PRO-CTCAE Version 1.0 Release Notes
May 11 2023

English
Adjusted labeling of English PRO-CTCAE item library to include “(Universal)” following validation testing in USA, Australia, Canada, and the UK to create a single, harmonized version.
Apr 25 2023

Spanish
Adjusted labeling of Spanish PRO-CTCAE item library to include “(Universal)” following validation testing in USA, Spain, and Chile to create a single, harmonized version.
Apr 25 2023

Russian
Adjusted labeling of Russian PRO-CTCAE item library to include “(Universal)” following validation testing in Russia, Ukraine, and Israel to create a single, harmonized version.
Apr 25 2023

German
Adjusted labeling of German PRO-CTCAE item library to include “(Universal)” following validation testing in Germany, Austria, and Switzerland to create a single, harmonized version.
Apr 25 2023

Chinese (Traditional)
Adjusted labeling of Chinese (Traditional) PRO-CTCAE item library to include “(Universal)” following validation testing in USA, Taiwan, and Hong Kong to create a single, harmonized version.
Feb 21 2023

Arabic
- PRO-CTCAE Item 18. Symptom Term: Fecal incontinence: Parenthetical (الغائط) added to improve comprehension following validation testing in USA, Saudi Arabia, and Morocco.
- PRO-CTCAE Item 22. Symptom Term: Swelling: Parenthetical (انتفاخ) added to improve comprehension following validation testing in USA, Saudi Arabia, and Morocco.
- PRO-CTCAE Item 32. Symptom Term: Nail Ridging: Parenthetical (خطوط) added to improve comprehension following validation testing in USA, Saudi Arabia, and Morocco.
- PRO-CTCAE Item 70. Symptom Term: Unable to have orgasm: Minor grammatical adjustment made to emphasize universality of the question to all respondents regardless of gender following validation testing in USA, Saudi Arabia, and Morocco.
- Other Symptoms: Correction of typographical errors in the first question in 'Other Symptoms' section.
Nov 11 2022

Tamil
Correction of typographical errors in item 31a (Symptom term: nail loss) and item 32a (Symptom term: nail ridging).
Sep 20 2022

Korean
Correction of minor typographical errors in items 11, 55, and 64.
Jul 6 2022

Arabic
Correction of minor typographical error in the English anchoring content in the 'Other Symptoms' question.
Jul 6 2022

Hebrew
Correction of minor typographical error in the English anchoring content in the 'Other Symptoms' question.
May 11 2022

Hebrew
Respondent instructions corrected to include the phrase “over the past 7 days”.
May 11 2022

Portuguese (Brazil)
Correction of typographical error in item 28.
Apr 21 2022

Italian
Correction of typographical error in item 64.
Mar 25 2022

English
Correction of a minor typographical error in item 57.
Jan 28 2022

Hebrew
Correction of typographical errors in items 7a, 14b, 39a, and 58a.
Jan 28 2022

Multiple Languages
Languages affected
English; Afrikaans; Arabic; Bulgarian; Chinese (Simplified); Chinese (Traditional); Czech; Danish; Dutch (for Belgium and the Netherlands); Finnish; French (Canada); French (Belgium, France, and Switzerland); German; Greek; Hebrew; Hungarian; Italian; Japanese; Korean; Malay; Norwegian; Polish; Portuguese (Brazil); Portuguese (Portugal); Romanian; Russian; Slovak; Spanish; Swedish; Tamil; Thai; Turkish; Ukrainian
Updates
Adjusted labeling of PRO-CTCAE from “PRO-CTCAE™” to “PRO-CTCAE®”.
Jan 28 2022

Multiple Languages
Languages
English; Chinese (Simplified); Italian
Updates
Adjusted labeling of Pediatric PRO-CTCAE/Ped-PRO-CTCAE/Ped-PRO-CTCAE [Caregiver] from “Pediatric-PRO-CTCAE™”/“Ped-PRO-CTCAE™/Ped-PRO-CTCAE™[Caregiver]” to “Pediatric-PRO-CTCAE®”/“Ped-PRO-CTCAE® / Ped-PRO-CTCAE®[Caregiver]”.
Jun 2 2020

