Table 2 Adverse events occurring in >5% of all patients dosed with rhIL-11
Patients given various daily doses of rhIL-11 | ||||||
|---|---|---|---|---|---|---|
Patients given placebo | 1 × 5 μg/kg | 2 × 2.5 μg/kg | 1 × 15 μg/kg | 2 × 7.5 μg/kg | All patients | |
Adverse event | (n = 19) | (n = 17) | (n = 19) | (n = 19) | (n = 16) | (n = 90) |
Reaction at injection site | 0 | 11 (64.7) | 13 (68.4) | 11 (57.9) | 8 (50.0) | 43 (47.8) |
Headache | 5 (26.3) | 1 (5.9) | 5 (26.3) | 5 (26.3) | 1 (6.3) | 17 (18.9) |
Pharyngitis | 1 (5.3) | 2 (11.8) | 3 (15.8) | 3 (15.8) | 6 (37.5) | 15 (16.7) |
Nausea | 4 (21.1) | 1 (5.9) | 1 (5.3) | 2 (10.5) | 2 (12.5) | 10 (11.1) |
Asthenia | 1 (5.3) | 0 | 3 (15.8) | 4 (21.1) | 1 (6.3) | 9 (10.0) |
Rhinitis | 1 (5.3) | 3 (17.6) | 3 (15.8) | 1 (5.3) | 1 (6.3) | 9 (10.0) |
Abdominal pain | 2 (10.5) | 3 (17.6) | 2 (10.5) | 0 | 1 (6.3) | 8 (8.9) |
Diarrhea | 2 (10.5) | 1 (5.9) | 1 (5.3) | 1 (5.3) | 3 (18.8) | 8 (8.9) |
Pain | 2 10.5) | 4 (23.5) | 1 (5.3) | 0 | 1 (6.3) | 8 (8.9) |
Rash | 2 (10.5) | 1 (5.9) | 0 | 5 (26.3) | 0 | 8 (8.9) |
Infection | 0 | 1 (5.9) | 1 (5.3) | 4 (21.1) | 1 (6.3) | 7 (7.8) |
Dizziness | 1 (5.3) | 2 (11.8) | 0 | 1 (5.3) | 2 (12.5) | 6 (6.7) |
Edema | 1 (5.3) | 4 (23.5) | 1 (5.3) | 0 | 0 | 6 (6.7) |
Cough increased | 0 | 2 (11.8) | 1 (5.3) | 1 (5.3) | 1 (6.3) | 5 (5.6) |
Dyspepsia | 1 (5.3) | 0 | 2 (10.5) | 0 | 2 (12.5) | 5 (5.6) |
Dyspnea | 3 (15.8) | 0 | 0 | 1 (5.3) | 1 (6.3) | 5 (5.6) |
Flu syndrome | 0 | 2 (11.8) | 2 (10.5) | 0 | 1 (6.3) | 5 (5.6) |