Table 6.
The number of events and participants by adverse events type in the anakinra trial
| Anakinra (n=35) |
Placebo (n=34) |
|||
|---|---|---|---|---|
| Number of events |
Number of participants (%) |
Number of events |
Number of participants (%) |
|
| Allergic or immunological | 3 | 3 (9%) | 1 | 1 (3%) |
| Auditory or ear | 0 | 0 (0%) | 2 | 2 (6%) |
| Blood or bone marrow | 3 | 2 (6%) | 0 | 0 (0%) |
| Constitutional symptoms | 1 | 1 (3%) | 3 | 2 (6%) |
| Dermatological or skin | 24 | 19 (54%) | 11 | 9 (26%) |
| Endocrine | 1 | 1 (3%) | 1 | 1 (3%) |
| Gastrointestinal | 7 | 6 (17%) | 3 | 3 (9%) |
| Infection | 17 | 11 (31%) | 12 | 8 (24%) |
| Lymphatics | 1 | 1 (3%) | 0 | 0 (0%) |
| Metabolic or laboratory | 3 | 1 (3%) | 0 | 0 (0%) |
| Musculoskeletal or soft tissue | 5 | 4 (11%) | 2 | 2 (6%) |
| Neurological | 2 | 2 (6%) | 1 | 1 (3%) |
| Ocular or visual | 3 | 2 (6%) | 1 | 1 (3%) |
| Pain | 14 | 7 (20%) | 10 | 7 (21%) |
| Pulmonary or upper respiratory | 3 | 3 (9%) | 4 | 3 (9%) |
| Renal or genitourinary | 1 | 1 (3%) | 0 | 0 (0%) |
| Sexual or reproductive function | 1 | 1 (3%) | 0 | 0 (0%) |
| Vascular | 1 | 1 (3%) | 0 | 0 (0%) |
| Total events | 90 | · · | 51 | · · |
Each adverse event category by treatment group was tested using a one-sided Fisher’s exact test. Only the difference between groups in the adverse event category dermatological or skin reached statistical significance (p=0·017). Of the 28 participants who had dermatological or skin reactions, 21 had injection-site reactions, 17 of whom were from the anakinra group (p=0·0009).