Table 3.
Incidence of the most common (≥5%) AEs by treatment cycle (SES)
| Treatment cycle | |||||
|---|---|---|---|---|---|
| AE, n (%) | 1 (n=76) | 2 (n=72) | 3 (n=68) | 4 (n=66) | 5 (n=64) |
| Patients with ≥1 AE | 53 (70) | 50 (66) | 50 (66) | 36 (47) | 35 (46) |
| Dysphagia* | 14 (18) | 10 (14) | 11 (16) | 7 (11) | 10 (16) |
| Nasopharyngitis | 10 (13) | 11 (15) | 11 (16) | 11 (17) | 8 (13) |
| Headache | 8 (11) | 16 (22) | 9 (13) | 6 (9) | 8 (13) |
| Neck pain | 6 (8) | 5 (7) | 6 (9) | 3 (5) | 5 (8) |
| Dry mouth | 4 (5) | 3 (4) | 4 (6) | 1 (2) | 1 (2) |
| Back pain | 3 (4) | 3 (4) | 4 (6) | 1 (2) | 0 (0) |
| Diarrhoea | 1 (1) | 0 (0) | 5 (7) | 0 (0) | 2 (3) |
*Patients were directly questioned about swallowing difficulties and evaluated for dysphagia using a 5–point dysphagia scale adapted from Comella et al20 at all visits and through telephone interviews.
AE, adverse event; SES, safety evaluation set.