Skip to main content

Table 2 Proportion of patients who evaluated items as “difficult to understand” or “difficult to answer”

From: Japanese translation and linguistic validation of the US National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Items

Dimension

Difficult to understand

Difficult to answer

n/N

%

n/N

%

ACHING JOINTS

Frequency

0/10

 

0/10

 

ACHING JOINTS

Severity

0/10

 

1/10

10.0%

ACHING JOINTS

Interference

0/10

 

1/10

10.0%

ACHING MUSCLES

Frequency

0/10

 

0/10

 

ACHING MUSCLES

Severity

0/10

 

1/10

10.0%

ACHING MUSCLES

Interference

0/10

 

1/10

10.0%

ACNE OR PIMPLES ON THE FACE OR CHEST

Severity

2/10

20.0%

1/10

10.0%

ANXIETY

Frequency

1/11

9.1%

1/11

9.1%

ANXIETY

Severity

3/11

27.3%

3/11

27.3%

ANXIETY

Interference

1/11

9.1%

2/11

18.2%

ARM OR LEG SWELLING

Frequency

0/16

 

1/16

6.3%

ARM OR LEG SWELLING

Severity

0/11

 

2/11

18.2%

ARM OR LEG SWELLING

Interference

0/11

 

2/11

18.2%

BED SORES

Presence

0/11

 

0/11

 

BLOATING OF THE ABDOMEN (BELLY)

Frequency

0/10

 

0/10

 

BLOATING OF THE ABDOMEN (BELLY)

Severity

0/10

 

1/10

10.0%

BLURRY VISION

Severity

0/10

 

3/10

30.0%

BLURRY VISION

Interference

0/10

 

0/10

 

BODY ODOR

Severity

1/11

9.1%

3/11

27.3%

BREAST AREA ENLARGEMENT OR TENDERNESS

Severity

0/10

 

0/10

 

BRUISE EASILY (BLACK AND BLUE MARKS)

Presence

0/10

 

2/10

20.0%

CHANGE IN THE COLOR OFYOUR FINGERNAILS OR TOENAILS

Presence

0/11

 

0/11

 

CONSTIPATION

Severity

0/11

 

1/11

9.1%

COUGH

Severity

0/11

 

0/11

 

COUGH

Interference

0/11

 

1/11

9.1%

DECREASED APPETITE

Severity

0/11

 

0/11

 

DECREASED APPETITE

Interference

1/11

9.1%

3/11

27.3%

DECREASED SEXUAL INTEREST

Severity

0/10

 

5/10

50.0%

DIFFICULTY GETTING OR KEEPING AN ERECTION

Severity

0/6

 

0/6

 

DIFFICULTY SWALLOWING

Severity

0/11

 

1/11

9.1%

DIZZINESS

Severity

0/11

 

0/11

 

DIZZINESS

Interference

0/11

 

1/11

9.1%

DRY MOUTH

Severity

0/11

 

0/11

 

DRY SKIN

Severity

0/10

 

1/10

10.0%

EJACULATION PROBLEMS

Presence

1/6

16.7%

0/6

 

FATIGUE, TIREDNESS, OR LACK OF ENERGY

Severity

0/11

 

0/11

 

FATIGUE, TIREDNESS, OR LACK OF ENERGY

Interference

1/11

9.1%

1/11

9.1%

FEEL THAT NOTHING COULD CHEER YOU UP

Frequency

0/11

 

1/11

9.1%

FEEL THAT NOTHING COULD CHEER YOU UP

Severity

1/11

9.1%

1/11

9.1%

FEEL THAT NOTHING COULD CHEER YOU UP

Interference

1/11

9.1%

1/11

9.1%

FLASHING LIGHTS IN FRONT OF YOUR EYES

Presence

0/10

 

0/10

 

FREQUENT URINATION

Frequency

0/11

 

0/11

 

FREQUENT URINATION

Interference

0/11

 

1/11

9.1%

HAIR LOSS

Amount

1/11

9.1%

1/11

9.1%

HAND-FOOT SYNDROME

Severity

0/11

 

0/11

 

HEADACHE

Frequency

0/11

 

0/11

 

HEADACHE

Severity

0/11

 

1/11

9.1%

HEADACHE

Interference

0/11

 

1/11

9.1%

HEARTBURN

Frequency

0/10

 

0/10

 

HEARTBURN

Severity

0/10

 

1/10

10.0%

HICCUPS

Frequency

0/11

 

0/11

 

HICCUPS

Severity

0/11

 

1/11

9.1%

HIVES (ITCHY RED BUMPS ON THE SKIN)

Presence

1/10

10.0%

0/10

 

HOARSE VOICE

Severity

1/11

9.1%

0/11

 

HOT FLASHES

Frequency

1/10

10.0%

1/10

10.0%

HOT FLASHES

Severity

1/10

10.0%

1/10

10.0%

INCREASED PASSING OF GAS (FLATULENCE)

Presence

0/10

 

1/10

10.0%

INCREASED SKIN SENSITIVITY TO SUNLIGHT

Presence

1/10

10.0%

0/10

 

INSOMNIA

Severity

0/11

 

1/11

9.1%

INSOMNIA

Interference

0/11

 

0/11

 

MISS AN EXPECTED MENSTRUAL PERIOD

Presence

0/5

 

1/5

20.0%

IRREGULAR MENSTRUAL PERIODS

Presence

0/5

 

0/5

 

ITCHY SKIN

Severity

1/11

9.1%

0/11

 

LOOSE OR WATERY STOOLS (DIARRHEA)

Frequency

0/11

 

