TABLE 7.
Top 20 positive preferred terms (PTs) for donanemab by report frequency in FAERS.
| PT | Number of reports | ROR (95% CI) | PRR (χ2) | IC025 | EBGM05 |
|---|---|---|---|---|---|
| Amyloid related imaging abnormality-oedema/effusion# | 95 | 2,673.58 (2,121.15–3,369.88) | 2,458.96 (188,622.95) | 6.18 | 1,576.62 |
| Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits a | 81 | 2,459.70 (1919.82–3,151.41) | 2,291.35 (151,840.45) | 5.94 | 1,464.49 |
| Headache a | 72 | 7.26 (5.72–9.21) | 6.88 (364.71) | 2.32 | 5.42 |
| Infusion related reaction a | 57 | 36.03 (27.60–47.04) | 34.34 (1841.71) | 4.05 | 26.22 |
| Amyloid related imaging abnormalities a | 37 | 5,069.82 (3,413.69–7,529.43) | 4,911.29 (123,202.94) | 4.69 | 2,243.18 |
| Cerebral haemorrhage a | 32 | 66.82 (46.98–95.04) | 65.04 (2006.01) | 3.95 | 45.44 |
| Flushing a | 28 | 24.10 (16.56–35.08) | 23.55 (603.93) | 3.18 | 16.15 |
| Confusional state% | 26 | 10.79 (7.32–15.92) | 10.58 (225.72) | 2.40 | 7.16 |
| Cerebral microhaemorrhage a | 22 | 1771.69 (1,123.76–2,793.19) | 1738.76 (32,715.08) | 3.85 | 944.38 |
| Brain oedema a | 19 | 99.50 (63.10–156.89) | 97.92 (1805.86) | 3.41 | 61.52 |
| Chills a | 19 | 9.32 (5.92–14.68) | 9.19 (138.82) | 2.05 | 5.84 |
| Cerebrovascular accident% | 18 | 8.81 (5.53–14.03) | 8.69 (122.56) | 1.96 | 5.45 |
| Seizure% | 16 | 6.30 (3.84–10.31) | 6.22 (70.26) | 1.54 | 3.80 |
| Back pain% | 15 | 3.74 (2.25–6.23) | 3.71 (29.79) | 0.94 | 2.23 |
| Blood pressure decreased a | 12 | 10.80 (6.12–19.08) | 10.70 (105.56) | 1.81 | 6.05 |
| Blood pressure increased a | 12 | 4.10 (2.32–7.24) | 4.07 (27.81) | 0.91 | 2.30 |
| Erythema a | 12 | 3.61 (2.04–6.37) | 3.58 (22.37) | 0.77 | 2.03 |
| Chest discomfort a | 9 | 4.87 (2.53–9.38) | 4.84 (27.43) | 0.89 | 2.51 |
| Anaphylactic reaction a | 8 | 7.12 (3.55–14.26) | 7.07 (41.73) | 1.11 | 3.53 |
| Feeling cold% | 7 | 15.16 (7.21–31.90) | 15.08 (91.93) | 1.42 | 7.16 |
a
PT, listed in the FDA, label; %, PT, reported in clinical trials or previous literature but not listed in the label. Abbreviations: PT, preferred term; ROR, reporting odds ratio; CI, confidence interval; IC025, lower limit of 95% CI, of IC; EBGM05, lower limit of 95% CI, of EBGM.