Results and lessons learnt from a randomized controlled trial: prophylactic treatment of vestibular migraine with metoprolol (PROVEMIG)

Table 4 Safety assessment by study treatment group (safety sample) during the 6-month treatment period

Safety assessment	Placebo (n = 59)	Metoprolol (n = 62)
Deaths, n	0	0
Patients with SUSARs, n	0	0
Patients with early termination from the study due to SAEs^a, n (%)	2 (3.4)	1 (1.6)
Treatment-related SAEs, n (%)	1 (1.7)	1 (1.6)
Patients with at least one SAE, n (%); total number of SAEs	8 (13.5); 10	6 (9.7); 7
Patients with early termination due to adverse events^a, n (%)	4 (6.7)	8 (12.9)

Percentages (%) are based on the number of patients in the safety sample
Reasonable possibility for a causal relationship = drug-event relationship reported as “possible”, “probable”, or missing according to the adverse event case report form
^a Adverse event or serious adverse event (SAE) leading to treatment discontinuation according to the adverse event case report form
SUSAR suspected unexpected serious adverse reactions

ISSN: 1745-6215