Table 5.
Patients With Treatment-emergent Adverse Events (≥2% of Patients in Any Treatment Group) by System Organ Class and Preferred Term (Population: Safety)
| System Organ Class Preferred Term | ZTI-01 | PIP-TAZ |
|---|---|---|
| (N = 233), n (%) | (N = 231), n (%) | |
| Any AEs | 99 (42.5) | 74 (32.0) |
| Any TEAEs | 98 (42.1) | 74 (32.0) |
| Mild | 84 (36.1) | 49 (21.2) |
| Moderate | 35 (15.0) | 38 (16.5) |
| Severe | 5 (2.1) | 4 (1.7) |
| Drug-related TEAEs | 48 (20.6) | 32 (13.9) |
| SAEs | 5 (2.1) | 6 (2.6) |
| Drug-related SAE | 1 (0.4) | 1 (0.4) |
| TEAEs leading to study drug discontinuation | 7 (3.0) | 6 (2.6) |
| Serious TEAEs leading to study drug discontinuation | 0 (0) | 1 (0.4) |
| Gastrointestinal disorders | 25 (10.7) | 17 (7.4) |
| Nausea | 10 (4.3) | 3 (1.3) |
| Diarrhea | 9 (3.9) | 11 (4.8) |
| Vomiting | 9 (3.9) | 1 (0.4) |
| General disorders and administration site conditions | 14 (6.0) | 14 (6.1) |
| Infusion site phlebitis | 2 (0.9) | 6 (2.6) |
| Infections and infestations | 17 (7.3) | 20 (8.7) |
| Urinary tract infection | 4 (1.7) | 5 (2.2) |
| Investigations | 20 (8.6) | 8 (3.5) |
| Alanine aminotransferase increased | 20 (8.6) | 6 (2.6) |
| Aspartate aminotransferase increased | 17 (7.3) | 6 (2.6) |
| Metabolism and nutrition disorders | 17 (7.3) | 4 (1.7) |
| Hypokalemia | 15 (6.4) | 3 (1.3) |
| Nervous system disorders | 10 (4.3) | 7 (3.0) |
| Headache | 6 (2.6) | 5 (2.2) |
Medical Dictionary for Regulatory Activities Version 19.0 was used to code TEAEs. Percentages were calculated using the number of patients in the safety population as the denominator. Treatment-emergent adverse events were defined as adverse events that newly appeared, increased in frequency, or worsened in severity following initiation of study drug. An adverse event was programmatically defined as treatment emergent if the start date and time was on or after the start date and time of the first dose of study drug.
Abbreviations: AE, adverse event; PIP-TAZ, piperacillin-tazobactam; SAE, serious adverse event; TEAE, treatment-emergent adverse event; fosfomycin for injection.