Table 3 Four adverse reaction signals on the 27 system organ class levels of ADC drugs
System organ class | T-DM1 | T-DXd | ||||||
|---|---|---|---|---|---|---|---|---|
ROR(95%CI) | PRR(95%CI) | IC(95%CI) | EBGM(95%CI) | ROR(95%CI) | PRR(95%CI) | IC(95%CI) | EBGM(95%CI) | |
Eye disorders | 1.75(1.55–1.98) | 1.73(1.53–1.96) | 0.78(0.60–0.96) | 1.72(1.52–1.95) | 0.87(0.74–1.02) | 0.87(0.74–1.02) | -0.20(-0.44–0.03) | 0.87(0.74–1.02) |
Blood and lymphatic system disorders | 1.18(1.08–1.28) | 1.17(1.08–1.26) | 0.22(0.10–0.34) | 1.17(1.07–1.27) | 0.93(0.85–1.01) | 0.93(0.86–1.01) | -0.10(-0.22–0.03) | 0.94(0.86–1.02) |
Vascular disorders | 0.78(0.67–0.91) | 0.78(0.68–0.91) | -0.35(-0.57– -0.13) | 0.79(0.68–0.91) | 0.52(0.44–0.62) | 0.53(0.45–0.62) | -0.92(-1.16– -0.67) | 0.53(0.45–0.63) |
Cardiac disorders | 1.10(0.97–1.24) | 1.09(0.97–1.23) | 0.13(-0.05–0.31) | 1.09(0.97–1.24) | 0.68(0.59–0.79) | 0.69(0.60–0.79) | -0.53(-0.74– -0.32) | 0.69(0.60–0.80) |
Gastrointestinal disorders | 0.78(0.73–0.84) | 0.80(0.75–0.85) | -0.32(-0.42– -0.22) | 0.80(0.75–0.86) | 1.33(1.26–1.40) | 1.28(1.23–1.34) | 0.35(0.28–0.43) | 1.28(1.21–1.35) |
Reproductive system and breast disorders | 0.68(0.51–0.91) | 0.68(0.51–0.91) | -0.54(-0.96– -0.11) | 0.69(0.51–0.92) | 0.24(0.15–0.38) | 0.24(0.15–0.38) | -2.04(-2.63– -1.34) | 0.24(0.15–0.38) |
Renal and urinary disorders | 0.95(0.80–1.14) | 0.95(0.80–1.14) | -0.07(-0.33–0.19) | 0.95(0.80–1.14) | 0.91(0.77–1.08) | 0.91(0.77–1.07) | -0.14(-0.38–0.11) | 0.91(0.77–1.08) |
Social circumstances | 0.17(0.09–0.34) | 0.17(0.09–0.34) | -2.53(-3.36– -1.43) | 0.17(0.09–0.35) | 0.87(0.65–1.16) | 0.87(0.65–1.16) | -0.20(-0.62–0.22) | 0.87(0.65–1.16) |
Pregnancy, puerperium and perinatal conditions | 0.53(0.24–1.18) | 0.53(0.24–1.18) | -0.91(-1.90–0.28) | 0.53(0.24–1.19) | 0.00(0.00–0.00) | 0.00(0.00–0.00) | 0.00(0.00–0.00) | 0.00(0.00–0.00) |
General disorders and administration site conditions | 1.15(1.10–1.22) | 1.13(1.08–1.18) | 0.17(0.10–0.25) | 1.13(1.07–1.19) | 1.47(1.40–1.53) | 1.37(1.32–1.42) | 0.45(0.38–0.51) | 1.37(1.31–1.43) |
Skin and subcutaneous tissue disorders | 0.38(0.35–0.42) | 0.41(0.37–0.45) | -1.28(-1.43– -1.14) | 0.41(0.37–0.45) | 0.30(0.27–0.33) | 0.32(0.29–0.35) | -1.63(-1.78– -1.48) | 0.32(0.29–0.36) |
Endocrine disorders | 0.49(0.30–0.82) | 0.50(0.30–0.82) | -1.01(-1.68– -0.24) | 0.50(0.30–0.83) | 0.42(0.25–0.70) | 0.42(0.26–0.70) | -1.23(-1.90– -0.45) | 0.43(0.26–0.71) |
