National Cancer Institute PRO-CTCAE
Evaluates symptomatic toxicity in patients on cancer clinical trials
Provided byInstructions
Over the last 7 days, please rate each symptom listed below.
When asked, select the severity level at its worst (ranging from None to Very Severe)
When asked, rate how much the symptom interfered with your daily activities.
1. Dry Mouth
PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials.
It was designed to be used as a companion to the Common Terminology Criteria for Adverse Events (CTCAE), the standard lexicon for adverse event reporting in cancer clinical trials.
The PRO-CTCAE Item Library (PDF, 164 KB) includes 124 items representing 78 symptomatic toxicities drawn from the CTCAE.
PRO-CTCAE has been developed and tested with a conditional branching logic that helps to reduce respondent burden. Conditional branching is employed for electronic administration of PRO-CTCAE symptom terms that have two or more attributes (e.g., fatigue severity and interference or pain frequency, severity and interference). The logic branches from frequency, then to severity, and then to interference. For example, if frequency is greater than "Never", you next pose the severity question, and if severity is greater than "None", you pose the interference question.
For more information on development and testing of the PRO-CTCAE Measurement System, refer to https://healthcaredelivery.cancer.gov/pro-ctcae/testing.html
Scoring
There are 80 core symptom based questions. Some questions are only asking for it's presence/absence (choices are yes or no) and some questions will include up to 3 parts representing symptom attributes. Questions with multiple parts will be labeled as 1a., 1b., and 1c. The letters a, b ,c represent symptom attributes, to include:
Frequency
Severity
Interference
Amount
Attribute based questions will have choices with a value of 0 to 4.
Note: If the first attribute question is none or 0, the second and third attribute questions will not appear.
See the following document for how each symptom is represented https://healthcaredelivery.cancer.gov/pro-ctcae/item-library.pdf
Questions asking about one of the above attributes will be scored with a Composite Grade or 1-3.
-Grade 0 (Absent): 0 points
-Grade 1 (Mild): 1 point
-Grade 2 (Moderate): 2 points
-Grade 3 (Severe): 3 or 4 points
Scoring for questions with only one attribute (A):
-Grade 0: 0 points
-Grade 1: 1 point
-Grade 2: 2 points
-Grade 3: 3 or 4 points
Scoring for questions with only two attributes (A):
A1 (points) | A2 (points) | Grade |
0 | - | 0 |
1 | 0 | 1 (max=1) |
1 | 1 | 1 (max=1) |
2 | 0 | 1 (A1 only elevated) |
2 | 1 | 2 |
1 | 2 | 2 |
2 | 2 | 2 |
3+ (any) | 3+ (any) | 3 |
One important practical note: one research group applying Basch et al.'s conversion tables specifically excluded configurations where a patient rated severity as zero but interference above zero, treating these as illogical combinations suggesting data entry error rather than valid responses. This is clinically relevant for Mouth/Throat Sores specifically — it would be unusual (though not impossible) for a patient to report no severity but meaningful interference. That group excluded rather than graded those combinations.
The branch logic for this item: If the patient answers "None" on the severity question (S=0), the interference question will be hidden by branch logic and auto-coded as 0. The S=0/I>0 combination will never actually occur.
Scoring for questions with three attributes (A):
-Grade 0:
Note: If first attribute 0 then other two attributes will not be asked
-Grade 1
The full set of Grade 1 combinations:
F (points) | S (points) | I (Points) | Reason |
1 | 0 | - | max=1 |
1 | 1 | 0 | max=1 |
1 | 1 | 1 | max=1 |
1 | 2 | 0 | * |
2 | 0 | 0 | F only elevated** |
*When F=1, Grade 2 only triggers when both S and I are elevated (at least one = 2, the other > 0). A lone S=2 or lone I=2 with F=1 stays Grade 1 per boundary rule.
**When F=2, Grade 2 triggers as soon as either S or I is > 0 — because frequency being elevated means S and I are no longer isolated. The only F=2 exceptions that stay Grade 1 are S=0/I=0.
-Grade 2:
The full set of Grade 2 combinations
F (Points) | S (points) | I (points) |
1 | 2 | 1 |
1 | 1 | 2 |
1 | 2 | 2 |
2 | 1 | 0 |
2 | 1 | 1 |
2 | 2 | 0 |
2 | 2 | 1 |
2 | 1 | 2 |
2 | 2 | 2 |
The key thing to notice is the asymmetry between F=1 and F=2 rows:
-When F=1, Grade 2 only triggers when both S and I are elevated (at least one = 2, the other > 0). A lone S=2 or lone I=2 with F=1 stays Grade 1 per boundary rule.
-When F=2, Grade 2 triggers as soon as either S or I is > 0 — because frequency being elevated means S and I are no longer isolated. The only F=2 exceptions that stay Grade 1 are S=0/I=0.
