Table 8 Ovary and uterus related adverse events with positive signals for fluvastatin.
Classification | PTs | Proportional rate ratio (PRR) by age groups (years) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Overall | 0–18 | 19–39 | 40–59 | ≥ 60 | ||||||||||||
N | PRR | χ2 | N | PRR | χ2 | N | PRR | χ2 | N | PRR | χ2 | N | PRR | χ2 | ||
Uterine neoplasms | Uterine polyp | 3 | 9.80 | 15.66 | – | – | – | – | – | – | – | – | – | 3 | 26.36 | 48.95 |
Uterine cancer | 3 | 5.85 | 7.67 | – | – | – | – | – | – | – | – | – | – | – | – | |
Uterine leiomyoma | 9 | 6.78 | 38.69 | – | – | – | – | – | – | 5 | 6.84 | 19.40 | 3 | 14.98 | 26.09 | |
Uterine disorders (excl neoplasms) | Endometrial hypertrophy | 3 | 27.74 | 52.32 | – | – | – | – | – | – | 3 | 58.11 | 113.03 | – | – | – |
Menopause related conditions | Postmenopausal haemorrhage | 4 | 12.03 | 30.05 | – | – | – | – | – | – | – | – | – | 3 | 14.16 | 24.43 |
