
1
2015-05-15
-P7D
5
STUDYX
QS
23-P0001
5
PT01004A
PT01-Cracking Corners of Mouth Severity
PRO-CTCAE V1.0
ORAL
Mild
1
1
Y
1
2015-05-15
-P7D
6
STUDYX
QS
23-P0001
6
PT01005A
PT01-Voice Quality Changes Presence
PRO-CTCAE V1.0
ORAL
No
0
0
Y
1
2015-05-15
-P7D
7
STUDYX
QS
23-P0001
7
PT01006A
PT01-Hoarseness Severity
PRO-CTCAE V1.0
ORAL
Mild
1
1
Y
1
2015-05-15
-P7D
8
STUDYX
QS
23-P0001
8
PT01007A
PT01-Taste Changes Severity
PRO-CTCAE V1.0
GASTROINTESTINAL
Mild
1
1
Y
1
2015-05-15
-P7D
9
STUDYX
QS
23-P0001
9
PT01008A
PT01-Decreased Appetite Severity
PRO-CTCAE V1.0
GASTROINTESTINAL
Mild
1
1
Y
1
2015-05-15
-P7D
10
STUDYX
QS
23-P0001
10
PT01008B
PT01-Decreased Appetite Interference
PRO-CTCAE V1.0
GASTROINTESTINAL
Somewhat
2
2
Y
1
2015-05-15
-P7D
11
STUDYX
QS
23-P0001
11
PT01009A
PT01-Nausea Frequency
PRO-CTCAE V1.0
GASTROINTESTINAL
Occasionally
2
2
Y
1
2015-05-15
-P7D
12
STUDYX
QS
23-P0001
12
PT01009B
PT01-Nausea Severity
PRO-CTCAE V1.0
GASTROINTESTINAL
Mild
1
1
Y
1
2015-05-15
-P7D
13
STUDYX
QS
23-P0001
13
PT01010A
PT01-Vomiting Frequency
PRO-CTCAE V1.0
GASTROINTESTINAL
Occasionally
2
2
Y
1
2015-05-15
-P7D
14
STUDYX
QS
23-P0001
14
PT01010B
PT01-Vomiting Severity
PRO-CTCAE V1.0
GASTROINTESTINAL
Mild
1
1
Y
1
2015-05-15
-P7D
15
STUDYX
QS
23-P0001
15
PT01011A
PT01-Heartburn Frequency
PRO-CTCAE V1.0
GASTROINTESTINAL
Occasionally
2
2
Y
1
2015-05-15
-P7D
16
STUDYX
QS
23-P0001
16
PT01011B
PT01-Heartburn Severity
PRO-CTCAE V1.0
GASTROINTESTINAL
Mild
1
1
Y
1
2015-05-15
-P7D
17
STUDYX
QS
23-P0001
17
PT01012A
PT01-Gas Presence
PRO-CTCAE V1.0
GASTROINTESTINAL
No
0
0
Y
1
2015-05-15
-P7D
18
STUDYX
QS
23-P0001
18
PT01013A
PT01-Bloating Frequency
PRO-CTCAE V1.0
GASTROINTESTINAL
Occasionally
2
2
Y
1
2015-05-15
-P7D
19
STUDYX
QS
23-P0001
19
PT01013B
PT01-Bloating Severity
PRO-CTCAE V1.0
GASTROINTESTINAL
Mild
1
1
Y
1
2015-05-15
-P7D
20
STUDYX
QS
23-P0001
20
PT01014A
PT01-Hiccups Frequency
PRO-CTCAE V1.0
GASTROINTESTINAL
Never
0
0
Y
1
2015-05-15
-P7D
21
STUDYX
QS
23-P0001
21
PT01014B
PT01-Hiccups Severity
PRO-CTCAE V1.0
GASTROINTESTINAL
None
0
0
Y
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
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
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
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The suppqs dataset shows the items in the qs dataset which have assigned responses (QSDRVFL = "Y") due to electronic conditional branching and also relates the symptom terms from the PRO-CTCAE ITEM LIBRARY (Version 1.0) to each symptom item represented in the qs dataset.
