Table 3. Number of patients with adverse events.

	SSGn = 135	PMn = 135
Deaths	3 (2.2%)	2 (1.4%)
Patients with SAE *	8 (5.9%)	5 (3.7%)
Treatment-emergent†	7 (5.2%)	3 (2.2%)
During follow-up	1 (0.7%)	2 (1.4%)
Unrelated to study drug	3 (2.2%)	2 (1.4%)
Unlikely, possibly or probably related	5 (3.7%)	3 (2.2%)
Patients with at least one AE at any time	99 (73.3%)	77 (57.0%)
TEAEs†	90 (66.7%)	65 (48.2%)
AEs during follow-up	35 (25.9%)	33 (24.4%)
TEAEs
Total number of TEAEs	169	112
Total patient-days at risk	8100	6885
TEAE rate	0.021	0.016
TEAE rate ratio (95% CI) comparing PM with SSG, adjusted for centre	0.78 (0.61 to 0.99, p = 0.041)

Data are n (%) unless otherwise stated. AE = adverse event. SAE = serious adverse event. TEAE = treatment-emergent adverse event.

*No patient experienced more than one SAE.

†: TEAEs defined as onset being between day 1 of treatment and 30 days after end of treatment inclusive. AEs occurring during follow-up had onset recorded as between day 31 of trial and end of study.