Table 3.
Adverse drug reactions occurring with an incidence >0.001 up to September 2012.
| Adverse drug reaction*,** | Events (N = 129), n (%) | Patients (N = 88), n | Incidence (patient-years† = 2851.16) |
|---|---|---|---|
| Headache | 30 (23.3) | 25 | 0.00877 |
| Hypothyroidism | 11 (8.5) | 10 | 0.00351 |
| Arthralgia | 7 (5.4) | 7 | 0.00246 |
| Pain in extremity | 9 (7.0) | 7 | 0.00246 |
| Injection-site haematoma | 5 (3.0) | 5 | 0.00175 |
| Decreased glucose tolerance | 12 (9.3) | 5 | 0.00175 |
| Asthenia | 3 (2.3) | 3 | 0.00105 |
| Injection-site pain | 3 (2.3) | 3 | 0.00105 |
| Increased blood creatine phosphokinase | 4 (3.1) | 3 | 0.00105 |
| Myalgia | 3 (2.3) | 3 | 0.00105 |
*
Preferred term/MeDRA dictionary.
**
Mild or moderate.
†
Until cut-off date.