Table 3.

Summary tracking matrix showing PRO-CTCAE modified terms and reasons for modifications

Initial Version	Modified Version	Reason(s) for the Modification
Absence of menstrual period*	Miss an expected menstrual period	To clarify that the term is aimed towards women who are expecting menstrual periods.
Aching joints*	Aching joints (such as elbows, knees, shoulders)	To clarify that the term should encompass multiple joints.
Acne*†	Acne or pimples on the face or chest	To clarify that the term does not refer solely to facial rash experienced by adolescents, rather than adults.
Body odor more than usual*†	Body odor	The phrase “more than usual” caused confusion and did not add substantive meaning to the term.
Breast area enlargement*†	Breast area enlargement or tenderness	The term “tenderness” was included to provide additional context.
Changes in sense of taste or problems tasting food*	Problems with tasting food or drink	To clarify that liquids should be considered in responses.
Decreased sweating*†	Unexpected decrease in sweating	The word “unexpected” was included to provide additional context.
Diarrhea±	Loose or watery stools (diarrhea)	The term was revised per consensus decision by expert panel.
Difficulty sleeping (insomnia)*	Insomnia (Including difficulty falling asleep, staying asleep, or waking up early)	The parenthetical phrase was included to provide additional explanation of the symptom.
Felt Unhappy*	Sad or unhappy feelings	Patients felt the addition of the term “sad” would help to clarify meaning.
Hives†	Hives (itchy red bumps on the skin)	The parenthetical phrase was added to clarify the difference between hives and rash.
Irregular menstrual periods compared to usual*†	Irregular menstrual periods	The phrase “compared to usual” was removed to reduce confusion.
Loss of control of stool or bowels*	Loss of control of bowel movements	The word “stool” was removed to reduce confusion.
Pressure or bed sores†	Bed sores	The word “pressure” was removed to reduce confusion.
Shaking chills/shivering*	Shivering or shaking chills	The sentence structure was changed to reduce confusion.
Sweats (excessive sweating)* †	Unexpected or excessive sweating during the day or nighttime (not related to hot flashes)	Detail was included to add context and to distinguish sweating from hot flashes.
Wheezing*†	Wheezing (whistling noise in the chest with breathing)0	The parenthetical phrase was added to clarify the meaning of “wheezing”.

^*Modified version tested in Round 2

^†Modified version tested in Round 3

^±Modified version tested in Rounds 2 and 3 per expert decision