TABLE 4.
MedDRA preferred term | RD12014 group (n = 49) | Victoza group (n = 49) | Total (n = 49) |
---|---|---|---|
Any AE | 11 (22.4) | 16 (32.7) | 24 (49.0) |
Number of events | 14 | 19 | 33 |
Any TRAE | 11 (22.4) | 12 (24.5) | 21 (42.9) |
Number of events | 13 | 12 | 25 |
Any SAE | 0 | 0 | 0 |
AEs | |||
Serum uric acid increased | 3 (6.1) | 3 (6.1) | 6 (12.2) |
Blood bilirubin increased | 2 (4.1) | 3 (6.1) | 5 (10.2) |
Blood triglyceride increased a | 1 (2.0) | 3 (6.1) | 4 (8.2) |
Blood glucose decreased | 1 (2.0) | 2 (4.1) | 3 (6.1) |
Upper respiratory tract infection b | 0 (0) | 2 (4.1) | 2 (4.1) |
Total bile acid increased | 1 (2.0) | 1 (2.0) | 2 (4.1) |
Conjugated bilirubin increased | 2 (4.1) | 0 (0) | 2 (4.1) |
Alanine aminotransferase increased | 1 (2.0) | 0 (0) | 1 (2.0) |
Neutrophil count increased | 0 (0) | 1 (2.0) | 1 (2.0) |
Aspartate aminotransferase increased | 1 (2.0) | 0 (0) | 1 (2.0) |
Vomit a | 0 (0) | 1 (2.0) | 1 (2.0) |
Nausea a | 0 (0) | 1 (2.0) | 1 (2.0) |
Diarrhea | 1 (2.0) | 0 (0) | 1 (2.0) |
Abdominal distention | 1 (2.0) | 0 (0) | 1 (2.0) |
Fever | 0 (0) | 1 (2.0) | 1 (2.0) |
Hematuria a | 0 (0) | 1 (2.0) | 1 (2.0) |
Note: Data are presented as number of subjects (%).
Abbreviations: AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event.
AEs were not considered treatment‐related.
One of the upper respiratory tract infections was not considered treatment‐related.