Table 6.
Summary of treatment-related AEs
| System organ class preferred terma | Safety population [n (%)]b |
|
|---|---|---|
| Solithromycin 800/400 mg (N = 64) | Levofloxacin 750 mg (N = 68) | |
| Patients with at least 1 TEAE considered related to study drug | 7 (10.9) | 13 (19.1) |
| Cardiac disorders | 0 (0.0) | 2 (2.9) |
| Bradycardia | 0 (0.0) | 1 (1.5) |
| Palpitations | 0 (0.0) | 1 (1.5) |
| Gastrointestinal disorders | 5 (7.8) | 7 (10.3) |
| Abdominal discomfort | 0 (0.0) | 1 (1.5) |
| Constipation | 0 (0.0) | 1 (1.5) |
| Diarrhea | 3 (4.7) | 2 (2.9) |
| Flatulence | 1 (1.6) | 1 (1.5) |
| Nausea | 1 (1.6) | 3 (4.4) |
| Investigations | 1 (1.6) | 1 (1.5) |
| ALT increased | 0 (0.0) | 1 (1.5) |
| AST increased | 0 (0.0) | 1 (1.5) |
| Blood CPK increased | 1 (1.6) | 0 (0.0) |
| GGT increased | 0 (0.0) | 1 (1.5) |
| Metabolism and nutrition disorders | 1 (1.6) | 1 (1.5) |
| Hyponatremia | 1 (1.6) | 1 (1.5) |
| Nervous system disorders | 0 (0.0) | 3 (4.4) |
| Convulsions | 0 (0.0) | 1 (1.5) |
| Dysgeusia | 0 (0.0) | 1 (1.5) |
| Headache | 0 (0.0) | 1 (1.5) |
| Hypoaesthesia | 0 (0.0) | 1 (1.5) |
| Psychiatric disorders | 0 (0.0) | 1 (1.5) |
| Hallucination, visual | 0 (0.0) | 1 (1.5) |
| Insomnia | 0 (0.0) | 1 (1.5) |
| Nightmares | 0 (0.0) | 1 (1.5) |
a
CPK, creatine phosphokinase; GGT, gamma-glutamyltransferase.
b
n, number of patients with selected comorbidities; N, total number of patients in the population; %, 100 × (n/N).