Table 1.
Core outcome set and corresponding PRO-CTCAE items
| MedDRA system organ classes1 | Core outcome sets2,3 | Corresponding PRO-CTCAE items4 |
|---|---|---|
| Gastrointestinal disorders | ➝ | |
| Constipation2 | Constipation | |
| Diarrhea2 | Diarrhea | |
| Nausea2 | Nausea | |
| Bloating3 | Bloating | |
| Vomiting3 | Vomiting | |
| Cramping3 | Bloating/abdominal pain | |
| Indigestion3 | Diarrhea, constipation, abdominal pain | |
| General disorders and administration site conditions | ➝ | |
| Pain2 | Abdominal pain | |
| Abdominal pain3 | Abdominal pain | |
| Fatigue2 | Fatigue | |
| Metabolism and nutrition disorders | ➝ | |
| Anorexia (appetite loss)2 | Decreased appetite | |
| Weight gain3 | N/A | |
| Weight loss3 | Decreased appetite | |
| Nervous system disorders | ➝ | |
| Sensory neuropathy2 | Numbness & tingling | |
| Psychiatric disorders | ➝ | |
| Anxiety (includes worry)2 | Anxious | |
| Cognitive problems2 | Concentration, memory | |
| Depression (includes sadness)2 | Discouraged, sad | |
| Fear of recurrence/disease progression3 | N/A | |
| Insomnia2 | Insomnia | |
| Reproductive system and breast disorders | ➝ | |
| Sexual dysfunction3 | Decreased libido | |
| Vaginal dryness | ||
| Respiratory, thoracic, and mediastinal disorders | ➝ | |
| Dyspnea2 | Shortness of breath | |
| Unique symptoms in total | 21 | 18 |
MedDRA Medical Dictionary for Regulatory Activities, PRO-CTCAE Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events
1Medical Dictionary for Regulatory Activities (MEDDRA) [Internet]. Available from: https://www.meddra.org/ [39], 2Reeve et al. [41], 3Donovan et al. [42],4PRO-CTCAE. PRO-CTCAE® Measurement System website [Internet]. Available from: https://healthcaredelivery.cancer.gov/pro-ctcae [17]