TABLE 3.
Safety outcomes from the extension periods of the combined 301 and 302 studies period (27 weeks to 2‐year data cut)
| 27 weeks to 2‐year data cut (N = 434) | ||
|---|---|---|
| Patients, n (%) | Events, n (rate) a | |
| TEAEs | ||
| Any TEAE b | 391 (90.1) | 2327 (351.5) |
| Related TEAEs | 98 (22.6) | 236 (35.6) |
| Unrelated TEAEs | 381 (87.8) | 2091 (315.8) |
| Grade 1 | 333 (76.7) | 1347 (203.5) |
| Grade 2 | 280 (64.5) | 794 (119.9) |
| Grade 3 | 100 (23.0) | 159 (24.0) |
| Grade 4 | 19 (4.4) | 25 (3.8) |
| TEAE considered a MAVE | 6 (1.4) c | 8 (1.2) |
| Most common TEAEs (in ≥ 10% of patients) | ||
| Upper respiratory tract infection | 80 (18.4) | 103 (15.6) |
| Nasopharyngitis | 70 (16.1) | 108 (16.3) |
| Headache | 56 (12.9) | 75 (11.3) |
| Pyrexia | 44 (10.1) | 52 (7.9) |
| Fatigue | 39 (9.0) | 70 (10.6) |
| SAEs | ||
| Any SAE | 86 (19.8) | 121 (18.3) |
| Related SAE | 10 (2.3) | 12 (1.8) |
| Unrelated SAE | 80 (18.4) | 109 (16.5) |
| SAE leading to study discontinuation | 3 (0.7) d | 3 (0.5) |
| Death | 4 (0.9) e , f | – |
Abbreviations: AE, adverse event; MAVE, major adverse vascular event; SAE, serious adverse event, TEAE, treatment‐emergent adverse event.
Rate of AE adjusted by patient‐years of exposure, defined as (number of events)/(100 patient‐years). The data cut‐off is the 2‐year visit except early terminations (i.e. Day 743 or Day 757 for patients randomized to ravulizumab or eculizumab, respectively).
TEAEs are AEs with a start date and start time on or after the date and time of the first infusion of study drug; grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life‐threatening.
Eight MAVEs were recorded; 1 patient had two events of pulmonary embolism, 1 patient had two events of cerebral infarction; the other MAVEs included thrombophlebitis, deep vein thrombosis, jugular vein thrombosis, and peripheral artery thrombosis. Six events were considered to be unrelated to treatment and two events were unlikely related to treatment. None of these events led to change in dose.
Three discontinuations were recorded: acute myeloid leukemia, myelodysplastic syndrome, and lung adenocarcinoma.
Four deaths unrelated to study drug were reported: pulmonary sepsis, acute myeloid leukemia, lung adenocarcinoma, and lung neoplasm malignant.
The two deaths leading to study drug discontinuation were acute myeloid leukemia and lung adenocarcinoma.