Table 4 Summary of findings, including GRADE quality assessment for the comparison between elagolix and placebo 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 | 4 | 890 | 1.25 | 1.15, 1.36 | P < 0.001 | 0 | High |
Serious AE | 4 | 890 | 0.93 | 0.48, 1.81 | P = 0.830 | 0 | Low |
Severe AE | 3 | 605 | 1.53 | 0.86, 2.73 | P = 0.150 | 0 | Low |
AE led to discontinuation | 4 | 890 | 1.66 | 1.05, 2.64 | P = 0.030 | 0 | Low |
Hot flush | 4 | 890 | 7.47 | 4.99, 11.18 | P < 0.001 | 8 | Moderate |
Headache | 4 | 890 | 1.88 | 1.25, 2.83 | P = 0.003 | 0 | Low |
Abdominal pain | 2 | 495 | 1.17 | 0.37, 3.66 | P = 0.790 | 6 | Low |
Dizziness | 2 | 495 | 1.26 | 0.48, 3.29 | P = 0.640 | 18 | Low |
Nausea | 4 | 890 | 1.00 | 0.53, 1.92 | P = 0.990 | 41 | Low |
Fatigue | 4 | 890 | 0.77 | 0.33, 1.79 | P = 0.550 | 0 | Low |
Hypertension | 2 | 495 | 1.25 | 0.14, 10.93 | P = 0.840 | * | Low |