Table 2.
Variable | Overall (n = 36) | Placebo Pooled (n = 12) | AB002 1.5 µg/kg (n = 12) | AB002 3 µg/kg (n = 12) |
---|---|---|---|---|
Patients With TEAE | 2 (6%) | 1 (8%) | 1 (8%) | 0 (0%) |
Patients Without TEAE | 34 (94%) | 11 (92%) | 11 (92%) | 12 (100%) |
Number of TEAEs | 3 | 1 | 2 | 0 |
AEa / Severityb / Relatedness | Hypotension / Grade 2 / Unlikely |
Muscle spasms / Grade 1 / Unrelated Baclofen toxicity / Grade 3 / Unrelated |
aAEs are classified according to MedDRA version 21.1.
bSeverity: Grade 1 = mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Potentially life-threatening.