NCI PRO CTCAE Items English; Item Library Version 1.0

Transcript

1 NCI - PRO -ENGLISH -CTCAE™ ITEMS Item Library Version 1.0 As individuals go through treatment for their cancer they sometimes experience nt symptoms and side effects. For each question, please check or mark differe X an in the one box that best describes your experiences over the past 7 days... CTCAE™ Symptom Term: - 1. PRO Dry mouth In the last 7 days, what was the SEVERITY of your DRY MOUTH at its WORST? a. Ο Mild Ο Severe Ο None Ο Very severe Ο Moderate PRO CTCAE™ Symptom Term: Difficulty swallowing - 2. ast 7 days, what was the S EVERITY of your DIFFICLTY SWALLOWING at i ts WORST? In the l a. Ο None Ο Moderate Ο Severe Ο Very severe Ο Mild 3. - CTCAE™ Symptom Term: Mouth/throat sores PRO In the last 7 days, what was the SEVERITY of your MOUTH OR THROAT SORES at their WORST? a. Ο Mild Ο Moderate Ο None Ο Very severe Ο Severe b. In the last 7 days, how much did MOUTH OR THROAT SORES INTERFERE with your usual or daily activities? Ο Not at all Ο A little bit Ο Somewhat Ο Quite a bit Ο Very much 4. PRO CTCAE™ Symptom Term: Cracking at the corners of the mouth (cheilosis/cheilitis) - In the last 7 days, what was the SEVERITY of SKIN CRACKING AT THE CORNERS OF YOUR MOUTH at its a. WORST? Ο Mild Ο Moderate Ο Severe Ο Very severe Ο None 5. - CTCAE™ Symptom Term: PRO Voice quality changes b. In the last 7 days, did you have any VOICE CHANGES? Ο Yes Ο No 1 0 PRO Hoarseness CTCAE™ Symptom Term: 6. - In the last 7 days, what was the SEVERITY of your HOARSE VOICE at its WORST? a. Ο None Ο Very severe Ο Mild Ο Severe Ο Moderate -CTCAE ™ items and information herein were developed by the Division of Cancer Control and Population The PRO Sciences in the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, in Bethesda, Maryland, Use of the PRO - CTCAE™ is subject to NCI’s Terms of Use. A. U.S. Version date: 12/20 /2017

2 NCI - PRO -ENGLISH -CTCAE™ ITEMS Item Library Version 1.0 - CTCAE™ Symptom Term: Taste changes 7. PRO ITH TASTING FOOD OR DRINK at their In the last 7 days, what was the SEVERITY of your PROBLEMS W a. WORST? Ο Mild Ο Moderate Ο Severe Ο Very severe Ο None - 8. Symptom Term: Decreased appetite CTCAE™ PRO the SEVERITY of your DECREASED APPETITE at its WORST? In the last 7 days, what was a. Ο Mild Ο Moderate Ο Severe Ο Very severe Ο None b. did DECREASED APPETITE INTERFERE with your usual or daily activities? In the last 7 days, how much ΟA little bit Ο Somewhat Ο Quite a bit Ο Very much Ο Not at all - CTCAE™ Symptom Term: Nausea 9. PRO In the last 7 days, how OFTEN a. id you have NAUSEA? d Ο Never Ο Rarely Ο Occasionally Ο Frequently Ο Almost constantly b. In the last 7 days, what was the SEVERITY of your NAUSEA at its WORST? Ο None Ο Mild Ο Moderate Ο Severe Ο Very severe 10. PRO CTCAE™ Symptom Term: Vomiting - In the last 7 days, how OFTEN a. did you have VOMITING? Ο Rarely Ο Occasionally Ο Frequently Ο Almost constantly Ο Never In the last 7 days, what was the SEVERITY of your VOMITING at its WORST? b. Ο None Ο Moderate Ο Severe Ο Very severe Ο Mild Heartburn PRO CTCAE™ Symptom Term: 11. - a. In the last 7 days, how OFTEN did you have HEARTBURN? Ο Never Ο Rarely Ο Occasionally Ο Frequently Ο Almost constantly b. In the last 7 days, what was the SEVERITY of your HEARTBURN at its WORST? Ο Very severe Ο Moderate Ο Severe Ο None Ο Mild PRO - CTCAE™ Symptom Term: Gas 12. a. In the last 7 days, did you have any INCREASED PASSING OF GAS (FLATULENCE)? Ο Yes Ο No s and informa The PRO -CTCAE ™ item tion herein were developed by the Division of Cancer Control and Population Sciences in the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, in Bethesda, Maryland, Use of the PRO - CTCAE™ is subject to NCI’s Terms of Use. U.S. A. Version date: 12/20 /2017