-Grade 3:
With F>0 enforced by branch logic, and any attribute ≥3 triggering Grade 3, here are all combinations systematically. F, S, and I each run 0–4 but at least one must be ≥3:
Where F=3 or F=4 (S and I can be anything 0–4):
F (points) | S (points) | I (points) |
3 | 0 | - |
3 | 1 | 0 |
3 | 2 | 0 |
3 | 3 | 0 |
3 | 4 | 0 |
3 | 0 | - |
3 | 1 | 1 |
3 | 2 | 1 |
3 | 3 | 1 |
3 | 4 | 1 |
3 | 0 | - |
3 | 1 | 2 |
3 | 2 | 2 |
3 | 3 | 2 |
3 | 4 | 2 |
3 | 0 | - |
3 | 1 | 3 |
3 | 2 | 3 |
3 | 3 | 3 |
3 | 4 | 3 |
3 | 0 | - |
3 | 1 | 4 |
3 | 2 | 4 |
3 | 3 | 4 |
3 | 4 | 4 |
4 | 0 | - |
4 | 1 | 0 |
4 | 2 | 0 |
4 | 3 | 0 |
4 | 4 | 0 |
4 | 0 | - |
4 | 1 | 1 |
4 | 2 | 1 |
4 | 3 | 1 |
4 | 4 | 1 |
4 | 0 | - |
4 | 1 | 2 |
4 | 2 | 2 |
4 | 3 | 2 |
4 | 4 | 2 |
4 | 0 | - |
4 | 1 | 3 |
4 | 2 | 3 |
4 | 3 | 3 |
4 | 4 | 3 |
4 | 0 | - |
4 | 1 | 4 |
4 | 2 | 4 |
4 | 3 | 4 |
4 | 4 | 4 |
Where F=1 or F=2, S≥3 or I≥3 (F alone doesn't trigger, but S or I does):
F (points) | S (points) | I (points) |
1 | 3 | 0 |
1 | 4 | 0 |
1 | 3 | 1 |
1 | 4 | 1 |
1 | 1 | 3 |
1 | 1 | 4 |
1 | 3 | 2 |
1 | 4 | 2 |
1 | 2 | 3 |
1 | 2 | 4 |
1 | 3 | 3 |
1 | 4 | 3 |
1 | 3 | 4 |
1 | 4 | 4 |
2 | 3 | 0 |
2 | 4 | 0 |
2 | 3 | 1 |
2 | 4 | 1 |
2 | 1 | 3 |
2 | 1 | 4 |
2 | 3 | 2 |
2 | 4 | 2 |
2 | 2 | 3 |
2 | 2 | 4 |
2 | 3 | 3 |
2 | 4 | 3 |
2 | 3 | 4 |
2 | 4 | 4 |
Overview Publications
Kluetz PG, Chingos DT, Basch EM, Mitchell SA. Patient-Reported Outcomes in Cancer Clinical Trials: Measuring Symptomatic Adverse Events With the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Am Soc Clin Oncol Educ Book. 2016;35:67-73. Review. [View Abstract]
Minasian LM, O'Mara A, Mitchell SA. Clinician and Patient Reporting of Symptomatic Adverse Events in Cancer Clinical Trials: Using CTCAE and PRO-CTCAE® to Provide Two Distinct and Complementary Perspectives Patient Relat Outcome Meas. 2022 Dec 8;13:249-258. doi:10.2147/PROM.S256567. [View Abstract]
Smith AW, Mitchell SA, K De Aguiar C, Moy C, Riley WT, Wagster MV, M Werner E. News from the NIH: Person-centered outcomes measurement: NIH-supported measurement systems to evaluate self-assessed health, functional performance, and symptomatic toxicity. Transl Behav Med. 2016 Sep;6(3):470-4. [Look up in PubMed]
More publications can be found at https://healthcaredelivery.cancer.gov/pro-ctcae/pubs.html
All questions & possible results
1. Dry Mouth
1a. What was the SEVERITY of your DRY MOUTH at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
2. Difficulty Swallowing
2a. What was the SEVERITY of your DIFFICULTY SWALLOWING at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
3. Mouth/Throat Sores
3a. What was the SEVERITY of your MOUTH OR THROAT SORES at their WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
3b. How much did MOUTH OR THROAT SORES INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
4. Cracking at the Corners of the Mouth (Cheilosis/Cheilitis)
4a. What was the SEVERITY of SKIN CRACKING AT THE CORNERS OF YOUR MOUTH at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
5. Voice Quality Changes
5a. Did you have any VOICE CHANGES?
Select one option:
- Yes
- No
6. Hoarseness
6a. What was the SEVERITY of your HOARSE VOICE at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
7. Taste Changes
7a. What was the SEVERITY of your PROBLEMS WITH TASTING FOOD OR DRINK at their WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
8. Decreased Appetite
8a. What was the SEVERITY of your DECREASED APPETITE at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
8b. How much did DECREASED APPETITE INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
9. Nausea
9a. How OFTEN did you have NAUSEA?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
9b. What was the SEVERITY of your NAUSEA at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
10. Vomiting
10a. How OFTEN did you have VOMITING?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
10b. What was the SEVERITY of your VOMITING at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
11. Heartburn
11a. How OFTEN did you have HEARTBURN?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
11b. What was the SEVERITY of your HEARTBURN at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
12. Gas
12a. Did you have any INCREASED PASSING OF GAS (FLATULENCE)?
Select one option:
- Yes
- No
13. Bloating
13a. How OFTEN did you have BLOATING OF THE ABDOMEN (BELLY)?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
13b. What was the SEVERITY of your BLOATING OF THE ABDOMEN (BELLY) at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
14. Hiccups
14a. How OFTEN did you have HICCUPS?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
14b. What was the SEVERITY of your HICCUPS at their WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
15. Constipation
15a. What was the SEVERITY of your CONSTIPATION at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
16. Diarrhea
16a. How OFTEN did you have LOOSE OR WATERY STOOLS (DIARRHEA/DIARRHOEA)?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
17. Abdominal Pain
17a. How OFTEN did you have PAIN IN THE ABDOMEN (BELLY AREA)?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
17b. What was the SEVERITY of your PAIN IN THE ABDOMEN (BELLY AREA) at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
17c. How much did PAIN IN THE ABDOMEN (BELLY AREA) INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
18. Fecal Incontinence
18a. How OFTEN did you LOSE CONTROL OF BOWEL MOVEMENTS?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
18b. How much did LOSS OF CONTROL OF BOWEL MOVEMENTS INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
19. Shortness of Breath
19a. What was the SEVERITY of your SHORTNESS OF BREATH at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
19b. How much did your SHORTNESS OF BREATH INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
20. Cough
20a. What was the SEVERITY of your COUGH at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
20b. How much did COUGH INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
21. Wheezing
21a. What was the SEVERITY of your WHEEZING (WHISTLING NOISE IN THE CHEST WITH BREATHING) at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
22. Swelling
22a. How OFTEN did you have ARM OR LEG SWELLING?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
22b. What was the SEVERITY of your ARM OR LEG SWELLING at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
22c. How much did ARM OR LEG SWELLING INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
23. Heart Palpitations
23a. How OFTEN did you feel a POUNDING OR RACING HEARTBEAT (PALPITATIONS)?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
23b. What was the SEVERITY of your POUNDING OR RACING HEARTBEAT (PALPITATIONS) at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
24. Rash
24a. Did you have any RASH?
