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PRO-CTCAE Version 1.0 Release Notes
Feb 24 2025
Chinese (Simplified)
Minor typographical errors were corrected in the free text item soliciting additional symptoms to report.
Nov 11 2024
Czech
PRO-CTCAE Item 53b. Symptom Term: Fatigue: Correction of typographical error to add missing term VYČERPANOST.
Jul 5 2024
Chinese (Simplified)
- Pediatric PRO-CTCAE®/Pediatric PRO-CTCAE® [Caregiver] versioning updated to v1.1 to correspond to changes made to the English source following validation testing and harmonization in Canada, the UK, and Australia.
- Ped-PRO-CTCAE Item 9a, 9b, 9c. Symptom Term: Nausea: Parenthetical updated for translation of ‘nausea’ to ‘like you might have to throw up’ to correspond to changes made to the English source. Corresponding phrasing changes made to Ped-PRO-CTCAE [Caregiver] items 9a, 9b, 9c.
- Ped-PRO-CTCAE Item 35a, 35b. Symptom Term: Flashing lights: Item was revised to update translation of ‘flashes of light’ to ‘flashes or sparks of light’ and reference to eyes being open or closed was clarified as ‘that were there even when your eyes were closed’ to correspond to changes made to the English source. Corresponding phrasing changes made to Ped-PRO-CTCAE [Caregiver] items 35a, 35b.
- Ped-PRO-CTCAE Item 39a, 39b. Symptom Term: Concentration: Added translation of ‘for example’ to the parenthetical to correspond to changes made to the English source. Corresponding phrasing changes made to Ped-PRO-CTCAE [Caregiver] items 39a, 39b.
- Ped-PRO-CTCAE Item 44a, 44b, 44c. Symptom Term: Joint Pain: Added translation of ‘like your’ to the parenthetical to correspond to changes made to the English source. Corresponding phrasing changes made to Ped-PRO-CTCAE [Caregiver] items 44a, 44b, 44c.
Jul 5 2024
Italian
- Pediatric PRO-CTCAE®/Pediatric PRO-CTCAE® [Caregiver] versioning updated to v1.1 to correspond to changes made to the English source following validation testing and harmonization in Canada, the UK, and Australia.
- Ped-PRO-CTCAE Item 9a, 9b, 9c. Symptom Term: Nausea: Parenthetical updated from ‘nausea’ to ‘come se dovessi vomitare’ to correspond to changes made to the English source. Corresponding phrasing changes made to Ped-PRO-CTCAE [Caregiver] items 9a, 9b, 9c.
- Ped-PRO-CTCAE Item 35a, 35b. Symptom Term: Flashing lights: Item was revised to update ‘visto dei lampi’ to ‘visto dei lampi o delle scintille di luce’ and reference to eyes being open or closed was clarified as ‘anche quando avevi gli occhi chiusi’ to correspond to changes made to the English source. Corresponding phrasing changes made to Ped-PRO-CTCAE [Caregiver] items 35a, 35b.
- Ped-PRO-CTCAE Item 39a, 39b. Symptom Term: Concentration: Added ‘ad esempio’ to the parenthetical to correspond to changes made to the English source. Corresponding phrasing changes made to Ped-PRO-CTCAE [Caregiver] items 39a, 39b.
- Ped-PRO-CTCAE Item 44a, 44b, 44c. Symptom Term: Joint Pain: Added ‘come’ to the parenthetical to correspond to changes made to the English source. Corresponding phrasing changes made to Ped-PRO-CTCAE [Caregiver] items 44a, 44b, 44c.
Jul 5 2024
English
- Pediatric PRO-CTCAE®/Pediatric PRO-CTCAE® [Caregiver] versioning updated to v1.1 to incorporate changes made to items following validation testing and harmonization in Canada, the UK, and Australia.
- Adjusted labeling of English Pediatric PRO-CTCAE®/Pediatric PRO-CTCAE® [Caregiver] item libraries to include “(Universal)” following validation testing in USA, Australia, Canada, and the UK to create a single, harmonized version.
- Ped-PRO-CTCAE Item 9a, 9b, 9c. Symptom Term: Nausea: Parenthetical updated from ‘nausea’ to ‘like you might have to throw up’ to improve comprehension following validation testing in Canada, the UK, and Australia. Corresponding phrasing changes made to Ped-PRO-CTCAE [Caregiver] items 9a, 9b, 9c.
- Ped-PRO-CTCAE Item 15a, 15b, 15c. Symptom Term: Constipation: ‘Poo’ added as alternative phrasing for ‘poop’ to improve comprehension following validation testing in Canada, the UK, and Australia. Corresponding phrasing changes made to Ped-PRO-CTCAE [Caregiver] items 15a, 15b, 15c.
- Ped-PRO-CTCAE Item 16a, 16b. Symptom Term: Diarrhea: ‘Poo’ added as alternative phrasing for ‘poop’ to improve comprehension following validation testing in Canada, the UK, and Australia. Corresponding phrasing changes made to Ped-PRO-CTCAE [Caregiver] items 16a, 16b.
- Ped-PRO-CTCAE Item 18a, 18b. Symptom Term: Fecal incontinence: ‘Poo’ added as alternative phrasing for ‘poop’, and ‘pooing’ added as an alternative phrasing for ‘pooping’, to improve comprehension following validation testing in Canada, the UK, and Australia. Corresponding phrasing changes made to Ped-PRO-CTCAE [Caregiver] items 18a, 18b.