3 NCI - PRO -ENGLISH -CTCAE™ ITEMS Item Library Version 1.0 - CTCAE™ Symptom Term: Bloating 13. PRO (BELLY) ? In the last 7 days, how OFTEN a. did you have BLOATING OF THE ABDOMEN Ο Rarely Ο Occasionally Ο Frequently Ο Almost constantly Ο Never In the last 7 days, what was (BELLY) at its WORST? b. the SEVERITY of your BLOATING OF THE ABDOMEN Ο Mild Ο Moderate Ο Severe Ο Very severe Ο None PRO - 14. Symptom Term: Hiccups CTCAE™ a. the last 7 days, how OFTEN did you have HICCUPS? In Ο Occasionally Ο Frequently Ο Almost constantly Ο Never Ο Rarely In the last 7 days, what was the SEVERITY of your HICCUPS at their WORST? b. Ο Mild Ο Moderate Ο None Ο Severe Ο Very severe 15. - CTCAE™ Symptom Term: PRO Constipation a. In the last 7 days, what was the SEVERITY of your CONSTIPATION at its WORST? Ο None Ο Mild Ο Moderate Ο Severe Ο Very severe 16. PRO CTCAE™ Symptom Term: Diarrhea /Diarrhoea - In / DIARRHOEA )? a. the last 7 days, how OFTEN did you have LOOSE OR WATERY STOOLS (DIARRHEA Ο Rarely Ο Occasionally Ο Frequently Ο Almost constantly Ο Never PRO - CTCAE™ 17. Abdominal pain Symptom Term: a. did you have PAIN IN THE ABDOMEN (BELLY AREA )? In the last 7 days, how OFTEN Ο Never Ο Occasionally Ο Frequently Ο Almost constantly Ο Rarely b. In the last 7 days, what was the SEVERITY of your PAIN IN THE ABDOMEN (BELLY AREA ) at its WORST? Ο None Ο Moderate Ο Severe Ο Very severe Ο Mild c. In the last 7 days, how much did PAIN IN THE ABDOMEN (BELLY AREA ) INTERFERE with your usual or daily activities? Ο Not at all Ο A little bit Ο Somewhat Ο Quite a bit Ο Very much s and inform -CTCAE item The PRO ation herein were developed by the Division of Cancer Control and Population ™ Sciences in the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, in Bethesda, Maryland, Use of the PRO - CTCAE™ is subject to NCI’s Terms of Use. A. U.S. Version date: 12/20 /2017

4 NCI - PRO -ENGLISH -CTCAE™ ITEMS Item Library Version 1.0 - CTCAE™ Symptom Term: Fecal incontinence 18. PRO a. In the last 7 days, how OFTEN did you LOSE CONTROL OF BOWEL MOVEMENTS? Ο Occasionally Ο Frequently Ο Rarely Ο Never Ο Almost constantly In the last 7 days, how much did LOSS OF CONTROL OF BOWEL MOVEMENTS INTERFERE with your b. usual or daily activities? Ο A little bit Ο Somewhat Ο Not at all Ο Quite a bit Ο Very much PRO CTCAE™ Symptom Term: - 19. Shortness of breath In the last 7 days, what was the SEVERITY of your SHORTNESS OF BREATH at its WORST? a. Ο None Ο Moderate Ο Severe Ο Very severe Ο Mild b. In the last 7 days, how much did your SHORTNESS OF BREATH INTERFERE with your usual or dail y activities? Ο Not at all Ο A little bit Ο Somewhat Ο Quite a bit Ο Very much PRO - CTCAE™ Symptom Term: Cough 20. In the last 7 days, what was the SEVERITY of your COUGH at its WORST? a. Ο Mild Ο None Ο Severe Ο Very severe Ο Moderate b. In the last 7 days, how much did COUGH INTERFERE with your usual or daily activities? Ο Not at all Ο Somewhat Ο Quite a bit Ο Very much Ο A little bit PRO - Symptom Term: Wheezing CTCAE™ 21. the SEVERITY of your WHEEZING (WHISTLING NOISE IN THE CHEST WITH In the last 7 days, what was a. BREATHING) at its WORST? Ο Mild Ο Moderate Ο None Ο Very severe Ο Severe 22. - CTCAE™ Symptom Term: PRO Swelling a. In the last 7 days, how OFTEN did you have ARM OR LEG SWELLING? Ο Never Ο Rarely Ο Occasionally Ο Frequently Ο Almost constantly b. In the last 7 days, what was the SEVERITY of your ARM OR LEG SWELLING at its WORST? Very severe Ο Moderate Ο Severe Ο None Ο Ο Mild c. In the last 7 days, how much did ARM OR LEG SWELLING INTERFERE with your usual or daily activities? Ο Not at all Ο A little bit Ο Somewhat Ο Quite a bit Ο Very much tems and inf -CTCAE i The PRO ormation herein were developed by the Division of Cancer Control and Population ™ Sciences in the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, in Bethesda, Maryland, Use of the PRO - CTCAE™ is subject to NCI’s Terms of Use. A. U.S. Version date: 12/20 /2017

