Table 4.
Signal strength of AE reports not related with solriamfetol at the Preferred Term (PT) level in FAERS database(case number >10).
| SOC | Preferred Terms (PTs) | Solriamfetol Cases Reporting PT |
ROR(95 % two-sided CI) | PRR (χ2) | IC(IC025) | EBGM(EBGM05) |
|---|---|---|---|---|---|---|
| General disorders and administration site conditions | Drug ineffective | 374 | 4.78 (4.29–5.32) | 4.38 (999.80) | 2.13 (1.91) | 4.38 (3.94) |
| Injury, poisoning and procedural complications | Off label use | 158 | 2.64 (2.25–3.10) | 2.57 (153.95) | 1.36 (1.16) | 2.57 (2.19) |
| General disorders and administration site conditions | Therapeutic response decreased | 35 | 11.51 (8.25–16.07) | 11.41 (332.11) | 3.51 (2.52) | 11.39 (8.16) |
| Injury, poisoning and procedural complications | Product administration interrupted | 28 | 36.39 (25.07–52.84) | 36.12 (950.82) | 5.17 (3.56) | 35.92 (24.74) |
| Exposure during pregnancy | 26 | 6.57 (4.47–9.66) | 6.53 (121.76) | 2.71 (1.84) | 6.52 (4.43) | |
| General disorders and administration site conditions | Therapeutic response unexpected | 23 | 9.92 (6.58–14.95) | 9.86 (182.97) | 3.30 (2.19) | 9.85 (6.53) |
| Drug ineffective for unapproved indication | 23 | 6.11 (4.06–9.21) | 6.08 (97.65) | 2.60 (1.73) | 6.08 (4.03) | |
| Therapeutic response shortened | 20 | 7.77 (5.01–12.07) | 7.74 (117.27) | 2.95 (1.90) | 7.73 (4.98) | |
| Pre-existing condition improved | 18 | 53.28 (33.46–84.83) | 53.02 (911.04) | 5.72 (3.59) | 52.58 (33.03) | |
| Nervous system disorders | Narcolepsy | 14 | 140.05 (82.38–238.08) | 139.51 (1883.33) | 7.09 (4.17) | 136.49 (80.29) |
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.