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1. As a CDISC QRS standard, the instrument name is PRO-CTCAE V1.0, as provided in this supplement. 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 instrument 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 from the overall PRO-CTCAE V1.0.

2. For the PRO-CTCAE V1.0, QSORRES is populated 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 rated on a binary response scale and rated from 0-1 (e.g., 0 = “No” and 1 = “Yes”);
      2. Items rated on multiple (more than two) response scale and rated from 0-1 (e.g., 0 = “No”, 1 = “Yes”, and “Not applicable” or "Not Applicable"); or
      3. Items rated on multiple (more than two) response scale and rated from 0-1 (e.g., 0 = “No”, 1 = “Yes”, “Not sexually active”, and “Prefer not to answer”).
   2. 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”).
   3. 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”, "Not sexually
      active", and “Prefer not to answer”).
   4. Items assessing 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”).
   5. 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”).
3. The CRF represents up to 5 "other symptoms" to be recorded. In discusions discussions with NIH, it was agreed to provide up to 10 "other symptoms" to be recorded if they existed. QSTESTCDs (QSTESTCDs "PT01082A" thru "PT0191A") and severity of the symptom at its worst (QSTESTCDs "PT01082B" thru "PT0191B").
4. Total scoring instructions have not yet been developed. Item-level scores are not combined (i.e., No total score nor symptom-specific scores are calculated.).
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 recommended 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 at: https://healthcaredelivery.cancer.gov/pro-ctcae/faqs.html.evaluation interval.
6. Items are divided into 14 subcategories represented in the QSSCAT variable. These categorizations represent how the symptom terms are categorized in the PRO-CTCAE V1.0 Item Library (Version 1.0). See Section 4, SDTM Mapping Strategy, for a list of these subcategory values. 
   1. The symptomatic AE being measured by a given item (e.g., the Symptom Term represented on the CRF corresponding to a given item) is stored in the SUPPQS dataset with the QNAM = "QSSYMTRMQSSYMPTM". This matches the symptom term identified in the PRO-CTCAE V1.0 Item Library (Version 1.0).

7. Electronic Conditional branching is used 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 conditional branching approach at: https://healthcaredelivery.cancer.gov/pro-ctcae/faqs.html.

   These branching items on the 

   . In the conduct of 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:

8. QSSTAT = "NOT DONE".

9. QSREASND = "LOGICALLY SKIPPED ITEM".
   

10. 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

it expects responses for each item and there should be no missing responses.

11. 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 the PRO-CTCAE V1.0 website for a list of available translations at: https://healthcaredelivery.cancer.gov/pro-ctcae/.language translations.
12. Terminology

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

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

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All PRO-CTCAE V1.0 Interference Questions

All PRO-CTCAE V1.0 Frequency Questions

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All PRO-CTCAE V1.0 Amount Questions

--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"

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

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

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

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

--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"

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