Table 3.
Overall Summary of adverse events (safety population)
| VLA1553 (n=3082) | Placebo (n=1033) | Total (n=4115) | ||
|---|---|---|---|---|
| Any adverse events | 1926 (62·5%, 60·8–64·2) 6415 | 463 (44·8%, 41·8–47·9) 1071 | 2389 (58·1%, 56·5–59·6) 7486 | |
| Any related adverse events | 1575 (51·1%, 49·3–52·9) 4621 | 322 (31·2%, 28·4–34·1) 647 | 1897 (46·1%, 44·6–47·6) 5268 | |
| Any related severe adverse events | 62 (2·0%, 1·5–2·6) 70 | 1 (0·1%, 0·0–0·5) 3 | 63 (1·5%, 1·2–2·0) 73 | |
| Any serious adverse events | 46 (1·5%, 1·1–2·0) 73 | 8 (0·8%, 0·3–1·5) 10 | 54 (1·3%, 1·0–1·7) 83 | |
| Any related serious adverse events | 2 (0·1%, 0·0–0·2) 2 | 0 (0%, 0·0–0·4) 0 | 2 (0·0%, 0·0–0·2) 2 | |
| Any adverse events of special interest | 10 (0·3%, 0·2–0·6) 26 | 1 (0·1%, 0·0–0·5) 2 | 11 (0·3%, 0·1–0·5) 28 | |
| Any adverse event with a frequency ≥10% in at least one study arm | ||||
| Headache | 986 (32·0%, 30·3–33·7) 1028 | 160 (15·5%, 13·3–17·8) 178 | 1146 (27·8%, 26·5–29·2) 1206 | |
| Fatigue | 886 (28·7%, 27·2–30·4) 893 | 137 (13·3%, 11·3–15·5) 139 | 1023 (24·9%, 23·5–26·2) 1032 | |
| Myalgia | 750 (24·3%, 22·8–25·9) 758 | 82 (7·9%, 6·4–9·8) 84 | 832 (20·2%, 19·0–21·5) 842 | |
| Arthralgia | 554 (18·0%, 16·6–19·4) 589 | 63 (6·1%, 4·7–7·7) 70 | 617 (15·0%, 13·9–16·1) 659 | |
| Injection site pain | 413 (13·4%, 12·2–14·7) 519 | 101 (9·8%, 8·0–11·8) 122 | 514 (12·5%, 11·5–13·5) 641 | |
| Pyrexia | 427 (13·9%, 12·7–15·1) 429 | 13 (1·3%, 0·7–2·1) 13 | 440 (10·7%, 9·8–11·7) 442 | |
| Nausea | 359 (11·6%, 10·5–12·8) 364 | 63 (6·1%, 4·7–7·7) 64 | 422 (10·3%, 9·3–11·2) 428 | |
| Any serious adverse event with a frequency ≥0·2% in at least one study arm by system organ class | ||||
| Infections and infestations | 9 (0·3%, 0·1–0·6) 9 | 3 (0·3%, 0·1–0·8) 3 | 12 (0·3%, 0·2–0·5) 12 | |
| Injury, poisoning, and procedural complications | 8 (0·3%, 0·1–0·5) 15 | 1 (0·1%, 0·0–0·5) 1 | 9 (0·2%, 0·1–0·4) 16 | |
| Psychiatric disorders | 7 (0·2%, 0·1–0·5) 8 | 2 (0·2%, 0·0–0·7) 4 | 9 (0·2%, 0·1–0·4) 12 | |
| Cardiac disorders | 5 (0·2%, 0·1–0·4) 7 | 0 (0%, 0·0–0·4) 0 | 5 (0·1%, 0·0–0·3) 7 | |
Data are n (%, 95% CI) N. For each category, participants were included only once, even if they experienced multiple events in that category. Related adverse events are those recorded as probably related or possibly related on the eCRF. Adverse events of special interest counts are for the overall event and the adverse event of special interest symptom count includes a count of all symptoms contributing to the event. Two-sided exact Clopper-Pearson 95% CIs are presented. eCRF=electronic case report form. n=number of participants. N=number of events.