Safety analysis of the CareRA trial
| COBRA Classic | COBRA Slim (high risk) | COBRA Avant Garde | MTX-TSU | COBRA Slim (low risk) | Total | |
|---|---|---|---|---|---|---|
| Number of patients | 98 | 98 | 93 | 47 | 43 | 379 |
| Total number of AEs | 394 | 353 | 452 | 150 | 150 | 1499 |
| Total number of AEs related to therapy | 184 | 131 | 175 | 54 | 51 | 595 |
| GI tract-related AEs | 45 | 48 | 67 | 20 | 15 | 195 |
| General malaise-related AEs | 52 | 22 | 30 | 11 | 12 | 127 |
| Liver function abnormalities | 17 | 17* | 22 | 6 | 3 | 65 |
| Hair loss | 7 | 10 | 16 | 3 | 5 | 41 |
| Infection/inflammation-related AEs | 11† | 8 | 7 | 7 | 2* | 35 |
| Changed appetite-related AEs | 18 | 3 | 9 | 4 | 34 | |
| GC-related AEs | 9 | 5 | 7 | 21 | ||
| Blood level-related AEs | 7 | 3* | 4 | 2* | 16 | |
| Itch and rash | 4 | 3 | 1 | 3 | 2 | 13 |
| Diabetes-related AEs | 2 | 1 | 2* | 1 | 6 | |
| Visual impairment-related AEs | 1 | 1 | 2 | 4 | ||
| Kidney function abnormalities | 1 | 2 | 3 | |||
| Miscellaneous | 11 | 10 | 10* | 4 | 35 | |
| Serious AEs | 15 | 15 | 10 | 7 | 7 | 54 |
| Serious AEs related to therapy* | 2 | 2 | 2 | 0 | 2 | 8 |
Total number of AEs (related to therapy) include serious AEs (related to therapy).
*One serious AE related to therapy.
†Two serious AEs related to therapy. Online supplementary material 3 gives detailed information per type of AE related to therapy.
AE, adverse event; GC, glucocorticoid; GI, gastrointestinal; MTX, methotrexate; TSU, tight step-up.