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) |
|
|
||||||
|
Values shown in parentheses are percentages. |
||||||
|
Moreland et al. Arthritis Res 2001 3:247 doi:10.1186/ar309 |
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