5 NCI - PRO -ENGLISH -CTCAE™ ITEMS Item Library Version 1.0 - CTCAE™ Symptom Term: Heart palpitations 23. PRO did you feel a POUNDING OR RACING HEARTBEAT (PALPITATIONS)? In a. the last 7 days, how OFTEN Ο Rarely Ο Occasionally Ο Frequently Ο Almost constantly Ο Never In the last 7 days, what was b. the SEVERITY of your POUNDING OR RACING HEARTBEAT its WORST? (PALPITATIONS)? at Ο Mild Ο Moderate Ο None Ο Severe Ο Very severe PRO 24. CTCAE™ Symptom Term: Rash - a. you have any RASH? In the last 7 days, did Ο No Ο Yes - Symptom Term: PRO Skin dryness CTCAE™ 25. the SEVERITY of your DRY SKIN at its WORST? In the last 7 days, what was a. Ο None Ο Moderate Ο Severe Ο Very severe Ο Mild 26. PRO - CTCAE™ Symptom Term: Acne a. In the last 7 days, what was the SEVERITY of your ACNE OR PIMPLES ON THE FACE OR CHEST at its WORST? Ο None Ο Mild Ο Moderate Ο Severe Ο Very severe PRO CTCAE™ Symptom Term: Hair loss 27. - In the last 7 days, did you have any HAIR LOSS? a. Ο Somewhat Ο Not at all Ο Quite a bit Ο Very much Ο A little bit PRO - CTCAE™ Symptom Term: Itching 28. a. In the last 7 days, what was the SEVERITY of your ITCHY SKIN at its WORST? Ο None Ο Moderate Ο Severe Ο Very severe Ο Mild 29. CTCAE™ Symptom Term: - Hives PRO a. In the last 7 days, did you have any HIVES (ITCHY RED BUMPS ON THE SKIN)? Ο Yes Ο No RO ™ ite -CTCAE ms and information herein were developed by the Division of Cancer Control and Population The P Sciences in the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, in Bethesda, Maryland, Use of the PRO - CTCAE™ is subject to NCI’s Terms of Use. A. U.S. Version date: 12/20 /2017

6 NCI - PRO -ENGLISH -CTCAE™ ITEMS Item Library Version 1.0 - CTCAE™ Symptom Term: Hand - foot syndrome 30. PRO FOOT SYNDROME (A RASH OF THE HANDS - In the last 7 days, what was a. the SEVERITY of your HAND OR FEET THAT CAN CAUSE CRACKING, PEELING, REDNESS OR PAIN) at its WORST? Ο None Ο Severe Ο Mild Ο Very severe Ο Moderate PRO - CTCAE™ Symptom Term: 31. Nail loss a. you LOSE ANY FINGERNAILS OR TOENAILS? In the last 7 days, did Ο Yes Ο No PRO - CTCAE™ Symptom Term: Nail ridging 32. In the last 7 days, did you have any RIDGES OR BUMPS ON YOUR FINGERNAILS OR TOENAILS? a. Ο Yes Ο No PRO - 33. Symptom Term: Nail discoloration CTCAE™ a. In the last 7 days, did you have any CHANGE IN THE COLOR OF YOUR FINGERNAILS OR TOENAILS? Ο Yes Ο No PRO - Symptom Term: Sensitivity to sunlight 34. CTCAE™ you have any INCREASED SKIN SENSI TI VITY TO SUNLIGHT? a. In the last 7 days, did Ο No Ο Yes 35. - CTCAE™ Symptom Term: Bed/pressure sores PRO In the last 7 days, did you have any BED SORES? a. Ο Yes Ο No 36. PRO - CTCAE™ Symptom Term: Radiation skin reaction a. the last 7 days, what was the SEVERITY of your SKIN BURNS FROM RADIATION at their WORST? In Ο Mild Ο Moderate Ο Severe Ο Very severe Ο Not applicable Ο None e PRO -CTCAE ™ Th items and information herein were developed by the Division of Cancer Control and Population Sciences in the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, in Bethesda, Maryland, - CTCAE™ is subject to NCI’s Terms of Use of the PRO Use. U.S. A. Version date: 12/20 /2017