Select one option:
- Yes
- No
25. Skin Dryness
25a. What was the SEVERITY of your DRY SKIN at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
26. Acne
26a. What was the SEVERITY of your ACNE OR PIMPLES ON THE FACE OR CHEST at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
27. Hair Loss
27a. Did you have any HAIR LOSS?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
28. Itching
28a. What was the SEVERITY of your ITCHY SKIN at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
29. Hives
29a. Did you have any HIVES (ITCHY RED BUMPS ON THE SKIN)?
Select one option:
- Yes
- No
30. Hand-Foot Syndrome
30a. What was the SEVERITY of your HAND-FOOT SYNDROME (A RASH OF THE HANDS OR FEET THAT CAN CAUSE CRACKING, PEELING, REDNESS OR PAIN) at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
31. Nail Loss
31a. Did you LOSE ANY FINGERNAILS OR TOENAILS?
Select one option:
- Yes
- No
32. Nail Ridging
32a. Did you have any RIDGES OR BUMPS ON YOUR FINGERNAILS OR TOENAILS?
Select one option:
- Yes
- No
33. Nail Discoloration
33a. Did you have any CHANGE IN THE COLOR OF YOUR FINGERNAILS OR TOENAILS?
Select one option:
- Yes
- No
34. Sensitivity to Sunlight
34a. Did you have any INCREASED SKIN SENSITIVITY TO SUNLIGHT?
Select one option:
- Yes
- No
35. Bed/Pressure Sores
35a. Did you have any BED SORES?
Select one option:
- Yes
- No
36. Radiation Skin Reaction
36a. What was the SEVERITY of your SKIN BURNS FROM RADIATION at their WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
- Not applicable
37. Skin Darkening
37a. Did you have any UNUSUAL DARKENING OF THE SKIN?
Select one option:
- Yes
- No
38. Stretch Marks
38a. Did you have any STRETCH MARKS?
Select one option:
- Yes
- No
39. Numbness & Tingling
39a. What was the SEVERITY of your NUMBNESS OR TINGLING IN YOUR HANDS OR FEET at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
39b. How much did NUMBNESS OR TINGLING IN YOUR HANDS OR FEET INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
40. Dizziness
40a. What was the SEVERITY of your DIZZINESS at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
40b. How much did DIZZINESS INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
41. Blurred Vision
41a. What was the SEVERITY of your BLURRY VISION at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
41b. How much did BLURRY VISION INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
42. Flashing Lights
42a. Did you have any FLASHING LIGHTS IN FRONT OF YOUR EYES?
Select one option:
- Yes
- No
43. Visual Floaters
43a. Did you have any SPOTS OR LINES (FLOATERS) THAT DRIFT IN FRONT OF YOUR EYES?
Select one option:
- Yes
- No
44. Watery Eyes
44a. What was the SEVERITY of your WATERY EYES (TEARING) at their WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
44b. How much did WATERY EYES (TEARING) INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
45. Ringing in Ears
45a. What was the SEVERITY of RINGING IN YOUR EARS at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
46. Concentration
46a. What was the SEVERITY of your PROBLEMS WITH CONCENTRATION at their WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
46b. How much did PROBLEMS WITH CONCENTRATION INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
47. Memory
47a. What was the SEVERITY of your PROBLEMS WITH MEMORY at their WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
47b. How much did PROBLEMS WITH MEMORY INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
48. General Pain
48a. How OFTEN did you have PAIN?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
48b. What was the SEVERITY of your PAIN at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
48c. How much did PAIN INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
49. Headache
49a. How OFTEN did you have a HEADACHE?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
49b. What was the SEVERITY of your HEADACHE at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
49c. How much did your HEADACHE INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
50. Muscle Pain
50a. How OFTEN did you have ACHING MUSCLES?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
50b. What was the SEVERITY of your ACHING MUSCLES at their WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
50c. How much did ACHING MUSCLES INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
51. Joint Pain
51a. How OFTEN did you have ACHING JOINTS (SUCH AS ELBOWS, KNEES, SHOULDERS)?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
51b. What was the SEVERITY of your ACHING JOINTS (SUCH AS ELBOWS, KNEES, SHOULDERS) at their WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
51c. How much did ACHING JOINTS (SUCH AS ELBOWS, KNEES, SHOULDERS) INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
52. Insomnia
52a. What was the SEVERITY of your INSOMNIA (INCLUDING DIFFICULTY FALLING ASLEEP, STAYING ASLEEP, OR WAKING UP EARLY) at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
52b. How much did INSOMNIA (INCLUDING DIFFICULTY FALLING ASLEEP, STAYING ASLEEP, OR WAKING UP EARLY) INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
53. Fatigue
53a. What was the SEVERITY of your FATIGUE, TIREDNESS, OR LACK OF ENERGY at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
53b. How much did FATIGUE, TIREDNESS, OR LACK OF ENERGY INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
54. Anxious
54a. How OFTEN did you feel ANXIETY?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
54b. What was the SEVERITY of your ANXIETY at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
54c. How much did ANXIETY INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
55. Discouraged
55a. How OFTEN did you FEEL THAT NOTHING COULD CHEER YOU UP?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
55b. What was the SEVERITY of your FEELINGS THAT NOTHING COULD CHEER YOU UP at their WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
55c. How much did FEELING THAT NOTHING COULD CHEER YOU UP INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
56. Sad
56a. How OFTEN did you have SAD OR UNHAPPY FEELINGS?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
56b. What was the SEVERITY of your SAD OR UNHAPPY FEELINGS at their WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
56c. How much did SAD OR UNHAPPY FEELINGS INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
57. Irregular Periods/Vaginal Bleeding
57a. Did you have any IRREGULAR MENSTRUAL PERIODS?
Select one option:
- Yes
- No
- Not applicable
58. Missed Expected Menstrual Period
58a. Did you MISS AN EXPECTED MENSTRUAL PERIOD?
