Table 4.
Safety signals of sacituzumab govitecan in cases aged >65.
| AE | n | ROR(95CI) | IC(IC025) |
|---|---|---|---|
| Diarrhoea | 22 | 4.65 (3.03-7.14) | 4.48(2.92) |
| Disease progression | 18 | 21.84 (13.64-34.99) | 21.04(13.13) |
| Febrile neutropenia | 16 | 31.92 (19.39-52.56) | 30.85(18.73) |
| Sepsis | 15 | 20.22 (12.09-33.82) | 19.60(11.72) |
| Neutropenia | 14 | 13.58 (7.98-23.12) | 13.20(7.76) |
| Fatigue | 11 | 1.82 (1.00-3.30) | 1.80(0.99) |
| Thrombocytopenia | 9 | 11.78 (6.09-22.79) | 11.57(5.98) |
| Asthenia | 8 | 3.17 (1.57-6.37) | 3.13(1.56) |
| Anaemia | 8 | 6.27 (3.12-12.61) | 6.18(3.07) |
| Death | 7 | 1.12 (0.53-2.36) | 1.12(0.53) |
| Hypotension | 7 | 5.03 (2.38-10.61) | 4.97(2.36) |
| Alopecia | 6 | 3.83 (1.71-8.58) | 3.80(1.70) |
| Colitis | 6 | 20.03 (8.95-44.84) | 19.78(8.84) |
| Vomiting | 5 | 1.68 (0.69-4.05) | 1.67(0.69) |
| Weight decreased | 5 | 2.28 (0.95-5.52) | 2.27(0.94) |
| Weight increased | 5 | 2.98 (1.24-7.20) | 2.96(1.23) |
| Acute kidney injury | 5 | 3.29 (1.36-7.94) | 3.27(1.35) |
| General physical health deterioration | 5 | 5.34 (2.21-12.89) | 5.29(2.19) |
| White blood cell count decreased | 5 | 5.38 (2.23-12.98) | 5.33(2.21) |
| Atrial fibrillation | 5 | 6.91 (2.86-16.69) | 6.85(2.84) |
| Septic shock | 5 | 16.63 (6.89-40.15) | 16.45(6.82) |
| Neutropenic sepsis | 5 | 101.11 (41.83-244.43) | 99.72(41.25) |
| Neutropenic colitis | 5 | 282.05 (116.36-683.66) | 276.45(114.05) |
| Pain | 4 | 0.69 (0.26-1.84) | 0.69(0.26) |
| Dyspnoea | 4 | 0.99 (0.37-2.64) | 0.99(0.37) |
| Rash | 4 | 1.21 (0.45-3.23) | 1.21(0.45) |
| Abdominal pain | 4 | 2.48 (0.93-6.64) | 2.47(0.92) |
| Nausea | 3 | 0.56 (0.18-1.75) | 0.57(0.18) |
| Condition aggravated | 3 | 1.04 (0.33-3.23) | 1.04(0.33) |
| Pyrexia | 3 | 1.18 (0.38-3.67) | 1.18(0.38) |
| Constipation | 3 | 1.88 (0.60-5.85) | 1.88(0.60) |
| Somnolence | 3 | 2.23 (0.72-6.95) | 2.22(0.71) |
| Urinary tract infection | 3 | 2.28 (0.73-7.10) | 2.27(0.73) |
| Hemoglobin decreased | 3 | 4.34 (1.39-13.50) | 4.32(1.39) |
| Myocardial infarction | 3 | 4.43 (1.42-13.78) | 4.41(1.42) |
| Stress | 3 | 4.91 (1.58-15.27) | 4.88(1.57) |
| Dysphagia | 3 | 5.19 (1.67-16.15) | 5.16(1.66) |
| Leukopenia | 3 | 8.59 (2.76-26.72) | 8.54(2.74) |
| Speech disorder | 3 | 8.70 (2.79-27.07) | 8.65(2.78) |
| Pneumonitis | 3 | 14.10 (4.53-43.9) | 14.01(4.50) |
| Mucosal inflammation | 3 | 16.68 (5.36-51.92) | 16.57(5.32) |
| Eating disorder | 3 | 18.12 (5.82-56.41) | 18.00(5.78) |
| Febrile bone marrow aplasia | 3 | 121.33 (38.9-378.43) | 120.07(38.50) |