Table 1. Summary of treatment emergent adverse events (AEs).
| Number of patients (%)
|
||||
|---|---|---|---|---|
| MedDRA system organ classification (SOC) | MedDRA preferred term | Placebo (n = 42) | TID60 (n = 43) | BID120 (n = 42) |
| One or more AEs* | All patients with AEs | 4 (9.5) | 5 (11.6) | 4 (9.5) |
| Gastrointestinal disorders | Patients with AEs | 1 (2.4) | 1 (2.3) | 1 (2.4) |
| Abdominal pain upper | 1 (2.4) | 0 | 0 | |
| Nausea | 0 | 1 (2.3) | 1 (2.4) | |
| General disorders and administration site conditions | Patients with AEs | 1 (2.4) | 1 (2.3) | 1 (2.4) |
| Fatigue | 1 (2.4) | 0 | 1 (2.4) | |
| Mucous membrane disorder NOS | 0 | 1 (2.3) | 0 | |
| Immune system disorders | Patients with AEs | 0 | 0 | 1 (2.4) |
| Conjunctivitis allergic | 0 | 0 | 1 (2.4) | |
| Investigations | Patients with AEs | 0 | 1 (2.3) | 0 |
| Heart rate increased | 0 | 1 (2.3) | 0 | |
| Musculoskeletal and connective tissue disorders | Patients with AEs | 2 (4.8) | 0 | 2 (4.8) |
| Back pain | 1 (2.4) | 0 | 0 | |
| Musculoskeletal chest pain | 0 | 0 | 1 (2.4) | |
| Neck pain | 0 | 0 | 1 (2.4) | |
| Torticollis | 1 (2.4) | 0 | 0 | |
| Nervous system disorders | Patients with AEs | 0 | 2 (4.7) | 1 (2.4) |
| Agitation | 0 | 1 (2.3) | 0 | |
| Sedation | 0 | 1 (2.3) | 0 | |
| Somnolence | 0 | 1 (2.3) | 0 | |
| Vertigo | 0 | 0 | 1 (2.4) | |
| Renal and urinary disorders | Patients with AEs | 0 | 1 (2.3) | 0 |
| Cystitis NOS | 0 | 1 (2.3) | 0 | |
| Respiratory, thoracic, and mediastinal disorders | Patients with AEs | 0 | 1 (2.3) | 0 |
| Sinusitis NOS | 0 | 1 (2.3) | 0 | |
Patients reporting individual AEs may not add up to the number of patients within a SOC because a subject may have reported more than one AE with in a SOC term. MeDRA, medical dictionary regulatory applications; NOS, not otherwise specified.
*
No significant difference among treatments in proportion of patients with AEs.