7 NCI - PRO -ENGLISH -CTCAE™ ITEMS Item Library Version 1.0 - CTCAE™ Symptom Term: Skin darkening 37. PRO you have any UNUS AL DARKENING OF THE SKIN? In the last 7 days, did a. U Ο No Ο Yes - PRO Symptom Term: Stretch marks 38. CTCAE™ you have any STRETCH MARKS? a. In the last 7 days, did Ο Yes Ο No PRO - CTCAE™ Symptom Term: Numbness & tingling 39. In the last 7 days, what was a. the SEVERITY of your NUMBNESS OR TINGLING IN YOUR HANDS OR FEET at its WORST? Ο Moderate Ο Severe Ο Very severe Ο Mild Ο None In the last 7 days, how much did NUMBNESS OR TINGLING IN YOUR HANDS OR FEET INTERFERE with b. your usual or daily activities? Ο A little bit Ο Not at all Ο Quite a bit Ο Very much Ο Somewhat 40. - CTCAE™ Symptom Term: PRO Dizziness a. In the last 7 days, what was the SEVERITY of your DIZZINESS at its WORST? Ο None Ο Mild Ο Moderate Ο Severe Ο Very severe b. In the last 7 days, how much did DIZZINESS INTERFERE with your usual or daily activities? Ο Somewhat Ο Quite a bit Ο Very much Ο Not at all Ο A little bit PRO - CTCAE™ Symptom Term: 41. Blurred vision a. the SEVERITY of your BLURRY VISION at its WORST? In the last 7 days, what was Ο Mild Ο None Ο Moderate Ο Severe Ο Very severe b. In the last 7 days, how much did BLURRY VISION INTERFERE with your usual or daily activities? Ο Not at all Ο Somewhat Ο Quite a bit Ο Very much Ο A little bit 42. PRO - CTCAE™ Symptom Term: Flashing lights a. In the last 7 days, did you have any FLASHING LIGHTS IN FRONT OF YOUR EYES? Ο Yes Ο No The PRO -CTCAE ™ items and information herein were developed by the Division of Cancer Control and Population Sciences in the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, in Bethesda, Maryland, Use of the PRO - CTCAE™ is subject to NCI’s Terms of Use. A. U.S. Version date: 12/20 /2017

8 NCI - PRO -ENGLISH -CTCAE™ ITEMS Item Library Version 1.0 - CTCAE™ Symptom Term: Visual floaters 43. PRO you have any SPOTS OR LINES In the last 7 days, did a. (FLOATERS) THAT DRIFT IN FRONT OF YOUR EYES? Ο No Ο Yes - CTCAE™ Symptom Term: Watery eyes PRO 44. the SEVERITY of your WATERY EYES (TEARING) at their WORST? n the last 7 days, what was a. I Ο Mild Ο Moderate Ο Severe Ο Very severe Ο None In b. the last 7 days, how much did WATERY EYES (TEARING) INTERFERE with your usual or daily activities? Ο Quite a bit Ο Somewhat Ο A little bit Ο Very much Ο Not at all PRO - CTCAE™ Symptom Term: 45. Ringing in ears a. the SEVERITY of RINGING IN YOUR EARS at its WORST? In the last 7 days, what was Ο Mild Ο None Ο Moderate Ο Severe Ο Very severe 46. PRO - CTCAE™ Symptom Term: Concentration a. In the last 7 days, what was the SEVERITY of your PROBLEMS WITH CONCENTRAT I ON at their WORST? Ο Very severe Ο Moderate Ο Severe Ο Mild Ο None In the last 7 days, how much did PROBLEMS WITH CONCENTRATION INTERFERE with your usual or b. daily activities? Ο A little bit Ο Somewhat Ο Quite a bit Ο Very much Ο Not at all PRO - CTCAE™ Symptom Term: Memory 47. a. In the last 7 days, what was the SEVERITY of your PROBLEMS WITH MEMORY at their WORST? Ο Very severe Ο None Ο Moderate Ο Severe Ο Mild b. In the last 7 days, how much did PROBLEMS WITH MEMORY INTERFERE with your usual or daily activities? Ο Not at all Ο A little bit Ο Somewhat Ο Quite a bit Ο Very much The PRO ™ items and information herein were developed by the Division of Cancer Control and Population -CTCAE Sciences in the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, in Bethesda, Maryland, Use. Use of the PRO - CTCAE™ is subject to NCI’s Terms of A. U.S. Version date: 12/20 /2017

