Table 2.
Number of Patients Experiencing Adverse Event During Each Exposure Period | ||||
---|---|---|---|---|
Adverse Events | Weeks 0–52 | Weeks 52–104 | Weeks 104–156 | *Total (Weeks 0–156+) |
Diarrhea | 205 (17.3%) | 15 (2.3%) | 7 (1.7%) | 221 (18.7%) |
Nausea | 186 (15.7%) | 5 (0.8%) | 6 (1.5%) | 195 (16.5%) |
URTI** | 184 (15.5%) | 58 (8.9%) | 27 (6.7%) | 227 (19.2%) |
Headache | 181 (15.3%) | 43 (6.6%) | 12 (1.9%) | 201 (17.0%) |
Notes: *Total number of patients does not equal the sum of the three 52-week exposure periods because some of the patients are counted more than once in each of the three timeframes if they experienced the adverse event at more than one period throughout the study. **Upper respiratory tract infection.