Table 3

Adverse events considered possibly related to treatment

IFN-β-1a (n=10) (total)Placebo (n=8)* (total)
*One patient who was originally assigned to the placebo group was removed prior to the analysis (for details see “study population and patient disposal”). This patient was removed from the efficacy analysis but not from analysis of side effects.
IFN, interferon.
At least one adverse event10 (100%) 5 (63%)
Anaemia 2 (20%)
Headache 2 (20%) 2 (25%)
Influenza-like symptoms 3 (30%) 2 (25%)
Injection site inflammation 5 (50%)
Injection site pain 3 (30%) 2 (25%)
Injection site reaction 2 (20%)
Nausea 2 (20%) 1 (13%)
Pain 2 (20%)
Rash 2 (20%) 1 (13%)
Other (in one patient per group)14 5
Total3713