Table 2.
Signal strength of reports of niraparib at the System Organ Class (SOC) level in FAERS database.
| System organ class (SOC) | Niraparib cases reporting SOC | ROR (95% two-side Cl) | PRR (χ2) | IC (IC025) | EBGM (EBGM05) |
|---|---|---|---|---|---|
| General disorders and administration site conditions | 6849 | 2.23 (2.15–2.31)* | 1.51 (1919.11) | 0.59 (0.55) * | 1.51 (1.45) |
| Investigations | 6136 | 8.52 (8.21–8.83)* | 4.58 (19,236.96) * | 2.18 (2.14) * | 4.55 (4.39) * |
| Gastrointestinal disorders | 6100 | 4.93 (4.76–5.11)* | 2.88 (9118.11) * | 1.52 (1.48) * | 2.87 (2.77) * |
| Nervous system disorders | 4681 | 2.54 (2.45–2.64)* | 1.93 (2623.36) | 0.94 (0.89) * | 1.92 (1.85) |
| Injury, poisoning and procedural complications | 4303 | 1.40 (1.35–1.46)* | 1.25 (312.76) | 0.33 (0.28) * | 1.25 (1.21) |
| Psychiatric disorders | 3466 | 2.82 (2.71–2.93)* | 2.28 (2855.85) * | 1.19 (1.13) * | 2.28 (2.19) * |
| Vascular disorders | 3023 | 1.96 (1.88–2.04)* | 1.71 (1044.53) | 0.77 (0.71) * | 1.71 (1.64) |
| Cardiac disorders | 2679 | 2.37 (2.27–2.47)* | 2.05 (1623.36) * | 1.03 (0.97) * | 2.05 (1.96) |
| Respiratory, thoracic and mediastinal disorders | 2675 | 1.77 (1.69–1.85)* | 1.59 (687.24) | 0.67 (0.61) * | 1.59 (1.52) |
| Musculoskeletal and connective tissue disorders | 2557 | 2.04 (1.95–2.13)* | 1.81 (1049.19) | 0.85 (0.79) * | 1.81 (1.73) |
| Skin and subcutaneous tissue disorders | 2343 | 1.29 (1.23–1.35)* | 1.23 (121.58) | 0.30 (0.23) * | 1.23 (1.18) |
| Metabolism and nutrition disorders | 1999 | 2.69 (2.56–2.82)* | 2.4 (1750.42) * | 1.26 (1.19) * | 2.39 (2.28) * |
| Blood and lymphatic system disorders | 1945 | 3.81 (3.63–4.00)* | 3.34 (3340.09) * | 1.73 (1.66) * | 3.33 (3.17) * |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1941 | 2.19 (2.09–2.3)* | 1.99 (1045.46) | 0.99 (0.92) * | 1.99 (1.90) |
| Infections and infestations | 1583 | 1.25 (1.18–1.32)* | 1.21 (67.50) | 0.28 (0.20) * | 1.21 (1.15) |
| Surgical and medical procedures | 1271 | 3.54 (3.34–3.75)* | 3.26 (2053.40) * | 1.70 (1.61) * | 3.25 (3.07) * |
| Renal and urinary disorders | 1262 | 1.60 (1.51–1.70)* | 1.54 (255.62) | 0.62 (0.53) * | 1.54 (1.45) |
| Reproductive system and breast disorders | 677 | 1.31 (1.21–1.41)* | 1.29 (46.14) | 0.36 (0.25) * | 1.29 (1.19) |
| Eye disorders | 551 | 1.11 (1.02–1.21)* | 1.10 (5.53) | 0.14 (0.01) * | 1.10 (1.01) |
| Immune system disorders | 500 | 0.41 (0.38–0.45) | 0.44 (397.38) | − 1.19 (− 1.32) | 0.44 (0.40) |
| Hepatobiliary disorders | 425 | 1.36 (1.23–1.49)* | 1.34 (38.12) | 0.42 (0.28) * | 1.34 (1.22) |
| Social circumstances | 287 | 2.08 (1.85–2.33)* | 2.05 (155.59) * | 1.02 (0.85) * | 2.05 (1.82) |
| Ear and labyrinth disorders | 212 | 1.42 (1.24–1.62)* | 1.41 (25.58) | 0.49 (0.29) * | 1.41 (1.23) |
| Endocrine disorders | 171 | 0.55 (0.48–0.64) | 0.56 (60.68) | − 0.84 (− 1.06) | 0.56 (0.48) |
| Product issues | 91 | 0.18 (0.14–0.22) | 0.18 (347.2) | − 2.45 (− 2.76) | 0.18 (0.15) |
| Congenital, familial and genetic disorders | 19 | 0.28 (0.18–0.43) | 0.28 (35.93) | − 1.87 (− 2.53) | 0.28 (0.18) |
| Pregnancy, puerperium and perinatal conditions | 13 | 0.06 (0.03–0.10) | 0.06 (192.62) | − 4.05 (− 4.85) | 0.06 (0.04) |
*Indicates statistically significant signals in algorithm. ROR reporting odds ratio; CI confidence interval; PRR proportional reporting ratio; χ2, chi-squared; IC information component; IC025 the lower limit of 95% CI of the IC; EBGM empirical Bayesian geometric mean; EBGM05, the lower limit of 95% CI of EBGM.