Table 3.
TEAEs with perampanel and withdrawal from trials
| TEAEs | Dose of perampanel | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 2 mg | 4 mg | 8 mg | |||||||
| No. of studies | Sample size (perampanel/placebo) | Risk ratio (95 % CI) | No. of studies | Sample size (perampanel/placebo) | Risk ratio (95 % CI) | No. of studies | Sample size (perampanel/placebo) | Risk ratio (95 % CI) | |
| Dizziness | 1 | 180/185 | 1.03 (0.55–1.91) | 2 | 274/236 | 1.29 (0.69–2.41) | 3 | 431/442 | 3.44 (2.48–4.77) |
| Somnolence | 1 | 180/185 | 1.88 (0.96–3.69) | 2 | 274/236 | 1.19 (0.66–2.17) | 3 | 431/442 | 2.17 (1.19–3.93) |
| Headache | 1 | 180/185 | 1.03 (0.53–1.99) | 2 | 274/236 | 1.05 (0.61–1.80) | 3 | 431/442 | 1.00 (0.68–1.46) |
| Fatigue | 1 | 180/185 | 1.64 (0.55–4.93) | 2 | 274/236 | 1.85 (0.69–4.97) | 2 | 298/321 | 1.73 (0.95–3.14) |
| Nasopharyngitis | 1 | 180/185 | 2.40 (0.63–9.13) | 2 | 274/236 | 0.76 (0.04–13.84) | 1 | 169/185 | 1.09 (0.22–5.35) |
| Worsening seizures | 1 | 180/185 | 0.73 (0.43–1.25) | 1 | 172/185 | 0.54 (0.29–0.99) | 3 | 431/442 | 0.63 (0.42–0.93) |
| Fall | – | – | – | – | – | – | 1 | 133/121 | 1.48 (0.63–3.44) |
| Irritability | – | – | – | – | – | – | 1 | 133/121 | 1.52 (0.57–4.05) |
| Ataxia | – | – | – | – | – | – | 1 | 133/121 | 15.48 (0.90–265.34) |
| Upper respiratory tract infection | 1 | 180/185 | 2.26 (0.80–6.38) | 1 | 172/185 | 1.29 (0.40–4.15) | 1 | 169/185 | 0.66 (0.16–2.71) |
| Gait disturbance | 1 | 180/185 | 0.51 (0.05–5.62) | 1 | 172/185 | 1.08 (0.15–7.55) | 1 | 169/185 | 4.93 (1.08–22.48) |
| Sleep disorder | – | – | – | – | – | – | 1 | 129/136 | 3.16 (0.33–30.02) |
| Anxiety | – | – | – | – | – | – | 1 | 129/136 | 5.27 (0.26–108.72) |
| Aggression | – | – | – | – | – | – | 1 | 129/136 | 2.11 (0.19–22.97) |
| Confusional state | – | – | – | – | – | – | 1 | 129/136 | Not estimablea |
| Anger | – | – | – | – | – | – | 1 | 129/136 | Not estimablea |
| Withdrawal | |||||||||
| Any cause | 1 | 180/185 | 1.41 (0.81–2.45) | 2 | 274/236 | 0.85 (0.49–1.48) | 3 | 431/442 | 1.31 (0.93–1.85) |
| Adverse events | 1 | 180/185 | 1.71 (0.64–4.62) | 2 | 274/236 | 0.94 (0.39–2.27) | 3 | 431/442 | 1.82 (1.01–3.25) |
| Lack of therapeutic effect | 1 | 180/185 | 7.19 (0.37–138.28) | 1 | 172/185 | Not estimablea | 3 | 431/442 | 0.57 (0.09–3.48) |
| TEAEs | Dose of perampanel | ||||
|---|---|---|---|---|---|
| 12 mg | Overall | ||||
| No. of studies | Sample size (perampanel/placebo) | Risk ratio (95 % CI) | Sample size (perampanel/placebo) | Risk ratio (95 % CI) | |
| Dizziness | 3 | 293/267 | 4.94 (3.27–7.48) | 1178/503 | 2.86 (2.16, 3.79) |
| Somnolence | 3 | 293/267 | 3.11 (0.81–11.97) | 1178/503 | 1.96 (1.40, 2.76) |
| Headache | 3 | 293/267 | 1.04 (0.67–1.60) | 1178/503 | 0.99 (0.74, 1.33) |
| Fatigue | 2 | 159/146 | 1.25 (0.34–4.49) | 911/382 | 1.54 (0.96, 2.45) |
| Nasopharyngitis | – | – | – | 623/236 | 0.88 (0.41, 1.90) |
| Worsening seizures | 2 | 255/257 | 0.74 (0.44–1.24) | 1038/442 | 0.67 (0.49, 0.91) |
| Fall | 1 | 134/121 | 1.92 (0.86–4.29) | 267/121 | 1.70 (0.80, 3.60) |
| Irritability | 1 | 134/121 | 2.86 (1.18–6.92) | 267/121 | 2.19 (0.93, 5.14) |
| Ataxia | 1 | 134/121 | 29.82 (1.81–491.80) | 267/121 | 22.31 (1.37, 363.80) |
| Upper respiratory tract infection | – | – | – | 521/185 | 1.42 (0.54, 3.73) |
| Gait disturbance | – | – | – | 521/185 | 2.13 (0.48, 9.43) |
| Sleep disorder | 1 | 121/136 | 2.25 (0.21–24.48) | 250/136 | 2.72 (0.32, 23.05) |
| Anxiety | 1 | 121/136 | 5.61 (0.27–115.81) | 250/136 | 4.91 (0.27, 90.56) |
| Aggression | 1 | 121/136 | 1.12 (0.07–17.78) | 250/136 | 1.63 (0.17, 15.54) |
| Confusional state | 1 | 121/136 | 7.86 (0.41–150.66) | 250/136 | 3.82 (0.20, 73.43) |
| Anger | 1 | 121/136 | 5.61 (0.27–115.81) | 250/136 | 2.73 (0.13, 56.44) |
| Withdrawal | |||||
| Any cause | 3 | 293/267 | 1.78 (1.11–2.87) | 1178/503 | 1.35 (1.02, 1.78) |
| Adverse events | 3 | 293/267 | 3.18 (1.18–8.58) | 1178/503 | 2.05 (1.30, 3.25) |
| Lack of therapeutic effect | 2 | 255/257 | 0.97 (0.20–4.76) | 1038/442 | 0.99 (0.26, 3.82) |
TEAEs treatment-emergent adverse events
aZero count for both the perampanel and placebo groups