Table 2

Summary of safety data at time of unblinding (ITT population)
Number (%) of patients with Masitinib (N = 27) Placebo (N = 8)
At least one AE (all) 22 (81.5%) 6 (75.0%)
At least one AE (masitinib related) 19 (70.4%) N/A
Severe AE (all) 8 (29.6%) 1 (12.5%)
Severe AE (masitinib related) 7 (26.0%) N/A
Serious AE (all) 9 (33.3%) 2 (25.0%)
Serious AE (masitinib related) 4 (14.8%) N/A
Death (all) 0 (0.0%) 0 (0.0%)
AE leading to permanent discontinuation (all) 7 (26.0%) 0 (0.0%)

All = regardless of causality. Masitinib related = suspected or not assessable. N = number of patients, intent-to-treat population. N/A = not applicable. ITT = intent-to-treat.

Vermersch et al.

Vermersch et al. BMC Neurology 2012 12:36   doi:10.1186/1471-2377-12-36

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