TABLE 2.
Summary of safety outcomes/adverse events in PRESENCE
| Event, N (%) | Placebo (N = 86) | 10 mg LY3154207 (N = 86) | 30 mg LY3154207 (N = 85) | 75 mg LY3154207 (N = 87) | Overall (N = 344) |
|---|---|---|---|---|---|
| Deaths | 0 (0.0) | 0 (0.0) | 1 (1.2) | 1 (1.1) | 2 (0.6) |
| SAEs | 3 (3.5) | 5 (5.8) | 3 (3.5) | 10 (11.5) | 21 (6.1) |
| Participants with ≥1 TEAE | 44 (51.2) | 50 (58.1) | 55 (64.7) | 65 (74.7) ** | 214 (62.2) * |
| TEAEs occurring in at least 5% of participants, N (%) | |||||
| Falls | 4 (4.7) | 12 (14.0) | 7 (8.2) | 12 (13.8) | 35 (10.2) |
| Dizziness | 4 (4.7) | 4 (4.7) | 6 (7.1) | 10 (11.5) | 24 (7.0) |
| Nausea | 3 (3.5) | 2 (2.3) | 7 (8.2) | 8 (9.2) | 20 (5.8) |
| Hallucination | 4 (4.7) | 2 (2.3) | 5 (5.9) | 9 (10.3) | 20 (5.8) |
| Fatigue | 4 (4.7) | 2 (2.3) | 1 (1.2) | 9 (10.3) | 16 (4.7) * |
| Headache | 1 (1.2) | 2 (2.3) | 8 (9.4) * | 7 (8.0) | 18 (5.2) * |
| Dyskinesia | 2 (2.3) | 2 (2.3) | 3 (3.5) | 5 (5.7) | 12 (3.5) |
| Vomiting | 3 (3.5) | 0 (0.0) | 2 (2.4) | 7 (8.0) | 12 (3.5) * |
| Insomnia | 0 (0.0) | 4 (4.7) | 4 (4.7) | 5 (5.7) | 13 (3.8) |
| Diarrhea | 1 (1.2) | 2 (2.3) | 5 (5.9) | 2 (2.3) | 10 (2.9) |
Safety analysis included the 14 participants that were discontinued due to sponsor decision. Figures in bold type denote statistical significance.
*
P < 0.05.
**
P < 0.01.
Abbreviations: N, number of participants; SAE, serious adverse event; TEAE, treatment‐emergent adverse event.