Table 3.
Safety signals of sacituzumab govitecan in cases aged 18-65.
| AE | n | ROR(95CI) | IC(IC025) |
|---|---|---|---|
| Disease progression | 123 | 54.90 (45.6-66.10) | 49.81(41.37) |
| Death | 59 | 3.36 (2.59-4.36) | 3.26(2.51) |
| Diarrhoea | 58 | 4.23 (3.26-5.51) | 4.10(3.15) |
| Neutropenia | 42 | 14.15 (10.40-19.24) | 13.73(10.09) |
| Nausea | 37 | 2.46 (1.77-3.41) | 2.42(1.75) |
| Fatigue | 33 | 1.89 (1.34-2.67) | 1.87(1.32) |
| Febrile neutropenia | 32 | 21.91 (15.42-31.12) | 21.38(15.05) |
| Alopecia | 27 | 6.02 (4.11-8.82) | 5.92(4.04) |
| Vomiting | 20 | 2.33 (1.50-3.63) | 2.31(1.49) |
| White blood cell count decreased | 19 | 7.10 (4.52-11.18) | 7.02(4.46) |
| Weight decreased | 19 | 3.02 (1.92-4.75) | 2.99(1.90) |
| Neutrophil count decreased | 19 | 19.35 (12.30-30.44) | 19.06(12.11) |
| Anaemia | 18 | 4.87 (3.06-7.75) | 4.82(3.02) |
| Constipation | 14 | 3.05 (1.80-5.17) | 3.03(1.79) |
| Weight increased | 13 | 2.69 (1.56-4.64) | 2.67(1.55) |
| Hypotension | 12 | 2.97 (1.68-5.24) | 2.95(1.67) |
| Abdominal pain | 12 | 2.58 (1.46-4.56) | 2.57(1.45) |
| Heart rate increased | 10 | 4.87 (2.61-9.07) | 4.84(2.60) |
| Thrombocytopenia | 10 | 4.48 (2.41-8.35) | 4.45(2.39) |
| Colitis | 10 | 11.51 (6.18-21.45) | 11.42(6.13) |
| Dehydration | 9 | 3.93 (2.04-7.57) | 3.91(2.03) |
| Platelet count decreased | 9 | 3.65 (1.89-7.03) | 3.63(1.89) |
| Neutropenic colitis | 9 | 176.55 (91.15-341.97) | 172.42(89.01) |
| Weight fluctuation | 8 | 24.26 (12.10-48.65) | 24.07(12.00) |
| Pancytopenia | 7 | 6.83 (3.25-14.36) | 6.80(3.23) |
| Liver function test increased | 6 | 9.85 (4.41-21.97) | 9.80(4.39) |
| Septic shock | 6 | 6.87 (3.08-15.33) | 6.84(3.07) |
| Bone pain | 6 | 5.34 (2.39-11.91) | 5.32(2.38) |
| Pneumonitis | 5 | 8.12 (3.37-19.56) | 8.09(3.36) |
| Pleural effusion | 5 | 4.56 (1.89-10.97) | 4.54(1.89) |
| Neutropenic sepsis | 5 | 34.79 (14.44-83.85) | 34.55(14.34) |
| Stomatitis | 5 | 3.65 (1.52-8.79) | 3.64(1.51) |
| Gastrooesophageal reflux disease | 5 | 3.28 (1.36-7.88) | 3.27(1.36) |
| Candida infection | 5 | 11.11 (4.61-26.74) | 11.06(4.59) |
| Blood bilirubin increased | 4 | 9.54 (3.57-25.45) | 9.50(3.56) |
| Neutrophil count abnormal | 4 | 56.17 (20.99-150.28) | 55.70(20.82) |
| SARS-CoV-2 test positive | 4 | 4.71 (1.77-12.57) | 4.70(1.76) |
| Throat irritation | 4 | 4.61 (1.73-12.30) | 4.60(1.72) |
| Hypokalemia | 4 | 4.45 (1.67-11.88) | 4.44(1.66) |
| Leukopenia | 4 | 3.95 (1.48-10.55) | 3.94(1.48) |
| Enteritis | 4 | 29.01 (10.86-77.51) | 28.85(10.80) |
| Oxygen saturation decreased | 4 | 2.67 (1.00-7.13) | 2.66(1.00) |
| Hemorrhoids | 3 | 8.45 (2.72-26.26) | 8.43(2.71) |
| Cholestasis | 3 | 7.87 (2.53-24.44) | 7.85(2.53) |
| Hypersomnia | 3 | 5.16 (1.66-16.03) | 5.15(1.66) |
| Neuralgia | 3 | 5.12 (1.65-15.90) | 5.11(1.65) |
| Pain of skin | 3 | 3.79 (1.22-11.76) | 3.78(1.22) |
| Limb discomfort | 3 | 3.66 (1.18-11.38) | 3.66(1.18) |
| Liver disorder | 3 | 3.40 (1.09-10.56) | 3.39(1.09) |
| Myelosuppression | 3 | 3.35 (1.08-10.41) | 3.35(1.08) |
| Enterocolitis | 3 | 21.86 (7.03-67.96) | 21.77(7.01) |
| Muscle atrophy | 3 | 14.54 (4.68-45.18) | 14.49(4.66) |
| Wound infection | 3 | 14.16 (4.56-44.00) | 14.11(4.54) |