Table 6. Adverse Events in the Safety Population.
| Induction Period | Active Period | Maintenance Period | ||||||
| CCX282-B | ||||||||
| Event | Placebo (N = 144) | 250 mg q.d. (N = 98) | 250 mg b.i.d. (N = 96) | 500 mg q.d. (N = 97) | All (N = 291) | 250 mg b.i.d. CCX282-B (N = 318) | Placebo (N = 95) | 250 mg b.i.d. CCX282-B (N = 145) |
| No. of subjects (%) | ||||||||
| Any event | 90 (63) | 62 (64) | 56 (58) | 56 (58) | 174 (60) | 88 (28) | 58 (61) | 98 (68) |
| Event in ≥5% of placebo or CCX282-B group overall | ||||||||
| Abdominal pain | 19 (13) | 16 (17) | 18 (19) | 12 (12) | 46 (16) | 14 (4) | 19 (20) | 19 (13) |
| Crohn’s disease | 10 (7) | 9 (9) | 14 (14) | 6 (6) | 29 (10) | 12 (4) | 7 (7) | 17 (12) |
| Diarrhoea | 11 (8) | 10 (10) | 7 (7) | 7 (7) | 24 (8) | 12 (4) | 14 (15) | 15 (10) |
| Nausea | 10 (7) | 8 (8) | 10 (10) | 6 (6) | 24 (8) | 4 (1) | 7 (7) | 6 (4) |
| Dyspepsia | 5 (4) | 7 (7) | 3 (3) | 9 (9) | 19 (7) | 1 (0.3) | 0 | 5 (3) |
| Headache | 7 (5) | 6 (6) | 8 (8) | 5 (5) | 19 (7) | 2 (1) | 3 (3) | 3 (2) |
| Arthralgia | 8 (6) | 10 (10) | 3 (3) | 3 (3) | 16 (6) | 3 (1) | 7 (7) | 14 (10) |
| Pyrexia | 8 (6) | 5 (5) | 4 (4) | 5 (5) | 14 (5) | 8 (3) | 2 (2) | 7 (5) |
| Abdominal tenderness | 3 (2) | 3 (3) | 5 (5) | 4 (4) | 12 (4) | 1 (0.3) | 6 (6) | 4 (3) |
| Vomiting | 5 (4) | 4 (4) | 5 (5) | 3 (3) | 12 (4) | 8 (3) | 2 (2) | 8 (6) |
| Serious adverse events | 15 (10) | 5 (5) | 11 (11) | 9 (9) | 25 (9) | 12 (4) | 9 (10) | 13 (9) |
| Events leading to study treatment withdrawal | 19 (13) | 8 (8) | 5 (5) | 7 (7) | 20 (7) | 9 (3) | 6 (6) | 10 (7) |
| Gastrointestinal events leading to study treatment withdrawal | 14 (10) | 6 (6) | 3 (3) | 5 (5) | 14 (5) | 9 (3) | 4 (4) | 9 (6) |
| Crohn’s disease leading to study treatment withdrawal | 6 (4) | 3 (3) | 0 | 1 (1) | 4 (1) | 5 (2) | 1 (1) | 4 (3) |
| Adverse events leading to death | 1 (1) | 0 | 0 | 0 | 0 | 1 (0.3)a | 0 | 0 |
| Infection or infestation | 23 (16) | 11 (11) | 18 (19) | 18 (19) | 47 (16) | 20 (6) | 19 (20) | 35 (24) |
| Transaminase increase >3× upper limit | 1 (1) | 0 | 1 (1) | 0 | 1 (0.3) | 0 | 1 (1) | 1 (0.7) |
a
Event occurred 39 days after study discontinuation.