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|
AEs, no. (%)
|
Placebo (n = 126)
|
Monthly fremanezumab (n = 134)
|
Quarterly fremanezumab (n = 133)
|
|---|
|
≥ 1 injection-site reaction AE
|
15 (12)
|
21 (16)
|
14 (10)
|
|
≥ 1 AE
|
52 (41)
|
63 (47)
|
55 (41)
|
|
≥ 1 SAE
|
3 (2)
|
0
|
1 (< 1)
|
|
AEs leading to discontinuation
|
2 (2)
|
0
|
2 (1)
|
|
AEsa
|
|
Injection-site erythema
|
6 (5)
|
9 (7)
|
6 (4)
|
|
Injection-site pain
|
4 (3)
|
9 (7)
|
3 (2)
|
|
Injection-site induration
|
3 (2)
|
4 (3)
|
7 (5)
|
|
Injection-site bruising
|
2 (2)
|
2 (2)
|
2 (1)
|
|
Injection-site pruritus
|
2 (2)
|
2 (2)
|
2 (1)
|
|
Nasopharyngitis
|
6 (5)
|
6 (5)
|
4 (3)
|
|
Upper respiratory tract infection
|
1 (< 1)
|
–
|
7 (5)
|
|
Influenza
|
0
|
2 (2)
|
4 (3)
|
|
Nausea
|
2 (2)
|
3 (2)
|
2 (1)
|
|
Constipation
|
2 (2)
|
3 (2)
|
0
|
|
Dyspepsia
|
2 (2)
|
0
|
2 (1)
|
|
Urinary tract infection
|
2 (2)
|
1 (< 1)
|
0
|
|
Foot fracture
|
0
|
2 (2)
|
0
|
|
Road traffic accident
|
0
|
2 (2)
|
0
|
|
International normalized ratio increased
|
2 (2)
|
7 (5)
|
2 (1)
|
|
Hemoglobin decreased
|
0
|
2 (2)
|
0
|
|
Neck pain
|
0
|
1 (< 1)
|
3 (2)
|
|
Pain in extremity
|
2 (2)
|
0
|
3 (2)
|
|
Insomnia
|
1 (< 1)
|
3 (2)
|
3 (2)
|
|
Anxiety
|
0
|
1 (< 1)
|
2 (1)
|
|
Alopecia
|
2 (2)
|
1 (< 1)
|
1 (< 1)
|
- AE, adverse event, SAE, serious adverse event
- aAEs that occurred in ≥ 2 patients in any treatment group were reported
