Table 2.
Key adverse events
| Variable, n% | PE (n = 100) | PA (n = 106) | HR (95%) | p-value |
|---|---|---|---|---|
| Immune-related event | 21 (21%) | 16 (15.1) | 2.00 (0.21–3.53) | 0.271 |
| Hypothyroidism | 11 (11.0) | 8 (7.5) | 4.00 (0.38–2.71) | 0.393 |
| Hyperthyroidism | 7 (7.0) | 5 (4.7) | 1.00 (0.12–3.43) | 0.485 |
| Thyroiditis | 3 (3.0) | 2 (1.9) | 2.00 (0.37–4.81) | 0.605 |
| Pneumonitis or interstitial lung disease | 3 (3.0) | 2 (1.9) | 2.00 (0.74–4.35) | 0.605 |
| Vitiligo | 1 (1.0) | 1 (0.9) | 4.00 (0.28–6.54) | 1.000 |
| Colitis | 2 (2.0) | 2 (1.9) | 3.00 (0.43–4.22) | 0.953 |
| Fatigue (asthenia) | 7 (7.0) | 1 (0.9) | 3.00 (1.79–3.88) | 0.025a |
| Musculoskeletal eventb | 9 (9.0) | 1 (0.9) | 5.00 (3.65–6.85) | 0.007a |
| Fracturec | 1 (1.0) | 4 (3.8) | 3.00 (0.31–4.76) | 0.196 |
| Hypertensiond | 1 (1.0) | 2 (1.9) | 2.00 (0.28–3.41) | 1.000 |
| Fall | 2 (2.0) | 1 (0.9) | 2.00 (0.83–3.73) | 0.612 |
| Cognitive and memory impairmente | 2 (2.0) | 1 (0.9) | 2.00 (0.14–3.47) | 0.612 |
| Cardiovascular event | 2 (1.0) | 2 (1.9) | 3.00 (0.27–4.19) | 0.953 |
aStatistically significant
bincluded musculoskeletal pain, pain in extremity, arthralgia, myalgia, stiffness, muscular weakness, and muscle spasms; c included bone and joint injuries; d included hypertensive retinopathy, increased blood pressure, systolic hypertension, and hypertensive crisis; e included cognitive disorders, amnesia, Alzheimer’s disease, dementia, senile dementia, mental impairment, and vascular dementia
PE pembrolizumab plus enzalutamide, PA pembrolizumab alone, HR Hazard ratio