TABLE 2.
Baseline demographics, epilepsy characteristics, and previous and ongoing medical conditions that may influence body weight (SS).
| Overall population | Seizure type subgroup | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| All (N = 209) | Sex | Age group | |||||||||
| Male (n = 113) | Female (n = 96) | 1 mo to <1 year (n = 13) | 1 to <2 years (n = 19) | 2 to <4 years (n = 11) | 4 to <8 years (n = 61) | 8 to <12 years (n = 52) | ≥12 years (n = 53) | Focal‐onset (n = 154) | Primary generalized/unknown (n = 55) | ||
| Age, mean (SD), years a | 7.9 (4.6) | 8.0 (4.3) | 7.8 (4.8) | 0.7 (0.2) | 1.4 (0.4) | 2.7 (0.6) | 5.7 (1.1) | 10.0 (1.1) | 13.7 (1.2) | 8.6 (4.3) | 6.1 (4.7) |
| Body weight, mean (SD), kg a | 30.7 (21.1) | 30.6 (18.5) | 30.9 (23.9) | 6.9 (2.0) | 9.9 (2.0) | 13.4 (2.5) | 21.4 (6.3) | 33.9 (11.4) | 55.2 (22.6) | 33.2 (21.0) | 23.9 (20.0) |
| BMI, mean (SD), kg/m2 | 18.1 (5.0) | 17.9 (4.2) | 18.3 (5.8) | 16.5 (2.7) | 16.1 (2.2) | 16.8 (2.4) | 16.3 (3.2) | 17.5 (3.8) | 21.9 (6.9) | 18.4 (5.2) | 17.1 (4.3) |
| Racial group, n (%) | |||||||||||
| White | 156 (74.6) | 82 (72.6) | 74 (77.1) | 10 (76.9) | 15 (78.9) | 11 (100.0) | 44 (72.1) | 38 (73.1) | 38 (71.7) | 107 (69.5) | 49 (89.1) |
| Other | 50 (23.9) | 29 (25.7) | 21 (21.9) | 3 (23.1) | 4 (21.1) | 0 | 16 (26.2) | 13 (25.0) | 14 (26.4) | 44 (28.6) | 6 (10.9) |
| Black | 3 (1.4) | 2 (1.8) | 1 (1.0) | 0 | 0 | 0 | 1 (1.6) | 1 (1.9) | 1 (1.9) | 3 (1.9) | 0 |
| Epilepsy history | |||||||||||
| Duration of epilepsy, mean (SD), years b | 4.7 (3.7) d | 5.1 (3.8) | 4.2 (3.6) e | 0.4 (0.3) f | 0.8 (0.5) | 2.0 (0.9) | 3.4 (1.7) | 6.0 (3.0) | 7.9 (4.1) | 5.0 (3.8) | 3.9 (3.5) g |
| Age at diagnosis, mean (SD), years | 3.3 (3.3) d | 3.0 (3.1) | 3.7 (3.6) e | 0.2 (0.3) f | 0.7 (0.5) | 0.8 (0.9) | 2.4 (1.8) | 4.0 (3.2) | 5.9 (4.0) | 3.7 (3.3) | 2.4 (3.2) g |
| Percentage of life with epilepsy, mean (SD), % c | 59.4(29.3) d | 64.1 (28.9) | 53.8 (28.8) e | 65.3 (32.7) f | 53.3 (30.2) | 71.2 (30.4) | 58.4 (28.3) | 61.1 (29.7) | 57.2 (28.9) | 58.1 (29.5) | 63.1 (28.6) g |
| Number of previous ASMs h | |||||||||||
| Median (Q1–Q3) | 2 (0–4) | 2 (1–3) | 1 (0–4) | 1 (0–2) | 1 (0–2) | 1 (0–5) | 2 (0–3) | 1.5 (0–4) | 3 (1–4) | 2 (1–4) | 1 (0–3) |
| 0 to 1, n (%) | 102 (48.8) | 51 (45.1) | 51 (53.1) | 9 (69.2) | 14 (73.7) | 6 (54.5) | 25 (41.0) | 26 (50.0) | 22 (41.5) | 69 (44.8) | 33 (60.0) |
| 2 to 3, n (%) | 54 (25.8) | 35 (31.0) | 19 (19.8) | 4 (30.8) | 4 (21.1) | 1 (9.1) | 22 (36.1) | 10 (19.2) | 13 (24.5) | 43 (27.9) | 11 (20.0) |
