Table 4. Treatment-Emergent Adverse Events (TEAEs) in Safety Population.
| Type of Adverse Event | No. (%) | |
|---|---|---|
| Lefamulin (n = 368) | Moxifloxacin (n = 368) | |
| Total TEAEs | 120 (32.6) | 92 (25.0) |
| Severe | 13 (3.5) | 10 (2.7) |
| Moderate | 44 (12.0) | 27 (7.3) |
| Mild | 63 (17.1) | 55 (14.9) |
| TEAEs occurring in >1% in either group | ||
| Diarrheaa | 45 (12.2) | 4 (1.1) |
| Nauseab | 19 (5.2) | 7 (1.9) |
| Vomiting | 12 (3.3) | 3 (0.8) |
| Hypertension | 5 (1.4) | 5 (1.4) |
| Respiratory tract viral infection | 5 (1.4) | 1 (0.3) |
| Headache | 4 (1.1) | 6 (1.6) |
| Gastritis | 4 (1.1) | 2 (0.5) |
| Pneumonia | 4 (1.1) | 1 (0.3) |
| Chronic obstructive pulmonary disease | 4 (1.1) | 0 |
| Urinary tract infection | 3 (0.8) | 6 (1.6) |
| ALT increased | 3 (0.8) | 4 (1.1) |
| AST increased | 2 (0.5) | 4 (1.1) |
| Anemia | 0 | 4 (1.1) |
| Insomnia | 0 | 4 (1.1) |
| Treatment-related TEAEs | 58 (15.8) | 29 (7.9) |
| Diarrhea | 34 (9.2) | 3 (0.8) |
| Nausea | 15 (4.1) | 6 (1.6) |
| Serious TEAEs | 17 (4.6) | 18 (4.9) |
| Treatment-related serious TEAEs | 0 | 1 (0.3) |
| TEAEs leading to death | 5 (1.4)c | 3 (0.8) |
| 28-d all-cause mortalityd | 3 (0.8) | 3 (0.8) |
| TEAEs leading to discontinuation of study drug | 12 (3.3) | 9 (2.4) |
| TEAEs leading to withdrawal from study | 5 (1.4) | 5 (1.4) |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase.
a
In the lefamulin group, diarrhea was mild in 32 patients and moderate in 13 patients; in the moxifloxacin group, diarrhea was mild in 4 patients.
b
In the lefamulin group, nausea was mild in 16 patients and moderate in 3 patients; in the moxifloxacin group, nausea was mild in 6 patients and moderate in 1 patient.
c
Two deaths occurred beyond the 28-day window (details appear in the Adverse Events and Tolerability section).
d
Assessed in the intent-to-treat population (370 in the lefamulin group vs 368 in the moxifloxacin group).