Select one option:
- Yes
- No
- Not applicable
59. Vaginal Discharge
59a. Did you have any UNUSUAL VAGINAL DISCHARGE?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
60. Vaginal Dryness
60a. What was the SEVERITY of your VAGINAL DRYNESS at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
61. Painful Urination
61a. What was the SEVERITY of your PAIN OR BURNING WITH URINATION at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
62. Urinary Urgency
62a. How OFTEN did you feel an URGE TO URINATE ALL OF A SUDDEN?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
62b. How much did SUDDEN URGES TO URINATE INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
63. Urinary Frequency
63a. Were there times when you had to URINATE FREQUENTLY?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
63b. How much did FREQUENT URINATION INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
64. Change in Usual Urine Color
64a. Did you have any URINE COLOR CHANGE?
Select one option:
- Yes
- No
65. Urinary Incontinence
65a. How OFTEN did you have LOSS OF CONTROL OF URINE (LEAKAGE)?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
65b. How much did LOSS OF CONTROL OF URINE (LEAKAGE) INTERFERE with your usual or daily activities?
Select one option:
- Not at all
- A little bit
- Somewhat
- Quite a bit
- Very much
66. Achieve and Maintain Erection
66a. What was the SEVERITY of your DIFFICULTY GETTING OR KEEPING AN ERECTION at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
- Not sexually active
- Prefer not to answer
67. Ejaculation
67a. How OFTEN did you have EJACULATION PROBLEMS?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
- Not sexually active
- Prefer not to answer
68. Decreased Libido
68a. What was the SEVERITY of your DECREASED SEXUAL INTEREST at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
- Not sexually active
- Prefer not to answer
69. Delayed Orgasm
69a. Did you feel that it TOOK TOO LONG TO HAVE AN ORGASM OR CLIMAX?
Select one option:
- Yes
- No
- Not sexually active
- Prefer not to answer
70. Unable to Have Orgasm
70a. Were you UNABLE TO HAVE AN ORGASM OR CLIMAX?
Select one option:
- Yes
- No
- Not sexually active
- Prefer not to answer
71. Pain with Sexual Intercourse
71a. What was the SEVERITY of your PAIN DURING VAGINAL SEX at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
- Not sexually active
- Prefer not to answer
72. Breast Swelling and Tenderness
72a. What was the SEVERITY of your BREAST AREA ENLARGEMENT OR TENDERNESS at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
73. Bruising
73a. Did you BRUISE EASILY (BLACK AND BLUE MARKS)?
Select one option:
- Yes
- No
74. Chills
74a. How OFTEN did you have SHIVERING OR SHAKING CHILLS?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
74b. What was the SEVERITY of your SHIVERING OR SHAKING CHILLS at their WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
75. Increased Sweating
75a. How OFTEN did you have UNEXPECTED OR EXCESSIVE SWEATING DURING THE DAY OR NIGHTTIME (NOT RELATED TO HOT FLASHES/FLUSHES)?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
75b. What was the SEVERITY of your UNEXPECTED OR EXCESSIVE SWEATING DURING THE DAY OR NIGHTTIME (NOT RELATED TO HOT FLASHES/FLUSHES) at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
76. Decreased Sweating
76a. Did you have an UNEXPECTED DECREASE IN SWEATING?
Select one option:
- Yes
- No
77. Hot Flashes
77a. How OFTEN did you have HOT FLASHES/FLUSHES?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
77b. What was the SEVERITY of your HOT FLASHES/FLUSHES at their WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
78. Nosebleed
78a. How OFTEN did you have NOSEBLEEDS?
Select one option:
- Never
- Rarely
- Occasionally
- Frequently
- Almost constantly
78b. What was the SEVERITY of your NOSEBLEEDS at their WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
79. Pain and Swelling at Injection Site
79a. Did you HAVE ANY PAIN, SWELLING, OR REDNESS AT A SITE OF DRUG INJECTION OR IV?
Select one option:
- Yes
- No
- Not applicable
80. Body Odor
80a. What was the SEVERITY of your BODY ODOR at its WORST?
Select one option:
- None
- Mild
- Moderate
- Severe
- Very Severe
Possible results
51. Joint Pain Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Chills Severity: None (0)
Numbness & Tingling Severity: Severe (3)
47. Memory Composite Grade 0 - Absent
No clinically meaningful symptom present.
70. Unable To Have Orgasm - Prefer not to answer
Hand-foot Syndrome Severity: Moderate (2)
Anxious Frequency: Occasionally (2)
13. Bloating Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
14. Hiccups Composite Grade 0 - Absent
No clinically meaningful symptom present.
66. Achieve and Maintain Erection Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-4.3
80. Body Odor Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
44. Watery Eyes Composite Grade 0 - Absent
No clinically meaningful symptom present.
21. Wheezing Composite Grade 0 - Absent
No clinically meaningful symptom present.
51. Joint Pain Composite Grade 0 - Absent
No clinically meaningful symptom present.
71. Pain With Sexual Intercourse - Prefer not to answer
Joint Pain Frequency: Rarely (1)
Headache Severity: Very Severe (4)
65. Urinary Incontinence Composite Grade 0 - Absent
No clinically meaningful symptom present.
26. Acne Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Nosebleed Severity: Very Severe (4)
Hoarseness Severity: Severe (3)
Nausea Frequency: Almost constantly (4)
16. Diarrhea Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Sad Frequency: Almost constantly (4)
Mouth/Throat Sores Severity: Moderate (2)
50. Muscle Pain Composite Grade 0 - Absent
No clinically meaningful symptom present.
Acne Severity: Moderate (2)
53. Fatigue Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Sad Severity: Severe (3)
Decreased Libido Severity: Mild (1)
Hiccups Frequency: Occasionally (2)
Hot Flashes Severity: Mild (1)
Taste Changes Severity: Mild (1)
Concentration Severity: Severe (3)
Headache Severity: Mild (1)
66. Achieve and Maintain Erection - Prefer not to answer
Insomnia Severity: Moderate (2)
62. Urinary Urgency Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
41. Blurred Vision Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
60. Vaginal Dryness Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
General Pain Severity: Mild (1)
46. Concentration Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Urinary Frequency Frequency: Rarely (1)
62. Urinary Urgency Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Urinary Urgency Frequency: Occasionally (2)
Muscle Pain Severity: Very Severe (4)
77. Hot Flashes Composite Grade 0 - Absent
No clinically meaningful symptom present.