- Ped-PRO-CTCAE Item 35a, 35b. Symptom Term: Flashing lights: Item was revised to update ‘flashes of light’ to ‘flashes or sparks of light’ and reference to eyes being open or closed was clarified as ‘that were there even when your eyes were closed’ to improve comprehension following validation testing in Canada, the UK, and Australia. Corresponding phrasing changes made to Ped-PRO-CTCAE [Caregiver] items 35a, 35b.
- Ped-PRO-CTCAE Item 39a, 39b. Symptom Term: Concentration: Added ‘for example’ to the parenthetical to improve clarity following validation testing in Canada, the UK, and Australia. Corresponding phrasing changes made to Ped-PRO-CTCAE [Caregiver] items 39a, 39b.
- Ped-PRO-CTCAE Item 44a, 44b, 44c. Symptom Term: Joint Pain: Added ‘like your’ to the parenthetical to improve clarity following validation testing in Canada, the UK, and Australia. Corresponding phrasing changes made to Ped-PRO-CTCAE [Caregiver] items 44a, 44b, 44c.
- Ped-PRO-CTCAE Item 58a, 58b, 58c. Symptom Term: Hot flashes: ‘Hot flashes’ updated to ‘hot flashes / flushes’ to improve comprehension following validation testing in Canada, the UK, and Australia. Corresponding phrasing changes made to Ped-PRO-CTCAE [Caregiver] items 58a, 58b, 58c.
May 21 2024
Slovak
PRO-CTCAE Item 74a. Correction of minor typographical error.
May 21 2024
Malay
- PRO-CTCAE Item 17a. Correction of minor typographical error.
- PRO-CTCAE Item 17b. Correction of minor typographical error.
- PRO-CTCAE Item 17c. Correction of minor typographical error.
May 21 2024
Tamil
PRO-CTCAE Item 19b. Correction of minor typographical error.
May 21 2024
Greek
- PRO-CTCAE Item 16. Correction of minor typographical error.
- PRO-CTCAE Item 17a. Correction of minor typographical error.
- PRO-CTCAE Item 53a. Correction of minor typographical error.
- PRO-CTCAE Item 53b. Correction of minor typographical error.
May 21 2024
Portuguese (Portugal)
- Correction of minor typographical errors in respondent instructions.
- PRO-CTCAE Item 9a. Correction of minor typographical error.
May 21 2024
Chinese (Simplified)
PRO-CTCAE Item 16. Correction of minor typographical error.
May 21 2024
Southern Sotho/Sesotho
- PRO-CTCAE Item 53a. Correction of minor typographical error.
- PRO-CTCAE Item 53b. Correction of minor typographical error.
May 21 2024
Hebrew
Correction of respondent instructions for consistent use of inclusive language throughout the instrument and to improve syntax.
Oct 19 2023
Arabic
PRO-CTCAE Item 10a. Correction of minor typographical error.
Aug 3 2023
Chinese (Simplified)
Adjusted labeling of item library from "Simplified Chinese" to "Chinese (Simplified) (Universal)" following completion of validation testing in China, Singapore, and Malaysia.
Jul 20 2023
German
PRO-CTCAE Item 68a. Correction of minor typographical error.
Jul 17 2023
Polish
Correction of typographical errors in items 15a, 16a, 29a, 34a, 35a, 38a, 42a, 43a, 49a, 53a, 54a, 55a, 63a, 65a, 69a, 70a, 73a, 75a and the "Other Symptoms" question stem, to ensure consistent use of inclusive language throughout the PRO-CTCAE-Polish item library.
Jun 26 2023
Croatian
- Adjusted labeling of PRO-CTCAE-Croatian item library to include “(Universal)”, following completion of validation testing in both Croatia and in Bosnia and Herzegovina.
- PRO-CTCAE Item 4. Correction of minor typographical error.
- PRO-CTCAE Item 28. Correction of minor typographical error.
- PRO-CTCAE Item 38. Symptom Term: Stretch Marks: Parenthetical (LINIJE ILI BRAZDE NA KOŽI) added to improve comprehension following validation testing in Bosnia and Herzegovina.
- PRO-CTCAE Item 52b. Correction of minor typographical error.
- PRO-CTCAE Item 75a. Symptom Term: Increased Sweating: Parenthetical adjusted to include additional descriptive term (NEPOVEZANO S NALETIMA VRUĆINE / VALUNZIMA) to improve comprehension following validation testing in Bosnia and Herzegovina.
- PRO-CTCAE Item 75b. Symptom Term: Increased Sweating: Parenthetical adjusted to include additional descriptive term (NEPOVEZANO S NALETIMA VRUĆINE / VALUNZIMA) to improve comprehension following validation testing in Bosnia and Herzegovina. Correction of minor typographical errors in the response choices.
- PRO-CTCAE Item 77a. Symptom Term: Hot Flashes: Symptom term adjusted to NALETE VRUĆINE / VALUNGE following validation testing in Bosnia and Herzegovina.
- PRO-CTCAE Item 77b. Symptom Term: Hot Flashes: Symptom term adjusted to NAJGOREINALETI VRUĆINE / VALUNZI following validation testing in Bosnia and Herzegovina. A minor grammatical change was also made to correspond with this adjustment to the symptom term.
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.