Table 2 Adverse events included in the PRO-CTCAE for melanoma patients receiving immunotherapy based on findings in medical records, literature review and product information
Frequency of Adverse Events | CTCAE terms | Literature review | Medical records | Product information | PRO-CTCAE symptom terms |
|---|---|---|---|---|---|
Very common (may affect more than 1 in 10 people) | Vomiting | X | x | Vomiting | |
Nausea | x | x | x | Nausea | |
Anorexia | x | x | x | Decreased appetite | |
Diarrhea | x | x | x | Diarrhea/Loose or watery stool | |
Abdominal pain | x | x | x | Abdominal pain | |
Constipation | x | x | Constipation | ||
Rash | x | x | x | Rash | |
Pruritus | x | x | x | Itching | |
Dyspnea | x | Shortness of breath | |||
Myalgia | x | x | Muscle pain | ||
Arthralgia | x | x | x | Joint pain | |
Fatigue | x | x | x | Fatigue | |
Injection site reaction | x | Pain and swelling at injection site | |||
Headache | x | x | Headache | ||
Chills | x | x | Chills | ||
̽Asthenia | x | x | |||
Common (may effect up to 1 in 10 people | Mucositis (oral) | x | x | x | Mouth/throat sores |
Dry skin | x | x | x | Skin dryness | |
Alopecia | x | x | Hair loss | ||
Blurred vision | x | x | x | Blurred vision | |
Cough | x | x | x | Cough | |
Dysgeusia | x | x | x | Taste changes | |
Dizziness | x | x | x | Dizziness | |
Edema | x | x | Swelling | ||
Pain | x | x | General pain | ||
Peripheral sensory neuropathy | x | x | Numbness & tingling | ||
Hot Flashes | x | x | Hot flashes | ||
̽Flu –like symptoms | x | x | |||
̽Pain in extremity | x | x | |||
̽Back pain | x | x | |||
Uncommon/not present | Depression (2 items) | x | Discouraged Sad | ||
Blood in stool |