Table 2 Signal detection for CDK4/6 inhibitors-associated musculoskeletal toxicities (top 30 PTs)
PTs | All | Palbociclib | Ribociclib | Abemaciclib | ||||
|---|---|---|---|---|---|---|---|---|
Case reports | ROR (95% CI) | Case reports | ROR (95% CI) | Case reports | ROR (95% CI) | Case reports | ROR (95% CI) | |
Arthralgia | 2784 | 1.42 (1.37, 1.48) | 2209 | 1.52 (1.45, 1.6) | 485 | 1.07 (0.97, 1.18) | 90 | 1.59 (1.26, 2) |
Back pain | 1934 | 1.81 (1.73, 1.9) | 1421 | 1.76 (1.67, 1.86) | 472 | 2.12 (1.93, 2.34) | 41 | 1.31 (0.95, 1.81) |
Pain in extremity | 1906 | 1.36 (1.3, 1.43) | 1370 | 1.29 (1.22, 1.37) | 488 | 1.73 (1.57, 1.91) | 48 | 1.23 (0.91, 1.66) |
Bone pain | 1249 | 4.72 (4.45, 5.01) | 935 | 4.67 (4.36, 5) | 283 | 5.14 (4.55, 5.81) | 31 | 4.19 (2.91, 6.03) |
Muscle spasms | 821 | 0.92 (0.85, 0.98) | 663 | 0.99 (0.92, 1.07) | 110 | 0.59 (0.49, 0.71) | 48 | 2.12 (1.57, 2.86) |
Myalgia | 737 | 0.96 (0.89, 1.03) | 615 | 1.07 (0.98, 1.16) | 99 | 0.59 (0.48, 0.72) | 23 | 1.07 (0.7, 1.63) |
Muscular weakness | 404 | 0.78 (0.71, 0.86) | 313 | 0.8 (0.72, 0.9) | 72 | 0.66 (0.52, 0.83) | 19 | 1.35 (0.85, 2.13) |
Arthritis | 381 | 0.97 (0.88, 1.07) | 338 | 1.15 (1.03, 1.28) | 35 | 0.4 (0.29, 0.56) | 8 | 0.68 (0.34, 1.37) |
Joint swelling | 334 | 0.53 (0.47, 0.59) | 265 | 0.56 (0.49, 0.63) | 56 | 0.38 (0.3, 0.5) | 13 | 0.67 (0.39, 1.17) |
Musculoskeletal chest pain | 291 | 4.15 (3.69, 4.67) | 200 | 3.76 (3.26, 4.33) | 87 | 5.81 (4.69, 7.2) | 4 | 1.95 (0.73, 5.23) |
Musculoskeletal stiffness | 282 | 0.62 (0.55, 0.69) | 229 | 0.67 (0.59, 0.76) | 44 | 0.43 (0.32, 0.58) | 9 | 0.66 (0.34, 1.28) |
Mobility decreased | 268 | 0.74 (0.65, 0.83) | 180 | 0.66 (0.57, 0.76) | 69 | 0.89 (0.7, 1.13) | 19 | 1.85 (1.17, 2.93) |
Neck pain | 261 | 0.98 (0.87, 1.11) | 201 | 1.01 (0.88, 1.16) | 57 | 1.01 (0.77, 1.31) | 3 | 0.39 (0.13, 1.23) |
Musculoskeletal pain | 255 | 1.01 (0.89, 1.14) | 214 | 1.13 (0.98, 1.29) | 38 | 0.8 (0.58, 1.1) | 3 | 0.5 (0.16, 1.54) |
Limb discomfort | 252 | 1.4 (1.24, 1.59) | 175 | 1.29 (1.11, 1.5) | 70 | 1.81 (1.43, 2.3) | 7 | 1.34 (0.64, 2.83) |
Spinal pain | 220 | 3.25 (2.84, 3.72) | 110 | 2.13 (1.76, 2.57) | 107 | 7.26 (5.98, 8.82) | 3 | 1.45 (0.47, 4.53) |
Bone disorder | 203 | 2.92 (2.54, 3.36) | 138 | 2.62 (2.21, 3.11) | 63 | 4.38 (3.41, 5.62) | NA | NA |
Osteonecrosis of jaw | 191 | 1.63 (1.41, 1.88) | 141 | 1.6 (1.35, 1.89) | 33 | 1.47 (1.04, 2.07) | 17 | 6.07 (3.74, 9.86) |
Arthropathy | 178 | 0.61 (0.53, 0.71) | 158 | 0.72 (0.62, 0.85) | 18 | 0.27 (0.17, 0.43) | NA | NA |
Osteoporosis | 147 | 0.7 (0.59, 0.82) | 101 | 0.64 (0.52, 0.77) | 43 | 0.86 (0.63, 1.16) | 3 | 0.43 (0.14, 1.35) |
Joint stiffness | 134 | 1.06 (0.89, 1.25) | 113 | 1.19 (0.99, 1.43) | 18 | 0.65 (0.41, 1.03) | 3 | 0.82 (0.26, 2.55) |
Pain in jaw | 131 | 0.92 (0.78, 1.1) | 108 | 1.02 (0.84, 1.23) | 16 | 0.54 (0.33, 0.87) | 7 | 1.81 (0.86, 3.82) |
Musculoskeletal discomfort | 122 | 1.39 (1.16, 1.66) | 87 | 1.32 (1.07, 1.63) | 33 | 1.8 (1.28, 2.54) | NA | NA |
Bone lesion | 122 | 8.66 (7.2, 10.41) | 34 | 3.04 (2.17, 4.28) | 87 | 28.08 (22.55, 34.97) | NA | NA |
Osteoarthritis | 105 | 0.53 (0.44, 0.65) | 80 | 0.54 (0.44, 0.68) | 25 | 0.57 (0.38, 0.84) | NA | NA |
Spinal disorder | 86 | 1.97 (1.59, 2.44) | 54 | 1.64 (1.25, 2.14) | 31 | 3.26 (2.29, 4.65) | NA | NA |
Back disorder | 77 | 0.98 (0.78, 1.23) | 71 | 1.21 (0.95, 1.52) | 6 | 0.36 (0.16, 0.8) | NA | NA |
Pathological fracture | 67 | 3.23 (2.54, 4.12) | 47 | 3 (2.25, 4.01) | 16 | 3.36 (2.05, 5.5) | 4 | 6.25 (2.33, 16.74) |
Osteopenia | 64 | 0.81 (0.63, 1.03) | 50 | 0.84 (0.63, 1.11) | 12 | 0.61 (0.35, 1.08) | NA | NA |
Musculoskeletal disorder | 56 | 0.55 (0.42, 0.71) | 53 | 0.69 (0.53, 0.91) | 3 | 0.14 (0.05, 0.44) | NA | NA |