Table 2 Four adverse reaction signals on the 27 system organ class levels of mAb drugs
System organ class | Trastuzumab | Pertuzumab | ||||||
|---|---|---|---|---|---|---|---|---|
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 | 0.85(0.80–0.91) | 0.85(0.80–0.91) | -0.21(-0.31– -0.11) | 0.86(0.81–0.92) | 0.67(0.57–0.79) | 0.67(0.57–0.79) | -0.57(-0.80– -0.32) | 0.68(0.57–0.80) |
Blood and lymphatic system disorders | 1.30(1.26–1.34) | 1.28(1.25–1.32) | 0.33(0.29–0.38) | 1.26(1.22–1.30) | 1.96(1.86–2.08) | 1.88(1.78–1.98) | 0.89(0.81–0.97) | 1.86(1.75–1.96) |
Vascular disorders | 1.13(1.08–1.19) | 1.13(1.08–1.19) | 0.16(0.09–0.23) | 1.12(1.07–1.18) | 1.24(1.13–1.38) | 1.24(1.12–1.36) | 0.30(0.15–0.45) | 1.23(1.12–1.36) |
Cardiac disorders | 3.51(3.40–3.63) | 3.34(3.24–3.45) | 1.51(1.47–1.56) | 2.86(2.76–2.95) | 1.98(1.83–2.15) | 1.94(1.80–2.09) | 0.94(0.82–1.05) | 1.91(1.77–2.07) |
Gastrointestinal disorders | 0.89(0.86–0.91) | 0.90(0.88–0.92) | -0.14(-0.18– -0.11) | 0.90(0.88–0.93) | 1.21(1.15–1.27) | 1.18(1.13–1.23) | 0.24(0.17–0.31) | 1.18(1.12–1.24) |
Reproductive system and breast disorders | 0.91(0.83–1.01) | 0.91(0.83–1.01) | -0.12(-0.26–0.02) | 0.92(0.83–1.01) | 0.72(0.57–0.92) | 0.73(0.57–0.92) | -0.46(-0.80– -0.11) | 0.73(0.58–0.92) |
Renal and urinary disorders | 0.83(0.78–0.90) | 0.84(0.78–0.90) | -0.24(-0.35– -0.14) | 0.85(0.79–0.91) | 0.86(0.74–1.01) | 0.86(0.74–1.01) | -0.21(-0.44–0.02) | 0.87(0.74–1.01) |
Social circumstances | 0.16(0.12–0.21) | 0.16(0.12–0.21) | -2.54(-2.90– -2.14) | 0.17(0.13–0.22) | 0.15(0.08–0.28) | 0.15(0.08–0.28) | -2.73(-3.48– -1.74) | 0.15(0.08–0.28) |
Pregnancy, puerperium and perinatal conditions | 3.37(2.92–3.90) | 3.36(2.91–3.89) | 1.52(1.30–1.72) | 2.87(2.48–3.32) | 0.87(0.51–1.47) | 0.87(0.51–1.47) | -0.20(-0.94–0.56) | 0.87(0.51–1.47) |
General disorders and administration site conditions | 1.14(1.12–1.16) | 1.12(1.10–1.14) | 0.15(0.12–0.18) | 1.11(1.09–1.13) | 1.06(1.01–1.10) | 1.05(1.01–1.09) | 0.07(0.00–0.13) | 1.05(1.00–1.09) |
Skin and subcutaneous tissue disorders | 0.53(0.51–0.54) | 0.55(0.54–0.57) | -0.81(-0.86– -0.76) | 0.57(0.55–0.59) | 0.71(0.66–0.75) | 0.73(0.69–0.77) | -0.45(-0.54– -0.36) | 0.73(0.69–0.78) |
Endocrine disorders | 0.67(0.57–0.79) | 0.67(0.57–0.79) | -0.54(-0.78– -0.29) | 0.69(0.58–0.81) | 0.30(0.17–0.51) | 0.30(0.17–0.51) | -1.73(-2.43– -0.88) | 0.30(0.17–0.52) |
