AEs through week 24 by treatment group
| Adalimumab Weeks 0–12 | Placebo | |
|---|---|---|
| Number of patients with AEs | 10 | 10 |
| Total number of AEs | 12 | 12 |
| Infections | ||
| Common cold | 4 | 3 |
| Gingivitis | 0 | 1 |
| Cystitis | 0 | 2 |
| Septic arthritis | 0 | 1 |
| Dermatomycosis | 0 | 1 |
| Skin | ||
| Diffuse rash | 2 | 0 |
| Other | 0 | 2 |
| Gastrointestinal | ||
| Nausea | 1 | 0 |
| Psychological | ||
| Depression | 1 | 0 |
| Other | 4 | 2 |
| Total number of SAEs | 1 | 1 |
| Death | 1 | 0 |
| Hospital admission | 0 | 1 |
| Adalimumab Weeks 12–24 | ||
| Number of patients with AEs | 8 | 11 |
| Total number of AEs | 9 | 13 |
| Infections | ||
| Common cold | 3 | 3 |
| Sinusitis | 0 | 1 |
| Otitis | 0 | 1 |
| Tooth abscess | 1 | 1 |
| Cystitis | 0 | 3 |
| Skin | ||
| Injection-site reaction | 0 | 1 |
| Other | 0 | 1 |
| Gastrointestinal | ||
| Diarrhoea | 0 | 1 |
| Bloating | 1 | 0 |
| Psychological | ||
| Depression | 1 | 0 |
| Psychosis | 0 | 1 |
| Other | 3 | 0 |
| Total number of SAEs | 0 | 1 |
| Hospital admission | 0 | 1 |
Values are the number of events. Patients may be counted in more than one AE category and may be counted more than once within one sort of AE.
AE, adverse event; SAE, serious adverse event.