Table 3.
Summary of TEAEs.
| Patients, n (%) | Pooled analysis of 5 clinical trials (TEAEs with incidence of ≥2% of patients in any subgroup) | Deliver trial (TEAEs with incidence of ≥1.5% of patients in any subgroup) | ||||
|---|---|---|---|---|---|---|
| Eptinezumab | Placebo (n = 791) | Eptinezumab | Placebo (n = 298) | |||
| 100 mg (n = 701) | 300 mg (n = 823) | 100 mg (n = 299) | 300 mg (n = 294) | |||
| Any TEAE | 366 (52.2) | 467 (56.7) | 414 (52.3) | 127 (42) | 120 (41) | 119 (40) |
| Any study-drug–related TEAE | 92 (13.1) | 124 (15.1) | 74 (9.4) | NA | NA | NA |
| Any serious TEAE | 11 (1.6) | 17 (2.1) | 11 (1.4) | 5 (2) | 7 (2) | 4 (1) |
| Any TEAE leading to infusion interruption | 11 (1.6) | 19 (2.3) | 6 (0.8) | 1 (<1) | 3 (1) | 0 |
| Any TEAE leading to discontinuation | 9 (1.3) | 19 (2.3) | 8 (1.0) | 1 (<1) | 6 (2) | 1 (<1) |
| TEAEs with incidence of ≥1% | ||||||
| Upper respiratory tract infection | 45 (6.4) | 64 (7.8) | 48 (6.1) | – | – | – |
| COVID-19 | – | – | – | 20 (7) | 17 (6) | 16 (5) |
| Nasopharyngitis | 44 (6.3) | 72 (8.7) | 41 (5.2) | 5 (2) | 9 (3) | 3 (1) |
| Dizziness | 27 (3.9) | 16 (1.9) | 21 (2.7) | 2 (1) | 4 (1) | 5 (2) |
| Fatigue | 20 (2.9) | 24 (2.9) | 13 (1.6) | 2 (1) | 6 (2) | 4 (1) |
| Diarrhea | NA | NA | 6 (0.8) | 0 | 5 (2) | 5 (2) |
| Nausea | NA | NA | 26 (3.3) | 4 (1%) | 5 (2%) | 4 (1%) |
| Urinary tract infection | – | – | – | 1 (<1) | 5 (2) | 4 (1) |
| Upper abdominal pain | – | – | – | 5 (2) | 4 (1) | 2 (1) |
| Arthralgia | – | – | – | 5 (2) | 4 (1) | 0 |
| Back pain | – | – | – | 5 (2) | 3 (1) | 4 (1) |
Pooled analysis of the NCT01772524, NCT02275117, PROMISE-1, PROMISE- 2, and PREVAIL (primary treatment phase only) studies. Clinical trials included percentage with one decimal place (81), whereas DELIVER trial rounded up percentages and did not report any decimal places (31). In the pooled analysis of five clinical trials, diarrhea and nausea were reported in 30 (1.4%) and 69 (3.3%) patients, respectively, in all eptinezumab doses (1,000 mg, 300 mg, 100 mg, 30 mg, and 10 mg), but data for the 100 mg and 300 mg doses, separately, was not available (81). The ‘–‘symbol indicates that no mention on that event was made in the study article.