Table 3.
Any grade adverse events (> 20% in the CET group)
| Adverse events | Studies involved | CET group | PET group | Risk ratio [95% CI] | P | ||
|---|---|---|---|---|---|---|---|
| Event/total | % | Event/total | % | ||||
| Neutropenia | 7 | 1570/2103 | 74.66% | 106/1463 | 7.25% | 10.92 [7.62, 15.65] | < 0.00001 |
| White blood cell count decreased | 2 | 328/662 | 49.55% | 50/499 | 10.02% | 4.93 [1.74, 13.99] | 0.003 |
| Leukopenia | 7 | 900/2103 | 42.80% | 79/1463 | 5.40% | 7.41 [5.69, 9.66] | < 0.00001 |
| Nausea | 6 | 726/1934 | 37.54% | 301/1292 | 23.30% | 1.67 [1.47, 1.90] | < 0.00001 |
| Fatigue | 6 | 604/1800 | 33.56% | 359/1310 | 27.40% | 1.18 [1.05, 1.32] | 0.003 |
| Diarrhea | 7 | 697/2103 | 33.14% | 288/1463 | 19.69% | 1.51 [1.16, 1.96] | 0.002 |
| Anemia | 7 | 670/2103 | 31.86% | 122/1463 | 8.34% | 3.64 [2.57, 5.14] | < 0.00001 |
| Hypercalcemia | 1 | 96/328 | 29.27% | 50/165 | 30.30% | 0.97 [0.73, 1.29] | 0.81 |
| Hyponatremia | 1 | 90/328 | 27.44% | 37/165 | 22.42% | 1.22 [0.88, 1.71] | 0.24 |
| Thrombocytopenia | 4 | 328/1204 | 27.24% | 27/836 | 3.23% | 7.59 [4.86, 11.86] | < 0.00001 |
| Alopecia | 6 | 472/1800 | 26.22% | 159/1310 | 12.14% | 2.10 [1.78, 2.48] | < 0.00001 |
| Arthralgia | 7 | 550/2103 | 26.15% | 409/1463 | 27.96% | 0.98 [0.88, 1.09] | 0.61 |
| Hot flush | 4 | 305/1303 | 23.41% | 275/974 | 28.23% | 0.86 [0.71, 1.05] | 0.05 |
| Headache | 5 | 375/1631 | 22.99% | 257/1139 | 22.56% | 1.05 [0.87, 1.26] | 0.50 |
| Vomiting | 6 | 436/1934 | 22.54% | 192/1292 | 14.86% | 1.63 [1.18, 2.25] | 0.003 |
| Hypokalemia | 2 | 110/497 | 22.13% | 29/336 | 8.63% | 2.25 [1.51, 3.35] | < 0.0001 |
| Hypocalcemia | 1 | 72/328 | 21.95% | 28/165 | 16.97% | 1.29 [0.87, 1.92] | 0.20 |
| Cough | 5 | 320/1472 | 21.74% | 201/1145 | 17.55% | 1.21 [1.03, 1.42] | 0.02 |
| Aspartate aminotransferase increased | 5 | 308/1422 | 21.66% | 167/1113 | 15.00% | 1.50 [0.94, 2.41] | 0.0002 |
| Constipation | 5 | 349/1631 | 21.40% | 182/1139 | 15.98% | 1.37 [1.16, 1.62] | 0.0001 |
| Alanine aminotransferase increased | 5 | 301/1422 | 21.17% | 165/1113 | 14.82% | 1.55 [0.90, 2.66] | 0.11 |
| Back pain | 5 | 331/1631 | 20.29% | 229/1139 | 20.11% | 1.04 [0.89, 1.21] | 0.64 |
Abbreviations CET: CDK4/6 inhibitors plus endocrine therapy; CI: Confidence interval; PET: Placebo plus endocrine therapy; RR: Risk ratio