| ≥4, n (%) | 53 (25.4) | 27 (23.9) | 26 (27.1) | 0 | 1 (5.3) | 4 (36.4) | 14 (23.0) | 16 (30.8) | 18 (34.0) | 42 (27.3) | 11 (20.0) |
| Previous and ongoing medical conditions | |||||||||||
| Any previous and ongoing conditions, n (%) i | 189 (90.4) | 104 (92.0) | 85 (88.5) | 10(76.9) | 18 (94.7) | 11 (100) | 55 (90.2) | 44 (84.6) | 51 (96.2) | 138 (89.6) | 51 (92.7) |
| Gastrointestinal disorders | |||||||||||
| Any gastrointestinal disorder, n (%) j | 43 (20.6) | 22 (19.5) | 21 (21.9) | 4 (30.8) | 6 (31.6) | 7 (63.6) | 12 (19.7) | 8 (15.4) | 6 (11.3) | 28 (18.2) | 15 (27.3) |
| Gastrointestinal disorders reported by ≥5% of all patients, n (%) | |||||||||||
| Gastroesophageal reflux disease | 17 (8.1) | 8 (7.1) | 9 (9.4) | 2 (15.4) | 3 (15.8) | 4 (36.4) | 6 (9.8) | 1 (1.9) | 1 (1.9) | 9 (5.8) | 8 (14.5) |
| Constipation | 16 (7.7) | 8 (7.1) | 8 (8.3) | 0 | 2 (10.5) | 4 (36.4) | 4 (6.6) | 3 (5.8) | 3 (5.7) | 9 (5.8) | 7 (12.7) |
| Metabolism and nutrition disorders | |||||||||||
| Any metabolism and nutrition disorder, n (%) j | 26 (12.4) | 13 (11.5) | 13 (13.5) | 1 (7.7) | 1 (5.3) | 6 (54.5) | 7 (11.5) | 4 (7.7) | 7 (13.2) | 18 (11.7) | 8 (14.5) |
| Metabolism and nutrition disorders reported by ≥1% of all patients, n (%) | |||||||||||
| Feeding disorder | 4 (1.9) | 4 (3.5) | 0 | 1 (7.7) | 0 | 1 (9.1) | 1 (1.6) | 1 (1.9) | 0 | 2 (1.3) | 2 (3.6) |
| Obesity | 4 (1.9) | 2 (1.8) | 2 (2.1) | 0 | 0 | 1 (9.1) | 1 (1.6) | 0 | 2 (3.8) | 2 (1.3) | 2 (3.6) |
| Decreased appetite | 3 (1.4) | 0 | 3 (3.1) | 0 | 0 | 0 | 2 (3.3) | 1 (1.9) | 0 | 1 (0.6) | 2 (3.6) |
| Failure to thrive | 3 (1.4) | 2 (1.8) | 1 (1.0) | 0 | 0 | 1 (9.1) | 2 (3.3) | 0 | 0 | 2 (1.3) | 1 (1.8) |
| Metabolic acidosis | 2 (1.0) | 0 | 2 (2.1) | 0 | 0 | 0 | 1 (1.6) | 1 (1.9) | 0 | 1 (0.6) | 1 (1.8) |
Abbreviations: ASM, antiseizure medication; BMI, body mass index; BRV, brivaracetam; mo, month; SD, standard deviation; SS, safety set.
a
At BRV initiation in N01266.
b
Relative to date of diagnosis.
c
Percentage of life with epilepsy is calculated as epilepsy duration based on first diagnosis divided by age at informed consent * 100.
d
n = 208.
e
n = 95.
f
n = 12.
g
n = 54.
h
Previous ASMs are those taken before BRV and which stopped before the date of first study dose in N01266.
i
Includes both resolved and ongoing medical conditions at the day of first study dose in N01266.
j
System Organ Class (Medical Dictionary for Regulatory Activities, Version 18.1).