Immune system disorders | 0.83(0.64–1.07) | 0.83(0.64–1.07) | -0.27(-0.63–0.10) | 0.83(0.64–1.07) | 0.38(0.27–0.54) | 0.38(0.27–0.54) | -1.38(-1.85– -0.85) | 0.38(0.27–0.54) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.91(0.84–0.99) | 0.92(0.85–0.99) | -0.12(-0.25–0.00) | 0.92(0.84–1.00) | 0.59(0.54–0.65) | 0.61(0.55–0.67) | -0.71(-0.85– -0.57) | 0.61(0.55–0.67) |
Psychiatric disorders | 0.31(0.26–0.37) | 0.32(0.27–0.37) | -1.65(-1.90– -1.39) | 0.32(0.27–0.38) | 0.33(0.28–0.38) | 0.34(0.29–0.39) | -1.56(-1.79– -1.33) | 0.34(0.29–0.40) |
Respiratory, thoracic and mediastinal disorders | 1.31(1.22–1.41) | 1.29(1.20–1.38) | 0.36(0.25–0.47) | 1.29(1.19–1.39) | 2.33(2.20–2.46) | 2.17(2.07–2.28) | 1.10(1.02–1.18) | 2.14(2.03–2.27) |
Congenital, familial and genetic disorders | 0.65(0.34–1.25) | 0.65(0.34–1.25) | -0.62(-1.49–0.35) | 0.65(0.34–1.25) | 0.31(0.13–0.74) | 0.31(0.13–0.74) | -1.69(-2.70– -0.33) | 0.31(0.13–0.75) |
Surgical and medical procedures | 0.45(0.33–0.61) | 0.45(0.33–0.61) | -1.14(-1.56– -0.68) | 0.45(0.33–0.61) | 1.13(0.95–1.36) | 1.13(0.95–1.35) | 0.18(-0.09–0.44) | 1.13(0.94–1.35) |
Musculoskeletal and connective tissue disorders | 0.64(0.58–0.71) | 0.66(0.59–0.72) | -0.60(-0.75– -0.45) | 0.66(0.59–0.73) | 0.28(0.24–0.32) | 0.29(0.26–0.33) | -1.76(-1.96– -1.55) | 0.29(0.26–0.34) |
Injury, poisoning and procedural complications | 0.82(0.74–0.91) | 0.83(0.75–0.91) | -0.27(-0.42– -0.12) | 0.83(0.75–0.92) | 2.07(1.95–2.21) | 1.98(1.87–2.10) | 0.97(0.87–1.06) | 1.96(1.84–2.08) |
Nervous system disorders | 1.45(1.35–1.55) | 1.41(1.33–1.50) | 0.49(0.39–0.59) | 1.41(1.31–1.51) | 0.74(0.68–0.81) | 0.75(0.69–0.82) | -0.40(-0.53– -0.28) | 0.76(0.69–0.82) |
Investigations | 1.47(1.38–1.55) | 1.41(1.34–1.48) | 0.49(0.40–0.57) | 1.40(1.32–1.49) | 0.81(0.75–0.87) | 0.82(0.77–0.88) | -0.28(-0.38– -0.18) | 0.82(0.77–0.88) |
Infections and infestations | 1.35(1.24–1.47) | 1.33(1.23–1.44) | 0.41(0.29–0.53) | 1.33(1.22–1.44) | 1.39(1.29–1.50) | 1.37(1.28–1.47) | 0.45(0.34–0.56) | 1.36(1.27–1.47) |
Hepatobiliary disorders | 3.09(2.82–3.40) | 3.00(2.74–3.28) | 1.56(1.41–1.69) | 2.94(2.68–3.23) | 1.46(1.29–1.65) | 1.45(1.29–1.63) | 0.53(0.35–0.70) | 1.44(1.28–1.63) |
Ear and labyrinth disorders | 1.05(0.76–1.45) | 1.05(0.76–1.44) | 0.07(-0.40–0.53) | 1.05(0.76–1.45) | 0.42(0.27–0.67) | 0.42(0.27–0.67) | -1.23(-1.85– -0.52) | 0.43(0.27–0.68) |
Metabolism and nutrition disorders | 0.91(0.80–1.03) | 0.91(0.80–1.02) | -0.14(-0.32–0.04) | 0.91(0.80–1.03) | 1.34(1.22–1.47) | 1.33(1.21–1.46) | 0.40(0.26–0.54) | 1.32(1.20–1.46) |
Product issues | 0.70(0.44–1.13) | 0.70(0.44–1.13) | -0.50(-1.16–0.20) | 0.71(0.44–1.14) | 0.57(0.35–0.93) | 0.57(0.35–0.93) | -0.81(-1.48– -0.07) | 0.57(0.35–0.93) |