$titleHtml
suppqs.xpt
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
QORIG
STUDYX
QS
23-P0001
QSSEQ
21
QSCBRFL
Conditional Branching Item Indicator
Y
ASSIGNED
STUDYX
QS
23-P0001
QSSEQ
25
QSCBRFL
Conditional Branching Item Indicator
Y
ASSIGNED
STUDYX
QS
23-P0001
QSSEQ
26
QSCBRFL
Conditional Branching Item Indicator
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
STUDYX
QS
23-P0001
QSTESTCD
PT01071A
QSSYMPTM
Symptom Term
PAIN W/SEXUAL INTERCOURSE
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01072A
QSSYMPTM
Symptom Term
BREAST SWELLING AND TENDERNESS
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01073A
QSSYMPTM
Symptom Term
BRUISING
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01074A
QSSYMPTM
Symptom Term
CHILLS
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01074B
QSSYMPTM
Symptom Term
CHILLS
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01075A
QSSYMPTM
Symptom Term
INCREASED SWEATING
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01075B
QSSYMPTM
Symptom Term
INCREASED SWEATING
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01076A
QSSYMPTM
Symptom Term
DECREASED SWEATING
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01077A
QSSYMPTM
Symptom Term
HOT FLASHES
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01077B
QSSYMPTM
Symptom Term
HOT FLASHES
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01078A
QSSYMPTM
Symptom Term
NOSEBLEED
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01078B
QSSYMPTM
Symptom Term
NOSEBLEED
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01079A
QSSYMPTM
Symptom Term
PAIN AND SWELLING AT INJECTION SITE
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01080A
QSSYMPTM
Symptom Term
BODY ODOR
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01081
QSSYMPTM
Symptom Term
ANY OTHER SYMPTOMS REPORTED
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01082A
QSSYMPTM
Symptom Term
OTHER SYMPTOM 1
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01082B
QSSYMPTM
Symptom Term
OTHER SYMPTOM 1
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01083A
QSSYMPTM
Symptom Term
OTHER SYMPTOM 2
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01083B
QSSYMPTM
Symptom Term
OTHER SYMPTOM 2
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01084A
QSSYMPTM
Symptom Term
OTHER SYMPTOM 3
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01084B
QSSYMPTM
Symptom Term
OTHER SYMPTOM 3
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01085A
QSSYMPTM
Symptom Term
OTHER SYMPTOM 4
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01085B
QSSYMPTM
Symptom Term
OTHER SYMPTOM 4
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01086A
QSSYMPTM
Symptom Term
OTHER SYMPTOM 5
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01086B
QSSYMPTM
Symptom Term
OTHER SYMPTOM 5
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01087A
QSSYMPTM
Symptom Term
OTHER SYMPTOM 6
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01087B
QSSYMPTM
Symptom Term
OTHER SYMPTOM 6
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01088A
QSSYMPTM
Symptom Term
OTHER SYMPTOM 7
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
$warningHtml
Example 2: PRO-CTCAE V1.0 measuring the subset of symptoms from the followingsubcategories as represented in the PRO-CTCAE ITEM LIBRARY (Version 1.0).
RESPIRATORY
CARDIO/CIRCULATORY
NEUROLOGICAL
ATTENTION/MEMORY
The table represents the subset of items from the PRO-CTCAE V1.0measurement 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".
