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. 2014 Aug 22;7:523–530. doi: 10.2147/JPR.S65974

Table 4.

Treatment-emergent adverse events (TEAEs)

TEAE Number of patients (%)*
Placebo
(n=51)
Fasinumab
0.1 mg/kg
(n=53)
0.3 mg/kg
(n=54)
All doses
(n=107)
Any TEAE 23 (45.1) 27 (50.9) 35 (64.8) 62 (57.9)
Serious TEAEs 1 (2.0) 1 (1.9) 2 (3.7) 3 (2.8)
TEAEs resulting in study discontinuation 0 1 (1.9) 0 1 (1.9)
Treatment-related TEAEs 6 (11.8) 7 (13.2) 13 (24.1) 20 (18.7)
Most common TEAEs, occurring in ≥2% of combined fasinumab doses
 Paresthesia 0 1 (1.9) 10 (18.5) 11 (10.3)
 Arthralgia 3 (5.9) 2 (3.8) 8 (14.8) 10 (9.3)
 Pain in extremity 1 (2.0) 0 8 (14.8) 8 (7.5)
 Headache 2 (3.9) 2 (3.8) 5 (9.3) 7 (6.5)
 Anxiety 0 2 (3.8) 3 (5.6) 5 (4.7)
 Nausea 1 (2.0) 3 (5.7) 2 (3.7) 5 (4.7)
 Upper respiratory tract infection 3 (5.9) 1 (1.9) 4 (7.4) 5 (4.7)
 Nasopharyngitis 1 (2.0) 1 (1.9) 3 (5.6) 4 (3.7)
 Decreased vibratory sense 1 (2.0) 2 (3.8) 1 (1.9) 3 (2.8)
 Dizziness 1 (2.0) 2 (3.8) 1 (1.9) 3 (2.8)
 Hypoesthesia 0 1 (1.9) 2 (3.7) 3 (2.8)
 Muscle spasms 0 0 3 (5.6) 3 (2.8)
 Myalgia 0 2 (3.8) 1 (1.9) 3 (2.8)
 Urinary tract infection 1 (2.0) 2 (3.8) 1 (1.9) 3 (2.8)

Note:

*

Safety analysis set.