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Table 2 Summary of safety data at time of unblinding (ITT population)

From: Masitinib treatment in patients with progressive multiple sclerosis: a randomized pilot study

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%)

  1. 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.