Table 3 Treatment-emergent adverse events by preferred term occurring in at least two patients from all pateclizumab-treated groups combined during either single or multiple ascending dose phasesa
SAD cohorts, n(%) | MAD cohorts, n(%) | ||||||
|---|---|---|---|---|---|---|---|
Adverse events | Placebo (n= 6) | All active (n= 24) | Placebo (n= 7) | 1.0 mg/kg SC (n= 8) | 3.0 mg/kg SC (n= 16) | 5.0 mg/kg IV (n= 4) | All active (n= 28) |
Any event | 3 (50.0) | 20 (66.7) | 4 (57.1) | 7 (87.5) | 8 (50.0) | 1 (25.0) | 20 (57.1) |
Fatigue | 0 (0.0) | 2 (8.3) | 1 (14.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Rheumatoid arthritis | 0 (0.0) | 2 (8.3) | 0 (0.0) | 1 (12.5) | 1 (6.3) | 0 (0.0) | 2 (7.1) |
Rash | 0 (0.0) | 2 (8.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Diarrhea | 0 (0.0) | 1 (4.2) | 0 (0.0) | 3 (37.5) | 1 (6.3) | 0 (0.0) | 4 (14.3) |
Vomiting | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (25.0) | 0 (0.0) | 0 (0.0) | 2 (7.1) |
Nasopharyngitis | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (12.5) | 0 (0.0) | 2 (7.1) |
Headache | 0 (0.0) | 1 (4.2) | 0 (0.0) | 2 (25.0) | 1 (6.3) | 1 (25.0) | 4 (14.3) |
Rhinorrhea | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 1 (6.3) | 0 (0.0) | 2 (7.1) |