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Revision History
| Date | Version |
|---|---|
| 2022-04-0721 | 1.0 Draft |
| Info |
|---|
The CDISC PRO-CTCAE V1.0 supplement version 1.0 was developed based on the NCI/NIH PRO-CTCAE® website. The website’s PRO-CTCAE Version 1.0 Release Notes indicate the revisions made by NCI/NIH on the PRO-CTCAE 1.0 measurement system. The measurement system version is 1.0 based on the website's release notes (specific correction of typographical errors in the different CRF translations). NCI/NIH will notify CDISC of any major changes in the future that would require a change control to the CDISC PRO-CTCAE V1.0 supplement version. |
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PRO-CTCAE ITEM LIBRARY (Version 1.0) symptom terms
| QNAM | QLABEL | QVAL |
| QSSYMPTM | Symptom Term | ABDOMINAL PAIN |
| ACHIEVE AND MAINTAIN ERECTION | ||
| ACNE | ||
| ANXIOUS | ||
| ANY OTHER SYMPTOMS REPORTED | ||
| BED/PRESSURE SORES | ||
| BLOATING | ||
| BLURRED VISION | ||
| BODY ODOR | ||
| BREAST SWELLING AND TENDERNESS | ||
| BRUISING | ||
| CHANGE IN USUAL URINE COLOR | ||
| CHILLS | ||
| CONCENTRATION | ||
| CONSTIPATION | ||
| COUGH | ||
| CRACKING AT THE CORNERS OF THE MOUTH (CHEILOSIS/CHEILITIS) | ||
| DECREASED APPETITE | ||
| DECREASED LIBIDO | ||
| DECREASED SWEATING | ||
| DELAYED ORGASM | ||
| DIARRHEA | ||
| DIFFICULTY SWALLOWING | ||
| DISCOURAGED | ||
| DIZZINESS | ||
| DRY MOUTH | ||
| EJACULATION | ||
| FATIGUE | ||
| FECAL INCONTINENCE | ||
| FLASHING LIGHTS | ||
| GAS | ||
| GENERAL PAIN | ||
| HAIR LOSS | ||
| HAND-FOOT SYNDROME | ||
| HEADACHE | ||
| HEARTBURN | ||
| HEART PALPITATIONS | ||
| HICCUPS | ||
| HIVES | ||
| HOARSENESS | ||
| HOT FLASHES |
| INCREASED SWEATING | ||
| INSOMNIA | ||
| IRREGULAR PERIODS/VAGINAL BLEEDING | ||
| ITCHING | ||
| JOINT PAIN | ||
| MEMORY | ||
| MISSED EXPECTED MENSTRUAL PERIOD | ||
| MOUTH/THROAT SORES | ||
| MUSCLE PAIN | ||
| NAIL DISCOLORATION | ||
| NAIL LOSS | ||
| NAIL RIDGING | ||
| NAUSEA | ||
| NOSEBLEED | ||
| NUMBNESS & TINGLING | ||
| OTHER SYMPTOM | ||
| PAIN AND SWELLING AT INJECTION SITE | ||
| PAIN W/SEXUAL INTERCOURSE | ||
| PAINFUL URINATION | ||
| RADIATION SKIN REACTION | ||
| RASH | ||
| RINGING IN EARS | ||
| SAD | ||
| SENSITIVITY TO SUNLIGHT | ||
| SHORTNESS OF BREATH | ||
| SKIN DARKENING | ||
| SKIN DRYNESS | ||
| STRETCH MARKS | ||
| SWELLING | ||
| TASTE CHANGES | ||
| UNABLE TO HAVE ORGASM | ||
| URINARY FREQUENCY | ||
| URINARY INCONTINENCE | ||
| URINARY URGENCY | ||
| VAGINAL DISCHARGE | ||
| VAGINAL DRYNESS | ||
| VISUAL FLOATERS | ||
| VOICE QUALITY CHANGES | ||
| VOMITING | ||
| WATERY EYES | ||
| WHEEZING | ||
| OTHER SYMPTOM 1 | ||
| OTHER SYMPTOM 2 | ||
| OTHER SYMPTOM 3 | ||
| OTHER SYMPTOM 4 | ||
| OTHER SYMPTOM 5 | ||
| OTHER SYMPTOM 6 | ||
| OTHER SYMPTOM 7 | ||
| OTHER SYMPTOM 8 | ||
| OTHER SYMPTOM 9 | ||
| OTHER SYMPTOM 10 |
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