Serious adverse events occurring in more than one patient by body system in 275 patients.

<p>N, number of patients; n, number of events; %, percentage based on N = 275.</p

Overview of numbers and percentages of mild, moderate, and severe adverse events according to relationship to INFb-1a treatment.

<p>Overview of numbers and percentages of mild, moderate, and severe adverse events according to relationship to INFb-1a treatment.</p

Most common likely or definitely INFb-1a-related adverse events by body system in 275 patients.

<p>N, number of patients; n, number of events;</p><p>*, in at least 4 patients; totalling 371 (95.6%);</p>†<p>, patients could have events in more than one category.</p

Overview of adverse events in 275 patients from the safety analysis set.

<p>N, number of patients; n, number of AEs; AE, adverse event;</p><p>*, patients could appear in more than one category;</p>†<p>, not related, unlikely related or assessment missing;</p>‡<p>, likely related or definitely related;</p>#<p>, two AEs in one patient were reported as leading to death.</p

Incidences of most common adverse events as reported in the pivotal phase III study (Jacobs et a. 1996), the dose-comparing phase IIIb study (Clanet et al. 2002), an observational phase IV study (Fernandez et al. 2003), the SPC text, and as found in the present study.

<p>SPC, Summary of Product Characteristics; n.m.f., not more frequent than in placebo-treated patients (Jacobs et al. 1996).</p

Adverse events leading to withdrawal in more than one patient presented by body system in 275 patients.

<p>N, number of patients; n, number of events.</p

Correlations between cognitive scores and working hours.

<p>Max., maximum; *, P<0.04; all other P values >0.125.</p

Work-related questions.

<p>Work-related questions.</p

Correlations between confounding variables and HRQoL, and working hours.

<p>Max., maximum;</p><p>*P<0.005;</p><p>**P<0.05.</p

Mean (SD) cognitive domain scores in patients and in the normative data set.

<p>Mean (SD) cognitive domain scores in patients and in the normative data set.</p