TABLE 2.
Patient disposition and primary reasons for discontinuation for patients with FBTCS (Studies 207/307/335 OLEx) or GTCS (Study 332 OLEx)
| FBTCS, n = 720 | GTCS, n = 138 | |
|---|---|---|
| Treated, n (%) | 720 (100.0) | 138 (100.0) 24 , 25 |
| Completed | 22 (3.1) | 78 (56.5) |
| Discontinued [overall] a | 548 (76.1) | 60 (43.5) 24 , 25 |
| Discontinued [excluding administrative/other reasons] | 340 (47.2) | 46 (33.3) |
| Ongoing b | 150 (20.8) | 0 (0.0) |
| Primary reason for discontinuation from therapy, n (%) | ||
| Administrative/other c | 208 (28.9) | 14 (10.1) |
| Patient choice | 117 (16.3) | 16 (11.6) |
| Inadequate therapeutic effect | 102 (14.2) | 7 (5.1) |
| AE | 79 (11.0) | 12 (8.7) |
| Withdrawal of consent | 2 (0.3) | 8 (5.8) |
| Lost to follow‐up | 16 (2.2) | 2 (1.4) |
| Pregnancy | 2 (0.3) | 1 (0.7) |
Abbreviations: AE, adverse event;FBTCS, focal to bilateral tonic‐clonic seizures; GTCS, generalized tonic‐clonic seizures; OLEx, open‐label extension.
For Study 307, most patients were listed as “discontinued” because Eisai stopped the study following the approval of perampanel.
At time of analysis.
“Administrative/other” reasons for discontinuation include sponsor request for study closure (Study 307, after receipt of a positive opinion for perampanel from the Committee for Medicinal Products for Human Use; Study 332 OLEx, after closure of sites in China at the end of the double‐blind study and these sites declined continued access to perampanel on the expanded access program); continuation of treatment on Study 341 (NCT02427607), 37 an expanded access program, or commercial perampanel; lack of efficacy; noncompliance with protocol; and no longer meeting inclusion criteria.