Table 7 Adverse events considered to be related to study drug‡ that occurred at an incidence rate of ≥ 0.2 incident events per 100 patient-years in one or both groups
Adverse Event | Incidence Rate per 100 Patient-years†| ||
|---|---|---|---|
| Â | Sitagliptin 100 mg | Non-exposed | Difference between Sitagliptin and Non-exposed (95% CI)* |
Gastrointestinal disorders SOC | |||
Abdominal discomfort | 0.3 | 0.3 | 0.0 (-0.3, 0.3) |
Abdominal distension | 0.3 | 0.2 | 0.1 (-0.1, 0.3) |
Abdominal pain | 0.1 | 0.5 | -0.5 (-0.8, -0.2) |
Abdominal pain upper | 0.5 | 0.8 | -0.2 (-0.6, 0.1) |
Constipation | 0.8 | 0.5 | 0.4 (0.1, 0.8) |
Diarrhea | 2.4 | 4.5 | -1.8 (-2.7, -1.0) |
Dry mouth | 0.1 | 0.3 | -0.1 (-0.4, 0.1) |
Dyspepsia | 0.5 | 0.5 | 0.0 (-0.3, 0.3) |
Flatulence | 0.3 | 0.5 | -0.1 (-0.4, 0.2) |
Gastritis | 0.1 | 0.5 | -0.3 (-0.6, -0.1) |
Gastroesophageal reflux disease | 0.2 | 0.1 | 0.1 (-0.1, 0.3) |
Nausea | 1.3 | 1.8 | -0.4 (-1.0, 0.1) |
Vomiting | 0.4 | 0.4 | -0.0 (-0.3, 0.3) |
General disorders and administration site conditions SOC | |||
Fatigue | 0.6 | 0.7 | -0.2 (-0.6, 0.2) |
Peripheral Edema | 0.4 | 0.6 | -0.2 (-0.5, 0.1) |
Infections and infestations SOC | |||
Upper respiratory tract infection | 0.4 | 0.3 | 0.2 (-0.1, 0.5) |
Urinary tract infection | 0.3 | 0.1 | 0.1 (-0.1, 0.3) |
Investigations SOC | |||
ALT increased | 0.5 | 0.4 | 0.0 (-0.3, 0.3) |
AST increased | 0.3 | 0.4 | -0.2 (-0.5, 0.1) |
Blood creatine phosphokinase increased | 0.2 | 0.1 | 0.1 (-0.0, 0.3) |
Blood glucose decreased | 0.3 | 0.5 | -0.2 (-0.5, 0.0) |
Blood glucose increased | 0.3 | 0.5 | -0.2 (-0.5, 0.1) |
Blood uric acid increased | 0.3 | 0.2 | 0.1 (-0.2, 0.3) |
Creatinine renal clearance decreased | 0.3 | 0.3 | 0.0 (-0.2, 0.2) |
Glycosylated hemoglobin increased | 0.1 | 0.2 | -0.1 (-0.3, 0.1) |
Weight decreased | 0.2 | 0.1 | 0.1 (-0.1, 0.3) |
Weight increased | 0.2 | 0.5 | -0.3 (-0.6, -0.0) |
Metabolism and nutrition disorders SOC | |||
Decreased appetite | 0.2 | 0.2 | 0.1 (-0.1, 0.3) |
Hyperglycemia | 0.1 | 0.2 | -0.1 (-0.4, 0.0) |
Hypoglycemia | 3.5 | 7.5 | -3.8 (-5.0, -2.8) |
Musculoskeletal and connective tissue disorders SOC | |||
Arthralgia | 0.2 | 0.2 | -0.0 (-0.3, 0.2) |
Muscle spasms | 0.1 | 0.2 | -0.1 (-0.3, 0.1) |
Myalgia | 0.1 | 0.2 | -0.1 (-0.3, 0.1) |
Nervous system disorders SOC | |||
Dizziness | 0.6 | 0.5 | 0.1 (-0.2, 0.4) |
Headache | 1.2 | 1.1 | 0.1 (-0.4, 0.6) |
Paraesthesia | 0.1 | 0.3 | -0.2 (-0.4, -0.0) |
Psychiatric disorders SOC | |||
Insomnia | 0.2 | 0.1 | 0.1 (-0.1, 0.3) |
Respiratory, thoracic, and mediastinal disorders SOC | |||
Cough | 0.2 | 0.1 | 0.0 (-0.2, 0.2) |
Skin and subcutaneous tissue disorders SOC | |||
Pruritus | 0.2 | 0.2 | -0.0 (-0.3, 0.2) |
Rash | 0.4 | 0.2 | 0.2 (-0.0, 0.5) |
Urticaria | 0.1 | 0.2 | -0.1 (-0.3, 0.1) |
Vascular disorders SOC | |||
Hypertension | 0.3 | 0.2 | 0.1 (-0.1, 0.3) |