Table 3.
Detected signals for drospirenone-containing oral contraceptives by WHO-ART code PT and labelling
| No | Adverse event (PT) | The number of AE | PRR* | ROR* | IC025 | Χ2 | Label | ||
| Korea | USA | UK | |||||||
| Satisfying three criteria | |||||||||
| 1 | Xerophthalmia | 6 | 99.90† | 99.9† | 0.17† | 13.74 | N | N | Y |
| 2 | Endometriosis | 11 | 99.90† | 99.9† | 0.54† | 25.20 | Y | N | N |
| 3 | Thrombosis | 6 | 99.90† | 99.9† | 0.17† | 13.74 | Y | Y | Y |
| 4 | Varicose vein | 6 | 99.90† | 99.9† | 0.17† | 13.74 | Y | Y | Y |
| 5 | IUD complication | 5 | 99.90† | 99.9† | 0.05† | 11.45 | N | N | N |
| 6 | Weight decrease | 10 | 22.89† | 28.69† | 0.39† | 19.05 | Y | Y | Y |
| 7 | Pulmonary embolism | 10 | 11.44† | 2.40† | 0.29† | 15.90 | Y | Y | Y |
| 8 | Anxiety | 19 | 10.87† | 18.25† | 0.58† | 29.68 | Y | Y | N |
| 9 | Uterine haemorrhage | 23 | 10.53† | 7.22† | 0.65† | 35.50 | Y | Y | Y |
| 10 | Chloasma | 14 | 4.58† | 6.57† | 0.20† | 13.07 | Y | Y | Y |
| 11 | Alopecia | 20 | 4.16† | 4.18† | 0.30† | 17.09 | Y | Y | Y |
| 12 | Dyspnoea | 22 | 3.87† | 4.02† | 0.30† | 17.47 | N | N | N |
| 13 | Depression | 36 | 3.43† | 3.17† | 0.39† | 24.96 | Y | Y | Y |
| 14 | Appetite increased | 17 | 3.24† | 3.12† | 0.12† | 10.94 | Y | Y | Y |
| 15 | Chest pain | 27 | 2.94† | 3.26† | 0.23† | 15.21 | N | N | N |
| 16 | Temperature changed sensation | 18 | 2.94† | 3.02† | 0.09† | 10.13 | N | N | Y |
| 17 | Migraine | 20 | 2.69† | 3.58† | 0.08† | 9.81 | Y | Y | Y |
| 18 | Breast pain | 21 | 2.53† | 2.91† | 0.35† | 27.98 | Y | Y | Y |
| 19 | Somnolence | 20 | 2.41† | 3.75† | 0.01† | 8.06 | Y | N | Y |
| 20 | Pruritus | 41 | 2.41† | 2.60† | 0.22† | 16.54 | Y | Y | Y |
| 21 | Fatigue | 21 | 2.40† | 2.53† | 0.02† | 8.42 | N | N | N |
| 22 | Headache | 132 | 2.34† | 2.13† | 0.43† | 51.35 | Y | Y | Y |
| Satisfying two criteria | |||||||||
| 23 | Hypertrichosis | 3 | 99.9† | 99.9† | −0.32 | 6.87 | Y | Y | Y |
| 24 | Urinary incontinence | 3 | 99.9† | 99.9† | −0.32 | 6.87 | Y | N | N |
| 25 | Skin exfoliation | 3 | 99.9† | 99.9† | −0.32 | 6.87 | Y | N | Y |
| 26 | Pneumothorax | 4 | 99.9† | 99.9† | −0.11 | 9.16 | N | N | N |
| 27 | Cerebral infarction | 4 | 99.9† | 99.9† | −0.11 | 9.16 | Y | Y | Y |
| 28 | Thromboembolism | 3 | 99.9† | 99.9† | −0.32 | 6.87 | Y | Y | Y |
| 29 | Osteoporosis | 3 | 99.9† | 99.9† | −0.32 | 6.87 | N | N | N |
| 30 | Candidiasis | 3 | 99.9† | 99.9† | −0.32 | 6.87 | Y | Y | N |
| 31 | Hepatic function abnormal | 5 | 11.44† | 7.58† | −0.11 | 7.95 | Y | N | Y |
| 32 | Pallor | 4 | 9.16† | 99.9† | −0.29 | 5.81 | N | N | N |
| 33 | Hyperlipidaemia | 4 | 9.16† | 6.10† | −0.29 | 5.81 | Y | Y | N |
| 34 | Deep vein thrombophlebitis | 4 | 9.16† | 4.06† | −0.29 | 5.81 | N | N | N |
| 35 | Tinnitus | 6 | 6.87† | 2.74† | −0.10 | 7.52 | N | N | N |
| 36 | Frequent urination | 8 | 4.58† | 11.35† | −0.06 | 7.46 | N | N | N |
| 37 | Cystitis | 7 | 4.01† | 2.92† | −0.18 | 5.75 | Y | Y | N |
| 38 | Emotional lability | 10 | 2.86† | 2.18† | −0.16 | 5.39 | Y | Y | Y |
| 39 | Dyspepsia | 101 | 2.60† | 1.53 | 0.46† | 47.26 | Y | Y | Y |
| 40 | Acne | 95 | 2.42† | 1.99 | 0.40† | 38.99 | Y | Y | Y |
| 41 | Weight increase | 62 | 2.41† | 1.43 | 0.32† | 25.08 | Y | Y | Y |
| 42 | Breast pain female | 21 | 2.40† | 0.81 | 0.02† | 8.42 | Y | Y | Y |
| 43 | Asthenia | 17 | 2.29† | 3.41† | −0.08 | 6.19 | Y | Y | Y |
| 44 | Pain | 18 | 2.29† | 2.56† | −0.06 | 6.55 | Y | Y | Y |
| 45 | Paresthesia | 13 | 2.29† | 2.11† | −0.18 | 4.73 | N | N | Y |
| 46 | Urticaria | 49 | 2.29† | 1.77 | 0.23† | 17.93 | Y | Y | N |
| 47 | Nausea | 296 | 2.16† | 1.82 | 0.47† | 100.69 | Y | Y | Y |
| Satisfying one criterion | |||||||||
| 48 | Myalgia | 10 | 2.54† | 1.03 | −0.23 | 4.44 | N | N | Y |
| 49 | Insomnia | 21 | 2.18† | 1.95 | −0.04 | 6.93 | N | N | Y |
| 50 | Oedema generalised | 15 | 2.02† | 1.36 | −0.21 | 4.11 | Y | Y | Y |
| 51 | Vaginitis | 15 | 2.45† | 1.46 | −0.08 | 6.24 | Y | Y | Y |
| 52 | Candidiasis genital | 5 | 5.72† | 1.38 | −0.26 | 5.57 | Y | Y | Y |
| 53 | Dizziness | 82 | 1.90 | 1.47 | 0.20† | 19.29 | Y | Y | Y |
| 54 | Vomiting | 136 | 1.55 | 1.51 | 0.12† | 16.25 | Y | Y | Y |
PRR: PRR ≥2, χ2 ≥4 and number of AE ≥3. ROR: ROR ≥2, χ2 ≥4 and number of AE ≥3. IC: underlimit of 95% CI ≥0.
*If the number of AE of interest with all other drugs is 0, the PRR and ROR were set at 99.9 arbitrarily since the values cannot be computed.
†Satisfies the criteria.
AE, adverse event; IC, information component; IUD, intrauterine device; PRR, proportional reporting ratio; PT, preferred term; ROR, reporting OR; WHO-ART, WHO Adverse Reaction Terminology.