Table 1. The reporting odds ratio (ROR) of conventional doxorubicin and liposomal doxorubicin in the FAERS database.
| Adverse events | Total | Conventional Doxorubicin (conventional-DOX) |
Pegylated Liposome Doxorubicin (PEGylated-liposome DOX) |
Non-Pegylated Liposome Doxorubicin (non-PEGylated-liposome DOX) |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Case b) | ROR c) | 95%CI d) | Case b) | ROR c) | 95%CI d) | Case b) | ROR c) | 95%CI d) | |||
| PT code a) | 6157897 | 5039 | 3780 | 349 | |||||||
| 10016288 | Febrile Neutropenia | 19141 | 403 | 28.46 | (25.68–31.54) | 114 | 10.03 | (8.32–12.09) | 35 | 35.81 | (25.25–50.80) |
| 10037660 | Pyrexia | 123825 | 402 | 4.24 | (3.82–4.69) | 200 | 2.73 | (2.36–3.14) | 43 | 6.85 | (4.98–9.43) |
| 10029354 | Neutropenia | 33406 | 353 | 13.95 | (12.51–15.55) | 166 | 8.46 | (7.24–9.89) | 31 | 17.89 | (12.37–25.87) |
| 10028813 | Nausea | 267546 | 351 | 1.65 | (1.48–1.84) | 277 | 1.74 | (1.54–1.97) | 4 | 0.26 | (0.10–0.68) |
| 10013968 | Dyspnoea | 189849 | 331 | 2.21 | (1.98–2.47) | 254 | 2.27 | (2.00–2.57) | 7 | 0.64 | (0.30–1.36) |
| 10012735 | Diarrhoea | 174346 | 295 | 2.14 | (1.90–2.40) | 136 | 1.28 | (1.08–1.52) | 16 | 1.65 | (1.00–2.72) |
| 10047700 | Vomiting | 164691 | 286 | 2.19 | (1.95–2.47) | 192 | 1.95 | (1.68–2.25) | 6 | 0.64 | (0.28–1.43) |
| 10035664 | Pneumonia | 97081 | 275 | 3.61 | (3.20–4.08) | 154 | 2.65 | (2.26–3.12) | 8 | 1.46 | (0.73–2.95) |
| - | Death | 236778 | 271 | 1.42 | (1.26–1.61) | 236 | 1.67 | (1.46–1.90) | 5 | 0.36 | (0.15–0.88) |
| - | Fatigue | 213979 | 267 | 1.55 | (1.37–1.76) | 218 | 1.70 | (1.48–1.95) | 11 | 0.90 | (0.50–1.65) |
| - | Pain | 181319 | 263 | 1.82 | (1.60–2.06) | 151 | 1.37 | (1.17–1.61) | 3 | 0.29 | (0.09–0.89) |
| 10002034 | Anaemia | 74130 | 260 | 4.48 | (3.95–5.07) | 175 | 3.99 | (3.43–4.65) | 11 | 2.67 | (1.47–4.87) |
| 10043554 | Thrombocytopenia | 38176 | 237 | 7.95 | (6.98–9.07) | 133 | 5.86 | (4.93–6.97) | 9 | 4.24 | (2.19–8.23) |
| 10003549 | Asthenia | 130494 | 221 | 2.12 | (1.85–2.43) | 158 | 2.02 | (1.72–2.36) | 6 | 0.81 | (0.36–1.81) |
| 10031264 | Osteonecrosis | 14428 | 213 | 19.06 | (16.60–21.88) | 62 | 7.13 | (5.54–9.16) | 3 | 3.69 | (1.18–11.51) |
| 10040047 | Sepsis | 39218 | 212 | 6.88 | (6.00–7.90) | 79 | 3.33 | (2.67–4.17) | 8 | 3.66 | (1.82–7.38) |
| - | Disease Progression | 35325 | 201 | 7.24 | (6.28–8.34) | 153 | 7.34 | (6.24–8.63) | 12 | 6.17 | (3.47–10.98) |
| 10051398 | Malignant Neoplasm Progression | 20003 | 176 | 11.20 | (9.63–13.02) | 155 | 13.22 | (11.25–15.53) | 3 | 2.66 | (0.85–8.29) |
| 10003988 | Back Pain | 80619 | 171 | 2.65 | (2.28–3.09) | 131 | 2.71 | (2.28–3.23) | 5 | 1.10 | (0.45–2.65) |
| - | Bone Disorder | 9724 | 170 | 22.45 | (19.24–26.19) | 43 | 7.30 | (5.40–9.87) | 1 | -† | -† |
