Table 7 Summary of findings, including GRADE quality assessment for comparison between elagolix and elagolix with estradiol/norethindrone acetate by adverse events
Adverse event | No of trials | No of participants | Risk Ratio (RR) | 95% Confidence interval (CI) | P value | Random effect; I2 statistic (%) | GRADE quality |
|---|---|---|---|---|---|---|---|
Any AE | 5 | 1403 | 1.13 | 1.03, 1.25 | P = 0.010 | 68 | Moderate |
Serious AE | 5 | 1403 | 1.23 | 0.68, 2.24 | P = 0.500 | 0 | Low |
Severe AE | 4 | 979 | 0.90 | 0.45, 1.83 | P = 0.780 | 51 | Low |
AE led to discontinuation | 5 | 1403 | 1.31 | 0.92, 1.87 | P = 0.130 | 0 | Low |
Hot flush | 5 | 1403 | 2.67 | 2.30, 3.10 | P < 0.001 | 0 | Moderate |
Headache | 5 | 1403 | 1.16 | 0.84, 1.62 | P = 0.370 | 22 | Low |
Abdominal pain | 2 | 493 | 1.02 | 0.14, 7.47 | P = 0.990 | 47 | Low |
Dizziness | 2 | 493 | 0.87 | 0.38, 2.02 | P = 0.750 | 0 | Low |
Nausea | 5 | 1403 | 0.63 | 0.43, 0.91 | P = 0.010 | 0 | Low |
Fatigue | 5 | 1403 | 0.43 | 0.23, 0.80 | P = 0.008 | 0 | Low |
Hypertension | 3 | 809 | 0.60 | 0.23, 1.59 | P = 0.300 | 0 | Low |