Immune system disorders | 1.31(1.21–1.42) | 1.31(1.21–1.42) | 0.36(0.24–0.47) | 1.28(1.18–1.39) | 1.88(1.63–2.17) | 1.87(1.62–2.15) | 0.88(0.67–1.09) | 1.84(1.60–2.13) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1.03(1.00–1.06) | 1.03(1.00–1.06) | 0.04(-0.01–0.09) | 1.03(1.00–1.06) | 0.58(0.53–0.64) | 0.60(0.55–0.65) | -0.74(-0.86– -0.61) | 0.60(0.55–0.66) |
Psychiatric disorders | 0.37(0.35–0.39) | 0.38(0.36–0.40) | -1.33(-1.41– -1.24) | 0.40(0.38–0.42) | 0.28(0.24–0.33) | 0.29(0.25–0.34) | -1.78(-2.00– -1.55) | 0.29(0.25–0.34) |
Respiratory, thoracic and mediastinal disorders | 1.19(1.15–1.23) | 1.18(1.14–1.21) | 0.22(0.17–0.26) | 1.16(1.13–1.20) | 1.31(1.23–1.40) | 1.29(1.22–1.37) | 0.36(0.27–0.46) | 1.29(1.21–1.37) |
Congenital, familial and genetic disorders | 1.28(1.07–1.54) | 1.28(1.07–1.54) | 0.33(0.06–0.59) | 1.26(1.05–1.51) | 0.35(0.17–0.73) | 0.35(0.17–0.74) | -1.50(-2.40– -0.36) | 0.35(0.17–0.74) |
Surgical and medical procedures | 0.44(0.40–0.50) | 0.45(0.40–0.50) | -1.11(-1.27– -0.94) | 0.46(0.41–0.52) | 0.61(0.49–0.76) | 0.62(0.50–0.76) | -0.69(-1.00– -0.37) | 0.62(0.50–0.77) |
Musculoskeletal and connective tissue disorders | 0.67(0.64–0.69) | 0.68(0.65–0.70) | -0.52(-0.58– -0.47) | 0.69(0.67–0.72) | 0.47(0.43–0.52) | 0.49(0.44–0.53) | -1.03(-1.17– -0.88) | 0.49(0.44–0.54) |
Injury, poisoning and procedural complications | 1.10(1.06–1.14) | 1.09(1.06–1.13) | 0.12(0.07–0.17) | 1.09(1.05–1.12) | 0.75(0.68–0.81) | 0.75(0.69–0.82) | -0.40(-0.53– -0.27) | 0.76(0.69–0.83) |
Nervous system disorders | 1.21(1.17–1.24) | 1.19(1.16–1.22) | 0.23(0.19–0.27) | 1.17(1.14–1.21) | 1.01(0.94–1.08) | 1.01(0.95–1.07) | 0.01(-0.09–0.11) | 1.01(0.94–1.08) |
Investigations | 1.05(1.02–1.08) | 1.04(1.02–1.07) | 0.06(0.02–0.09) | 1.04(1.01–1.07) | 0.98(0.92–1.04) | 0.98(0.93–1.04) | -0.03(-0.11–0.06) | 0.98(0.93–1.04) |
Infections and infestations | 1.10(1.06–1.14) | 1.10(1.06–1.13) | 0.12(0.07–0.17) | 1.09(1.05–1.13) | 1.55(1.46–1.66) | 1.52(1.43–1.61) | 0.59(0.49–0.69) | 1.51(1.41–1.61) |
Hepatobiliary disorders | 1.08(1.02–1.15) | 1.08(1.02–1.14) | 0.10(0.02–0.19) | 1.07(1.01–1.14) | 1.04(0.92–1.19) | 1.04(0.92–1.18) | 0.06(-0.13–0.25) | 1.04(0.92–1.18) |
Ear and labyrinth disorders | 1.13(1.00–1.27) | 1.12(1.00–1.27) | 0.16(-0.02–0.33) | 1.11(0.99–1.26) | 0.57(0.40–0.82) | 0.58(0.40–0.82) | -0.79(-1.29– -0.25) | 0.58(0.40–0.83) |
Metabolism and nutrition disorders | 0.80(0.76–0.84) | 0.80(0.77–0.84) | -0.29(-0.37– -0.22) | 0.82(0.78–0.86) | 1.03(0.93–1.13) | 1.03(0.93–1.13) | 0.04(-0.11–0.18) | 1.02(0.93–1.13) |
Product issues | 0.38(0.30–0.48) | 0.38(0.30–0.48) | -1.33(-1.66– -0.96) | 0.40(0.31–0.51) | 0.34(0.20–0.61) | 0.34(0.20–0.61) | -1.52(-2.25– -0.65) | 0.35(0.20–0.61) |