Adverse event category | Adverse event | Grade | Frequency, N (%) |
Allergy/immunology | Allergic reaction/hypersensitivity | 1 | 15 (0.29) |
2 | 8 (0.15) | ||
Cardiac arrhythmia | Supraventricular arrhythmia | ||
Atrial fibrillation/flutter | 1/2 | 25 (0.48) | |
Atrial tachycardia | 1/2 | 4 (0.08) | |
Supraventricular tachycardia | 1/2 | 3 (0.06) | |
Vasovagal episode | 2 (no LOC) | 40 (0.80) | |
3 (with LOC) | 5 (0.10) | ||
Ventricular arrhythmia | |||
Bigeminy | 1 | 11 (0.20) | |
PVC | 1 | 210 (4) | |
Ventricular tachycardia | 1/2 | 18 (0.34) | |
3 | 10 (0.18) | ||
4 (resusc) | 1 (0.02) | ||
Ventricular fibrillation | 4 (resusc) | 1 (0.02) | |
Cardiac general | Cardiac troponin I elevation | 3* | 2 (0.04) |
Hypertension | 1/2 | 111 (2.1) | |
Constitutional symptoms | Fatigue | 1/2 | 70 (1.3) |
Gastrointestinal | Xerostomia | 1 | 1038 (19.8) |
Neurology | Confusion | 1/2 | 10 (0.20) |
Dizziness | 1 | 386 (7.4) | |
Memory impairment | 2 | 2 (0.04) | |
Tremor | 1 | 125 (2.4) | |
Pain | Headache | 1/2 | 278 (5.3) |
3 | 52 (1.0) | ||
Back pain | 1/2 | 73 (1.4) | |
3 | 26 (0.50) | ||
Pulmonary | Dyspnoea | 1 | 47 (0.9) |
Renal/genitourinary | Urinary retention | 1 | 41 (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).