A phase 3, randomised, placebo-controlled study of erenumab for the prevention of chronic migraine in patients from Asia: the DRAGON study

Table 3 Summary of treatment-emergent AE by preferred term (≥ 1.5% in erenumab group) during the DBTP (Safety analysis set)

	Erenumab 70 mg N = 279 n (%)	Placebo N = 278 n (%)
Any AE	127 (45.5)	132 (47.5)
Any treatment-related AE	36 (12.9)	37 (13.3)
AEs leading to study treatment discontinuation	2 (0.7)	2 (0.7)
Any SAE	7 (2.5)	7 (2.5)
Any treatment-related SAE	1 (0.4)	0
SAEs leading to study treatment discontinuation	1 (0.4)	0
Deaths	0	0
Treatment-emergent AEs (at least 1.5% in erenumab 70 mg group) by preferred term
Constipation	24 (8.6)	9 (3.2)
Upper respiratory tract infection	15 (5.4)	20 (7.2)
Nasopharyngitis	10 (3.6)	5 (1.8)
Dizziness	5 (1.8)	12 (4.3)
Pain in extremity	5 (1.8)	1 (0.4)

Preferred terms are sorted in descending order of frequency in erenumab 70 mg column and then alphabetically
A patient with multiple occurrences of an AE under one treatment is counted only once in this AE category for that treatment
A patient with multiple AEs is counted only once in the "at least one AE" row
N, number of patients in the analysis set; n, number of patients reporting at least one occurrence of an adverse event in that class
MedDRA Version 24.0 has been used for the reporting of AEs
AE Adverse event, DBTP Double-blind treatment phase, SAE Serious adverse event, MedDRA Medical Dictionary for Regulatory Activities

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