Table 5.
Treatment-emergent Adverse Events of Special Interest (All Cause and Treatment-related)—Pooled Phase 3
| AESI (All Cause) |
AESI (Related) |
|||
|---|---|---|---|---|
| Special Interest Preferred Term | Delafloxacin (N = 741) n (%) |
VAN/AZ (N = 751) n (%) |
Delafloxacin (N = 741) n (%) |
VAN/AZ (N = 751) n (%) |
| Subjects with at least one TEAE of special interest | 52 (7.0) | 69 (9.2) | 25 (3.4) | 43 (5.7) |
| Hepatic related events | 23 (3.1) | 30 (4.0) | 16 (2.2) | 20 (2.7) |
| Increased ALT | 14 (1.9) | 14 (1.9) | 10 (1.3) | 10 (1.3) |
| Increased AST | 10 (1.3) | 14 (1.9) | 6 (0.8) | 10 (1.3) |
| Increased transaminases | 3 (0.4) | 5 (0.7) | 3 (0.4) | 2 (0.3) |
| Increased hepatic enzyme | 2 (0.3) | 2 (0.3) | 1 (0.1) | 2 (0.3) |
| Liver function test abnormal | 0 | 2 (0.3) | 0 | 2 (0.3) |
| Hypertransaminasaemia | 2 (0.3) | 1 (0.1) | 1 (0.1) | 1 (0.1) |
| Increased gamma-glutamyltransferase | 1 (0.1) | 1 (0.1) | 0 | 0 |
| Hepatic cirrhosis | 0 | 1 (0.1) | 0 | 0 |
| Potential myopathy | 15 (2.0) | 34 (4.5) | 7 (0.9) | 20 (2.7) |
| Increased blood creatinine Phosphokinase | 8 (1.1) | 15 (2.0) | 3 (0.4) | 7 (0.9) |
| Increased blood creatinine | 2 (0.3) | 4 (0.5) | 1 (0.1) | 4 (0.5) |
| Myalgia | 1 (0.1) | 2 (0.3) | 0 | 1 (0.1) |
| Renal impairment | 2 (0.3) | 1 (0.1) | 2 (0.3) | 0 |
| Renal failure – acute | 1 (0.1) | 7 (0.9) | 1 (0.1) | 3 (0.4) |
| Musculoskeletal pain | 1 (0.1) | 2 (0.3) | 0 | 1 (0.1) |
| Renal failure | 0 | 3 (0.4) | 0 | 3 (0.4) |
| Decreased creatinine renal clearance | 0 | 1 (0.1) | 0 | 1 (0.1) |
| Hyperglycemia | 6 (0.8) | 4 (0.5) | 2 (0.3) | 1 (0.1) |
| Hyperglycemia | 2 (0.3) | 2 (0.3) | 2 (0.3) | 1 (0.1) |
| Diabetes mellitus | 3 (0.4) | 1 (0.1) | 0 | 0 |
| Type 2 diabetes mellitus | 1 (0.1) | 1 (0.1) | 0 | 0 |
| Potential peripheral neuropathy | 4 (0.5) | 3 (0.4) | 1 (0.1) | 2 (0.3) |
| Paraesthesia | 4 (0.5) | 1 (0.1) | 1 (0.1) | 1 (0.1) |
| Hypoaesthesia | 1 (0.1) | 1 (0.1) | 0 | 1 (0.1) |
| Neuropathy peripheral | 0 | 1 (0.1) | 0 | 0 |
| Potential QT prolongation | 2 (0.3) | 1 (0.1) | 0 | 1 (0.1) |
| Syncope | 2 (0.3) | 0 | 0 | 0 |
| Loss of consciousness | 0 | 1 (0.1) | 0 | 1 (0.1) |
| Potential tendon disorder | 3 (0.4) | 1 (0.1) | 0 | 0 |
| Tendonitis | 3 (0.4) | 0 | 0 | 0 |
| Trigger finger | 0 | 1 (0.1) | 0 | 0 |
| Hypoglycemia | 2 (0.3) | 3 (0.4) | 1 (0.1) | 2 (0.3) |
| C. difficile infection | 1 (0.1) | 0 | 1 (0.1) | 0 |
| Convulsions | 0 | 1 (0.1) | 0 | 1 (0.1) |
| Potential phototoxicity | 0 | 0 | 0 | 0 |
Abbreviations: AESI, adverse events of special interest; ALT, alanine transaminase; AST, aspartate transaminase; TEAE, treatment-emergent adverse event; VAN/AZ, vancomycin/aztreonam.