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The PRO-CTCAE V1.0 VERSION DATE 4/26/2020 is a patient-reported outcome (PRO) instrument developed to capture symptomatic adverse events of patients in cancer clinical trials. The PRO-CTCAE V1.0 VERSION DATE 4/26/2020 was designed to be used in conjunction with the Common Terminology Criteria for Adverse Events (CTCAE).[1] It consists of an item library rather than a static/fixed question type of instrument. You should use the form builder at: https://healthcaredelivery.cancer.gov/pro-ctcae/instrument.htmlas described on the PRO-CTCAE website to build CRFs and instructions provided by NCI to select the items to implement in your clinical study. The PRO-CTCAE V1.0 VERSION DATE 4/26/2020 includes multiple choice questions on the frequency, severity, interference, presence/absence and/or amount of specific adverse events.

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1. As a CDISC QRS standard, the instrument name is PRO-CTCAE V1.0 VERSION DATE 4/26/2020, 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 VERSION DATE 4/26/2020 user's instrument should be titled "PRO-CTCAE sponsor-specified symptoms..." based on the usersponsor's discretion when they identify the specific items being used. This will distinctly describe the subsetted instrument from the overall PRO-CTCAE V1.0 VERSION DATE 4/26/2020.

2. For the PRO-CTCAE V1.0 VERSION DATE 4/26/2020, 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 VERSION DATE 4/26/2020 are as follows:

   1. Depending on the symptomatic AE being measured, items assessing symptom presence/absence are rated as follows:
      1. Items rated on a binary response scale and scored rated from " 0-1 " (e.g., " 0 " = “No” and "1" 1 = “Yes”);
      2. Items rated on multiple (more than two) response scale and scored 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 scored 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 scored 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 scored 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 scored 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 scored 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 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 VERSION DATE 4/26/2020 is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. The recommended evaluation interval for the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 is the past 7 days (QSEVLINT = "-P7D". Please reference the PRO-CTCAE website for more details on the evaluation interval at: https://healthcaredelivery.cancer.gov/pro-ctcae/faqs.html.
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 = "QSSYMTRM". This matches the symptom term identified in the PRO-CTCAE V1.0 Item Library (Version 1.0).

7. Conditional branching is used in the conduct of the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 for symptom terms that have two or more items. The logic branches from frequency, then to severity, then to interference. For example, if frequency is > (greater than) never, you next pose the severity question, and if severity>none, you pose the interference question. Please reference the PRO-CTCAE website for more details on the conditional branching approach at: https://healthcaredelivery.cancer.gov/pro-ctcae/faqs.html.

   1. These branching items on the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 may be logically skipped per the instrument instructions. For example, if the item "In the last 7 days, how OFTEN did you have PAIN IN THE ABDOMEN (BELLY AREA)?" (QSTESTCD = "PT01017A") is answered as "Never", 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:

      1. QSSTAT = "NOT DONE".

      2. QSREASND = "LOGICALLY SKIPPED ITEM".
         

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

      4. 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.
8. The language in which the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 was administered (e.g., English, Spanish, Japanese) is collected with the Form Builder application and may be represented as a supplemental qualifier with QNAM = "QSLANG". Reference the PRO-CTCAE V1.0 website for a list of available translations at: https://healthcaredelivery.cancer.gov/pro-ctcae/.
9. 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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