Table 1.
Adverse events for which items were assessed in each round of cognitive interviews, listed by PRO-CTCAE terms used in each respective round.
| Round 1, Script 1 N = 22 (12 males, 10 females) |
Round 1, Script 2 N = 22 (11 males, 11 females) |
Round 1, Script 3 N = 16 (9 males, 7 females) |
|---|---|---|
| Aching joints | Acne | Change in the color of your fingernails or toenails |
| Aching muscles | Arm or leg swelling | Loss of fingernails or toenails |
| Blurred vision | Bloating of the abdomen (belly) | Problems with concentration |
| Changes in sense of taste or problems tasting food | Body odor more than usual | Rash |
| Constipation | Breast area enlargement | Ridges or bumps on your fingernails or toenails |
| Cough | Bruising easily | Ringing in the ears |
| Decreased appetite | Decreased sweating | Shaking chills/shivering |
| Decreased sexual interest | Difficulty swallowing | Shortness of breath |
| Diarrhea | Felt like nothing could cheer you up | Skin burn from radiation |
| Difficulty sleeping (insomnia) | Felt unhappy | Skin cracking at the corners of your mouth |
| Dizziness | Flashing lights in front of your eyes | Spots or lines (floaters) that drift in front of your eyes |
| Dry mouth | Hair loss | Stretch marks |
| Dry skin | Hand-foot syndrome (a rash of the hands or feet that can cause cracking, peeling, redness or pain) | Sweats (excessive sweating) |
| Fatigue (tiredness, lack of energy) | Hives | Tremor, shaking |
| Feeling anxiety | Hot flashes | Unusual darkening of the skin |
| Heartburn | Increased passing of gas (flatulence) | Urine color change |
| Hiccups | Increased skin sensitivity to sunlight | Voice changes (hoarseness, loss of voice) |
| Increased need to urinate | Nosebleeds | Vomiting |
| Itchy skin | Pain in the abdomen (belly area) | Watery eyes (tearing) |
| Loss of control of urine (leakage) | Pain or burning with urination | Wheezing |
| Loss of control of stool or bowels | Pain, swelling, or redness at a site of drug injection or IV | Difficulty getting or keeping an erection (male only) |
| Mouth or throat sores | Pounding or racing heartbeat | Ejaculation problems (male only) |
| Nausea | Pressure or bed sores | Absence of menstrual period (female only) |
| Numbness or tingling in hands or feet | Problems feeling orgasm or climax | Irregular menstrual period compared to usual (female only) |
| Pain | Problems with memory | Pain during vaginal sex (female only) |
| Unusual vaginal discharge (female only) | ||
| Vaginal dryness (female only) |
| Round 2, Scripts 1 and 2 (17 males, 30 females) |
|---|
| Aching joints (such as elbows, knees, shoulders) |
| Acne |
| Arm or leg swelling |
| Bed sores or pressure sores |
| Bloating of the abdomen (belly) |
| Blurred vision |
| Body odor |
| Breast area enlargement or tenderness |
| Bruising easily (black and blue marks) |
| Constipation |
| Decreased sweating |
| Diarrhea |
| Feeling anxiety or worry |
| Felt that nothing could cheer you up |
| Flashing lights in front of your eyes |
| Hand-foot syndrome (a rash of the hands or feet that can cause cracking, peeling, redness or pain) |
| Heartburn |
| Hives |
| Insomnia (including difficulty falling asleep, staying asleep, or waking up early) |
| Itchy skin |
| Mouth or throat sores |
| Nosebleeds |
| Problems having orgasm or climax |
| Rash |
| Sad or unhappy feelings |
| Skin burns from radiation |
| Spots or lines (floaters) that drift in front of your eyes |
| Stretch marks |
| Tremors |
| Unexpected or excessive sweating during the day or nighttime (not related to hot flashes) |
| Unusual darkening of the skin |
| Vomiting |
| Wheezing (whistling noise in the chest with breathing) |
| Ejaculation problems (male only) |
| Irregular menstrual periods (female only) |
| Pain during vaginal sex (female only) |
| Unusual vaginal discharge (female only) |
| Round 3, Scripts 1 and 2 (11 males, 9 females) |
|---|
| Acne or pimples on the face or chest |
| Bed sores |
| Blurry vision |
| Body odor |
| Breast area enlargement or tenderness |
| Constipation |
| Hand-foot syndrome (a rash of the hands or feet that can cause cracking, peeling, redness or pain) |
| Headache* |
| Hives (itchy red bumps on the skin) |
| Hoarse voice** |
| Loose or watery stools |
| Mouth or throat sores |
| Rash |
| Skin burns from radiation |
| Spots or lines (floaters) that drift in front of your eyes |
| Stretch marks |
| Took too long to have an orgasm or climax† |
| Tremors |
| Unable to have orgasm or climax† |
| Unexpected decrease in sweating |
| Unusual darkening of the skin |
| Urge to urinate all of a sudden‡ |
| Urinate frequently‡ |
| Voice changes** |
| Vomiting |
| Wheezing (whistling noise in the chest with breathing) |
| Ejaculation problems (male only) |
| Irregular menstrual periods (female only) |
| Pain during vaginal sex (female only) |
| Unusual vaginal discharge (female only) |
*
Added per expert panel consensus
**
Split from Voice changes (hoarseness, loss of voice) item per expert decision
†
Split from “Problems having orgasm or climax” item per expert panel consensus
‡
Split from “Increased need to urinate: per expert panel consensus