9 NCI - PRO -ENGLISH -CTCAE™ ITEMS Item Library Version 1.0 - CTCAE™ Symptom Term: General pain 48. PRO did you have PAIN? a. In the last 7 days, how OFTEN Ο Occasionally Ο Never Ο Almost constantly Ο Rarely Ο Frequently he las t 7 d ays, w hat was the SEVERITY of y our P AIN a t its W ORST? b. In t Ο Mild Ο Moderate Ο Severe Ο Very severe Ο None ast 7 days, how much did PAIN INTERFERE with your usual or daily activities? In the l c. Ο A little bit Ο Somewhat Ο Not at all Ο Quite a bit Ο Very much PRO 49. CTCAE™ Symptom Term: Headache - a. did you have a HEADACHE? In the last 7 days, how OFTEN Ο Occasionally Ο Frequently Ο Almost constantly Ο Never Ο Rarely In the last 7 days, what was the SEVERITY of your HEADACHE at its WORST? b. Ο Mild Ο Moderate Ο Severe Ο Very severe Ο None c. did your HEADACHE INTERFERE with your usual or daily activities? In the last 7 days, how much Ο Somewhat Ο Quite a bit Ο Not at all Ο Very much Ο A little bit PRO - CTCAE™ Symptom Term: Muscle pain 50. a. In the last 7 days, how OFTEN did you have ACHING MUSCLES? Ο Never Ο Occasionally Ο Frequently Ο Almost constantly Ο Rarely In t t 7 d ays, w hat was the SEVERITY o f you r ACHIN G MUSCLES at t heir WORST? b. he las Ο Mild Ο Moderate Ο Severe Ο Very severe Ο None In the l INTERFERE with your usual or daily activities? G MUSCLES c. ast 7 days, how much did ACHIN Ο Somewhat Ο Quite a bit Ο Very much Ο Not at all Ο A little bit Joint pain PRO CTCAE™ Symptom Term: 51. - a. In the last 7 days, how OFTEN did you have ACHING JOINTS (SUCH AS ELBOWS, KNEES, SHOULDERS)? Ο Never Ο Rarely Ο Occasionally Ο Frequently Ο Almost constantly b. In the last 7 days, what was the SEVERITY of your ACHING JOINTS (SUCH AS ELBOWS, KNEES, SHOULDERS) at their WORST? Ο Very severe Ο Mild Ο Moderate Ο None Ο Severe c. In the l ast 7 days, how much did ACHING JOINTS (SUCH AS ELBOWS, KNEES, SHOULDERS) INTERFERE with your usual or daily activities? Ο Not at all Ο A little bit Ο Somewhat Ο Quite a bit Ο Very much ™ items a AE -CTC nd information herein were developed by the Division of Cancer Control and Population The PRO Sciences in the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, in Bethesda, Maryland, Use of the PRO - CTCAE™ is subject to NCI’s Terms of Use. A. U.S. Version date: 12/20 /2017

