Table 2.
Treatment-emergent adverse events reported by subjects
Number of adverse events [number of subjects with adverse event] | ||||
---|---|---|---|---|
MedDRA preferred term | Healthy subjects (10 µg exenatide) (n = 8) | Mild RI (10 µg exenatide) (n = 8) | Moderate RI (5 µg exenatide)* (n = 7) | ESRD (5 µg exenatide) (n = 8) |
Vomiting NOS | 9 [6] | 6 [3] | 0 | 10 [7] |
Nausea | 8 [8] | 1 [1] | 0 | 8 [7] |
Headache† | 7 [5] | 2 [2] | 0 | 6 [5] |
Dizziness | 1 [1] | 3 [2] | 0 | 0 |
Malaise | 0 | 0 | 0 | 2 [2] |
Tachycardia | 1 [1]‡ | 0 | 0 | 1 [1]§ |
Other¶ | 2 [1] | 5 [2] | 0 | 1 [1] |
Total | 28 [8] | 17 [5] | 0 | 28 [7] |
Two subjects in this group received 10 µg exenatide.
Five headache events were probably not related to exenatide.
Medical Dictionary for Regulatory Activities (MedDRA) term: Tachycardia NOS (NOS = not otherwise specified).
MedDRA term: Sinus tachycardia.
Dyspepsia, cold sweat and increased sweating (not related to hypoglycaemia), asthenia (twice), dry throat, abdominal pain upper, dyspnoea. Each reported by one subject.