Table 4 Most common adverse events occurring in ≥2% of patients (treated patients population)
AE, n (%) | Saxagliptin + Metformin (n = 74) | Placebo + Metformin (n = 86) |
|---|---|---|
Hypoglycemia | ||
All reported | 4 (5.4) | 1 (1.2) |
Confirmed | 0 | 1 (1.2) |
Infections and infestations | 5 (6.8) | 11 (12.8) |
Bronchitis | 1 (1.4) | 2 (2.3) |
Nasopharyngitis | 1 (1.4) | 2 (2.3) |
Musculoskeletal and connective tissue disorders | 4 (5.4) | 8 (9.3) |
Back pain | 2 (2.7) | 3 (3.5) |
Muscle spasms | 1 (1.4) | 3 (3.5) |
Gastrointestinal disorders | 3 (4.1) | 6 (7.0) |
Diarrhea | 1 (1.4) | 3 (3.5) |
Blood and lymphatic system disorders | 3 (4.1) | 0 |
Lymphadenopathy | 2 (2.7) | 0 |
Vascular disorders | 2 (2.7) | 3 (3.5) |
Hypertension | 2 (2.7) | 2 (2.3) |
Nervous system disorders | 2 (2.7) | 5 (5.8) |
Dizziness | 2 (2.7) | 0 |
Headache | 0 | 3 (3.5) |
Respiratory, thoracic, and mediastinal disorders | 2 (2.7) | 3 (3.5) |
Sinus congestion | 1 (1.4) | 2 (2.3) |
Hepatobiliary disorders | 1 (1.4) | 2 (2.3) |
Cholecystitis | 0 | 2 (2.3) |
Psychiatric disorders | 0 | 2 (2.3) |
Insomnia | 0 | 2 (2.3) |