10 NCI - PRO -ENGLISH -CTCAE™ ITEMS Item Library Version 1.0 - CTCAE™ Symptom Term: Insomnia 52. PRO ( INCLUDING DIFFICULTY FALLING In the last 7 days, what was the SEVERITY of your INSOMNIA a. ASLEEP, STAYING ASLEEP, OR WAKING UP EARLY ) at its WORST? Ο Mild Ο Moderate Ο Severe Ο None Ο Very severe In the last 7 did INSOMNIA ( INCLUDING DIFFICULTY FALLING ASLEEP, STAYING days, how much b. INTERFERE with your usual or daily activities? ) ASLEEP, OR WAKING UP EARLY Ο A little bit Ο Somewhat Ο Quite a bit Ο Very much Ο Not at all 53. PRO CTCAE™ Symptom Term: Fatigue - In the last 7 days, what was a. the SEVERITY of your FATIGUE, TIREDNESS, OR LACK OF ENERGY at its WORST? Ο Severe Ο None Ο Mild Ο Very severe Ο Moderate In the last 7 days, how much did FATIGUE, TIREDNESS, OR LACK OF ENERGY INTERFERE with your b. usual or daily activities? Ο Not at all Ο A little bit Ο Somewhat Ο Quite a bit Ο Very much Anxious 54. CTCAE™ Symptom Term: - PRO a. In the last 7 days, how OFTEN did you feel ANXIETY? Ο Never Ο Rarely Ο Occasionally Ο Frequently Ο Almost constantly b. In the last 7 days, what was the SEVERITY of your ANXIETY at its WORST? Ο Mild Ο Moderate Ο Severe Ο Very severe Ο None In the last 7 days, how much did ANXIETY INTERFERE with your usual or daily activities? c. Ο A little bit Ο Somewhat Ο Not at all Ο Quite a bit Ο Very much PRO 55. CTCAE™ Symptom Term: Discouraged - a. did you FEEL THAT NOTHING COULD CHEER YOU UP? In the last 7 days, how OFTEN Ο Never Ο Rarely Ο Occasionally Ο Frequently Ο Almost constantly b. In the last 7 days, what was the SEVERITY of your FEELINGS THAT NOTHING COULD CHEER YOU UP at their WORST? Ο None Ο Mild Ο Moderate Ο Severe Ο Very severe In the last 7 days, how much did FEELING THAT NOTHING COULD CHEER YOU UP INTERFERE with your c. usual or daily activities? Ο Not at all Ο A little bit Ο Somewhat Ο Quite a bit Ο Very much E™ items and inf The PRO ormation herein were developed by the Division of Cancer Control and Population -CTCA Sciences in the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, in Bethesda, Maryland, Use. Use of the PRO - CTCAE™ is subject to NCI’s Terms of A. U.S. Version date: 12/20 /2017

11 NCI - PRO -ENGLISH -CTCAE™ ITEMS Item Library Version 1.0 - CTCAE™ Symptom Term: Sad 56. PRO In the last 7 days, how OFTEN a. did you have SAD OR UNHAPPY FEELINGS? Ο Rarely Ο Occasionally Ο Frequently Ο Almost constantly Ο Never the SEVERITY of your SAD OR UNHAPPY FEELINGS at their WORST ? b. In the last 7 days, what was Ο Mild Ο Moderate Ο Severe Ο Very severe Ο None In the l ast c. EELINGS INTE R FERE with your usual or daily 7 days, how much did SAD OR UNHAPPY F activities? Ο A little bit Ο Somewhat Ο Quite a bit Ο Very much Ο Not at all - CTCAE™ Symptom Term: Irregular periods/vaginal bleeding 57. PRO a. the last 7 days, did you have any IRREGULAR MENSTRUAL PERIODS? In Ο Yes Ο No Ο Not Applicable 58. - CTCAE™ Symptom Term: Missed expected menstrual period PRO a. In the last 7 days, did you MISS AN EXPECTED MENSTRUAL PERIOD? Ο Yes Ο Not applicable Ο No Vaginal discharge PRO Symptom Term: CTCAE™ 59. - In the last 7 days, did you have any UNUSUAL VAGINAL DISCHARGE? a. Ο A little bit Ο Somewhat Ο Not at all Ο Very much Ο Quite a bit 60. - CTCAE™ Symptom Term: PRO Vaginal dryness a. In the last 7 days, what was the SEVERITY of your VAGINAL DRYNESS at its WORST? Ο None Ο Mild Ο Moderate Ο Severe Ο Very severe 61. - CTCAE™ Symptom Term: Painful urination PRO a. In the last 7 days, what was the SEVERITY of your PAIN OR BURNING WITH URINATION at its WORST? Ο None Ο Mild Ο Moderate Ο Severe Ο Very severe RO ™ ite -CTCAE ms and information herein were developed by the Division of Cancer Control and Population The P Sciences in the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, in Bethesda, Maryland, Use of the PRO - CTCAE™ is subject to NCI’s Terms of Use. A. U.S. Version date: 12/20 /2017

