Table 2 Adverse events considered possibly, probably, or related to treatment in ⩾10% of patients by cohort.
| Adverse event by preferred term† | No (%) of patients by stage A dose* | ||||
|---|---|---|---|---|---|
| Placebo (n = 10) (22) | 0.1 mg/kg fontolizumab (n = 6) (13) | 1.0 mg/kg fontolizumab (n = 14) (31) | 4.0 mg/kg fontolizumab (n = 15) (34) | Total (n = 45) | |
| Nausea | 1 (10) | 1 (17) | 3 (21) | 4 (27) | 9 (20) |
| Asthenia | 1 (10) | 2 (33) | 1 (7) | 3‡ (20) | 7 (16) |
| Headache | 0 | 1 (17) | 3 (21) | 2 (13) | 6 (13) |
| Vomiting | 0 | 0 | 1 (7) | 4§ (27) | 5 (11) |
| Arthralgia | 1 (10) | 0 | 3 (21) | 1 (7) | 5 (11) |
| Abdominal pain | 0 | 0 | 1 (7) | 3§ (20) | 4 (9) |
| Dizziness | 1 (10) | 0 | 2 (14) | 1 (7) | 4 (9) |
| Chills | 0 | 0 | 0 | 3‡ (20) | 3 (7) |
| Fever | 0 | 0 | 0 | 3‡ (20) | 3 (7) |
| Amblyopia | 1 (10) | 0 | 1 (7) | 0 | 2 (4) |
| Injection site inflammation | 1 (10) | 0 | 0 | 0 | 1 (2) |
| Peripheral oedema | 1 (10) | 0 | 0 | 0 | 1 (2) |
*Events counted by unique preferred term per patient.
†Events listed in descending order of frequency.
‡Patient 0703 reported asthenia, chills, and fever attributed to Crohn's disease flare; all were considered possibly related to study drug and each is counted here.
§Patient 0713 reported vomiting and abdominal pain due to functional stenosis; both events were considered possibly related to study drug and each is counted here.