Pain With Sexual Intercourse Severity: Moderate (2)
Vomiting Severity: Very Severe (4)
11. Heartburn Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Cracking Corners of Mouth (Cheilosis/Chelitis) Severity: Very Severe (4)
Taste Changes Severity: Severe (3)
Nausea Frequency: Frequently (3)
Nosebleed Severity: Severe (3)
Pain With Sexual Intercourse Severity: Very Severe (4)
Hiccups Severity: Mild (1)
28. Itching Composite Grade 0 - Absent
No clinically meaningful symptom present.
Concentration Severity: Moderate (2)
Swelling Severity: None (0)
Joint Pain Severity: Mild (1)
Swelling Frequency: Frequently (3)
66. Achieve and Maintain Erection Composite Grade 0 - Absent
No clinically meaningful symptom present.
Cracking Corners of Mouth (Cheilosis/Chelitis) Severity: Mild (1)
Vaginal Discharge Amount: Quite a bit (3)
Achieve and Maintain Erection Severity: Moderate (2)
54. Anxious Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
27. Hair Loss Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-4.3
Painful Urination Severity: Severe (3)
Ringing in Ears Severity: Mild (1)
19. Shortness of Breath Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
80. Body Odor Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Diarrhea Frequency: Almost constantly (4)
8. Decreased Appetite Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
40. Dizziness Composite Grade 0 - Absent
No clinically meaningful symptom present.
Skin Dryness Severity: Mild (1)
19. Shortness of Breath Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Heartburn Frequency: Almost constantly (4)
13. Bloating Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Achieve and Maintain Erection Severity: Mild (1)
3. Mouth/Throat Sores Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Sad Severity: Moderate (2)
41. Blurred Vision Composite Grade 0 - Absent
No clinically meaningful symptom present.
39. Numbness & Tingling Composite Grade 0 - Absent
No clinically meaningful symptom present.
Watery Eyes Severity: Moderate (2)
Abdominal Pain Frequency: Almost constantly (4)
23. Heart Palpitations Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
55. Discouraged Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Pain With Sexual Intercourse Severity: Mild (1)
47. Memory Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Watery Eyes Severity: Very Severe (4)
Dry mouth Severity: Moderate (2)
Vomiting Severity: Severe (3)
Headache Frequency: Almost constantly (4)
Hair Loss Amount: Somewhat (2)
74. Chills Composite Grade 0 - Absent
No clinically meaningful symptom present.
78. Nosebleed Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Vomiting Severity: None (0)
Joint Pain Severity: Severe (3)
Muscle Pain Severity: Severe (3)
71. Pain With Sexual Intercourse Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
4. Cracking Corners of Mouth (Cheilosis/Chelitis) Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
21. Wheezing Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-4.3
Vaginal Discharge Amount: Very Much (4)
General Pain Severity: Moderate (2)
Nausea Severity: Very Severe (4)
66. Achieve and Maintain Erection Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Bloating Frequency: Occasionally (2)
Swelling Frequency: Occasionally (2)
30. Hand-foot Syndrome Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Shortness of Breath Severity: Severe (3)
Urinary Urgency Frequency: Frequently (3)
67. Ejaculation Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Heart Palpitations Frequency: Occasionally (2)
71. Pain With Sexual Intercourse Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-4.3
Dry mouth Severity: Very Severe (4)
Abdominal Pain Severity: Mild (1)
Sad Severity: None (0)
Breast Swelling and Tenderness Severity: Mild (1)
74. Chills Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
20. Cough Composite Grade 0 - Absent
No clinically meaningful symptom present.
Skin Dryness Severity: Very Severe (4)
26. Acne Composite Grade 0 - Absent
No clinically meaningful symptom present.
67. Ejaculation Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Abdominal Pain Frequency: Frequently (3)
Concentration Severity: Very Severe (4)
80. Body Odor Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-4.3
Chills Frequency: Rarely (1)
Bloating Severity: Severe (3)
2. Difficulty Swallowing Composite Grade 0 - Absent
No clinically meaningful symptom present.
Joint Pain Severity: Very Severe (4)
Mouth/Throat Sores Severity: Severe (3)
Muscle Pain Severity: Moderate (2)
10. Vomiting Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Radiation Skin Reaction Severity: Moderate (2)
Body Odor Severity: Moderate (2)
54. Anxious Composite Grade 0 - Absent
No clinically meaningful symptom present.
Hair Loss Amount: Quite a bit (3)
Joint Pain Frequency: Almost constantly (4)
Difficulty Swallowing Severity: Severe (3)
Blurred Vision Severity: Mild (1)
45. Ringing in Ears Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Urinary Incontinence Frequency: Frequently (3)
30. Hand-foot Syndrome Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Numbness & Tingling Severity: Moderate (2)
45. Ringing in Ears Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Itching Severity: Very Severe (4)
68. Decreased Libido Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
9. Nausea Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
1. Dry Mouth Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
16. Diarrhea Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Radiation Skin Reaction Severity: Very Severe (4)
Urinary Incontinence Frequency: Occasionally (2)
Fatigue Severity: Mild (1)
Vomiting Frequency: Rarely (1)
Heartburn Frequency: Frequently (3)
Heart Palpitations Severity: Very Severe (4)
Achieve and Maintain Erection Severity: Very Severe (4)
36. Radiation Skin Reaction Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-4.3
Vaginal Dryness Severity: Very Severe (4)
40. Dizziness Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Urinary Incontinence Frequency: Almost constantly (4)
3. Mouth/Throat Sores Composite Grade 0 - Absent
No clinically meaningful symptom present.