12 NCI - PRO -ENGLISH -CTCAE™ ITEMS Item Library Version 1.0 - CTCAE™ Symptom Term: Urinary urgency 62. PRO did you feel an URGE TO URINATE ALL OF A SUDDEN? a. In the last 7 days, how OFTEN Ο Occasionally Ο Never Ο Almost constantly Ο Rarely Ο Frequently the last 7 days, how much did SUDDEN URGES TO URINATE INTERFERE with your usual or daily b. In activities? Ο Not at all Ο Somewhat Ο Quite a bit Ο Very much Ο A little bit - CTCAE™ Symptom Term: Urinary frequency 63. PRO In the last 7 days, were a. when you had to URINATE FREQUENTLY? there times Ο Never Ο Rarely Ο Occasionally Ο Frequently Ο Almost constantly In the last 7 days, how much did FREQUENT URINATION INTERFERE with your usual or daily activities? b. Ο A little bit Ο Somewhat Ο Quite a bit Ο Very much Ο Not at all PRO Symptom Term: CTCAE™ 64. Change in usual urine color - In the last 7 days, did a. you have any URINE COLOR CHANGE? Ο No Ο Yes 65. - CTCAE™ Symptom Term: Urinary incontinence PRO a. In the last 7 days, how OFTEN did you have LOSS OF CONTROL OF URINE (LEAKAGE)? Ο Never Ο Occasionally Ο Frequently Ο Almost constantly Ο Rarely In the last 7 days, how much did LOSS OF CONTROL OF URINE (LEAKAGE) INTERFERE with your usual b. or daily activities? Ο A little bit Ο Somewhat Ο Quite a bit Ο Very much Ο Not at all 66. - CTCAE™ Symptom Term: PRO Achieve and maintain erection a. In the last 7 days, what was the SEVERITY of your DIFFICULTY GETTING OR KEEPING AN ERECTION at its WORST? Ο None Ο Mild Ο Moderate Ο Severe Ο Very severe Ο Not sexually active Ο Prefer not to answer PRO - CTCAE™ Symptom Term: Ejaculation 67. In the last 7 days, how OFTEN did you have EJACULATION PROBLEMS? a. Ο Frequently Ο Occasionally Ο Rarely Ο Almost Ο Never Ο Not sexually Ο Prefer not to constantly active answer ™ item TCAE -C s and information herein were developed by the Division of Cancer Control and Population The PRO Sciences in the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, in Bethesda, Maryland, Use of the PRO - CTCAE™ is subject to NCI’s Terms of Use. A. U.S. Version date: 12/20 /2017

13 NCI - PRO -CTCAE™ ITEMS -ENGLISH Item Library Version 1.0 CTCAE™ Symptom Term: Decreased libido - PRO 68. the SEVERITY of your DECREASED SEXUAL INTEREST at its WORST? In the last 7 days, what was a. Ο Mild Ο Moderate Ο Severe Ο None Ο Not sexually active Ο Prefer not to Ο Very severe answer Delayed orgasm - Symptom 69. CTCAE™ PRO Term: In the last 7 days, did you feel that it TOOK TOO LONG TO HAVE AN ORGASM OR CLIMAX? a. Ο No Ο Not sexually active Ο Prefer not to answer Ο Yes PRO 70. Symptom Term: Unable to have orgasm - CTCAE™ you In the last 7 days, were UNABLE TO HAVE AN ORGASM OR CLIMAX? a. Ο No Ο Yes Ο Prefer not to answer Ο Not sexually active PRO - CTCAE™ Symptom Term: Pain w/sexual intercourse 71. In the last 7 days, what was the SEVERITY of your PAIN DURING VAGINAL SEX at its WORST? a. Ο Mild Ο Ο Prefer not to Ο Severe Ο Very severe Ο Not sexually Ο None Moderate active answer 72. PRO CTCAE™ Symptom Term: Breast swelling and tenderness - In the last 7 days, what was the SEVERITY of your BREAST AREA ENLARGEMENT OR TENDERNESS at its a. WORST? Ο Mild Ο Moderate Ο Severe Ο Very severe Ο None PRO - CTCAE™ Symptom Term: Bruising 73. In the last 7 days, did a. (BLACK AND BLUE MARKS) ? you BRUISE EASILY Ο Yes Ο No 74. PRO - CTCAE™ Symptom Term: Chills a. In the last 7 days, how OFTEN did you have SHIVERING OR SHAKING CHILLS? Ο Almost constantly Ο Occasionally Ο Never Ο Rarely Ο Frequently b. In the last 7 days, what was the SEVERITY of your SHIVERING OR SHAKING CHILLS at their WORST? Ο None Ο Mild Ο Moderate Ο Severe Ο Very severe RO ™ item -CTCAE s and information herein were developed by the Division of Cancer Control and Population The P Sciences in the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, in Bethesda, Maryland, Use of the PRO - CTCAE™ is subject to NCI’s Terms of Use. A. U.S. Version date: 12/20 /2017

