Table 3.
Signal Strength of AEs of Olaparib at the System Organ Class (SOC) Level in FAERS Database
| System Organ Class (SOC) | Olaparib Cases Reporting SOC | ROR (95% Two-Sided CI) | PRR (95% Two-Sided CI) | χ2 | IC (IC025) | EBGM (EBGM05) |
|---|---|---|---|---|---|---|
| General disorders and administration site conditions | 3095 | 1.45 (1.38–1.53) | 1.23 (1.20–1.27) | 226.57 | 0.30 (0.24) | 1.23 (1.18) |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1862 | 6.84 (6.48–7.22) | 5.14 (4.95–5.34) | 6559.87 | 2.36 (2.28) | 5.13 (4.86) |
| Gastrointestinal disorders | 1567 | 1.47 (1.38–1.55) | 1.35 (1.29–1.41) | 174.76 | 0.43 (0.35) | 1.35 (1.28) |
| Blood and lymphatic system disorders | 1485 | 6.08 (5.74–0.6.45) | 4.91 (4.69–5.13) | 4828.85 | 2.29 (2.20) | 4.89 (4.61) |
| Investigations | 1101 | 1.56 (1.46–1.67) | 1.46 (1.39–1.55) | 183.67 | 0.55 (0.45) | 1.46 (1.37) |
| Injury, poisoning and procedural complications | 1001 | 0.52 (0.49–0.56) | 0.60 (0.56–0.63) | 372.34 | −0.75 (−0.84) | 0.60 (0.56) |
| Nervous system disorders | 830 | 0.54 (0.49–0.58) | 0.60 (0.56–0.63) | 290.93 | −0.75 (−0.85) | 0.60 (0.55) |
| Respiratory, thoracic and mediastinal disorders | 814 | 0.86 (0.80–0.92) | 0.88 (0.82–0.93) | 16.75 | −0.19 (−.30) | 0.88 (0.81) |
| Vascular disorders | 562 | 0.50 (0.45–0.54) | 0.54 (0.50–0.58) | 262.21 | −0.89 (−1.01) | 0.54 (0.50) |
| Musculoskeletal and connective tissue disorders | 530 | 0.62 (0.57–0.68) | 0.65 (0.60–0.70) | 113.47 | −0.62 (−0.75) | 0.65 (0.60) |
| Cardiac disorders | 519 | 0.65 (0.59–0.71) | 0.67 (0.62–0.73) | 92.76 | −0.57 (−0.70) | 0.67 (0.62) |
| Skin and subcutaneous tissue disorders | 514 | 0.44 (0.41–0.49) | 0.49 (0.45–0.53) | 327.09 | −1.03 (−1.16) | 0.49 (0.45) |
| Infections and infestations | 485 | 0.65 (0.59–0.72) | 0.68 (0.63–0.74) | 83.199 | −0.56 (−0.70) | 0.68 (0.62) |
| Metabolism and nutrition disorders | 476 | 1.01 (0.92–1.11) | 1.01 (0.93–1.10) | 0.08 | 0.02 (−0.12) | 1.01 (0.92) |
| Psychiatric disorders | 361 | 0.41 (0.36–0.45) | 0.44 (0.40–0.49) | 297.12 | −1.19 (−1.34) | 0.44 (0.39) |
| Renal and urinary disorders | 344 | 0.83 (0.74–0.93) | 0.84 (0.76–0.93) | 11.36 | −0.25 (−0.42) | 0.84 (0.75) |
| Immune system disorders | 326 | 0.52 (0.46–0.58) | 0.54 (0.49–0.60) | 138.32 | −0.88 (−1.05) | 0.54 (0.49) |
| Reproductive system and breast disorders | 310 | 1.37 (1.22–1.53) | 1.35 (1.21–1.50) | 29.01 | 0.43 (0.26) | 1.35 (1.20) |
| Hepatobiliary disorders | 275 | 1.75 (1.55–1.97) | 1.72 (1.53–1.93) | 84.36 | 0.78 (0.59) | 1.72 (1.52) |
| Eye disorders | 93 | 0.33 (0.26–0.40) | 0.34 (0.28–0.41) | 125.98 | −1.56 (−1.88) | 0.34 (0.28) |
| Surgical and medical procedures | 58 | 0.26 (0.20–0.34) | 0.27 (0.21–0.35) | 118.68 | −1.89 (−2.28) | 0.27 (0.21) |
| Endocrine disorders | 47 | 0.27 (0.20–0.36) | 0.28 (0.21–0.37) | 90.25 | −1.84 (−2.27) | 0.28 (0.21) |
| Congenital, familial and genetic disorders | 45 | 1.21 (0.90–1.62) | 1.20 (0.90–1.61) | 1.57 | 0.27 (−0.20) | 1.20 (0.90) |
| Ear and labyrinth disorders | 32 | 0.38 (0.27–0.54) | 0.38 (0.27–0.54) | 32.02 | −1.38 (−1.91) | 0.38 (0.27) |
| Product issues | 20 | 0.07 (0.05–0.11) | 0.08 (0.05–0.12) | 236.92 | −3.73 (−4.38) | 0.08 (0.05) |
| Social circumstances | 13 | 0.19 (0.11–0.32) | 0.19 (0.11–0.32) | 45.89 | −2.41 (−3.23) | 0.19 (0.11) |
| Pregnancy, puerperium and perinatal conditions | 4 | 0.03 (0.01–0.09) | 0.04 (0.01–0.09) | 108.09 | −4.83 (−6.29) | 0.04 (0.01) |
Notes: Bold indicates statistically significant signals in four algorithms.
Abbreviations: ROR, reporting odds ratio; CI, confidence interval; PRR, proportional reporting ratio; χ2, chi-squared; IC, information component; EBGM, empirical Bayesian geometric mean.