qs.xpt
qsxx.xpt.xpt
Row
STUDYID
DOMAIN
USUBJID
QSSEQ
QSTESTCD
QSTEST
QSCAT
QSSCAT
QSORRES
QSSTRESC
QSSTRESN
QSSTAT
QSREASND
QSLOBXFL
VISITNUM
QSDTC
QSEVLINT
1
STUDYX
QS
23-P0001
1
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
2
PT01019B
PT01-Shortness of Breath Interference
PRO-CTCAE V1.0
RESPIRATORY
Somewhat
2
2
Y
1
2015-05-15
-P7D
3
STUDYX
QS
23-P0001
3
PT01020A
PT01-Cough Severity
PRO-CTCAE V1.0
RESPIRATORY
Mild
1
1
Y
1
2015-05-15
-P7D
4
STUDYX
QS
23-P0001
4
PT01020B
PT01-Cough Interference
PRO-CTCAE V1.0
RESPIRATORY
Somewhat
2
2
Y
1
2015-05-15
-P7D
5
STUDYX
QS
23-P0001
5
PT01021A
PT01-Wheezing Severity
PRO-CTCAE V1.0
RESPIRATORY
Mild
1
1
Y
1
2015-05-15
-P7D
6
STUDYX
QS
23-P0001
6
PT01022A
PT01-Swelling Frequency
PRO-CTCAE V1.0
CARDIO/CIRCULATORY
Occasionally
2
2
Y
1
2015-05-15
-P7D
7
STUDYX
QS
23-P0001
7
PT01022B
PT01-Swelling Severity
PRO-CTCAE V1.0
CARDIO/CIRCULATORY
Mild
1
1
Y
1
2015-05-15
-P7D
8
STUDYX
QS
23-P0001
8
PT01022C
PT01-Swelling Interference
PRO-CTCAE V1.0
CARDIO/CIRCULATORY
Somewhat
2
2
Y
1
2015-05-15
-P7D
9
STUDYX
QS
23-P0001
9
PT01023A
PT01-Heart Palpitations Frequency
PRO-CTCAE V1.0
CARDIO/CIRCULATORY
Occasionally
2
2
Y
1
2015-05-15
-P7D
10
STUDYX
QS
23-P0001
10
PT01023B
PT01-Heart Palpitations Severity
PRO-CTCAE V1.0
CARDIO/CIRCULATORY
Mild
1
1
Y
1
2015-05-15
-P7D
11
STUDYX
QS
23-P0001
11
PT01039A
PT01-Numbness & Tingling Severity
PRO-CTCAE V1.0
NEUROLOGICAL
Mild
1
1
Y
1
2015-05-15
-P7D
12
STUDYX
QS
23-P0001
12
PT01039B
PT01-Numbness & Tingling Interference
PRO-CTCAE V1.0
NEUROLOGICAL
Somewhat
2
2
Y
1
2015-05-15
-P7D
13
STUDYX
QS
23-P0001
13
PT01040A
PT01-Dizziness Severity
PRO-CTCAE V1.0
NEUROLOGICAL
Mild
1
1
Y
1
2015-05-15
-P7D
14
STUDYX
QS
23-P0001
14
PT01040B
PT01-Dizziness Interference
PRO-CTCAE V1.0
NEUROLOGICAL
Somewhat
2
2
Y
1
2015-05-15
-P7D
15
STUDYX
QS
23-P0001
15
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
16
PT01046B
PT01-Concentration Problems Interference
PRO-CTCAE V1.0
ATTENTION/MEMORY
Somewhat
2
2
Y
1
2015-05-15
-P7D
17
STUDYX
QS
23-P0001
17
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
18
PT01047B
PT01-Memory Problems Interference
PRO-CTCAE V1.0
ATTENTION/MEMORY
Somewhat
2
2
Y
1
2015-05-15
-P7D
19
STUDYX
QS
23-P0001
19
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
20
PT01082A
PT01-Other Symptom 1
PRO-CTCAE V1.0
OTHER SYMPTOMS
Another symptom 1
Another symptom 1
Y
1
2015-05-15
-P7D
21
STUDYX
QS
23-P0001
21
PT01082B
PT01-Other Symptom 1 Severity
PRO-CTCAE V1.0
OTHER SYMPTOMS
Mild
1
1
Y
1
2015-05-15
-P7D
22
STUDYX
QS
23-P0001
22
PT01083A
PT01-Other Symptom 2
PRO-CTCAE V1.0
OTHER SYMPTOMS
Another symptom 2
Another symptom 2
Y
1
2015-05-15
-P7D
23
STUDYX
QS
23-P0001
23
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
24
PT01084A
PT01-Other Symptom 3
PRO-CTCAE V1.0
OTHER SYMPTOMS
NOT DONE
1
2015-05-15
-P7D
25
STUDYX
QS
23-P0001
25
PT01084B
PT01-Other Symptom 3 Severity
PRO-CTCAE V1.0
OTHER SYMPTOMS
NOT DONE
1
2015-05-15
-P7D
26
STUDYX
QS
23-P0001
26
PT01085A
PT01-Other Symptom 4
PRO-CTCAE V1.0
OTHER SYMPTOMS
NOT DONE
1
2015-05-15
-P7D
27
STUDYX
QS
23-P0001
27
PT01085B
PT01-Other Symptom 4 Severity
PRO-CTCAE V1.0
OTHER SYMPTOMS
NOT DONE
1
2015-05-15
-P7D
28
STUDYX
QS
23-P0001
28
PT01086A
PT01-Other Symptom 5
PRO-CTCAE V1.0
OTHER SYMPTOMS
NOT DONE
1
2015-05-15
-P7D
29
STUDYX
QS
23-P0001
