Table 3 Positive signal detection results of liposomal doxorubicin and CDOX.
SOC | PTs | CDOX | Doxil | Myocet | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
ROR (95%CI) | PRR (X2) | IC025 | ROR (95%CI) | PRR (X2) | IC025 | ROR (95%CI) | PRR (X2) | IC025 | ||
Blood and lymphatic system disorders | Anaemia | 4.24 (4.10; 4.39) | 4.12 (8402.09) | 1.90 | 4.57 (4.15; 5.04) | 4.42 (1125.53) | 1.81 | 4.01 (2.67; 6.02) | 3.89 (52.13) | 0.47 |
Pancytopenia | 9.36 (8.96; 9.78) | 9.17 (14,995.22) | 2.98 | 9.13 (8.02; 10.39) | 8.94 (1659.32) | 2.68 | 7.13 (4.03; 12.63) | 7.02 (62.09) | 0.44 | |
Neutropenia | 12.97 (12.64; 13.31) | 12.14 (62,022.04) | 3.42 | 8.18 (7.45; 8.97) | 7.84 (2829.84) | 2.64 | 15.58 (11.84; 20.49) | 14.31 (697.06) | 2.63 | |
Thrombocytopenia | 7.91 (7.65; 8.18) | 7.64 (20,281.80) | 2.76 | 7.00 (6.30; 7.78) | 6.79 (1778.29) | 2.39 | 8.49 (5.81; 12.40) | 8.16 (176.88) | 1.47 | |
Cardiac disorders | Cardiomyopathy | 12.87 (12.00; 13.81) | 12.76 (8528.89) | 3.33 | 7.05 (5.38; 9.24) | 7.02 (272.40) | 1.76 | – | – | – |
Cardiotoxicity | 38.87 (36.41; 41.49) | 38.41 (33,183.86) | 4.73 | 17.96 (14.10; 22.86) | 17.84 (1053.77) | 3.03 | 37.36 (19.34; 72.17) | 36.85 (313.55) | 0.93 | |
General disorders and administration site conditions | Febrile neutropenia | 42.45 (41.44; 43.48) | 38.51 (264,943.39) | 4.90 | 17.53 (16.02; 19.20) | 16.71 (7301.35) | 3.70 | 34.68 (26.63; 45.15) | 31.49 (1803.81) | 3.53 |
Mucosal inflammation | 21.68 (20.74; 22.67) | 21.19 (37,920.92) | 4.09 | 16.18 (14.04; 18.65) | 15.88 (2723.60) | 3.40 | 19.02 (11.40; 31.75) | 18.60 (249.98) | 1.50 | |
Pyrexia | 3.00 (2.91; 3.09) | 2.90 (5662.74) | 1.42 | 2.45 (2.22; 2.71) | 2.39 (333.59) | 0.92 | 5.31 (4.02; 7.01) | 4.95 (172.95) | 1.29 | |
Infections and infestations | Sepsis | 6.04 (5.82; 6.28) | 5.89 (11,590.60) | 2.39 | 3.26 (2.81; 3.78) | 3.22 (271.75) | 1.17 | 5.78 (3.71; 9.03) | 5.64 (76.70) | 0.76 |
Musculoskeletal and connective tissue disorders | Bone disorder | 2.59 (2.28; 2.95) | 2.59 (228.21) | 0.92 | 4.47 (3.32; 6.01) | 4.46 (117.72) | 1.07 | – | – | – |
Bone pain | 3.14 (2.93; 3.36) | 3.12 (1181.85) | 1.39 | – | – | – | – | – | – | |
Osteonecrosis | 3.06 (2.81; 3.34) | 3.05 (712.26) | 1.30 | 3.49 (2.74; 4.46) | 3.48 (114.72) | 0.94 | – | – | – | |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Malignant neoplasm progression | 4.36 (4.16; 4.58) | 4.30 (4453.89) | 1.92 | 8.40 (7.57; 9.32) | 8.13 (2305.32) | 2.64 | 5.56 (3.38; 9.13) | 5.44 (58.30) | 0.51 |
Nervous system disorders | leukoencephalopathy | 8.19 (6.91; 9.72) | 8.18 (836.43) | 2.34 | 7.42 (4.39; 12.55) | 7.41 (77.29) | 0.69 | – | – | – |
Respiratory, thoracic and mediastinal disorders | Interstitial lung disease | 6.81 (6.44; 7.19) | 6.72 (6361.84) | 2.51 | 13.49 (12.00; 15.17) | 13.13 (3241.89) | 3.26 | – | – | – |
Pleural effusion | 4.12 (3.88; 4.37) | 4.08 (2615.42) | 1.80 | 5.36 (4.59; 6.27) | 5.29 (563.81) | 1.85 | – | – | – | |
Skin and subcutaneous tissue disorders | Palmar-plantar erythrodysaesthesia syndrome | 6.16 (5.69; 6.68) | 6.13 (2596.88) | 2.30 | 36.13 (32.60; 40.06) | 34.78 (12,345.37) | 4.63 | 19.69 (11.59; 33.44) | 19.28 (242.77) | 1.42 |
Vascular disorders | Pulmonary embolism | 2.48 (2.34; 2.63) | 2.46 (986.82) | 1.09 | 2.41 (2.02; 2.89) | 2.40 (98.07) | 0.65 | – | – | – |