14 NCI - PRO -ENGLISH -CTCAE™ ITEMS Item Library Version 1.0 - CTCAE™ Symptom Term: Increased sweating 75. PRO In the last 7 days, how OFTEN did you have UNEXPECTED OR EXCESSIVE SWEATING DURING THE DAY a. OR NIGH T TIME (NOT RELATED TO HOT FLASHES /FLUSHES )? Ο Rarely Ο Occasionally Ο Frequently Ο Never Ο Almost constantly In the last 7 days, what was the SEVERITY of your UNEXPECTED OR EXCESSIVE SWEATING DURING b. THE DAY OR NIGH T TIME (NOT RELATED TO HOT FLASHES /FLUSHES ) at its WORST? Ο Mild Ο Moderate Ο Severe Ο Very severe Ο None 76. PRO CTCAE™ Symptom Term: Decreased sweating - In the last 7 days, did you have an UNEXPECTED DECREASE IN SWEATING? a. Ο No Ο Yes - CTCAE™ 77. Symptom Term: Hot flashes /flushes PRO In the last 7 days, how OFTEN did you have HOT FLASHES /FLUSHES a. ? Ο Never Ο Rarely Ο Occasionally Ο Frequently Ο Almost constantly b. In the last 7 days, what was the SEVERITY of your HOT FLASHES /FLUSHES at their WORST? Ο None Ο Mild Ο Moderate Ο Severe Ο Very severe 78. PRO CTCAE™ Symptom Term: Nosebleed - In the last 7 days, how OFTEN a. did you have NOSEBLEEDS? Ο Rarely Ο Occasionally Ο Frequently Ο Almost constantly Ο Never In the last 7 days, what was the SEVERITY of your NOSEBLEEDS at their WORST? b. Ο None Ο Moderate Ο Severe Ο Very severe Ο Mild PRO - CTCAE™ Symptom Term: Pain and swelling at injection site 79. a. In the last 7 days, did you HAVE ANY PAIN, SWELLING, OR REDNESS AT A SITE OF DRUG INJECTION OR IV? Ο Yes Ο No Ο Not applicable Body odor PRO 80. Symptom Term: - CTCAE™ a. In the last 7 days, what was the SEVERITY of your BODY ODOR at its WORST? Ο None Ο Mild Ο Moderate Ο Severe Ο Very severe E™ items a The PRO nd information herein were developed by the Division of Cancer Control and Population -CTCA Sciences in the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, in Bethesda, Maryland, Use. Use of the PRO - CTCAE™ is subject to NCI’s Terms of A. U.S. Version date: 12/20 /2017

15 NCI - PRO -ENGLISH -CTCAE™ ITEMS Item Library Version 1.0 OTHER SYMPTOMS Do you have any other symptoms that you wish to report? Ο Yes Ο No Please list any other symptoms: In the last 7 days, what was the SEVERITY 1. of this symptom at its WORST? O None O Mild O Moderate O Severe O Very Severe In the last 7 days, what was the SEVERITY 2. of this symptom at its WORST? O None O Mild O Moderate O Severe O Very Severe 3. In the last 7 days, what was the SEVERITY of this symptom at its WORST? O None O Mild O Moderate O Severe O Very Severe In the last 7 days, what was the SEVERITY 4. of this symptom at its WORST? O None O Mild O Moderate O Severe O Very Severe 5. In the last 7 days, what was the SEVERITY of this symptom at its WORST? O None O Mild O Moderate O Severe O Very Severe O-CTCAE ™ ite The PR ms and information herein were developed by the Division of Cancer Control and Population Sciences in the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, in Bethesda, Maryland, Use of the PRO - CTCAE™ is subject to NCI’s Terms of Use. A. U.S. Version date: 12/20 /2017

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