| Event | All patients with fistula (adalimumab and placebo) (n = 117) | All adalimumab patients with fistula (eow and weekly combined) (n = 70) |
| No (%) | No (%) | |
| Adverse event | 112 (95.7) | 70 (100) |
| Serious adverse event | 33 (28.2) | 22 (31.4) |
| Adverse event leading to discontinuation of study medication | 19 (16.2) | 13 (18.6) |
| Infectious adverse event | 76 (65.0) | 53 (75.7) |
| Serious infectious adverse event | 13 (11.1)* | 10 (14.3)† |
| Serious gastrointestinal adverse event | 15 (12.8)‡ | 13 (18.6)§ |
| Malignant neoplasm | 1 (0.9) | 0 |
| Injection-site pain | 7 (6.0) | 4 (5.7) |
| Opportunistic infection | 0 | 0 |
| Congestive heart failure | 0 | 0 |
| Demyelinating disorder | 0 | 0 |
| Death | 0 | 0 |
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*Fifteen events were reported in 13 patients: nine events of abscess (four perianal, two abdominal, one rectal, one scrotal, one not specified), one event of clostridial infection, one event of sepsis, one event of pneumonia, one event of tuberculosis, one event of otitis media and one event of post-procedural infection. †Twelve events were reported in 10 patients: eight events of abscess (three perianal, two abdominal, one rectal, one scrotal, one not specified), one event of clostridial infection, one event of pneumonia, one event of tuberculosis and one event of otitis media. ‡Seventeen events were reported in 15 patients: 10 events of Crohn’s disease (CD), four events of obstruction (two intestinal, two small intestinal), two events of fistula (one anal, one intestinal) and one event of abdominal mass. §Fifteen events were reported in 13 patients: eight events of CD, four events of obstruction (two intestinal, two small intestinal), two events of fistula (one anal, one intestinal), and one event of abdominal mass. CHARM, Crohn’s Trial of the fully Human Antibody Adalimumab for Remission Maintenance.
