Common adverse events in laquinimod dose groups and pooled placebo group
| Preferred term n (%) | Pooled placebo (n=63) | LAQ 0.5 mg (n=29) | LAQ 1.0 mg (n=30) | LAQ 1.5 mg (n=29) | LAQ 2.0 mg (n=29) |
|---|---|---|---|---|---|
| Headache | 13 (20.6) | 7 (24.1) | 8 (26.7) | 7 (24.1) | 13 (44.8) |
| Abdominal pain | 8 (12.7) | 5 (17.2) | 4 (13.3) | 7 (24.1) | 7 (24.1) |
| Nausea | 4 (6.3) | 1 (3.4) | 6 (20) | 2 (6.9) | 6 (20.7) |
| Vomiting | 5 (7.9) | 5 (17.2) | 6 (20) | 1 (3.4) | 6 (20.7) |
| Abdominal pain upper | 3 (4.8) | 1 (3.4) | 0 (0) | 2 (6.9) | 5 (17.2) |
| Myalgia | 1 (1.6) | 0 (0) | 1 (3.3) | 0 (0) | 5 (17.2) |
| Pyrexia | 8 (12.7) | 7 (24.1) | 1 (3.3) | 6 (20.7) | 4 (13.8) |
| Crohn's disease* | 7 (11.1) | 2 (6.9) | 5 (16.7) | 5 (17.2) | 4 (13.8) |
| Diarrhoea | 2 (3.2) | 6 (20.7) | 1 (3.3) | 0 (0) | 3 (10.3) |
| Asthenia | 3 (4.8) | 1 (3.4) | 2 (6.7) | 3 (10.3) | 2 (6.9) |
| Back pain | 5 (7.9) | 3 (10.3) | 3 (10.0) | 4 (13.8) | 1 (3.4) |
| Dizziness | 1 (1.6) | 1 (3.4) | 1 (3.3) | 3 (10.3) | 1 (3.4) |
| Tachycardia | 0 (0) | 0 (0) | 0 (0) | 3 (10.3) | 1 (3.4) |
| Cough | 2 (3.2) | 2 (6.9) | 3 (10.0) | 2 (6.9) | 1 (3.4) |
| Abdominal distension | 0 (0) | 3 (10.3) | 0 (0) | 1 (3.4) | 1 (3.4) |
| Alanine aminotransferase increased | 1 (1.6) | 0 (0) | 3 (10.0) | 0 (0) | 1 (3.4) |
| Rectal haemorrhage | 0 (0) | 0 (0) | 1 (3.3) | 3 (10.3) | 0 (0) |
| Fatigue | 2 (3.2) | 2 (6.9) | 0 (0) | 3 (10.3) | 0 (0) |
*Exacerbation of Crohn's disease.