Table 3.
Treatment-related adverse events
| Arm A pBCAR3 n=3 |
Arm B pIRS2 n=3 |
Arm C Both n=9 |
Total n=15 |
||||||||||
| Category | Adverse event | G1 | G2 | G3 | G1 | G2 | G3 | G1 | G2 | G3 | G1 | G2 | G3 |
| Gastrointestinal | Constipation | 1 | 1 | ||||||||||
| Diarrhea | 1 | 2 | 3 | ||||||||||
| Mucositis oral | 1 | 1 | |||||||||||
| Nausea | 2 | 1 | 3 | ||||||||||
| General and administration site |
Chills | 1 | 1 | 1 | 3 | 1 | 5 | 2 | |||||
| Edema limbs | 1 | 1 | |||||||||||
| Fatigue | 2 | 1 | 2 | 5 | 1 | 9 | 2 | ||||||
| Fever | 1 | 1 | 1 | 3 | |||||||||
| Influenza like symptoms | 1 | 1 | 1 | 1 | |||||||||
| Injection site reaction | 3 | 3 | 9 | 15 | |||||||||
| Pain | 2 | 2 | |||||||||||
| Immune system | Autoimmune disorder | 2 | 1 | 3 | |||||||||
| Investigations | Lymphocyte count decreased | 1 | 1 | ||||||||||
| Metabolism/nutrition | Anorexia | 1 | 1 | ||||||||||
| Musculoskeletal/ connective tissue |
Arthralgia | 1 | 3 | 4 | |||||||||
| Myalgia | 2 | 4 | 6 | ||||||||||
| Nervous system | Dizziness | 1 | 2 | 3 | |||||||||
| Headache | 1 | 1 | 4 | 5 | 1 | ||||||||
| Psychiatric | Agitation | 1 | 1 | ||||||||||
| Respiratory/thoracic/ mediastinal |
Cough | 1 | 1 | ||||||||||
| Sore throat | 1 | 1 | |||||||||||
| Skin/subcutaneous tissue | Dry skin | 1 | 1 | ||||||||||
| Skin induration | 3 | 1 | 4 | 5 | 5 | 8 | |||||||
| Skin ulceration | 1 | 1 | 1 | 1 | |||||||||
| Vascular | Flushing | 1 | 1 | ||||||||||
| Hot flashes | 1 | 1 | |||||||||||
| Participant highest grade* | Any | 3 | 3 | 9 | 15 | ||||||||
*There were no grade 3–5 treatment-related adverse events.
pBCAR3, phosphopeptide from breast cancer antiestrogen resistance 3; pIRS2, phosphopeptide from insulin receptor substrate 2.