1/11

9.1%

LOSE ANY FINGERNAILS OR TOENAILS

Presence

1/10

10.0%

1/10

10.0%

LOSS OF CONTROL OF BOWEL MOVEMENTS

Frequency

0/10

 

0/10

 

LOSS OF CONTROL OF BOWEL MOVEMENTS

Interference

0/10

 

0/10

 

LOSS OF CONTROL OF URINE (LEAKAGE)

Frequency

0/11

 

1/11

9.1%

LOSS OF CONTROL OF URINE (LEAKAGE)

Interference

0/11

 

1/11

9.1%

MOUTH OR THROAT SORES

Severity

0/11

 

0/11

 

MOUTH OR THROAT SORES

Interference

0/11

 

1/11

9.1%

NAUSEA

Frequency

0/11

 

0/11

 

NAUSEA

Severity

0/11

 

1/11

9.1%

NOSEBLEEDS

Frequency

0/10

 

0/10

 

NOSEBLEEDS

Severity

0/10

 

0/10

 

NUMBNESS OR TINGLING IN YOUR HANDS OR FEET

Severity

1/11

9.1%

1/11

9.1%

NUMBNESS OR TINGLING IN YOUR HANDS OR FEET

Interference

1/11

9.1%

0/11

 

PAIN

Frequency

0/11

 

1/11

9.1%

PAIN

Severity

0/11

 

2/11

18.2%

PAIN

Interference

0/11

 

2/11

18.2%

PAIN DURING VAGINAL SEX

Severity

0/5

 

0/5

 

PAIN IN THE ABDOMEN (BELLY AREA)

Frequency

0/11

 

0/11

 

PAIN IN THE ABDOMEN (BELLY AREA)

Severity

0/11

 

1/11

9.1%

PAIN IN THE ABDOMEN (BELLY AREA)

Interference

0/11

 

1/11

9.1%

PAIN OR BURNING WITH URINATION

Severity

0/10

 

0/10

 

PAIN, SWELLING, OR REDNESSAT A SITE OF DRUG INJECTION OR IV

Presence

0/11

 

0/11

 

POUNDING OR RACING HEARTBEAT (PALPITATIONS)

Frequency

0/10

 

1/10

10.0%

POUNDING OR RACING HEARTBEAT (PALPITATIONS)

Severity

0/10

 

2/10

20.0%

PROBLEMS WITH CONCENTRATION

Severity

1/11

9.1%

1/11

9.1%

PROBLEMS WITH CONCENTRATION

Interference

1/11

9.1%

1/11

9.1%

PROBLEMS WITH MEMORY

Severity

2/10

20.0%

1/10

10.0%

PROBLEMS WITH MEMORY

Interference

1/10

10.0%

0/10

 

PROBLEMS WITH TASTING FOOD OR DRINK

Severity

0/11

 

1/11

9.1%

RASH

Presence

0/11

 

0/11

 

RIDGES OR BUMPS ON YOUR FINGERNAILSOR TOENAILS

Presence

0/10

 

2/10

20.0%

RINGING IN YOUR EARS

Severity

0/10

 

0/10

 

SAD OR UNHAPPY FEELINGS

Frequency

0/11

 

1/11

9.1%

SAD OR UNHAPPY FEELINGS

Severity

1/11

9.1%

2/11

18.2%

SAD OR UNHAPPY FEELINGS

Interference

0/11

 

1/11

9.1%

SHIVERING OR SHAKING CHILLS

Frequency

0/10

 

1/10

10.0%

SHIVERING OR SHAKING CHILLS

Severity

0/10

 

0/10

 

SHORTNESS OF BREATH

Severity

1/10

10.0%

0/10

 

SHORTNESS OF BREATH

Interference

1/10

10.0%

0/10

 

SKIN BURNS FROM RADIATION

Severity

0/10

 

4/10

40.0%

SKIN CRACKING AT THE CORNERS OF YOUR MOUTH

Severity

1/10

10.0%

0/10

 

SPOTS OR LINES THAT DRIFT IN FRONT OF YOUR EYES (FLOATERS)

Presence

0/10

 

0/10

 

STRETCH MARKS

Presence

2/10

20.0%

0/10

 

SUDDEN URGES TO URINATE

Frequency

1/10

10.0%

0/10

 

SUDDEN URGES TO URINATE

Interference

1/10

10.0%

0/10

 

TOOK TOO LONG TO HAVE AN ORGASM OR CLIMAX

Presence

0/10

 

4/10

40.0%

UNABLE TO HAVE AN ORGASM OR CLIMAX

Presence

0/10

 

4/10

40.0%

UNEXPECTED DECREASE IN SWEATING

Presence

1/10

10.0%

1/10

10.0%

UNEXPECTED OR EXCESSIVE SWEATINGDURING THE DAY OR NIGHTTIME

Frequency

0/10

 

0/10

 

UNEXPECTED OR EXCESSIVE SWEATINGDURING THE DAY OR NIGHTTIME

Severity

0/10

 

0/10

 

UNUSUAL DARKENING OF THE SKIN

Presence

0/10

 

0/10

 

UNUSUAL VAGINAL DISCHARGE

Presence

0/5

 

0/5

 

URINE COLOR CHANGE

Presence

0/10

 

0/10

 

VOICE CHANGES

Presence

0/10

 

0/10

 

VOMITING

Frequency

0/10

 

0/10

 

VOMITING

Severity

0/10

 

0/10

 

WATERY EYES (TEARING)

Severity

1/10

10.0%

1/10

10.0%

WATERY EYES (TEARING)

Interference

0/10

 

0/10

 

WHEEZING

Severity

0/10

 

0/10