Table 2. Clinically relevant adverse events (treatment and possibly treatment-related).

ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase.

Systemic class
of adverse event
Adverse eventNumber of
patients affected
Dose group (1 = low dose,
2 = high dose) and time
of adverse events
after Rheumavax
Blood/bone marrowLymphopenia (0.5 × 109 to
0.9 × 109/liter)
31 (day 30), 2 (day 30),
2 (day 90)
Leukopenia (3.9 × 109 to 3.0 × 109/liter)31 (day 30), 2 (day 60), 2 (day 60)
Neutropenia (1.9 × 109 to 1.5 × 109/liter)22 (day 30), 2 (day 60)
Hemoglobin (100–134 g/liter)32 (days 30, 60, 90), 2 (day 90),
2 (days 30, 60, 90)
Metabolic/laboratoryGlucose (2–2.9 mM)12 (day1)
HepaticALP (120–300 U/liter)11 (day 180)
AST (36–86 U/liter)21 (day 90), 1 (day 90)
HepaticBilirubin (19–35 mM)11 (day 180)
ALT (46–112 U/liter)21 (day 180)
MusculoskeletalHeadache12 (day 90)