Table 2.
Overview of treatment‐emergent adverse events during the TDP (safety population) and CP (randomized safety population)
| Test dose phase | Comparative phase MDZ–NS | Comparative phase placebo | |||
|---|---|---|---|---|---|
| N = 292 | DB only (n = 91) | DB + OL (n = 43) | DB PBO only (n = 26) | DB PBO + OL MDZ–NS (n = 41) | |
| ≥1 TEAE | 150 (51.4) | 24 (26.4) | 13 (30.2) | 6 (23.1) | 9 (22.0) |
| Mild | 81 (27.7) | 17 (18.7) | 9 (20.9) | 5 (19.2) | 4 (9.8) |
| Moderate | 49 (16.8) | 4 (4.4) | 3 (7.0) | 1 (3.8) | 5 (12.2) |
| Severe | 20 (6.8) | 3 (3.3) | 1 (2.3) | 0 | 0 |
| ≥1 Treatment‐related TEAE | 108 (37.0) | 20 (22.0) | 13 (30.2) | 5 (19.2) | 7 (17.1) |
| Mild | 63 (21.6) | 13 (14.3) | 9 (20.9) | 4 (15.4) | 3 (7.3) |
| Moderate | 34 (11.6) | 4 (4.4) | 3 (7.0) | 1 (3.8) | 4 (9.8) |
| Severe | 11 (3.8) | 3 (3.3) | 1 (2.3) | 0 | 0 |
| ≥1 Serious TEAE | 14 (4.8) | 1 (1.1) | 0 | 0 | 1 (2.4) |
| ≥1 Treatment‐related serious TEAE | 3 (1.0) | 0 | 0 | 0 | 0 |
| Discontinuation due to TEAE | 16 (5.5) | 0 | 0 | 0 | 0 |
Adverse events were assigned to TDP if they occurred after administration of test dose and before CP dose, and to CP only at/after the CP dose, not based on randomization
Abbreviations: DB, double‐blind; MDZ–NS, midazolam nasal spray; OL, open‐label; PBO, placebo; TEAE, treatment‐emergent adverse event