Table 3.
Adverse Events, Trial Discontinuation, and Serious Adverse Events.*
| Event | Placebo (N = 126) |
Ibudilast (N = 129) |
P Value |
|---|---|---|---|
| no. of patients (%) | |||
| Any adverse event | 111 (88) | 119 (92) | 0.26 |
| Gastrointestinal event | |||
| Abdominal pain | 0 | 6 (5)† | 0.03 |
| Abdominal pain, upper | 0 | 5 (4)† | 0.06 |
| Diarrhea | 9 (7) | 21 (16)† | 0.03 |
| Nausea | 19 (15) | 35 (27)† | 0.02 |
| Vomiting | 3 (2) | 9 (7)† | 0.10 |
| Fatigue | 11 (9) | 14 (11) | 0.57 |
| Infection | |||
| Skin infection | 7 (6)† | 1 (1) | 0.06 |
| Upper respiratory tract infection | 24 (19)† | 13 (10) | 0.05 |
| Urinary tract infection | 41 (33) | 35 (27) | 0.34 |
| Fall | 20 (16) | 29 (22) | 0.18 |
| Musculoskeletal event | |||
| Back pain | 15 (12) | 10 (8) | 0.27 |
| Neck pain | 4 (3)† | 0 | 0.06 |
| Pain in the arms or legs | 13 (10)† | 5 (4) | 0.05 |
| Headache | 15 (12) | 23 (18)‡ | 0.19 |
| Psychiatric event | |||
| Depression | 4 (3) | 12 (9)† | 0.05 |
| Insomnia | 11 (9) | 14 (11) | 0.57 |
| Withdrawal from the trial | |||
| For any reason | 14 (11) | 21 (16) | 0.24 |
| Owing to adverse event | 5 (4) | 10 (8) | 0.21 |
| Serious adverse event | 24 (19) | 20 (16) | 0.46 |
*
Shown are adverse events with an incidence of more than 10% in either group or a difference in incidence between groups (P≤0.10).
†
The incidence was higher than that in the other group (P≤0.10).
‡
The frequency of headaches (total number of headaches per unit of time) was higher in the ibudilast group than in the placebo group (P = 0.09).