Table 2 Severity and frequency of observed adverse events (CTCAE v3.0 nomenclature24) in 5250 studies (see Appendix)
Adverse event categoryAdverse eventGradeFrequency, N (%)
Allergy/immunologyAllergic reaction/hypersensitivity115 (0.29)
28 (0.15)
Cardiac arrhythmiaSupraventricular arrhythmia
    Atrial fibrillation/flutter1/225 (0.48)
    Atrial tachycardia1/24 (0.08)
    Supraventricular tachycardia1/23 (0.06)
Vasovagal episode2 (no LOC)40 (0.80)
3 (with LOC)5 (0.10)
Ventricular arrhythmia
    Bigeminy111 (0.20)
    PVC1210 (4)
    Ventricular tachycardia1/218 (0.34)
310 (0.18)
4 (resusc)1 (0.02)
    Ventricular fibrillation4 (resusc)1 (0.02)
Cardiac generalCardiac troponin I elevation3*2 (0.04)
Hypertension1/2111 (2.1)
Constitutional symptomsFatigue1/270 (1.3)
GastrointestinalXerostomia11038 (19.8)
NeurologyConfusion1/210 (0.20)
Dizziness1386 (7.4)
Memory impairment22 (0.04)
Tremor1125 (2.4)
PainHeadache1/2278 (5.3)
352 (1.0)
Back pain1/273 (1.4)
326 (0.50)
PulmonaryDyspnoea147 (0.9)
Renal/genitourinaryUrinary retention141 (0.80)
  • *Elevation to a level consistent with unstable angina as defined by the manufacturer.

  • CTCAE, Common Terminology Criteria for Adverse Events version 3.0; LOC, loss of consciousness; PVC, premature ventricular complex; resusc, resuscitated; grades correspond to mild (1), moderate (2), severe (3), life-threatening (4), death (5).