Table 2 Most frequently reported SOCs and PTs for each antibiotic with proven efficacy against CRE in different spontaneous reporting systems

Colistin

General 12.8%

Acute kidney injury 4.8%

Respiratory 16.4%

Acute kidney injury 10.7%

Investigation 17.0%

Acute kidney injury 8.5%

Renal 8.9%

Drug ineffective 3.0%

Skin 15.6%

Oral paraesthesia 5.3%

Renal 14.1%

Blood creatinine increased 3.2%

Infections 8.9%

Drug resistance 2.4%

Renal 15.1%

Pruritus 4.9%

General 13.4%

Drug interaction 3.2%

Respiratory 4.9%

Pathogen resistance 1.8%

Nervous 11.6%

Erythema 4.4%

Nervous 9.4%

Blood urea increased 2.8%

Nervous 4.7%

Multiple organ dysfunction syndrome 1.7%

General 11.1%

Cough 4.0%

Gastrointestinal 9.4%

Off-label use 2.1%

Meropenem

General 9.9%

Drug ineffective 2.3%

Skin 48.2%

Erythema 11.4%

Skin 14.3%

Neutropenia 3.1%

Infections 8.0%

Pyrexia 1.9%

Blood 10.8%

Rash 8.4%

General 12.9%

Rash 2.3%

Investigation 5.9%

Drug interaction 1.4%

General 7.6%

Urticaria 6.3%

Investigation 11.7%

Nausea 2.3%

Skin 5.7%

Sepsis 1.1%

Respiratory 4.5%

Pruritus 5.0%

Blood 9.3%

Anaphylactic reaction 2.1%

Blood 5.2%

Thrombocytopenia 1.1%

Gastrointestinal 4.1%

Thrombocytopenia 2.8%

Nervous 8.6%

Pyrexia – Liver function test abnormal 1.8%

Tigecycline

General 13.1%

Drug ineffective 4.1%

Gastrointestinal 28.3%

Nausea 7.8%

General 17.2%

Liver function test abnormal 4.6%

Infections 9.4%

Death 2.2%

Skin 21.0%

Vomiting 6.8%

Gastrointestinal 16.7%

Drug ineffective 4.6%

Gastrointestinal 7.9%

Nausea 2.2%

Investigation 11.9%

Erythema 5.9%

Investigation 14.3%

Nausea 3.7%

Investigation 6.8%

Pancreatitis 2.1%

Hepatobiliary 8.7%

Rash 4.6%

Infections 11.8%

Acute pancreatitis 3.2%

Blood 5.1%

Sepsis 1.7%

Blood 6.4%

Acute pancreatitis 4.1%

Ear 6.4%

Thrombocytopenia – Death 2.8%

Gentamicin

General 9.0%

Acute kidney injury 4.4%

Skin 40.3%

Erythema 10.0%

Renal 13.9%

Acute kidney injury 8.0%

Renal 7.6%

Pyrexia 2.1%

Renal 11.8%

Urticaria 7.9%

Ear 11.9%

Hypotension 6.3%

Infections 5.8%

Drug ineffective 1.4%

General 10.4%

Acute kidney injury 6.3%

Vascular 8.9%

Anaphylactic reaction 5.6%

Skin 5.3%

Renal failure 1.3%

Eye 6.9%

Rash 6.0%

Nervous 8.4%

Ototoxicity 2.2%

Investigations 4.6%

Dizziness 1.1%

Nervous 3.9%

Pruritus 4.6%

Immune 8.1%

Deafness 2.1%

Ceftazidime/Avibactam

General 22.0%

Death 6.7%

General 28.2%

Thrombocytopenia 7.7%

Investigations 25.0%

Product use issue 18.8%

Infections 10.4%

Drug ineffective 5.9%

Infections 20.5%

Direct Coombs test positive 7.7%

Infections 18.8%

Hypernatraemia 15.6%

Injury 8.0%

Off-label use 4.1%

Skin 12.8%

Septic shock 7.7%

Injury 18.8%

Platelet count decreased 6.3%

Investigations 6.3%

Pathogen resistance 3.7%

Investigations 10.3%

Multiple organ dysfunction syndrome 7.7%

Metabolism 15.6%

ALT increased 6.3%

Renal 4.9%

Drug resistance 3.5%

Blood 7.7%

Condition aggravated 7.7%

General 12.5%

Pathogen resistance 6.3%