Adverse events, vital signs, and laboratory variables
| Placebo (n=33) | 10 mg DS-8500a (n=32) | 75 mg DS-8500a (n=34) | |
| TEAEs (n) | 2 | 4 | 3 |
| Patients with any TEAE* | 2 (6.1) | 4 (12.5) | 3 (8.8) |
| Type of TEAE | |||
| Pharyngitis | 0 (0) | 1 (3.1) | 0 (0) |
| Oropharyngeal pain | 0 (0) | 1 (3.1) | 0 (0) |
| Gingivitis | 0 (0) | 1 (3.1) | 0 (0) |
| Hordeolum | 0 (0) | 0 (0) | 1 (2.9) |
| Post-traumatic neck syndrome | 1 (3.0) | 0 (0) | 0 (0) |
| Musculoskeletal stiffness | 1 (3.0) | 0 (0) | 0 (0) |
| Triglyceride increased | 0 (0) | 0 (0) | 1 (2.9) |
| Urinary occult blood positive | 0 (0) | 1 (3.1) | 1 (2.9) |
| Body weight (kg) | |||
| Baseline | 71.38±11.35 | 71.16±8.98 | 68.77±13.41 |
| Day 28 | 71.02±11.34 | 70.81±9.26 | 68.50±13.51 |
| SBP (mm Hg) | |||
| Baseline | 120.7±14.7 | 129.1±12.3 | 121.9±18.6 |
| Day 28 | 115.8±15.7 | 120.6±10.4 | 116.5±17.9 |
| DBP (mm Hg) | |||
| Baseline | 74.8±11.5 | 80.1±7.6 | 74.4±12.8 |
| Day 28 | 72.2±12.0 | 76.7±9.0 | 71.5±11.5 |
| Pulse rate (beats/min) | |||
| Baseline | 66.8±8.46 | 66.6±10.16 | 62.9±9.37 |
| Day 28 | 65.6±8.10 | 64.1±10.08 | 61.4±8.93 |
*There were no drug-related TEAEs, serious TEAEs, severe TEAEs, or TEAEs leading to study drug discontinuation.
DBP, diastolic blood pressure; SBP, systolic blood pressure; TEAE, treatment-emergent adverse event.