French (Belgium, France and Switzerland)
Correction of typographical error in item 76 and in the response choices for the 'Other Symptoms' questions.
Jun 2 2020

Portuguese (Brazil)
Correction of typographical error in respondent instructions.
Jun 2 2020

Turkish
Correction of typographical error in item 52b.
May 11 2020

Czech
Correction of a minor typographical error in item 51a.
Apr 29 2020

Danish
Correction to the questions soliciting additional symptoms to include the recall period of "In the last 7 days" to the questions soliciting additional symptoms.
Apr 15 2020

Chinese (Traditional)
Respondent instructions rephrased to be inclusive of electronic administration.
Previous respondent instructions: As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please check or mark an X in the one box that best describes your experiences over the past 7 days…
Revised respondent instructions: As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please select the one response that best describes your experiences over the past 7 days.
Minor phrasing revisions to address findings from linguistic validation study performed in Hong Kong:
- PRO-CTCAE Item 35. Symptom Term: Bed/pressure sores:
Parenthetical added to improve comprehension. - PRO-CTCAE Item 51. Symptom Term: Joint pain:
Elaboration of the term 'elbows' added to improve comprehension.
Apr 9 2020

Multiple Languages
Languages
Chinese (Simplified); Czech; Danish; Dutch (for Belgium and the Netherlands); French (Canada); French (Belgium, France, and Switzerland); German; Hungarian; Japanese; Korean; Malay; Polish; Portuguese (Brazil); Portuguese (Portugal); Romanian; Spanish (Universal); Turkish
Updates
Respondent instructions rephrased to be inclusive of electronic administration.
Previous respondent instructions: As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please check or mark an X in the one box that best describes your experiences over the past 7 days…
Revised respondent instructions: As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please select the one response that best describes your experiences over the past 7 days.
Apr 8 2020

Italian
Respondent instructions rephrased to be inclusive of electronic administration.
Previous respondent instructions: As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please check or mark an X in the one box that best describes your experiences over the past 7 days…
Revised respondent instructions: As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please select the one response that best describes your experiences over the past 7 days…
Correction of minor typographical errors in items 9a, 9b, 12a, 21a, 29a, 30a, 31a, 48a, 48b, 48c, 51a, 51b, 51c, 52a, 52b, 53b, and 75b.
Mar 30 2020

English (Universal)
Respondent instructions rephrased to be inclusive of electronic administration.
Previous respondent instructions: As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please check or mark an X in the one box that best describes your experiences over the past 7 days…
Revised respondent instructions: As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please select the one response that best describes your experiences over the past 7 days.
Mar 18 2020

Greek
Respondent instructions rephrased to be inclusive of electronic administration.
Previous respondent instructions: As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please check or mark an X in the one box that best describes your experiences over the past 7 days…
Revised respondent instructions: As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please select the one response that best describes your experiences over the past 7 days.
Feb 6 2020

Russian (Universal)
Correction of minor typographical errors in items 22b and 65a.
Feb 1 2020

Greek
Correction of typographical error in phrasing of item 44b, the interference item for watery eyes.
Feb 1 2018

English (Universal)
- PRO-CTCAE Item 16. Symptom Term: Diarrhea: UK spelling was added to the item "DIARRHEA/DIARRHOEA"
- PRO-CTCAE Item 75. Symptom Term: Increased sweating: "(Not related to hot flashes)" revised to "(Not related to hot flashes/flushes)" to localize for UK
- PRO-CTCAE Item 77. Symptom Term: Hot flashes: Hot flashes revised to Hot flashes/flushes to localize for UK
Feb 1 2018

Spanish (Universal)
- PRO-CTCAE Item 6. Symptom Term: Hoarseness: Parenthetical (VOZ RONCA) added to improve comprehension
- PRO-CTCAE Item 38. Symptom Term: Stretch marks: Parenthetical (RAYAS O LÍNEAS) added to improve comprehension
- PRO-CTCAE Item 72. Symptom Term: Breast swelling and tenderness: Parenthetical (SENSIBILIDAD AL TOCARLO) added to improve comprehension.