Table 4.
Grade 3–5 adverse events (> 1% in the CET group)
| Adverse events | Studies involved | CET group | PET group | Risk ratio [95% CI] | P | ||
|---|---|---|---|---|---|---|---|
| Event/total | % | Event/total | % | ||||
| Neutropenia | 7 | 1249/2103 | 59.39% | 20/1463 | 1.37% | 42.16 [20.45, 86.90] | < 0.00001 |
| Leukopenia | 7 | 507/2103 | 24.11% | 7/1463 | 0.48% | 27.95 [12.00, 65.11] | < 0.00001 |
| White blood cell count decreased | 2 | 86/662 | 12.99% | 3/499 | 0.60% | 21.99 [6.99, 69.19] | < 0.00001 |
| Hypertension | 3 | 65/925 | 7.03% | 57/777 | 7.34% | 1.11 [0.79, 1.54] | 0.55 |
| Alanine aminotransferase increased | 5 | 84/1422 | 5.91% | 15/1113 | 1.35% | 3.51 [1.31, 9.44] | 0.01 |
| Hypokalemia | 2 | 25/497 | 5.03% | 4/336 | 1.19% | 3.06 [0.04, 240.13] | 0.62 |
| Anemia | 7 | 105/2103 | 4.99% | 25/1463 | 1.71% | 2.45 [1.54, 3.89] | < 0.00001 |
| Hyponatremia | 1 | 16/328 | 4.88% | 0/165 | 0.00% | 16.65 [1.01, 275.82] | 0.05 |
| Aspartate aminotransferase increased | 5 | 54/1422 | 3.80% | 13/1113 | 1.17% | 3.38 [1.84, 6.21] | < 0.0001 |
| Thrombocytopenia | 4 | 33/1204 | 2.74% | 4/836 | 0.48% | 4.45 [1.41, 14.02] | 0.001 |
| Diarrhea | 7 | 51/2103 | 2.43% | 10/1463 | 0.68% | 2.53 [1.16, 5.53] | 0.0008 |
| Electrocardiogram QT prolonged | 3 | 18/760 | 2.37% | 3/614 | 0.49% | 2.85 [0.81, 9.95] | 0.03 |
| Pneumonia | 1 | 6/303 | 1.98% | 1/153 | 0.65% | 3.03 [0.37, 24.94] | 0.30 |
| Fatigue | 6 | 33/1800 | 1.83% | 5/1310 | 0.38% | 3.76 [1.62, 8.76] | 0.002 |
| Dyspnea | 2 | 13/778 | 1.67% | 5/556 | 0.90% | 1.77 [0.38, 8.34] | 0.20 |
| Back pain | 5 | 27/1631 | 1.66% | 9/1139 | 0.79% | 2.10 [0.97, 4.52] | 0.03 |
| γ-Glutamyltransferase increased | 3 | 12/760 | 1.58% | 13/614 | 2.12% | 0.72 [0.33, 1.61] | 0.52 |
| Vomiting | 6 | 27/1934 | 1.40% | 12/1292 | 0.93% | 1.39 [0.49, 3.91] | 0.14 |
| Hypokalaemia | 1 | 4/303 | 1.32% | 0/153 | 0.00% | 4.56 [0.25, 84.14] | 0.31 |
| Asthenia | 3 | 13/1035 | 1.26% | 0/665 | 0.00% | 4.66 [0.82, 26.49] | 0.04 |
| Abdominal pain | 3 | 13/1060 | 1.23% | 3/677 | 0.44% | 2.19 [0.67, 7.18] | 0.16 |
| Blood creatinine increased | 2 | 7/631 | 1.11% | 0/318 | 0.00% | 7.57 [0.43, 131.71] | 0.16 |
| Dyspnoea | 1 | 3/288 | 1.04% | 1/290 | 0.34% | 3.02 [0.32, 28.87] | 0.34 |
Abbreviations: CET: CDK4/6 inhibitors plus endocrine therapy; CI: Confidence interval; PET: Placebo plus endocrine therapy; RR: Risk ratio