| 10029331 | Neuropathy Peripheral | 23664 | 169 | 9.05 | (7.76–10.56) | 111 | 7.87 | (6.52–9.52) | 0 | -† | -† |
| - | Infection | 38600 | 166 | 5.42 | (4.64–6.33) | 67 | 2.86 | (2.25–3.65) | 8 | 3.72 | (1.85–7.50) |
| 10033661 | Pancytopenia | 20256 | 163 | 10.20 | (8.72–11.93) | 119 | 9.90 | (8.24–11.89) | 6 | 5.30 | (2.36–11.88) |
| 10035598 | Pleural Effusion | 24089 | 161 | 8.45 | (7.22–9.90) | 98 | 6.80 | (5.56–8.31) | 2 | 1.47 | (0.37–5.89) |
| 10006002 | Bone Pain | 20459 | 157 | 9.71 | (8.28–11.39) | 32 | 2.56 | (1.81–3.63) | 1 | -† | -† |
| 10012174 | Dehydration | 54385 | 157 | 3.62 | (3.08–4.24) | 98 | 2.99 | (2.45–3.66) | 3 | 0.97 | (0.31–3.03) |
| 10003239 | Arthralgia | 118887 | 154 | 1.60 | (1.36–1.88) | 59 | 0.81 | (0.62–1.04) | 0 | -† | -† |
| 10028116 | Mucosal Inflammation | 8673 | 151 | 22.27 | (18.92–26.22) | 77 | 14.87 | (11.85–18.65) | 7 | 14.52 | (6.87–30.70) |
| 10000081 | Abdominal Pain | 82672 | 146 | 2.19 | (1.86–2.59) | 148 | 3.00 | (2.54–3.53) | 3 | 0.64 | (0.20–1.99) |
| 10002855 | Anxiety | 104278 | 145 | 1.72 | (1.46–2.03) | 58 | 0.90 | (0.70–1.17) | 1 | -† | -† |
| 10007636 | Cardiomyopathy e) | 6807 | 103 | 19.13 | (15.72–23.29) | 21 | 5.06 | (3.29–7.78) | 0 | -† | -† |
| 10048610 | Cardiotoxicity e) | 1673 | 33 | 24.73 | (17.50–34.94) | 9 | 8.82 | (4.58–17.00) | 1 | -† | -† |
| 10037377 | Pulmonary embolism e) | 46729 | 78 | 2.06 | (1.65–2.57) | 65 | 2.29 | (1.79–2.93) | 7 | 2.68 | (1.27–5.66) |
| - | Alopecia e) | 43514 | 79 | 2.24 | (1.79–2.80) | 29 | 1.09 | (0.75–1.57) | 2 | 0.81 | (0.20–3.25) |
| - | Palmar-plantar erythrodysaesthesia syndrome e) | 6972 | 37 | 6.56 | (4.74–9.07) | 250 | 64.77 | (56.84–73.80) | 11 | 28.76 | (15.77–52.45) |
| SMQ code f) | |||||||||||
| 20000028 | Haematopoietic cytopenias affecting more than one type of blood cell | 51358 | 347 | 8.85 | (7.93–9.87) | 187 | 6.21 | (5.36–7.19) | 11 | 3.87 | (2.12–7.06) |
| 20000029 | Haematopoietic erythropenia | 127689 | 383 | 3.89 | (3.51–4.32) | 257 | 3.45 | (3.04–3.92) | 13 | 1.83 | (1.05–3.18) |
| 20000030 | Haematopoietic leucopenia | 114301 | 973 | 12.75 | (11.89–13.68) | 409 | 6.43 | (5.81–7.13) | 76 | 14.73 | (11.42–18.99) |
| 20000031 | Haematopoietic thrombocytopenia | 73937 | 335 | 5.88 | (5.26–6.57) | 208 | 4.80 | (4.17–5.52) | 11 | 2.68 | (1.47–4.88) |
| 20000042 | Interstitial lung disease | 49703 | 286 | 7.43 | (6.59–8.38) | 181 | 6.20 | (5.34–7.20) | 23 | 8.67 | (5.68–13.24) |
a) Preferred term,
b) Number of patients with adverse events,
c) Reporting Odds Ratio,
d) Confidence interval,
e) Selected PTs based on characteristic adverse events associated with DOX,
f) Standardized MedDRA Queries,
†Number of cases < 2.