72. Breast Swelling and Tenderness Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Bloating Frequency: Frequently (3)
Taste Changes Severity: Moderate (2)
44. Watery Eyes Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
General Pain Severity: Very Severe (4)
Heart Palpitations Severity: Severe (3)
Hoarseness Severity: Very Severe (4)
Hoarseness Severity: Mild (1)
Cough Severity: Severe (3)
Discouraged Severity: Moderate (2)
Memory Severity: Mild (1)
Diarrhea Frequency: Frequently (3)
69. Delayed Orgasm - Prefer not to answer
Concentration Severity: Mild (1)
Acne Severity: Mild (1)
Discouraged Frequency: Almost constantly (4)
Wheezing Severity: Moderate (2)
Hot Flashes Severity: Severe (3)
44. Watery Eyes Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Ejaculation Frequency: Almost constantly (4)
Sad Severity: Mild (1)
Hiccups Frequency: Almost constantly (4)
Heartburn Frequency: Occasionally (2)
16. Diarrhea Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Anxious Frequency: Almost constantly (4)
Chills Severity: Severe (3)
Numbness & Tingling Severity: Mild (1)
22. Swelling Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Sad Frequency: Occasionally (2)
20. Cough Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
51. Joint Pain Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Fatigue Severity: Very Severe (4)
Painful Urination Severity: Moderate (2)
71. Pain With Sexual Intercourse Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
30. Hand-foot Syndrome Composite Grade 0 - Absent
No clinically meaningful symptom present.
15. Constipation Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
General Pain Severity: None (0)
55. Discouraged Composite Grade 0 - Absent
No clinically meaningful symptom present.
45. Ringing in Ears Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-4.3
Urinary Frequency Frequency: Frequently (3)
Nausea Frequency: Occasionally (2)
50. Muscle Pain Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Heartburn Frequency: Rarely (1)
Hoarseness Severity: Moderate (2)
48. General Pain Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
4. Cracking Corners of Mouth (Cheilosis/Chelitis) Composite Grade 0 - Absent
No clinically meaningful symptom present.
Joint Pain Frequency: Frequently (3)
Vomiting Frequency: Occasionally (2)
27. Hair Loss Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
52. Insomnia Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
55. Discouraged Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
56. Sad Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Difficulty Swallowing Severity: Very Severe (4)
General Pain Frequency: Occasionally (2)
Nosebleed Severity: Moderate (2)
Nosebleed Frequency: Frequently (3)
Abdominal Pain Severity: None (0)
74. Chills Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Heart Palpitations Frequency: Frequently (3)
48. General Pain Composite Grade 0 - Absent
No clinically meaningful symptom present.
Bloating Frequency: Rarely (1)
Nosebleed Severity: Mild (1)
Vaginal Discharge Amount: Somewhat (2)
Skin Dryness Severity: Severe (3)
Nausea Frequency: Rarely (1)
Itching Severity: Mild (1)
47. Memory Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Memory Severity: Moderate (2)
62. Urinary Urgency Composite Grade 0 - Absent
No clinically meaningful symptom present.
Acne Severity: Very Severe (4)
Memory Interference: Not at all (0)
36. Radiation Skin Reaction Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
77. Hot Flashes Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
23. Heart Palpitations Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Abdominal Pain Frequency: Rarely (1)
Nosebleed Frequency: Occasionally (2)
Radiation Skin Reaction Severity: Mild (1)
Discouraged Frequency: Rarely (1)
69. Delayed Orgasm - Not sexually active
4. Cracking Corners of Mouth (Cheilosis/Chelitis) Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Abdominal Pain Severity: Severe (3)
Hand-foot Syndrome Severity: Severe (3)
49. Headache Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Memory Severity: Severe (3)
Heart Palpitations Frequency: Almost constantly (4)
Decreased Libido Severity: Very Severe (4)
63. Urinary Frequency Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
53. Fatigue Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Anxious Severity: None (0)
Shortness of Breath Severity: Moderate (2)
Swelling Severity: Moderate (2)
13. Bloating Composite Grade 0 - Absent
No clinically meaningful symptom present.
Abdominal Pain Severity: Moderate (2)
6. Hoarseness Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Hot Flashes Severity: Very Severe (4)
Insomnia Severity: Very Severe (4)
Ringing in Ears Severity: Moderate (2)
Fatigue Severity: Severe (3)
Body Odor Severity: Severe (3)
9. Nausea Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Heart Palpitations Severity: None (0)
72. Breast Swelling and Tenderness Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-4.3
Muscle Pain Frequency: Frequently (3)
Headache Severity: None (0)
68. Decreased Libido Composite Grade 0 - Absent
No clinically meaningful symptom present.
Anxious Frequency: Rarely (1)
Vaginal Dryness Severity: Moderate (2)
Painful Urination Severity: Very Severe (4)
46. Concentration Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Joint Pain Severity: Moderate (2)
40. Dizziness Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Watery Eyes Severity: Severe (3)
Cough Severity: Moderate (2)
Heartburn Severity: Severe (3)
10. Vomiting Composite Grade 0 - Absent
No clinically meaningful symptom present.
Increased Sweating Severity: Severe (3)
52. Insomnia Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Constipation Severity: Very Severe (4)
1. Dry Mouth Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-4.3
13. Bloating Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Cough Severity: Very Severe (4)
Vaginal Dryness Severity: Mild (1)
72. Breast Swelling and Tenderness Composite Grade 0 - Absent
No clinically meaningful symptom present.
Discouraged Frequency: Frequently (3)
Bloating Severity: Very Severe (4)
Mouth/Throat Sores Severity: Very Severe (4)
Sad Severity: Very Severe (4)
22. Swelling Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Fecal Incontinence Frequency: Occasionally (2)
68. Decreased Libido Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-4.3
Hiccups Severity: Very Severe (4)
Anxious Severity: Severe (3)
46. Concentration Composite Grade 0 - Absent
No clinically meaningful symptom present.
Dizziness Severity: Moderate (2)
Memory Severity: Very Severe (4)
54. Anxious Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
36. Radiation Skin Reaction Composite Grade 0 - Absent
No clinically meaningful symptom present.
Pain With Sexual Intercourse Severity: Severe (3)
66. Achieve and Maintain Erection - Not sexually active
61. Painful Urination Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
11. Heartburn Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
6. Hoarseness Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
3. Mouth/Throat Sores Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
14. Hiccups Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Headache Frequency: Rarely (1)
Wheezing Severity: Severe (3)
63. Urinary Frequency Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
67. Ejaculation Composite Grade 0 - Absent
No clinically meaningful symptom present.
