Table 2.
Signal strength of reports of Osimertinib at the System Organ Class (SOC) level in FAERS database.
| System organ class (SOC) | Osimertinib cases reporting SOC |
ROR (95% two-sided CI) |
PRR (χ2) |
IC (IC 025) |
EBGM (EBGM 05) |
|---|---|---|---|---|---|
| General disorders and administration site conditions | 6396 | 2.26 (2.17–2.35)* | 1.51 (1824.95) | 0.60 (0.55)* | 1.51 (1.46) |
| Respiratory, thoracic and mediastinal disorders | 1965 | 1.32 (1.26–1.39)* | 1.26 (125.75) | 0.34 (0.27)* | 1.26 (1.20) |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1957 | 2.62 (2.49–2.75)* | 2.32 (1595.83)* | 1.21 (1.14)* | 2.32 (2.21)* |
| Gastrointestinal disorders | 1380 | 0.66 (0.62–0.70) | 0.70 (214.75) | − 0.51 (− 0.59) | 0.70 (0.66) |
| Nervous system disorders | 1262 | 0.50 (0.47–0.53) | 0.56 (568.56) | − 0.85 (− 0.93) | 0.56 (0.52) |
| Skin and subcutaneous tissue disorders | 1155 | 0.62 (0.58–0.66) | 0.66 (240.22) | − 0.60 (− 0.69) | 0.66 (0.62) |
| Cardiac disorders | 1125 | 0.91 (0.86–0.97) | 0.92 (8.18) | − 0.12 (− 0.21) | 0.92 (0.87) |
| Vascular disorders | 1065 | 0.60 (0.56–0.64) | 0.64 (253.24) | − 0.64 (− 0.73) | 0.64 (0.60) |
| Investigations | 990 | 0.78(0.73–0.83) | 0.80 (57.25) | − 0.33 (− 0.42) | 0.80 (0.75) |
| Injury, poisoning and procedural complications | 926 | 0.23 (0.21–0.24) | 0.29 (2218.16) | − 1.77 (− 1.86) | 0.29 (0.27) |
| Musculoskeletal and connective tissue disorders | 786 | 0.56 (0.52–0.60) | 0.59 (248.34) | − 0.75 (− 0.86) | 0.59 (0.55) |
| Metabolism and nutrition disorders | 770 | 1.00 (0.93–1.07) | 1.00 (0.00) | − 0.01 (− 0.11) | 1.00 (0.93) |
| Infections and infestations | 760 | 0.60 (0.56–0.65) | 0.63 (186.18) | − 0.67 (− 0.78) | 0.63 (0.59) |
| Immune system disorders | 677 | 0.63 (0.58–0.68) | 0.65 (138.15) | − 0.62 (− 0.73) | 0.65 (0.6) |
| Blood and lymphatic system disorders | 573 | 1.09 (1.00–1.18) | 1.08 (3.68) | 0.11 (− 0.01) | 1.08 (0.99) |
| Hepatobiliary disorders | 487 | 1.74 (1.59–1.90)* | 1.70 (144.90) | 0.76 (0.63)* | 1.70 (1.55) |
| Psychiatric disorders | 417 | 0.27 (0.25–0.30) | 0.30 (788.24) | − 1.74 (− 1.89) | 0.30 (0.27) |
| Renal and urinary disorders | 282 | 0.37 (0.32–0.41) | 0.38 (302.13) | − 1.39 (− 1.56) | 0.38 (0.34) |
| Congenital, familial and genetic disorders | 251 | 4.10 (3.61–4.64)* | 4.02 (570.66)* | 1.98 (1.80)* | 4.01 (3.54)* |
| Eye disorders | 232 | 0.49 (0.43–0.56) | 0.50 (118.88) | − 0.99 (− 1.18) | 0.50 (0.44) |
| Reproductive system and breast disorders | 72 | 0.15 (0.12–0.19) | 0.15 (351.19) | − 2.70 (− 3.05) | 0.15 (0.12) |
| Endocrine disorders | 72 | 0.25 (0.20–0.32) | 0.26 (158.35) | − 1.96 (− 2.30) | 0.26 (0.20) |
| Ear and labyrinth disorders | 49 | 0.35(0.26–0.46) | 0.35 (59) | − 1.51 (− 1.93) | 0.35 (0.27) |
| Surgical and medical procedures | 31 | 0.08 (0.06–0.12) | 0.09 (314.21) | − 3.55 (− 4.07) | 0.09 (0.06) |
| Social circumstances | 29 | 0.23 (0.16–0.33) | 0.23 (76.47) | − 2.14 (− 2.68) | 0.23 (0.16) |
| Product issues | 14 | 0.03 (0.02–0.05) | 0.03 (452.88) | − 5.04 (− 5.81) | 0.03 (0.02) |
| Pregnancy, puerperium and perinatal conditions | 2 | 0.01 (0–0.04) | 0.01 (196.22) | − 6.62 (− 8.67) | 0.01 (0.00) |
ROR reporting odds ratio, CI confidence interval, PRR proportional reporting ratio, χ2 chi-squared, IC information component, IC 025 the lower limit of 95% CI of the IC, EBGM empirical Bayesian geometric mean, EBGM 05 the lower limit of 95% CI of EBGM.
*Indicates statistically significant signals in algorithm.