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Revision History

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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 National Cancer Institute (NCI) at the NATIONAL INSTITUTES OF HEALTH National Institutes of Health (NIH)   owns the copyright for the PRO-CTCAE V1.0 measurement system and 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 developed QSTESTCD and QSTEST for each item based on the actual text on the measurement system. 

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1. 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.

2. For the PRO-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:

   1. Depending on the symptomatic AE being measured, items assessing symptom presence/absence are rated as follows:
      1. Items assessing symptom presence/absence are rated on a binary response scale and rated from 1-0 -1 (e.g., 1 = “Yes” and 0 = “No” and 1 = “Yes”);
      2. Items assessing symptom presence/absence rated on a multiple (more than two) response scale and rated from 1-0 -1 (e.g., 1 = “Yes” and 0 = “No”, 1 = “Yes”, and “Not applicable”);
   2. 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”).
   3. Items assessing symptom severity are rated on a 5-point scale rated from 0-4 (e.g., 0 = “None”, 1 = “Mild”, 2 = “Moderate”, 3 = “Severe”, and 4 = “Very severe”).
      1. 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")
   4. 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”).
   5. 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”).
   6. QSTESTCD = "PT01066A " to "PT01071A" sexual symptoms have specific responses .
      1. QSTESTCD=PT01069A and QSTESTCD=PT01070A assessing sexual symptom presence/absence are rated on multiple (more than two) response scale and rated from 1-0 -1 (e.g., 1 = “Yes” and 0 = “No”, 1 = “Yes”, “Not sexually active”, and “Prefer not to answer”).

      2. 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”).

      3. 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”, and 4 = “Almost constantly”, "Not sexually active", and “Prefer not to answer”).
3. 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 "PT0191APT01091A") and severity of the symptom at its worst (QSTESTCDs "PT01082B" thru "PT0191BPT01091B").
4. 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.).
5. 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 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.
6. 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. 
   1. The symptomatic AE being measured by a given item (e.g., the Symptom Term represented on the CRF corresponding to a given item) is stored in the SUPPQS dataset with the QNAM = "QSSYMPTM". This matches the symptom term identified in the PRO-CTCAE V1.0 Item Library (Version 1.0). The exception to this is the solicited verbatim symptom terms QSTESTCD = "PT010081 PT01081 to PT01091B"with QNAM = "OTHER SYMPTOMS".

7. Electronic conditional branching is recommended by NCI/NIH in the conduct 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. In the conduct of the PRO-CTCAE V1.0 it expects responses for each item and there should be no missing responses. Electronic branched severity items are assigned responses of 0 = "None" and electronic branched interference items are assigned 0 = "Not al all".

8. 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.
9. Terminology

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

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

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

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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".

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.

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All PRO-CTCAE V1.0 Presence/Absence Questions

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