Table 1.
Frequency of patients from all studies with potentially clinically significant abnormalities during avelumab treatment at different doses based on locally read ECGs
| Parameter | Patients n (%) | ||||
|---|---|---|---|---|---|
| 1 mg/kg (n = 4) | 3 mg/kg (n = 18) | 10 mg/kg (n = 1769) | 20 mg/kg (n = 27) | Total (N = 1818) | |
| Heart rate (bpm) | |||||
| ≤ 50 and decrease from baseline ≥ 20 | 0 (0.0) | 0 (0.0) | 24 (1.4) | 0 (0.0) | 24 (1.3) |
| ≥ 120 and increase from baseline ≥ 20 | 0 (0.0) | 1 (5.6) | 47 (2.7) | 0 (0.0) | 48 (2.6) |
| QRS interval (ms) | |||||
| ≥ 120 | 0 (0.0) | 1 (5.6) | 165 (9.3) | 4 (14.8) | 170 (9.4) |
| PQ/PR interval (ms) | |||||
| ≥ 220 and increase from baseline ≥ 20 | 0 (0.0) | 0 (0.0) | 109 (6.2) | 4 (14.8) | 113 (6.2) |
| QTcF interval (ms) | |||||
| > 450 and ≤ 480 | 0 (0.0) | 4 (22.2) | 312 (17.6) | 7 (25.9) | 323 (17.8) |
| > 480 and ≤ 500 | 0 (0.0) | 0 (0.0) | 63 (3.6) | 2 (7.4) | 65 (3.6) |
| > 500 | 0 (0.0) | 0 (0.0) | 44 (2.5) | 0 (0.0) | 44 (2.4) |
| ΔQTcF (ms) | |||||
| Increase from baseline > 30 and ≤ 60 | 0 (0.0) | 7 (38.9) | 393 (22.2) | 6 (22.2) | 406 (22.3) |
| Increase from baseline > 60 | 0 (0.0) | 0 (0.0) | 79 (4.5) | 1 (3.7) | 80 (4.4) |
| QTcP interval (ms) | |||||
| > 450 and ≤ 480 | 1 (25.0) | 5 (27.8) | 383 (21.7) | 8 (29.6) | 397 (21.8) |
| > 480 and ≤ 500 | 0 (0.0) | 0 (0.0) | 71 (4.0) | 2 (7.4) | 73 (4.0) |
| > 500 | 0 (0.0) | 0 (0.0) | 41 (2.3) | 0 (0.0) | 41 (2.3) |
| ΔQTcP (ms) | |||||
| Increase from baseline > 30 and ≤ 60 | 0 (0.0) | 5 (27.8) | 351 (19.8) | 5 (18.5) | 361 (19.9) |
| Increase from baseline > 60 | 0 (0.0) | 0 (0.0) | 65 (3.7) | 2 (7.4) | 67 (3.7) |
ECG electrocardiogram, QTcF QTc derived from Fridericia’s formula, QTcP QTc derived from a project-specific formula