Table 4.
Treatment-emergent adverse events during double-blind treatment (safety population).
| TEAE | Placebo group (n = 97)†, n (%) | BMT groups, n (%) |
||
|---|---|---|---|---|
| 0.75 mg (n = 100) | 1.25 mg (n = 99)† | 1.75 mg (n = 98) | ||
| Any TEAE‡: | 49 (51) | 64 (64) | 61 (62) | 67 (68) |
| – Nausea | 3 (3) | 18 (18) | 22 (22) | 24 (24) |
| – Flushing | 0 | 17 (17) | 14 (14) | 17 (17) |
| – Headache | 3 (3) | 9 (9) | 9 (9) | 14 (14) |
| – Injection-site pain | 3 (3) | 6 (6) | 6 (6) | 7 (7) |
| – Upper respiratory tract infection | 4 (4) | 8 (8) | 5 (5) | 4 (4) |
| – Injection-site pruritus | 0 | 4 (4) | 4 (4) | 6 (6) |
| Any TEAE leading to withdrawal§: | 2 (2) | 0 | 5 (5) | 6 (6) |
| – Vomiting | 0 | 0 | 1 (1) | 2 (2) |
| – Nausea | 0 | 0 | 0 | 3 (3) |
| – Flushing | 0 | 0 | 1 (1) | 1 (1) |
†
During visit 2 (prior to randomization) one patient inadvertently received a treatment kit containing BMT 1.25 mg in place of the assigned placebo. In accordance with the study protocol, this individual was considered a 1.25 mg BMT patient within the safety population.
‡
The types listed each had an incidence ≥5% among all BMT users.
§
The types listed each occurred in >1 BMT user. The listing excludes hypertension, which was coded as an adverse event in two placebo and three BMT users among the 26 protocol-mandated ambulatory blood-pressure monitoring-based withdrawals.
BMT: Bremelanotide; TEAE: Treatment-emergent adverse event.