Table 4.
TEAEs since prior visit, by etiology (FAS)
| Patients, n (%) |
3 months | 6 months | 12 months | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Post-stroke epilepsy status | BTRE status | TBIE status | Post-stroke epilepsy status | BTRE status | TBIE status | Post-stroke epilepsy status | BTRE status | TBIE status | ||||||||||
| With post-stroke epilepsy n = 44 |
Without post-stroke epilepsy n = 1302 |
With BTRE n = 65 |
Without BTRE n = 1281 |
With TBIE n = 42 |
Without TBIE n = 1304 |
With post-stroke epilepsy n = 39 |
Without post-stroke epilepsy n = 1177 |
With BTRE n = 53 |
Without BTRE n = 1163 |
With TBIE n = 38 |
Without TBIE n = 1178 |
With post-stroke epilepsy n = 36 |
Without post-stroke epilepsy n = 1057 |
With BTRE n = 48 |
Without BTRE n = 1045 |
With TBIE n = 33 |
Without TBIE n = 1060 |
|
| Any TEAEs | 15 (34.1) | 313 (24.0) | 18 (27.7) | 310 (24.2) | 8 (19.0) | 320 (24.5) | 10 (25.6) | 157 (13.3) | 7 (13.2) | 160 (13.8) | 2 (5.3) | 165 (14.0) | 6 (16.7) | 84 (7.9) | 6 (12.5) | 84 (8.0) | 1 (3.0) | 89 (8.4) |
| Severity of TEAEsa,b | ||||||||||||||||||
| Mild | 7 (77.8)c | 110 (53.7)d | 8 (61.5)e | 109 (54.2)f | 3 (60.0)g | 114 (54.5)h | 5 (71.4)i | 55 (57.9)j | 3 (100.0)k | 57 (57.6)l | 2 (100.0)m | 58 (58.0)n | 4 (100.0)o | 23 (42.6)p | 1 (50.0)m | 26 (46.4)q | 1 (100.0)r | 26 (45.6)s |
| Moderate | 2 (22.2)c | 75 (36.6)d | 4 (30.8)e | 73 (36.3)f | 2 (40.0)g | 75 (35.9)h | 2 (28.6)i | 35 (36.8)j | 0 | 37 (37.4)l | 0 | 37 (37.0)n | 0 | 28 (51.9)p | 1 (50.0)m | 27 (48.2)q | 0 | 28 (49.1)s |
| Severe | 0 | 19 (9.3)d | 1 (7.7)e | 18 (9.0)f | 0 | 19 (9.1)h | 0 | 5 (5.3)j | 0 | 5 (5.1)l | 0 | 5 (5.0) | 0 | 3 (5.6)p | 0 | 3 (5.4)q | 0 | 3 (5.3)s |
| Life-threatening | 0 | 1 (0.5)d, t | 0 | 1 (0.5)f, t | 0 | 1 (0.5)h, t | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Psychiatric TEAEsu | 6 (13.6) | 76 (5.8) | 5 (7.7) | 77 (6.0) | 0 | 82 (6.3) | 1 (2.6) | 27 (2.3) | 3 (5.7) | 25 (2.1) | 0 | 28 (2.4) | 1 (2.8) | 25 (2.4) | 2 (4.2) | 24 (2.3) | 0 | 26 (2.5) |
| Cognitive TEAEs | 1 (2.3) | 40 (3.1) | 2 (3.1) | 39 (3.0) | 1 (2.4) | 40 (3.1) | 0 | 18 (1.5) | 1 (1.9) | 17 (1.5) | 0 | 18 (1.5) | 0 | 12 (1.1) | 1 (2.1) | 11 (1.1) | 0 | 12 (1.1) |
| Behavioral TEAEs | 4 (9.1) | 60 (4.6) | 3 (4.6) | 61 (4.8) | 2 (4.8) | 62 (4.8) | 1 (2.6) | 29 (2.5) | 1 (1.9) | 29 (2.5) | 0 | 30 (2.5) | 0 | 12 (1.1) | 1 (2.1) | 11 (1.1) | 0 | 12 (1.1) |
| TEAEsv,w reported by ≥ 3% of patients at any time point | ||||||||||||||||||
| Depression | 3 (6.8) | 32 (2.5) | 3 (4.6) | 32 (2.5) | 0 | 35 (2.7) | 0 | 3 (0.3) | 0 | 3 (0.3) | 0 | 3 (0.3) | 1 (2.8) | 3 (0.3) | 0 | 4 (0.4) | 0 | 4 (0.4) |
| Aggression | 2 (4.5) | 18 (1.4) | 2 (3.1) | 18 (1.4) | 0 | 20 (1.5) | 0 | 11 (0.9) | 1 (1.9) | 10 (0.9) | 0 | 11 (0.9) | 0 | 6 (0.6) | 0 | 6 (0.6) | 0 | 6 (0.6) |
| Fatigue | 2 (4.5) | 58 (4.5) | 5 (7.7) | 55 (4.3) | 2 (4.8) | 58 (4.4) | 1 (2.6) | 15 (1.3) | 1 (1.9) | 15 (1.3) | 0 | 16 (1.4) | 1 (2.8) | 8 (0.8) | 1 (2.1) | 8 (0.8) | 0 | 9 (0.8) |
| Somnolence | 2 (4.5) | 38 (2.9) | 1 (1.5) | 39 (3.0) | 0 | 40 (3.1) | 3 (7.7) | 23 (2.0) | 0 | 26 (2.2) | 0 | 26 (2.2) | 1 (2.8) | 15 (1.4) | 0 | 16 (1.5) | 0 | 16 (1.5) |
| Irritability | 1 (2.3) | 45 (3.5) | 2 (3.1) | 44 (3.4) | 2 (4.8) | 44 (3.4) | 1 (2.6) | 20 (1.7) | 0 | 21 (1.8) | 0 | 21 (1.8) | 0 | 5 (0.5) | 0 | 5 (0.5) | 0 | 5 (0.5) |
| Dizziness | 0 | 48 (3.7) | 2 (3.1) | 46 (3.6) | 1 (2.4) | 47 (3.6) | 0 | 12 (1.0) | 1 (1.9) | 11 (0.9) | 0 | 12 (1.0) | 0 | 6 (0.6) | 0 | 6 (0.6) | 0 | 6 (0.6) |
AE adverse event, BTRE brain tumor–related epilepsy, FAS full analysis set, TBIE traumatic brain injury–related epilepsy, TEAE treatment-emergent adverse event
aPatients with reported severity; bExcluding patients who had an AE that was not further described; cn = 9; dn = 205; en = 13; fn = 201; gn = 5; hn = 209; in = 7; jn = 95; kn = 3; ln = 99; mn = 2; nn = 100; on = 4; pn = 54; qn = 56; rn = 1; sn = 57; tOne TEAE of suicide was documented as life-threatening; uBehavioral TEAEs that fulfilled the criteria for psychiatric TEAEs were included in the psychiatric TEAEs category; vMedical Dictionary for Regulatory Activities version 24.1; wPatients with recorded AE that was not further described at 3 months/6 months/12 months: patients with post-stroke epilepsy, 3 (6.8%)/2 (5.1%)/1 (2.8%); patients without post-stroke epilepsy, 26 (2.0%)/38 (3.2%)/16 (1.5%); patients with BTRE, 1 (1.5%)/1 (1.9%)/2 (4.2%); patients without BTRE, 28 (2.2%)/39 (3.4%)/15 (1.4%); patients with TBIE 2, (4.8%)/1 (2.6%)/1 (3.0%), patients without TBIE, 27 (2.1%)/39 (3.3%)/16 (1.5%)