Table 1.
Treatment-emergent nausea and vomiting adverse events occurring during approximately 1 day following a single subcutaneous exenatide dose (10 μg) by MedDRA Preferred Term, intensity and anti-emetic treatment [population: ITT (n = 120)]
Group by anti-emetic treatment | |||||||||
---|---|---|---|---|---|---|---|---|---|
Non-premedicated (n = 60)* | Premedicated (n = 60)* | All subjects (n = 120)* | |||||||
Preferred term Intensity | n† | (%) | Events | n† | (%) | Events | n† | (%) | Events |
Nausea | 37 | (61.7) | 41 | 10 | (16.7) | 12 | 47 | (39.2) | 53 |
Mild | 35 | (58.3) | 36 | 8 | (13.3) | 10 | 43 | (35.8) | 46 |
Moderate | 5 | (8.3) | 5 | 2 | (3.3) | 2 | 7 | (5.8) | 7 |
Severe | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 |
Vomiting | 23 | (38.3) | 47 | 4 | (6.7) | 5 | 27 | (22.5) | 52 |
Mild | 23 | (38.3) | 36 | 4 | (6.7) | 5 | 27 | (22.5) | 41 |
Moderate | 2 | (3.3) | 11 | 0 | (0.0) | 0 | 2 | (1.7) | 11 |
Severe | 0 | (0.0) | 0 | 0 | (0.0) | 0 | 0 | (0.0) | 0 |
Number of ITT subjects in the corresponding group.
Number of subjects who experienced the adverse event.
Percentages are based on the number of ITT subjects in each group or in ‘All subjects’. Subjects experiencing multiple episodes of a given adverse event are counted once.
ITT, intent to treat; MedDRA®, Medical Dictionary for Regulatory Activities version 11.