Table 2.
Signal strength of reports of solriamfetol at the System Organ Class (SOC) level in FAERS database.
| System Organ Class(SOC) | Solriamfetol Cases Reporting SOC |
ROR(95 % two-sided CI) | PRR (χ2) | IC(IC025) | EBGM(EBGM05) |
|---|---|---|---|---|---|
| Psychiatric disorders | 392 | 3.03 (2.72–3.37) | 2.76 (460.64) | 1.46 (1.31) | 2.75 (2.48) |
| Nervous system disorders | 363 | 1.85 (1.65–2.06) | 1.74 (123.23) | 0.80 (0.72) | 1.74 (1.56) |
| Endocrine disorders | 17 | 1.77 (1.10–2.85) | 1.77 (5.66) | 0.82 (0.51) | 1.77 (1.10) |
| General disorders and administration site conditions | 761 | 1.66 (1.53–1.81) | 1.49 (148.45) | 0.58 (0.53) | 1.49 (1.37) |
| Pregnancy, puerperium and perinatal conditions | 18 | 1.53 (0.96–2.43) | 1.53 (3.29) | 0.61 (0.38) | 1.53 (0.96) |
| Cardiac disorders | 90 | 1.41 (1.14–1.74) | 1.40 (10.46) | 0.48 (0.39) | 1.40 (1.13) |
| Investigations | 180 | 1.14 (0.98–1.33) | 1.14 (3.09) | 0.18 (0.16) | 1.14 (0.98) |
| Immune system disorders | 51 | 1.09 (0.82–1.43) | 1.09 (0.35) | 0.12 (0.09) | 1.09 (0.82) |
| Social circumstances | 18 | 1.02 (0.64–1.63) | 1.02 (0.01) | 0.03 (0.02) | 1.02 (0.64) |
| Congenital, familial and genetic disorders | 8 | 0.99 (0.50–1.99) | 0.99 (0.00) | −0.01 (−0.02) | 0.99 (0.50) |
| Ear and labyrinth disorders | 14 | 0.93 (0.55–1.57) | 0.93 (0.08) | −0.11 (−0.18) | 0.93 (0.55) |
| Gastrointestinal disorders | 180 | 0.90 (0.77–1.04) | 0.90 (1.94) | −0.14 (−0.17) | 0.90 (0.78) |
| Surgical and medical procedures | 45 | 0.85 (0.63–1.14) | 0.85 (1.25) | −0.24 (−0.32) | 0.85 (0.63) |
| Metabolism and nutrition disorders | 56 | 0.84 (0.65–1.10) | 0.84 (1.64) | −0.24 (−0.32) | 0.84 (0.65) |
| Vascular disorders | 57 | 0.82 (0.63–1.07) | 0.82 (2.22) | −0.28 (−0.36) | 0.82 (0.63) |
| Injury, poisoning and procedural complications | 304 | 0.82 (0.73–0.92) | 0.84 (10.88) | −0.26 (−0.29) | 0.84 (0.74) |
| Respiratory, thoracic and mediastinal disorders | 77 | 0.61 (0.49–0.77) | 0.62 (18.11) | −0.68 (−0.85) | 0.62 (0.50) |
| Reproductive system and breast disorders | 13 | 0.61 (0.36–1.06) | 0.61 (3.18) | −0.70 (−1.21) | 0.61 (0.36) |
| Skin and subcutaneous tissue disorders | 86 | 0.54 (0.44–0.67) | 0.56 (32.13) | −0.85 (−1.05) | 0.56 (0.45) |
| Renal and urinary disorders | 30 | 0.49 (0.34–0.71) | 0.50 (15.41) | −1.00 (−1.44) | 0.50 (0.35) |
| Musculoskeletal and connective tissue disorders | 63 | 0.49 (0.38–0.62) | 0.50 (33.56) | −1.01 (−1.30) | 0.50 (0.39) |
| Hepatobiliary disorders | 13 | 0.46 (0.27–0.80) | 0.46 (8.08) | −1.10 (−1.90) | 0.47 (0.27) |
| Eye disorders | 22 | 0.41 (0.27–0.62) | 0.41 (18.60) | −1.27 (−1.94) | 0.41 (0.27) |
| Infections and infestations | 51 | 0.29 (0.22–0.39) | 0.31 (84.63) | −1.70 (−2.25) | 0.31 (0.23) |
| Product issues | 8 | 0.12 (0.06–0.25) | 0.13 (49.40) | −2.98 (−5.97) | 0.13 (0.06) |
| Blood and lymphatic system disorders | 3 | 0.05 (0.02–0.16) | 0.05 (50.77) | −4.21 (−13.07) | 0.05 (0.02) |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 7 | 0.05 (0.02–0.11) | 0.05 (122.78) | −4.22 (−8.87) | 0.05 (0.03) |
ROR, reporting odds ratio; CI, confidence interval; PRR, proportional reporting ratio; χ2, chi-information component; 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.