Chills Severity: Mild (1)
72. Breast Swelling and Tenderness Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Fecal Incontinence Frequency: Frequently (3)
Vomiting Severity: Mild (1)
25. Skin Dryness Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
65. Urinary Incontinence Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Anxious Severity: Very Severe (4)
70. Unable To Have Orgasm - Not sexually active
Nausea Severity: Moderate (2)
Hot Flashes Severity: None (0)
Decreased Libido Severity: Moderate (2)
Vomiting Frequency: Almost constantly (4)
Sad Frequency: Rarely (1)
67. Ejaculation - Prefer not to answer
63. Urinary Frequency Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
1. Dry Mouth Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Vomiting Frequency: Frequently (3)
Wheezing Severity: Mild (1)
15. Constipation Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Increased Sweating Severity: Very Severe (4)
Bloating Severity: Moderate (2)
Vaginal Dryness Severity: Severe (3)
78. Nosebleed Composite Grade 0 - Absent
No clinically meaningful symptom present.
Ejaculation Frequency: Occasionally (2)
17. Abdominal Pain Composite Grade 0 - Absent
No clinically meaningful symptom present.
54. Anxious Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Constipation Severity: Mild (1)
75. Increased Sweating Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
56. Sad Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
41. Blurred Vision Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
10. Vomiting Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Decreased Appetite Severity: Moderate (2)
Increased Sweating Frequency: Occasionally (2)
25. Skin Dryness Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-4.3
Heartburn Severity: Mild (1)
68. Decreased Libido Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
49. Headache Composite Grade 0 - Absent
No clinically meaningful symptom present.
18. Fecal Incontinence Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Increased Sweating Frequency: Frequently (3)
Hiccups Frequency: Frequently (3)
62. Urinary Urgency Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
77. Hot Flashes Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Skin Dryness Severity: Moderate (2)
7. Taste Changes Composite Grade 0 - Absent
No clinically meaningful symptom present.
Discouraged Severity: None (0)
50. Muscle Pain Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Headache Severity: Severe (3)
Abdominal Pain Frequency: Occasionally (2)
71. Pain With Sexual Intercourse Composite Grade 0 - Absent
No clinically meaningful symptom present.
Heart Palpitations Frequency: Rarely (1)
44. Watery Eyes Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
47. Memory Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
60. Vaginal Dryness Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Nausea Severity: Mild (1)
Nosebleed Severity: None (0)
Hiccups Severity: Severe (3)
Heart Palpitations Severity: Mild (1)
2. Difficulty Swallowing Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Chills Frequency: Almost constantly (4)
26. Acne Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Muscle Pain Severity: Mild (1)
Taste Changes Severity: Very Severe (4)
Muscle Pain Frequency: Rarely (1)
Fatigue Severity: Moderate (2)
Shortness of Breath Interference: Somewhat (2)
60. Vaginal Dryness Composite Grade 0 - Absent
No clinically meaningful symptom present.
53. Fatigue Composite Grade 0 - Absent
No clinically meaningful symptom present.
Hot Flashes Frequency: Occasionally (2)
Bloating Severity: None (0)
36. Radiation Skin Reaction Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
50. Muscle Pain Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
63. Urinary Frequency Composite Grade 0 - Absent
No clinically meaningful symptom present.
56. Sad Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
59. Vaginal Discharge Composite Grade 0 - Absent
No clinically meaningful symptom present.
Hiccups Frequency: Rarely (1)
Constipation Severity: Severe (3)
30. Hand-foot Syndrome Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-4.3
17. Abdominal Pain Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Muscle Pain Frequency: Almost constantly (4)
27. Hair Loss Composite Grade 0 - Absent
No clinically meaningful symptom present.
Blurred Vision Severity: Moderate (2)
58. Missed Expected Menstrual Period - No
Heartburn Severity: None (0)
Joint Pain Frequency: Occasionally (2)
52. Insomnia Composite Grade 0 - Absent
No clinically meaningful symptom present.
78. Nosebleed Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
68. Decreased Libido - Prefer not to answer
16. Diarrhea Composite Grade 0 - Absent
No clinically meaningful symptom present.
22. Swelling Composite Grade 0 - Absent
No clinically meaningful symptom present.
21. Wheezing Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
18. Fecal Incontinence Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
8. Decreased Appetite Composite Grade 0 - Absent
No clinically meaningful symptom present.
2. Difficulty Swallowing Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
23. Heart Palpitations Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Headache Severity: Moderate (2)
14. Hiccups Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Swelling Frequency: Almost constantly (4)
56. Sad Composite Grade 0 - Absent
No clinically meaningful symptom present.
61. Painful Urination Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Increased Sweating Severity: None (0)
19. Shortness of Breath Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Body Odor Severity: Mild (1)
Radiation Skin Reaction Severity: Severe (3)
Constipation Severity: Moderate (2)
Anxious Severity: Moderate (2)
Urinary Urgency Frequency: Rarely (1)
Hot Flashes Frequency: Frequently (3)
6. Hoarseness Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Bloating Severity: Mild (1)
Anxious Frequency: Frequently (3)
Cracking Corners of Mouth (Cheilosis/Chelitis) Severity: Moderate (2)
39. Numbness & Tingling Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
20. Cough Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
22. Swelling Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Urinary Frequency Frequency: Almost constantly (4)
Breast Swelling and Tenderness Severity: Moderate (2)
11. Heartburn Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Insomnia Severity: Severe (3)
4. Cracking Corners of Mouth (Cheilosis/Chelitis) Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Vomiting Severity: Moderate (2)
Headache Frequency: Occasionally (2)
59. Vaginal Discharge Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Breast Swelling and Tenderness Severity: Severe (3)
Decreased Libido Severity: Severe (3)
74. Chills Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Decreased Appetite Severity: Mild (1)
9. Nausea Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Blurred Vision Severity: Severe (3)
Diarrhea Frequency: Occasionally (2)
48. General Pain Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Heart Palpitations Severity: Moderate (2)
17. Abdominal Pain Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
49. Headache Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
78. Nosebleed Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Headache Frequency: Frequently (3)
Nosebleed Frequency: Almost constantly (4)
23. Heart Palpitations Composite Grade 0 - Absent
No clinically meaningful symptom present.
