Table 4.
Serious adverse events up to the last study visit considered by the blinded investigators to be related to the study drug ordered by incidence in the overall ceftazidime–avibactam ± metronidazole treatment group (pooled safety population)
| MedDRA v19.0 preferred term, n (%) | Ceftazidime–avibactam ± metronidazole (N = 2024) | Comparator (N = 2026) |
|---|---|---|
| Diarrhoeaa,b | 2 (0.1) | 0 (0.0) |
| Accidental overdose | 1 (0.0) | 0 (0.0) |
| Acute coronary syndrome | 1 (0.0) | 0 (0.0) |
| Acute kidney injurya | 1 (0.0) | 0 (0.0) |
| Alanine aminotransferase increaseda,b | 1 (0.0) | 0 (0.0) |
| Aspartate aminotransferase increaseda,b | 1 (0.0) | 0 (0.0) |
| Chronic hepatitis C | 1 (0.0) | 0 (0.0) |
| Hepatic enzyme increaseda,b | 1 (0.0) | 0 (0.0) |
| Hepatic function abnormala,b | 1 (0.0) | 0 (0.0) |
| Hypersensitivitya | 1 (0.0) | 0 (0.0) |
| Liver function test abnormala,b | 1 (0.0) | 0 (0.0) |
| Pyrexiaa,b | 1 (0.0) | 0 (0.0) |
| Subacute hepatic failure | 1 (0.0) | 0 (0.0) |
| Blood creatinine increaseda | 0 (0.0) | 1 (0.0) |
| Clostridium difficile colitisa | 0 (0.0) | 1 (0.0) |
| Confusional statea | 0 (0.0) | 1 (0.0) |
| Drug eruption | 0 (0.0) | 1 (0.0) |
| Hyperkalaemia | 0 (0.0) | 1 (0.0) |
| Transaminases increaseda,b | 0 (0.0) | 1 (0.0) |
The investigator was blinded in all studies except for the open-label REPRISE study
n number of patients, N number of patients in treatment group
aAdverse events that are considered to be listed for ceftazidime as defined in the Ceftazidime Summary of Product Characteristics 2016 [23]
bAdverse events that are considered to be listed for metronidazole as defined in the Metronidazole Summary of Product Characteristics 2017 [31]