TABLE 3.
Summary of adverse event comparisons between fostamatinib and placebo (24 weeks).
| Outcome a | Number of studies | Fostamatinib (event/total) | Placebo (event/total) | Relative risk | 95% CI | I 2 c | p |
|---|---|---|---|---|---|---|---|
| Any AE b | 2 | 105/123 | 44/61 | 1.18 | 0.99, 1.40 | 0% | 0.46 |
| Any severe AE b | 2 | 18/123 | 8/61 | 1.11 | 0.51, 2.40 | 0% | 0.80 |
| AE causing withdrawal from treatment | 3 | 13/123 | 4/61 | 1.37 | 0.47, 4.03 | 0% | 0.57 |
| Rescue medication b | 2 | 31/123 | 26/61 | 0.59 | 0.39, 0.90 | 0% | 0.01 |
| Any bleeding b | 2 | 8/123 | 10/61 | 0.41 | 0.17, 0.99 | 0% | 0.05 |
| Hypertension b | 2 | 37/123 | 7/61 | 2.57 | 1.21, 5.43 | 0% | 0.01 |
| Nausea b | 2 | 20/123 | 4/61 | 2.23 | 0.84, 5.90 | 0% | 0.11 |
| Diarrhea b | 2 | 41/123 | 7/61 | 2.69 | 0.98, 7.32 | 13% | 0.05 |
| Neutropenia b | 2 | 10/123 | 0/61 | 5.63 | 0.75, 42.14 | 0% | 0.09 |
Abbreviation: CI, confidence interval.
a
AE, adverse event.
b
Data from FIT‐1 and FIT‐2 were treated as one study in meta‐analysis.
c
The I 2 statistic may be biased when the number of contributing studies is small, and the 95% CI should be included in the interpretation of a point estimate.