55. Discouraged Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Dry mouth Severity: Severe (3)
40. Dizziness Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Discouraged Severity: Mild (1)
Itching Severity: Severe (3)
67. Ejaculation Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Discouraged Frequency: Occasionally (2)
Heartburn Severity: Very Severe (4)
Discouraged Severity: Severe (3)
59. Vaginal Discharge Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-4.3
20. Cough Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Watery Eyes Severity: Mild (1)
Dizziness Severity: Very Severe (4)
Difficulty Swallowing Severity: Moderate (2)
Shortness of Breath Severity: Very Severe (4)
Fecal Incontinence Frequency: Rarely (1)
General Pain Frequency: Frequently (3)
Abdominal Pain Severity: Very Severe (4)
Hot Flashes Frequency: Rarely (1)
Joint Pain Severity: None (0)
Hand-foot Syndrome Severity: Very Severe (4)
60. Vaginal Dryness Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-4.3
59. Vaginal Discharge Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Achieve and Maintain Erection Severity: Severe (3)
Difficulty Swallowing Severity: Mild (1)
Decreased Appetite Severity: Very Severe (4)
11. Heartburn Composite Grade 0 - Absent
No clinically meaningful symptom present.
18. Fecal Incontinence Composite Grade 0 - Absent
No clinically meaningful symptom present.
28. Itching Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Swelling Severity: Mild (1)
7. Taste Changes Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
61. Painful Urination Composite Grade 0 - Absent
No clinically meaningful symptom present.
10. Vomiting Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Shortness of Breath Severity: Mild (1)
Numbness & Tingling Severity: Very Severe (4)
Wheezing Severity: Very Severe (4)
Hot Flashes Frequency: Almost constantly (4)
51. Joint Pain Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Increased Sweating Frequency: Almost constantly (4)
Ejaculation Frequency: Frequently (3)
1. Dry Mouth Composite Grade 0 - Absent
No clinically meaningful symptom present.
Mouth/Throat Sores Severity: Mild (1)
68. Decreased Libido - Not sexually active
Diarrhea Frequency: Rarely (1)
Itching Severity: Moderate (2)
Anxious Severity: Mild (1)
45. Ringing in Ears Composite Grade 0 - Absent
No clinically meaningful symptom present.
General Pain Frequency: Rarely (1)
39. Numbness & Tingling Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
28. Itching Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-4.3
36. Radiation Skin Reaction Composite Grade 0 - Not Applicable
Urinary Incontinence Frequency: Rarely (1)
Muscle Pain Frequency: Occasionally (2)
Urinary Urgency Frequency: Almost constantly (4)
Blurred Vision Severity: Very Severe (4)
Chills Severity: Moderate (2)
3. Mouth/Throat Sores Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Dizziness Severity: Severe (3)
26. Acne Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-4.3
5. Voice Quality Changes - Yes
65. Urinary Incontinence Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
75. Increased Sweating Composite Grade 0 - Absent
No clinically meaningful symptom present.
Breast Swelling and Tenderness Severity: Very Severe (4)
Swelling Severity: Very Severe (4)
Insomnia Severity: Mild (1)
25. Skin Dryness Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
75. Increased Sweating Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Swelling Severity: Severe (3)
17. Abdominal Pain Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Urinary Frequency Frequency: Occasionally (2)
2. Difficulty Swallowing Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Vaginal Discharge Amount: A little bit (1)
General Pain Severity: Severe (3)
Chills Frequency: Occasionally (2)
Nosebleed Frequency: Rarely (1)
Increased Sweating Severity: Mild (1)
Acne Severity: Severe (3)
Fecal Incontinence Frequency: Almost constantly (4)
Ringing in Ears Severity: Severe (3)
27. Hair Loss Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Hiccups Severity: Moderate (2)
67. Ejaculation - Not sexually active
Ejaculation Frequency: Rarely (1)
Chills Frequency: Frequently (3)
15. Constipation Composite Grade 0 - Absent
No clinically meaningful symptom present.
Hair Loss Amount: Very Much (4)
Nausea Severity: None (0)
Sad Frequency: Frequently (3)
8. Decreased Appetite Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
48. General Pain Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
14. Hiccups Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Increased Sweating Severity: Moderate (2)
25. Skin Dryness Composite Grade 0 - Absent
No clinically meaningful symptom present.
15. Constipation Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Nausea Severity: Severe (3)
71. Pain With Sexual Intercourse - Not sexually active
Dizziness Severity: Mild (1)
77. Hot Flashes Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Heartburn Severity: Moderate (2)
39. Numbness & Tingling Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
46. Concentration Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Increased Sweating Frequency: Rarely (1)
49. Headache Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
52. Insomnia Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Hair Loss Amount: A little bit (1)
Bloating Frequency: Almost constantly (4)
Cracking Corners of Mouth (Cheilosis/Chelitis) Severity: Severe (3)
7. Taste Changes Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Body Odor Severity: Very Severe (4)
Hiccups Severity: None (0)
General Pain Frequency: Almost constantly (4)
21. Wheezing Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
41. Blurred Vision Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
Hand-foot Syndrome Severity: Mild (1)
66. Achieve and Maintain Erection Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
65. Urinary Incontinence Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Ringing in Ears Severity: Very Severe (4)
8. Decreased Appetite Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
18. Fecal Incontinence Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Swelling Frequency: Rarely (1)
Decreased Appetite Severity: Severe (3)
19. Shortness of Breath Composite Grade 0 - Absent
No clinically meaningful symptom present.
Chills Severity: Very Severe (4)
Hot Flashes Severity: Moderate (2)
Muscle Pain Severity: None (0)
Cough Severity: Mild (1)
75. Increased Sweating Composite Grade 2 - Moderate
Causing some limitation in daily activities.
From Grade 0-3.
Discouraged Severity: Very Severe (4)
7. Taste Changes Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Dry mouth Severity: Mild (1)
28. Itching Composite Grade 1 - Mild
Noticeable but not limiting daily activities.
From Grade 0-3.
80. Body Odor Composite Grade 0 - Absent
No clinically meaningful symptom present.
Painful Urination Severity: Mild (1)
6. Hoarseness Composite Grade 0 - Absent
No clinically meaningful symptom present.
9. Nausea Composite Grade 0 - Absent
No clinically meaningful symptom present.
61. Painful Urination Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-4.3
53. Fatigue Composite Grade 3 - Severe
Causing substantial limitation in daily activities.
From Grade 0-3.
Citation
For more information on development and testing of the PRO-CTCAE Measurement System, refer to https://healthcaredelivery.cancer.gov/pro-ctcae/testing.html