29
PT01086B
PT01-Other Symptom 5 Severity
PRO-CTCAE V1.0
OTHER SYMPTOMS
NOT DONE
1
2015-05-15
-P7D
30
STUDYX
QS
23-P0001
30
PT01087A
PT01-Other Symptom 6
PRO-CTCAE V1.0
OTHER SYMPTOMS
NOT DONE
1
2015-05-15
-P7D
31
STUDYX
QS
23-P0001
31
PT01087B
PT01-Other Symptom 6 Severity
PRO-CTCAE V1.0
OTHER SYMPTOMS
NOT DONE
1
2015-05-15
-P7D
32
STUDYX
QS
23-P0001
32
PT01088A
PT01-Other Symptom 7
PRO-CTCAE V1.0
OTHER SYMPTOMS
NOT DONE
1
2015-05-15
-P7D
33
STUDYX
QS
23-P0001
33
PT01088B
PT01-Other Symptom 7 Severity
PRO-CTCAE V1.0
OTHER SYMPTOMS
NOT DONE
1
2015-05-15
-P7D
34
STUDYX
QS
23-P0001
34
PT01089A
PT01-Other Symptom 8
PRO-CTCAE V1.0
OTHER SYMPTOMS
NOT DONE
1
2015-05-15
-P7D
35
STUDYX
QS
23-P0001
35
PT01089B
PT01-Other Symptom 8 Severity
PRO-CTCAE V1.0
OTHER SYMPTOMS
NOT DONE
1
2015-05-15
-P7D
36
STUDYX
QS
23-P0001
36
PT01090A
PT01-Other Symptom 9
PRO-CTCAE V1.0
OTHER SYMPTOMS
NOT DONE
1
2015-05-15
-P7D
37
STUDYX
QS
23-P0001
37
PT01090B
PT01-Other Symptom 9 Severity
PRO-CTCAE V1.0
OTHER SYMPTOMS
NOT DONE
1
2015-05-15
-P7D
38
STUDYX
QS
23-P0001
38
PT01091A
PT01-Other Symptom 10
PRO-CTCAE V1.0
OTHER SYMPTOMS
NOT DONE
1
2015-05-15
-P7D
39
STUDYX
QS
23-P0001
39
PT01091B
PT01-Other Symptom 10 Severity
PRO-CTCAE V1.0
OTHER SYMPTOMS
NOT DONE
1
2015-05-15
-P7D
$warningHtml
The suppqs dataset relates the symptom terms from the PRO-CTCAE ITEM LIBRARY (Version 1.0) to each symptom item represented in the subset of symptoms in the qs dataset.
$titleHtml
suppqsxx.xpt.xpt
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
QORIG
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
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
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
PT01081
QSSYMPTM
Symptom Term
ANY OTHER SYMPTOMS REPORTED
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01082A
QSSYMPTM
Symptom Term
OTHER SYMPTOM 1
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01082B
QSSYMPTM
Symptom Term
OTHER SYMPTOM 1
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01083A
QSSYMPTM
Symptom Term
OTHER SYMPTOM 2
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01083B
QSSYMPTM
Symptom Term
OTHER SYMPTOM 2
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01084A
QSSYMPTM
Symptom Term
OTHER SYMPTOM 3
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01084B
QSSYMPTM
Symptom Term
OTHER SYMPTOM 3
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01085A
QSSYMPTM
Symptom Term
OTHER SYMPTOM 4
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01085B
QSSYMPTM
Symptom Term
OTHER SYMPTOM 4
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01086A
QSSYMPTM
Symptom Term
OTHER SYMPTOM 5
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01086B
QSSYMPTM
Symptom Term
OTHER SYMPTOM 5
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01087A
QSSYMPTM
Symptom Term
OTHER SYMPTOM 6
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01087B
QSSYMPTM
Symptom Term
OTHER SYMPTOM 6
CRF
STUDYX
QS
23-P0001
QSTESTCD
PT01088A
QSSYMPTM
Symptom Term
OTHER SYMPTOM 7
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
$warningHtml
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, the PRO-CTCAE V1.0symptom terms are grouped into subcategories as represented in the PRO-CTCAE ITEM LIBRARY (Version 1.0). 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.