Table 2.
Selected Adverse Events from TheraP and VISION
| Adverse Event |
TheraP |
VISION |
||
|---|---|---|---|---|
| Arm | Lu-PSMA (n = 98) |
Cabazitaxel (n = 85) |
Lu-PSMA/SC (n = 529) |
SC (n = 205) |
| Fatigue (%) Grade 1–2 (Grade ≥3) |
70.4 (5.1) |
71.8 (3.5) |
37.2 (5.9) |
21.5 (1.5) |
| Nausea (%) Grade 1–2 (Grade ≥3) |
39.8 (1.0) |
34.1 (0) |
34.0 (1.3) |
16.1 (0.5) |
| Dry mouth (%) Grade 1–2 (Grade ≥3) |
60.2 (0) |
21.2 (0) |
38.8 (0) |
0.5 (0) |
| Dry eyes (%) Grade 1–2 (Grade ≥3) |
29.6 (0) |
3.5 (0) |
3.0 (0) |
1.0 (0) |
| Anemia (%) Grade 1–2 (Grade ≥3) |
19.4 (8.2) |
12.9 (8.2) |
18.9 (12.9) |
8.3 (4.9) |
| Thrombocytopenia (%) Grade 1–2 (Grade ≥3) |
18.4 (11.2) |
4.7 (0) |
9.3 (7.9) |
3.4 (1) |
| Leukopenia (%) Grade 1–2 (Grade ≥3) |
10.2 (1.0) |
5.9 (1.2) |
10.0 (2.5) |
1.5 (0.5) |
| Neutropenia (%) Grade 1–2 (Grade ≥3) |
7.1 (4.1) |
4.7 (12.9) |
5.1 (3.4) |
1.0 (0.5) |
| Diarrhea (%) Grade 1–2 (Grade ≥3) |
18.4 (1.0) |
51.8 (4.7) |
18.1 (0.8) |
2.4 (0.5) |
| Increased serum creatinine (%) Grade 1–2 (Grade ≥3) |
4.1 (0) |
2.4 (0) |
5.1 (0.2) |
2.0 (0.5) |
Lu-PSMA = [177Lu]Lu-PSMA-617, SC = standard care