Table 4.
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.